Publications by authors named "Qun Shi"

69 Publications

Complete mitochondrial genome of (Cladocera: Bosminidae) and its phylogenetic analysis.

Mitochondrial DNA B Resour 2021 5;6(9):2567-2568. Epub 2021 Aug 5.

College of Animal Science and Technology, Yangzhou University, Yangzhou, China.

is a globally distributed zooplankton that adapts to a eutrophic environment. In this study, we cultivated monoclonal and determined its complete mitochondrial gene sequence using the Illumina HiSeq 4000 platform. It was 15,209 bp in length, including 13 protein-coding genes, 22 tRNA genes, and 2 rRNA genes, with the A + T content (69.2%) significantly higher than the G + C content (30.9%). All 22 typical tRNA genes had a classical cloverleaf structure, except for tRNAIle. The complete mitochondrial genome of nine other cladoceran species was used to reconstruct a phylogenetic tree, showing that has a closer relationship with than other cladocerans.
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http://dx.doi.org/10.1080/23802359.2021.1959442DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8344229PMC
August 2021

Customized eye modeling for optical quality assessment in myopic femto-LASIK surgery.

Sci Rep 2021 Aug 6;11(1):16049. Epub 2021 Aug 6.

School of Physics and Optoelectronic Engineering, Foshan University, Foshan, 528000, Guangdong, China.

Refractive surgery is recognized as an effective method for myopia treatment, but it can induce night vision disturbances such as glare. We present an eye modeling method for the optical quality assessment in response to the structural changes in the eyes by femto-LASIK surgery. Customized eye models were built from the measurements of 134 right eyes pre- and post-operatively. Optical performance was evaluated using spot diagrams, point spread functions (PSFs), modulation transfer functions (MTFs), and chromatic aberrations at various fields (0°-30°), different pupil diameters (2-6 mm), and initial myopias (- 1.25 to - 10.5 D). Pupil size and initial myopia are the two major factors that affect visual performance of post-operative eyes. The results of spot diagrams, PSFs, and MTFs indicated that post-operative visual performance deteriorated as the visual field and pupil size increased, and it was significantly influenced by initial myopia. Post-operative chromatic aberrations were also affected by initial myopia. As pupil size increased, the post-operative longitudinal chromatic aberrations tended to decrease slightly, while the transverse chromatic aberrations remained similar. The use of eye modeling for refractive surgery assessment could possibly provide a more personalized surgical approach, could improve the prediction accuracy of refractive surgery outcomes, and promote the invention and development of better surgical methods.
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http://dx.doi.org/10.1038/s41598-021-95730-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8346559PMC
August 2021

Factors associated with corneal high-order aberrations before and after femtosecond laser-assisted keratomileusis.

Ann Transl Med 2021 Jun;9(12):989

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guangzhou, China.

Background: Corneal high-order aberrations (HOAs) are related to visual quality. However, the factors associated with corneal HOAs before and after femtosecond laser-assisted in situ keratomileusis (FS-LASIK) have not yet been elucidated. The aim of this study is to observe the factors related to corneal HOAs before and after FS-LASIK.

Methods: Prospective observational study was designed to measure corneal HOAs in 149 eyes of 75 patients before and 6 months after FS-LASIK. The relationship between spherical diopter and corneal parameters, including K1 and K2 (horizontal and vertical refractive power of the cornea, respectively), the aspheric characteristics of the cornea (Q), mean radius of the curvature of the cornea (Rm), and central corneal thickness (CCT), with corneal HOAs were analyzed.

Results: The spherical diopter was correlated with trefoil at 30° before surgery and with vertical coma, four-order astigmatism at 0°, trefoil at 30°, spherical aberration, and six-order spherical aberration after surgery (P<0.05). CCT was correlated with vertical coma, four-order astigmatism at 0°, trefoil at 30°, and six-order spherical aberration after surgery (P<0.05). K1 was correlated with spherical aberration and six-order astigmatism at 0° before surgery (P<0.05). K2 was correlated with spherical aberration, six-order astigmatism at 45°, astigmatism at 0°, six-order astigmatism at 0° before surgery, and trefoil at 30° after surgery (P<0.05). Q was correlated with spherical aberration, six-order spherical aberration, and six-order astigmatism at 45° (P<0.05). Rm was correlated with six-order astigmatism at 0°, spherical aberration, six-order astigmatism at 45° before surgery, and astigmatism at 0° after surgery (P<0.05).

Conclusions: Corneal parameters and spherical diopter are related to the HOAs of the cornea before and after FS-LASIK.
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http://dx.doi.org/10.21037/atm-21-2367DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8267252PMC
June 2021

miR-4443 targets TRIM14 to suppress metastasis and energy metabolism of papillary thyroid carcinoma (PTC) in vitro.

Cell Biol Int 2021 Sep 12;45(9):1917-1925. Epub 2021 Jul 12.

Department of Pathology, Yangpu Hospital, School of Medicine, Tongji University, Shanghai, China.

Tripartite motif-containing protein 14 (TRIM14) is a tumor-promoter in papillary thyroid carcinoma (PTC). We found that miR-4443 expression was significantly downregulated in PTC tumor tissue, and was negatively associated with TRIM14. This study was designed to investigate the relationship between miR-4443 and TRIM14 on metastasis and energy metabolism in PTC and the underlying mechanisms. To this end, human PTC cells (SW1736 and MZ-CRC-1) were transfected with a miR-4443 mimic or miR-4443 inhibitor + siRNA-TRIM14, and then dual-luciferase assay, Transwell, Seahorse, and western blot analyses were performed to assess the function of miR-4443 and the underlying mechanism. We found that ectopic expression of miR-4443 inhibited PTC cell migration, invasion, ATP production, and aerobic glycolysis, while inhibition of miR-4443 had the opposite effect. miR-4443 directly targeted TRIM14 and reduced both TRIM14 mRNA and protein levels. Silencing TRIM14 significantly reversed miR-4443 inhibition-induced PTC cell migration, invasion, ATP production, aerobic glycolysis, and phosphorylation of the transcription factor STAT3. These findings suggest that miR-4443 is a tumor suppressor in PTC and inhibits metastasis and energy metabolism via the suppression of TRIM14 signaling.
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http://dx.doi.org/10.1002/cbin.11631DOI Listing
September 2021

UPLC-MS based plasma metabolomics and lipidomics reveal alterations associated with IgG4-related disease.

