Short-term effects of cannabinoids in patients with HIV-1 infection - A randomized, placebo-controlled clinical trial
Short-term effects of cannabinoids in patients with HIV-1 infection - A randomized, placebo-controlled clinical trial
复制标题
DOI：
10.7326/0003-4819-139-4-200308190-00008
复制
发表时间：
2003-08-19
影响因子：
39.2
通讯作者：
Schambelan, M
中科院分区：
文献类型：
--
作者：
Abrams, DI;Hilton, JF;Schambelan, M
背景：大麻素的使用可能通过两种机制改变HIV RNA水平：免疫调节或大麻素-蛋白酶抑制剂相互作用（因为两者共享细胞色素P-450代谢途径）。目的：探讨吸食大麻对hiv感染者病毒载量的短期影响。设计：随机、安慰剂对照、21天干预试验。地点：加州旧金山旧金山总医院住院综合临床研究中心。参与者：67例HIV-1感染患者。干预：参与者被随机分配到3.95%的四氢大麻酚大麻烟，2.5毫克的大麻酚（delta-9-四氢大麻酚）胶囊，或安慰剂胶囊，每天三次，饭前服用。测量：HIV RNA水平，CD4（+）和CD8（+）细胞亚群，以及蛋白酶抑制剂的药代动力学分析。结果：62名研究参与者符合主要终点（大麻组，20名患者；大麻酚组，22名患者；安慰剂组，20名患者）。36名参与者（58%）的基线HIV RNA水平低于50拷贝/mL，中位CD4（+）细胞计数为340x10(9)个细胞/L。当对基线变量进行调整时，与安慰剂相比，从基线到第21天log（10）病毒载量变化的估计平均效应大麻为-0.07 (95% CI, -0.30至0.13)，大麻酚为-0.04 （CI, -0.20至0.14）。与安慰剂相比，大麻和大麻酚中病毒载量的调整平均变化分别为-15% （CI， -50%至34%）和-8% （CI， -37%至37%）。CD4（+）和CD8（+）细胞计数似乎都没有受到大麻素的不利影响。结论：在21天的治疗中，吸烟和口服大麻素对HIV感染者的HIV RNA水平、CD4（+）和CD8（+）细胞计数或蛋白酶抑制剂水平似乎并不安全。
Background: Cannabinoid use could potentially alter HIV RNA levels by two mechanisms: immune modulation or cannabinoid-protease inhibitor interactions (because both share cytochrome P-450 metabolic pathways).Objective: To determine the short-term effects of smoked marijuana on the viral load in HIV-infected patients.Design: Randomized, placebo-controlled, 21-day intervention trial.Setting: The inpatient General Clinical Research Center at the San Francisco General Hospital, San Francisco, California.Participants: 67 patients with HIV-1 infection.Intervention: Participants were randomly assigned to a 3.95%-tetrahydrocannabinol marijuana cigarette, a 2.5-mg dronabinol (delta-9-tetrahydrocannabinol) capsule, or a placebo capsule three times daily before meals.Measurements: HIV RNA levels, CD4(+) and CD8(+) cell subsets, and pharmacokinetic analyses of the protease inhibitors.Results: 62 study participants were eligible for the primary end point (marijuana group, 20 patients; dronabinol group, 22 patients; and placebo group, 20 patients). Baseline HIV RNA level was less than 50 copies/mL for 36 participants (58%), and the median CD4(+) cell count was 340x10(9) cells/L. When adjusted for baseline variables, the estimated average effect versus placebo on change in log(10) viral load from baseline to day 21 was -0.07 (95% CI, -0.30 to 0.13) for marijuana and -0.04 (CI, -0.20 to 0.14) for dronabinol. The adjusted average changes in viral load in marijuana and dronabinol relative to placebo were -15% (CI, -50% to 34%) and -8% (CI, -37% to 37%), respectively. Neither CD4(+) nor CD8(+) cell counts appeared to be adversely affected by the cannabinoids.Conclusions: Smoked and oral cannabinoids did not seem to be unsafe in people with HIV infection with respect to HIV RNA levels, CD4(+) and CD8(+) cell counts, or protease inhibitor levels over a 21-day treatment.