Sampi K, Taguchi T
Saitama Cancer Center.
Gan To Kagaku Ryoho. 1990 Apr;17(4 Pt 2):922-8.
In a cross-over design of a study of prevention of emesis induced by cancer chemotherapy done in Saitama Cancer Center, the efficacy of oral lorazepam was superior to that of i.v. domperidone. And then, we proceeded a parallel study with use of oral lorazepam and oral domperidone. However, in this situation lorazepam was not superior to domperidone despite accrual of more than 60 patients. Recently, a multi-institutional study has been started in October of 1988 in an evaluation of the efficacy and safety of the new anti-emetic drug of a 5HT3 receptor antagonist, ondansetron. Two methods of its administration were designed. In one study ondansetron was given 2 hr prior to non-platinum chemotherapy as an 2 or 8 mg dose by oral administration, followed by receiving it 6 hr and 12 hr after chemotherapy. In another study, it was given 15 min prior to cisplatin including chemotherapy as an 2 or 8 mg loading dose by i.v. injection over 5 min, followed by continuous infusion at a rate of 0.25 mg/h or 1 mg/h for 24 h, respectively. Efficacy was assessed by measurement of the number of episodes of retching and vomiting occurring in the 24h after administration of chemotherapy and by an assessment of nausea during the same period. This time the major efficacy category was adopted, which is made up of the complete responder and major responder categories of both vomiting and nausea. 19 patients were evaluable for efficacy in the non-platinum group; the major efficacy rates showed 45% in 2 mg-given group and 88% in 8 mg-given group, respectively. 108 patients were evaluable for efficacy in the cisplatin group: the major efficacy rates showed more than 70% in both 2 mg and 8 mg-given group. However, in the patients given more than 75 mg/mg2 of cisplatin, the major efficacy rates were 55% in the 2 mg-given group, compared to 73% in the 8 mg-given group. Ondansetron was well tolerated, with no significant drug-related adverse events.
在埼玉癌症中心进行的一项预防癌症化疗引起呕吐的研究的交叉设计中，口服劳拉西泮的疗效优于静脉注射多潘立酮。然后，我们使用口服劳拉西泮和口服多潘立酮进行了一项平行研究。然而，在这种情况下，尽管纳入了60多名患者，但劳拉西泮并不比多潘立酮更具优势。最近，一项多机构研究于1988年10月启动，旨在评估新型5羟色胺3（5HT3）受体拮抗剂昂丹司琼的抗呕吐药物的疗效和安全性。设计了两种给药方法。在一项研究中，在非铂类化疗前2小时口服2毫克或8毫克剂量的昂丹司琼，然后在化疗后6小时和12小时再次服用。在另一项研究中，在含顺铂化疗前15分钟静脉注射2毫克或8毫克负荷剂量的昂丹司琼，持续5分钟，然后分别以0.25毫克/小时或1毫克/小时的速率持续输注24小时。通过测量化疗给药后24小时内干呕和呕吐发作的次数以及同期恶心的评估来评估疗效。这次采用了主要疗效类别，该类别由呕吐和恶心的完全缓解者和主要缓解者类别组成。非铂类组有19名患者可评估疗效；主要有效率在2毫克给药组为45%，在8毫克给药组为88%。顺铂组有108名患者可评估疗效：2毫克和8毫克给药组的主要有效率均超过70%。然而，在接受超过75毫克/平方米顺铂的患者中，2毫克给药组的主要有效率为55%，而8毫克给药组为73%。昂丹司琼耐受性良好，没有明显的药物相关不良事件。