Rheumatology (Oxford) 2021 07;60(7):3252-3261

Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences.

Objective: The pathogenesis of IgG4-related disease (IgG4-RD) remains unclear. Metabolomic profiling of IgG4-RD patients offers an opportunity to identify novel pathophysiological targets and biomarkers. This study aims to identify potential plasma biomarkers associated with IgG4-RD.

Methods: Thirty newly diagnosed IgG4-RD patients, age-matched healthy controls and post-treated IgG4-RD patients were enrolled. Patients' clinical data, laboratory parameters and plasma were collected. Plasma was measured for ultraperformance liquid chromatography-tandem mass spectrometry based metabolomics and lipidomics profiling. Multivariate and univariate statistical analyses were conducted to identify potential biomarkers. The receiver operating characteristic and the correlations between biomarkers and clinical parameters were investigated.

Results: The plasma metabolites are altered among healthy controls, newly diagnosed IgG4-RD and post-treated IgG4-RD groups. Of the identified features, eight metabolites were significantly perturbed in the IgG4-RD group, including glyceric acid 1,3-biphosphate (1,3-BPG), uridine triphosphate (UTP), uridine diphosphate glucose (UDP-Glc) or uridine diphosphate galactose (UDP-Gal), lysophospholipids, linoleic acid derivatives and ceramides. Receiver operating characteristic analysis indicated that UTP, UDP-Glc/UDP-Gal and LysoPC (18:1) had high sensitivity and specificity in diagnosis of IgG4-RD. A Pearson correlation analysis showed that 1,3-BPG and UTP were strongly correlated with clinical parameters.

Conclusion: IgG4-RD patients have a unique plasma metabolomic profile compared with healthy controls. Our study suggested that metabolomic profiling may provide important insights into pathophysiology and testable biomarkers for diagnosis of IgG4-RD.
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http://dx.doi.org/10.1093/rheumatology/keaa775DOI Listing
July 2021

Iguratimod treatment reduces disease activity in early primary Sjögren's syndrome: An open-label pilot study.

Mod Rheumatol 2021 Mar 3;31(2):394-398. Epub 2020 Aug 3.

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

Objectives: To evaluate the efficacy and safety of iguratimod in patients with early primary Sjögren's syndrome (pSS).

Methods: Twenty-seven disease-modifying antirheumatic drug-naive female patients met the revised American-European Consensus Group criteria for pSS were enrolled in this open-label pilot study. Patients were treated with iguratimod 25 mg twice a day for 24 weeks. The disease activity was assessed with European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) and EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at 12 and 24 weeks. Salivary and lacrimal gland function, laboratory, and subjective variables were also assessed. Generalized estimating equations were used to analyze parameters over time.

Results: ESSDAI (median, 5 versus 2 versus 2,  < .01), IgG (median, 26.6 versus 22.4 versus 21.4 g/L,  < .01) and rheumatoid factor (median, 119.9 versus 94.1 versus 83.8 lU/mL,  < .01) levels decreased significantly during iguratimod treatment. ESSPRI, salivary and lacrimal gland function, fatigue and health-related quality of life did not change during treatment. One patient experienced thrombocytopenia, and no other serious adverse effects were observed.

Conclusion: In this study, iguratimod treatment is safe and effective for improving disease activity and laboratory parameters in early pSS patients.
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http://dx.doi.org/10.1080/14397595.2020.1789335DOI Listing
March 2021

Identification of the miRNA-3185/CYP4A11 axis in cardiac tissue as a biomarker for mechanical asphyxia.

Forensic Sci Int 2020 Jun 13;311:110293. Epub 2020 Apr 13.

Department of Forensic Medicine, School of Basic Medical Sciences, Fudan University, Shanghai 200032, China. Electronic address:

Death by mechanical asphyxia is one of the most difficult conclusions to make in forensic science, especially in corpses displaying slight or no trauma to the surface of the body. Therefore, death by mechanical asphyxia is difficult to prove in medico-legal practice. MicroRNAs (miRNAs) are a class of small, non-coding RNAs involved in the regulation of numerous physiological and pathological cellular processes. In the present study, we demonstrate that significantly increased expression of miR-3185 in cardiac tissues was detected among cases of mechanical asphyxia compared to case of craniocerebral injury, hemorrhagic shock, sudden cardiac death and poisoning. We observed no correlation between the expression of miR-3185 and postmortem interval, age or temperature. Further work indicated that CYP4A11 is a putative target gene of miR-3185 and expressed at a relatively low level in cardiac tissue specimens from cases of mechanical asphyxia compared with specimens from cases of craniocerebral injury, hemorrhagic shock, sudden cardiac death and poisoning. Our results suggest that the miRNA-3185/CYP4A11 axis is associated with mechanical asphyxia-induced death and may provide new insight into asphyxial death investigations.
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http://dx.doi.org/10.1016/j.forsciint.2020.110293DOI Listing
June 2020

Metagenomic profiling of the pro-inflammatory gut microbiota in ankylosing spondylitis.

J Autoimmun 2020 02 2;107:102360. Epub 2019 Dec 2.

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, The Ministry of Education Key Laboratory, Beijing, 100730, China.

Objective: Gut dysbiosis has been reported implicated in ankylosing spondylitis (AS), a common chronic inflammatory disease mainly affects sacroiliac joints and spine. Utilizing deep sequencing on the feces of untreated AS patients, our study aimed at providing an in-depth understanding of AS gut microbiota.

Methods: We analyzed the fecal metagenome of 85 untreated AS patients and 62 healthy controls by metagenomic shotgun sequencing, and 23 post-treatment feces of those AS patients were collected for comparison. Comparative analyses among different cohorts including AS, rheumatoid arthritis and Behcet's disease were performed to uncover some common signatures related to inflammatory arthritis. Molecular mimicry of a microbial peptide was also demonstrated by ELISpot assay.

