Publications by authors named "Jie Lv"

225 Publications

A meta-analysis and systematic review of holmium laser treatment of bladder stones.

Transl Androl Urol 2021 Aug;10(8):3465-3475

Department of Urology, Luzhou People's Hospital, Luzhou, China.

Background: Holmium lasers have been used to treat bladder stones and achieve good therapeutic effects, but its efficacy remains to be explored.

Methods: The PubMed, Embase, Medline, Ovid, Springer, and Web of Sciences databases were searched from their establishment to December 31, 2020. Studies of randomized control trials (RCTs) examining the treatment of vesical calculi by holmium laser lithotripsy were identified. The Cochrane Handbook for Systematic Reviews of Intervention 5.0.2 was used to assess risk bias, and Rev Man5.3 was used to conduct the meta-analysis.

Results: A total of 10 studies, comprising 1,642 subjects, were included. The meta-analysis results showed that the surgery time and the hospitalization time of patients treated with holmium laser lithotripsy decreased, and the calculus removal rate increased. The experimental group had a lower incidence of adverse reactions, such as postoperative urinary tract infection, mucosal damage, vesical perforation, residual calculi, hematuria, and abdominal pain than the control group; however, no notable difference was observed in relation to surgery time, hospital stay, the calculus removal rate, mucosal damage, bladder perforation, hematuria, and abdominal pain between the 2 groups.

Discussion: Holmium laser lithotripsy significantly reduced the hospitalization time of patients treated with holmium laser lithotripsy and elevated the removal rate.
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http://dx.doi.org/10.21037/tau-21-563DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8421822PMC
August 2021

BRD4 inhibition protects against myocardial ischemia/reperfusion injury by suppressing inflammation and oxidative stress through PI3K/AKT signaling pathway.

J Cardiovasc Pharmacol 2021 Sep 8. Epub 2021 Sep 8.

Clinical Laboratory, Women & Children's Health Care Hospital of Linyi, Linyi 276000, Shandong, China Clinical Laboratory, Women & Children's Health Care Hospital of Gaoqing, Zibo 256300, Shandong, China Clinical Laboratory, Weifang Mental Health Center, Weifang 262400, Shandong, China Clinical Laboratory, People's Hospital of Rizhao, Rizhao 276800, Shandong, China.

Abstract: This study aims to investigate the effect and the related mechanisms of bromodomain containing protein 4 (BRD4) inhibition on myocardial ischemia/ reperfusion (I/R) injury. In vivo and in vitro myocardial I/R models were constructed. Expression of BRD4 was examined by RT-qPCR and Western blot. I/R injury was evaluated by analyzing cardiac function and the activity of biochemical markers of myocardial injury. Inflammation and oxidative stress were determined by measuring the levels of myeloperoxidase (MPO), TNF-α, IL-6, malondialdehyde (MDA) and superoxide dismutase (SOD). The activation of PI3K/AKT signaling pathway was tested by the phosphorylation of p85 and AKT. We found BRD4 was significantly increased in the myocardial tissues following myocardial I/R injury. BRD4 inhibition suppressed the indices of cardiac function and the biochemical markers of myocardial injury. I/R-induced inflammation and oxidative stress were suppressed by shBRD4 in vivo and in vitro. In addition, BRD4 inhibition significantly increased the relative protein expression levels of p-p85, p-AKT T308 and p-AKT S473. In conclusion, this study for the first time demonstrated the protective effect of BRD4 inhibition on myocardial I/R injury in vivo and in vitro, and this effect was related to the suppression of inflammation and oxidative stress through the activation of PI3K/AKT signaling pathway.
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http://dx.doi.org/10.1097/FJC.0000000000001138DOI Listing
September 2021

sp. nov., isolated from soil of Pu-erh tea cellar.

Int J Syst Evol Microbiol 2021 Sep;71(9)

Key Laboratory of Pu-er Tea Science, Ministry of Education, Yunnan Agricultural University, Kunming 650201, PR China.

A Gram-reaction-negative, yellow-pigmented, non-spore-forming rod, aerobic, motile bacterium, designated SJY3, was isolated from soil samples collected from a Pu-erh tea cellar in Bolian Pu-erh tea estate Co. Ltd. in Pu'er city, Yunnan, south-west China. Phylogenetic analysis based on 16S rRNA gene sequences showed that the isolate belonged to the genus . The closest phylogenetic relative was CICC 24458 (99.5 %), followed by CCUG45783 (97.9 %), CCUG43427A (97.8 %), and DSM 18055 (97.8 %). The major fatty acids were C and C 7 and/or C 6. The major respiratory quinone was ubiquinone Q-8 and the major polar lipids were diphosphatidylglycerol, phosphatidylglycerol, and phosphatidylethanolamine. Genome sequencing revealed a genome size of 5.97 M bp and a G+C content of 65.4 mol%. Pairwise determined whole genome average nucleotide identity (gANI) values and digital DNA-DNA hybridization (dDDH) values were all below the threshold. Although the 16S rRNA gene similarity of stain SJY3 and CICC 24458 was more than 99 %, the gANI, dDDH values and genomic tree clearly indicated that they were not of the same species. In summary, strain SJY3 represents a new species, for which we propose the name sp. nov. with the type strain SJY3 (=CGMCC 1.17158=KCTC 82193).
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http://dx.doi.org/10.1099/ijsem.0.004992DOI Listing
September 2021

Coordinated Approach Fusing RCMDE and Sparrow Search Algorithm-Based SVM for Fault Diagnosis of Rolling Bearings.

Sensors (Basel) 2021 Aug 5;21(16). Epub 2021 Aug 5.

School of Mechanical Engineering, Xinjiang University, Urumqi 830047, China.

We propose a novel fault-diagnosis approach for rolling bearings by integrating variational mode decomposition (VMD), refined composite multiscale dispersion entropy (RCMDE), and support vector machine (SVM) optimized by a sparrow search algorithm (SSA). Firstly, VMD was selected from various signal decomposition methods to decompose the original signal. Then, the signal features were extracted by RCMDE as the input of the diagnosis model. Compared with multiscale sample entropy (MSE) and multiscale dispersion entropy (MDE), RCMDE proved to be superior. Afterwards, SSA was used to search the optimal parameters of SVM to identify different faults. Finally, the proposed coordinated VMD-RCMDE-SSA-SVM approach was verified and evaluated by the experimental data collected by the wind turbine drivetrain diagnostics simulator (WTDS). The results of the experiments demonstrate that the proposed approach not only identifies bearing fault types quickly and effectively but also achieves better performance than other comparative methods.
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http://dx.doi.org/10.3390/s21165297DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8402100PMC
August 2021

Organocatalyst-controlled site-selective arene C-H functionalization.

