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中药联合血管内皮生长因子受体酪氨酸激酶抑制剂治疗中晚期原发性肝癌的系统评价和 Meta 分析。

Combinatorial treatment with traditional medicinal preparations and VEGFR-tyrosine kinase inhibitors for middle-advanced primary liver cancer: A systematic review and meta-analysis.

机构信息

Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

Graduate College, Beijing University of Chinese Medicine, Beijing, China.

出版信息

PLoS One. 2024 Nov 22;19(11):e0313443. doi: 10.1371/journal.pone.0313443. eCollection 2024.

Abstract

BACKGROUND

This study aimed to investigate the therapeutic efficacy and safety of Traditional medicine preparations (TMPs) given in combination with vascular endothelial growth factor receptor (VEGFR)-associated multi-targeted tyrosine kinase inhibitors (TKIs) for the treatment of middle to advanced-stage primary liver cancer (PLC).

METHODS

This systematic literature survey employed 10 electronic databases and 2 clinical trial registration platforms to identify relevant studies on the use of TMPs + VEGFR-TKIs to treat patients with middle-advanced PLC. Furthermore, a meta-analysis was performed following the PRISMA guidelines using the risk ratio (RR) at 95% confidence intervals (CI) or standardized mean difference as effect measures.

RESULTS

A total of 26 studies comprising 1678 middle-advanced PLC patients were selected. The meta-analysis revealed that compared with VEGFR-TKI mono-treatment, the co-therapy of TMPs + VEGFR-TKIs considerably enhanced the objective response rate (RR = 1.49, 95% CI: 1.31-1.69), disease control rate (RR = 1.23, 95% CI: 1.16-1.30), and one-year overall survival (RR = 1.49, 95% CI: 1.28-1.74). Furthermore, the co-therapy was associated with reduced incidences of liver dysfunction (RR = 0.64, 95% CI: 0.45-0.91), proteinuria (RR = 0.43, 95% CI: 0.24-0.75), hypertension (RR = 0.66, 95% CI: 0.53-0.83), hand-foot skin reactions (RR = 0.63, 95% CI: 0.49-0.80), myelosuppression (RR = 0.63, 95% CI: 0.46-0.87), and gastrointestinal reactions (RR = 0.64, 95% CI: 0.45-0.92). Moreover, the co-therapy indicated no increase in the incidences of rash and fatigue.

CONCLUSION

This systematic analysis revealed that co-therapy with TMPs + VEGFR-TKIs has a higher effectiveness and safety profile for treating middle-advanced PLC patients. However, further validation using randomized control trials is required.

PROSPERO REGISTRATION NO

CRD42022350634.

摘要

背景

本研究旨在探讨中药制剂(TMPs)联合血管内皮生长因子受体(VEGFR)相关多靶点酪氨酸激酶抑制剂(TKIs)治疗中晚期原发性肝癌(PLC)的疗效和安全性。

方法

本系统文献检索采用 10 个电子数据库和 2 个临床试验注册平台,检索 TMPs+VEGFR-TKIs 治疗中晚期 PLC 患者的相关研究。并按照 PRISMA 指南进行荟萃分析,采用风险比(RR)及其 95%置信区间(CI)或标准化均数差作为效应量。

结果

共纳入 26 项研究,包括 1678 例中晚期 PLC 患者。荟萃分析显示,与 VEGFR-TKI 单药治疗相比,TMPs+VEGFR-TKIs 联合治疗可显著提高客观缓解率(RR=1.49,95%CI:1.31-1.69)、疾病控制率(RR=1.23,95%CI:1.16-1.30)和 1 年总生存率(RR=1.49,95%CI:1.28-1.74)。此外,联合治疗还降低了肝功能异常(RR=0.64,95%CI:0.45-0.91)、蛋白尿(RR=0.43,95%CI:0.24-0.75)、高血压(RR=0.66,95%CI:0.53-0.83)、手足皮肤反应(RR=0.63,95%CI:0.49-0.80)、骨髓抑制(RR=0.63,95%CI:0.46-0.87)和胃肠道反应(RR=0.64,95%CI:0.45-0.92)的发生率,且不增加皮疹和乏力的发生率。

结论

本系统分析表明,TMPs+VEGFR-TKIs 联合治疗中晚期 PLC 患者具有更高的疗效和安全性。但仍需进一步开展随机对照试验进行验证。

PROSPERO 注册号:CRD42022350634。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f27/11584121/b0938c5c8cab/pone.0313443.g001.jpg

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