消癌平注射液联合一线化疗治疗晚期胃癌疗效的系统评价及Meta分析

A systematic review and Meta-analysis of the efficacy of Xiaoaiping injection combined with first-line chemotherapy in the treatment of advanced gastric cancer

关键词:  胃癌  消癌平注射液  一线化疗  系统评价  Meta分析

Key words:  gastric cancer  Xiaoaiping injection  first-line chemotherapy  systematic review  Meta-analysis

摘要:

[目的] 评价消癌平注射液联合一线化疗治疗晚期胃癌的疗效及安全性。[方法] 检索发表于中国知网（CNKI）、万方数据库（WanFang）、维普数据库（VIP）、Pubmed以及Web of science共5个中英文数据库中有关消癌平注射液联合一线化疗方案治疗晚期胃癌的随机对照试验（RCT），检索时间范围设定为各数据库自建库以来至2023年10月27日，对符合纳入排除标准的研究进行偏倚风险评价及Meta分析。[结果] 共纳入10项RCT，共包含814例晚期胃癌患者；在近期疗效方面消癌平注射液联合一线化疗方案能够有效提升客观缓解率（ORR）[RR：1.35， 95%CI（1.15，1.58），P=0.0002]以及卡氏评分（KPS）[RR：1.62，95%CI（1.16，2.26），P=0.005]；且3-4级不良反应事件（SAE）发生数量少于单纯化疗[RR：0.32，95%CI（0.06，0.90），P=0.04]；在远期生存获益方面，消癌平注射液联合一线化疗方案在无进展生存期（PFS）[HR：0.32，95%CI（0.17，0.62），P=0.0007]以及总生存期（OS）[HR：0.33，95%CI（0.16， 0.65），P=0.002]方面均优于单纯化疗；GRADE分级结果显示，ORR、KPS、PFS、OS为低等级质量证据，SAE为极低等级质量证据。[结论] 消癌平注射液联合一线化疗具有良好的临床疗效及安全性，但纳入文献的方法学质量较低，尚需要更加全面的大样本、多中心、随机双盲对照实验进行验证。

Abstract:

[Objective] To evaluate the efficacy and safety of Xiaoaiping injection combined with first-line chemotherapy in the treatment of advanced gastric cancer. [Methods] We searched for randomized controlled trials（RCTs） of Xiaoaiping injection combined with first-line chemotherapy regimen in the treatment of advanced gastric cancer in five Chinese and English databases published in CNKI，Wanfang Database，VIP Database，Pubmed and Web of Science，and the time range was set from the establishment of each database to October 27，2023，and the risk of bias assessment and Meta-analysis of studies that met the inclusion criteria were conducted. [Results] A total of 10 RCTs were included，including 814 patients with advanced gastric cancer，and in terms of short-term efficacy，Xiaoaiping injection combined with first-line chemotherapy regimen could improve the objective response rate（ORR） [RR：1.35，95%CI（1.15，1.58），P=0.0002] and increase the Karnofsky performance score（KPS） [RR：1.62，95%CI（1.16，2.26），P=0.005] and the number of grade 3-4 adverse events（SAEs） was lower than that of chemotherapy alone [RR：0.32，95%CI（0.06，0.90），P=0.04]；in terms of long-term survival benefit，Xiaoaiping injection combined with first-line chemotherapy was significantly more effective in progression-free survival（PFS） [HR：0.32，95%CI（0.17，0.62），P=0.001] and overall survival（OS） [HR：0.33，95%CI（0.16，0.65），P=0.002] was better than chemotherapy alone，and the GRADE results showed that ORR，KPS scores，PFS，and OS were of low quality，while SAE was of very low quality. [Conclusion] Xiaoaiping injection combined with first-line chemotherapy has good clinical efficacy and safety，but the methodological quality of the included literature is low，and more comprehensive large-sample，multicenter，randomized double-blind controlled trials are needed for verification.