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目的了解参芪扶正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Cochrane临床对照试验资料库(The Cochrane Central Register of Controlled Trials)、MEDLINE(1989~2008.12)、EMbase(1989~2008.12)、中国Co-chrane中心临床对照试验资料数据库、中国生物医学文献数据库(CBMdisk)和中国中医药科技文献数据库(TCMLRS)中1989年~2009年2月发表的文献;手检初步入选的全文及相关文献。收集有关参芪扶正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16个,但其方法学质量均欠佳(C级)。与对照组相比,参芪扶正注射液对恶性肿瘤化疗有明显减毒作用[OR1.67,95%CI(1.30,2.15),P<0.0001];明显减轻骨髓抑制作用[WBC OR0.23,95%CI(0.14,0.37),P<0.00001;血小板计数OR0.71,95%CI(0.39,1.29),P=0.26;血红蛋白计数OR0.25,95%CI(0.14,0.43),P<0.0001];明显减轻消化道毒副反应[OR0.27,95%CI(0.13,0.58),P=0.0007];明显改善生活质量[OR3.92,95%CI(2.77,5.57),P=0.0007]。结论目前有关参芪扶正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。本试验提示,该药对恶性肿瘤化疗可能具有一定的减毒作用,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。有待根据高质量随机对照临床试验结果进一步证实。
Objective To understand the clinical study of Shenqi Fuzheng Injection in adjuvant chemotherapy of tumor and its efficacy and safety. Methods The Cochrane Central Register of Controlled Trials, MEDLINE (1989 ~ 2008.12), EMbase (1989 ~ 2008.12), Cochrane Central Register of Controlled Trials (Cochrane Central Register of Controlled Trials), China Collaborative Cochrane Central Register of Controlled Trials Database, China Biomedical Literature Database CBMdisk) and the Chinese Medical Science and Technology Literature Database (TCMLRS) from 1989 to February 2009 published in the literature; handwritten initial selection of the full text and related literature. A randomized controlled trial comparing Shenqi Fuzheng injection-assisted chemotherapy with conventional chemotherapy was conducted. Two reviewers independently evaluated the quality of the included literature and conducted a Meta-analysis. Results A total of 16 eligible RCTs were included, but their methodological quality was poor (Grade C). Compared with the control group, Shenqi Fuzheng injection significantly attenuated the chemotherapy of malignant tumor [OR1.67,95% CI (1.30,2.15), P <0.0001], significantly reduced the bone marrow suppression [WBC OR0.23, 95% CI (0.39, 1.29), P = 0.26; Hemoglobin count OR 0.25, 95% CI (0.14, 0.43), P <0.0001 ]; Significantly reduce gastrointestinal toxicity [OR0.27, 95% CI (0.13,0.58), P = 0.0007]; significantly improve the quality of life [OR3.92,95% CI (2.77,5.57), P = 0.0007] . Conclusion At present, the clinical research of Shenqifuzheng injection on malignant tumor chemotherapy still lags behind the application of scientific research methodology. The test suggests that the drug may have some attenuation of malignant tumor chemotherapy, but does not rule out the poor quality of test methods and published bias; the existing data did not suggest the occurrence of serious adverse reactions / events. To be further confirmed by high-quality randomized controlled clinical trials.