Anwikar S R, Bandekar M S, Smrati Bajpai, Pazare A P, Tatke P A, Kshirsagar N A
CU Shah College of Pharmacy, SNDT Women's University, Mumbai, India.
Int J Risk Saf Med. 2011;23(3):163-9. doi: 10.3233/JRS-2011-0532.
To collect data on suspected adverse drug reactions of HAART therapy; analyze the data; and find out frequency of preventable adverse drug reactions in order to minimize the harm to the patients.
Retrospective study.
ADR data associated with the use of HAART from November 2005 to December 2007 was collected retrospectively from records of patients using the ART treatment from NACO at a tertiary referral centre under the National Pharmacovigilance Programme. These ADRs were analyzed for causality (WHO scale), severity (Hartwig et al. scale) and preventability (Schumock and Thornton scale).
Data of 1844 patients (1198-Male & 645-Female) enrolled from November 2005 to December 2007 was collected. 222 patients developed about 228 ADRs with prevalence of 12.36%. Peripheral neuropathy and anemia were highly prevalent ADRs. Nevirapine induced rash and SJ syndrome developed within first month of treatment followed by anemia, hepatitis and gastritis which developed within 6 months after initiation of ART. 96.49% ADRs were found to be possible and 3.50% probable by WHO probability scale. 20 (8.77%) were mild, 176 (77.19%) were moderate and 32 (14.02%) were severe in nature. 183 (80.26%) ADRs were found to be non-serious whereas 45 (19.74%) were serious. Only 2.63% ADRs were found to be preventable which included vomiting and rash. Odds ratio with 95% CI was calculated.
It has been observed that antiretroviral therapy has many serious and life threatening adverse drug reactions that may affect a variety of organ systems. Zidovudine use was observed as a risk factor for anemia. Stavudine for peripheral neuropathy, where as nevirapine use was identified as a risk factor for skin reactions. Active pharmacovigilance programme should be implemented and awareness should be created among physicians about reporting any suspected adverse drug reaction so that unreported ADRs and unknown risk factors could be identified.
收集高效抗逆转录病毒治疗（HAART）的疑似药物不良反应数据；分析这些数据；找出可预防的药物不良反应的发生率，以尽量减少对患者的伤害。
回顾性研究。
从国家药物警戒计划下的一家三级转诊中心接受抗逆转录病毒治疗（ART）的患者记录中，回顾性收集2005年11月至2007年12月期间与使用HAART相关的药物不良反应（ADR）数据。对这些ADR进行因果关系（WHO标准）、严重程度（Hartwig等人的标准）和可预防性（Schumock和Thornton标准）分析。
收集了2005年11月至2007年12月期间登记的1844例患者（男性1198例，女性645例）的数据。222例患者出现了约228例ADR，发生率为12.36%。周围神经病变和贫血是非常常见的ADR。奈韦拉平引起的皮疹和史蒂文斯-约翰逊综合征在治疗的第一个月内出现，随后贫血、肝炎和胃炎在开始ART治疗后的6个月内出现。根据WHO概率标准，96.49%的ADR被认为是可能的，3.50%是很可能的。20例（8.77%）为轻度，176例（77.19%）为中度，32例（14.02%）为重度。183例（80.26%）ADR被认为不严重，而45例（19.74%）为严重。仅2.63%的ADR被认为是可预防的，包括呕吐和皮疹。计算了95%置信区间的比值比。
据观察，抗逆转录病毒疗法有许多严重且危及生命的药物不良反应，可能影响多个器官系统。齐多夫定的使用被视为贫血的危险因素。司他夫定与周围神经病变有关，而奈韦拉平的使用被确定为皮肤反应的危险因素。应实施积极的药物警戒计划，并提高医生对报告任何疑似药物不良反应的认识，以便识别未报告的ADR和未知的危险因素。
