Fleming G F, Vokes E E, McEvilly J M, Janisch L, Francher D, Smaldone L
Department of Medicine, University of Chicago, IL 60637.
Cancer Chemother Pharmacol. 1991;28(3):226-7. doi: 10.1007/BF00685516.
We conducted a double-blind, randomized crossover study to compare the toxicity and antiemetic efficacy of the 5-hydroxytryptamine3 receptor antagonist batanopride with that of metoclopramide in 21 chemotherapy-naive patients receiving at least 70 mg/m2 cisplatin. The study was terminated when hypotension was observed following the infusion of batanopride at other institutions testing similar drug schedules. Although we observed no hypotension following treatment with batanopride in this trial, we did note asymptomatic prolongation of the corrected QT interval (QTc), PR interval, and QRS complex on the EKG in the batanopride arm. Of 15 evaluable patients, 8 experienced less than or equal to 2 episodes of emesis within 24 h of the first batanopride infusion, whereas 9/15 subjects experienced less than or equal to 2 emetic episodes following the administration of metoclopramide. Overall, the evidence suggests that this dosing schedule for batanopride may be too toxic for clinical use.
我们进行了一项双盲、随机交叉研究，以比较5-羟色胺3受体拮抗剂巴坦必利与甲氧氯普胺在21例初次接受化疗、接受至少70mg/m²顺铂治疗的患者中的毒性和止吐效果。在其他测试类似药物方案的机构中，在输注巴坦必利后观察到低血压，该研究因此终止。尽管在本试验中我们未观察到巴坦必利治疗后出现低血压，但我们确实注意到巴坦必利组心电图上校正QT间期（QTc）、PR间期和QRS波群出现无症状延长。在15例可评估患者中，8例在首次输注巴坦必利后24小时内呕吐发作少于或等于2次，而15例受试者中有9例在给予甲氧氯普胺后呕吐发作少于或等于2次。总体而言，证据表明巴坦必利的这种给药方案临床使用时毒性可能过大。
