中国药物警戒 ›› 2018, Vol. 15 ›› Issue (7): 419-428.

• 安全性评价与合理用药 • 上一篇    下一篇

复方丹参滴丸与硝酸异山梨酯、单硝酸异山梨酯治疗冠心病心绞痛有效性和安全性的贝叶斯网状Meta分析

张丹丹1, 刘欢2, 陈嘉音2, 金晶2, 熊尧4, 杨悦2,3,*   

  1. 1沈阳药科大学生命科学与生物制药学院,辽宁 沈阳 110016;
    2沈阳药科大学工商管理学院,辽宁 沈阳 110016;
    3沈阳药科大学国际食品药品政策与法律研究中心,辽宁 沈阳 110016;
    4西南财经大学公共管理学院,四川 成都 611130
  • 收稿日期:2018-08-08 修回日期:2018-08-08 出版日期:2018-07-20 发布日期:2018-08-08
  • 通讯作者: *杨悦,女,博士,教授·博导,药事法规与药品政策。E-mail：yyue@vip.126.com
  • 作者简介:张丹丹,女,在读硕士,临床药学。

Bayesian Network Meta-analysis of Randomized Controlled Trials Comparing Fufangdanshen Dripping Pills, Isosorbide Nitrate and Isosorbide Mononitrate in Treating Coronary Heart Disease Angina

ZHANG Dandan1, LIU Huan2, CHEN Jiayin2, JIN Jing2, XIONG Yao4, YANG Yue2,3,*   

  1. 1School of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
    2School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
    3International Food&Drug Policy and Law Research Center, Liaoning Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
    4School of Public Administration, Southwestern University of Finance and Economics, Sichuan Chengdu 611130, China
  • Received:2018-08-08 Revised:2018-08-08 Online:2018-07-20 Published:2018-08-08

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摘要： 目的 采用贝叶斯网状Meta分析方法评价复方丹参滴丸与硝酸异山梨酯、单硝酸异山梨酯对比或联用治疗心绞痛的临床疗效。方法 计算机检索Cochrane Library、PubMed、EMbase、中国知网、万方、维普数据库,检索时间截至2017年12月10日,纳入复方丹参滴丸与硝酸异山梨酯、单硝酸异山梨酯对比或联用治疗心绞痛的随机对照研究,采用EndNote X8进行文献管理和去重。根据《Cochrane系统评价员手册》（5.3.3版）对纳入研究的质量进行评价,采用RevMan 5.0绘制风险评估图。网状Meta分析采用R软件（V.3.4.4）Gemtc程序包通过马尔科夫链-蒙特卡洛（MCMC）方法进行分析,使用等级排序概率表不同干预措施疗效优劣概率排序,Stata14.0绘制漏斗图以评估发表偏倚。直接Meta分析采用RevMan5.0软件进行分析。结果 共纳入41篇随机对照试验,包括4 679名患者。网状Meta分析结果：①心绞痛临床疗效（n=41）中复方丹参滴丸疗效最优的概率最大,复方丹参滴丸疗效优于硝酸异山梨酯、单硝酸异山梨酯[OR=3.7,95%Crl（2.9,4.7）;OR=4.3,95%Crl（1.7,13）],复方丹参滴丸+硝酸异山梨酯优于硝酸异山梨酯[OR=2.5,95%Crl（1.5,4.4）],复方丹参滴丸+单硝酸异山梨酯优于单硝酸异山梨酯[OR=3.6,95%Crl（2.4,5.5）];②心电图临床疗效（n=30）中复方丹参滴丸+单硝酸异山梨酯疗效最优概率最大,复方丹参滴丸优于硝酸异山梨酯[OR=2.7,95%Crl（2.2,3.3）],复方丹参滴丸+硝酸异山梨酯优于硝酸异山梨酯[OR=2.9,95%Crl（1.8,5.1)],复方丹参滴丸+单硝酸异山梨酯优于硝酸异山梨酯、单硝酸异山梨酯[OR=6.2,95%Crl（2.3,17）;OR=3.8,95%Crl（2.5,5.9）];③不良反应（n=26）中复方丹参滴丸不良反应最小概率最大,复方丹参滴丸不良反应较硝酸异山梨酯、单硝酸异山梨酯较小[OR=0.036,95%Crl（0.0061,0.093）;OR=0.049,95%Crl（0.0022,0.40）],联用时不增加硝酸酯类不良反应。与直接Meta分析结果基本一致。结论 复方丹参滴丸对比硝酸异山梨酯、单硝酸异山梨酯在改善心绞痛疗效、心电图临床疗效、不良反应方面更具有优势,与硝酸异山梨酯、单硝酸异山梨酯联用不增加不良反应。然而纳入的随机对照研究质量不高,需要更高质量的试验支持本研究结论。

