一项评价雷莫司琼联合地塞米松注射液预防急性化疗诱导性恶心呕吐的有效性和安全性的随机、双盲、平行、对照研究。
A randomized, double-blind, parallel, comparative study to evaluate the efficacy and safety of ramosetron plus dexamethasone injection for the prevention of acute chemotherapy-induced nausea and vomiting.
机构信息
Division of Hematology/Oncology, Tri-Service General Hospital, Taipei, Taiwan.
出版信息
Jpn J Clin Oncol. 2010 Apr;40(4):294-301. doi: 10.1093/jjco/hyp169. Epub 2009 Dec 20.
OBJECTIVE
To evaluate the efficacy of intravenous ramosetron plus dexamethasone for the prevention of acute chemotherapy-induced nausea and vomiting.
METHODS
Cancer patients scheduled to receive chemotherapy containing either of the four drugs (cisplatin, doxorubicin, epirubicin or oxaliplatin) were enrolled. They were randomized to receive intravenous ramosetron 0.3 mg plus dexamethasone 20 mg or granisetron 3 mg plus dexamethasone 20 mg 30 min before chemotherapy on day 1. The primary efficacy parameter is complete response rate, which was defined by the proportion of patients without vomiting and no requirement for rescue drugs within 24 h after chemotherapy.
RESULTS
A total of 285 patients were enrolled. The primary efficacy analysis included 274 patients. The complete response rate was 77.37% in the ramosetron 0.3 mg plus dexamethasone 20 mg group (137 patients) and 81.75% in the granisetron 3 mg plus dexamethasone 20 mg group (137 patients) with a difference of -4.38% (95% confidence interval: -14.64, 5.89). Therefore, non-inferiority of ramosetron 0.3 mg plus dexamethasone 20 mg to granisetron 3 mg plus dexamethasone 20 mg was demonstrated with non-inferiority margin -15%. For patients treated with cisplatin, non-inferiority of ramosetron 0.3 mg plus dexamethasone 20 mg to granisetron 3 mg plus dexamethasone 20 mg could not be demonstrated. Only a few patients required rescue medications, 7.3% in the ramosetron 0.3 mg plus dexamethasone 20 mg group and 5.1% in the granisetron 3 mg plus dexamethasone 20 mg group (P = 0.44). All 285 patients were included for safety analysis; 36.11% (52/144) and 23.40% (33/141) experienced at least one adverse event within 24 h in the ramosetron 0.3 mg plus dexamethasone 20 mg and granisetron 3 mg plus dexamethasone 20 mg groups, respectively. Four ramosetron-related adverse events among 144 patients were observed including two moderate elevation of liver enzymes and one each of mild hiccup and moderate skin rash.
CONCLUSIONS
The combination of ramosetron plus dexamethasone was an effective treatment to prevent acute chemotherapy-induced nausea and vomiting.
目的
评价静脉注射雷莫司琼联合地塞米松预防急性化疗诱导性恶心和呕吐的疗效。
方法
纳入计划接受含有顺铂、多柔比星、表柔比星或奥沙利铂四种药物之一的化疗的癌症患者。他们被随机分配在第 1 天化疗前 30 分钟接受静脉注射雷莫司琼 0.3 mg 加地塞米松 20 mg 或格拉司琼 3 mg 加地塞米松 20 mg。主要疗效参数是完全缓解率，定义为化疗后 24 小时内无呕吐且无需使用解救药物的患者比例。
结果
共纳入 285 例患者。主要疗效分析包括 274 例患者。雷莫司琼 0.3 mg 加地塞米松 20 mg 组的完全缓解率为 77.37%（137 例），格拉司琼 3 mg 加地塞米松 20 mg 组为 81.75%（137 例），差异为-4.38%（95%置信区间：-14.64，5.89）。因此，雷莫司琼 0.3 mg 加地塞米松 20 mg 与格拉司琼 3 mg 加地塞米松 20 mg 的非劣效性得到证实，非劣效性边界为-15%。对于接受顺铂治疗的患者，雷莫司琼 0.3 mg 加地塞米松 20 mg 与格拉司琼 3 mg 加地塞米松 20 mg 之间的非劣效性无法得到证实。只有少数患者需要解救药物，雷莫司琼 0.3 mg 加地塞米松 20 mg 组为 7.3%，格拉司琼 3 mg 加地塞米松 20 mg 组为 5.1%（P=0.44）。所有 285 例患者均纳入安全性分析；雷莫司琼 0.3 mg 加地塞米松 20 mg 组和格拉司琼 3 mg 加地塞米松 20 mg 组分别有 36.11%（52/144）和 23.40%（33/141）的患者在 24 小时内发生至少一次不良事件。在雷莫司琼 0.3 mg 加地塞米松 20 mg 组和格拉司琼 3 mg 加地塞米松 20 mg 组中，分别有 4 例雷莫司琼相关不良事件，包括 2 例中度肝酶升高和 1 例轻度呃逆和 1 例中度皮疹。
结论
雷莫司琼联合地塞米松是预防急性化疗诱导性恶心和呕吐的有效治疗方法。
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