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[1]张云皎 刘兆兰 柴倩云 严晓艺 韩梅 刘建平.辨证论治糖尿病视网膜病变随机对照临床试验系统综述[J].环球中医药,2016,9(07):881-886.[doi:10.3969/j.issn.1674-1749.2016.07.038]
　ZHANG Yun-jiao,LIU Zhao-lan,CHAI Qian-yun,et al.A systematic review of randomized controlled clinical trials of TCM with syndrome differentiation and treatment in treating diabetic retinopathy[J].,2016,9(07):881-886.[doi:10.3969/j.issn.1674-1749.2016.07.038]
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辨证论治糖尿病视网膜病变随机对照临床试验系统综述()
     
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《环球中医药》[ISSN:1006-6977/CN:61-1281/TN]

卷:
第9卷
期数:
2016年07期
页码:
881-886
栏目:
综述
出版日期:
2016-07-06

文章信息/Info

Title:
A systematic review of randomized controlled clinical trials of TCM with syndrome differentiation and treatment in treating diabetic retinopathy
作者:
张云皎 刘兆兰 柴倩云 严晓艺 韩梅 刘建平
100029 北京中医药大学循证医学中心[张云皎(硕士研究生)、刘兆兰、严晓艺(硕士研究生)、韩梅、刘建平]；中医杂志社(柴倩云)
Author(s):
ZHANG Yun-jiao;  LIU Zhao-lan; CHAI Qian-yun; et al.
Center for Evidence-Based Medicine, Beijing University of Chinese Medicine, Beijing 100029,China
关键词:
辨证论治; 中药; 糖尿病视网膜病变; 随机对照临床试验; 系统综述
Keywords:
Syndrome differentiation and treatment; Traditional Chinese medicine; Diabetic retinopathy; Randomized clinical trials; Systematic review
分类号:
R587.1
DOI:
10.3969/j.issn.1674-1749.2016.07.038
文献标志码:
A
摘要:
目的 评价辨证论治中药治疗糖尿病视网膜病变的的疗效与安全性。方法 检索中国生物医学文献数据库、中国知网、维普网、万方数据库、PubMed、Cochrane Library中的临床试验注册库,纳入从建库至2015年12月的辨证论治中药治疗糖尿病视网膜病变的随机对照临床试验。设计资料提取表进行资料提取,文献质量评价采用Cochrane手册推荐的“偏倚风险”评估工具,数据分析使用RevMan 5.3软件。结果 纳入16项试验3612名受试者。2个试验评价为低偏倚风险,其余均为高偏倚风险。中药加常规治疗对比西药加常规治疗中,2项辨证为瘀血阻络的试验(106人)在降低全血黏度低切上有统计学意义(MD:-1.88 mPa.s,95%CI:[-2.13, -1.63])。中药加常规治疗对比安慰剂加常规治疗中,2项辨证为(气阴两虚、瘀血阻络)的试验(47人)在减少视网膜毛细血管无灌注区面积及毛细渗漏范围上有统计学差异(MD:-0.19 PD, 95%CI:[-0.34, -0.04]、MD:-0.15 PD,95%CI:[-0.25, -0.06])。纳入试验没有报告严重不良事件。 结论 辨证为气阴两虚、瘀血阻络的患者使用芪灯明目胶囊和芪明颗粒在减小视网膜毛细血管无灌注区及毛细血管渗漏范围上有潜在疗效且无严重不良事件发生。但由于纳入试验的样本量较小和辨证治疗的异质性较大,需要慎重解释结果并在将来的研究中加以验证。
Abstract:
Objective To evaluate the efficacy and safety of TCM with syndrome differentiation and treatment in treating diabetic retinopathy. Methods Randomized clinical trials(RCTs)of TCM with syndrome differentiation and treatment in treatment of DR in The Chinese Biomedical Database(SinoMed), China National Knowledge Infrastructure(CNKI), Chinese VIP Information(VIP), Chinese Academic Conference Papers Database and Chinese Dissertation Database(Wangfang), PubMed, Cochrane Library were selected from their inception to December, 2015. A data extraction form was used to extract data. The risk of bias tool which recommended by Cochrane handbook was used to evaluated methodological quality. RevMan 5.3 software was used to performed data analysis. Results 16 RCTs including 3612 subjects. Two trials were assessed as low risk of bias and the other trials were high. TCM combined with routine treatment compared with western medicine combined with routine treatment, 2 trials were belong to blood-stasis obstruction(106)in reducing the whole blood viscosity low shear was statistically significant(MD:-1.88 mPa.s,95%CI:[-2.13, -1.63]). TCM plus conventional medicine compared with placebo plus conventional medicine, retinal capillary non-perfusion zone area(n=47；2 trials；MD:-0.19 PD；95%CI:-0.34 to -0.04)and capillary leak scope(n=47；2trials；MD:-0.15 PD；95%CI:-0.25 to -0.06)had significance difference. No serious adverse events were reported. Conclusions For patients with deficiency of both Qi and Yin, blood stasis syndrome, using Qideng Mingmu capsule and Qi Ming granule in reducing retinal capillary non perfusion area and capillary leakage area has potential effect and has no serious adverse events. However, due to the small sample size and heterogeneity of syndrome differentiation treatment, the results of the study need to be carefully interpreted and validated in the future research.

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备注/Memo

备注/Memo:
基金项目: 国家中医药管理局“十二五”中医药行业科研专项(201207007)；北京中医药大学在读研究生项目(2015-JYB-XS139)
作者简介: 张云皎(1989- ),2013级在读硕士研究生。研究方向:中医药循证医学临床疗效与安全性评价。E-mail:yunjiao_zhang@163.com
通讯作者: 刘建平(1961- ),博士,教授,博士生导师。研究方向:中医药循证医学临床疗效与安全性评价。E-mail:jiangping_l@hotmail.com
更新日期/Last Update: 2016-07-06