关键词: 复方丹参滴丸, 硝酸异山梨酯, 单硝酸异山梨酯, 贝叶斯网状Meta分析

Abstract: Objective To evaluate the safety and efficacy of Fufangdanshen dripping pills, isosorbide nitrate and isosorbide mononitrate in treating angina by Bayesian network meta-analysis. Methods Randomized controlled trials comparing Fufangdanshen dripping pills, isosorbide nitrate and isosorbide ononitrate in treating angina were searched in the Cochrane Library, PubMed, EMBASE, CNKI, Wanfang and Weipu databases. Search time was as of December 10, 2017. The EndNote X8 was used to document management and deduplication. Cochrane Reviewers handbook(5.3.3) was used to evaluate quality of studies included. The risk of bias was evaluated by RevMan(V.5.0). The Gemtc package of R software(V.3.4.4) was used to carry out Bayesian network meta-analysis through the Markov chain-Monte Carlo (MCMC). Rank probabilities were used to evaluate efficacy of different treatments. Stata 14.0 draws funnel maps were used to evaluate publication bias. Direct meta-analysis was evaluated by RevMan(V.5.0). Results 41 RCTs and 4 679 patients were included. Network meta-analysis shows: ①Probability of the efficacy of Fufangdanshen dripping pills was the biggest in angina clinical efficacy(n=41), Fufangdanshen dripping pills was more effective than isosorbide nitrate and isosorbide mononitrate[OR=3.7,95%Crl(2.9,4.7), OR=4.3,95%Crl(1.7,13)], Fufangdanshen dripping pills+isosorbide nitrate is more effective than isosorbide nitrate[OR=2.5,95%Crl(1.5,4.4)], Fufangdanshen dripping pills+isosorbide mononitrate was more effective than isosorbide mononitrate [OR=3.6,95%Crl(2.4,5.5)]; ②Probability of the efficacy of Fufangdanshen dripping pills+isosorbide mononitrate was the biggest in ECG clinical efficacy(n=30), Fufangdanshen dripping pills was more effective than isosorbide nitrate[OR=2.7,95%Crl(2.2,3.3)], Fufangdanshen dripping pills+isosorbide nitrate was more effective than isosorbide nitrate[OR=2.9,95%Crl(1.8,5.1)], Fufangdanshen dripping pills+isosorbide mononitrate was more effective than isosorbide nitrate and isosorbide mononitrate[OR=6.2,95%Crl(2.3,17); OR=3.8,95%Crl(2.5,5.9)]; ③Probability of the efficacy of Fufangdanshen dripping pills was the biggest in adverse drug reaction (n=26), Fufangdanshen dripping pills are smaller than isosorbide nitrate and isosorbide mononitrate in adverse drug reactions[OR=0.036, 95%Crl(0.0061,0.093; OR=0.049, 95%Crl(0.0022, 0.40). There was no difference between the incidence of adverse reactions of Fufangdanshen dripping pills+nitrate drugs and nitrate drugs. The above results were consistent with the direct meta analysis. Conclusion Fufangdanshen dripping pills was more effective than isosorbide nitrate and isosorbide mononitrate in angina clinical efficacy and ECG clinical efficacy and adverse drug reactions. There was no difference between the incidences of adverse reactions of fangdanshen dripping pills+nitrate drugs and nitrate drugs. However, The quality of randomized controlled trials incluced were low. The study results are still supported by high-quality research.

Key words: Fufangdanshen dripping pills, isosorbide nitrate, isosorbide mononitrate, bayesian network meta-analysis

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