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| 中药治疗糖尿病视网膜病变的安全性系统评价 |
| Systematic Review of Safety on Randomized Controlled Trials of Chinese Medicine for Diabetic Retinopathy |
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| DOI： |
| 中文关键词: 糖尿病视网膜病变 中药 中成药 安全性 系统评价 |
| 英文关键词:Diabetic retinopathy Traditional Chinese medicine Chinese patent medicine Safety Systematic review |
| 基金项目: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） |
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| 中文摘要: |
| 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、PubMed、CNKI、SinoMed、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，4 104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。 |
| 英文摘要: |
| ABSTRACT Objective:To make a summary and assessment of traditional Chinese medicines(TCM) formula, Chinese patent medicine and safety index of TCM for diabetic retinopathy (DR). Methods:The randomized clinical trials (RCTs) of Chinese medicine for DR were searched in 6 databases from their inception to December, 2015. The risk of bias assessment tool which recommended by Cochrane handbook was used to evaluated methodological quality. Two authors independently screened for inclusion, extracted data and assessed the risk of bias. RevMan 5.3 was applied to analyse data. Results: 56 studies and 4 104 participants were included. 37 kinds of TCM decoction and 15 kinds of Chinese patent medicine were used. Three trials were assessed as low risk of bias and the other trials were high. 14 studies reported safety index and 5 studies had observed adverse events.Conclusion:The purpose of current clinical trials was to investigate the efficacy of drugs; the safety of drugs needed more attention. The results suggested improving the observations and reports of safety index for enhancing the clinical reference value in future research. |
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