Rukmangathen Rajalakshmi, Brahmanapalli Vasundara Devi, Thammisetty Durga Prasad, Pemmasani Deepishka, Gali Sai Deepak, Atmakuru Ramesh Babu
ADR Monitoring Centre, Sri Venkateswara Medical College, Tirupati, Andhra Pradesh, India.
Department of Pharmacy Practice, Sri Padmavathi School of Pharmacy, Tiruchanoor, Andhra Pradesh, India.
Perspect Clin Res. 2020 Oct-Dec;11(4):158-163. doi: 10.4103/picr.PICR_133_18. Epub 2019 Sep 5.
Human immunodeficiency virus-infected patients do not adhere to their antiretroviral therapy (ART) due to adverse effects of drugs. The continuous monitoring of adverse drug reactions (ADRs) may ensure the safe use of drugs in patients. Hence, a retrospective analysis was carried out to assess the ADRs pattern, causality, and severity associated with various antiretroviral drug regimens in patients receiving ART.
A retrospective, analytical study was carried out at ART nodal center in Sri Venkateswara Ramnarain Ruia Government General Hospital, Tirupati. Data were collected by spontaneous reporting of health-care professionals from ART centers using Suspected ADR Reporting Forms of Indian Pharmacopoeia Commission to record the ADRs occurred in the patients who underwent treatment from December 2015 to November 2016. A total of 299 ADR reports were collected during the study period. The causality and severity of the reported ADRs were assessed using suitable scales.
From a total of 299 ADR reports, females (63.81%) experienced higher ADRs than males (36.12%). The highest number of ADRs was reported to zidovudine/lamivudine/nevirapine (ZLN) regimen (76.92%) than tenofovir/lamivudine/efavirenz (TLE) regimen (23.07%). Cutaneous reactions were higher (34.34%) among patients receiving ZLN therapy, and drowsiness (53.62%) was the most common ADR in patients receiving TLE regimen. According to the World Health Organization causality assessment scale, most of the ADRs were possible (75.92%). On the assessment of Modified Hartwig and Siegel Severity Scale, 55.09% of ADRs were moderate.
The study showed an increased incidence of ADRs to ART which calls for efficient pharmacovigilance systems to improve patient care and drug safety.
感染人类免疫缺陷病毒的患者因药物不良反应而不坚持抗逆转录病毒治疗（ART）。持续监测药物不良反应（ADR）可确保患者安全用药。因此，进行了一项回顾性分析，以评估接受ART治疗的患者中与各种抗逆转录病毒药物方案相关的ADR模式、因果关系和严重程度。
在蒂鲁伯蒂的斯里韦恩卡特斯瓦拉·拉姆纳拉扬·鲁亚政府综合医院的ART节点中心进行了一项回顾性分析研究。数据通过ART中心的医护人员使用印度药典委员会的疑似ADR报告表自发报告收集，以记录2015年12月至2016年11月接受治疗的患者中发生的ADR。研究期间共收集了299份ADR报告。使用合适的量表评估报告的ADR的因果关系和严重程度。
在总共299份ADR报告中，女性（63.81%）经历的ADR比男性（36.12%）多。报告齐多夫定/拉米夫定/奈韦拉平（ZLN）方案的ADR数量最多（76.92%），高于替诺福韦/拉米夫定/依非韦伦（TLE）方案（23.07%）。接受ZLN治疗的患者中皮肤反应较高（34.34%），嗜睡（53.62%）是接受TLE方案患者中最常见的ADR。根据世界卫生组织因果关系评估量表，大多数ADR是可能的（75.92%）。根据改良的哈特维希和西格尔严重程度量表评估，55.09%的ADR为中度。
该研究表明ART的ADR发生率增加，这需要有效的药物警戒系统来改善患者护理和药物安全性。
