参麦注射液辅助肿瘤化疗的系统评价

Shen-Mai Injection as an Adjunct Therapy to Tumor Chemotherapy: A Systematic Review

目的 了解参麦注射液辅助肿瘤化疗的临床研究质量及其疗效和安全性。方法 计算机检索中国生物医学文献数据库(CBMdisk,Issue3)和中国中医药科技文献数据库(TCMLRS,1981～2001),收集有关参麦注射液辅助肿瘤化疗与常规化疗相比较的随机对照试验文献,由两名评价者独立评价纳入研究的文献质量,并进行了Meta分析。结果 纳入符合纳入标准的RCT共13个,但其方法学质量均欠佳(C级)。与对照组相比,参麦注射液对恶性肿瘤化疗有明显增效作用[OR1 73,95%CI(1 27,2 34),P=0 0004];有明显减轻骨髓抑制毒性作用[WBCOR0 29,95%CI(0 16,0 52),P=0 00004;血小板计数OR0 11,95%CI(0 02,0 49),P=0 004];能明显减轻消化道毒副反应[OR0 26,95%CI(0 16,0 43),P<0 00001]。结论 目前有关参麦注射液对恶性肿瘤化疗的临床研究在科研方法学的应用方面仍有差距。本研究提示,该药对恶性肿瘤化疗可能具有一定的解毒增效作用,但不排除试验方法学质量低下及发表性偏倚有关;现有资料未提示发生严重不良反应事件。本文结论有待根据高质量随机对照临床试验结果进一步证实。

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 (19812001). 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 \[OR 1.73 95%CI (1.27, 2.34),P=0.000 4\], reduced the side effect of bone marrow inhibition \[OR 0.29, 95%CI (0.16, 0.52),P=0.000 04 in WBC counting and OR 0.11, 95%CI (0.02, 0.49),P=0.004\] in PLT count. And Shen Mai injection relieved the symptoms of nausea and vomiting \[OR 0.26, 95%CI (0.16, 0.43),P <0.000 01\]. 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.