中药治疗糖尿病视网膜病变的安全性系统评价

发布时间：2018-03-03 01:22

本文选题：糖尿病视网膜病变　切入点：中药　出处：《药物流行病学杂志》2017年03期 　论文类型：期刊论文

【摘要】：目的:对中药治疗糖尿病视网膜病变的中药组方、中成药信息及文中报道的安全性指标进行概述及评价。方法:系统检索Cochrane Library、Pub Med、CNKI、Sino Med、VIP和万方数据库,从建库至2015年12月。纳入中药与常规治疗或西药或安慰剂比较的随机对照试验。两名作者独立进行文献筛选、资料提取和纳入研究质量评价,质量评价采用Cochrane协作网的偏倚风险评估工具。应用RevMan 5.3进行数据分析。结果:共纳入56项研究,4104名受试者。中药治疗方法包括37种中药汤剂,15种中成药。3个试验评价为低偏倚风险,其余为高偏倚风险。14项试验报告了安全性指标,5项试验发生了不良事件。结论:虽然本研究结果显示中药治疗组与对照组相比患者不良事件发生情况无差异,但是现有的临床试验对药物安全性重视程度不够,建议今后的研究能够完善对安全性指标的监测及报告,增加研究的临床参考价值。
[Abstract]:Objective: to summarize and evaluate the traditional Chinese medicine prescription for diabetic retinopathy, the information of Chinese patent medicine and the safety index reported in this paper. From the establishment of the library to December 2015. The randomized controlled trials in which traditional Chinese medicine was compared with conventional therapy or western medicine or placebo. The two authors independently conducted literature screening, data extraction and evaluation of the quality of the study. The quality evaluation was carried out with the bias risk assessment tool of Cochrane cooperation network. The data were analyzed with RevMan 5.3. Results: a total of 4104 subjects were included in 56 studies. The therapeutic methods of traditional Chinese medicine included 37 kinds of traditional Chinese medicine decoction and 15 kinds of Chinese patent medicine. Three experiments were conducted. Evaluated as low bias risk, The other 14 trials reported adverse events in 5 trials. Conclusion: although the results of this study showed that there was no difference in the occurrence of adverse events between the Chinese medicine treatment group and the control group, there was no significant difference in the incidence of adverse events between the Chinese medicine treatment group and the control group. However, the current clinical trials do not pay enough attention to the safety of drugs. It is suggested that future studies can improve the monitoring and reporting of safety indicators and increase the clinical reference value of the research.
【作者单位】：北京中医药大学循证医学中心;
【基金】：2013年教育部新世纪优秀人才支持计划项目(编号:NCET-13-0694) 2013年北京市科技新星计划项目(编号:Z131107000413031)
【分类号】：R259;R276.7

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