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复方斑蝥胶囊联合化疗治疗消化道恶性肿瘤临床疗效和生活质量的 Meta分析
何国平,赵轩竹,王华庆
0
天津中医药大学天津 301617;天津市人民医院肿瘤诊治中心,天津市中西结合肿瘤研究所天津 300121
摘要:
目的:系统评价复方斑蝥胶囊联合化疗治疗消化道恶性肿瘤的临床疗效和生活质量改善情况,为临床使用复方斑蝥胶囊提供循证医学依据。方法:通过计算机检索 CNKI、VIP、WangFang、Pubmed、Web of Science、Cochrane、 Embase数据库,收集建库日期至 2020年 7月 13日发表的有关复方斑蝥胶囊治疗消化道恶性肿瘤的随机对照研究。采用 RevMan 5.3软件进行统计分析, Stata 14.0软件进行 Meta回归分析、发表偏倚评估(漏斗图法、 Egger法检验)。结果:共纳入 14篇文献,共计 1 110例患者。 Meta分析显示: KPS评分( RR=1.30,95%CI=[1.15,1.47])、不良反应(胃肠道反应 RR=0.43,95%CI=[0.27,0.69])、骨髓抑制( RR=0.38,95%CI=[0.17,0.85]、神经毒性( RR=0.45,95%CI=[0.28,0.75])、肝肾损害(RR=0.58,95%CI=[0.38,0.89]);其中恶心呕吐( RR=0.67,95%CI=[0.55,0.82])、腹泻 RR=0.65,95%CI=[0.45,0.94]、白细胞减少( RR=0.46,95%CI=[0.34,0.62])、血小板减少( RR=0.48,95%CI=[0.35,0.66]);临床总有效率( RR=1.61,95%CI= [1.37,1.89])均优于对照组;但在免疫功能方面,两组差异无统计学意义( CD3+:SMD=0.7,95%CI=[-0.52,1.92]、CD4+: SMD=-0.15,95%CI=[-1.76,1.46]、CD8+:SMD= -0.60,95%CI=[-1.49,0.29]、CD4+/CD8+:SMD= 0.96,95%CI=[-0.15,2.06])。敏感性分析结果变化小,说明效应值稳定性高。结论:复方斑蝥胶囊联合化疗治疗消化道恶性肿瘤,在改善患者生活质量,提高临床疗效,减轻不良反应方面优于单纯化疗治疗。
关键词:  复方斑蝥胶囊  恶性肿瘤  中西医结合治疗  Meta分析  随机对照试验
DOI:10.3969/j.issn.1007-6948.2021.01.019
投稿时间:2020-06-05
基金项目:
Meta-analysis of Clinical Efficacy and Quality of Life of FufangBanmao Capsules Combined with Chemotherapy in the Treatment of Gastrointestinal Malignant Tumors
HE Guo-ping,ZHAO Xuan-zhu,WANG Hua-qing
Tianjin University of Traditional Chinese Medicine,Tianjin(301617),China
Abstract:
Objective To systematically evaluate the clinical ef?cacy and quality of life of FufangBanmao Capsules combined with chemotherapy in the treatment of gastrointestinal malignant tumors, and provide evidence-based medical evidence for the clinical use of FufangBanmao Capsules. Methods Retrieve CNKI, VIP, WangFang Data, Pubmed, Web of Science, Cochrane, Embase database through computer,A randomized controlled study on the treatment of gastrointestinal malignant tumors with FufangBanmao Capsules was collected, and the retrieval time was set from the date of the establishment of each database to july13, 2020. Statistical analysis was performed using RevMan 5.3 software, and Stata 14.0 software was used for metaregression analysis and publication bias assessment (Funnel chart method, Egger test). Results A total of 14 articles were included and a total of 1 110 patients were included. Meta analysis showed: KPS score (RR=1.30, 95%CI=[1.15,1.47]); adverse reactions (gastrointestinal reaction RR=0.43,95%CI=[0.27,0.69], bone marrow suppression RR=0.38,95 %CI=[0.17,0.85], neurotoxicity RR=0.45,95%CI=[0.28,0.75], liver and kidney damage RR=0.58,95%CI=[0.38,0.89]); among them nausea and vomiting RR=0.67, 95%CI=[0.55,0.82], diarrhea RR=0.65,95%CI=[0.45,0.94], leukopenia RR=0.46,95%CI=[0.34,0.62], thrombocytopenia RR=0.48,95%CI =[0.35,0.66]); the total clinical effective rate (RR=1.61,95%CI=[1.37,1.89]) is better than the control group;But in terms of immune function, the difference between the two groups was not statistically significant(CD3+:SMD= 0.7,95%CI=[-0.52,1.92], CD4+: SMD=-0.15,95%CI=[-1.76,1.46], CD8+:SMD= -0.60,95%CI=[-1.49,0.29], CD4+/CD8+:SMD= 0.96,95%CI= [-0.15,2.06]). After the sensitivity analysis, the result change is small, indicating that the effect value stability is high. Conclusion FufangBanmao Capsules combined with chemotherapy is superior to chemotherapy alone in improving patients’quality of life, improving clinical ef?cacy, and reducing adverse reactions. However, due to the limitation of the quality and quantity of the included studies, the above conclusions need to be veri?ed by adding more high-quality studies.
Key words:  FufangBanmao Capsules  malignant tumor  Chinese and western medicine therapy  Meta analysis  randomized controlled trial

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