| ObjectiveThrough the meta analysis of the clinical randomized controlled trial of traditional Chinese medicine injections on heart failure,the efficacy and safety of traditional Chinese medicine injections in the intervention of heart failure were evaluated from 6 outcome indexes,so as to provide evidence-based medical evidence for the intervention of these injections on heart failure and provide some guidance for clinical medication.MethodsAccording to the meta analysis and writing process stipulated by Cochrane collaboration Network,we formulate the retrieval strategy and search the relevant databases:,China National Knowledge lnfrastructure(CNKI)database,Wanfang Medical Database,VIP Journal full-text Database(VIP),Chinese Biomedical Literature Service system(CBM);English Database:Pubmed,Embase,web of science and Cochrane library.The related literatures about the intervention of traditional Chinese medicine injection on heart failure were searched,and the database was established until February 2021.After excluding the duplicate literatures,Though the established inclusion and exclusion criterias choosing the literatures,then import the literatures into NoteExpress software,extract data from the final included literatures,and evaluate the included literatures according to the bias risk assessment method recommended by Cochrance collaboration Network.The data of the 6 outcome indexes were imported into RevMan5.4 software.All the figures related to meta analysis were carried out in RevMan5.4 software,using random effect model combined with effect.When testing the heterogeneity of the study,if the heterogeneity(I2)is less than 50%,the heterogeneity is acceptable;if it is more than 50%,the source of heterogeneity is found by sensitivity analysis、subgroup analysis、meta regression and so on.If the source of heterogeneity can not be found,only descriptive analysis is carried out.The odds ratio(OR)value of the binary variable is selected as the merge statistic,and the confidence interval(CI)is 95%.For the continuous variables,the mean difference MD are selected as the merge statistic,and the Cl is 95%.Z test was used to determine whether the final combined effect was statistically significant,if the probability value(P)>0.5,the difference was not statistically significant;P≤0.05,the difference was statistically significant.At last,the funnel chart was drawn to evaluate the stability and reliability of the results when the number of intervention literatures in the outcome index was more than 10.ResultsA total of 3135 related literatures were obtained from the database,and 57 literatures were selected to meet the criteria.All of them were randomized controlled trials,a total of 9374 patients were included,including 4731 patients in the treatment group and 4644 patients in the control group,with a maximum sample size of 328 patients and a minimum sample size of 100 patients.Among the included literatures,47 articles[9-12,14-18,19-25,26,29,30,33,34,37,39,40,42-50,52-54,56-65]reported the clinical effect of improving cardiac function classification Ⅰ-Ⅱ and effective rate of symptom and physical sign,51 articles[9-19,21,22,24-29,31-38,39,43,41,43,47,49,61,63-65]reported the left ventricular ejection fraction and 14[14,15,26,28,30,31,33,44-47,57,59,66]for N-terminal precursor B-type natriuretic peptide and 14[14,15,17,33,44,46,48,54,55,56,58,62,64,65]reported 6-minute walking distance respectively.19[14,15,25,29,31,33,35,36,38,45-48,56,60,52,55,58,66]reported left ventricular end-systolic diameter,27 articles[9,13,14,15,17,29.32-34,35.36,38,45-48,52,53,55,56,58,60,61,64.66]reported left ventricular end-diastolic diameter,2 reported mortality[28,55],1 reported Hospitalization time[29],2 reported Lees heart failure score[27,58],1 reported quality of life[56]Adverse reactions were reported in 11 articles[14,28,33,34,38,48,52,57-60]Meta-analysis results of clinical effect of improving cardiac function classification Ⅰ-Ⅱ and effective rate of symptom and physical sign:XinXiong sodium chloride injection Chi2=0.05,df=1(P=0.83),I2=0,P=0.0002;Salvianolate injectionChi2=0.02,df=1(P=0.89),I2=0,P=0.0004;FuF