Matsui K, Fukuoka M, Takada M, Kusunoki Y, Yana T, Tamura K, Yoshida T, Iida K, Hirashima T, Tsukada H, Ushijima S, Miyawaki H, Masuda N
Department of Internal Medicine, Osaka Prefectural Habikino Hospital, Japan.
Br J Cancer. 1996 Jan;73(2):217-21. doi: 10.1038/bjc.1996.38.
Despite recent advances in control of acute emesis following cisplatin-based chemotherapy regimens, delayed emesis remains a significant cause of treatment-related morbidity and factors associated with delayed emesis have not yet been evaluated. A prospective randomised trial was conducted to compare the efficacy and toxicity of granisetron, dexamethasone plus prochlorperazine with granisetron alone in controlling cisplatin-induced delayed emesis and to identify the important factors that influence its occurrence and severity. Seventy cisplatin-naive patients with inoperable solid tumors participated in the trial. Patients who received 80 mg m-2 or 100 mg m-2 of cisplatin were randomly assigned to receive either granisetron 40 micrograms kg-1 intravenously (i.v.) on day 1, dexamethasone 20 mg i.v. on days 2 and 3 and prochlorperazine 5 mg orally thrice daily on days 1-5 or granisetron 40 micrograms kg-1 i.v. on day 1 alone. There was no difference in their acute antiemetic efficacy. A combination regimen was more effective than granisetron alone in preventing delayed symptoms, with superior rates of complete plus major responses of 77% vs 51% (P = 0.0460). Treatment arm was the only determinant factor for the occurrence of delayed emesis (P = 0.0101).
尽管在基于顺铂的化疗方案后急性呕吐的控制方面取得了最新进展，但延迟性呕吐仍然是治疗相关发病率的一个重要原因，且与延迟性呕吐相关的因素尚未得到评估。进行了一项前瞻性随机试验，以比较格拉司琼、地塞米松加丙氯拉嗪联合用药与单独使用格拉司琼在控制顺铂引起的延迟性呕吐方面的疗效和毒性，并确定影响其发生和严重程度的重要因素。70例未接受过顺铂治疗的不可切除实体瘤患者参与了该试验。接受80mg/m²或100mg/m²顺铂治疗的患者被随机分配，要么在第1天静脉注射40μg/kg格拉司琼，在第2天和第3天静脉注射20mg地塞米松，在第1 - 5天每天口服3次5mg丙氯拉嗪，要么仅在第1天静脉注射40μg/kg格拉司琼。它们的急性止吐疗效没有差异。联合治疗方案在预防延迟症状方面比单独使用格拉司琼更有效，完全加主要缓解率分别为77%和51%，差异有统计学意义（P = 0.0460）。治疗组是延迟性呕吐发生的唯一决定因素（P = 0.0101）。
