Lane M, Smith F E, Sullivan R A, Plasse T F
Baylor College of Medicine, Division of Clinical Oncology, Houston, Texas.
Am J Clin Oncol. 1990 Dec;13(6):480-4. doi: 10.1097/00000421-199012000-00006.
Nineteen patients receiving cancer chemotherapy were randomized in a double-blind fashion to receive either (a) dronabinol, 10 mg plus placebo q.i.d.; (b) prochlorperazine, 10 mg plus placebo q.i.d.; or (c) dronabinol plus prochlorperazine, each 10 mg q.i.d. There were six evaluable patients in each of the two single-agent groups and five in the combination group. The median duration and severity per episode of nausea was significantly greater in the group receiving prochlorperazine alone versus the other two groups. The median duration per episode of vomiting was also significantly greater in the prochlorperazine group than in the other two groups. The proportion of patients vomiting was the same in all groups; however, only one patient in the combination group versus three each in the single-agent groups experienced nausea (p = NS). The majority of side effects were associated with the CNS, including somnolence, dizziness, and confusion. Side effects were somewhat more common in both groups receiving dronabinol, though they were not statistically different from the side effects in the group receiving prochlorperazine as a single agent. Efficacy, as measured by duration of nausea and vomiting and by severity of nausea, was significantly greater in both groups receiving dronabinol.
19名接受癌症化疗的患者被随机分为双盲组,分别接受以下治疗:(a) 屈大麻酚,10毫克加安慰剂,每日4次;(b) 丙氯拉嗪,10毫克加安慰剂,每日4次;或(c) 屈大麻酚加丙氯拉嗪,各10毫克,每日4次。两个单药治疗组各有6名可评估患者,联合治疗组有5名。单独接受丙氯拉嗪治疗的组中,每次恶心发作的持续时间中位数和严重程度显著高于其他两组。丙氯拉嗪组每次呕吐发作的持续时间中位数也显著长于其他两组。所有组中呕吐患者的比例相同;然而,联合治疗组只有1名患者出现恶心,而单药治疗组各有3名患者出现恶心(p = 无统计学意义)。大多数副作用与中枢神经系统有关,包括嗜睡、头晕和意识模糊。在接受屈大麻酚治疗的两组中,副作用略为常见,不过与单独接受丙氯拉嗪治疗组的副作用在统计学上并无差异。在接受屈大麻酚治疗的两组中,以恶心和呕吐的持续时间以及恶心的严重程度衡量的疗效显著更高。