雷莫西尤单抗治疗癌症患者时高血压的发生率及风险：已发表研究的荟萃分析

Incidence and risk of hypertension with ramucirumab in cancer patients: a meta-analysis of published studies.

作者信息

Wang Jianhua, Wang Zexing, Zhao Yunzhao

机构信息

Department of General Surgery, Jiansu Province of Traditional Chinese Medicine, 100 Shizi Street, Hongshan Road, Nanjing, 210028, Jiangsu, People's Republic of China.

出版信息

Clin Drug Investig. 2015 Apr;35(4):221-8. doi: 10.1007/s40261-015-0272-z.

DOI:10.1007/s40261-015-0272-z

PMID:25697774

Abstract

BACKGROUND AND OBJECTIVE

Ramucirumab is a novel antiangiogenic agent approved as second-line therapy for patients with advanced stomach cancer and gastroesophageal junction adenocarcinoma. Although existing evidence from clinical trials has demonstrated hypertension is one of the major adverse events of this agent, overall risks have yet to be reported.

METHODS

We carried out a meta-analysis of published studies to determine the overall incidence and relative risk (RR) of hypertension associated with ramucirumab. Statistical analyses were conducted to calculate the summary incidence, RRs, and 95 % confidence intervals (CIs) by using a random effects model.

RESULTS

Eleven studies with a total of 3,851 patients with multiple cancers were included. The overall incidence of all-grade hypertension was 20.0 % (95 % CI 15.0-26.0) with 8.6 % (95 % CI 6.3-11.7) being high-grade hypertension. The risk of developing hypertension was greater in ramucirumab-treated patients (RR for all grades 2.77, 95 % CI 1.94-3.94, p < 0.001, RR for high-grade 3.58, 95 % CI 2.45-5.23, p < 0.001).

CONCLUSIONS

Administration of ramucirumab to patients with cancer is associated with increased risk of hypertension.

摘要

背景与目的

雷莫西尤单抗是一种新型抗血管生成药物，被批准用于晚期胃癌和胃食管交界腺癌患者的二线治疗。尽管临床试验的现有证据表明高血压是该药物的主要不良事件之一，但总体风险尚未见报道。

方法

我们对已发表的研究进行了荟萃分析，以确定与雷莫西尤单抗相关的高血压的总体发生率和相对风险（RR）。采用随机效应模型进行统计分析，计算汇总发生率、RR及95%置信区间（CI）。

结果

纳入11项研究，共3851例患有多种癌症的患者。所有级别的高血压总体发生率为20.0%（95%CI 15.0 - 26.0），其中重度高血压为8.6%（95%CI 6.3 - 11.7）。接受雷莫西尤单抗治疗的患者发生高血压的风险更高（所有级别RR为2.77，95%CI 1.94 - 3.94，p < 0.001；重度RR为3.58，95%CI 2.45 - 5.23，p < 0.001）。