帕洛诺司琼联合地塞米松预防含多天顺铂方案化疗引起恶心、呕吐的临床观察

A Cross-over Study of Palonosetron and Dexamethasone fro the Prevention fo Nausea and Vomiting in Patients Receiving Multipleday Cisplatin Chemotherapy

目的观察和比较5-HT3受体拮抗剂帕洛诺司琼与托烷司琼联合地塞米松预防含多天顺铂方案化疗引起恶心、呕吐的疗效及安全性。方法将连续使用2周期含多天顺铂方案化疗的住院恶性肿瘤患者,按随机、交叉自身对照的方法分为AB、BA组。AB组病例第1周期的第1、3天化疗前静脉滴注帕洛诺司琼0.25 mg,并于每天化疗前静脉滴注地塞米松10 mg。BA组病例第1周期的第1~3天化疗前均分别静脉滴注托烷司琼5 mg和地塞米松10 mg。第2周期的止吐方案为两组病例第1周期的止吐方案交叉使用。观察化疗开始后7 d内患者恶心、呕吐的控制情况及不良反应发生率。结果共入组49例病例,47例可评价疗效：AB组23例,BA组24例;两组患者在年龄、性别、有无化疗史及病种等方面无显著性差异（P〉0.05）。帕洛诺司琼组在延迟期和全期的化疗相关性恶心呕吐（CINV）的完全控制率显著高于托烷司琼组,分别为57.4%（27/47）和34.0%（16/47）,P=0.023;55.3%（26/47）和29.8%（14/47）,P=0.012。但在急性CINV方面,两组患者的完全控制率无显著性差异,分别为63.8%（30/47）和53.2%（22/47）,P〉0.05。两种止吐药物的不良反应多表现为便秘、头痛、疲劳、呃逆等,发生率较低,程度较轻,差异无统计学意义（P〉0.05）。结论帕洛诺司琼对含多天顺铂方案化疗引起的迟发性CINV的完全控制率优于托烷司琼。多剂量帕洛诺司琼联合全程使用地塞米松的不良反应轻微。

Objective In order to assess the safety and antiemetic efficacy of multiple-day dosing of palonosetron plus dexamethasone, we conducted this study that compared palonosetron to tropisetron combined with dexamethasone in malignant patients receiving multiple-day cisplatin-based chemotherapy. Methods Patients receiving two consecutive identical courses of a 3-day cisplatin-based chemotherapy were randomly assigned to group AB and group BA. Palonosetron was administered on day 1 and 3, combined with dexametha-sone every day during the entire period of chemotherapy for the initial course of group AB. And tropisetron plus dexamethasone was administered daily for group BA during the entire period of chemotherapy. Patients were crossover to the opposite treatment with the second course. Results In all, 49 patients were screened for the study and 47 were evaluable. 21 patients were randomly assigned to group AB and 24 to group BA. During the delayed phase（d 4-7）, nausea and vomiting were absent in 57.4% of patients of the palonosetron group and 34.0% of the control group（P =0.023）. During the overall period of observation（d 1-7）, the number was 55.3% and 29.8%, P =0.012. During the acute phase（d 1-3）, the absent of nausea and vomiting was numerically superior with palonosetron（63.8% and 53.2%）, but there was no statistical difference between the groups, P =0.097. There was no statistical difference of toxicity with palonosetron compared with tropisetron, P〉0.05. Conclusion There was a significant improvement in totally control of delayed CINV with multiple-day dosing of palonosetron plus dexamethasone for patients receiving multiple-day cisplatinbased chemotherapy, and it was safe and well tolerated.