吡格列酮在印度2型糖尿病患者中的应用、疗效及安全性：一项系统评价及与欧洲药品管理局评估报告的比较
Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report.
作者信息
Pai Sarayu A, Kshirsagar Nilima A
机构信息
National Institute for Research in Reproductive Health (ICMR), Mumbai, India.
出版信息
Indian J Med Res. 2016 Nov;144(5):672-681. doi: 10.4103/ijmr.IJMR_650_15.
BACKGROUND & OBJECTIVES: With pioglitazone ban and subsequent revoking in India along with varying regulatory decisions in other countries, it was decided to carry out a systematic review on its safety, efficacy and drug utilization in patients with type 2 diabetes mellitus (T2DM) in India and compare with the data from the European Medicines Agency Assessment Report (EMA-AR).
METHODS
Systematic review was performed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, searching Medline/PubMed, Google Scholar and Science Direct databases using 'pioglitazone AND India AND human' and 'pioglitazone AND India AND human AND patient' and compared with EMA-AR. Spontaneous reports in World Health Organization VigiBase from India were compared with VigiBase data from other countries.
RESULTS
Sixty six publications, 26 (efficacy), 32 (drug utilization) and eight (safety), were retrieved. In India, pioglitazone was used at 15-30 mg/day mostly with metformin and sulphonylurea, being prescribed to 26.7 and 8.4 per cent patients in north and south, respectively. The efficacy in clinical trials (CTs) was similar to those in EMA-AR. Incidence of bladder cancer in pioglitazone exposed and non-exposed patients was not significantly different in an Indian retrospective cohort study. There were two cases and a series of eight cases of bladder cancer published but none reported in VigiBase.
INTERPRETATION & CONCLUSIONS: In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed.
背景与目的
随着吡格列酮在印度被禁及随后的解禁，以及其他国家不同的监管决定，决定对其在印度2型糖尿病（T2DM）患者中的安全性、有效性和药物利用情况进行系统评价，并与欧洲药品管理局评估报告（EMA - AR）的数据进行比较。
方法
按照系统评价和Meta分析的首选报告项目（PRISMA）指南进行系统评价，使用“吡格列酮 AND 印度 AND 人类”以及“吡格列酮 AND 印度 AND 人类 AND 患者”检索Medline/PubMed、谷歌学术和科学Direct数据库，并与EMA - AR进行比较。将印度在世界卫生组织药物不良反应数据库中的自发报告与其他国家的药物不良反应数据库数据进行比较。
结果
检索到66篇出版物，其中26篇（有效性）、32篇（药物利用）和8篇（安全性）。在印度，吡格列酮大多以15 - 30毫克/天的剂量与二甲双胍和磺脲类药物联合使用，分别有26.7%和8.4%的北方和南方患者使用。临床试验（CTs）中的疗效与EMA - AR中的相似。在一项印度回顾性队列研究中，暴露于吡格列酮和未暴露于吡格列酮的患者中膀胱癌的发生率没有显著差异。有两篇关于膀胱癌的病例报道以及一系列八例膀胱癌病例发表，但在药物不良反应数据库中均未报告。
解读与结论
在印度，可能由于剂量较低、膀胱癌的背景发病率较低以及流行病学研究中的样本量较小，未发现膀胱癌与吡格列酮之间存在显著关联。需要分别向印度临床试验注册中心和印度药物警戒计划报告CTs和药物不良反应，同时进行与药品说明书中的警告相符的研究以及更大样本量的流行病学研究。
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