Results: We identified AS-enriched species including Bacteroides coprophilus, Parabacteroides distasonis, Eubacterium siraeum, Acidaminococcus fermentans and Prevotella copri. Pathway analysis revealed increased oxidative phosphorylation, lipopolysaccharide biosynthesis and glycosaminoglycan degradation in AS gut microbiota. Microbial signatures of AS gut selected by random forest model showed high distinguishing accuracy. Some common signatures related to autoimmunity, such as Bacteroides fragilis and type III secretion system (T3SS), were also found. Finally, in vitro experiments demonstrated an increased amount of IFN-γ producing cells triggered by a bacterial peptide of AS-enriched species, mimicking type II collagen.

Conclusions: These findings collectively indicate that gut microbiota was perturbed in untreated AS patients with diagnostic potential, and some AS-enriched species might be triggers of autoimmunity by molecular mimicry. Additionally, different inflammatory arthritis shared some common microbial signatures.
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http://dx.doi.org/10.1016/j.jaut.2019.102360DOI Listing
February 2020

Different clinical patterns of IgG4-RD patients with and without eosinophilia.

Sci Rep 2019 11 11;9(1):16483. Epub 2019 Nov 11.

Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China.

It has been reported that patients with IgG4-related disease (IgG4-RD) showed an elevated incidence of eosinophilia. We aim to explore the clinical patterns of IgG4-RD patients with and without eosinophilia. Four hundred and twenty-five IgG4-RD patients referred to Peking Union Medical College Hospital were enrolled. Blood eosinophil count higher than 0.5 × 10/L was defined as eosinophilia. Clinical features of all the participants were collected and analyzed statistically. Eighty-seven patients (20%) with eosinophilia were found. As compared to those with a normal range of blood eosinophil count, male predominance, longer disease duration, increased prevalence of dacryoadenitis, sialadenitis, lymphadenopathy, and skin rash, higher IgG4-RD responder index, more organ involvement and higher levels of serum IgG4 (17.0 g/L vs 6.5 g/L, P < 0.001) was found in patients with eosinophilia. There was no significant difference in the incidence of allergic disease between the two groups. Peripheral eosinophil counts were positively correlated with disease duration, the number of involved organs, IgG4-RD responder index, and serum IgG4. Higher recurrence rate during follow-up period was found in patients with eosinophilia [28.6% (20/70) vs 17.1% (42/245), P = 0.034]. IgG4-RD patients with eosinophilia exhibited different clinical patterns from patients without. Eosinophilia appeared independent of allergies in IgG4-RD.
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http://dx.doi.org/10.1038/s41598-019-52847-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6848131PMC
November 2019

Complement C1q synergizes with PTX3 in promoting NLRP3 inflammasome over-activation and pyroptosis in rheumatoid arthritis.

J Autoimmun 2020 01 7;106:102336. Epub 2019 Oct 7.

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, The Ministry of Education Key Laboratory, Beijing, 100730, China; Clinical Immunology Center, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China. Electronic address:

Excessive inflammatory cytokines play crucial roles in the pathogenesis of rheumatoid arthritis (RA), however, the underlying mechanism remains unclear. In this study, we demonstrated that pentaxin 3 (PTX3), an essential component of innate immunity, was elevated in RA and preferentially bound to CD14 monocytes. C1q promoted the binding and resulted in increased cell proliferation, activation and caspase-1-related late apoptotic cells (7-AADannexin V), as well as enhanced release of inflammatory cytokines including TNF-α, IL-1β and IL-6. Serum from RA patients, compared with healthy controls, induced gasdermin D (GSDMD)-dependent pyroptosis in monocytes, and this ability was associated with disease activity. Moreover, PTX3 synergized with C1q to promote pyroptosis in RA-serum pre-incubated monocytes by coordinately enhancing NLRP3 inflammasome over-activation and inducing GSDMD cleavage, cell swelling with large bubbles, caspase-1-dependent cell death and inflammatory cytokine release including IL-6. On the other hand, IL-6 promoted PTX3 plus C1q-induced pyroptosis in both normal and RA serum pre-incubated monocytes. These findings collectively implicated an important role of IL-6 in driving PTX3 plus C1q-mediated pyroptosis in RA and shed lights on a potential new treatment strategy targeting pyroptosis-mediated persistent inflammatory cytokine release.
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http://dx.doi.org/10.1016/j.jaut.2019.102336DOI Listing
January 2020

Antibiotic prophylaxis in perioperative period of percutaneous nephrolithotomy: a systematic review and meta-analysis of comparative studies.

World J Urol 2020 Jul 27;38(7):1685-1700. Epub 2019 Sep 27.

Department of Dalian Medical University, Dalian, Liaoning, People's Republic of China.

Objective: To explore the efficacy of antibiotic prophylaxis in perioperative period of percutaneous nephrolithotomy (PCNL) by conducting a systematic review and meta-analysis.

Materials And Methods: A systematic literature search using Pubmed, Embase, and the Chinese SinoMed, CNKI, WanFang and VIP databases was performed to find comparative studies on the efficacy of different antibiotic prophylaxis strategies in PCNL for preventing postoperative sepsis. The last search was conducted on 21 April 2019. All selected articles were reviewed independently by two, and in case of discordance, three reviewers. Summarized unadjusted odds ratios (ORs) or risk ratios (RRs) with 95% confidence intervals (CIs) were calculated to assess the efficacy of different antibiotic prophylaxis strategies.

