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康艾注射液联合铂类化疗对晚期非小细胞肺癌患者免疫功能的影响:一项荟萃分析。

Effect of kangai injection combined with platinum-based chemotherapy on the immune function of patients with advanced non-small-cell lung cancer: A meta-analysis.

作者信息

Zhu Dongwei, Xu Yong, Feng Fanchao, Wang Zhichao, Han Di, Zhou Xianmei

机构信息

Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China; Department of Respiratory and Critical Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing 210029, China.

Department of Respiratory and Critical Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing 210029, China.

出版信息

Phytomedicine. 2022 Jun;100:154088. doi: 10.1016/j.phymed.2022.154088. Epub 2022 Mar 31.

Abstract

BACKGROUND

Kangai injection (KAI) is a well-known Chinese patent medicine applied for several different types of cancers in the clinic as an auxiliary therapeutic approach, which is refined from three herbal extracts (Astragalus, Ginseng and Matrine).

PURPOSE

To systematically evaluate the effect of combination treatment of platinum-based chemotherapy and KAI on patients with advanced non-small-cell lung cancer (NSCLC).

STUDY DESIGN

A meta-analysis of randomized clinical trials.

MATERIALS AND METHODS

The randomized controlled trials (RCTs) about stage Ⅲ-Ⅳ NSCLC using KAI combined platinum-based chemotherapy were electronically retrieved from eight electronic databases up to July 2021. We applied RevMan 5.4, Stata 16.0, TSA 0.9.5.10 Beta and GRADE Pro-GDT to evaluate the quality of the included RCTs and perform the meta-analysis.

RESULTS

19 RCTs were included, consisting a total sample size of 1,389 cases. Meta-analysis revealed that compared with chemotherapy alone, KAI combined with platinum-based chemotherapy was associated with significantly higher objective response rate (ORR) [RR = 1.36, 95%CI (1.21,1.54), p< 0.00001], higher disease control rate (DCR) [RR = 1.15, 95%CI (1.09,1.21), p< 0.00001], greater Karnofsky performance status (KPS) [RR = 1.75, 95%CI (1.41,2.18), p< 0.00001], lower white blood cell toxicity [RR = 0.67, 95%CI (0.55,0.82), p = 0.0001], lower platelet toxicity [RR = 0.60, 95%CI (0.47,0.75), P  < 0.0001], and lower incidence of vomiting [RR = 0.66, 95%CI (0.57,0.76), p< 0.00001]. In terms of the immune function, KAI united with chemotherapy significantly raised the ratio of CD3 cells [MD = 10.65, 95%CI (8.21,13.09), p< 0.00001], CD4 cells [MD = 7.67, 95%CI (6.31,9.03), p< 0.00001], NK cells [MD = 4.97, 95%CI (3.03,6.92), p< 0.00001], and CD4/ CD8 [MD = 0.32, 95%CI (0.19,0.45), p< 0.00001], and decreased the percentage of CD8 cells [MD = -5.56, 95%CI (-7.51,-3.61), p< 0.00001].

CONCLUSIONS

This meta-analysis identified that the combination treatment of KAI and platinum-based chemotherapy was more beneficial to patients with advanced NSCLC when compared to chemotherapy alone, which could significantly improve the clinical efficacy, enhance the immune function, and reduce chemotherapy toxicity. Our study provides a theoretical basis and treatment guidance for patients with NSCLC.

摘要

背景

康艾注射液(KAI)是一种著名的中成药,在临床上作为辅助治疗方法应用于多种不同类型的癌症,它是由三种草药提取物(黄芪、人参和苦参碱)精制而成。

目的

系统评价康艾注射液联合铂类化疗对晚期非小细胞肺癌(NSCLC)患者的疗效。

研究设计

随机临床试验的荟萃分析。

材料与方法

通过电子检索截至2021年7月的八个电子数据库,获取关于Ⅲ-Ⅳ期NSCLC使用康艾注射液联合铂类化疗的随机对照试验(RCT)。我们应用RevMan 5.4、Stata 16.0、TSA 0.9.5.10 Beta和GRADE Pro-GDT来评估纳入的RCT的质量并进行荟萃分析。

结果

纳入19项RCT,总样本量为1389例。荟萃分析显示,与单纯化疗相比,康艾注射液联合铂类化疗的客观缓解率(ORR)显著更高[RR = 1.36,95%CI(1.21,1.54),p < 0.00001],疾病控制率(DCR)更高[RR = 1.15,95%CI(1.09,1.21),p < 0.00001],卡氏功能状态(KPS)更好[RR = 1.75,95%CI(1.41,2.18),p < 0.00001],白细胞毒性更低[RR = 0.67,95%CI(0.55,0.82),p = 0.0001],血小板毒性更低[RR = 0.60,95%CI(0.47,0.75),P < 0.0001],呕吐发生率更低[RR = 0.66,95%CI(0.57,0.76),p < 0.00001]。在免疫功能方面,康艾注射液联合化疗显著提高了CD3细胞比例[MD = 10.65,95%CI(8.21,13.09),p < 0.00001]、CD4细胞比例[MD = 7.67,95%CI(6.31,9.03),p < 0.00001]、NK细胞比例[MD = 4.97,95%CI(3.03,6.92),p < 0.00001]以及CD4/CD8比例[MD = 0.32,95%CI(0.19,0.45),p < 0.00001],并降低了CD8细胞百分比[MD = -5.56,95%CI(-7.51,-3.61),p < 0.00001]。

结论

本荟萃分析表明,与单纯化疗相比,康艾注射液联合铂类化疗对晚期NSCLC患者更有益,可显著提高临床疗效,增强免疫功能,并降低化疗毒性。我们的研究为NSCLC患者提供了理论依据和治疗指导。

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