单剂量和多次重复剂量盐酸帕洛诺司琼注射液预防化疗所致恶心、呕吐的临床观察

临床肿瘤学杂志

单剂量和多次重复剂量盐酸帕洛诺司琼注射液预防化疗所致恶心、呕吐的临床观察

吴昌平1，王湛2，王杰军2，陶敏3，宋勇4，胡冰5，
华东6，双跃荣7，蔡莉8，史恒军9，张大昕10，陈锦飞11

1 常州市第一人民医院肿瘤科 2 上海长征医院肿瘤科 3 苏州大学附属第一医院肿瘤科4 南京军区南京总医院呼吸科5 安徽省立医院化疗科 6 无锡市第四人民医院肿瘤科7 江西省肿瘤医院内一科8 哈尔滨医科大学附属肿瘤医院内四科 9 唐都医院中医科10 哈尔滨医科大学第一附属医院肿瘤科11 南京市第一医院肿瘤科

收稿日期:2012-07-15 修回日期:2012-08-11 出版日期:2012-09-29 发布日期:2012-09-29
通讯作者: 王杰军

The clinical observation of single and multipleday dosing of palonosetron preventing chemotherapyinduced nausea and vomiting

Received:2012-07-15 Revised:2012-08-11 Online:2012-09-29 Published:2012-09-29

摘要/Abstract

摘要： 目的观察单剂量和多次重复剂量盐酸帕洛诺司琼预防化疗所致恶心、呕吐的疗效和安全性。
方法451例患者随机进入单剂量组（A组，232例，盐酸帕洛诺司琼025mg 化疗前静滴 d1）或多次重复剂量组（B组，219例，盐酸帕洛诺司琼025mg 化疗前静滴 d1、d3、d5；化疗时间≤2天的患者，如果在化疗后第4天无呕吐、恶心发生，第5天停用盐酸帕洛诺司琼），分析两组的疗效及不良反应。结果 B组化疗全程的恶心、呕吐完全缓解率明显高于A组（52.97％ vs.38.36％， P=0.002）。A、B两组在急性期恶心、呕吐完全缓解率的差异无统计学意义（58.19％ vs.62.56％， P=0.340），但在延迟期B组恶心、呕吐完全缓解率明显高于A组（65.30％ vs.46.98％， P＜0.001）。A、B两组在急性期呕吐完全缓解率的差异无统计学意义（86.64％ vs.87.21％， P=0.860），但在延迟期B组呕吐完全缓解率明显高于A组（89.95％ vs.71.12％， P＜0.001）。A、B两组在急性期恶心完全缓解率无明显差异（58.19％ vs.62.56％， P=0.340），但在延迟期B组恶心完全缓解率明显高于A组（66.21％ vs.51.72％， P=0.0018）。B组解救治疗率低于A组（11.42％ vs.19.83％， P=0.014）。A、B两组的不良反应发生率分别为8.19％和10.05％（P=0.390）。结论多次重复剂量盐酸帕洛诺司琼较单剂量盐酸帕洛诺司琼可以提高化疗患者的延迟期恶心、呕吐完全缓解率，且两者不良反应发生率相似。

Abstract: Objective To evaluate the antiemetic efficacy and safety of single and multipleday dosing of palonosetron in patients receiving chemotherapy.
MethodsA total of 451 patients were randomized to receive a single intravenous dose of palonosetron 025 mg 30 min before chemotherapy on day 1（group A， n=232）， or palonosetron 025 mg once daily 30 min before chemotherapy on days 1，3 and 5（group B， n=219）. In group B， patients that received chemotherapy less than 2 days， and who were without vomiting and nausea occurred on the fourth day after chemotherapy， were not received palonosetron on day 5. The clinical effects and adverse reaction were analyzed between two groups.
ResultsThe complete remission（CR） rates for emesis and nausea in the whole chemotherapy course of group B was 52.97％，higher than 38.36％ of group A（P=0.002）. The CR rates for acute emesis and nausea were 5819％ for group A and 62.56％ for group B（P=0.340）， which demonstrated no statistical difference. Comparisons of CR rates for delayed emesis and nausea yielded statistical difference between group A and group B（46.98％ vs.65.30％， P＜0.001）. There was no statistical difference in CR rates for acute emesis between group A and group B（86.64％ vs.87.21％， P=0.860）. CR rates for emesis were significantly higher for group B than group A during the delayed period （89.95％ vs.71.12％， P＜0.001）. There was no statistical difference in CR rates for acute nausea between group A and group B（58.19％ vs.62.56％， P=0.340）. CR rates for nausea were significantly higher for group B than group A during the delayed period （66.21％ vs.51.72％， P=0.0018）.The rate of rescue treatment for group B was lower than group A（11.42％ vs.19.83％， P=0.014）. There was no statistical difference in incidence of adverse reactions between group A and group B（8.19％ vs.10.05％， P=0.390）. Conclusion Multipleday dosing of palonosetron is superior to a single dose of palonosetron in the prevention of delayed emesis and nausea. There is no statistical difference in incidence of adverse reactions between the two groups.

吴昌平1，王湛2，王杰军2，陶敏3，宋勇4，胡冰5，
华东6，双跃荣7，蔡莉8，史恒军9，张大昕10，陈锦飞11. 单剂量和多次重复剂量盐酸帕洛诺司琼注射液预防化疗所致恶心、呕吐的临床观察[J]. 临床肿瘤学杂志, 2012, 17(9): 790-.

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