Results: Thirteen independent studies comprising up to 1549 individuals were included. Compared with single dose before anesthesia, preoperative prophylactic antibiotics significantly reduced postoperative sepsis (OR 0.31, 95% CI 0.20-0.50; P < 0.00001) and fever (OR 0.26, 95% CI 0.14-0.48; P < 0.0001). But no remarkable difference in sepsis risk between patients with and without postoperative prophylactic antibiotics was detected (RR 1.19, 95% CI 0.72-1.97; P = 0.49). And patients receiving postoperative prophylactic antibiotics were at a significantly high risk of fever (OR 1.88, 95% CI 1.01-3.05; P = 0.05). Compared with single dose before anesthesia, preoperative prophylactic antibiotics significantly reduced positive pelvic urine (RR 0.22, 95% CI 0.09-0.54; P = 0.0009) and stone cultures (RR 0.40, 95% CI 0.25-0.64; P = 0.0001).

Conclusions: The conclusion is drawn that preoperative prophylactic antibiotics indeed lowered the risk of postoperative sepsis and fever, whereas its postoperative use seems unnecessary. Besides, preoperative prophylactic antibiotics reduced positive pelvic urine and stone cultures significantly, which are a risk factor for sepsis. In our meta-analysis, the efficacy of different types of antibiotics and different courses of preoperative antibiotics could not be assessed. To verify the correctness of these conclusions, randomized controlled trials with a larger sample size and more rigorous study design are required.
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http://dx.doi.org/10.1007/s00345-019-02967-5DOI Listing
July 2020

Efficacy and safety of iguratimod plus corticosteroid as bridge therapy in treating mild IgG4-related diseases: A prospective clinical trial.

Int J Rheum Dis 2019 Aug 27;22(8):1479-1488. Epub 2019 Jun 27.

Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

Aim: The purpose of this study is to evaluate the therapeutic efficacy and safety of iguratimod plus corticosteroid as bridge therapy in the treatment of mild immunoglobulin G4-related disease (IgG4-RD).

Methods: Newly diagnosed IgG4-RD patients, without internal organ involvement were enrolled. Patients were given one dose of diprospan, intramuscular injection, and iguratimod, 25 mg, twice daily, for 24 weeks and were followed up at 0, 12 and 24 weeks. Follow-up indexes included IgG4-RD responder index (IgG4-RD RI), serology and imaging, plasma cytokines and adverse drug effect. Flow cytometry was performed for T, B cell subsets and plasma was collected for liquid chromatography mass spectrometry (LC-MS)-based metabolomic profiling and data processing.

Results: Thirty patients were enrolled. At week 24, 9 (30.0%) patients achieved complete response, 17 (56.7%) patients with partial response, and 4 (13.3%) patients had no response to treatment. IgG4-RD RI, serum IgG and IgG4 levels decreased significantly at weeks 12 and 24 after treatment, as well as CD3+ CD8+ T cells, plasmablast/plasma cells and memory B cells. The LC-MS based plasma metabolomic profiles revealed significant changes between untreated patients and healthy donors, which became much similar to normal states after treatment.

Conclusion: Iguratimod plus corticosteroid as bridge therapy is effective for the treatment of mild IgG4-RD, it can improve the clinical symptoms, reduce serum IgG and IgG4 levels, especially plasmablasts/plasma cells and memory B cells. In addition, the metabolite profiling became similar to normal controls after treatment.
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http://dx.doi.org/10.1111/1756-185X.13633DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6772123PMC
August 2019

Conditionally replicative adenovirus carrying shRNA targeting EZH2 inhibits prostate cancer growth and invasion.

Oncol Rep 2019 Jul 13;42(1):273-282. Epub 2019 May 13.

Department of Oncology, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, Jiangsu 225001, P.R. China.

The present study aimed to construct conditionally replicative adenovirus (CRAds) carrying small hairpin (sh)RNA targeting enhancer of zeste homolog 2 (EZH2), in order to study its effect on inhibiting prostate cancer (PCa) cell growth and invasion. Immunohistochemical analyses of EZH2 was performed in tumor tissue samples from PCa and benign prostate hyperplasia (BPH). The human telomerase reverse transcriptase (hTERT) promoter was chosen to transcriptionally control EZH2 gene expression to obtain adenoviral replication (Ad‑hTERT‑EZH2shRNA) in human PCa cell lines. The inhibitory effect of Ad‑hTERT‑EZH2shRNA on EZH2 expression was evaluated by reverse transcription‑-quantitative polymerase chain reaction and western blot analyses. Cell Counting Kit‑8 assays were used to examine the effects of the Ad‑hTERT‑EZH2shRNA on cell proliferation. Transwell Matrigel invasion assays were used to detected cell invasion. Immunohistochemistry showed that EZH2 staining was stronger in castration‑resistant prostate cancer (CRPC) samples, compared with androgen‑dependent prostate cancer (ADPC) samples, and was absent in BPH. Furthermore, EZH2 expression knockdown suppressed PCa cell proliferation and invasion. In addition, it was found that Ad‑hTERT‑EZH2shRNA selectively replicated and significantly reduced the expression of EZH2 in PCa cells lines. The growth ability and invasion of DU145 and PC3 cells in vitro was effectively inhibited by Ad‑hTERT‑EZH2shRNA. Silencing the expression of EZH2 led to decreased expression of CCND1 and Ki67 and increased expression of E‑cadherin, as determined by western blot analysis. Thus, it was shown that CRAds armed with EZH2 shRNA exhibited significant antitumor effects in human PCa cells. Ad‑hTERT‑EZH2shRNA may be developed as a treatment for hormone‑refractory PCa.
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http://dx.doi.org/10.3892/or.2019.7157DOI Listing
July 2019

Forensic appraisal of death due to acute alcohol poisoning: three case reports and a literature review.

Forensic Sci Res 2019 Mar 18;5(4):341-347. Epub 2019 Mar 18.

Department of Forensic Medicine, School of Basic Medical Sciences, Fudan University, Shanghai, China.

Death due to acute alcohol poisoning lacks specific anatomical characteristics, compared with other deaths due to drug poisoning. We report three forensic cases of death from acute alcohol poisoning due to inhibition of the respiratory centre and eventual asphyxia. Blood alcohol concentrations in the three fatalities were 5.28, 3.33 and 3.78 mg/mL, respectively. Lethal doses and blood alcohol concentrations showed differences between individuals. Detailed auxiliary tests besides autopsy were undertaken. These cases show that forensic scientists should exclude other causes of death, combine the autopsy with auxiliary tests, and then make an appraisal.
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http://dx.doi.org/10.1080/20961790.2019.1572259DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7781983PMC
March 2019

Clinicopathological characteristics and survival outcomes of bladder neuroendocrine carcinomas: a population-based study.

