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一项关于接受大剂量顺铂化疗的患者中,高剂量甲氧氯普胺加地塞米松与格拉司琼加地塞米松对比的随机交叉研究。

A randomized cross-over study of high-dose metoclopramide plus dexamethasone versus granisetron plus dexamethasone in patients receiving chemotherapy with high-dose cisplatin.

作者信息

Ohmatsu H, Eguchi K, Shinkai T, Tamura T, Ohe Y, Nisio M, Kunikane H, Arioka H, Karato A, Nakashima H

机构信息

Department of Internal Medicine and Thoracic Oncology, National Cancer Center Central Hospital, Tokyo.

出版信息

Jpn J Cancer Res. 1994 Nov;85(11):1151-8. doi: 10.1111/j.1349-7006.1994.tb02921.x.

Abstract

We carried out a randomized, single-blind, cross-over trial to compare the antiemetic effect, for both acute and delayed emesis, of granisetron plus dexamethasone (GRN+Dx) with that of high-dose metoclopramide plus dexamethasone (HDMP+Dx). Fifty-four patients with primary or metastatic lung cancer, given single-dose cisplatin (> 80 mg/m2) chemotherapy more than twice, were enrolled in this study. They were treated with both HDMP+Dx and GRN+Dx in two consecutive chemotherapy courses. On day 1, patients experienced a mean of 2.5 (SD = 4.3) and 0.1 (SD = 0.4) episodes of vomiting in the HDMP+Dx and the GRN+Dx groups, respectively (P = 0.0008). Complete response rate on day 1 was 45 and 90% in the HDMP+Dx and the GRN+Dx groups, respectively (P = 0.0001). Patients treated with GRN+Dx had a tendency to suffer more episodes of vomiting than the HDMP+Dx group on days 2-5, but it was not statistically significant. Twenty-four patients (57%) preferred the GRN+Dx treatment and 14 patients (33%), HDMP+Dx. In the HDMP+Dx group, nine patients (21%) had an extrapyramidal reaction, and 5 patients (12%) had constipation that lasted for at least two days. In contrast, no patients had extrapyramidal reactions, and 18 patients (43%) had constipation in the GRN+Dx group (P < 0.01). GRN+Dx was more effective than HDMP+Dx only in preventing the acute emesis induced by cisplatin. An effective treatment for delayed emesis is still needed.

摘要

我们进行了一项随机、单盲、交叉试验,以比较格拉司琼加地塞米松(GRN+Dx)与高剂量甲氧氯普胺加地塞米松(HDMP+Dx)对急性和迟发性呕吐的止吐效果。54例接受过两次以上单剂量顺铂(>80mg/m²)化疗的原发性或转移性肺癌患者纳入本研究。他们在两个连续的化疗疗程中分别接受HDMP+Dx和GRN+Dx治疗。第1天,HDMP+Dx组和GRN+Dx组患者的呕吐发作次数分别为平均2.5次(标准差=4.3)和0.1次(标准差=0.4)(P=0.0008)。第1天的完全缓解率在HDMP+Dx组和GRN+Dx组分别为45%和90%(P=0.0001)。在第2-5天,接受GRN+Dx治疗的患者比HDMP+Dx组有更多呕吐发作的趋势,但差异无统计学意义。24例患者(57%)更喜欢GRN+Dx治疗,14例患者(33%)更喜欢HDMP+Dx治疗。在HDMP+Dx组,9例患者(21%)出现锥体外系反应,5例患者(12%)便秘持续至少两天。相比之下,GRN+Dx组无患者出现锥体外系反应,18例患者(43%)出现便秘(P<0.01)。GRN+Dx仅在预防顺铂引起的急性呕吐方面比HDMP+Dx更有效。仍需要一种有效的迟发性呕吐治疗方法。

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