Huang Jian, Wang Xiao-Jia, Yu Ding, Jin Ye-Ning, Zhen Lei-Zhen, Xu Nong, Liu Wei, Deng Yong-Chuan, Wu Shi-Xiu, He Jia
Zhejiang Cancer Hospital, Hangzhou 310022;
Exp Ther Med. 2013 May;5(5):1418-1426. doi: 10.3892/etm.2013.996. Epub 2013 Mar 8.
The current study aimed to evaluate the efficacy and safety of palonosetron hydrochloride injection for preventing chemotherapy-induced moderate and severe nausea and vomiting. A multi-centered, randomly stratified, double-blind, double-dummy, parallel-group and positive-controlled trial was performed. A total of 240 patients who underwent chemotherapy treatment which induced moderate or severe vomiting were divided into the experimental and control groups. Half an hour before chemotherapy, the experimental group received a 0.25-mg palonosetron hydrochloride injection, whereas the control group received a 3-mg granisetron injection. The acute vomiting complete remission rate (CRR) of the experimental group was not significantly different compared with that of the control group (P=0.35). The delayed vomiting CRR of the experimental group was significantly higher compared with that of the control group (P=0.002). No difference in full course vomiting CRR, vomiting control time, treatment failure time or acute nausea CRR was identified between the two groups. No significant differences in adverse events were observed between the experimental group and the control group. No significant differences in adverse reactions occurred between the experimental group and the control group (12.50%). Palonosetron hydrochloride injection had a better effect on delayed vomiting CRR than granisetron hydrochloride injection. The two injections exhibited similar effects on acute vomiting CRR, full course vomiting CRR, vomiting control time, treatment failure time (days), acute nausea CRR and adverse events.
本研究旨在评估盐酸帕洛诺司琼注射液预防化疗所致中重度恶心和呕吐的有效性及安全性。进行了一项多中心、随机分层、双盲、双模拟、平行组和阳性对照试验。共有240例接受诱导中重度呕吐化疗的患者被分为试验组和对照组。化疗前半小时，试验组接受0.25mg盐酸帕洛诺司琼注射液，而对照组接受3mg格拉司琼注射液。试验组的急性呕吐完全缓解率（CRR）与对照组相比无显著差异（P = 0.35）。试验组的延迟呕吐CRR显著高于对照组（P = 0.002）。两组在全程呕吐CRR、呕吐控制时间、治疗失败时间或急性恶心CRR方面未发现差异。试验组和对照组之间未观察到不良事件的显著差异。试验组和对照组之间不良反应发生率无显著差异（12.50%）。盐酸帕洛诺司琼注射液在延迟呕吐CRR方面比盐酸格拉司琼注射液效果更好。两种注射液在急性呕吐CRR、全程呕吐CRR、呕吐控制时间、治疗失败时间（天）、急性恶心CRR和不良事件方面表现出相似的效果。
