李潇 南梦蝶 许晶 范秋月 侯丽 陈信义

摘要 目的：系統评价通关藤制剂对中晚期肿瘤化疗患者免疫功能影响，为临床用药提供循证医学依据。方法：计算机检索PubMed、EMBase、Cochrane Library、中国知网（CNKI）、维普中文科技期刊（VIP）、万方数字化期刊（Wanfang Data）、中国生物医学文献（CBM）等数据库，检索时限为各库建库时间至2020年10月，搜索通关藤制剂联合化疗治疗中晚期恶性肿瘤的临床随机对照试验，对纳入研究质量评价后，采用Revman5.3软件进行Meta分析。结果：共纳入11个RCT，总样本数为828例，观察组使用通关藤制剂联合化疗414例，对照组单用化疗414例。分析结果显示，与单纯化疗比较，与单纯化疗比较，通关藤制剂联合化疗可提高进中晚期肿瘤化疗患者CD3+水平[MD=10.77，95%CI（8.67，12.86），P<0.000 01]、CD4+水平[MD=6.94，95%CI（4.42，9.45），P<0.000 01]、CD4+/CD8+水平[MD=1.02，95%CI（0.88，1.17），P<0.000 01]增强机体NK细胞活性[MD=2.38，95%CI（0.83，3.86），P=0.002]。对CD8+水平无影响[MD=1.01，95%CI（-0.36，2.37），P=0.15]，CD4+/CD8+亚组分析：不同瘤种亚组[MD=0.28，95%CI（0.24，0.32，P<0.000 01]，肺癌组与消化道肿瘤组之间差异有统计学意义，不同用药途径亚组[MD=1.02，95%CI（0.88，1.17，P=0.13]、各组差异无统计学意义，不同化疗方案组[MD=1.02，95%CI（0.88，1.17，P=0.4]，各组差异无统计学意义，CD4+/CD8+水平与不同肿瘤有相关性，与用药途径及化疗方案无相关性。结论：通关藤制剂能提升中晚期肿瘤化疗患者免疫功能，与不同瘤种有相关性、与给药方式、化疗方案无相关性，但仍需要进一步大样本的随机对照试验证实。

关键词 通关藤;化学治疗;中晚期恶性肿瘤;免疫功能;CD3+;CD4+;CD4+/CD8+;Meta分析

Meta-analysis of Effect of Marsdenia Tenacissima Extract （MTE） on Immune Function in Patients with Intermediated and Advanced Cancer Treated By Chemotherapy

LI Xiao，NAN Mengdie，XU Jing，FAN Qiuyue，HOU Li，CHEN Xinyi

（Dongzhimen Hospital，Affiliated to Beijing University of Chinese Medicine，Beijing 100700，China）

Abstract Objective：To systematically assess the effect of Marsdenia tenacissima extract （MTE） on the immune function in patients with intermediated and advanced cancer treated by chemotherapy，and to provide evidence for clinical practice.Methods：Database of PubMed，EMBase，Cochrane Library，CNKI，VIP，Wanfang Data，CBM and other databases was retrieved.The search time limit was from the establishment of each database to October 2020.The clinical randomized controlled trial of MTE preparation combined with chemotherapy in the treatment of advanced malignant tumors was searched.After the quality of the included studies was evaluated，the Revman5.3 software was used for Meta analysis.Results：A total of 11 RCTs were included，and the total number of samples was 828.The experimental group used MTE preparation combined with chemotherapy for 414 cases，and the control group used chemotherapy alone for 414 cases.The analysis results showed that compared with chemotherapy alone，the combination of MTE and chemotherapy could increase the CD3+ level of patients with intermediated and advanced cancer [MD=10.77，95%CI （8.67，12.86），P<0.000 01]，CD4+ level [MD=6.94，95%CI （4.42，9.45），P<0.000 01]，CD4+/CD8+ level [MD=1.02，95%CI （0.88，1.17），P<0.000 01] and enhance the activity of NK cells [MD=2.38，95% CI （0.83，3.86），P=0.002]，whereas the combination showed no effect on CD8+ level [MD=1.01，95% CI （-0.36，2.37），P=0.15].Subgroup analysis result indicated that in terms of different categories of cancer，the CD4+/CD8+ level varied [MD=0.28，95% CI （0.24，0.32，P<0.000 01] and there was a statistical difference between lung cancer subgroup and the gastrointestinal cancer subgroup.There was no statistical difference of CD4+/CD8+ level among the subgroups of different administrations [MD=1.02，95% CI （0.88，1.17，P=0.13].There was no statistical difference of CD4+/CD8+ level among subgroups of different chemotherapeutics [MD=1.02，95%CI （0.88，1.17），P=0.4].The CD4+/CD8+ levels were correlated with different categories of cancer，but had no correlation with the administration types and chemotherapeutics.Conclusion：MTEs are likely to improve the immune function of patients with intermediated and advanced cancer treated by chemotherapy.There is correlation with categories of cancer，but no correlation with the administration methods and chemotherapeutics.However，the evidence needs further larger sample randomized controlled trials to confirm.

Keywords Marsdenia tenacissima extract; Chemotherapy; Advanced malignant tumors; Immune function; CD3+;CD4+;CD4+/CD8+; Meta-analysis

中图分类号：R242文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.03.006

化疗作为治疗中晚恶性肿瘤的主要治疗手段，有助于缩小肿瘤体积，使患者临床获益，但可导致免疫功能下降，增加患者感染风险，降低生命质量，影响化疗疗效[1]。研究发现，联合中药治疗，在一定程度上能够减轻化疗的不良反应，调整机体免疫功能，减少肿瘤复发、转移，从而延长生存期。通关藤类制剂（包括消癌平注射液、消癌平片、消癌平口服液等）为中药通关藤提取物，临床应用广泛，与化疗联合应用可起到提高有效率，减轻化疗不良反应的协同作用[2-3]。近年来，基础实验发现通关藤苷H可以抑制Lewis肺癌细胞生长和转移同时调节免疫细胞因子IL-2、IL-10的表达水平，提高荷瘤小鼠的免……