摘要
目的:系统评价鸦胆子油乳注射液联合吉西他滨+顺铂(GP)方案化疗治疗非小细胞肺癌(NSCLC)的临床疗效和安全性。方法:计算机检索CNKI、WanFang Data、VIP、SinoMed、PubMed、EMbase、the Cochrane Library数据库,搜集有关鸦胆子油乳注射液联合GP方案化疗治疗NSCLC的随机对照试验(RCT),检索时限均为从建库至2022年6月11日,由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3及Stata12.0软件进行Meta分析和发表偏倚检验。结果:共纳入20个RCT,累计1 766例患者。Meta分析结果显示,对比仅用GP方案化疗,鸦胆子油乳注射液联合GP方案化疗治疗NSCLC可提高临床总有效率[RR=1.23,95%CI(1.12,1.35),P<0.001]和生活质量改善率[RR=1.62,95%CI(1.40,1.87),P<0.001],降低患者白细胞减少发生率[RR=0.78,95%CI(0.70,0.87),P<0.001];但两组患者胃肠道反应发生率差异无统计学意义[RR=0.82,95%CI(0.65,1.04),P>0.05]。结论:当前证据表明,相较于仅用GP方案化疗,鸦胆子油乳注射液联合GP方案化疗治疗NSCLC,可显著提高患者临床总有效率和生活质量改善率,降低白细胞减少发生率。但本研究结论仍需设计更加严谨的多中心、大样本随机盲法试验的数据支持。
Objective:To systematically evaluate the clinical efficacy of Brucea Javanica oil emulsion injection combining gemcitabine plus cisplatin(GP) chemotherapy in the treatment of non-small cell lung cancer(NSCLC).Methods:CNKI,WanFang Data,VIP,SinoMed,PubMed,EMbase and the Cochrane Library databases were electronically searched to collect randomized controlled trials(RCTs) about NSCLC treated by Brucea Javancia oil emulsion injection combining GP chemotherapy from inception to June 11 th,2022.Two reviewers independently screened the literature,extracted data,and assessed the risk of bias of the included studies.Then,meta-analysis and publication bias test was performed by using RevMan 5.3 and Stata 12.0 softwares.Results:A total of 20 RCTs involving 1 766 patients were included.The results of meta-analysis showed that,compared with only GP chemotherapy,Brucea Javanica oil emulsion injection combining GP chemotherap could improve the clinical effectiveness rate(RR=1.23,95%CI 1.12 to 1.35,P<0.001) and the term of performance status(RR=1.62,95%CI 1.40 to 1.87,P<0.001),reduce the incidence of leukopenia(RR=0.78,95%CI 0.70 to 0.87,P<0.001).However,there was no significant difference in the incidence of gastrointestinal reactions between two groups(RR=0.82,95%CI 0.65 to 1.04,P=0.10).Conclusion:The current evidence shows that,compared with only GP chemotherapy,Brucea Javanica oil emulsion injection combining GP chemotherapy in the treatment of NSCLC can significantly improve the clinical effectiveness rate,performance status,and reduce the incidence of leukopenia in patients.However,the conclusions of this study need to be confirmed by more well-designed multi-center,large-sample sizes,and randomized controlled trials.
作者
勾越洋
巫志姗
王郝嘉
时锐
黄佳奇
翟弋焱
吴嘉瑞
Gou Yueyang;Wu Zhishan;Wang Haojia;Shi Rui;Huang Jiaqi;Zhai Yiyan;Wu Jiarui(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 100102,China)
出处
《药物流行病学杂志》
CAS
2022年第10期651-658,共8页
Chinese Journal of Pharmacoepidemiology
基金
国家自然科学基金项目(编号:82074284)。
关键词
鸦胆子油乳注射液
非小细胞肺癌
吉西他滨+顺铂化疗方案
随机对照试验
META分析
Brucea Javanica oil emulsion injection
Non-small cell lung cancer
Gemcitabine plus cisplatin chemotherapy
Randomized controlled trials
Meta-analysis
