Jha Anshu Kumar, Gadgade Akash, Shenoy Ashok K, Chowta Mukta N, Ramapuram John T
Department of Pharmacology, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
Department of Medicine, Kasturba Medical College, Manipal University, Mangalore, Karnataka, India.
Perspect Clin Res. 2015 Jan-Mar;6(1):34-8. doi: 10.4103/2229-3485.148808.
The advancement and development of new drugs and treatment strategies increase the risk of unusual Adverse Events (AEs) in HIV patients.
The objective of our study was to assess the incidence, types and nature of AEs in HIV positive subjects.
Patients with WHO stage IV disease irrespective of the CD4 cell count, or WHO stage III disease with a CD4 cell count <350 cell/cu. Mm, or, WHO stage I or II disease with a CD4 cell count of <200 cells/cu. mm, and on prior anti-retroviral therapy for not more than six months preceding the observation date, were included in the study. After initiation of therapy, the patients were examined for the occurrence any adverse events including the type and severity, or any other abnormal laboratory findings. Causality assessment of the adverse events was done using the Naranjo's scale.
Out of 327 patients studied prospectively, 43 patients developed AEs. Out of these, 23 (53.5%) were males and 20 (46.5%) were females. A total of 53 (16.21%) AEs were reported. Antitubercular drugs caused the maximum AEs (28.3%) followed by zidovudine (20.7%), nevirapine (15.0%) and efavirenz (5.6%). Stavudine, ethambutol, sulfamethoxazole and trimethoprim, and atazanavir were also responsible for 3.7% of AEs individually. Causality assessment done according to the Naranjo's scale revealed that 66.04% AEs were 'probable' and 33.96% were 'possible'.
Anemia, hepatitis and dermatological adverse effects are the most common AEs. Antitubercular drugs contributed significantly for the incidence of AEs in these patients. Frequency of AEs was slightly more in males compared to females.
新药和治疗策略的进步与发展增加了HIV患者出现异常不良事件（AE）的风险。
我们研究的目的是评估HIV阳性受试者中不良事件的发生率、类型和性质。
纳入世界卫生组织（WHO）IV期疾病患者（无论CD4细胞计数如何），或WHO III期疾病且CD4细胞计数<350个/立方毫米的患者，或WHO I期或II期疾病且CD4细胞计数<200个/立方毫米的患者，且在观察日期前接受抗逆转录病毒治疗不超过6个月。治疗开始后，对患者进行检查，以确定是否发生任何不良事件，包括类型和严重程度，或任何其他异常实验室检查结果。使用Naranjo量表对不良事件进行因果关系评估。
在327名前瞻性研究的患者中，43名患者出现了不良事件。其中，23名（53.5%）为男性，20名（46.5%）为女性。共报告了53例（16.21%）不良事件。抗结核药物导致的不良事件最多（28.3%），其次是齐多夫定（20.7%）、奈韦拉平（15.0%）和依非韦伦（5.6%）。司他夫定、乙胺丁醇、磺胺甲恶唑和甲氧苄啶以及阿扎那韦也分别导致了3.7%的不良事件。根据Naranjo量表进行的因果关系评估显示，66.04%的不良事件为“很可能”，33.96%为“可能”。
贫血、肝炎和皮肤不良反应是最常见的不良事件。抗结核药物对这些患者不良事件的发生率有显著影响。男性不良事件的发生率略高于女性。
