目的 系统评价贞芪扶正制剂联合含铂化疗对肺癌患者免疫功能的影响，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（Wangfang Data）、中国生物医学文献（CBM）等数据库，检索时限从各数据库建库时间至2020年5月，搜索贞芪扶正联合含铂化疗药对比单纯含铂化疗药治疗肺癌的临床随机对照试验（RCT）。对纳入研究质量评价后，提取数据并运用RevMan5.3软件进行Meta分析。结果 共纳入10个RCT，总样本数为844例，试验组使用贞芪扶正联合含铂化疗428例，对照组单用含铂化疗416例。分析结果显示，与单纯含铂化疗相比，贞芪扶正制剂联合含铂化疗治疗肺癌可以改善肿瘤客观缓解率[RR＝0.65，95% CI（0.53，0.78），P<0.01]；增强机体CD3⁺水平[MD＝4.78，95% CI（2.29，7.27），P<0.01]、CD4⁺水平[MD＝5.15，95% CI（3.10，7.20），P<0.01]、CD8⁺水平[MD＝3.42，95% CI（1.28，5.55），P<0.05]、CD4⁺/CD8⁺水平[MD＝0.23，95% CI（0.12，0.35），P<0.01]、Th1/Th2水平[MD＝2.69，95% CI（2.24，3.13），P<0.01]、Th17/Treg水平[MD＝0.30，95% CI（0.21，0.39），P<0.01]；提高机体NK细胞百分比[MD＝3.37，95% CI（1.49，5.25），P<0.01]。结论 在常规含铂化疗的基础上加用贞芪扶正制剂可以提高肺癌患者化疗的近期疗效，增强机体免疫功能。由于纳入研究质量有限，仍需更多高质量的RCT来予以验证。

Objective To systematically evaluate the effect of Zhenqi Fuzheng preparation combined with platinum-based chemotherapy on immune function of lung cancer patients, and provide evidence-based medical basis for clinical medication. Methods The randomized controlled trials (RCT) about Zhenqi Fuzheng preparation combined with platinum-based chemotherapeutic drugs versus platinum-based chemotherapeutic drugs in the treatment of lung cancer in PubMed, EMBase, Cochrane Library, CNKI, VIP, CBM and WanFang Database were collected from the time of establishing database to May, 2020. After evaluating the quality of the included studies, data were extracted and the Meta-analysis was performed using RevMan5.3. Results Ten RCTs with 844 patients and 428 cases in the treatment group and 416 cases in the control group were enrolled. The treatment group was given Zhenqi Fuzheng preparation combined with platinum-based chemotherapy while the control group was only given platinum-based chemotherapy. The Meta-analysis showed that compared with chemotherapy treatment alone, Zhenqi Fuzheng preparation combined with platinum-based chemotherapy to treat lung cancer can improve the objective tumor response rate[RR=0.65, 95% CI (0.53, 0.78), P < 0.01], enhance the body CD3⁺ level[MD=4.78, 95% CI (2.29,7.27), P < 0.01]; CD4⁺ level[MD=5.15, 95% CI (3.10, 7.20), P < 0.01]; CD8⁺ level[MD=3.42,95% CI (1.28, 5.55), P < 0.05]; CD4⁺/CD8⁺ level[MD=0.23, 95% CI (0.12, 0.35), P < 0.01], Th1/Th2 level[MD=2.69, 95% CI (2.24, 3.13), P < 0.01], Th17/Treg level[MD=0.30, 95% CI (0.21, 0.39), P < 0.01], as well as increase the percentage of NK cells in the body[MD=3.37, 95% CI (1.49,5.25), P < 0.01]. Conclusion On the basis of conventional platinum-based chemotherapy, Zhenqi Fuzheng preparation can be applied to improve the short-term efficacy of chemotherapy in lung cancer patients and enhance their immune function. Due to the limited quality of the included studies, more high-quality RCTs are still needed for verification.

R28;R734

江苏高校优势学科建设工程（中西医结合）