南印度某三级医院患者卡培他滨化疗方案的不良反应概况及其易感因素

IF 0.7 Q4 PHARMACOLOGY & PHARMACY
Avishek Amar, Jayanthi Mathaiyan, Biswajit Dubashi
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引用次数: 0

摘要

背景:卡培他滨是一种重要的用于胃肠道肿瘤的药物,已知与许多药物不良反应(adr)相关,导致剂量调整或停药。目的:本研究的目的是确定与卡培他滨化疗方案(CBCR)相关的药物不良反应(adr)的频率和模式。方法:在印度南部的一个区域癌症中心进行前瞻性观察研究。总共招募了120名接受CBCR的癌症患者,并对其进行了访谈,以了解在整个化疗周期中是否发生了任何不良反应。根据CTCAE标准(v4.03)对药物不良事件的严重程度进行分级,并使用WHO和Naranjo量表进行因果关系评估。采用改良的Schumock和Thornton量表对adr进行可预防性评价。采用卡方检验分析癌症类型、性别和化疗方案之间不良反应发生频率的差异。结果:在整个治疗周期中报告的大多数不良反应(96.6%)来自胃肠道系统,其次是神经相关事件(93.3%)。在检测到的各种不良反应中,皮肤/指甲变色和疲劳/虚弱是最常见的报告。因果关系分析将大多数不良反应归为“可能”类别(按WHO标准为50.5%,按Naranjo标准为50.9%)。大多数不良反应的严重程度为I级(54.5%),被认为“可能可以预防”。结论:CBCR与几种不良反应相关,但大多数为I级严重程度,主要影响胃肠道系统。根据因果关系分析,大多数不良反应被归类为“可能”,大多数被认为是“可能预防的”。未来的研究可以集中在改善这些不良反应,以避免剂量调整或停止化疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adverse Drug Reaction Profile of Capecitabine-based Chemotherapy Regimen and its Predisposing Factors in Patients Attending a Tertiary Care Hospital in South India.

Background: Capecitabine, an important drug used for solid tumors involving the gastrointestinal tract, is known to be associated with many Adverse Drug Reactions (ADRs) leading to dose modification or discontinuation.

Objective: The objective of this study was to determine the frequency and pattern of adverse drug reactions (ADRs) associated with capecitabine-based chemotherapy regimens (CBCR).

Methods: A prospective observational study was carried out at a regional cancer center in South India. A total of 120 cancer patients receiving CBCR were recruited and interviewed for the occurrence of any ADRs during the complete course of chemotherapy cycles. The adverse drug events were graded for severity as per the CTCAE criteria (v4.03), and causality assessment was done using the WHO and Naranjo scales. The preventability assessment of the ADRs was conducted using the modified Schumock and Thornton scale. The chi-squared test was used to analyze the difference in the frequency of ADRs among cancer types, genders, and chemotherapy regimens.

Results: The majority of ADRs (96.6%) reported throughout the treatment cycles were from the gastrointestinal system, followed by neurology-related events (93.3%). Among the various ADRs detected, skin/nail discoloration and fatigue/weakness were the most frequently reported. Causality analysis classified most ADRs under the "possible" category (50.5% by the WHO scale and 50.9% by the Naranjo scale). Most ADRs were of Grade I severity (54.5%) and were deemed "probably preventable."

Conclusion: CBCR was associated with several ADRs, though most were of Grade I severity and primarily affected the gastrointestinal system. The majority of ADRs were classified as "possible" based on causality analysis, and most were deemed "probably preventable." Future research could focus on ameliorating these ADRs to avoid dose adjustments or discontinuation of chemotherapy.

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来源期刊
Current drug safety
Current drug safety PHARMACOLOGY & PHARMACY-
CiteScore
2.10
自引率
0.00%
发文量
112
期刊介绍: Current Drug Safety publishes frontier articles on all the latest advances on drug safety. The journal aims to publish the highest quality research articles, reviews and case reports in the field. Topics covered include: adverse effects of individual drugs and drug classes, management of adverse effects, pharmacovigilance and pharmacoepidemiology of new and existing drugs, post-marketing surveillance. The journal is essential reading for all researchers and clinicians involved in drug safety.
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