Bruntsch U, Drechsler S, Hiller E, Eiermann W, Tulusan A H, Bühner M, Hartenstein R, Koenig H J, Gallmeier W M
5th Med. Department, City Hospital, Nuremberg, Federal Republic of Germany.
Drugs. 1992;43 Suppl 3:23-6. doi: 10.2165/00003495-199200433-00006.
In a multicentre trial, 78 patients with a variety of malignancies, who had experienced insufficient control of emesis (greater than or equal to 3 episodes within 24 hours) while receiving standard antiemetics during previous chemotherapy, were randomly assigned to receive tropisetron 5mg once daily for 5 days or conventional antiemetic drugs. No attempt was made to standardise the conventional antiemetic treatment, which was given according to the usual practice of the participating institutions. Emesis was evaluated by counting emetic episodes and nausea by asking the patients to record on a diary chart the duration and severity of the nausea. Emesis was much better controlled with tropisetron than with standard drugs, complete control during the first 24 hours being achieved in 42% and 8% of patients, respectively, (p less than 0.001). Nausea was of significantly shorter duration (6.9 vs 10.3 hours; p less than 0.01) and was less severe (p less than 0.005) in the tropisetron group. The patients' overall assessment of treatment outcome was markedly better for tropisetron than for the standard antiemetic therapy. The superior efficacy of tropisetron was especially marked during the first 24 hours. For delayed nausea, no significant difference between treatments was seen. No serious adverse effects were observed.
在一项多中心试验中，78例患有各种恶性肿瘤的患者，在先前化疗期间接受标准止吐药治疗时呕吐控制不佳（24小时内呕吐发作≥3次），被随机分配接受每日一次5mg托烷司琼治疗，共5天，或接受传统止吐药物治疗。未尝试对传统止吐治疗进行标准化，而是根据参与机构的常规做法进行给药。通过计算呕吐发作次数评估呕吐情况，通过让患者在日记图表上记录恶心的持续时间和严重程度来评估恶心情况。托烷司琼对呕吐的控制效果明显优于标准药物，在最初24小时内分别有42%和8%的患者实现了完全控制，（p<0.001）。托烷司琼组恶心的持续时间明显较短（6.9小时对10.3小时；p<0.01），且严重程度较低（p<0.005）。患者对治疗结果的总体评估显示，托烷司琼明显优于标准止吐疗法。托烷司琼的卓越疗效在最初24小时尤为明显。对于延迟性恶心，各治疗组之间未见显著差异。未观察到严重不良反应。