Nat Chem 2021 Oct 9;13(10):982-991. Epub 2021 Aug 9.

Shenzhen Grubbs Institute and Department of Chemistry, Guangdong Provincial Key Laboratory of Catalysis, Southern University of Science and Technology, Shenzhen, China.

Over the past three decades, organocatalysis has emerged as a powerful catalysis platform and has gradually been incorporated into the routine synthetic toolbox to obtain chiral molecules. However, its application in the site- and enantioselective functionalization of inactive aryl C-H bonds remains in its infancy. Here, we present an organocatalyst-controlled para-selective arene C-H functionalization strategy that addresses this issue, which remains an enduring challenge in arene functionalization chemistry. By emulating enzyme catalysis, the chiral phosphoric acid catalyst offers an ideal chiral environment for stereoinduction, and the projecting substituents give control of chemo- and site-selectivity. Various types of nucleophile are compatible with this method, affording more than 100 para-selective adducts with stereodefined carbon centres or axes in viable molecular contexts. This protocol is expected to provide a general strategy for para-selective functionalization of arene C-H bonds in a controlled manner.
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http://dx.doi.org/10.1038/s41557-021-00750-xDOI Listing
October 2021

Biphasic GA 68-labeled prostate specific membrane antigen-11 positron emission tomography/computed tomography scans in the differential diagnosis and risk stratification of initial primary prostate cancer.

Quant Imaging Med Surg 2021 Aug;11(8):3619-3628

Department of Nuclear Medicine, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.

Background: This study aimed to assess the value of biphasic GA 68-labeled prostate-specific membrane antigen-11 (Ga-PSMA-11) positron emission tomography/computed tomography (PET/CT) scan in the differential diagnosis and risk stratification of initial primary prostate cancer (PCa).

Methods: A total of 51 patients with PCa (8 low- and intermediate-risk PCa patients and 43 high-risk PCa patients) and 36 patients with benign prostate lesions, who underwent standard whole-body imaging and delayed pelvic imaging of Ga-PSMA-11 PET/CT, were enrolled in this prospective study. The PET parameters, such as maximum and mean standard uptake value (SUVmax and SUVmean), and maximum and mean standard retention index of PET images were calculated and compared in different prostate lesions. The diagnostic performances of the PET parameters were evaluated by receiver operating characteristic (ROC) curves.

Results: All the PET parameters of PCa participants were significantly higher than those of participants with benign prostate lesions (P<0.001). The SUVmean of delayed imaging had the best performance in the diagnosis of PCa with an area under the curve (AUC) of 0.918 (95% CI: 0.858 to 0.977), the sensitivity of 90.0%, and specificity of 83.3%. The SUVmax and SUVmean of high-risk PCa participants were significantly higher than those of low- and intermediate-risk PCa participants (P<0.005). The SUVmax of standard imaging had the best performance in predicting high-risk PCa with an AUC of 0.890 (95% CI: 0.799 to 0.980), a sensitivity of 76.7%, and a specificity of 100.0%.

Conclusions: The biphasic Ga-PSMA-11 PET/CT scan had good performance in discriminating prostate cancer from benign prostate diseases. The SUVmean of the prostate lesion at delayed imaging of Ga-PSMA-11 PET/CT had the best value in the differential diagnosis of PCa, and the SUVmax at standard imaging was most valuable in predicting the risk stratification of PCa.
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http://dx.doi.org/10.21037/qims-20-1312DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8245961PMC
August 2021

Get ready for the CRISPR/Cas system: A beginner's guide to the engineering and design of guide RNAs.

J Gene Med 2021 Jul 16:e3377. Epub 2021 Jul 16.

Cancer Research Institute, School of Basic Medical Sciences, State Key Laboratory of Organ Failure Research, National Clinical Research Center of Kidney Disease, Key Laboratory of Organ Failure Research (Ministry of Education), Southern Medical University, Guangzhou, China.

The clustered regularly interspaced short palindromic repeats (CRISPR) system is a state-of-the-art tool for versatile genome editing that has advanced basic research dramatically, with great potential for clinic applications. The system consists of two key molecules: a CRISPR-associated (Cas) effector nuclease and a single guide RNA. The simplicity of the system has enabled the development of a wide spectrum of derivative methods. Almost any laboratory can utilize these methods, although new users may initially be confused when faced with the potentially overwhelming abundance of choices. Cas nucleases and their engineering have been systematically reviewed previously. In the present review, we discuss single guide RNA engineering and design strategies that facilitate more efficient, more specific and safer gene editing.
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http://dx.doi.org/10.1002/jgm.3377DOI Listing
July 2021

Pharmacokinetic bioequivalence, safety, and immunogenicity of GB222, a bevacizumab biosimilar candidate, and bevacizumab in Chinese healthy males: a randomized clinical trial.

Expert Opin Biol Ther 2021 Jul 26:1-10. Epub 2021 Jul 26.

Department of Pharmacy, Peking University People's Hospital, Beijing, China.

Background: This study was conducted to compare the similarity of the pharmacokinetics (PKs), safety, and immunogenicity of GB222, a potential bevacizumab biosimilar, to that of reference bevacizumab in Chinese healthy males.

Research Design And Methods: This was a randomized, double-blind, single-dose, parallel-group clinical trial performed in 84 Chinese healthy males, who were randomly assigned to receive a single infusion dose of 1 mg/kg GB222 or bevacizumab with an 84-days follow-up. The primary endpoint was the area under the plasma concentration-time curve (AUC) from zero to the last quantifiable concentration at time t (AUC). The second endpoints were the safety and immunogenicity evaluation. The PK bioequivalence was verified by the 90% confidence intervals (CIs) of the geometrical mean (GM) ratio for AUC falling within the bioequivalence margin, 80-125%.

Results: The PK profiles of GB222 and bevacizumab were comparable. The 90% CIs of GM ratio of GB222 to bevacizumab for AUC was within the pre-specified bioequivalence margin. The most common treatment-related adverse event was sinus bradycardia. Seventeen subjects (20.2%) tested positive for anti-drug antibodies (ADAs).

Conclusion: GB222 was found to be comparable to bevacizumab in terms of PKs, safety, and immunogenicity for Chinese healthy males.

Trial Registration: ChiCTR-IIR-17,011,143.
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http://dx.doi.org/10.1080/14712598.2021.1954157DOI Listing
July 2021

Devosia sediminis sp. nov., isolated from subterranean sediment.

