Publications by authors named "Chiara Guarnieri"

8 Publications

  • Page 1 of 1

Human Intravenous Immunoglobulin Alleviates Neuropathic Symptoms in a Rat Model of Paclitaxel-Induced Peripheral Neurotoxicity.

Int J Mol Sci 2021 Jan 21;22(3). Epub 2021 Jan 21.

Experimental Neurology Unit, School of Medicine and Surgery, and NeuroMI (Milan Center for Neuroscience), University of Milano-Bicocca, 20900 Monza, Italy.

The onset of chemotherapy-induced peripheral neurotoxicity (CIPN) is a leading cause of the dose reduction or discontinuation of cancer treatment due to sensory symptoms. Paclitaxel (PTX) can cause painful peripheral neuropathy, with a negative impact on cancer survivors' quality of life. While recent studies have shown that neuroinflammation is involved in PTX-induced peripheral neurotoxicity (PIPN), the pathophysiology of this disabling side effect remains largely unclear and no effective therapies are available. Therefore, here we investigated the effects of human intravenous immunoglobulin (IVIg) on a PIPN rat model. PTX-treated rats showed mechanical allodynia and neurophysiological alterations consistent with a severe sensory axonal polyneuropathy. In addition, morphological evaluation showed a reduction of intra-epidermal nerve fiber (IENF) density and evidenced axonopathy with macrophage infiltration, which was more prominent in the distal segment of caudal nerves. Three weeks after the last PTX injection, mechanical allodynia was still present in PTX-treated rats, while the full recovery in the group of animals co-treated with IVIg was observed. At the pathological level, this behavioral result was paralleled by prevention of the reduction in IENF density induced by PTX in IVIg co-treated rats. These results suggest that the immunomodulating effect of IVIg co-treatment can alleviate PIPN neurotoxic manifestations, probably through a partial reduction of neuroinflammation.
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http://dx.doi.org/10.3390/ijms22031058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7865319PMC
January 2021

Efficacy and safety of human intravenous immunoglobulin 5% (Ig VENA) in pediatric patients affected by primary immunodeficiency.

Int J Immunopathol Pharmacol 2020 Jan-Dec;34:2058738420943006

Section of Pediatrics, Division of Immunology, Department of Health Sciences, Meyer Children's University Hospital, University of Florence, Florence, Italy.

Patients affected by primary immunodeficiencies are characterized for high susceptibility for severe infections. Our data demonstrate Kedrion 5% intravenous immunoglobulin G (IVIg) treatment effective and safe as replacement therapy for children and adolescents affected by primary immunodeficiency. The particularities of our study are the selection of a long period of follow-up (71 patient-years of follow-up), and to the best of our knowledge, our study is one of few that assesses the safety and efficacy of intravenous immunoglobulin treatment of primary immunodeficiency specifically in a pediatric population.
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http://dx.doi.org/10.1177/2058738420943006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7493272PMC
September 2020

Pharmacokinetic characteristics of the triple inactivated plasma-derived Kedrion FIX concentrate: data from the KB037 clinical trial.

Data Brief 2020 Oct 15;32:106164. Epub 2020 Aug 15.

Presbyterian Hospital, Albuquerque, NM, USA.

The pharmacokinetics data of phase I/II clinical trials (EudraCT Number: 2005-006186-14) of the new, triple inactivated plasma-derived Kedrion FIX concentrate was designed according to the recommendations of SSC-ISTH [1,2]: 11 post-infusion FIX/time points samples during the first 72 h. The PK data were also analysed by a modified, less dense, 9 FIX/time points, sample design. The outcomes of the safety and efficacy study and the pharmacokinetics' results have been previously and partially described [3,4]. The single-dose PK at enrolment (PK I) and the end of the trial (PK II) were analyzed by WinNonlin 7.0 (Pharsight) and according to three different methods: Non-Compartment Analysis (NCA), One Compartment Method (OCM), and Two-Compartment Method (TCM). The outcomes of PK parameters by TCM show that a higher number of FIX/time concentration points may not always give a better definition of the decay curve. On the other hand, the Terminal HL of NCA is deeply affected by the goodness of the last two-three points. The quite long Kedrion FIX HL may allow for a cost/effective tailoring of prophylaxis in haemophilia B patients.
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http://dx.doi.org/10.1016/j.dib.2020.106164DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7452555PMC
October 2020

Rapid infusions of human normal immunoglobulin 50g/l are safe and well tolerated in immunodeficiencies and immune thrombocytopenia.

