天津医药

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帕诺洛司琼与托烷司琼分别联合地塞米松预防含顺铂化疗所致恶心呕吐的临床对照研究

于礼建1,龙桂宁1,崔建东1,黄彦泽2,张为民2,黄雪琴2,谭红香3,魏旺荣4   

  1. 1. 解放军３０３医院
    2. 广州军区总医院
    3. 广州市儿童医院
    4. 中山大学第五附属医院
  • 收稿日期:2010-01-27 修回日期:2010-04-16 出版日期:2010-11-15 发布日期:2010-11-15
  • 通讯作者: 于礼建

A clinical control trail of polonosetron plus dexamethasone versus tropisetron plus dexamethasone to prevent nausea and vomiting induced by cisplatin-based chemotherapy

  • Received:2010-01-27 Revised:2010-04-16 Published:2010-11-15 Online:2010-11-15

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摘要： 目的:观察和评价国产帕洛诺司琼联合地塞米松预防含高致吐性顺铂化疗引起的恶心、呕吐的有效性和安全性。方法:采用随机对照的试验方法，对使用含高致吐性顺铂（≥50mg/m2）化疗方案的患者,于化疗前半小时缓慢静脉推注帕洛诺司琼0.25mg (观察组)或静滴托烷司琼2mg (对照组)，两组均于第1、2、3天化疗前分别静脉滴入地塞米松16mg、8mg、8mg，观察患者化疗引起的急性期（0-24h）、延迟期（24-120h及全期（0-120h）的呕吐的完全缓解率及无呕吐发作百分比,必要时给予解救性止吐治疗(托烷司琼或甲氧氯普胺)。结果:共入组72例患者,观察组35例,对照组37例，观察组对化疗引起的急性期、延迟期完全缓解率(CRR)与对照组相比无显著性差异(82.9%vs75.7%、65.7% vs43.2%，P＞0.05),但前者对化疗引起的全期CRR明显高于对照组(65.7% vs40.5%，P＜0.05）)；观察组化疗后急性期无呕吐发作率与对照组相比无显著性差异（91.4%vs 83.8%， P＞0.05），但在延迟期及全期则具有显著性差异（77.1% vs48.6%、74.3%vs43.2%， P＜0.05）。两组不良反应主要为头痛、便秘、眩晕、腹部不适等，均症状轻微，患者耐受性好。 结论:国产帕洛诺司琼联合地塞米松能有效地预防高致吐性化疗所致急性期、延迟期呕吐反应，对于延迟期呕吐反应其疗效优于托烷司琼,且安全性好。

关键词: 化疗诱发的恶心, 呕吐, 5-HT3受体拮抗剂, 帕洛诺司琼, 托烷司琼

Abstract: Objective: To observe and assess the efficacy and safety of palonosetron made in China plus Dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy. Methods: This study was performed as a randomized，clinical control trial. The patients were received a single dose of palonosetron 0.25mg i.v. bolus (treatment group), or tropisetron 2mg i.v. drop (control group), each administered 30 min before initiation of highly emetogenic cisplatin-based (≥50mg/m2) chemotherapy,both with Dexamethasone (16 mg i.v. drop on day 1, 8 mg i.v. drop on day 2, 3) for prophylactic antiemesis. To observe the proportion of patients with a complete response(CR) and emesis-free during the acute phase (0-24h postchemotherapy )、delayed phase (24-120h postchemotherapy ) and both phases (0-120h postchemotherapy )，and administer rescue medication（tropisetron or Methoxychlorproeainamide ) if the patient needed. Results: 72 patients were included in the clinical trail: 35 patients in the palonosetron group and 37 patients in the tropisetron group. CR rates(CRR) were slightly higher (P ＞0.05) for palonosetron 0.25 mg than tropisetron during the acute (0-24 h) (82.9% versus 75.7%, respectively), delayed (24–120 h)( 65.7% versus 43.2%) phases , but CRR were significantly higher (P ＜0.05) for treatment group than control group during the both phases (0-120 h)( 65.7% vs40.5%).The percent of patients emisis-free for treatment group were numerically higher but not statistically different from control group during the acute phase(91.4% vs 83.8%， P＞0.05), but were significantly higher (P ＜0.05) than control group during the delayed and both phases(77.1% versus 48.6% 、74.3% versus 43.2%， P＜0.05).The adverse reaction of two groups patients included mainly headache、constipation、dizzy and Abdominal discomfort, which were very slight and well tolerated for the patients. Conclusions: Conclusions: palonosetron made in China plus Dexamethasone is effective and safe for preventing both acute and delayed nausea and vomiting with highly emetogenic chemotherapy, and it is superior to tropisetron in preventing chemotherapy-induced delayed nausea and vomiting.

Key words: chemotherapy-induced nausea and vomiting, emesis, 5-HT3 receptor antagonist, ondansetron, Palonosetron