盐酸托烷司琼防治化疗药物所致消化道反应的多中心Ⅱ期临床试验

Tropisetron Hydrochloride in Preventing and Treating Chemotherapy-induced Nausea and Vomiting: A Phase Ⅱ, Randomized, Multicenter, Double-blinded, Comparative Clinical Trial

背景与目的:5-羟色胺3(5-hydroxytryptamine3,5-HT3)受体阻断剂是临床最常用的化疗药物所致恶心、呕吐的预防治疗药,盐酸托烷司琼作为高效的5-HT3受体选择性阻断剂,已在临床应用多年。本试验目的在于评价国产盐酸托烷司琼注射液防治顺铂等化疗药物所致患者消化道反应的疗效及安全性。方法:本研究采用双盲、阳性药物交叉对照的方法,将5家医院收治的、需顺铂化疗的肿瘤患者随机分为A-B和B-A组,分别用试验药或对照药治疗。结果:共118例患者入组,其中A-B组60例,B-A组58例。国产盐酸托烷司琼和进口盐酸托烷司琼用药后患者急性呕吐的程度没有差异(P>0.05);两组对化疗药物所致恶心的平均抑制率分别为28.59%和29.21%;呕吐的平均抑制率分别为52.61%和51.94%;以上结果差异均无统计学意义(P>0.05)。用药后第3、6、10、21天生活质量(quality of life,QOL)评分两药差异没有统计学意义(P>0.05)。两药不良反应发生率分别为27.97%和22.03%,主要包括便秘、腹胀、眩晕、头痛和疲劳等,差异无统计学意义(P>0.05)。结论:国产盐酸托烷司琼注射液治疗顺铂等化疗药物所致急性和迟发性恶心、呕吐反应疗效可靠,而且维持时间长,不良反应较少,对患者生活质量也有改善,各项临床试验指标与进口盐酸托烷司琼相似。

BACKGROUND ＆ OBJECTIVE： Tropisetron hydrochloride （Navoban）, as a highly selective 5-hydroxytryptamine 3 （5-HT3） receptor antagonist, has been widely used in preventing and treating chemotherapyinduced nausea and vomiting for many years. This study was to evaluate the efficacy and safety of homemade tropisetron hydrochloride in preventing and treating cisplatin-based chemotherapy-induced nausea and vomiting. METHODS： A randomized, double-blinded, multicenter, comparative trial was conducted in cancer patients receiving cisplatin-based chemotherapy. All patients were assigned to group A-B or B-A randomly, and took homemade tropisetron hydrochloride and Navoban （positive control agent） to treat chemotherapy-induced nausea and vomiting. RESULTS. A total of 118 patients were enrolled. 60 in group A-B and 58 in group B-A. There was no difference in the efficacy of relieving acute vomiting between homemade tropisetron hydrochloride and Navoban （P〉0.05）. The inhibition rates of nausea and vomiting were 28.59% and 52.61% respectively in group A-B, while 29.21% and 51.94% in group B-A （P〉0.05）. In addition, quality of life （QOL） showed no significant difference between the 2 groups at Days 3, 6, 10, and 21 （P〉0.05）. Besides, the occurrence rate of adverse events, such as constipation, abdominal distention, vertigo, headache and fatigue, was 27.97% in group A-B and 22.03% in group B-A （P〉0.05）. CONCLUSION： Homemade tropisetron hydrochloride injection has both reliable efficacy and safety in preventing and treating cisplatin-induced acute or chronic nausea and vomiting; it is comparable with Navoban on many aspects, such as long action time, less adverse effects and improved QOL.