angDanS hen injection Chi2=0.91.df=1(P=0.34),I2=0,P=0.001;DaZhuHongJingTian injectionChi2=0.06,df=2(P=0.97),I2=0,P<0.0001;XueSaiTong injection Chi2=0.54,df=2(P=0.76),I2=0,P<0.00001;DanShenChuanXiongQin injection Chi2=0.31,df=3(P=0.96),I2=0,P<0.00001;DanHong injection Chi2=15.76,df=8(P=0.05),I2=49,P<0.00001.XinMaiLong injectionChi2=11.35,df=15(P=0.73),I2=0,P<0.00001.Among the 7 interventions,Danhong injection had moderate heterogeneity,while the rest of the interventions had no heterogeneity.The results of Z test showed that the P values were all less than 0.05,which suggested that the seven interventions can improve cardiac function,it can be widely used in clinical treatment.but more high-quality literatures is needed to verify the evidence strength of the results.Results of meta analysis of left ventricular ejection fraction:ShuXueNing injectionChi2=0.88,df=1(P=0.35),I2=0,P<0.00001;XinXiong sodium chloride injectionChi2=0.00,df=1(P=0.95),I2=0,P<0.00001;DanShenChuanXiongQin injectionChi2=0.10,df=1(P=0.76),I2=0,P<0.00001;Salvianolate injectionChi2=1.91,df=3(P=0.59),I2=0,P<0.00001;DanShenTongIIAHuangSuanNa inj ectionChi2=5.3,df=3(P=0.15),I2=43,P<0.00001;After sensitive analysis,Da ZhuHongJingTian injectionChi2=2.17,df=2(P=0.34),I2=8,P<0.00001;After sensitive analysis,DanHong injection Chi2=1.72,df=4(P=0.79),I2=0,P<0.00001.Among the 8 kinds of intervention measures,There was mild heterogeneity in DaZhuHongJingTian injection and moderate heterogeneity in DanShenTongIIAHuangSuanNa injection.no heterogeneity in the ShuXueNing,XinXiong sodium chloride,DanShenChuanXiongQin,Salvianolate and DanHong injections.XinMaiLong injection had high heterogeneity,XinMaiLong injection was analyzed by subgroup analysis.Results of subgroup analysis and sensitivity analysis of XinMaiLong injection to course of treatment=10 days Chi2=1.84,df=3(P=0.61),I2=0,P<0.00001;The course of treatment of=14 days Chi2=15.87,df=9(P=0.07),I2=42,P<0.00001.The results of Z test were all P≤0.05,suggesting that the 8 interventions could improve the results of left ventricular ejection fraction in patients with heart failure,it can be widely used in clinical treatment.Due to the small number of documents and low quality of literature,more high-quality literature is needed to verify the evidence strength of the results.The results of meta analysis of N-terminal B-type natriuretic peptide precursor:after excluding the literature that caused heterogeneity and those that could not be analyzed by subgroup analysis and meta,only two articles of DanHong injection were analyzed by meta,Chi2=0.14,df=1(P<0.71),I2=0%,MD=-112.49,95CI%=(-117.06,-107.92),Z=48.26(P<0.00001).As the heterogeneity of literature is too large and the number of literature is too small,more high-quality literature is needed for further evidence.The results of meta analysis of N-terminal B-type natriuretic peptide precursor caused by the intervention of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis need to be carefully explained.Meta analysis results for 6-minute walking distance:After sensitive analysis,DanHong injectionChi2=0.00,df=1(P=0.98),I2=0%,Z=7.43(P<0.00001);XinMaiLong injectionChi2=1.65,df=2(P=0.44),I2=0%,Z=6.28(P<0.00001).here was no heterogeneity in the two interventions.2 interventions of the Z test results P<0.00001,indicating that the result in the treatment group was better than that in the control group.Because the quantity of literatures are too small and the great heterogeneity of the literature,the results need to be explained carefully and more high-quality literatures are needed to verify the evidence strength of the results.Meta analysis results for Left ventricular end-systolic diameter:After sensitive analysis,DanHong injectionChi2=3.27,df=2(P=0.19),I2=39%,P<0.00001;XinMaiLong injectionChi2=0.05,df=1(P=0.83),I2=0%,P<0.00001.There was mild heterogeneity in DanHong injection and no heterogeneity in XinMaiLong injection.P<0.00001,indicating that the result in the treatment group was better than that in the control group.Because the quantity of literatures are too small and the great heterogeneity of the literature,the results need