自我报告的药物不良反应及其对HIV感染患者高效抗逆转录病毒治疗的影响：一项横断面研究。
Self-reported adverse drug reactions and their influence on highly active antiretroviral therapy in HIV infected patients: a cross sectional study.
作者信息
Tadesse Wondmagegn Tamiru, Mekonnen Alemayehu Berhane, Tesfaye Wubshet Hailu, Tadesse Yidnekachew Tamiru
机构信息
Department of Pharmacology, School of Medicine, Addis Ababa Science & Technology University, Addis Ababa, Ethiopia.
出版信息
BMC Pharmacol Toxicol. 2014 Jun 23;15:32. doi: 10.1186/2050-6511-15-32.
BACKGROUND
Patients on antiretroviral therapy have higher risk of developing adverse drug reactions (ADRs). The impact of ADRs on treatment adherence, treatment outcomes and future treatment options is quiet considerable. Thus, the purpose of this study was to describe the common self-reported ADRs and their impact on antiretroviral treatment.
METHODS
Cross-sectional study was conducted at antiretroviral therapy (ART) clinic of Gondar University Hospital. Semi-structured interview questionnaire was used to extract self-reported ADRs, socio-demographic, and psycho-social variables. Variables related to antiretroviral medication, laboratory values and treatment changes were obtained from medical charts. Chi-square and odds ratio with 95% confidence interval were used to determine the associations of dependent variables.
RESULT
A total of 384 participants were enrolled. At least one adverse drug reaction was reported by 345 (89.8%) study participants and the mean number of ADRs reported was 3.7 (±0.2). The most frequently reported ADRs were nausea (56.5%) and headache (54.9%). About 114 (31.0%) participants considered antiretroviral therapy to be unsuccessful if ADRs occurred and only 10 (2.6%) decided to skip doses as ADRs were encountered. Based on chart review, treatment was changed for 78 (20.3%) patients and from which 79% were due to documented ADRs (p = 0.00). Among them, CNS symptoms (27.4%) and anemia (16.1%) were responsible for the majority of changes. Around four percent of patients were non-adherent to ART. Non-adhered participants and those on treatment changes were not statistically associated with self-reported ADRs. Only unemployment status (AOR = 1.76 (1.15 - 2.70), p = 0.01) and ADR duration of less than one month (AOR = 1.95 (1.28-2.98), p = 0.001) were significantly associated with self-reported adverse effects of three or more in the multivariate analysis.
CONCLUSION
Self-reported ADRs to antiretroviral therapy are quite common. More of the reactions were of short lasting and their impact on adherence and treatment change were less likely. However, documented ADRs were the most prevalent reasons for ART switch. Moreover, the level of unemployment was a strong predictor of self-reported ADRs.
背景
接受抗逆转录病毒治疗的患者发生药物不良反应（ADR）的风险更高。ADR对治疗依从性、治疗结果和未来治疗选择的影响相当大。因此，本研究的目的是描述常见的自我报告的ADR及其对抗逆转录病毒治疗的影响。
方法
在贡德尔大学医院的抗逆转录病毒治疗（ART）诊所进行横断面研究。使用半结构化访谈问卷提取自我报告的ADR、社会人口统计学和心理社会变量。从病历中获取与抗逆转录病毒药物、实验室值和治疗变化相关的变量。使用卡方检验和95%置信区间的比值比来确定因变量的关联。
结果
共招募了384名参与者。345名（89.8%）研究参与者报告了至少一种药物不良反应，报告的ADR平均数量为3.7（±0.2）。最常报告的ADR是恶心（56.5%）和头痛（54.9%）。约114名（31.0%）参与者认为如果发生ADR，抗逆转录病毒治疗是不成功的，只有10名（2.6%）参与者因遇到ADR而决定跳过剂量。根据病历审查，78名（20.3%）患者的治疗发生了改变，其中79%是由于记录在案的ADR（p = 0.00）。其中，中枢神经系统症状（27.4%）和贫血（16.1%）是导致大多数治疗改变的原因。约4%的患者未坚持ART治疗。未坚持治疗的参与者和治疗发生改变的参与者与自我报告的ADR在统计学上无关联。在多变量分析中，只有失业状态（调整后比值比[AOR]=1.76[1.15 - 2.70]，p = 0.01）和ADR持续时间少于一个月（AOR = 1.95[1.28 - 2.98]，p = 0.001）与自我报告的三种或更多不良反应显著相关。
结论
自我报告的抗逆转录病毒治疗ADR相当常见。更多的反应持续时间较短，它们对依从性和治疗改变的影响较小。然而，记录在案的ADR是ART换药的最常见原因。此外，失业水平是自我报告ADR的有力预测因素。
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