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阿帕替尼联合PD-1/PD-L1抑制剂治疗恶性实体瘤有效性与安全性的Meta分析
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| 篇名： | 阿帕替尼联合PD-1/PD-L1抑制剂治疗恶性实体瘤有效性与安全性的Meta分析 |
| TITLE： | Meta-analysis of the efficacy and safety of apatinib combined with PD-1/PD-L1 inhibitors in the treatment of malignant solid tumors |
| 摘要： | 目的 评价阿帕替尼联合程序性死亡受体1/程序性死亡受体配体1（PD-1/PD-L1）抑制剂治疗恶性实体瘤的有效性与安全性。方法检索PubMed、WebofScience、Embase、CochraneLibrary、中国知网、维普网、万方数据、中国生物医学文献数据库，收集阿帕替尼联合PD-1/PD-L1抑制剂和（或）化疗/其他疗法（联合组）对比阿帕替尼或PD-1/PD-L1抑制剂单药和（或）化疗/其他疗法（对照组）治疗恶性实体瘤的随机对照研究（RCT），检索时限为建库至2025年5月。筛选文献、提取资料、评价文献质量后，采用RevMan5.3和Stata14.0软件进行Meta分析。结果共纳入28篇RCTs，包括2974例患者。联合组患者的客观缓解率[RR＝1.639，95%CI（1.452，1.851），P＜0.00001]，疾病控制率[RR＝1.284，95%CI（1.178，1.399），P＜0.00001]，CD3+、CD4+、CD4+/CD8+以及高血压、疲劳乏力、蛋白尿、血小板减少等不良反应的发生率均显著高于对照组（P＜0.05或P＜0.00001）；疾病进展率[RR＝0.497，95%CI（0.437，0.566），P＜0.00001]、血清肿瘤标志物水平、CD8+均显著低于对照组（P＜0.05或P＜0.00001）。不同类型肿瘤的亚组分析结果显示，联合组患者的客观缓解率和疾病控制率均显著高于对照组（P＜0.05）。敏感性分析结果显示，本研究结果的稳定性良好。发表偏倚分析结果显示，本研究存在发表偏倚的可能性较大。结论阿帕替尼联合PD-1/PD-L1抑制剂治疗不同类型肿瘤的疗效显著，但需注意高血压、疲劳乏力、蛋白尿、血小板减少的发生。 |
| ABSTRACT： | OBJECTIVE To evaluate the efficacy and safety of apatinib combined with PD-1/PD-L1 inhibitors in the treatment of malignant solid tumors. METHODS Randomized controlled trials （RCTs） on apatinib combined with PD-1/PD-L1 inhibitors （combination group） versus monotherapy （apatinib or PD-1/PD-L1）combined with （or） chemotherapy/other treatments （control group） in the treatment of malignant solid tumors were collected from PubMed， Web of Science， Embase， Cochrane Library， CNKI， VIP， Wanfang Data and China Biomedical Literature Database. The search time limit was from the establishment of the databases to May 2025. After literature screening， data extraction and literature quality evaluation， meta-analysis was performed using RevMan 5.3 and Stata 14.0. RESULTS A total of 28 RCTs involving 2 974 patients were included. The objective response rate [RR＝1.639， 95%CI（1.452，1.851）， P＜0.000 01]， disease control rate [RR＝1.284， 95%CI（1.178，1.399）， P＜0.000 01] and CD3+， CD4+， CD4+/CD8+ as well as the incidence of ADR such as hypertension， fatigue， proteinuria， thrombocytopenia were significantly higher in the combination group than control group （P＜0.05 or P＜0.000 01）. The progressive disease rate [RR＝ 0.497， 95%CI（0.437， 0.566）， P＜0.000 01] and serum tumor + marker levels and CD8 were significantly lower in the combination group than control group （P＜0.05 or P＜0.000 01）. Subgroup analysis results of different types of tumors showed that the objective response rate and disease control rate were significantly higher in the combination group than control group （P＜0.05）. The results of sensitivity analysis showed that the stability of this study was good. The results of publication bias analysis showed that there was a high possibility of publication bias in this study. CONCLUSIONS Apatinib combined with PD-1/ PD-L1 inhibitors has a significant efficacy in the treatment of different types of tumors， but attention should be paid to the occurrence of hypertension， fatigue， proteinuria and thrombocytopenia. |
| 期刊： | 2025年第36卷第16期 |
| 作者： | 王辰；李君；王宁；于新娟；于晓露；李廷天 |
| AUTHORS： | WANG Chen，LI Jun，WANG Ning，YU Xinjuan，YU Xiaolu，LI Tingtian |
| 关键字： | 阿帕替尼；PD-1抑制剂；PD-L1抑制剂；恶性实体瘤；Meta分析 |
| KEYWORDS： | apatinib； PD-1 inhibitor； PD-L1 inhibitor； malignant solid tumors； meta-analysis |
| 阅读数： | 10 次 |
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