Int Immunopharmacol 2017 Mar 7;44:38-42. Epub 2017 Jan 7.

Department of Molecular Medicine, "Sapienza" University of Rome, Italy.

Intravenous immunoglobulin (IVIg) is accepted as an effective and well-tolerated treatment for primary and secondary immunodeficiencies (ID) and immune thrombocytopenia (ITP). Adverse reactions of IVIg are usually mild, comprising transient flu-like symptoms, change in blood pressure and tachycardia. However IVIg therapy can be burdensome for both patients and healthcare facilities, since the infusion may take up to 4h to administer. The objective of our multicentre, prospective, open-label phase III trial was to evaluate the tolerability and safety of human normal immunoglobulin 50g/l (Ig VENA) at high intravenous infusion rates in adult patients with ID and ITP who had previously tolerated IVIg treatment, by progressively increasing infusion rate up to 8ml/kg/hr. 39 ID patients received three infusions, 5 ITP patients received up to a maximum of 5 infusions for a maximum of 5days. Overall 55 adverse events were reported in 18 patients, and all were mild and self-limiting. Two serious adverse events occurred in ID patients and 1 in an ITP patient; none was fatal or treatment-related. No clinically significant changes or abnormalities were observed in vital signs, laboratory results and HRQoL. In summary, in this study, more rapid IVIg infusions were well tolerated by ID and ITP patients, while maintaining their quality of life, helping to minimise the time spent in outpatient hospital visiting to potentially optimise adherence to treatment.
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http://dx.doi.org/10.1016/j.intimp.2016.12.030DOI Listing
March 2017

Blood pressure control and treatment adherence in hypertensive patients with metabolic syndrome: protocol of a randomized controlled study based on home blood pressure telemonitoring vs. conventional management and assessment of psychological determinants of adherence (TELEBPMET Study).

Trials 2013 Jan 23;14:22. Epub 2013 Jan 23.

Department of Cardiology, IRCCS Ospedale San Luca, Istituto Auxologico Italiano, Milano, Italy.

Background: Inadequate blood pressure control and poor adherence to treatment remain among the major limitations in the management of hypertensive patients, particularly of those at high risk of cardiovascular events. Preliminary evidence suggests that home blood pressure telemonitoring (HBPT) might help increasing the chance of achieving blood pressure targets and improve patient's therapeutic adherence. However, all these potential advantages of HBPT have not yet been fully investigated.

Methods/design: The purpose of this open label, parallel group, randomized, controlled study is to assess whether, in patients with high cardiovascular risk (treated or untreated essential arterial hypertension--both in the office and in ambulatory conditions over 24 h--and metabolic syndrome), long-term (48 weeks) blood pressure control is more effective when based on HBPT and on the feedback to patients by their doctor between visits, or when based exclusively on blood pressure determination during quarterly office visits (conventional management (CM)). A total of 252 patients will be enrolled and randomized to usual care (n = 84) or HBPT (n = 168). The primary study endpoint will be the rate of subjects achieving normal daytime ambulatory blood pressure targets (< 135/85 mmHg) 24 weeks and 48 weeks after randomization. In addition, the study will assess the psychological determinants of adherence and persistence to drug therapy, through specific psychological tests administered during the course of the study. Other secondary study endpoints will be related to the impact of HBPT on additional clinical and economic outcomes (number of additional medical visits, direct costs of patient management, number of antihypertensive drugs prescribed, level of cardiovascular risk, degree of target organ damage and rate of cardiovascular events, regression of the metabolic syndrome).

