目的 采用Meta分析考察達雷妥尤單抗聯(lián)合標準療法治療多發(fā)性骨髓瘤的有效性和安全性。方法 共納入8項研究19篇文獻，將從文獻中提取的數(shù)據(jù)采用Cochrane協(xié)作網(wǎng)的Revman 5.3軟件進行Meta分析，并生成森林圖和漏斗圖。結果 8項研究共納入4 525例患者，其中試驗組2 344例，對照組2 181例。對于總體反應率（ORR）的Meta分析結果顯示，達雷妥尤單抗聯(lián)合標準療法對比常規(guī)治療方法可提高多發(fā)性骨髓瘤患者的總體反應率，且差異具有統(tǒng)計學意義[RR＝1.18，95% CI（1.09～1.27）；P＜0.000 1]；對于完全緩解率（≥CR）的Meta分析結果顯示，達雷妥尤單抗聯(lián)合標準療法對比常規(guī)治療方法可以提高多發(fā)性骨髓瘤患者的≥CR率[RR＝2.02，95% CI（1.61～2.52）；P＜0.000 01]；對于疾病無進展生存期（PFS）的Meta分析顯示，達雷妥尤單抗聯(lián)合標準療法對比常規(guī)治療方法可以延長多發(fā)性骨髓瘤患者的PFS[HR＝0.47，95% CI（0.39～0.56）；P＜0.000 01]。達雷妥尤單抗聯(lián)合標準療法增加中性粒細胞缺乏風險、肺炎發(fā)生率。結論 達雷妥尤單抗聯(lián)合標準療法可以提高患者的總體反應率和完全緩解率，并且可以延長患者的疾病無進展生存期，對患者的治療有益，但也會增加患者中性粒細胞減少、肺炎等不良反應發(fā)生的風險，臨床使用時要具體關注這些不良反應，提高患者生存質量。

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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