Cancer Manag Res 2018 11;10:4479-4489. Epub 2018 Oct 11.

Department of Urology, Subei People's Hospital of Jiangsu Province (Clinical Medical College, Yangzhou University), Yangzhou, Jiangsu, People's Republic of China,

Background: Bladder neuroendocrine carcinomas (BNECs) are relatively a rare type of tumor. The aim of this study was to examine the clinicopathological characteristics and predictors of survival outcomes of patients with BNECs based on the analysis of the national Surveillance, Epidemiology, and End Results (SEER) database.

Materials And Methods: Kaplan-Meier analysis with log-rank test was used for survival comparisons. Multivariate Cox regression model was employed to analyze the effect of different treatments on overall survival (OS) and cancer-specific survival (CSS).

Results: A total of 910 patients were identified between 2004 and 2014. Overall, 648 (71.2%) patients had small cell neuroendocrine carcinoma (SCNEC), 35 (3.8%) had large cell neuroendocrine carcinoma (LCNEC), 10 (1.1%) had carcinoid tumor (well-differentiated neuroendocrine tumor), 16 (1.8%) had paraganglioma/pheochromocytoma (PGL/PHEO), 619 (68.0%) had a poorly differentiated or undifferentiated histology grade, 214 (23.5%) presented with metastatic disease, 586 (64.4%) underwent transurethral ablation/destruction for bladder tumor, and 245 (26.9%) had partial/total cystectomy. Cystectomy+chemotherapy+radiotherapy (CCR) has the highest long-term survival rate among various treatments. The 1-, 3-, and 5-years CSS of CCR were 56%, 56%, and 56%, respectively. By using multivariable Cox proportional hazard model, age, histology, N stage, SEER stage, tumor size, radiotherapy, chemotherapy, and local treatment of the primary site were identified as independent predictors for OS and CSS; all <0.05.

Conclusion: In BNEC, SCNEC has an absolute advantage in number. SCNEC/LCNEC tend to be older men. PGL/PHEO and carcinoid tumors have younger mean ages, earlier tumor stages, and better prognosis than SCNEC/LCNEC. Surgery, radiotherapy and chemotherapy are better than conservative treatment. However, whatever cystectomy or bladder sparing, chemotherapy should be a major component of treatment.
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http://dx.doi.org/10.2147/CMAR.S175286DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6190820PMC
October 2018

The effect of marital status on the survival of patients with bladder urothelial carcinoma: A SEER database analysis.

Medicine (Baltimore) 2018 Jul;97(29):e11378

Department of Dalian Medical University, Dalian, Liaoning Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Shangdong Department of Oncology Department of Urology, Subei People's Hospital of Jiangsu Province GClinical Medical College, Yangzhou University, Yangzhou, Jiangsu, China.

To identify whether marital status is associated with survival in patients with bladder urothelial carcinoma (UC). Using Surveillance, Epidemiology, and End Results population-based data, 133,846 patients diagnosed with bladder UC between 1988 and 2009 were identified. Kaplan-Meier methods and multivariable Cox regression models were used for survival analyses and evaluation of the association between marital status and survival, after controlling for gender, age, race, primary site, tumor (topography), lymph node, metastasis stage, pathological grading, and surgery. Patients in the married group had a higher proportion of men within group comparisons, more often white, older, earlier clinical stage at diagnosis, surgical treatment, all of which were statistically significant (P < .001). Widowed patients had the worst bladder UC cause-specific survival (CSS) compared with married, never married, and so on groups classified by stage and grade. The 5-year CSS of widowed patients compared with that of married patients was, respectively, all (P < .001), 89.8% versus 95.8% at noninvasive papillary carcinoma stage, 84.1% versus 91.6% at occur in situ stage, 74.3% versus 86.1% at I stage, 41.2% versus 61.6% at II stage, 39.2 versus 52.5% at III stage, and 8.8% versus 17.0% at IV stage. Widowed patients tend to have a significantly higher risk of bladder-cancer-specific mortality. Marital status was relevant to improved CSS in patients with bladder UC.
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http://dx.doi.org/10.1097/MD.0000000000011378DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6086512PMC
July 2018

Comparison of the impact of Tripterygium wilfordii Hook F and Methotrexate treatment on radiological progression in active rheumatoid arthritis: 2-year follow up of a randomized, non-blinded, controlled study.

Arthritis Res Ther 2018 04 10;20(1):70. Epub 2018 Apr 10.

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Clinical Immunology Center, Chinese Academy of Medical Sciences and Peking Union Medical College, The Ministry of Education Key Laboratory, Beijing, 100730, China.

Background: Tripterygium wilfordii Hook F (TwHF) alone or in combination with methotrexate (MTX) has been shown to be more effective than MTX monotherapy in controlling the manifestations in subjects with disease-modifying antirheumatic drug (DMARD)-naïve active rheumatoid arthritis (RA) over a 6-month period. The long-term impact of these therapies on disease activity and radiographic progression in RA has not been examined.

Methods: Patients with DMARD-naïve RA enrolled in the "Comparison of Tripterygium wilfordii Hook F with methotrexate in the Treatment of Active Rheumatoid Arthritis" (TRIFRA) study were randomly allocated into three arms with TwHF or MTX or the two in combination. Clinical indexes and radiographic data at baseline and year 2 was collected and compared using an intent-to-treat (ITT) and a per-protocol (PP) analysis. Two radiologists blinded to the treatment scored the images independently.

