Objective To assess the methodological quality of clinical studies using Shen-Mai injection as an adjunct therapy to tumor chemotherapy and to evaluate its efficacy and safety. Methods A comprehensive search strategy was designed to identify all randomized controlled trials (RCT) comparing Shen-Mai injection plus routine chemotherapy versus routine chemotherapy alone by searching for the CBMdisc (issue 3) and TCMLRS database (1981-2001). The methodological quality of the trials was assessed by two reviewers independently for which a meta analysis was perfermed. Results Thirteen RCTs met the inclusion criteria. methodological quality was poor (all the trials included were level C). Compared with the control group, the combined outcome of Shen-Mai injection increased the effect of chemotherapy (OR 1.73 95%CI 1.27 to 2.34, P＝0.000 4), reduced the side effect of bone marrow inhibition (OR 0.29, 95%CI 0.16 to 0.52, P＝0.000 04) in WBC counting and (OR 0.11, 95%CI 0.02 to 0.49, P＝0.004 in PLT count. And Shen-Mai injection relieved the symptoms of nausea and vomiting (OR 0.26, 95%CI 0.16 to 0.43, Plt;0.000 01). Conclusions The methodological quality of the trails using Shen-Mai injection should be improved. Based on the results of the review and the meta-analysis, Shen-Mai injection may have positive effects on chemotherapy in patients with malignant tumor, although the evidence is weak. No serious adverse events are reported. Further well-designed clinical trials should be performed.
Objective To assess the efficacy and safety of Shenmai injection for children with viral myocarditis. Methods All randomized and quasi-randomized controlled trials (RCTs and quasi-RCTs) of Shenmai injection for children with viral myocarditis were searched from CBM (1981 to November 2009), CNKI (1980 to November 2009) and VIP (1989 to November 2009), The Cochrane Library (Issue 1,2010), PubMed (1966 to 2009), EMbase (1966 to 2009). Cochrane systematic reviews Handbook 5.0.1 was taken as a reference to quality evaluation of the included studies, and the Cochrane Collaboration’s RevMan 5.0 software was used for data analyses. Results A total of 15 RCTs were included. The quality of the included trials was low. The result of meta-analyses showed that: (1) The effective rate (RR 1.16, 95%CI 1.07 to 1.25) and the ECG improvement rate (RR 1.55, 95%CI 1.25 to 1.93) in Shenmai injection group were better than those in the control group. CK and CK-MB in Shenmai injection were lower than those in the control group, but the AST level was similar in the two groups. (2) The effective rate (RR 1.12, 95%CI 1.01 to 1.25) and the ECG improvement rate (RR 1.35, 95%CI 1.07 to 1.70) in Shenmai injection group were better than those in the western medicine plus routine therapy (RT) group. CK, AST and LDH in Shenmai injection group were lower than those in the western medicine plus RT group, but CK-MB was similar in the two groups. (3) The effective rate (RR 1.26, 95%CI 1.12 to 1.42) in Shenmai injection plus RT and western medicine group was better than that in RT and western medicine group. CK and LDH-1 in Shenmai injection plus RT and western medicine group were lower than those in RT and western medicine group. Adverse reactions of Shenmai injection in 4 studies included mild rash, rubicundity and chest distress. No severe adverse reactions were reported. Conclusion The evidence currently available shows that Shenmai injection may have some effect on children with viral myocarditis, including improving the effective rate, reducing myocardial enzymes and improving the ECG improvement rate. However, because of the low methodological quality of the included trials, this conclusion needs to be interpreted cautionsly, and more well-designed, high-quality RCTs need to be performed.