Arch Microbiol 2021 Sep 19;203(7):4517-4523. Epub 2021 Jun 19.

College of Life Science and Technology, Beijing University of Chemical Technology, Beijing, 100029, China.

A novel Gram-negative, cream-colored, rod-shaped, aerobic, non-motile bacterium, designated MSA67, was isolated from a subterranean sediment sample of the Mohe Basin in Northeast China. Strain MSA67 was detected to grow at 4-40 °C (optimum 28-30 °C), pH 5.0-10.0 (optimum, pH 7.0) and in 0.0-8.0% (w/v) NaCl (optimum 2.0-3.0%). Phylogenetic analysis based on 16S rRNA gene sequence revealed that strain MSA67 was a member of the genus Devosia, with the highest similarity with D. riboflavina IFO13584 (98.0%) and D. chinhatensis IPL18 (97.0%). The major cellular fatty acids are C, Cω7c 11-methyl and Cω6c and/or Cω7c. The major polar lipids are diphosphatidylglycerol, phosphatidylglycerol, glycolipids and three unidentified phospholipids. The major respiratory quinone is ubiquinone 10 (Q-10). The genomic size of strain MSA67 is 4.1 MB and DNA G + C content is 63.6%. Based on genotypic, phenotypic and phylogenetic results, strain MSA67 is concluded to represent a novel species of the genus Devosia, for which the name Devosia sediminis sp. nov. is proposed. The type strain is MSA67 (= CGMCC 1.18467 = KCTC 82192).
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http://dx.doi.org/10.1007/s00203-021-02448-7DOI Listing
September 2021

No correlation between acetylcholine receptor antibody concentration and individual clinical symptoms of myasthenia gravis: A systematic retrospective study involving 67 patients.

Brain Behav 2021 07 2;11(7):e02203. Epub 2021 Jun 2.

Department of Neuroimmunology, Henan Institute of Medical and Pharmaceutical Sciences, Zhengzhou University, Zhengzhou, China.

Objective: To investigate the correlation between acetylcholine receptor antibodies (AChR-Ab) concentration levels and individualized clinical symptoms in patients with AChR myasthenia gravis (AChR-MG) in China.

Methods: ELISA was used to determine the concentration of AChR-Ab in patients with MG. The Myasthenia Gravis Foundation of America (MGFA) Clinical Classification, Quantitative Myasthenia Gravis (QMG) score, and MG-specific activities of daily living (MG-ADL) scoring systems were used to evaluate the clinical status of patients. Spearman correlation analysis was used to determine the correlation between the AChR-Ab concentration and clinical score. The changes in the antibody concentration and clinical score are shown in MGFA-antibody concentration-treatment plots.

Results: Autoantibody detection tests were performed in 67 patients, and their clinical scores were recorded. Forty-nine patients received immunosuppressive therapy, 17 patients received pyridostigmine only, and 1 patient under thymectomy without any medication. The AChR-Ab concentration correlated with the MGFA Classification in 5 (29.4%) patients in the pyridostigmine-only group and 15 (30.6%) patients in the immunosuppressive drug group. The changes in the MGFA Classification preceded the changes in the AChR-Ab concentration in 4 (23.5%) patients treated with pyridostigmine and 10 (20.4%) patients on immunosuppressive drugs. In patients on oral non-steroidal immunosuppressants, the AChR-Ab concentration changed by more than 50%, whereas the MGFA Classification did not increase. The AChR-Ab concentration decreased in 17/32 (53.1%) patients after thymectomy, and then increased, whereas the AChR-Ab concentration increased in 15/32 (46.9%) patients and the MGFA Classification decreased in 27/32 (81.8%) patients after thymectomy. The AChR-Ab concentration presented a slight correlation with the corresponding MGFA, QMG, and MG-ADL in patients with thymoma.

Discussion: In the Chinese AChR-MG population, the Changes in the AChR-Ab concentration in individuals with AChR-MG did not consistently correlate with the severity of clinical symptoms.
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http://dx.doi.org/10.1002/brb3.2203DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8323040PMC
July 2021

Phenylethanoid Glycosides Induce Apoptosis of Hepatocellular Carcinoma Cells by Mitochondria-Dependent and MAPK Pathways and Enhance Antitumor Effect through Combination with Cisplatin.

Integr Cancer Ther 2021 Jan-Dec;20:15347354211013085

Xinjiang University, Urumqi, Xinjiang, China.

is a type of Chinese herbal medicine and exerts various biological functions. Previous studies have been demonstrated that phenylethanoid glycosides (CTPG) exhibit antitumor effects on a variety of tumor cells. However, the antitumor effects of CTPG on HepG2 and BEL-7404 hepatocellular carcinoma (HCC) cells are still elusive. Our study showed that CTPG significantly inhibited the growth of HepG2 and BEL-7404 cells through the induction of cell cycle arrest and apoptosis, which was associated with the activation of MAPK pathways characterized by the up-regulated phosphorylation of p38, JNK, and ERK1/2 and mitochondria-dependent pathway characterized by the reduction of mitochondrial membrane potential. The release of cytochrome and the cleavage of caspase-3, -7, -9, and PARP were subsequently increased by CTPG treatment. Moreover, CTPG significantly suppressed the migration of HepG2 through reducing the levels of matrix metalloproteinase-2 and vascular endothelial growth factor. Interestingly, CTPG not only enhanced the proliferation of splenocytes but also reduced the apoptosis of splenocytes induced by cisplatin. In H22 tumor mouse model, CTPG combined with cisplatin further inhibited the growth of H22 cells and reduced the side effects of cisplatin. Taken together, CTPG inhibited the growth of HCC through direct antitumor effect and indirect immunoenhancement effect, and improved the antitumor efficacy of cisplatin.
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http://dx.doi.org/10.1177/15347354211013085DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8113936PMC
October 2021

The correlation between tumor-associated macrophage infiltration and progression in cervical carcinoma.

Biosci Rep 2021 05;41(5)

State Key Laboratory of Pathogenesis, Prevention and Treatment of High Incidence Diseases in Central Asia, Clinical Laboratory Center, Tumor Hospital Affiliated to Xinjiang Medical University, Urumqi 830011, China.