Discussion: The TELEBPMET Study will show whether HBPT is effective in improving blood pressure control and related medical and economic outcomes in hypertensive patients with metabolic syndrome. It will also provide a comprehensive understanding of the psychological determinants of medication adherence and blood pressure control of these patients.

Trial Registration: Clinical Trials.gov: NCT01541566.
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http://dx.doi.org/10.1186/1745-6215-14-22DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3576326PMC
January 2013

Validation of the visomat comfort eco blood pressure measuring device according to the International Protocol.

Blood Press Monit 2009 Aug;14(4):178-80

Department of Clinical and Experimental Medicine, University of Padova, Padua, Italy.

The objective of this study was to determine the accuracy of the UEBE visomat comfort eco blood pressure measuring device tested according to the requirements of the International Protocol of the European Society of Hypertension. The device evaluation was performed in 33 participants with a mean+/-SD age of 54.3+/-18.7 years (range 30-91 years). Their systolic blood pressure (SBP) was 144.0+/-23.7 mmHg (range 100-180 mmHg), diastolic blood pressure (DBP) was 86.2+/-14.4 mmHg (range 60-110 mmHg), and upper arm circumference was 29.4+/-2.8 cm (range 24.0-34.0 cm). Blood pressure measurements were performed in the sitting position. The visomat comfort eco passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean blood pressure differences for the visomat comfort eco (device-observer) were -0.5+/-5.7 mmHg for SBP and -1.4+/-5.3 mmHg for DBP. In conclusion, the present results show that the UEBE visomat comfort eco monitor can be recommended for clinical use in the adult population.
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http://dx.doi.org/10.1097/MBP.0b013e32832d429cDOI Listing
August 2009

Regular physical activity prevents development of left ventricular hypertrophy in hypertension.

Eur Heart J 2009 Jan 11;30(2):225-32. Epub 2008 Dec 11.

Clinica Medica 4, University of Padova, via Giustiniani, 2, 35128 Padova, Italy.

Aims: The longitudinal relationship between aerobic exercise and left ventricular (LV) mass in hypertension is not well known. We did a prospective study to investigate the long-term effect of regular physical activity on development of LV hypertrophy (LVH) in a cohort of young subjects screened for Stage 1 hypertension.

Methods And Results: We assessed 454 subjects whose physical activity status was consistent during the follow-up. Echocardiographic LV mass was measured at entry, every 5 years, and/or at the time of hypertension development before starting treatment. LVH was defined as an LV mass >/=50 g/m(2.7) in men and >/=47 g/m(2.7) in women. During a median follow-up of 8.3 years, 32 subjects developed LVH (sedentary, 10.3%; active, 1.7%, P = 0.000). In a logistic regression, physically active groups combined (n = 173) were less likely to develop LVH than sedentary group with a crude OR = 0.15 (CI, 0.05-0.52). After controlling for sex, age, family history for hypertension, hypertension duration, body mass, blood pressure, baseline LV mass, lifestyle factors, and follow-up length, the OR was 0.24 (CI, 0.07-0.85). Blood pressure declined over time in physically active subjects (-5.1 +/- 17.0/-0.5 +/- 10.2 mmHg) and slightly increased in their sedentary peers (0.0 +/- 15.3/0.9 +/- 9.7 mmHg, adjusted P vs. active = 0.04/0.06). Inclusion of changes in blood pressure over time into the logistic model slightly decreased the strength of the association between physical activity status and LVH development (OR = 0.25, CI, 0.07-0.87).

Conclusion: Regular physical activity prevents the development of LVH in young stage 1 hypertensive subjects. This effect is independent from the reduction in blood pressure caused by exercise.
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http://dx.doi.org/10.1093/eurheartj/ehn533DOI Listing
January 2009