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格拉司琼与阿立必利加地塞米松在细胞毒性治疗中抗呕吐效果的比较

[Comparison of the antiemetic effectiveness of granisetron and alizapride plus dexamethasone in cytostatic therapy].

作者信息

Bremer K, Uhlenbusch R

机构信息

Abteilung für Hämatologie und Onkologie, Medizinische Klinik der Augusta-Kranken-Anstalt, Bochum.

出版信息

Dtsch Med Wochenschr. 1991 Nov 29;116(48):1817-23. doi: 10.1055/s-2008-1063823.

Abstract

In a randomized single-blind international multicentre trial, two antiemetic regimens were compared in 115 oncology patients undergoing chemotherapy for the first time (cisplatin greater than 15 mg/m2, or ifosfamide greater than 1200 mg/m2 or etoposide greater than 120 mg/m2). One group received granisetron, a 5-hydroxytryptamine type-3-receptor antagonist, 40 micrograms/kg alone intravenously before chemotherapy, with, if necessary, up to two further doses daily of 40 micrograms/kg. The second group received a combination of alizapride plus dexamethasone (4 mg/kg alizapride and 8 mg/kg dexamethasone before chemotherapy, repeated, if necessary, after 4 and 8 hours up to two additional doses). There was good antiemetic efficacy (a maximum of one episode of vomiting in 24 hours = "major efficacy") in 50 of 62 patients (80.7%) in the granisetron group, and in 37 out of 53 (69.8%) of those treated with alizapride and dexamethasone; failure of antiemetic therapy occurred in 4.8% (granisetron) and 15.1% (combination) of patients. For the first day of each 5-day chemotherapy cycle, there was a higher rate of excellent antiemetic efficacy (no or only mild nausea, and no vomiting) with granisetron (90.3% vs 69.8%, P less than 0.006). The frequency (29% vs 32%) and nature of side effects (obstipation, diarrhoea, headaches, anxiety, vertigo), the causes of which were not differentiated, were similar. No extrapyramidal reactions occurred with granisetron. Of the 62 patients treated with granisetron, 47 did not require any further granisetron after the single daily prophylactic dose.

摘要

在一项随机单盲国际多中心试验中,对115例首次接受化疗的肿瘤患者(顺铂剂量大于15mg/m²,或异环磷酰胺剂量大于1200mg/m²,或依托泊苷剂量大于120mg/m²)的两种止吐方案进行了比较。一组在化疗前静脉注射格拉司琼,一种5-羟色胺3型受体拮抗剂,剂量为40μg/kg,必要时每天可额外追加两剂,剂量为40μg/kg。第二组接受阿立必利加地塞米松的联合治疗(化疗前阿立必利4mg/kg,地塞米松8mg/kg,必要时在4小时和8小时后重复给药,最多追加两剂)。格拉司琼组62例患者中有50例(80.7%)有良好的止吐效果(24小时内最多一次呕吐发作 = “主要疗效”),阿立必利和地塞米松治疗组53例中有37例(69.8%);止吐治疗失败的患者分别为4.8%(格拉司琼组)和15.1%(联合治疗组)。在每5天化疗周期的第一天,格拉司琼的止吐效果极佳(无或仅有轻度恶心,无呕吐)的发生率更高(90.3%对69.8%,P小于0.006)。副作用的频率(29%对32%)和性质(便秘、腹泻、头痛、焦虑、眩晕)未作区分,二者相似。格拉司琼未发生锥体外系反应。在接受格拉司琼治疗的62例患者中,47例在每日单剂量预防性给药后无需再使用格拉司琼。

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