Birch R, Weaver C H, Carson K, Buckner C D
Clinical Research Division of Response Oncology, Inc., Memphis, TN 38117, USA.
Bone Marrow Transplant. 1998 Oct;22(7):685-8. doi: 10.1038/sj.bmt.1701412.
The purpose of this study was to determine the optimal schedule of i.v. granisetron and dexamethosone for control of nausea and emesis in patients receiving high-dose chemotherapy (HDC). Seventy patients with breast cancer received high-dose cyclophosphamide, thiotepa and carboplatin (CTCb) for 3 consecutive days. All 70 received dexamethasone 12 mg i.v. and granisetron 1 mg i.v. prior to infusion of CTCb and were randomized to receive placebo (n = 37) or an additional identical dose of granisetron (n = 33) 12 h later. Beginning on day 2 of chemotherapy administration, 55 patients evaluable later self-administered a cocktail of diphenhydramine (benadryl), lorazepam (ativan) and dexamethasone (BAD). Fourteen of 37 patients (38%) receiving granisetron once a day and 15/33 (44%) receiving it twice a day had a complete response during the first 24 h following the first doses of chemotherapy (P = 0.52). In the 55 evaluable patients receiving BAD, 18 of 29 (62%) in the once daily group and 14/26 (54%) in the twice daily group required additional medications (P = 0.54). The median time to first emetic episode was 20 h (range 6.6-79.5) for patients receiving once a day and 21.4 hours (range 5.8-105.3) for patients receiving twice a day granisetron (P = 0.48). Five patients in the once daily and seven patients in the twice daily group had complete control of nausea and emesis throughout the study period (P = 0.37). It was concluded that there were no statistically significant differences in nausea and emetic control between dexamethasone with once daily or twice daily i.v. granisetron administration in patients receiving high-dose CTCb.
本研究的目的是确定静脉注射格拉司琼和地塞米松控制接受大剂量化疗（HDC）患者恶心和呕吐的最佳给药方案。70例乳腺癌患者连续3天接受大剂量环磷酰胺、噻替派和卡铂（CTCb）治疗。所有70例患者在输注CTCb前均静脉注射12mg地塞米松和1mg格拉司琼，并随机分为接受安慰剂组（n = 37）或12小时后接受额外相同剂量格拉司琼组（n = 33）。从化疗给药第2天开始，55例后来可评估的患者自行服用苯海拉明（苯那君）、劳拉西泮（阿替凡）和地塞米松（BAD）混合剂。每天接受一次格拉司琼的37例患者中有14例（38%），每天接受两次格拉司琼的33例患者中有15例（44%）在首次化疗剂量后的头24小时内完全缓解（P = 0.52）。在接受BAD的55例可评估患者中，每日一次组的29例中有18例（62%），每日两次组的26例中有14例（54%）需要额外用药（P = 0.54）。接受每日一次格拉司琼的患者首次呕吐发作的中位时间为20小时（范围6.6 - 79.5），接受每日两次格拉司琼的患者为21.4小时（范围5.8 - 105.3）（P = 0.48）。每日一次组的5例患者和每日两次组的7例患者在整个研究期间恶心和呕吐得到完全控制（P = 0.37）。得出的结论是，在接受大剂量CTCb的患者中，每日一次或每日两次静脉注射格拉司琼联合地塞米松在控制恶心和呕吐方面无统计学显著差异。