Objective To evaluate the clinical effect and safety of western medicine plus Shenmai Injection versus western medicine alone for heart failure (HF) patients. Methods We searched CNKI (January 1979 to April 2009), VIP (January 1989 to April 2009), CBM (1978 to 2009), PubMed (1978 to April 2009), The Cochrane Library (Issue 3, 2009), and other relevant databases and journals to identify randomized controlled trials (RCTs) about western medicine plus Shenmai Injection versus western medicine alone for HF patients. The methodological quality was assessed and the data was extralted according to the Cochrane Reviewer’s Handbook and related methods. Meta-analyses were performed using RevMan 5.0.2 software.Results Fifteen eligible studies involving 1174 HF patients were included. The results of meta-analyses showed that western medicine plus Shenmai Injection therapy could precisely improve the general therapeutic effects (RR=1.27, 95%CI 1.19 to 1.35, Plt;0.000 01), increase left ventricular ejection fraction (WMD=7.17, 95%CI 4.65 to 9.70, Plt;0.000 01), and make ventricular diastolic function better (minor weight literature: WMD=0.38, 95%CI 0.32 to 0.45, Plt;0.000 01; major weight literature: WMD=0.38, 95%CI 0.32 to 0.45). Meanwhile, only one study indicated that western medicine plus Shenmai Injection could increase 6-minute walking distance, reduce BNP, IL-6, and TNF-α levels, respectively. Conclusion By comparison with western medicine alone, western medicine plus Shenmai Injection can improve the therapeutic effect on HF patients.
ObjectiveTo systematically review the effectiveness of Shenmai injection for leukopenia after the tumor radiation and chemotherapy. MethodsSuch databases as PubMed (1966 to June 2013), The Cochrane Library (Issue 5, 2013), Web of Science (1980 to June 2013), VIP (1989 to June 2013), WanFang Data (1990 to June 2013), CNKI (1980 to June 2013) and CBM (1981 to June 2013) were searched to collect randomized controlled trials (RCTs) on Shenmai injection in treating leukopenia after the tumor radiation and chemotherapy. Literature selection, data extraction and methodological quality assessment of the included studies was conducted by two reviewers independently. Then meta-analysis was performed using RevMan 5.2 software. ResultsA total of 11 studies involving 1 009 patients were included. The results of meta-analysis showed that when Shenmai injection and normal oral drugs for rising leucocyte were used in the treatment of leukopenia after the tumor radiation and chemotherapy, significant differences were found in significant effectiveness (RR=1.57, 95%CI 1.39 to 1.78, P < 0.000 01), and total effectiveness (RR=1.27, 95%CI 1.19 to 1.36, P < 0.000 01), but no significant difference was found in effectiveness (RR=0.90, 95%CI 0.74 to 1.09, P=0.27). ConclusionIn the treatment of leucopenia through tumor radiation and chemotherapy, Shenmai injection is superior to normal oral drugs in effectiveness. However, the above conclusion should be further confirmed by conducting more large-scale and welldesigned RCTs due to the limited quantity and quality of the included studies.
ObjectiveTo analyze the clinical application and safety of Shenmai injection.MethodsWe collected clinical data of 30 012 patients using Shenmai injection from 26 hospitals nationwide from September, 2009 to June, 2013. The SPSS 15.0 software was used to analyze demographic characteristics, diagnostic information, and clinical application of the injection.ResultsAmong all patients, 14 270 were females (47.55%), 8 218 were aged 45-60 (27.38%), and 10 452 were aged 61-75 (34.83%). The primary use of Shenmai injection was as an adjuvant treatment of chemotherapy for cancer patients, and the top 3 cancers were lung cancer (1 533, 5.11%), breast cancer (1 509, 5.03%) and gastric cancer (847, 2.82%). The second important use of Shenmai injection was the treatment of coronary heart disease (5 703, 19.00%), of which the most common single dose was 50 mL (14 406, 48.00%), followed by 100 mL (10 804, 36.00%) and 200 mL (600, 2.00%). The solvents were used in 18 902 patients (62.98%), and the 5% glucose injection was used most frequently (84.64%). The adverse effects (AEs) rate was 0.15%, and 57.78% AEs occurred within 24 hours of infusion. The most common AEs were damage of the cardiovascular system, followed by damaging of blood system and respiratory system.ConclusionsShenmai injection has a wide range of applications and can be used in treatment of numerous diseases in the real-world, and the AEs have been linked to off-label uses.