参芪扶正注射液联合化疗干预进展期胃癌的临床循证研究

目的系统评价参芪扶正注射液联合化疗干预进展期胃癌的有效性及安全性。方法纳入参芪扶正注射液联合化疗干预进展期胃癌的随机对照试验,制定严格的纳入排除标准纳入试验研究、评价文献质量、提取数据,并使用RevMan 5.0软件进行Meta分析。结果共纳入16个试验,共有1 421例进展期胃癌患者,其中参芪组760例,对照组661例,合并结果显示:参芪注射液临床疗效(OR=1.86,95%CI(2.36,2.55),Z=3.86,P<0.01)、症候疗效(OR=5.05,95%CI(3.08,8.29),Z=6.41,P<0.01)、生活质量评分(OR=2.99,95%CI(2.31,3.87),Z=8.35,P<0.01)及免疫功能如CD3+(SMD=3.40,95%CI(2.22,4.58),Z=5.63,P<0.01)、CD4+(SMD=6.07,95%CI(5.31,6.83),Z=15.69,P<0.01)、CD4+/CD8+(SMD=0.38,95%CI(0.34,0.42),P<0.01)水平均显著高于对照组,另外参芪扶正注射液有助于降低化疗药物的骨髓抑制(2=5.072,P=0.024)、神经系统毒性(2=4.593,P=0.032)及肝脏损伤(2=2.247,P=0.134)。治疗过程中有少数患者有发热不良反应。结论参芪扶正注射液联合化疗干预进展期胃癌,可以提高临床疗效,缓解临床症状,提高免疫功能及生活质量,减少骨髓抑制,限于文献质量,结论需谨慎对待。

Clinical evidence-based research on Shenqifuzheng injection with chemotherapy in treatment of advanced gastric carcinoma

Objective It is to evaluate the efficacy and safety of Shenqifuzheng injection with chemotherapy in treatment of advanced gastric carcinoma.Methods Literatures were retrieved from Medline,EMBASE,Cochrane Library,CBM,VIP,CNKI databases by computer and from relevant Chinese medical journals by hand.Trial selection,quality evaluation and information extraction were performed according to including and excluding criteria.Meta-analysis was conducted using RevMan 5.0 software.Results Total 16 trials including 1 421 patients were included in the meta-analysis,760 cases in treatment group,661 cases in control group.The results showed the clinical effect(OR=1.86,95%CI(2.36,2.55),Z=3.86,P<0.01),symptom effect(OR=5.05,95%CI(3.08,8.29),Z=6.41,P<0.01),life quality(OR=2.99,95%CI(2.31,3.87),Z=8.35,P<0.01) and immune function such as CD3+(SMD=3.40,95%CI(2.22,4.58),Z=5.63,P<0.01),CD4+(SMD=6.07,95%CI(5.31,6.83),Z=15.69,P<0.01),CD4+/CD8+(SMD=0.38,95%CI(0.34,0.42),P<0.01) of Shenqifuzheng injection group were superior to control group.Besides,Shenqifuzheng injection decreased bone marrow suppression(χ2=5.072,P=0.024),neurotoxicity(χ2=4.593,P=0.032),liver damage(χ2=2.247,P=0.134) caused chemotherapeutics.There were several patients with fever in the course of treatment.Conclusion Shenqifuzheng injection with chemotherapy can increased curative effect,relieve symptom,improve immunological function and life quality,decrease bone marrow suppression.The conclusion need precaution for literature quality.