Saller R, Hellenbrecht D
Eur J Cancer Clin Oncol. 1986 Oct;22(10):1199-203. doi: 10.1016/0277-5379(86)90321-4.
The antiemetic effects of the benzamide metoclopramide (MCL, Paspertin) and of the butyrophenone droperidol (DRO, Dehydrobenzperidol) were compared by two sequential analytical trials in cisplatin treated patients. In the first trial (cisplatin 60-90 mg/m2) the drugs were given as loading infusions (MCL 0.5 mg/kg, and DRO 0.05 mg/kg, each per b.w./h over 2 hr), beginning 2 hr before cisplatin administration; this was followed by the maintenance infusion at half the dose, over 24 hr (total dose of MCL 7 mg/kg, and DRO 0.7 mg/kg b.w. per cycle, resp.). During the second trial (cisplatin 90-120 mg/m2) the antiemetic dosages were doubled (total dose of 14 or 1.4 mg/kg per cycle. After 12 and 14 treatment pairs, resp., MCL was significantly (P less than 0.05) more effective than DRO. Clinically antiemetic protection (i.e. less than three vomiting episodes) were seen in 9 of 12 and 13 of 14 patients, resp., compared with only 5 of 12 and 5 of 14 patients on DRO. The incidence of major extrapyramidal side-effects was more than 2-fold higher at DRO. The benefit/risk relationships (i.e. the relation between the prevented emetic episodes and the number of extrapyramidal reactions seen) of MCL were 2.7-3.0-fold better than those of DRO. The relatively higher antiemetic efficacy of MCL may be due to its additional gastrointestinal mechanisms.
通过两项连续的分析试验,比较了苯甲酰胺类甲氧氯普胺(MCL,胃复安)和丁酰苯类氟哌利多(DRO,氟哌啶醇)对顺铂治疗患者的止吐效果。在第一项试验(顺铂剂量为60 - 90mg/m²)中,药物作为负荷输注给药(MCL 0.5mg/kg,DRO 0.05mg/kg,均按体重每小时给药,持续2小时),在顺铂给药前2小时开始;随后以半量进行维持输注,持续24小时(每个周期MCL总剂量为7mg/kg,DRO总剂量为0.7mg/kg体重)。在第二项试验(顺铂剂量为90 - 120mg/m²)中,止吐剂量加倍(每个周期总剂量为14或1.4mg/kg)。分别在12对和14对治疗后,MCL的疗效显著优于DRO(P<0.05)。临床止吐保护(即呕吐发作少于3次)方面,接受MCL治疗的患者分别有12例中的9例和14例中的13例,而接受DRO治疗的患者分别只有12例中的5例和14例中的5例。DRO引起的主要锥体外系副作用发生率高出2倍多。MCL的效益/风险比(即预防的呕吐发作次数与观察到的锥体外系反应次数之间的关系)比DRO好2.7 - 3.0倍。MCL相对较高的止吐疗效可能归因于其额外的胃肠道作用机制。