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[静脉注射1毫克/体质量和3毫克/体质量格拉司琼预防血液系统恶性肿瘤患者化疗引起的恶心、呕吐及不良事件的比较]

[Comparison of 1 mg/body and 3 mg/body of intravenous granisetron for the prevention of chemotherapy-induced nausea and vomiting and adverse events in hematological malignancy patients].

作者信息

Motohashi Shinya, Hori Katsuhito, Ono Takaaki, Ohnishi Kazunori, Kawakami Junichi

机构信息

Department of Hospital Pharmacy, Hamamatsu University School of Medicine, Shizuoka, Japan.

出版信息

Yakugaku Zasshi. 2012;132(5):675-81. doi: 10.1248/yakushi.132.675.

Abstract

Granisetron is a selective 5-hydroxy tryptamine3 receptor antagonist and widely used for chemotherapy-induced nausea and vomiting (CINV). Recommended dose of intravenous granisetron in the USA and Europe has been set at 0.01 mg/kg (1 mg/body) in the antiemetic treatment guidelines established by the American Society of Clinical Oncology and National Comprehension Cancer Network. In contrast, the approved dose in Japan is 0.04 mg/kg (3 mg/body). Randomized controlled trials (RCTs) which compared 1 mg/body with 3 mg/body of intravenous granisetron for CINV had been reported in Japan. In these RCTs, however, hematological malignancy patients were excluded. We performed observational retrospective study to compare 1 mg/body with 3 mg/body of intravenous granisetron for the prevention of CINV and adverse events in hematological malignancy patients. Number of the patients and chemotherapy courses were 15 and 30 in the 1 mg/body group, and 15 and 27 in the 3 mg/body group, respectively. No nausea rates in the 1 and 3 mg/body group were 83% and 89% of courses, respectively. No vomiting rates in the 1 and 3 mg/body group were 97% and 100% of courses, respectively. The incidences of constipation in the 1 and 3 mg/body group were 34% and 45% of courses, respectively. Anaphylaxis and headache did not occur in both groups. Our findings suggested that 1 mg/body of intravenous granisetron can prevent from CINV in hematological malignancy patients, as well as 3 mg/body.

摘要

格拉司琼是一种选择性5-羟色胺3受体拮抗剂,广泛用于化疗引起的恶心和呕吐(CINV)。在美国和欧洲,美国临床肿瘤学会和国家综合癌症网络制定的止吐治疗指南中,静脉注射格拉司琼的推荐剂量设定为0.01mg/kg(1mg/人)。相比之下,日本批准的剂量为0.04mg/kg(3mg/人)。日本曾报道过比较静脉注射1mg/人和3mg/人格拉司琼治疗CINV的随机对照试验(RCT)。然而,在这些RCT中,血液系统恶性肿瘤患者被排除在外。我们进行了观察性回顾性研究,以比较静脉注射1mg/人和3mg/人格拉司琼预防血液系统恶性肿瘤患者CINV及不良事件的效果。1mg/人组的患者数量和化疗疗程分别为15例和30个疗程,3mg/人组分别为15例和27个疗程。1mg/人组和3mg/人组的无恶心率分别为疗程的83%和89%。1mg/人组和3mg/人组的无呕吐率分别为疗程的97%和100%。1mg/人组和3mg/人组便秘的发生率分别为疗程的34%和45%。两组均未发生过敏反应和头痛。我们的研究结果表明,静脉注射1mg/人的格拉司琼与3mg/人一样,可预防血液系统恶性肿瘤患者的CINV。

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