Tumor microenvironment (TME) plays a particularly important role in the progression, invasion and metastasis of cervical carcinoma (CC). Tumor-associated macrophages (TAMs) are significant components of the tumor microenvironment in CC. However, the results of studies on the correlation between TAMs and progression in CC are still controversial. This research aimed to investigate the relationship between TAMs infiltration and progression in CC. A total of 100 patients with CC were included in the study. The correlation between TAMs and clinicopathologic features was studied. Besides, a systematic literature search was conducted from legitimate electronic databases to specifically evaluate the role of TAMs in TME of cervical carcinoma. In the meta-analysis, high stromal CD68+ TAMs density was relevant to lymph node metastasis (WMD = 11.89, 95% CI: 5.30-18.47). At the same time, CD163+ M2 TAM density was associated with lymph node metastasis (OR = 2.42, 95% CI: 1.09-5.37; WMD = 39.37, 95% CI: 28.25-50.49) and FIGO stage (WMD = -33.60, 95% CI: -45.04 to -22.16). This was further confirmed in the experimental study of 100 tissues of cervical cancer. It supported a critical role of TAMs as a prospective predictor of cervical cancer. In conclusion, CD68+ TAM and CD163+ M2 TAM infiltration in CC were associated with tumor progression. And CD163+ M2 TAM infiltration was associated with more advanced FIGO stage and lymph node metastasis in CC.
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http://dx.doi.org/10.1042/BSR20203145DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8493445PMC
May 2021

15.3% Efficiency All-Small-Molecule Organic Solar Cells Achieved by a Locally Asymmetric F, Cl Disubstitution Strategy.

Adv Sci (Weinh) 2021 Apr 22;8(8):2004262. Epub 2021 Feb 22.

Chongqing Institute of Green and Intelligent Technology Chongqing School University of Chinese Academy of Sciences (UCAS Chongqing) Chinese Academy of Sciences Chongqing 400714 China.

Single junction binary all-small-molecule (ASM) organic solar cells (OSCs) with power conversion efficiency (PCE) beyond 14% are achieved by using non-fullerene acceptor Y6 as the electron acceptor, but still lag behind that of polymer OSCs. Herein, an asymmetric Y6-like acceptor, BTP-FCl-FCl, is designed and synthesized to match the recently reported high performance small molecule donor BTR-Cl, and a record efficiency of 15.3% for single-junction binary ASM OSCs is achieved. BTP-FCl-FCl features a F,Cl disubstitution on the same end group affording locally asymmetric structures, and so has a lower total dipole moment, larger average electronic static potential, and lower distribution disorder than those of the globally asymmetric isomer BTP-2F-2Cl, resulting in improved charge generation and extraction. In addition, BTP-FCl-FCl based active layer presents more favorable domain size and finer phase separation contributing to the faster charge extraction, longer charge carrier lifetime, and much lower recombination rate. Therefore, compared with BTP-2F-2Cl, BTP-FCl-FCl based devices provide better performance with FF enhanced from 71.41% to 75.36% and increased from 22.35 to 24.58 mA cm, leading to a higher PCE of 15.3%. The locally asymmetric F, Cl disubstitution on the same end group is a new strategy to achieve high performance ASM OSCs.
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http://dx.doi.org/10.1002/advs.202004262DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8061398PMC
April 2021

VEGF-C/VEGFR-3/iNOS Signaling in Osteosarcoma MG63 Cells Mediates Stimulatory Effects on Human Umbilical Vein Endothelial Cell Proliferation.

Chin Med Sci J 2021 Mar;36(1):35-42

Department of Orthopaedics, the Second Hospital of Shanxi Medical University, Taiyuan 030001, China.

Objective To assess the effects of vascular endothelial growth factor-C (VEGF-C)/vascular endothelial growth factor receptor-3 (VEGFR-3) signaling on nitric oxide (NO) production and inducible nitric oxide synthase (iNOS) expression in human osteosarcoma MG63 cells and the subsequent impact on the proliferation of human umbilical vein endothelial cells (HUVECs). MethodsMG63 cells were treated with VEGF-C alone (VEGF-C group), VEGF-C + iNOS inhibitor aminoguanidine (AG; AG group), and VEGF-C + VEGFR-3 inhibitor MAZ51 (MAZ51 group); untreated MG63 cells were used as controls. NO production was evaluated by a colorimetric method involving nitrate reductase. Meanwhile, mRNA and protein levels of iNOS were examined by reverse transcription polymerase chain reaction (RT-PCR) and Western blot. To explore the effect of VEGF-C/VEGFR-3/iNOS signaling of MG63 cells on proliferation of HUVECs, we set up six groups: HUVECs, HUVECs+MG63, HUVECs+VEGF-C, HUVECs+MG63+VEGF-C, HUVECs+MG63+VEGF-C+AG, and HUVECs+MG63+VEGF-C+MAZ51 groups. The proliferation of HUVEC cells was assessed by Cell Counting Kit-8 (CCK-8), 5-ethynyl-2'-deoxyuridine (EdU) incorporation assay, and proliferating cell nuclear antigen (PCNA) expression quantitation. ResultsVEGF-C treatment enhanced iNOS expression at both gene and protein levels (mRNA: LSD-=4.152, ; protein: LSD-=3.486, ) and increased NO release of MG63 cells (LSD-=3.774, ); treatment with either AG or MAZ51 decreased these effects (mRNA: LSD-=9.183, <0.001; LSD-=8.639, <0.001; protein: LSD-=5.170, <0.001; LSD-=7.255, <0.001; NO production:LSD-=10.326, <0.001; LSD-=10.540, <0.001). Interestingly, co-incubation of HUVECs with MG63 cells and/or VEGF-C significantly promoted HUVEC proliferation (EdU: LSD-=5.374, 0.001; LSD-=2.984, 0.05; LSD-=8.526, 0.001; PCNA: LSD-=9.267, <0.001; LSD-=5.515, 0.001; LSD-=14.873, 0.001).The proliferation effects of HUVEC induced by MG63 cells and VEGF-C attenuated by the treatment of AG (EdU: LSD-=10.770, 0.001; PCNA: LSD-=19.940, <0.001) or MAZ51 (EdU: LSD-=6.950, 0.001; PCNA: LSD-=14.001, <0.001). ConclusionIn human osteosarcoma MG63 cells, activation of VEGFR-3 by VEGF-C promotes iNOS expression and NO production, which subsequently induces HUVEC proliferation.
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http://dx.doi.org/10.24920/003753DOI Listing
March 2021

9,10-Anhydrodehydroartemisinin Attenuates Experimental Autoimmune Encephalomyelitis by Inhibiting Th1 and Th17 Cell Differentiation.

Inflammation 2021 Oct 31;44(5):1793-1802. Epub 2021 Mar 31.

Putuo People's Hospital, Shanghai Key Laboratory of Signaling and Disease Research, School of Life Sciences and Technology, Tongji University, Shanghai, 200092, China.

