目的 采用Meta分析考察达雷妥尤单抗联合标准疗法治疗多发性骨髓瘤的有效性和安全性。方法 共纳入8项研究19篇文献，将从文献中提取的数据采用Cochrane协作网的Revman 5.3软件进行Meta分析，并生成森林图和漏斗图。结果 8项研究共纳入4 525例患者，其中试验组2 344例，对照组2 181例。对于总体反应率（ORR）的Meta分析结果显示，达雷妥尤单抗联合标准疗法对比常规治疗方法可提高多发性骨髓瘤患者的总体反应率，且差异具有统计学意义[RR＝1.18，95% CI（1.09～1.27）；P＜0.000 1]；对于完全缓解率（≥CR）的Meta分析结果显示，达雷妥尤单抗联合标准疗法对比常规治疗方法可以提高多发性骨髓瘤患者的≥CR率[RR＝2.02，95% CI（1.61～2.52）；P＜0.000 01]；对于疾病无进展生存期（PFS）的Meta分析显示，达雷妥尤单抗联合标准疗法对比常规治疗方法可以延长多发性骨髓瘤患者的PFS[HR＝0.47，95% CI（0.39～0.56）；P＜0.000 01]。达雷妥尤单抗联合标准疗法增加中性粒细胞缺乏风险、肺炎发生率。结论 达雷妥尤单抗联合标准疗法可以提高患者的总体反应率和完全缓解率，并且可以延长患者的疾病无进展生存期，对患者的治疗有益，但也会增加患者中性粒细胞减少、肺炎等不良反应发生的风险，临床使用时要具体关注这些不良反应，提高患者生存质量。

Objective To study the efficacy and safety of daratumumab combined with standard therapy in treatment of multiple myeloma with meta-analysis method. Methods A total of 8 studies (19 literatures) were included. Meta-analysis was performed on the data extracted from the literatures using the RevMan 5.3 software of the Cochrane Collaborative Network, and forest plots and funnel plots were generated. Results A total of 4 525 cases were enrolled in the 8 studies, including 2 344 cases in treatment group and 2 181cases in control group. Meta-analysis of ORR showed that daratumumab combined with standard therapy improved ORR in patients with multiple myeloma, and the difference was statistically significant [RR=1.18, 95% CI (1.09 — 1.27), P < 0.000 1]. Meta-analysis results for ≥CR showed that daratumumab combined with standard treatment increased ≥CR rate in patients [RR=2.02, 95% CI (1.61 — 2.52), P < 0.000 01]. Meta-analysis of PFS showed that daratumumab combined with conventional therapy prolonged PFS in patients [HR=0.47, 95% CI (0.39 — 0.56), P < 0.000 01]. Daratumumab in combination with standard therapy increased the incidence of adverse events such as neutropenia and pneumonia. Conclusion Daratumumab combined with standard therapy has been shown to improve overall response rates and complete response rates, as well as to extend progression-free survival, but also increases the risk of adverse events such as neutropenia and pneumonia. Therefore, these adverse events should be paid attention to in the clinical application of the combination therapy to improve the quality of life of patients.

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