Ohmatsu H, Eguchi K, Shinkai T, Tamura T, Ohe Y, Nisio M, Kunikane H, Arioka H, Karato A, Nakashima H
Department of Internal Medicine and Thoracic Oncology, National Cancer Center Central Hospital, Tokyo.
Jpn J Cancer Res. 1994 Nov;85(11):1151-8. doi: 10.1111/j.1349-7006.1994.tb02921.x.
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.
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。