Department of Respiratory Medicine, Goa Medical College, Bambolim, Goa, 403202, India.
Department of Respiratory Medicine, Goa Medical College, Bambolim, Goa, 403202, India.
Indian J Tuberc. 2024;71 Suppl 1:S136-S140. doi: 10.1016/j.ijtb.2024.03.002. Epub 2024 Mar 6.
Pharmacovigilance entails monitoring of patients for timely detection of ADR and reporting them so that more information about drug safety can be obtained. This may help in the future for dose modification or alteration of regimen. In NTEP, ADSm (Active Drug Safety monitoring) is part of pharmacovigilance. In this study we shall be studying ADRs to Anti TB drugs in DRTB.
This study is observational, retrospective and record based, of patients admitted from 2021 to 2023 in the DOTS ward of Respiratory Medicine Department of a tertiary care hospital in Goa. Data such as age, sex, regimen, date of AKT initiation and adverse effects documented has been noted and compiled.
ADRs have been tabulated in the form of tables. Statistical analysis is done to find out the commonest ADR, time when they are likely to occur, which age and gender are most likely affected and if there are any other associated risk factors for ADRs.
This study will enable in future to better monitor patients with regard to particular adverse drug reaction, patient safety and if needed to alter the regimen as early as possible.
药物警戒需要对患者进行监测，以便及时发现不良反应并报告，从而获得更多关于药物安全性的信息。这有助于在未来调整剂量或改变治疗方案。在国家结核病控制项目中，ADSm（主动药物安全监测）是药物警戒的一部分。在这项研究中，我们将研究耐多药结核病患者的抗结核药物不良反应。
本研究是一项观察性、回顾性和基于记录的研究，对 2021 年至 2023 年期间在果阿一家三级护理医院呼吸内科 DOTS 病房住院的患者进行研究。记录并编制了年龄、性别、方案、AKT 起始日期和不良反应等数据。
以表格形式列出了不良反应。进行了统计学分析，以找出最常见的不良反应、可能发生的时间、最容易受影响的年龄和性别，以及是否存在其他不良反应的相关风险因素。
这项研究将有助于未来更好地监测特定药物不良反应、患者安全性的患者，并在需要时尽早改变治疗方案。
