罗格列酮安全性再评价:一项基于随机对照研究、队列研究、病例对照研究及病例报告的系统评价

发布时间：2018-05-10 16:08

  本文选题：糖尿病 + 罗格列酮　； 参考：《中国医院药学杂志》2017年21期

【摘要】：目的:评价与其他抗糖尿病口服药物相比,罗格列酮治疗2型糖尿病患者的安全性。方法:按照检索策略在EMbase、MEDLINE、The Cochrane library等6个数据库中进行电子检索,并人工进行补充检索。按纳入排除标准进行筛选,对纳入文献进行偏倚风险评估,并使用Revman 5.3软件进行统计学Meta分析。结果:共纳入63篇研究,其中随机对照试验17篇。研究结果显示,罗格列酮组的总不良反应发生率与其他口服糖尿病药物相比无显著差异,然而RCT研究结果提示罗格列酮组因不良反应退出的比例高于非TZD类药物组,但低于吡格列酮组。对于心脑血管不良反应发生率,RCT研究和队列研究结果都支持罗格列酮与其他糖尿病药物相比无统计学意义,但病例对照研究结果认为罗格列酮暴露组心脑血管不良反应发生率高于未暴露组。罗格列酮组的低血糖发生率与二甲双胍组无显著差异,且低于磺脲类。RCT研究结果提示罗格列酮组体质量升高的患者比例和水肿发生率高于其他口服降糖药。队列研究结果显示罗格列酮组的骨折发生率高于其他药物,但低于吡格列酮。对于膀胱癌的发病率,队列研究结果显示罗格列酮组发病率低于吡格列酮组以及其他非TZD类糖尿病药物组,而病例对照研究却得到了相反的结果。结论:应用罗格列酮治疗2型糖尿病,总体不良反应发生率不高于其他口服降糖药,且尚无确切证据证明该药致心脑血管事件的风险高于其他抗糖尿病药物,但应对其水肿、体质量增加、骨折的风险加以预防,并警惕其致肿瘤风险。
[Abstract]:Objective: to evaluate the safety of rosiglitazone in the treatment of type 2 diabetes. Methods: according to the retrieval strategy, electronic retrieval was carried out in 6 databases such as EMbase MEDLINEN and the Cochrane library, and supplementary retrieval was carried out manually. According to the inclusion exclusion criteria, the bias risk of the inclusion literature was evaluated, and the statistical Meta analysis was carried out using Revman 5.3 software. Results: a total of 63 studies were included, of which 17 were randomized controlled trials. The results showed that there was no significant difference in the incidence of total adverse reactions between rosiglitazone group and other oral diabetic drugs. However, the RCT study showed that rosiglitazone group had a higher rate of withdrawal due to adverse reactions than that of non-TZD drugs. But lower than pioglitazone group. Results of RCT and cohort studies support that rosiglitazone has no statistical significance compared with other diabetic drugs. Case-control study showed that the incidence of adverse cardiovascular and cerebrovascular reactions in rosiglitazone exposure group was higher than that in unexposed group. The incidence of hypoglycemia in rosiglitazone group was not significantly different from that in metformin group, and was lower than that in sulfonylurea .RCT study. The results showed that the proportion of patients with elevated body mass and the incidence of edema in rosiglitazone group were higher than those in other oral hypoglycemic drugs. The cohort study showed that rosiglitazone had a higher fracture rate than other drugs, but less than pioglitazone. Cohort studies showed that the incidence of bladder cancer in rosiglitazone group was lower than that in pioglitazone group and other non-diabetic drug groups, but the case-control study showed the opposite results. Conclusion: the overall adverse reaction rate of rosiglitazone in the treatment of type 2 diabetes is not higher than that of other oral hypoglycemic drugs, and there is no definite evidence to prove that the risk of cardiovascular and cerebrovascular events caused by rosiglitazone is higher than that of other antidiabetic drugs, but it should be treated with edema. Increased body mass, fracture risk to prevent, and to guard against its cancer risk.
【作者单位】： 山东大学药学院;山东省千佛山医院药学部;
【分类号】：R977.15
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本文编号：1869972