Chinese Journal of Pharmacovigilance ›› 2018, Vol. 15 ›› Issue (7): 419-428.

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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

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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