Human inflammatory disease, multiple sclerosis (MS), is a demyelinating disease of central nervous system (CNS). The experimental autoimmune encephalomyelitis (EAE) is the most commonly used as experimental model because of its key pathological features' approximation of MS. The interaction between complex elements in immune system and in the CNS determines the MS pathogenesis. However, there is no cure for MS and the treatment for MS still encounters great challenges. Thus, finding a more effective disease-modifying treatment is imminent. In the present study, we investigated whether 9,10-Anhydrodehydroartemisin (ADART), a compound derived from artemisinin, could decrease demyelination in EAE and the underlying mechanisms. In established EAE mice, 100 mg/kg 9,10-Anhydrodehydroartemisinin (ADART) effectively reduced CNS and peripheral immune system infiltration inflammatory cells including CD4 IFN-γ Th1 cells and CD4 IL-17A Th17 cells. Correspondingly, the serum level of IFN-γ and IL-17A was also reduced. In vitro, ADART almost completely inhibited Th17 differentiation, and partially inhibited Th1 differentiation in 10 μM. This research revealed that ADART could be a great promising avenue among current therapies for MS.
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http://dx.doi.org/10.1007/s10753-021-01456-5DOI Listing
October 2021

MiniCAFE, a CRISPR/Cas9-based compact and potent transcriptional activator, elicits gene expression in vivo.

Nucleic Acids Res 2021 04;49(7):4171-4185

Cancer Research Institute, School of Basic Medical Sciences, Southern Medical University, Guangzhou 510515, China.

CRISPR-mediated gene activation (CRISPRa) is a promising therapeutic gene editing strategy without inducing DNA double-strand breaks (DSBs). However, in vivo implementation of these CRISPRa systems remains a challenge. Here, we report a compact and robust miniCas9 activator (termed miniCAFE) for in vivo activation of endogenous target genes. The system relies on recruitment of an engineered minimal nuclease-null Cas9 from Campylobacter jejuni and potent transcriptional activators to a target locus by a single guide RNA. It enables robust gene activation in human cells even with a single DNA copy and is able to promote lifespan of Caenorhabditis elegans through activation of longevity-regulating genes. As proof-of-concept, delivered within an all-in-one adeno-associated virus (AAV), miniCAFE can activate Fgf21 expression in the liver and regulate energy metabolism in adult mice. Thus, miniCAFE holds great therapeutic potential against human diseases.
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http://dx.doi.org/10.1093/nar/gkab174DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8053112PMC
April 2021

Exploration and validation of related hub gene expression during SARS-CoV-2 infection of human bronchial organoids.

Hum Genomics 2021 03 16;15(1):18. Epub 2021 Mar 16.

Department of Clinical Laboratory Medicine, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510150, China.

Background: In the novel coronavirus pandemic, the high infection rate and high mortality have seriously affected people's health and social order. To better explore the infection mechanism and treatment, the three-dimensional structure of human bronchus has been employed in a better in-depth study on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Methods: We downloaded a separate microarray from the Integrated Gene Expression System (GEO) on a human bronchial organoids sample to identify differentially expressed genes (DEGS) and analyzed it with R software. After processing with R software, Gene Ontology (GO) and Kyoto PBMCs of Genes and Genomes (KEGG) were analyzed, while a protein-protein interaction (PPI) network was constructed to show the interactions and influence relationships between these differential genes. Finally, the selected highly connected genes, which are called hub genes, were verified in CytoHubba plug-in.

Results: In this study, a total of 966 differentially expressed genes, including 490 upregulated genes and 476 downregulated genes were used. Analysis of GO and KEGG revealed that these differentially expressed genes were significantly enriched in pathways related to immune response and cytokines. We construct protein-protein interaction network and identify 10 hub genes, including IL6, MMP9, IL1B, CXCL8, ICAM1, FGF2, EGF, CXCL10, CCL2, CCL5, CXCL1, and FN1. Finally, with the help of GSE150728, we verified that CXCl1, CXCL8, CXCL10, CCL5, EGF differently expressed before and after SARS-CoV-2 infection in clinical patients.

Conclusions: In this study, we used mRNA expression data from GSE150819 to preliminarily confirm the feasibility of hBO as an in vitro model to further study the pathogenesis and potential treatment of COVID-19. Moreover, based on the mRNA differentiated expression of this model, we found that CXCL8, CXCL10, and EGF are hub genes in the process of SARS-COV-2 infection, and we emphasized their key roles in SARS-CoV-2 infection. And we also suggested that further study of these hub genes may be beneficial to treatment, prognostic prediction of COVID-19.
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http://dx.doi.org/10.1186/s40246-021-00316-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7962432PMC
March 2021

Effects of propofol on cardiac function and miR-494 expression in rats with hepatic ischemia/reperfusion injury.

J Int Med Res 2021 Mar;49(3):300060521990988

Department of Hepatobiliary Surgery, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China.

Objective: This study aimed to investigate the effects of propofol on cardiac function and miR-494 expression in rats with hepatic ischemia/reperfusion (I/R) injury.

Methods: Forty healthy adult male Sprague-Dawley rats were allocated to the sham operation group and three hepatic I/R injury groups. The I/R injury groups included I/R injury only (I/R group), treatment with propofol (propofol group), and treatment with propofol + overexpressed miR-494 (propofol+miR-494 group). Apoptosis of myocardial cells and changes in cardiac function indices, including left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and left ventricular posterior wall thickness, as well as changes in miR-494, were monitored.

Results: The apoptotic rate of myocardial cells in the I/R group was higher, cardiac function was deteriorated, and miR-494 levels were elevated compared with the sham group. The apoptotic rate was lower, cardiac function was improved, and miR-494 levels were suppressed in the propofol group compared with the I/R group. The apoptotic rate was higher, cardiac function was deteriorated, and miR-494 levels were elevated in the propofol+miR-494 group compared with the propofol group.

Conclusion: Propofol plays a vital role in preventing myocardial cell apoptosis and improvement of cardiac function by suppressing miR-494 in a hepatic I/R injury rat model.
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http://dx.doi.org/10.1177/0300060521990988DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7944537PMC
March 2021

MACMIC Reveals A Dual Role of CTCF in Epigenetic Regulation of Cell Identity Genes.

Genomics Proteomics Bioinformatics 2021 Feb 5;19(1):140-153. Epub 2021 Mar 5.

