Sapapsap Bannawich, Thongnoi Poomipat, Pongpun Anchana, Kitcharoenpanya Supattra, Todsarot Teerarat, Petchsomrit Arpa, Leelakanok Nattawut
Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Burapha University, Chonburi, Thailand.
Friend Pharmacy, Chonburi, Thailand.
World J Oncol. 2024 Dec;15(6):902-921. doi: 10.14740/wjon1920. Epub 2024 Oct 30.
The incidence of cardiotoxicity events in patients who use 5-fluorouracil (5-FU) and capecitabine monotherapy remains unclear since previous studies reported the prevalence in patients who used combination regimens. We aimed to systematically review and meta-analyze the incidence of cardiotoxicity in fluorouracil and capecitabine monotherapy users.
The study protocol was registered with PROSPERO (CRD42023441627). Systematic searches were conducted in five databases (CINAHL, OpenGrey, PubMed, ScienceDirect, and Scopus). The Cochrane Risk-of-Bias tool and the Risk Of Bias In Non-randomized Studies were used to evaluate the risk of bias. Pooled prevalence and 95% confidence interval (CI) were calculated using the DerSimonian-Laird random effect models. The funnel plot was used to assess the publication bias.
Eighty studies were included. There were 24 randomized controlled trials (RCTs) with low to high risk of bias and 56 non-RCTs with critical risk of bias. The pooled prevalence of cardiotoxicity from 5-FU was 3.5% (95% CI: 2.7 - 4.2; P < 0.001; I = 73.86%). The pooled prevalence of cardiotoxicity in capecitabine users was 2.8% (95% CI: 1.6 - 4.0; P < 0.001; I = 72.62%).
The prevalence of cardiotoxicity from 5-FU and capecitabine was classified as common. Cardiotoxicity may have not been associated with the cumulative dose of 5-FU or capecitabine.
使用5-氟尿嘧啶（5-FU）和卡培他滨单药治疗的患者发生心脏毒性事件的发生率尚不清楚，因为先前的研究报告的是使用联合治疗方案患者的发生率。我们旨在系统评价和荟萃分析使用氟尿嘧啶和卡培他滨单药治疗患者的心脏毒性发生率。
该研究方案已在国际前瞻性系统评价注册库（PROSPERO，注册号：CRD42023441627）登记。在五个数据库（CINAHL、OpenGrey、PubMed、ScienceDirect和Scopus）中进行了系统检索。使用Cochrane偏倚风险工具和非随机研究中的偏倚风险工具评估偏倚风险。采用DerSimonian-Laird随机效应模型计算合并患病率和95%置信区间（CI）。采用漏斗图评估发表偏倚。
纳入80项研究。其中有24项随机对照试验（RCT），偏倚风险为低到高，56项非RCT，偏倚风险为高。5-FU导致心脏毒性的合并患病率为3.5%（95%CI：2.7 - 4.2；P < 0.001；I² = 73.86%）。卡培他滨使用者心脏毒性的合并患病率为2.8%（95%CI：1.6 - 4.0；P < 0.001；I² = 72.62%）。
5-FU和卡培他滨导致心脏毒性的患病率属于常见。心脏毒性可能与5-FU或卡培他滨的累积剂量无关。
