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通心络胶囊与丹参滴丸治疗冠心病心绞痛间接比较的系统评价
贾永亮1; 张时开1; 鲍菲飞1; 黄芳艺2; 梁少伟1,3
2011
Source Publication中国循证医学杂志
ISSN1672-2531
Volume11Issue:8Pages:919-931
Abstract

目的 已有数百篇关于复方丹参滴丸和通心络胶囊治疗冠心病心绞痛的随机对照试验报告发表,但尚
未见相关系统评价。本研究旨在遵循PRISMA 声明,系统评价通心络胶囊与复方丹参滴丸治疗冠心病心绞痛的临
床疗效,并提供间接比较通心络胶囊与复方丹参滴丸疗效的方法。方法 检索CNKI 等电子数据库并筛选出符合
纳入标准的RCT,用Jadad 评分量表进行质量评价。提取包括作者数量、样本量、疗程在内的RCT 基本特征和以
症状改善为主要治疗指标的数据,并统计不良事件。取优势比(OR)和95% 可信区间(CI)衡量效应值,然后采用
RevMan 5.0 软件进行Meta 分析、亚组分析、敏感性分析和其它统计分析。结果 共纳入65 个RCT,合计6 969 例
患者。其Jadad 评分量表的平均得分为2.11。通心络胶囊对比消心痛的总体疗效OR 为3.66[95%CI(2.67,5.02)],
复方丹参滴丸对比消心痛的总体疗效OR 为2.38[95%CI(1.90,2.99)]。两者总体疗效OR 有顯著差別(W=521.5,
P=0.049 45)。统计分析未发现可显著影响结果稳定性的因素。复方丹参滴丸和通心络胶囊不良事件发生率分别为
2.37% 和2.11%。结论 虽然纳入RCT 的质量不高,但通心络胶囊和复方丹参滴丸治疗心绞痛的疗效均显著好于
硝酸异山梨酯片,且有较弱的证据表明通心络胶囊的疗效优于复方丹参滴丸。

Other Abstract

Objective Danshen dripping pill (DSP) and tongxinluo capsule (TXL) are popular Chinese medicinal
products and often compared with isosorbide dinitrate (ISDN) in treating angina pectoris. Hundreds of randomized
controlled trials (RCTs) about DSP and TXL have been published; however, there has been no systematic review on comparing
DSP with TXL. Th is study aims to provide a comprehensive PRISMA-compliant systematic review with sensitivity
analysis and subgroup analysis to valuate indirectly the effi cacies of DSP and TXL in treating angina pectoris. Methods
RCTs published between 1994 and 2009 on DSP and TXL in treating angina pectoris for four or more weeks were
retrieved from databases. Th e qualities of RCTs included were evaluated with Jadad scale. Meta-analysis was performed
on overall eff ects of symptomatic and electrocardiographic (ECG) improvements. Odds ratios (OR) and 95% confi dence
intervals (95%CI) were used to measure the eff ect size. Subgroup analysis, sensitivity analysis and meta-regression were
conducted on basic characteristics of RCTs. Results 65 RCTs with 6 969 participants were included. Average Jadad
score was 2.11. Overall ORs were 3.66 (95%CI 2.67 to 5.02) for TXL versus ISDN and 2.38 (95%CI 1.90 to 2.99) for DSP
versus ISDN. Th ere was a signifi cant diff erence (W=521.5, P=0.049 45) in ORs between DSP and TXL. Statistical analyses
found no signifi cant factors aff ecting overall effi cacies of TXL and DSP. Th e rates of adverse events under DSP and TXL
treatments were 2.37% and 2.11%, respectively. Conclusion DSP and TXL are more eff ective than ISDN in treating angina
pectoris. TXL might be more eff ective than DSP. However, further RCTs of larger scale, multi-centre/country, longer
follow-up periods and higher quality are still required to verify.

Keyword复方丹参滴丸 通心络胶囊 冠心病心绞痛 随机对照试验 系统评价 Meta 分析
Language中文Chinese
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
Affiliation1.中国澳门特别行政区澳门大学中华医药研究院(澳门 999078)
2.中国澳门特别行政区澳门大学社会科学及人文学院(澳门 999078)
3.National e-Science Institute, School of Informatics, University of Edinburgh, Edinburgh EH8 9AB, United Kingdom
First Author AffilicationUniversity of Macau
Recommended Citation
GB/T 7714
贾永亮,张时开,鲍菲飞,等. 通心络胶囊与丹参滴丸治疗冠心病心绞痛间接比较的系统评价[J]. 中国循证医学杂志, 2011, 11(8), 919-931.
APA 贾永亮., 张时开., 鲍菲飞., 黄芳艺., & 梁少伟 (2011). 通心络胶囊与丹参滴丸治疗冠心病心绞痛间接比较的系统评价. 中国循证医学杂志, 11(8), 919-931.
MLA 贾永亮,et al."通心络胶囊与丹参滴丸治疗冠心病心绞痛间接比较的系统评价".中国循证医学杂志 11.8(2011):919-931.
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