Center for Bioinformatics and Computational Biology, Department of Cardiovascular Sciences, Institute for Academic Medicine, Houston Methodist Research Institute, Houston, TX 77030, USA; Center for Cardiovascular Regeneration, Department of Cardiovascular Sciences, Institute for Academic Medicine, Houston Methodist Research Institute, Houston, TX 77030, USA; Department of Cardiothoracic Surgeries, Weill Cornell Medical College, Cornell University, New York, NY 10065, USA; Houston Methodist Institute for Academic Medicine, Houston Methodist Research Institute, Houston, TX 77030, USA; Basic and Translational Research Division, Department of Cardiology, Boston Children's Hospital, Boston, MA 02115, USA; Department of Pediatrics, Harvard Medical School, Boston, MA 02115, USA. Electronic address:

Numerous studies of relationship between epigenomic features have focused on their strong correlation across the genome, likely because such relationship can be easily identified by many established methods for correlation analysis. However, two features with little correlation may still colocalize at many genomic sites to implement important functions. There is no bioinformatic tool for researchers to specifically identify such feature pairs. Here, we develop a method to identify feature pairs in which two features have maximal colocalization minimal correlation (MACMIC) across the genome. By MACMIC analysis of 3306 feature pairs in 16 human cell types, we reveal a dual role of CCCTC-binding factor (CTCF) in epigenetic regulation of cell identity genes. Although super-enhancers are associated with activation of target genes, only a subset of super-enhancers colocalized with CTCF regulate cell identity genes. At super-enhancers colocalized with CTCF, CTCF is required for the active marker H3K27ac in cell types requiring the activation, and also required for the repressive marker H3K27me3 in other cell types requiring repression. Our work demonstrates the biological utility of the MACMIC analysis and reveals a key role for CTCF in epigenetic regulation of cell identity. The code for MACMIC is available at https://github.com/bxia888/MACMIC.
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http://dx.doi.org/10.1016/j.gpb.2020.10.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8498966PMC
February 2021

Simultaneous adsorption and determination of bisphenol compounds in water medium with a Zr(IV)-based metal-organic framework.

Mikrochim Acta 2021 02 14;188(3):83. Epub 2021 Feb 14.

Institute of Quality Standards and Testing Technology for Agro-products, Chinese Academy of Agricultural Sciences, Beijing, 100081, People's Republic of China.

A chemically stable Zr(IV)-based metal-organic framework (BUT-17) has been explored for simultaneous adsorption and determination of bisphenol compounds (BPs) in aqueous medium. The prepared BUT-17 possesses a large surface area (2936 m g) and excellent fluorescent performance. An adsorption capacity of 111 mg g for bisphenol A (BPA) with a rapid adsorption rate (1.76 g mg min) is achieved by BUT-17. The excellent adsorption performance could be attributed to the hydrogen bond interaction between BPs and BUT-17. Furthermore, the fluorescent intensity of BUT-17 was quenched up to 92% due to the formation of complexes between BPs and BUT-17. Thus, a BUT-17-based fluorescent sensing method for the rapid determination of BPs has been established with the limit of detection of 10.0 ng mL for BPA and a linear range from 2.0 to 23.0 μg mL. These results indicate that as an outstanding multifunctional platform, BUT-17 is promising for the simultaneous removal and determination of BPs in water medium. Simultaneous removal and detection of BPs with BUT-17.
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http://dx.doi.org/10.1007/s00604-021-04742-zDOI Listing
February 2021

The role of regulatory B cells in Echinococcus granulosus-infected mice.

Parasitol Res 2021 Apr 1;120(4):1389-1404. Epub 2021 Feb 1.

State Key Laboratory of Pathogenesis, Prevention and Treatment of High Incidence Diseases in Central Asia, First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830000, China.

To investigate the phenotypic changes of the expression level of regulatory B cells and related molecules during the continuous infection of Echinococcus granulosus (E. granulosus) in mice and its relationship with E. granulosus infection and its immune effect. Experimental group mice were inoculated with protoscoleces suspension via intraperitoneally injection to prepare a mouse model of E. granulosus infection. Flow cytometry was used to detect the expression of regulatory B cells CD1dCD5CD19 cells and CD1dCD5CD19 IL-10 cells in spleen and peripheral blood of mice. The expressions of IL-10 and TGF-β1 in mouse serum were detected via ELISA. The liver pathological changes in mice were observed by H&E staining; Moreover, the expressions and distribution of IL-10 and TGF-β1 in mice liver were measured through immunohistochemistry. The ELISA test results showed no significant changes in serum IL-10 and TGF-β1 levels in early infected mice. However, at the middle and late stages of infection, the levels of IL-10 and TGF-β1 in the serum of mice increased significantly (P < 0.05). The proportion of CD1dCD5CD19Breg cells and the proportion of CD1dCD5CD19IL-10Breg cells in the spleen of mice infected with E. granulosus were increased at 90 days after infection, which indicating that Breg cells proliferated in the late stage of infection. CD1dCD5CD19 regulatory B cells may be one of the causes of immunosuppression of E. granulosus infection. It is speculated that Bregs inhibitory effect may play a role by regulating the expression of cytokines and inducing the secretion of inhibitory cytokines IL-10 and TGF-β1.
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http://dx.doi.org/10.1007/s00436-020-07025-3DOI Listing
April 2021

Colorimetric determination of amyloid-β peptide using MOF-derived nanozyme based on porous ZnO-CoO nanocages.

Mikrochim Acta 2021 01 27;188(2):56. Epub 2021 Jan 27.

College of Pharmacy, Hebei Medical University, Shijiazhuang, 050017, China.

A sensitive and rapid colorimetric biosensor has been developed for determination of amyloid-β peptide (Aβ) and study of amyloidogenesis based on the high peroxidase-like activity of porous bimetallic ZnO-CoO nanocages (NCs). Due to the high binding ability of Aβ monomer to ZnO-CoO NCs, the catalytic activity of ZnO-CoO NCs can be significantly suppressed by Aβ monomer. This finding forms the basis for a colorimetric assay for Aβ monomer detection. The detection limit for Aβ monomer is 3.5 nM with a linear range of 5 to 150 nM (R = 0.997). The system was successfully applied to the determination of Aβ monomer in rat cerebrospinal fluid. Critically, the different inhibition effects of monomeric and aggregated Aβ species on the catalytic activity of ZnO-CoO NCs enabled the sensor to be used for tracking the dynamic progress of Aβ aggregation and screening Aβ inhibitors. Compared with the commonly used thioflavin T fluorescence assay, this method provided higher sensitivity to the formation of Aβ oligomer at the very early assembly stage. Our assay shows potential application in early diagnosis and therapy of Alzheimer's disease (AD).
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http://dx.doi.org/10.1007/s00604-021-04705-4DOI Listing
January 2021

A four-bar knee joint measurement walking system for prosthesis design.