Results: Of 207 subjects 109 completed the 2-year follow up. The number of subjects withdrawing from the study and the number adhering to the initial regimens were similar among the three groups (p > = 0.05). In the ITT analysis, proportions of patients reaching American College of Rheumatology 50% (ACR50) response criteria were 46.4%, 58.0% and 50.7% in the MTX, TwHF and MTX + TwHF groups (TwHF vs MTX monotherapy, p = 0.004). Similar patterns were found in ACR20, ACR70, Clinical Disease Activity Index good responses, European League Against Rheumatism good response, remission rate and low disease activity rate at year 2. The results of the PP analysis agreed with those in the ITT analysis. The changes in total Sharp scores and joint erosion and joint space narrowing during the 2 years were associated with changes in disease activity measured by the 28-joint count Disease Activity Score and were comparable among the three groups (p > 0.05). Adverse events were similar in the three treatment groups.

Conclusions: During the 2-year therapy period, TwHF monotherapy was not inferior to MTX monotherapy in controlling disease activity and retarding radiological progression in patients with active RA.

Trial Registration: This is a follow-up study. Original trial registration: ClinicalTrials.gov , NCT01613079 . Registered on 4 June 2012.
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http://dx.doi.org/10.1186/s13075-018-1563-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5894170PMC
April 2018

DUSP1 and KCNJ2 mRNA upregulation can serve as a biomarker of mechanical asphyxia-induced death in cardiac tissue.

Int J Legal Med 2018 May 17;132(3):655-665. Epub 2017 Jun 17.

Department of Forensic Medicine, Schoolof Basic Medical Sciences, Fudan University, 131 Dongan Road, Shanghai, 200032, People's Republic of China.

The incidence of death by asphyxia is second to the incidence of death by mechanical injury; however, death by mechanical asphyxia may be difficult to prove in court, particularly in cases in which corpses do not exhibit obvious signs of asphyxia. To identify a credible biomarker of asphyxia, we first examined the expression levels of 47,000 mRNAs in human cardiac tissue specimens from individuals who died of mechanical asphyxia and compared the expression levels with the levels of the corresponding mRNAs in specimens from individuals who died of craniocerebral injury using microarray. We selected 119 differentially expressed mRNAs, examined the expression levels of these mRNAs in 44 human cardiac tissue specimens of individuals who died of mechanical asphyxia, craniocerebral injury, hemorrhagic shock, or other causes. That the expression of dual-specificity phosphatase 1 (DUSP1) and potassium voltage-gated channel subfamily J member 2 (KCNJ2) was upregulated in human cardiac tissues from the mechanical asphyxia group compared with control tissues, regardless of age, environmental temperature, and postmortem interval (PMI), indicating that DUSP1 and KCNJ2 may be associated with mechanical asphyxia-induced death and can thus serve as useful biomarkers of death by mechanical asphyxia.
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http://dx.doi.org/10.1007/s00414-017-1616-4DOI Listing
May 2018

Phytochemical and cytotoxic studies on the roots of Euphorbia fischeriana.

Bioorg Med Chem Lett 2017 01 23;27(2):266-270. Epub 2016 Nov 23.

School of Traditional Chinese Materia Medica, Key Laboratory of Structure-Based Drug Design and Discovery (Shenyang Pharmaceutical University), Ministry of Education, Wenhua Road 103, Shenyang 110016, PR China. Electronic address:

With the aim of supporting the folk applications of Euphorbia fischeriana, a phytochemical study was performed, which led to the discovery of 9 compounds, including three new ones (1-3) and six known ones (4-9). Their structures were determined by 1D, 2D NMR, and HRESIMS analysis. In the cytotoxic assays on Hep-3B cell line, 2 showed stronger inhibitory effects (IC 8.1μmol/L) than that of positive control, and 1, 8 and 9 also gave inhibitory effects in a certain degree with IC values of 12.5, 12.0 and 18.7μmol/L, respectively. While on A549, the cytotoxic activities of 1 (IC 11.9μmol/L) and 8 (IC 9.4μmol/L) were superior to that of 5-Fu, and those of 4 and 9 were moderate with IC values of 28.2 and 29.8μmol/L, respectively. In addition, both petroleum ether and dichloromethane extracts showed cytotoxic activities with different degree, while n-butanol extracts had no effect. The results clarified that the low-polarity fractions of E. fischeriana, including triterpenoids, abietane and tigliane-type diterpenoids might be the potential bioactive ingredients which will exert strong antitumor effects.
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http://dx.doi.org/10.1016/j.bmcl.2016.11.063DOI Listing
January 2017

G6PC3, ALDOA and CS induction accompanies mir-122 down-regulation in the mechanical asphyxia and can serve as hypoxia biomarkers.

Oncotarget 2016 10;7(46):74526-74536

Department of Forensic Medicine, School of Basic Medical Sciences, Fudan University, Shanghai, People's Republic of China.

Hypoxia influences different cellular biological processes. To reveal the dynamics of hypoxia's effects on miRNA regulation in vivo, we examined the expression levels of all miRNAs in human brain and heart specimens from cases of mechanical asphyxia compared with those from cases of craniocerebral injury and hemorrhagic shock. We further validated differently expressed miRNAs in another 84 human specimens and rat models. We found that mir-122 was significantly down-regulated and that its putative targets G6PC3, ALDOA and CS were increased in the brain and cardiac tissues in cases of mechanical asphyxia compared with craniocerebral injury and hemorrhagic shock. Our data indicate that mir-122 and its targets G6PC3, ALDOA and CS play roles in the hypoxia responses that regulate glucose and energy metabolism and can serve as hypoxia biomarkers.
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http://dx.doi.org/10.18632/oncotarget.12931DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5342684PMC
October 2016

Clinical characteristics of immunoglobulin G4-related disease: a prospective study of 118 Chinese patients.

Rheumatology (Oxford) 2015 Nov 22;54(11):1982-90. Epub 2015 Jun 22.

Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education.

Objective: To characterize the clinical features of IgG4-related disease (IgG4-RD) in China.

Methods: A prospective cohort study of IgG4-RD was carried out in Peking Union Medical College Hospital between 2011 and 2013. Patients with newly diagnosed IgG4-RD were enrolled.

