重复使用5-HT3受体拮抗剂预防多日化疗相关性恶心呕吐的疗效和安全性分析

Efficacy and safety of multiple-dose 5-HT3 receptor antagonists in preventing multi-daybased and highly emetogenic chemotherapy-induced nausea and vomiting

    摘要
  • 摘要:
      目的  探讨重复使用第一代5-HT3受体拮抗剂（5-HT3RA）托烷司琼与第二代5-HT3RA帕洛诺司琼预防多日高度催吐风险化疗所致恶心和呕吐（chemotherapy-induced nausea and vomiting，CINV）的疗效和安全性。
      方法  在接受含有高度催吐风险药物连续多日化疗的患者中，采用随机、交叉自身对照的方法分组，A方案组为：在第1周期化疗中，帕洛诺司琼0.25 mg，静脉滴注，d1、d3（必要时d5）。地塞米松（DXM）10 mg，静脉滴注，d1；5 mg，静脉滴注，d2~d5。第2周期为托烷司琼5 mg，静脉滴注，d1~d3（必要时d4、d5）；DXM用法同前。B方案组的止吐方案为第1周期使用托烷司琼，第2周期使用帕洛诺司琼（剂量、用法均同A方案组）。将A方案组第1个周期和B方案组第2个周期的患者归为帕洛诺司琼组，A方案第2个周期和B方案组第1个周期的患者归为托烷司琼组，比较帕洛诺司琼与托烷司琼预防CINV的疗效和不良反应。
      结果  共计入组91例患者。在d3至d5，帕洛诺司琼组每天恶心发生率分别为28.6%、30.8%和24.2%，托烷司琼组分别为42.8%、47.3%和39.6%，差异均有统计学意义（均P < 0.05）；在d4至d6，帕洛诺司琼组每天呕吐发生率分别为28.6%、18.7%和5.5%，托烷司琼组则为42.9%、34.1%和14.3%，差异均有统计学意义（均P < 0.05）；按时间段分析，帕洛诺司琼组在d4~5、d6~7和全程（d1~7）恶心和呕吐发生率均显著低于托烷司琼组（均P < 0.05）。帕洛诺司琼组全程（d1~7）解救药使用率为13.2%，低于托烷司琼组的24.2%，但差异无统计学意义（P=0.057）。帕洛诺司琼组与托烷司琼组的止吐药物相关性不良反应发生率的差异均无统计学意义（均P > 0.05）。
      结论  重复使用帕洛诺司琼预防持续多日高度催吐风险化疗相关的延迟性恶心呕吐的疗效优于托烷司琼，两者的安全性良好。

     

    Abstract:
      Objective  To evaluate efficacy and safety of multiple-dose tropisetron plus dexamethasone (DXM) versus palonosetron plus DXM for chemotherapy-induced nausea and vomiting. (CINV) in patients received multiple day-based highly emetogenic chemotherapy.
      Methods  Cancer patients who were receiving multiday-based highly emetogenic chemotherapy were randomly assigned to AB or BA groups. A randomized, cross self-controlled method was applied. Patients in AB group received palonosetron (0.25 mg) 30 min before chemotherapy on day 1 and 3 or additional day 5 in the first cycle; and with tropisetron (5 mg) 30 min before chemotherapy on day 1, 2, and 3, or supplementary days (day 4 and 5) in the second cycle. Patients in BA group were treated with tropisetron in the first cycle and with palonosetron in the second cycle. Tropisetron and palonosetron were administered with DXM (10 mg) on day 1, followed by additional doses (5 mg) on days 2 to 5. Palonosetron group comprised patients in the AB group in the first cycle and BA group in the second cycle, whereas tropisetron group included patients in the AB group in the second cycle and BA group in the first cycle. Efficacy and safety of tropisetron versus palonosetron in preventing CINV were evaluated.
      Results  Ninety-one patients were included in analyses. At day 3, 4, and 5, incidence rates of nausea in the palonosetron group reached 28.6%, 30.8%, and 24.2%, respectively, and those of the tropisetron group totaled 42.8%, 47.3%, and 39.6%, respectively (P < 0.05). At day 4, 5, and 6, incidence rates of vomiting in the palonosetron group measured 28.6%, 18.7%, and 5.5%, respectively, and those of the tropisetron group reached 42.9%, 34.1%, and 14.3%, respectively (P < 0.05). From day 4 to day 5, day 6 to day 7, and day 1 to day 7, the palonosetron group yielded significantly lower incidence rates of nausea and vomiting than tropisetron group (P < 0.05). Rate of rescue treatment in the palonosetron group was lower than that in tropisetron group (13.2% vs. 24.2%, P=0.057). No statistical difference in toxicities was observed between the two groups.
      Conclusion  Palonosetron plus DXM features better efficacy than that of tropisetron plus DXM against delayed CINV induced by multiple day-based highly emetogenic chemotherapy, which was well tolerated in the two treatments.

     

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