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首页> 外文期刊>International Journal of Pharmacological Research >Adverse event monitoring of antiretroviral drugs- A pharmacovigilance perspective
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Adverse event monitoring of antiretroviral drugs- A pharmacovigilance perspective

机译：抗逆转录病毒药物的不良事件监测-药物警戒的观点

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Objective: To monitor and evaluate adverse drug reactions (ADRs) to antiretroviral drugs in patients of HIV/AIDS by active and spontaneous/solicited ADR monitoring. Methods: A prospective observational study to monitor ADRs was carried out over 12 months in 187 patients of HIV/AIDS taking antiretroviral treatment. The ADRs reported were evaluated for incidence, frequency, causality, severity, seriousness and preventability. Causality assessment was done using the WHO-UMC and Naranjo scale, seriousness was considered as per the ADR reporting form, severity and preventability assessment were done as per the Hartwig severity scale and the modified Schumock and Thornton criteria respectively. Results: 103 patients (55.1%) reported at least one ADR and 108 ADR reports were collected. Mostly the ADRs came from the tenofovir + lamivudine + efavirenz regimen with efavirenz related to most number of ADRs (52.5%). Maximum ADRs belonged to the system organ class of neurological disorders (64.81%) followed by gastrointestinal (19.44%) and skin and appendages disorders (7.40%). Causality assessment by WHO-UMC scale revealed most of the reactions as ‘possible’ (99.2%) while Naranjo scale assessed most of them as ‘probable’ (69.8%). Most of the reactions (96.1%) were ‘mild’ in nature and no serious reactions were reported. Preventability assessment determined most reactions (94.6%) as ‘not preventable’. Conclusion: Antiretroviral drugs have a huge potential for causing ADRs specially neurological and gastrointestinal. Active pharmacovigilance is vital in recognizing such reactions to ensure timely management and optimal therapeutic outcomes.
机译：目的：通过主动和自发/主动ADR监测来监测和评估HIV / AIDS患者对抗逆转录病毒药物的不良药物反应（ADR）。方法：对187名接受抗逆转录病毒治疗的HIV / AIDS患者进行了为期12个月的前瞻性观察研究，以监测其ADR。评估报告的ADR的发生率，频率，因果关系，严重性，严重性和可预防性。使用WHO-UMC和Naranjo量表进行因果关系评估，根据ADR报告表评估严重程度，分别根据Hartwig严重度量表和修改后的Schumock和Thornton标准进行严重程度和可预防性评估。结果：103例患者（55.1％）报告了至少一项ADR，并收集了108份ADR报告。多数ADR来自替诺福韦+拉米夫定+依非韦伦方案，依非韦伦与大多数ADR有关（52.5％）。最大的ADR属于神经系统疾病的系统器官类别（64.81％），其次是胃肠道疾病（19.44％）以及皮肤和附件疾病（7.40％）。 WHO-UMC量表的因果关系评估显示，大多数反应为“可能”（99.2％），而Naranjo量表将大多数反应视为“可能”（69.8％）。大多数反应（96.1％）本质上是“轻度”，没有严重反应的报道。可预防性评估将大多数反应（94.6％）确定为“不可预防”。结论：抗逆转录病毒药物具有引起特别是神经系统和胃肠道不良反应的巨大潜力。主动药物警戒对于识别此类反应以确保及时治疗和最佳治疗效果至关重要。

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