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在东开普省公共部门诊所中,初治的HIV阳性患者使用依非韦伦后出现神经精神副作用的发生率。

Incidence of neuropsychiatric side effects of efavirenz in HIV-positive treatment-naïve patients in public-sector clinics in the Eastern Cape.

作者信息

Gaida Razia, Truter Ilse, Grobler Christoffel

机构信息

Department of Pharmacy, Nelson Mandela Metropolitan University, South Africa.

Drug Utilisation Research Unit, Nelson Mandela Metropolitan University, South Africa.

出版信息

South Afr J HIV Med. 2016 Jun 30;17(1):452. doi: 10.4102/sajhivmed.v17i1.452. eCollection 2016.

Abstract

BACKGROUND

It is acknowledged that almost half of patients initiated on efavirenz will experience at least one neuropsychiatric side effect.

OBJECTIVES

The aim was to determine the incidence and severity of neuropsychiatric side effects associated with efavirenz use in five public-sector primary healthcare clinics in the Eastern Cape.

METHOD

The study was a prospective drug utilisation study. A total of 126 medical records were reviewed to obtain the required information. After baseline assessment, follow-up reviews were conducted at 4 weeks, 12 weeks and 24 weeks from 2014 to 2015.

RESULTS

The participant group was 74.60% female ( = 94), and the average age was 37.57±10.60 years. There were no neuropsychiatric side effects recorded for any patient. After the full follow-up period, there were a total of 49 non-adherent patients and one patient had demised. A non-adherent patient was defined as a patient who did not return to the clinic for follow-up assessment and medication refills 30 days or more after the appointed date. Some patients ( = 11) had sent a third party to the clinic to collect their antiretroviral therapy (ART). The clinic pharmacy would at times dispense a two-month supply of medication resulting in the patient presenting only every two months.

CONCLUSION

Further pharmacovigilance studies need to be conducted to determine the true incidence of these side effects. Healthcare staff must be encouraged to keep complete records to ensure meaningful patient assessments. Patients being initiated on ART need to personally attend the clinic monthly for at least the first 6 months of treatment. Clinic staff should receive regular training concerning ART, including changes made to guidelines as well as reminders of side effects experienced.

摘要

背景

据公认,开始使用依非韦伦的患者中近一半会经历至少一种神经精神方面的副作用。

目的

旨在确定东开普省五家公共部门初级医疗保健诊所中与使用依非韦伦相关的神经精神副作用的发生率和严重程度。

方法

该研究是一项前瞻性药物利用研究。共查阅了126份病历以获取所需信息。在基线评估后,于2014年至2015年在第4周、第12周和第24周进行随访复查。

结果

参与者组中女性占74.60%(n = 94),平均年龄为37.57±10.60岁。没有任何患者记录到神经精神副作用。在整个随访期后,共有49名不依从患者,1名患者死亡。不依从患者定义为在指定日期后30天或更长时间未返回诊所进行随访评估和药物续方的患者。一些患者(n = 11)派第三方到诊所领取抗逆转录病毒疗法(ART)药物。诊所药房有时会发放两个月的药物供应量,导致患者每两个月才前来一次。

结论

需要进行进一步的药物警戒研究以确定这些副作用的真实发生率。必须鼓励医护人员保留完整记录以确保对患者进行有意义的评估。开始接受抗逆转录病毒治疗的患者在治疗的至少前6个月需要每月亲自到诊所就诊。诊所工作人员应接受关于抗逆转录病毒治疗的定期培训,包括指南的变化以及副作用提醒。

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