每日方案抗结核治疗的药物不良反应概况。

Q2 Medicine
Perspectives in Clinical Research Pub Date : 2022-10-01 Epub Date: 2021-07-12 DOI:10.4103/picr.PICR_279_20
K N Hari Sankar, Kevin Roch, Doyce Jom, Dhanya S Palappallil, Prabitha Panattil, Rajani K Sankaranarayanan
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引用次数: 2

摘要

目的:评估该院ADR监测中心(AMC)收到的ADR中药物不良反应(ADR)与每日方案抗结核治疗(ATT)的比例,并描述其模式。材料和方法:这是在喀拉拉邦中部一所政府医学院药学系进行的一项描述性研究,研究期间为2017年10月至2020年6月。ADR数据被录入结构化表格,使用SPSS for Windows Version 16.0 (SPSS Inc., Chicago, USA)对数据进行分析。结果:643例不良反应中,98例(15.24%)怀疑是由于每日服用ATT引起的,最常见的器官系统是肝胆46例(46.9%),其中肝炎35例,无症状性肝酶升高11例,其次是眼睛,视力下降26例。96例(97.95%)怀疑ADR存在可能因果关系,2例(2.04%)怀疑ADR存在可能因果关系。77例(78.6%)不良反应报告严重程度为4b级,57例(58.16%)可能可以预防。ATT方案开始后出现不良反应的平均天数为56.40±58.29天(范围1 ~ 180天)。视力下降的平均持续时间为125.23±55.46 d,其发病潜伏期在所有adr中最长。结论:在AMC报告的所有不良反应中,15.24%的不良反应是由ATT的日常方案引起的,肝炎是最常见的不良反应,其次是视力下降。大多数不良反应可能是因果关系,严重,严重程度为4b级,可能是可以预防的。
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 daily regimen antituberculosis treatment.

Adverse drug reaction profile of daily regimen antituberculosis treatment.

Adverse drug reaction profile of daily regimen antituberculosis treatment.

Objectives: The objective was to estimate the proportion of adverse drug reactions (ADRs) to daily regimen antituberculosis treatment (ATT) among the ADRs received in the ADR monitoring center (AMC) of the institution and to describe its pattern.

Materials and methods: This was a descriptive study conducted in the Department of Pharmacology of a Government Medical College in Central Kerala and the period under study was October 2017-June 2020. The data on ADR were entered into a structured pro forma and data were analyzed using SPSS for Windows Version 16.0 (SPSS Inc., Chicago, USA).

Results: Of the 643 ADRs, 98 (15.24%) were suspected to be due to the daily regimen of ATT. The most common organ system affected was hepatobiliary 46 (46.9%) namely hepatitis in 35 and asymptomatic elevated liver enzymes in 11 followed by eye with 26 reports of decreased vision. In 96 (97.95%), the suspected ADR had probable causality and in 2 (2.04%) it was possible. Seventy-seven (78.6%) ADR reports were serious as well as moderate-level 4b in severity and 57 (58.16%) were probably preventable. The mean days of onset of ADR after starting the ATT regimen were 56.40 ± 58.29 days (range 1-180). Decrease in vision with a mean duration of 125.23 ± 55.46 days had the longest latency in onset among all the ADRs.

Conclusions: Of all the ADRs reported to AMC 15.24% were due to the daily regimen of ATT. Hepatitis was the most common ADR encountered followed by decrease in vision. The majority of the ADRs were probable in causality, serious, moderate-level 4b in severity, and probably preventable.

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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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