Results: A total of 118 patients with IgG4-RD were enrolled, including 82 males and 36 females, aged 53.1 (s.d. 13.6) years. The most common symptom at onset was lacrimal gland swelling (38/32.2%). A range of organs were involved: 77 patients (65.3%) had lymphadenopathy, 76 (64.4%) had sialadenitis, 60 (50.8%) had dacryoadenitis, 45 (38.1%) had autoimmune pancreatitis, 32 (27.1%) had pulmonary involvement, 31 (26.3%) had periaortitis/retroperitoneal fibrosis, 29 (35.4% of male patients) had prostatitis and 29 (24.6%) had renal involvement. In addition, there were 21 (17.8%) cases of sclerosing cholangitis, 15 (12.7%) of sinusitis and 10 (8.5%) of inflammatory pseudotumour. Uncommon manifestations included mediastinal fibrosis, skin involvement, sclerosing thyroiditis, hypophysitis, orchitis and colitis. Multiple organ involvement was observed in 93 patients, whereas only 4.2% had only a single organ involved. A history of allergy was reported in 73 (61.9%) patients. The serum IgG4 level was elevated in 97.5% and was correlated with the number of organs involved. Most patients were treated with glucocorticoids alone or in combination with immunosuppressive drugs, and the majority usually improved within 3 months.

Conclusion: IgG4-RD is a systemic inflammatory and sclerosing disease. Parotid and lacrimal involvement (formerly called Mikulicz's disease), lymphadenopathy and pancreatitis are the most common manifestations. Patients with IgG4-RD showed favourable responses to treatment with glucocorticoids and immunosuppressive agents.
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http://dx.doi.org/10.1093/rheumatology/kev203DOI Listing
November 2015

Association between metabolic syndrome and lung function in middle-aged and elderly Chinese individuals.

Diabetes Res Clin Pract 2015 Jun 14;108(3):e46-8. Epub 2015 Mar 14.

Department of Endocrinology, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China; Department of Endocrinology, Xinhua Hospital Chongming Branch, School of Medicine, Shanghai Jiaotong University, Shanghai, China. Electronic address:

Subjects with metabolic syndrome (MetS) had lower FVC and FEV1 than non-MetS subjects and decreased gradually with the increasing number of MetS components. After adjusting for potential risk factors, the lowest quartile of FVC and FEV1 was associated with increased risk of MetS.
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http://dx.doi.org/10.1016/j.diabres.2015.03.007DOI Listing
June 2015

[Correlation between age and general morphology of transverse section of cartilago costalis].

Fa Yi Xue Za Zhi 2014 Dec;30(6):419-21

Objective: To study the correlation between age and general morphology of transverse section of cartilago costalis and its forensic significance.

Methods: Eighty-six corpses' cartilago costalis from the routine postmortem examination were collected and the morphological features of their transverse section were observed.

Results: With the increased age, there were regular changes in the color, structure, and material of the general morphology of transverse section of cartilago costalis. But the changes were not affected by gender.

Conclusion: The good correlation between general morphology of transverse section of cartilago costalis and age can be used to estimate age of the deceased rapidly.
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December 2014

Serum IgG subclasses in autoimmune diseases.

Medicine (Baltimore) 2015 Jan;94(2):e387

From the Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.

To characterize serum IgG subclass levels in several autoimmune diseases, including primary Sjogren syndrome (pSS), systemic sclerosis (SSc), systemic lupus erythematosus (SLE), and primary biliary cirrhosis (PBC). We aimed to analyze serum IgG subclass distribution and to test whether serum IgG4 levels are elevated in these diseases. Serum IgG subclass levels from 102 pSS, 102 SSc, 100 SLE, and 59 PBC patients, as well as 40 healthy controls (HCs), were measured using the immunonephelometric assay. The distribution of IgG subclasses among these autoimmune diseases was analyzed. In this cross-sectional study, serum IgG1 (IgG1/IgG) and/or IgG3 (IgG3/IgG) were significantly increased, compared with those in HCs. Only 6.34% of patients had levels of serum IgG4 >135 mg/dL. There were no significant differences in the frequency of elevated serum IgG4 levels between patients and HC. In pSS, serum IgG1 levels were much higher than those in other disease groups, whereas serum IgG2 and IgG3 levels were most prominently increased in PBC. A strikingly different serum IgG subclass distribution was detected in patients with autoimmune diseases compared with HCs. Serum IgG subclass levels also showed distinct characteristics among different autoimmune diseases. Serum IgG4 levels in these patients were lower or not much higher than those in HCs, which differed from IgG4-related diseases.
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http://dx.doi.org/10.1097/MD.0000000000000387DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4602543PMC
January 2015

α-Naphthoflavone modulates inflammatory response in adipocytes-macrophages interaction through NFκB signaling.

Int J Clin Exp Pathol 2014 15;7(11):7768-74. Epub 2014 Oct 15.

Department of Urology, Renmin Hospital, Wuhan University China ; Hubei Key Laboratory of Kidney Disease Pathogenesis and Intervention Huangshi, China.

Objective: Our previous study demonstrated that α-naphthoflavone (α-NF) inhibits mouse 3T3-L1 pre-adipocytes differentiation via PPARγ, a key transcription factor in adipogenesis. Due to the critical role of inflammation in adipogenesis, we speculated that the suppression role of α-NF in adipogenesis might involve in modulation of cytokines secretion raised by adipocyte differentiation cocktail. Therefore, the present study aims to investigate the role of α-NF in modulating of inflammatory response during adipocytes differentiation and adipocyte-macrophage interaction.

Methods: Conditioned medium from different doses of α-NF treated 10-day differentiated 3T3-L1 adipocytes were collected to culture RAW264.7 macrophages. Conditioned medium from activated macrophages and α-NF pre-treated macrophage were used to investigate the effects of α-NF in adipocytes differentiation. Cultured cells and medium were harvested for RT-PCR, Western blot and ELISA.

