帕洛诺司琼预防中重度致吐化疗引起的恶心呕吐77例

Palonosetron Hydrochloride Injection in Prevention of Moderate to Severe Chemotherapy-induced Nausea and Vomiting

目的评价帕洛诺司琼预防和控制中重度致吐化疗引起恶心呕吐的优势。方法对使用中重度致吐化疗的患者,随机分为A组77例和B组78例,A组给予盐酸帕洛诺司琼注射液0.25 mg,B组给予盐酸托烷司琼注射液5 mg,均于化疗前30 min缓慢静脉推注。严格观察患者急性呕吐、延迟性呕吐、恶心、不良反应发生情况,并进行生活质量评价。结果 A组、B组急性呕吐完全有效率、延迟性呕吐完全控制率、0～120 h呕吐完全控制率分别为81.8%和51.3%,70.1%和43.6%,67.5%和41.0%,差异均有统计学意义(P<0.05)。A、B组呕吐控制时间分别为(95.07±42.17)h和(62.07±50.13)h(P<0.05);每例呕吐发作次数分别为(1.46±2.12)和(2.96±3.13)次(P<0.05)。两组在用药后至首次接受解救治疗的时间接近(P>0.05),但解救治疗次数以A组为少,差异有统计学意义(P<0.05)。A组恶心分级为(0.86±0.69),明显低于B组(1.29±1.03)(P<0.05)。A组患者生活质量FLIE评分高于B组患者(P<0.05)。两组不良反应相似,主要为头痛、便秘、腹泻等。结论帕洛诺司琼预防中重度致吐化疗引起的恶心呕吐优于托烷司琼,尤其是延迟性呕吐,明显提高患者的生活质量,安全性高,值得临床推广应用。

Objective To assess the advantage of palonosetron hydrochloride injection for preventing chemotherapy-induced nausea and vomiting. Methods The patients were randomized to receive a single dose of palonosetron 0.25 mg （group A, n = 77 ）, or tropisetron 5 mg （group B, n = 78 ） 30 min before initiation of moderate or severe emetogenic chemotherapy. Acute and delayed vomiting, nausea, and adverse effect etc. in the patients were strictly observed and recorded. The quality of life （QOF） was evaluated. Results Effective rates for controlling acute and delayed vomiting, 0-120 h vomitting were significantly higher in group A （81.8%, 70.1% and 67.5% ） than in group B （51.3%, 43.6% and 41.0% ）. Time for controlling vomitting was （95.07 ±42.17 ） h and （ 62.07 ±50.13 ） h in group A and B, respectively （ P〈0.05 ）. The number of times was （1.46±2.12） per case and （2.96±3.13） per case in group A and B, respectively （P〈0.05）. The time length from chemotherapy to first rescue medication in group A was not longer than group B （P〉0.05）. However, the number of times of rescue medication in group A was significantly lower than that of group B （P〈0.05）. The nausea grade in group A was 0.86±0.69, which was significantly lower than that of group B （1.29±1.03）, P〈0.05. The FLIE score of group A was significantly higher than that of group B （P〈 0.05 ）. The adverse events were similar, including headache, constipation and diarrhea. Conclusion Plonosetron hydrochloride injection is superior to tropisetron for preventing chemotherapy-induced vomiting, and nausea, esoeciallv for delayed vomitina and nausea, and it can improve QOL.