Clifford David B, Evans Scott, Yang Yijun, Acosta Edward P, Goodkin Karl, Tashima Karen, Simpson David, Dorfman David, Ribaudo Heather, Gulick Roy M
Washington University School of Medicine, Neurology Department, St. Louis, Missouri 63110, USA.
Ann Intern Med. 2005 Nov 15;143(10):714-21. doi: 10.7326/0003-4819-143-10-200511150-00008.
Efavirenz is a commonly used antiretroviral drug that causes neurologic side effects in more than 50% of patients.
To characterize efavirenz-associated neurologic symptoms in a randomized, controlled study of initial antiretroviral treatment.
Substudy of a randomized, double-blind, controlled trial of combination antiretroviral regimens (A5095) that was performed between March 2001 and January 2002.
Multicenter academic clinical trial units.
HIV-infected patients who were initiating therapy in the context of a controlled trial.
Neuropsychological performance measures, including the Digit Symbol Substitution Test and the Trail Making Test (Parts A and B); symptom questionnaires; standardized assessments of sleep quality, anxiety, and depression; and efavirenz plasma concentrations.
Twenty of 303 (6.6%) enrolled participants prematurely discontinued the study. Neuropsychological performance improved in both groups over time without significant differences between patients who were receiving efavirenz and those who were not. The efavirenz group experienced more neurologic symptoms at week 1 (P < 0.001) but not at weeks 4, 12, or 24. A sleep index revealed that participants receiving efavirenz had more "bad dreams" during the first week of therapy (P = 0.038). No significant changes in anxiety or depressed mood were noted. Changes in efavirenz-associated neurologic symptoms were correlated to efavirenz plasma concentrations at week 1 but not at later time points. Twelve (6%) patients receiving efavirenz stopped taking the drug before the end of the study because of central nervous system symptoms.
Participant selection may have been biased in favor of patients with fewer psychiatric complications. The study design permitted substitution of a new drug in place of efavirenz in cases of treatment-limiting toxicity.
In a large controlled trial, efavirenz use was associated with neurologic symptoms distinct from depression and anxiety that began early in therapy but resolved by week 4. Improvement in neuropsychological performance was comparable in patients who were receiving efavirenz and those who were not.
依非韦伦是一种常用的抗逆转录病毒药物，超过50%的患者会出现神经方面的副作用。
在一项初始抗逆转录病毒治疗的随机对照研究中，对依非韦伦相关的神经症状进行特征描述。
2001年3月至2002年1月期间进行的抗逆转录病毒联合治疗方案随机双盲对照试验（A5095）的子研究。
多中心学术临床试验单位。
在对照试验背景下开始治疗的HIV感染患者。
神经心理学表现测量，包括数字符号替换测验和连线测验（A和B部分）；症状问卷；睡眠质量、焦虑和抑郁的标准化评估；以及依非韦伦血浆浓度。
303名登记参与者中有20名（6.6%）提前退出研究。两组的神经心理学表现均随时间改善，接受依非韦伦治疗的患者与未接受依非韦伦治疗的患者之间无显著差异。依非韦伦组在第1周出现更多神经症状（P<0.001），但在第4、12或24周时没有。一项睡眠指数显示，接受依非韦伦治疗的参与者在治疗的第一周有更多“噩梦”（P = 0.038）。未观察到焦虑或抑郁情绪有显著变化。依非韦伦相关神经症状的变化在第1周与依非韦伦血浆浓度相关，但在随后时间点则无相关性。12名（6%）接受依非韦伦治疗的患者因中枢神经系统症状在研究结束前停止用药。
参与者的选择可能偏向于精神并发症较少的患者。研究设计允许在出现治疗限制性毒性的情况下用新药替代依非韦伦。
在一项大型对照试验中，使用依非韦伦与治疗早期出现的、不同于抑郁和焦虑的神经症状相关，但在第4周时症状消失。接受依非韦伦治疗的患者与未接受依非韦伦治疗的患者在神经心理学表现改善方面相当。
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