Evaluation of Adverse Drug Reaction Profile of Drugs Used as First-Line Antiretroviral Therapy.

Evaluation of Adverse Drug Reaction Profile of Drugs Used as First-Line Antiretroviral Therapy.
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DOI:
10.1155/2018/8095609
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发表时间:
2018
影响因子:
--
通讯作者:
Hadigal S
Hadigal S
中科院分区:
其他
文献类型:
--
作者:
Chowta MN;Kamath P;Ramapuram JT;Shenoy KA;Hadigal S

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目的是研究接受一线抗逆转录病毒治疗的 HIV 患者的药物不良反应 (ADR) 情况。 这是一项前瞻性观察性研究,纳入了 171 名 HIV 患者,并进行了 6 个月的随访。记录人口统计详细信息、病史、HIV 感染详细信息(包括最近的 CD4 计数)、抗逆转录病毒治疗详细信息以及其他伴随药物治疗。通过审查患者记录以及直接采访患者/护理人员来引发药物不良反应。 171 名患者完成了研究,其中 88 名(51.5%)为男性,83 名(48.5%)为女性。研究对象包括 HIV 阳性、未接受过治疗的患者,他们开始接受 NACO 指南推荐的治疗方案。观察到的不良反应包括齐多夫定引起的血红蛋白下降或绝对贫血、头痛等非特异性症状以及替诺福韦、司他夫定和依非韦伦引起的非特异性不适感;司他夫定引起的血脂异常、胰腺炎、周围神经病变和乳酸性酸中毒;奈韦拉平引起的全身皮疹和依非韦伦肾毒性的一例。大多数 ADR 满足“可能”类别(60.1%),其余为“可能”。齐多夫定和奈韦拉平的 ADR 取代了所有其他药物。 胃肠道影响是最常见的不良反应,其中恶心是最常见的不良反应,其他是胃炎和腹泻。其他不良反应包括皮疹、肝毒性、贫血、中性粒细胞减少和血小板减少等血液恶液质以及疲劳。很少有乳酸性酸中毒、周围神经病变、头痛、脂肪萎缩和胰腺炎的病例报道。
The objective was to study the adverse drug reaction (ADR) profile in HIV patients receiving first-line antiretroviral therapy. This was a prospective, observational study that included 171 HIV patients with a follow-up at six months. Demographic details, medical history, details of HIV infection including most recent CD4 count, details of antiretroviral therapy, and other concomitant medication were recorded. Adverse drug reactions were elicited by reviewing patient records and also by interviewing the patient/attendants directly. 171 patients completed the study out of which 88 (51.5%) were males and 83 (48.5%) were females. The study subjects included HIV-positive, treatment naïve patients who were started on treatment regimens recommended by the NACO guidelines. The ADRs observed were a fall in haemoglobin or absolute anaemia in response to zidovudine, nonspecific symptoms like headache, and a nonspecific feeling of being unwell in response to tenofovir, stavudine, and efavirenz; dyslipidaemia, pancreatitis, peripheral neuropathy, and lactic acidosis in response to stavudine; generalised rash in response to nevirapine and one case of nephrotoxicity to efavirenz. Majority of the ADRs satisfied the ‘probable' category (60.1%), and the rest were “possible”. ADRs to zidovudine and nevirapine superseded all others. Gastrointestinal effects were the most commonly observed group of ADRs, with nausea being the most common ADR, the others being gastritis and diarrhoea. The other ADRs included rash, hepatotoxicity, blood dyscrasias like anaemia, neutropenia, and thrombocytopenia, and fatigue. Few cases of lactic acidosis, peripheral neuropathy, headache, lipoatrophy, and pancreatitis were reported.