我们的研究旨在评估乐伐替尼与索拉非尼在现实环境下治疗肝细胞癌（HCC）患者的疗效和安全性。我们通过 PubMed、Embase、Web of Science 和 Cochrane Library 数据库检索了 2000 年 1 月 1 日以来的相关文献截至2022年6月25日。评估了接受Lenvatinib治疗的HCC患者之间的总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、疾病控制率（DCR）以及治疗不良相关事件的差异和索拉非尼使用固定或随机效应模型。采用MINORS评估问卷评估纳入文献的质量。本次荟萃分析共纳入9项单臂研究和6项比较研究。在荟萃分析中，乐伐替尼的中位 OS 显着长于索拉非尼（P < 0.01，MD = 1.20，95% CI [0.92-1.48]），以及中位 PFS（P < 0.01，OR = 2.68，95% CI） [1.59-3.76]），以及较高的 ORR（P < 0.01，OR = 5.36，95% CI [3.42-8.40]）、DCR（P < 0.01，OR = 2.17，95% CI [1.64-2.86]）。乐伐替尼治疗组的高血压发生率高于索拉非尼治疗组（P < 0.01，MD = 5.27，95% CI [2.38-11.66]），且乐伐替尼和索拉非尼治疗组的手足综合征无显着差异。与索拉非尼相比，乐伐替尼治疗 HCC 患者获得了更好的 OS、PFS 以及更高的 ORR 和 DCR。然而，安全性数据表明乐伐替尼并未表现出显着优势。版权所有 © 2023 Wolters Kluwer Health, Inc. 保留所有权利。

Our study aimed to evaluate the efficacy and safety of Lenvatinib compared with Sorafenib for treating hepatocellular carcinoma (HCC) patients under real-world setting.We retrieved relevant literature through the PubMed, Embase, Web of Science, and Cochrane Library databases from 1 January 2000 to 25 June 2022. The differences in overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR) as well as treatment adverse related events were evaluated between HCC patients treated with Lenvatinib and Sorafenib using fixed or random-effects models. The MINORS evaluation questionnaire was used to assess the quality of the included literature.This meta-analysis included a total of 9 single-arm studies and 6 comparative studies. In the meta-analysis, Lenvatinib showed significantly longer median OS than Sorafenib (P < 0.01, MD = 1.20, 95% CI [0.92-1.48]), as well as median PFS (P < 0.01, OR = 2.68, 95% CI [1.59-3.76]), and higher ORR(P < 0.01, OR = 5.36, 95% CI [3.42-8.40]), DCR(P < 0.01, OR = 2.17, 95% CI [1.64-2.86]). The occurrence of Hypertension was higher in Lenvatinib than in Sorafenib treatment (P < 0.01, MD = 5.27, 95% CI [2.38-11.66]), and there was no significant difference in Hand-foot syndrome between Lenvatinib and Sorafenib.We found that treatment with Lenvatinib in HCC patients resulted in better OS, PFS, and higher ORR and DCR compared to Sorafenib. However, safety data indicated that Lenvatinib did not exhibit a significant advantage.Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.