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Analysis of Ornidazole Injection in Clinical Use at post-marketing Stage by Centralized Hospital Monitoring System

Current Medical Science 2019年第5期39卷 836-842页

作者： Ying ZHAO Zhe CHEN Pu HUANG Si-wei ZHENG Qi-ling XU Chen SHI Department of Pharmacy Union HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430022China Assumption College Worcester Mass 01609USA

This study aims to analyze the clinical use of ornidazole injection at the post-marketing stage by centralized hospital monitoring system method,and investigate its widespread use in patients,in order to regulate and guide the rational drug use,improve the drug specificity and provide a basis for drug *** study adopts a prospective,multi-center,large sample size,centralized hospital monitoring *** selected five leading hospitals in Hubei province,and observed the inpatients who received the ornidazole injection from July 1,2015 to October 31,*** basic information of patients was recorded,as well as the drug use and adverse *** statistical analysis was performed based on these data.A total of 4396 individuals were enrolled in this study,most of them were middle-aged female patients and the ornidazole injection was mainly used as prophylactic prior to surgery to prevent the infections,and surgical treatment of anaerobic infections,abdominal infections and pelvic *** irrational drug use existed mainly in the prescribing and administration process,including unreasonable dosing frequency,rapid intravenous drip speed and extended duration of drug *** cases of adverse reactions were collected during the monitoring,incidence rate of adverse reactions was 2.5‰;adverse drug reactions occurred within 30 *** study results fully reflected the usage of ornidazole injection in the real *** on the study,we calculated the adverse reaction incidence of ornidazole and identified the risk factors which may affect the safety of ornidazole *** results strongly recommend that the manufacturers should publish standards for inpatient use and doctors should prescribe with caution accordingly.

关键词： ornidazole injection centralized hospital monitoring system post-marketing reassessment clinical use adverse reaction

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post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome:A Multi-center,Randomized,Double-Blind,Double-Dummy and Positive Control Trial

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Chinese Journal of Integrative Medicine 2019年第12期25卷 887-894页

作者： TANG Xu-dong ZHANG Sheng-sheng HOU Xiao-hua LI Zhen-hua CHEN Su-ning FENG Pei-min YANG Xiao-nan LI Hui-zhen WU Jie-qiong XIA Pei-jun YANG Xiao-jun ZHOU Heng-jun WANG Hai-yan AI Yao-wei LI Kang Institute of Spleen-Stomach Diseases Xiyuan HospitalChina Academy of Chinese Medical SciencesBeijing(100091)China Department of Gastroenterology Beijing Hospital of Traditional Chinese MedicineCapital Medical UniversityBeijing(100010)China Department of Gastroenterology Union HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan(430022)China Department of Traditional Chinese Medicine Shengjing HospitalChina Medical UniversityShenyang(110004)China Department of Gastroenterology Affiliated Hospital of Chengdu University of Traditional Chinese MedicineChengdu(610075)China Department of Integrated Traditional Chinese and Western Medicine West China Hospital of Sichuan UniversityChengdu(610041)China Department of Gastroenterology the Second Affiliated Hospital of Tianjin University of Traditional Chinese MedicineTianjin(300250)China Department of Gastroenterology the Second Affiliated Hospital of Shaanxi College of Traditional Chinese MedicineXianyang(712000)Shaanxi ProvinceChina Department of Gastroenterology the Second Affiliated Hospital of Shandong Traditional Chinese Medicine UniversityJinan(250001)China Department of Gastroenterology Chongqing Traditional Chinese Medicine HospitalChongqing(400021)China Department of Gastroenterology Harbin Traditional Chinese Medicine HospitalHarbin(150076)China Department of Gastroenterology Yuncheng Central HospitalYuncheng(044031)Shanxi ProvinceChina Department of Gastroenterology The First Hospital of YichangYichang(443000)Hubei ProvinceChina Harbin Concise Pharmaceutical Technology Development Co. Ltd.Harbin(150001)China

Objective: To evaluate the efficacy and safety of Tongxiening Granules(痛泻宁颗粒, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea(IBS-D). Methods: A randomized, double-blind, double-dummy, and positive paral el control ed clinical trial was conducted from October 2014 to March 2016. Total y 342 patients from 13 clinical centers were enrolled and randomly assigned(at the ratio of 1:1) to a treatment group(171 cases) and a control group(171 cases) by a random coding table. The patients in the treatment group were administered oral y with TXNG(5 g per time) combined with pinaverium bromide Tablet simulator(50 mg per time), 3 times per day. The patients in the control group were given TXNG simulator(5 g per time) combined with pinaverium bromide Tablets(50 mg per time), 3 times per day. The treatment course lasted for 6 weeks. The improvement of Irritable Bowel Syndrome Symptom Severity Score(IBS-SSS) was used to evaluate the primary outcome. Secondary outcomes included adequate relief(AR) rate, Irritable Bowel Syndrome-Quality of Life Questionnaire(IBS-QOL), Hamilton Anxiety Scale(HAMA), Hamilton Depression Scale(HAMD), and the recurrence rate at fol ow-ups. Safety indices including the adverse events(AEs) and related laboratory tests were evaluated. Results: Primary outcome: IBS-SSS at baseline, weeks 2, 4, 6 showed no statistical significance in both full analysis set(FAS) and per protocol set(PPS, P>0.05). After 6 weeks of treatment, the total effective rate of IBS-SSS scores in the treatment group(147/171, 86.0%) was higher than the control group(143/171, 83.6%) by FAS(P>0.05). In regard to secondary outcomes, after 6-week treatment, there was no significant difference in AR rate, total score of IBS-QOL, improvement of HAMD and HAMA total scores between the two groups(P>0.05). The recurrence rate at 8-week fol ow-up was 12.35%(10/18) in treatment group and 15.79%(12/76) in control group, respectivery(P>0.05). A total of 21 AEs occurred in 1

