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

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

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。

Objective To evaluate the antiemetic efficacy and safety of single and multiple-day dosing of palonosetron in pa- tients receiving chemotherapy. Methods A total of 451 patients were randomized to receive a single intravenous dose of palonosetron 0. 25 mg 30 rain before chemotherapy on day 1 （ group A, n = 232 ） , or palonosetron 0.25 mg once daily 30 rain 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 vomi- ting and nausea occurred on the fourth day after chemotherapy, were not received palonosetron on day 5. The clinical effects and ad- verse reaction were analyzed between two groups. Results The 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）. CRrates 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 differ- ence in incidence of adverse reactions between the two groups.