Results: α-NF dose-dependently decreased TNF-α and IL-6 and increased IL-10 expression induced by IDM (Insulin, dexamethasone, isobutylmethylxanthine) in 3T3-L1 pre-adipocytes. Conditioned medium from α-NF treated 3T3-L1 differentiated cells inhibited inflammatory response in mouse macrophage cell line RAW264.7 in contrast to IDM control medium. NFĸB activation elicited by IDM was suppressed by α-NF in a dose-response manner. Consequently, decreased TNF-α and increased IL-10 secretion, downstream targets of NFĸB signaling pathway, were observed with α-NF in macrophages. Finally, Conditioned medium from α-NF pre-treated, LPS-activated macrophages ameliorated the suppression of 3T3-L1 adipogenesis by LPS activated macrophages.

Conclusion: Our results suggest that α-NF regulates inflammation response in both adipocytes and macrophages and adipocyte-macrophage interaction which contributes to pre-adipocyte differentiation.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270567PMC
September 2015

Effects of individual and multiple fatty acids (palmitate, oleate and docosahaexenoic acid) on cell viability and lipid metabolism in LO2 human liver cells.

Mol Med Rep 2014 Dec 18;10(6):3254-60. Epub 2014 Sep 18.

Department of Nutrition, The University of Tennessee at Knoxville, Knoxville, TN 37996, USA.

This study was designed to investigate the direct effects of fatty acids (FAs) on the cell viability and the expression levels of genes involved in lipid metabolism in LO2 human liver cells. Palmitate (PA), oleate (OA) and docosahaexenoic acid (DHA) were used to represent saturated, mono-unsaturated and polyunsaturated FAs, respectively. At concentrations of ≤3.2 µg/ml, treatment with single FAs increased the viability of the LO2 cells. At FA concentrations of >3.2 µg/ml, cell viability following OA treatment was increased, but PA or DHA treatment at these concentrations reduced cell viability. Administration of mixtures of these FAs in three ratios (PA:OA:DHA = 1:2:1, 1:1:1 and 1:1:2, respectively) increased the cell viability compared with the control group. The intracellular triglyceride (TG) levels following all types of treatment were significantly increased and the accumulation of TGs was markedly increased with high doses of DHA. In addition, peroxisome proliferator-activated receptor-γ was significantly upregulated in all groups, with the exception of the 1:1:1 group at 3.2 µg/ml and the 1:1:2 group at 12.8 µg/ml. The expression levels of sterol regulatory-element binding protein‑1c, liver X receptor α and apolipoprotein C‑I were significantly reduced in all groups with the exception of the DHA‑treated group and the 1:2:1 groups at 3.2 and 12.8 µg/ml. In conclusion, these results indicate that the type, concentration and mixture ratios of FAs are all important in determining the cell viability and lipid metabolism-related gene expression in LO2 hepatocytes.
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http://dx.doi.org/10.3892/mmr.2014.2579DOI Listing
December 2014

Response to D.M. Marcus's comment on the TRIFRA study (comparison of Tripterygium wilfordii Hook F vs methotrexate in the treatment of active rheumatoid arthritis).

Ann Rheum Dis 2014 Sep;73(9):e57

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

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http://dx.doi.org/10.1136/annrheumdis-2014-205973DOI Listing
September 2014

TwHF versus methotrexate in the treatment of rheumatoid arthritis: response to Landewe's comment on the TRIFRA study.

Ann Rheum Dis 2014 Oct 25;73(10):e63. Epub 2014 Jul 25.

Formerly National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Maryland, USA Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

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http://dx.doi.org/10.1136/annrheumdis-2014-206156DOI Listing
October 2014

The TRIFRA trial: efforts employed to minimise expectation bias.

Ann Rheum Dis 2014 Nov 23;73(11):e67. Epub 2014 Jul 23.

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

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http://dx.doi.org/10.1136/annrheumdis-2014-206197DOI Listing
November 2014

Comparison of Tripterygium wilfordii Hook F with methotrexate in the treatment of active rheumatoid arthritis (TRIFRA): a randomised, controlled clinical trial.

Ann Rheum Dis 2015 Jun 14;74(6):1078-86. Epub 2014 Apr 14.

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Objectives: To compare the efficacy and safety of Tripterygium wilfordii Hook F (TwHF) with methotrexate (MTX) in the treatment of active rheumatoid arthritis (RA).

Methods: Design: a multicentre, open-label, randomised controlled trial. All patients were assessed by trained investigators who were unaware of the therapeutic regimen.

Intervention: 207 patients with active RA were randomly allocated (1:1:1) to treatment with MTX 12.5 mg once a week, or TwHF 20 mg three times a day, or the two in combination. At week 12, if reduction of the 28-joint count Disease Activity Score (DAS28) was <30% in the monotherapy groups, the patient was switched to MTX+TwHF. The primary efficacy point was the proportion of patients achieving an American College of Rheumatology (ACR) 50 response at week 24.

Results: 174/207 (84.1%) patients completed 24 weeks of the trial. In an intention-to-treat analysis, the proportion of patients reaching the ACR50 response criteria was 46.4% (32/69), 55.1% (38/69) and 76.8% (53/69), respectively, in the MTX, TwHF and MTX+TwHF groups (TwHF vs MTX monotherapy, p=0.014; MTX+TwHF vs MTX monotherapy, p<0.001). Similar statistically significant patterns at week 24 were found for ACR20, ACR70, clinical Disease Activity Index good responses, EULAR good response, remission rate and low disease activity rate. Significant improvement in the Health Assessment Questionnaire and 36-item Short-Form Health Survey questionnaire scores from baseline to week 24 was seen in each treatment arm (p<0.05), though no significant difference was found among the treatment arms (p>0.05). The result of per-protocol analysis agreed with that seen in the intention-to-treat analysis. Seven, three and five women in the TwHF, MTX and combination groups, respectively, developed irregular menstruation (TwHF vs MTX monotherapy, p=0.216).

Conclusions: TwHF monotherapy was not inferior to, and MTX+TwHF was better than, MTX monotherapy in controlling disease activity in patients with active RA.

Trial Registration Number: NCT01613079.
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http://dx.doi.org/10.1136/annrheumdis-2013-204807DOI Listing
June 2015
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