to be explained carefully and more high-quality literatures are needed to verify the evidence strength of the results.Meta analysis results for Left ventricular end-diastolic diameter:After sensitive analysis,XinXiong sodium chloride injection Chi2=0.86,df=1(P=0.35),I2=0%,P<0.00001;DanShenTongⅡAHuangSuanNa injectionChi2=0.01,df=1(P=0.92),I2=0%,P<0.00001;DaZhuHongJingTian injectionChi2=0.00,df=1(P=0.99),I2=0%,P<0.0001;DanHong injectionChi2=2.31,df=2(P=0.31),I2=14%,P<0.00001;There was no heterogeneity in XinXiong sodium chloride injection,DanShenTongⅡAHuangSuanNa inj ection and DaZhuHongJingTian injection.DanHong injection had mild heterogeneity,XinMaiLong injection had high heterogeneity.XinMaiLong injection was analyzed by subgroup analysis.The course of treatment of XinMaiLong injection=14 daysChi2=3.93,df=4(P=0.42),I2=0%,P<0.00001;The course of treatment of XinMaiLong injection=10 days Chi2=49.06,df=4(P<0.00001),I2=92%,P=0.005.while there was no heterogeneity in the course of treatment of XinMaiLong injection is14 days.All the interventions P<0.0001,indicating that the result in the treatment group was better than that in the control group.However,the results need to be supported by more high-quality literature.The literatures with 10-day course of treatment of Xinmailong injection have great heterogeneity,and the source of heterogeneity can not be known,and the results need to be explained carefully.Meta analysis results for Adverse reaction:DaZhuHongJingTian injection:df=1(P=0.47),I2=0%,P=0.97;XinMaiLong injection:df=4(P=0.07),I2=54%,P=0.91.There was moderate heterogeneity of XinMaiLong injection.P>0.05,The results suggested that there was no significant difference in adverse reactions between the two intervention groups and the control group.but the number of literature is less,the degree of serviceability is not high,and more high-quality literature is needed to further support it.Conclusiontraditional Chinese medicine injections of activating blood flow and removing blood stasis has more obvious advantages in the treatment of heart failure.Traditional Chinese medicine combined with western medicine treatment can improve the objective index of western medicine,reduce symptoms and have fewer adverse reactions.In improving the clinical efficacy,XinXiong sodium chloride injection,Salvianolate injection,FuFangDanShen injection,DaZhuHongJingTian injection,XueSaiTong injection,DanShenChuanXiongQin injection,DanHong injection and XinMaiLong injection can improve cardiac function and symptoms and signs in patients with heart failure,it can be widely used in clinical treatment.In improving left ventricular ejection fraction,ShuXueNing injection,XinXiong sodium chloride injection,DanShenChuanXiongQin injection,Salvianolate injection,DanShenTong ⅡAHuangSuanNa injection,Da ZhuHongJingTian injection,DanHong injection and XinMaiLong injection can improve the result of left ventricular ejection fraction and can be widely used in clinical treatment.About 6-minute walking distance、left ventricular end-systolic diameter、Left ventricular end-diastolic diameter and Adverse reaction,need more high-quality literature to further support it.For the long-term outcome,more studies are needed to further verify whether the treatment of traditional Chinese medicine injections of activating blood flow and removing blood stasis combined with western medicine can improve the mortality and hospitalization rates.In the aspect of traditional Chinese medicine in the treatment of heart failure,taking this as a train of thought,traditional Chinese medicine has a broad prospect in the intervention of heart failure.In the future,more randomized controlled trials should be carried out to evaluate the efficacy of traditional Chinese medicine in the treatment of heart failure.We need to pay attention to the improvement of the quality of literatures and the setting of sample size,so as to improve the quality evaluation indicators and avoid the disadvantages such as poor quality of literatures,lack of evidence,careful interpretation of outcome indicators and so on. |
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