目的 评价薏苡仁提取物（康莱特注射液）联合化疗治疗胃癌的有效性和安全性。方法 通过全面检索不同的中文或英文数据库,所有数据库检索文献的时限为建库至2024年10月。分别由两名研究者对数据库进行独立文献检索,根据纳入与排除标准筛选文献,并评估最终符合条件的纳入文献。采用Cochrane工具对纳入文献进行质量评估。使用Review Manager 5.4统计软件进行数据分析,以相对危险度（RR）作为结果分析的效应指标处理二分类变量资料,以均数差（MD）作为结果分析的效应指标处理计量资料。通过I2检验比较不同研究结果之间的异质性,根据是否存在异质性选择固定效应模型或随机效应模型进行数据分析。结果 共纳入15篇符合要求的临床研究,试验组患者551例,对照组患者533例。与对照组相比,康莱特注射液联合化疗治疗胃癌的完全缓解率（RR=1.60,95% CI =1.24~2.06,P<0.01）、部分缓解率（RR=1.22,95% CI =1.03~1.45,P=0.02）、疾病有效率（RR=1.34,95% CI =1.19~1.50,P<0.01）、疾病控制率（RR=1.19,95% CI =1.11~1.28,P<0.01）、生活质量（RR=2.02,95% CI =1.49~2.75,P<0.01）均显著改善,而疾病进展率（RR=0.56,95% CI =0.43~0.72,P<0.01）、癌胚抗原（MD=-17.85,95% CI =-26.54~-9.15,P<0.01）、糖类抗原199（MD=-18.09,95% CI =-35.08~-1.10,P<0.01）、CD4/CD8（MD=0.18,95% CI =0.08~0.27,P<0.01）均显著减低,疾病稳定率（RR=0.93,95% CI =0.75~1.15,P=0.49）无显著差异。在不良反应方面,与对照组相比,康莱特注射液联合化疗治疗胃癌后的白细胞减少、神经毒性、胃肠道反应发生率显著降低（P<0.05）。结论 与单用化疗药物治疗胃癌相比,联合应用康莱特注射液可提高临床疗效、改善生活质量,并减少不良反应发生率。
Abstract
Objective To review the existing clinical studies systematically and objectively evaluate the efficacy and safety of Kanglaite injection combined with chemotherapy in the treatment of gastric cancer, so as to provide useful evidence for clinic. Methods Through comprehensive retrieval of different Chinese or English databases, the time limit for all database literature retrieval is from the establishment of the database to October 2024. Two researchers independently conducted literature searches on the database, screened the literature according to inclusion and exclusion criteria, and evaluated the final eligible included literaure. The quality of the included literature was assessed using the Cochrane tool. The data analysis was conducted using the Review Manager 5.4 statistical software. Relative risk was used as the effect indicator for the outcome analysis of binary variable data, and mean difference was used as the effect indicator for the outcome analysis of quantitative data. The heterogeneity among different research results was compared using the I2 test, and the fixed-effect model or random-effect model was selected for data analysis based on whether there was heterogeneity. Results A total of 15 eligible clinical studies were included, with 551 patients in the experimental group and 533 patients in the control group. Compared to the control group, Kanglaite Injection combined with chemotherapy demonstrated significant improvements in the complete remission rate （RR=1.60, 95% CI =1.24~2.06, P<0.01）, partial remission rate （RR=1.22, 95% CI =1.03~1.45, P=0.02）, disease efficiency rate （RR=1.34, 95% CI =1.19~1.50, P<0.01）, disease control rate （RR=1.19, 95% CI =1.11~1.28, P<0.01）, and quality of life improvement （RR=2.02, 95% CI =1.49~2.75, P<0.01）. Conversely, there were significant reductions in the disease progression rate （RR=0.56, 95% CI =0.43~0.72, P<0.01）, CEA （MD=-17.85, 95% CI =-26.54~-9.15,P<0.01）, CA199 （MD=-18.09, 95% CI =-35.08~-1.10, P<0.01）, CD4/CD8 ratio （MD=0.18, 95% CI =0.08~0.27,P<0.01）, and quality of life deterioration （RR=0.36, 95% CI =0.23~0.57, P<0.01）. However, there was no significant difference in the disease stabilization rate （RR=0.93, 95% CI =0.75~1.15, P=0.49）. In terms of adverse reactions, compared with the control group, the incidence of leukopenia, neurotoxicity, and gastrointestinal reactions significantly decreased after treatment with Kanglaite injection combined with chemotherapy for gastric cancer （P<0.05）. Conclusions Compared with patients treated with chemotherapy alone for gastric cancer, the combination of Kanglaite injection can improve clinical efficacy, improve quality of life, and reduce the incidence of adverse reactions, which can be further promoted in clinical practice.
关键词
胃癌 /
康莱特注射液 /
薏苡仁 /
化疗 /
系统评价
Key words
gastric cancer /
kanglaite injection /
coix seed /
chemotherapy /
system evaluation
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