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一项随机、多中心研究,比较新型5-羟色胺3(5-HT3)受体拮抗剂托烷司琼与含胃复安的止吐合剂在预防顺铂所致呕吐方面的疗效和耐受性。

A randomized, multicenter study comparing the efficacy and tolerability of tropisetron, a new 5-HT3 receptor antagonist, with a metoclopramide-containing antiemetic cocktail in the prevention of cisplatin-induced emesis.

作者信息

Sorbe B G, Högberg T, Glimelius B, Schmidt M, Wernstedt L, Hansen O, Sörensen B T, Räisänen I, van Oosterom A T, de Bruijn K M

机构信息

Department of Gynecologic Oncology, Orebro Medical Center Hospital, Sweden.

出版信息

Cancer. 1994 Jan 15;73(2):445-54. doi: 10.1002/1097-0142(19940115)73:2<445::aid-cncr2820730233>3.0.co;2-4.

DOI:10.1002/1097-0142(19940115)73:2<445::aid-cncr2820730233>3.0.co;2-4
PMID:8293412
Abstract

BACKGROUND

Chemotherapy-induced emesis is one of the most disturbing side effects in cancer therapy. Thus, antiemetic treatment is a mandatory adjunct in emetogenic chemotherapy.

METHODS

Tropisetron (Navoban, Sandoz Pharma Ltd., Basel, Switzerland), a new 5-HT3 receptor antagonist, was compared in a randomized multicenter trial with a high-dose metoclopramide-dexamethasone cocktail for the prevention of nausea and emesis during cisplatin-containing chemotherapy. Two hundred fifty-nine chemotherapy-naive patients were included and followed during two consecutive courses. The main cancer types were gynecologic tumors, followed by lung cancer, head and neck cancer, and bladder cancer. The cisplatin dose usually was in the range of 50-89 mg/m2. The efficacy and quality of life assessments and the safety recordings were done during the first 6 days of both courses of chemotherapy.

RESULTS

Acute vomiting was prevented in 63-64% of patients by both antiemetic regimens. The total rate of control of vomiting increased from 63% on day 1 to 93% on day 6 in the group receiving tropisetron. Acute nausea was prevented in 40% of the patients with tropisetron monotherapy and in 61% of patients receiving the antiemetic cocktail. With regard to delayed nausea, there were no significant differences between the two antiemetic regimens. Mild headache and constipation were more frequently associated with tropisetron, and extra-pyramidal side effects and sedation were associated with the antiemetic cocktail.

CONCLUSIONS

Tropisetron was easier to administer and better tolerated than the cocktail, and it seems to be a highly efficacious and safe new antiemetic drug.

摘要

背景

化疗引起的呕吐是癌症治疗中最令人困扰的副作用之一。因此,在致吐性化疗中,止吐治疗是必不可少的辅助手段。

方法

在一项随机多中心试验中,将新型5-羟色胺3(5-HT3)受体拮抗剂托烷司琼(Navoban,瑞士巴塞尔山德士制药有限公司)与高剂量甲氧氯普胺-地塞米松联合用药进行比较,以预防含顺铂化疗期间的恶心和呕吐。纳入259例未接受过化疗的患者,并在连续两个疗程中进行随访。主要癌症类型为妇科肿瘤,其次是肺癌、头颈癌和膀胱癌。顺铂剂量通常在50-89mg/m2范围内。在两个化疗疗程的前6天进行疗效和生活质量评估以及安全性记录。

结果

两种止吐方案均可使63%-64%的患者预防急性呕吐。接受托烷司琼治疗的组中,呕吐控制总率从第1天的63%增至第6天的93%。托烷司琼单药治疗可使40%的患者预防急性恶心,接受联合止吐药治疗的患者中这一比例为61%。关于延迟性恶心,两种止吐方案之间无显著差异。轻度头痛和便秘与托烷司琼的相关性更高,锥体外系副作用和镇静作用与联合止吐药有关。

结论

托烷司琼比联合用药更易于给药且耐受性更好,似乎是一种高效、安全的新型止吐药物。

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