帕洛诺司琼注射液预防化疗引起呕吐的疗效观察

Effect of palonosetron in prevention of chemotherapy-induced vomiting

目的 观察帕洛诺司琼注射液预防化疗引起呕吐的有效性和安全性.方法 采用多中心、分层随机、双盲双模拟、自身交叉对照临床试验设计,入组149例应用顺铂或蒽环类方案的恶性肿瘤患者.全部入组患者分为中致吐性化疗组,即顺铂≤50 mg/m2或多柔比星≥40 mg/m2（或吡柔比星≥40 mg/m2或表柔比星≥60 mg/m2）,高致吐性化疗组,即顺铂≥60 mg/m2.患者连续化疗2个周期,化疗前分别应用帕洛诺司琼和格拉司琼,如第1周期应用试验药物（帕洛诺司琼）,则第2周期应用对照药物（格拉司琼）,反之则相反.对比患者应用试验药物的化疗周期（试验组）与应用对照药物的化疗周期（对照组）急性和延迟性呕吐的完全控制率以及不良反应.结果 预防急性呕吐的完全控制率：中致吐性试验组和对照组分别为50.72％、48.00％,高致吐性试验组和对照组分别为45.76％、52.24％,差异均无统计学意义（χ2=0.153,P=0.695χ2=0.924,P=0.337）.预防延迟性呕吐的完全控制率：中致吐性试验组和对照组分别为59.42％ 、41.33％,差异有统计学意义（χ2=4.673,P=0.031）;而高致吐性试验组与对照组分别为37.29％、28.36％,差异无统计学意义（χ2=0.956,P=0.328）.第24小时至第5天呕吐次数的比较：中致吐性试验组中位数0.0次、对照组1.0次,差异有统计学意义（χ2=7.765,P=0.005）.试验、对照两组不良反应发生率均较低,程度也较轻.结论 帕洛诺司琼预防中、高致吐性化疗引起的急性及延迟性呕吐疗效确切,特别是在预防延迟性呕吐方面,帕洛诺司琼优于格拉司琼,且帕洛诺司琼不良反应轻微,值得在临床上推广使用.

Objective To evaluate the efficacy and safety of palonosetron in prevention of chemotherapy-induced vomiting.Methods Using multi-center, randomized, double-blind, self-cross-over controlled clinical trial design, 149 cancer patients received 2 cycles chemotherapy including cisplatin or anthracycline continuously.All the patients were divided into moderately emetogenic group （cisplatin≤50 mg/m2 or doxorubicin ≥40 mg/m2 or pirarubicin ≥40 mg/m2 or epirubicin ≥60 mg/m2） and highly emetogenic group （cisplatin ≥60 mg/m2）.All the patients received palonosetron or granisetron before chemotherapy respectively.If patients received palonosetron in the first cycles, the control drug granisetron would be used in the second cycles and vice versa.The complete control rates of acute vomiting and delayed vomiting, as well as the adverse effects of these antiemetic drugs in the experiment group and control group were observed.Results The complete control rate of acute vomiting between palonosetron cycles and granisetron cycles had no significant difference in moderately emetogenic group （50.72% vs.48.00% , χ2 =0.153, P =0.695） and highly emetogenic group （45.76% vs.52.24% , χ2 =0.924, P =0.337）.In moderately emetogenic group, the complete control rate of delayed vomiting in palonosetron cycles was significantly higher than that in granisetron cycles （59.42% vs.41.33%, χ2 =4.673, P =0.031）, while it had no significant difference in highly emetogenic group （37.29% vs.28.36%, χ2 =0.956, P =0.328）.And in moderately emetogenic group, the frequency of vomiting in palonosetron cycles was significantly less than that in granisetron cycles during 24 hours to 5 days （Median 0.0 vs.Median 1.0, χ2 =7.765, P =0.005）.The adverse effects in the two cycles had a lower incidence and a lesser degree similarly.Conclusion Palonosetron has a definite effect in prevention of acute and delayed chemotherapy-induced vomiting.Especially it is superior to granisetron for delayed vomiting.And it has lower adverse effects, so it is worth spreading in clinic.