CAJ | 학술논문

目的：系统评价参附注射液联合西药对扩张型心肌病的心功能及生活质量改善的有效性与安全性。方法检索CNKI、万方、CBM、维普、PubMed、EMbase、Clinical trails、Cochrane临床对照试验数据库，收集参附注射液治疗扩张型心肌病的随机对照试验，按纳入和排除标准由2名评价者独立选择文献、提取资料，交叉核对并进行方法学质量评估，采用Rev-Man5.3软件进行统计分析。共纳入8个随机对照试验，共536名受试者。结果 Meta分析结果显示：参附注射液联合西医常规用药治疗后，扩张型心肌病NYHA心功能分级改善的有效率（RR=1.25，95%CI：1.15~1.35，P＜0.00001）优于西医常规组；左室射血分数（LVEF）（MD=6.28，95%CI：3.29~9.27，P＜0.0001）高于对照组；左室舒张末期内径（LVEDd）（MD=-4.07，95%CI：-5.85~-2.28，P＜0.00001）低于对照组；脑钠肽（BNP）（MD=-132.38，95%CI：-205.66~-59.10，P=0.0004）低于对照组；6min步行试验（MD=35.86，95%CI：17.95~53.77，P＜0.0001）高于对照组；心率（MD=-4.91，95%CI：-7.27~-2.55，P＜0.0001）低于对照组。纳入的8个研究中，有2个研究观察了不良反应，1个研究报告有不良反应。结论在常规治疗基础上加用参附注射液可改善扩张型心肌病患者的心功能指标，因大部分研究未对参附注射液的安全性进行观察，故未能作出药物安全性方面的可靠分析。由于本系统评价纳入研究样本量小且质量较低，增加了本次系统评价结论产生偏倚的风险，因此参附注射液治疗扩张型心肌病疗效和安全性需要更多高质量临床试验加以证实。
목적：계통평개삼부주사액연합서약대확장형심기병적심공능급생활질량개선적유효성여안전성。방법검색CNKI、만방、CBM、유보、PubMed、EMbase、Clinical trails、Cochrane림상대조시험수거고，수집삼부주사액치료확장형심기병적수궤대조시험，안납입화배제표준유2명평개자독립선택문헌、제취자료，교차핵대병진행방법학질량평고，채용Rev-Man5.3연건진행통계분석。공납입8개수궤대조시험，공536명수시자。결과 Meta분석결과현시：삼부주사액연합서의상규용약치료후，확장형심기병NYHA심공능분급개선적유효솔（RR=1.25，95%CI：1.15~1.35，P＜0.00001）우우서의상규조；좌실사혈분수（LVEF）（MD=6.28，95%CI：3.29~9.27，P＜0.0001）고우대조조；좌실서장말기내경（LVEDd）（MD=-4.07，95%CI：-5.85~-2.28，P＜0.00001）저우대조조；뇌납태（BNP）（MD=-132.38，95%CI：-205.66~-59.10，P=0.0004）저우대조조；6min보행시험（MD=35.86，95%CI：17.95~53.77，P＜0.0001）고우대조조；심솔（MD=-4.91，95%CI：-7.27~-2.55，P＜0.0001）저우대조조。납입적8개연구중，유2개연구관찰료불량반응，1개연구보고유불량반응。결론재상규치료기출상가용삼부주사액가개선확장형심기병환자적심공능지표，인대부분연구미대삼부주사액적안전성진행관찰，고미능작출약물안전성방면적가고분석。유우본계통평개납입연구양본량소차질량교저，증가료본차계통평개결론산생편의적풍험，인차삼부주사액치료확장형심기병료효화안전성수요경다고질량림상시험가이증실。
Objective To review systematically the efficacy and safety of Shenfu Injection combining Western drugs for improving heart function and quality of life (QOL) in patients with dilated cardiomyopathy.Methods The databases of CNKI, WanFang Database, VIP Database, PubMed, EMbase, Clinicaltrails and CENTRAL were retrieved for collecting the randomized-controlled trails (RCT) about treatment of dilated cardiomyopathy with Shenfu Injection. All RCT were selected by 2 reviewers independently according to inclusion and exclusion criterions, and materials were extracted, checked crossly and given methodological quality evaluation. A Meta-analysis was conducted by using RevMan 5.3 software.Results There were totally 8 RCT included involving 536 subjects. The results of Meta-analysis showed that improvement rate of NYHA grading was better in treatment group than that in control group [RR=1.25, 95%CI: (1.15~1.35),P<0.00001], LVEF was higher in treatment group than that in control group [MD=6.28, 95%CI: (3.29~9.27),P<0.0001], LVEDd was lower in treatment group than that in control group [MD=-4.07, 95%CI: (-5.85, -2.28),P<0.00001], BNP was lower in treatment group than that in control group [MD=-132.38, 95%CI: (-205.66, -59.10),P=0.0004], 6MWD was higher in treatment group than that in control group [MD=35.86, 95%CI: (17.95, 53.77),P<0.0001] and heart rate was lower in treatment group than that in control group [MD=-4.91, 95%CI: (-7.27, -2.55),P<0.0001]. Among 8 RCT, adverse reactions were observed in 2 RCT and in 1 RCT report.Conclusion Shenfu Injection, based on routine therapy, can improve heart function indexes in patients with dilated cardiomyopathy. As most of studies did not observe the safety of Shenfu Injection, they have not given reliable analysis on the safety. The bias risk of this conclusion is increased because small sample and lower quality of the systematical review, and more high-quality trials are needed to confirm the curative effect and safety of Shenfu Injection.