Technol Health Care 2021 ;29(4):823-828

Shanghai University of Medicine and Health Sciences, Shanghai, China.

Background: Gait analysis is important for the lower limb prosthesis design. Simulating the natural motion of the human knee in different terrains is useful for the design and performance assessment of the prosthetic knee.

Objective: This study aimed to propose a four-bar knee joint measurement system which can simulate the natural knee motions to collect the kinetic parameters precisely and analyze the walking characteristics under different terrain conditions.

Methods: A low-cost four-bar knee joint mechanism was proposed and gait characteristics were assessed on level ground, ascending and descending stairs, and ascending and descending ramp.

Results: The initial knee flexion angle during stair ascent at heel strike is obviously larger than in other walking scenes. The stance phase accounts for 53% of a single gait cycle during stair descent, which is slightly lower than other walking scenarios. The period that both the hindfoot and forefoot contact the ground in ramp descent accounts for 18%, which is less than for the others. While the forefoot contacts the ground in ramp ascent, the maximum vertical ground reaction force of the forefoot occurs when the hindfoot and forefoot simultaneously contact the ground, whereas in other scenarios the forefoot contacts the ground solely.

Conclusions: The four-bar knee joint can simulate the natural motion of the human knee accurately. The gait characteristics analysis of different walking scenarios indicated that the low-cost four-bar knee joint exoskeleton was suitable for human knee joint simulation.
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http://dx.doi.org/10.3233/THC-202667DOI Listing
September 2021

Peripheral blood hsa-circRNA5333-4: A novel biomarker for myasthenia gravis.

Clin Immunol 2021 03 17;224:108676. Epub 2021 Jan 17.

Department of Neuroimmunology, BGI College & Henan Institute of Medical and Pharmaceutical Sciences in Academy of Medical Science, Zhengzhou University, Zhengzhou 450052, China. Electronic address:

In this study, the potential of specific Circular RNAs (circRNAs) as novel peripheral blood biomarkers for myasthenia gravis (MG) was explored. We analyzed circRNAs in the peripheral blood of three normal controls and three MG patients using RNA microarray. Candidate circRNAs were validated in three independent cohorts by Quantitative Real-time polymerase chain reaction (qPCR). Eleven differentially expressed circRNAs were initially identified and four were confirmed in the first independent cohort. Hsa_circ_0076490 and hsa-circ_5333-4 had the largest areas under the curve (AUCs) of the receiver operating characteristics (ROC) and were validated in the second cohort. In the third cohort, hsa-circRNA5333-4 had a larger AUC: 0.864 (95% confidence interval [CI] = 0.801-0.928, P < 0.001), a stronger correlation with the Quantitative Myasthenia Gravis Score (qMG): r = 0.505 (P < 0.001) and was correlated with gender and acetylcholine receptor antibody levels (P < 0.05). So hsa-circRNA5333-4 represents a novel biomarker for the diagnosis and monitoring of MG.
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http://dx.doi.org/10.1016/j.clim.2021.108676DOI Listing
March 2021

Study on the relationship between CXCR3 and its ligands and tubal tuberculosis.

Life Sci 2021 May 14;272:119047. Epub 2021 Jan 14.

State Key Laboratory of Pathogenesis, Prevention and Treatment of High Incidence Diseases in Central Asia, Clinical Laboratory Center, Tumor Hospital Affiliated to Xinjiang Medical University, Urumqi 830000, China. Electronic address:

Objective: Chemokines play an important role in Mycobacterium tuberculosis infection. We aimed to investigate CXCR3, CXCL9, CXCL10 and CXCL11 to explore the correlation between the severity of tubal tuberculosis and chemokines.

Methods: 26 patients with tubal tuberculosis diagnosed in our hospital from 2016 to 2019 were selected as the experimental group, and 18 female patients who underwent high-risk pregnancy supervision in our hospital from 2016 to 2018 were selected as the control group. The pathological manifestations of tubal tuberculosis were observed by HE staining, the expressions of CXCR3 and its ligands in fallopian tubes were detected by immunohistochemistry.

Results: Typical granulomatous structure of tubal tuberculosis was observed by HE staining and most of them were accompanied by massive necrosis in the experimental group, while no granulomatous lesions were found in the control group. The results of immunohistochemical staining showed that CXCR3 and its ligands were expressed in the cytoplasm and nucleus of oviduct epithelial cells and inflammatory cells, in the granuloma area. CXCL9, CXCL10 and CXCL11 were related to the severity of the disease.

Key Findings: CXCR3 and its ligands were positively expressed in tubal tuberculosis, especially CXCL9, CXCL10 and CXCL11 were positively correlated with the severity of fallopian tube disease.

Significance: It is helpful for clinical diagnosis and treatment detection, and provides a new therapeutic target for the study of female genital tuberculosis in the future.
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http://dx.doi.org/10.1016/j.lfs.2021.119047DOI Listing
May 2021

Effective Removal of Clenbuterol and Ractopamine from Water with a Stable Al(III)-Based Metal-Organic Framework.

Inorg Chem 2021 Feb 14;60(3):1814-1822. Epub 2021 Jan 14.

Beijing Key Laboratory for Green Catalysis and Separation and Department of Environmental Chemical Engineering, College of Environmental and Chemical Engineering, Beijing University of Technology, Beijing 100124, P. R. China.

Clenbuterol (CLE) and ractopamine (RAC) are two kinds of typical β-adrenergic agonists which pose a serious threat to the health of human beings. In this work, 10 kinds of metal-organic frameworks (MOFs) with high stability and various pore features are screened to assess adsorption performance for CLE and RAC. An Al(III)-MOF (BUT-19) with abundant ethyl groups exhibits exceptional performance in removing CLE and RAC from water. The maximum adsorption capacity for CLE and RAC are up to 294.1 and 366.3 mg/g under the optimum adsorption conditions, respectively. Meanwhile, the adsorption mechanism effects of pH, temperature, and coexisted ions are investigated systematically. It is found that the MOF pore size and weak hydrogen-bond interactions between CLE/RAC molecules and the MOF are the main causes leading to the extraordinary adsorption. This study provides a new idea for the purposeful design and synthesis of MOFs for removing environmental pollutants and sheds light on the depuration of contaminated water.
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http://dx.doi.org/10.1021/acs.inorgchem.0c03296DOI Listing
February 2021

Puerhibacterium puerhi gen. nov., sp. nov., a novel member of the family Promicromonosporaceae, isolated from Pu-erh tea pile-fermentation.

