新药与新担忧：通过对慢性丙型肝炎患者直接抗病毒药物的药物警戒获取见解

New drugs and new concerns: Gaining insight through Pharmacovigilance of direct acting Anti-Viral's in chronic HCV patients.

作者信息

Hashmi Zahid Yasin, Zia Muhammad Qasim, Bajwa Akram, Ahmed Maqsood, Anwer Naveed, Raza Mahwish, Baqar Jaffer Bin

机构信息

Zahid Yasin Hashmi, FCPS Liver Center Faisalabad, Pakistan.

Muhammad Qasim Zia, FCPS Allama Iqbal Memorial Teaching Hospital, Sialkot, Pakistan.

出版信息

Pak J Med Sci. 2021 Mar-Apr;37(2):299-304. doi: 10.12669/pjms.37.2.3400.

DOI:10.12669/pjms.37.2.3400

PMID:33679903

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7931287/

Abstract

OBJECTIVE

The study aimed to assess the safety profile of Direct Acting Anti-Viral's (DAAs) among patients with chronic Hepatitis C Virus (HCV).

METHODS

This multicenter, analytical cross-sectional study was conducted in six gastroenterology and Hepatology centers including Liver Center Faisalabad, Allama Iqbal Medical Institute and Liver Center DHQ Hospital Sialkot, Isra Hospital Hyderabad, Allied Hospital Faisalabad and Rehman Medical Institute Peshawar, between May 2018 and May 2019. The data regarding patient demographics, treatment plan and the frequency of Adverse Events (AEs), and their severity was collected using a pre-designed questionnaire and analyzed through SPSS version 20.0.

RESULTS

A total of 511 HCV patients were enrolled, with an overall male majority. Around 66.3% patients experienced a total of 419 AEs, out of which 61 events were suspected from DAAs while remaining 317 events were associated with Ribavirin. Pyrexia (24.6%) and fatigue (14.8%) were the most commonly reported AEs among patients receiving DAAs. Factors such as Ribavirin-based treatments and the presence of Cirrhosis were more likely to promote AEs occurrence OR [95%CI] i.e. 5.2(2.3-9.1) and 1.9(1.1-3.1) respectively (p < 0.05).

CONCLUSION

It is concluded from the study results that DAAs have displayed promising outcomes due to the minimal and minor AEs reported.

摘要

目的

本研究旨在评估直接作用抗病毒药物（DAAs）在慢性丙型肝炎病毒（HCV）患者中的安全性。

方法

本多中心分析性横断面研究于2018年5月至2019年5月在六个胃肠病学和肝病中心进行，包括费萨拉巴德肝脏中心、阿拉马·伊克巴勒医学院和锡亚尔科特DHQ医院肝脏中心、海得拉巴伊斯拉医院、费萨拉巴德联合医院和白沙瓦雷曼医学院。使用预先设计的问卷收集有关患者人口统计学、治疗方案、不良事件（AE）发生频率及其严重程度的数据，并通过SPSS 20.0版进行分析。

结果

共纳入511例HCV患者，男性总体占多数。约66.3%的患者共经历了419次AE，其中61次事件怀疑由DAAs引起，其余317次事件与利巴韦林有关。发热（24.6%）和疲劳（14.8%）是接受DAAs治疗患者中最常报告的AE。基于利巴韦林的治疗和肝硬化等因素更有可能促进AE的发生，比值比[95%置信区间]分别为5.2（2.3 - 9.1）和1.9（1.1 - 3.1）（p < 0.05）。