参麦注射液防治疾病的系统评价再评价

Overview of systematic reviews on Shenmai Injection in prevention and treatment of diseases

该文总结和评价参麦注射液在病毒性心肌炎、休克、肺心病、冠心病、粒细胞减少症和肿瘤化疗治疗中的有效性和安全性,为参麦注射液在临床合理用药方面提供证据支持。全面检索主要中、英文数据库,纳入主要研究参麦注射液在病毒性心肌炎、休克、肺心病、冠心病、粒细胞减少症和肿瘤化疗中应用的系统评价,提取主要有效性和安全性结局指标进行对比分析和总结,并使用方法学质量评价工具AMSTAR 2对纳入研究进行评估。最终纳入36篇系统评价,发表年限为2005-2020年,其中涉及的疾病有病毒性心肌炎、休克、肺心病、恶性肿瘤和冠心病,每类疾病的系统评价纳入的样本量分别为3 840、2 484、12 702、28 036、27 082例。结果表明,参麦注射液联合常规/西药治疗组在以上5种疾病防治中较常规/西药组显示出更好的疗效。纳入研究中报道的参麦注射液不良反应主要有颜面潮红、皮疹、心悸等,但发生率低且一般症状轻微,无需特殊治疗。因此在常规或西药治疗的基础上加用参麦注射液对疾病有更好的防治效果。建议今后开展更多大样本、多中心随机对照试验,并在制作系统评价时严格遵循相关的报告规范,以提高研究的科学性和透明性。

To summarize and evaluate the efficacy and safety of Shenmai Injection in the treatment of viral myocarditis, shock, pulmonary heart disease, coronary heart disease, neutropenia and tumor chemotherapy, so as to provide supportive evidences for clinical rational use of Shenmai Injection. By searching literatures about studies on the systematic reviews on Shenmai Injection in treatment of viral myocarditis, shock, pulmonary heart disease, coronary heart disease, neutropenia and tumor chemotherapy from the main Chinese and English databases. Primary efficacy and safety outcome measures were selected for comparative analysis and summary, and the appraisal tool of AMSTAR 2 was used to evaluate the included studies.A total of 36 systematic reviews(published from 2005 to 2020) were included, involving viral myocarditis, shock, pulmonary heart disease, malignant tumor and coronary heart disease. The number of cases included in each type of the above diseases was 3 840, 2 484, 12 702, 28 036 and 27 082, respectively. The comparison results showed that, Shenmai Injection combined with conventional/western medicine treatment groups had better efficacy than conventional/western medicine groups alone in the prevention and treatment of the above five diseases. The main adverse reactions of Shenmai Injection reported in the included studies were facial flushing, rash, palpitation, etc., but the incidence was low and the general symptoms were mild, so no special treatment was needed. Therefore, the application of Shenmai Injection on the basis of conventional treatment or western medicine treatment had better prevention and treatment efficacy of the diseases. It was suggested that more multi-center and larger sample-size randomized controlled trials should be carried out in the future, and the relevant reporting standards should be strictly followed in systematic reviews, so as to improve the scientificity and transparency of the study.