Arch Microbiol 2021 May 4;203(4):1509-1518. Epub 2021 Jan 4.

Key Laboratory of Pu-Er Tea Science, Ministry of Education, Yunnan Agricultural University, Kunming, 650201, China.

A Gram-staining positive aerobic bacterium, designated TLY-12, was isolated from the Pu-erh tea pile-fermentation process in Pu'er city, Yunnan, China. Strain TLY-12 grew at 15-37 °C (optimum, 30 °C), pH 6.0-11.0 (optimum, pH 9.0) and 0-9.0% (w/v) NaCl (optimum, 3.0%). The major cellular fatty acids were anteiso-C, C and iso-C. The respiratory quinone were menaquinones MK-9 (H) and MK-9 (H). The polar lipids were phosphatidylglycerol (PG), diphosphatidylglycerol (DPG), phosphatidylinositol (PI), phosphoglycolipid (PGL), glycolipid (GL) and an unidentified phospholipid (PL). The peptidoglycan contained glutamic acid, aspartic acid, alanine and lysine, with the last named being the diagnostic diamino acid. Whole-cell sugars of the isolate were ribose, galactose and glucose. Phylogenetic analyses of 16S rRNA gene showed that this strain belonged to the family Promicromonosporaceae, and was most closely related to Isoptericola cucumis DSM 101603, which gave sequence similarity of 97.9%. Genome sequencing revealed a genome size of 3.91 Mbp and a G + C content of 75.0%. Average nucleotide identity and digital DNA-DNA hybridization values were all below the species threshold of described Promicromonosporaceae species. Genome phylogenetic analysis showed that strain TLY-12 formed a separate evolutionary branch, and was parallel to other related genera of Promicromonosporaceae. Based on the phylogenetic, phenotypic, chemotaxonomic and genome pairwise data, strain TLY-12 is considered to represent a novel species in a new genus in the family Promicromonosporaceae, for which the name Puerhibacterium puerhi gen. nov, sp. nov. is proposed. The type strain is TLY-12 (= CGMCC 1.17157 = KCTC 49467).
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http://dx.doi.org/10.1007/s00203-020-02151-zDOI Listing
May 2021

Paenibacillus puerhi sp. nov., isolated from the rhizosphere soil of Pu-erh tea plants (Camellia sinensis var. assamica).

Arch Microbiol 2021 May 2;203(4):1375-1382. Epub 2021 Jan 2.

Key Laboratory of Pu-er Tea Science, Ministry of Education, Yunnan Agricultural University, Kunming, 650201, China.

An aerobic, Gram-staining-positive, rod-shaped, endospore-forming and motile bacterial strain, designated SJY2, was isolated from the rhizosphere soil of tea plants (Camellia sinensis var. assamica) collected in the organic tea garden of the Jingmai Pu-erh tea district in Pu'er city, Yunnan, southwest China. Phylogenetic analysis based on 16S rRNA gene sequences showed that the isolate belonged to the genus Paenibacillus. The closest phylogenetic relative was Paenibacillus filicis DSM 23916 (98.1% similarity). The major fatty acids (> 10% of the total fatty acids) were anteiso-C and isoC. The major respiratory quinone was MK-7 and the major polar lipid was diphosphatidylglycerol, phosphatidylglycerol, phosphatidylethanolamine and phosphatidylmonomethylethanolamine. The peptidoglycan contained glutamic acid, serine, alanine and meso-diaminopimelic acid. Genome sequencing revealed a genome size of 6.71 Mbp and a G + C content of 53.1%. Pairwise determined whole genome average nucleotide identity (gANI) values and digital DNA-DNA hybridization (dDDH) values suggested that strain SJY2 represents a new species, for which we propose the name Paenibacillus puerhi sp. nov. with the type strain SJY2 (= CGMCC 1.17156 = KCTC 43242).
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http://dx.doi.org/10.1007/s00203-020-02135-zDOI Listing
May 2021

Safety and tolerability of a humanized rabbit monoclonal antibody (SSS07) in healthy adults: Randomized double-blind placebo-controlled single ascending dose trial.

Int Immunopharmacol 2021 Feb 28;91:107263. Epub 2020 Dec 28.

Phase I Clinical Research Unit, The Sixth Affiliated Hospital of Guangzhou Medical University, Qingyuan People's Hospital, No. B24, Yinquan Road, Qingcheng District, Qingyuan City, Guangdong Province 511518, China; Department of Pharmacy, Peking University People's Hospital, Beijing 100034, China. Electronic address:

Background/objective: SSS07, a humanized rabbit monoclonal antibody, can selectively block human tumor necrosis factor-α (TNF-α). The objective of this study was to assess the safety, tolerability, and relative immunogenicity of SSS07 after multiple single subcutaneous (SC) doses in healthy volunteers.

Methods: A total of 71 healthy volunteers were randomized to six sequential ascending-dose groups (5, 15, 30, 50, 75, and 100 mg), and except for the 100 mg group that only had one subject who received a placebo, all of the other groups included two placebo-control subjects. Safety, tolerability, and immunogenicity were assessed by physical examinations, vital signs, electrocardiography (ECG), clinical laboratory tests, and plasma anti-drug antibody (ADA) over 28 days for each group. Their concentrations of TNF-α were also analyzed. Only after safety and tolerance were determined in the lower-dose groups was the next dose group initiated. The dose increments did not exceed 100 mg.

Results: No serious adverse events or dose-limited toxicity (DLT) were observed, so 100 mg was defined as the maximum tolerated dose (MTD). Overall, 71 AEs and 59 treatment-related adverse events (TRAEs) were reported in 36 (60.0%) and 30 (50.0%) volunteers, respectively, who received SSS07. All AEs and TRAEs were mild or moderate and expected based on previous results with similar types of drugs, without new safety concerns. Except for infections and administration site reactions, the frequency and intensity of the other TRAEs were similar for SSS07 and placebo. No severe acute immune reactions occurred. The lower dose's immunogenicity was stronger than the higher doses. The highest ADA titer was observed 3 to 6 months after administration.

Conclusion: SSS07 was generally safe and well tolerated in healthy Chinese volunteers. Higher immunogenicity was observed at low SSS07 concentration levels. The infections and administration site conditions might have been related to the immunogenicity and the degree of inhibition of TNF-α. However, the existence of ADA did not appear to affect the safety of the subjects throughout the follow-up period. These findings could support further investigations of treatments with humanized monoclonal antibodies.
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http://dx.doi.org/10.1016/j.intimp.2020.107263DOI Listing
February 2021
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