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本研究采用多中心安慰剂对照随机试验,评价应用重组人神经生长因子(rhNGF)治疗与人类免疫缺陷病毒(HIV)相关的感觉神经病的安全性和疗效。方法 选择符合美国神经病学会标准的成人HIV相关的感觉神经病270例,平均年龄(44.0±8.7)岁,其中男性占97.4%。符合条件的患者至少要有轻到中度的神经痛。本研究的双盲期包括18周药物治疗期和4周清除期。
In this study, a multicenter placebo-controlled randomized trial evaluating the safety and efficacy of recombinant human nerve growth factor (rhNGF) in the treatment of human immunodeficiency virus-associated sensory neuropathy. Methods Two hundred and seventy-five adults with HIV-related sensory neuropathy who met the criteria of the American College of Neurology were selected, with an average age of 44.0 ± 8.7 years, of whom 97.4% were male. Eligible patients should have at least mild to moderate neuralgia. The double-blind period in this study included an 18-week medication period and a 4-week washout period.