[关键词]
[摘要]
目的 根据现有临床资料系统评价紫龙金片辅助铂类为基础的化疗方案治疗肺癌的疗效和安全性。方法 计算机检索中国知网(CNKI)、维普(VIP)、中国生物医学文献数据库(CBM)、万方医学网(Wanfang)、中国临床试验注册中心、PubMed、Cochrane Library、EmBase等数据库,检索时限从建库起至2021年5月,根据预先制定的纳排标准,纳入所有紫龙金片联合铂类为基础的化疗方案治疗肺癌的随机对照试验(randomized controlled trial,RCT),由2名研究人员独立筛选文献、提取数据,并参照Cochrane Reviewers 5.1手册对文献进行方法学质量评价,采用RevMan 5.3软件进行Meta分析,并对发表偏倚进行检验。结果 最终纳入14篇文献,1026例肺癌患者,其中试验组513例,对照组513例。Meta分析结果显示,紫龙金片联合双药化疗能提高肿瘤的客观缓解率 [RR=1.55,95% CI (1.29,1.87),P<0.000 01]、疾病控制率 [RR=1.20,95% CI (1.12,1.29),P<0.000 01] 及生存质量 [RR=1.87,95% CI (1.52,2.30),P<0.000 01];减轻对白细胞、血红蛋白及血小板的抑制 [RR=0.66,95% CI (0.58,0.76),P<0.000 01;RR=0.62,95% CI (0.53,0.72),P<0.000 01;RR=0.57,95% CI (0.46,0.71),P<0.000 01]。但对肝功能、肾功能无明显改善 [RR=0.69,95% CI (0.40,1.19),P=0.18;RR=0.46,95% CI (0.20,1.08),P=0.07]。结论 紫龙金片联合铂类化疗药物治疗肺癌,可以提高近期疗效,改善生活质量,减少部分不良反应的发生,紫龙金片联合铂类在肺癌的治疗中是可选方案。但是受纳入研究的样本量、质量及发表性偏倚等诸多因素影响,致使该研究的结果证据质量较低,故在运用该结论时需谨慎。
[Key word]
[Abstract]
Objective The efficacy and safety of Zilongjin Tablets (紫龙金片) combined with platinum-based chemotherapy in the treatment of lung cancer were systematically evaluated according to the existing clinical data. Methods Several electronic databases, including PubMed, Wanfang, EmBase, Cochrane Library, CNKI, Wanfang, CBM, Chinese Clinical Trial Registryand, and VIP were comprehensively searched from the construction of library to May 2021. According to the pre-established entry and exclusion criteria, all randomized controlled trials (RCTs) of Zilongjin Tablets combined with platinum-based chemotherapy in the treatment of lung cancer were included. Two researchers independently screened the literature, extracted the data, and evaluated the methodological quality of the literatures according to the Cochrane Reviewers 5.1 manual. Meta-analysis was finished and the publication bias was tested by RevMan 5.3 software. Results A total of 14 articles were finally included, and that included 1026 lung cancer patients, and the experimental group and the control group were 513 cases respectively. Meta-analysis results showed that Zilongjin Tablets combined with dual-drug chemotherapy could improve the objective response rate of tumors [RR = 1.55, 95% CI (1.29, 1.87), P < 0.000 01], disease control rate [RR = 1.20, 95% CI (1.12, 1.29), P < 0.000 01], and quality of life [RR = 1.87, 95% CI (1.52, 2.30), P < 0.000 01]. It could reduce the inhibition of white blood cells, hemoglobin and platelets [RR = 0.66, 95% CI (0.58, 0.76), P < 0.000 01; RR = 0.62, 95% CI (0.53, 0.72), P<0.000 01; RR = 0.57, 95% CI (0.46, 0.71), P<0.000 01], respectively. However, there were no significant improvement of liver and renal function [RR = 0.69, 95% CI (0.40, 1.19), P = 0.18; RR = 0.46, 95% CI (0.20, 1.08), P = 0.07], respectively. Conclusion Based on the results of this study, Zilongjin Tablets combined with platinum chemotherapy drugs in the treatment of lung cancer can improve the short-term efficacy, improve the quality of life, and reduce the occurrence of some adverse reactions. Zilongjin Tablets is optional in the treatment of lung cancer. However, because of many factors such as the sample size, quality and publication bias of the included studies, the quality of the evidence for the results of the study is low, and caution should be exercised when you are going to apply this conclusion.
[中图分类号]
R285.64
[基金项目]
甘肃省卫生行业科研计划项目(GSWSKY-2015-35);甘肃省卫生行业科研计划项目(GSWSKY-2019-82);甘肃省兰州市科技发展指导性计划项目(2019-ZD-134);甘肃省中医药管理局科研项目(GZK-2014-76);甘肃省中医药管理局科研项目(GZKP-2021-20)