关键词： Tongxiening Granules irritable bowel syndrome with predominant diarrhea post-marketing evaluation randomized controlled trial

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Safety and Efficacy of Combination Therapy with Insulin Glargine and Oral Hypoglycaemic Agents Including DPP-4 Inhibitors in Japanese T2DM Patients: ALOHA 2 Study, a post-marketing Surveillance for Lantus<sup>®</sup>

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Journal of Diabetes Mellitus 2014年第4期4卷 273-289页

作者： Masayuki Kobayashi Shoko Tsukube Yukio Ikeda Yujin Shuto Sanofi K.K. Tokyo Japan Sanofi K.K. Tokyo Japanc

Aims: In the Add-on Lantus®?to Oral Hypoglycaemic Agents 2 (ALOHA 2) Study in Japanese adults with type 2 diabetes mellitus (T2DM), data on the safety and efficacy of combination therapy with insulin glargine (Lantus®) and oral anti-hyperglycaemic drugs (OADs) including dipeptidyl peptidase-4 (DPP-4) inhibitors in a real-life setting were collected and analyzed. Methods: This postmarketing surveillance was a prospective, observational, 24-week study that complied with the pharmaceutical affairs law and the ministerial ordinance of “Good post-marketing Study Practice (GPSP)” in Japan. Safety, efficacy and patient-reported outcomes (PROs);patients’ satisfaction with treatment (DTSQs and DTSQc) and patients’ self-reported health (EQ-5D and EQ-VAS) of combination therapy of insulin glargine and OADs were evaluated. Results: A total of 2,630 patients were enrolled. Of the 2,602 patients in the safety analysis population, 161 patients experienced 175 cases of adverse drug reactions, and the major adverse drug reaction was hypoglycaemia (140 patients, 5.38%). Out of those with hypoglycaemia, 11 patients (0.42%) had severe hypoglycaemia and the incidence rate (episodes per patient-year) was 0.019. Basal supported oral therapy (BOT) with insulin glargine substantially reduced the HbA1c, FPG and 2 hour-PPG levels for 24 weeks by -1.61%, -54.4 mg/dL and -74.5 mg/dL respectively. The mean weight was increased, however the change was +0.50 kg. In addition, the treatment satisfaction scores of DTSQs (mean treatment satisfaction score increased 3.6 from baseline to last observation) and DTSQc, EQ-5D index scores and EQ-VAS scores were significantly improved. Conclusion: Insulin glargine and OADs combination therapy was suggested to be effective and well tolerated. Patients’ satisfaction with treatment and their self-reported health improved in spite of the addition of injections to oral agents. The combination therapy of insulin glargine and OADs including DPP-4 inhibitors

关键词： ALOHA 2 Insulin Glargine Patient-Reported Outcomes post-marketing Surveillance Study Type 2 Diabetes

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Safety and Diagnostic Image Quality of Ultravist<sup>®</sup>in an Unselected Sub-Set of Chinese Patients: Data Analyses from a Previous post marketing Surveillance

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Open Journal of Radiology 2017年第1期7卷 63-74页

作者： Shuixing Zhang Changhong Liang Ziping Li Jary Wang Department of Radiology Guangdong General Hospital/Guangdong Academy of Medical Sciences Guangzhou China Department of Radiology The First Affiliated Hospital of Sun Yat-sen University Guangzhou China Medical & Scientific Affairs Bayer HealthCare Pharmaceuticals Beijing China

Background: Iopromide (Ultravist®) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the safety, tolerability and diagnostic image quality of Iopromide in an unselected sub-set of the Chinese population. Methods: we analysed data for Chinese ambulatory and in-patients who received Iopromide for an imaging procedure (in accordance with the local package insert and routine clinical practice), as part of an international post-marketing surveillance study. Use of premedication was at the discretion of the attending physician. Patient demographics, clinical history, type of examination, contrast quality and tolerability, including pre-specified adverse drug reactions, were recorded. All statistical analyses were descriptive. Results: case report forms for 20,000 Chinese patients (61.3% men) were analysed, of whom 153 patients (0.77%) had risk factors for idiosyncratic contrast media reactions (at-risk group). Use of premedication, most commonly corticosteroids, was recorded for 5658 patients (28.3%) and 86 at-risk patients (56.2% of the at-risk group), respectively. The mean (±standard deviation) dose of iodine administered was 29 ± 5.5 g. During the physician’s evaluation of image parameters, contrast quality was considered to be “good” (64.7%) or “excellent” (29.3%) in the majority of patients. 571 patients (2.9%) experienced at least one adverse drug reaction [most frequently nausea (0.70%) and dysgeusia (0.62%)], which were typically transient and of mild intensity. Two serious adverse drug reactions were reported [edema (n = 1), decreased blood pressure and dyspnea (n = 1)]. The incidence of adverse drug reactions was increased in the at-risk group versus the overall patient population, and tended to reduce with premedication (mainly corticosteroids). Conclusions: Iopromide was well tolerated and proved to be an efficient contrast agent in a lar

关键词： Contrast Media Iopromide Adverse Drug Reaction Chinese Sub-Population post-marketing Surveillance

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