中藥治療糖尿病視網(wǎng)膜病變的安全性系統(tǒng)評價
發(fā)布時間:2018-03-03 01:22
本文選題:糖尿病視網(wǎng)膜病變 切入點:中藥 出處:《藥物流行病學雜志》2017年03期 論文類型:期刊論文
【摘要】:目的:對中藥治療糖尿病視網(wǎng)膜病變的中藥組方、中成藥信息及文中報道的安全性指標進行概述及評價。方法:系統(tǒng)檢索Cochrane Library、Pub Med、CNKI、Sino Med、VIP和萬方數(shù)據(jù)庫,從建庫至2015年12月。納入中藥與常規(guī)治療或西藥或安慰劑比較的隨機對照試驗。兩名作者獨立進行文獻篩選、資料提取和納入研究質(zhì)量評價,質(zhì)量評價采用Cochrane協(xié)作網(wǎng)的偏倚風險評估工具。應用RevMan 5.3進行數(shù)據(jù)分析。結(jié)果:共納入56項研究,4104名受試者。中藥治療方法包括37種中藥湯劑,15種中成藥。3個試驗評價為低偏倚風險,其余為高偏倚風險。14項試驗報告了安全性指標,5項試驗發(fā)生了不良事件。結(jié)論:雖然本研究結(jié)果顯示中藥治療組與對照組相比患者不良事件發(fā)生情況無差異,但是現(xiàn)有的臨床試驗對藥物安全性重視程度不夠,建議今后的研究能夠完善對安全性指標的監(jiān)測及報告,增加研究的臨床參考價值。
[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.
【作者單位】: 北京中醫(yī)藥大學循證醫(yī)學中心;
【基金】:2013年教育部新世紀優(yōu)秀人才支持計劃項目(編號:NCET-13-0694) 2013年北京市科技新星計劃項目(編號:Z131107000413031)
【分類號】:R259;R276.7
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