基于Meta分析的参芪扶正注射液辅助常规化疗治疗非小细胞肺癌的系统评价
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摘要
目的:系统评价参芪扶正注射液联合常规化疗治疗中晚期非小细胞肺癌的临床疗效及安全性,为临床治疗与合理用药提供循证依据。方法:计算机检索中国期刊全文数据库、中文科技期刊全文数据库、中国生物医学文献数据库、万方数据库、Pub Med和the Cochrane Library等数据库,全面搜集参芪扶正注射液联合常规化疗治疗中晚期非小细胞肺癌的随机对照试验(对照组患者单用含顺铂化疗方案,观察组患者采用参芪扶正注射液联合含顺铂化疗方案),采用Cochrane风险评价表评价其研究质量,提取资料并通过RevMan 5.3软件进行数据整理,采用STATA 15.0软件进行文献荟萃分析(Meta分析)。结果:共纳入41篇文献,涉及3 189例患者。Meta分析结果显示,观察组患者临床总有效率明显优于对照组,差异有统计学意义(RR=1.23,95%CI=1.12～1.35,Z=4.35,P<0.000 1)。此外,参芪扶正注射液还可提高患者的生活质量,降低化疗引起的白细胞计数降低、血小板计数降低、血红蛋白水平降低及恶心呕吐等不良反应,提高患者的免疫功能,且未见严重不良反应。结论:参芪扶正注射液联合常规化疗对中晚期非小细胞肺癌有一定的治疗作用,且不良反应发生率低。但缺乏高质量的证据支持且样本量较小,尚需更多设计严谨的多中心、大样本的随机、双盲对照试验对研究结果予以进一步证实。
OBJECTIVE: To systematically evaluate the clinical efficacy and safety of Shenqifuzheng injection combined with conventional chemotherapy in treatment of non-small cell lung cancer,so as to provide evidence-based basis for clinical treatment and rational drug use. METHODS: CNKI,Chinese Science and Technology Journal Full-text Database,China Biomedical Literature Database,Wanfang Database,Pub Med and Cochrane Library were retrieved to collect randomized controlled trials( RCTs) of Shenqifuzheng injection combined with conventional chemotherapy in treatment of non-small cell lung cancer( the control group was treated with cisplatin alone,while the observation group received Shenqifuzheng injection combined with cisplatin). The Cochrane risk assessment was used to evaluate the quality,the data was extracted and compiled by Rev Man 5. 3 software,and meta-analysis( Meta-analysis) was performed using STATA 15. 0 software. RESYLTS: Totally 41 literature were involved,including 3 189 patients. According to meta-analysis,the total clinical effective rate of observation group was significantly better than that of control group,and the difference was statistically significant( RR = 1. 23,95% CI = 1. 12-1. 35,Z = 4. 35,P < 0. 000 1). In the meantime,shenqifuzheng injection can also improve patients' quality of life,reduce white blood cell count,platelet count,hemoglobin level and nausea and vomiting caused by chemotherapy,and improve patients' immune function without sever adverse drug reactions. CONCLUSIONS: Shenqifuzheng injection combined with conventional chemotherapy has a certain therapeutic effect on intermediate and advanced non-small cell lung cancer,and the incidence of adverse reactions is low. However,due to lack of high-quality evidence support and small sample size,more rigorous multi-center,largesample randomized,double-blind controlled trials are needed to further confirm the results.
OBJECTIVE: To systematically evaluate the clinical efficacy and safety of Shenqifuzheng injection combined with conventional chemotherapy in treatment of non-small cell lung cancer,so as to provide evidence-based basis for clinical treatment and rational drug use. METHODS: CNKI,Chinese Science and Technology Journal Full-text Database,China Biomedical Literature Database,Wanfang Database,Pub Med and Cochrane Library were retrieved to collect randomized controlled trials( RCTs) of Shenqifuzheng injection combined with conventional chemotherapy in treatment of non-small cell lung cancer( the control group was treated with cisplatin alone,while the observation group received Shenqifuzheng injection combined with cisplatin). The Cochrane risk assessment was used to evaluate the quality,the data was extracted and compiled by Rev Man 5. 3 software,and meta-analysis( Meta-analysis) was performed using STATA 15. 0 software. RESYLTS: Totally 41 literature were involved,including 3 189 patients. According to meta-analysis,the total clinical effective rate of observation group was significantly better than that of control group,and the difference was statistically significant( RR = 1. 23,95% CI = 1. 12-1. 35,Z = 4. 35,P < 0. 000 1). In the meantime,shenqifuzheng injection can also improve patients' quality of life,reduce white blood cell count,platelet count,hemoglobin level and nausea and vomiting caused by chemotherapy,and improve patients' immune function without sever adverse drug reactions. CONCLUSIONS: Shenqifuzheng injection combined with conventional chemotherapy has a certain therapeutic effect on intermediate and advanced non-small cell lung cancer,and the incidence of adverse reactions is low. However,due to lack of high-quality evidence support and small sample size,more rigorous multi-center,largesample randomized,double-blind controlled trials are needed to further confirm the results.
引文
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[25]崔瀚之,朱蕾,牛旗,等.参芪扶正注射液联合化疗治疗非小细胞肺癌的临床观察[J].现代肿瘤医学,2010,18(5):925-926.
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