Sorbe B, Hallén C, Skåre N G, Underskog I
Department of Gynecologic Oncology, Orebro Medical Center Hospital, Sweden.
Radiother Oncol. 1989 Jun;15(2):161-7. doi: 10.1016/0167-8140(89)90130-8.
In a prospective randomized and double-blind cross-over study, a new antiemetic regimen consisting of betamethasone (1 x 8 mg) and dixyrazine (a phenothiazine derivative) (4 x 10 mg) was compared with a standard high-dose metoclopramide (4 x 1 mg/kg) schedule for antiemetic treatment in doxorubicin and cisplatin chemotherapy. 100 consecutive patients (62 without prior experience of chemotherapy and 38 with prior experience) entered the study and were followed during 1-4 courses of chemotherapy. Effect and side effect parameters were recorded on questionnaires for patients and nurses using the visual analog scale for quantification. The correlation between the two ways of recording (self-scoring versus recording by nursing staff) was very high, both for effect variables (nausea and vomiting) and the adverse reactions (sedation and extrapyramidal reactions). The median number of courses per patient was 3.0 (range 1-4) and altogether 299 courses were studied. Full emetic protection was achieved in 58% with betamethasone-dixyrazine and in 34% with high-dose metoclopramide regardless of prior patient experience or the cytostatic agents administered. With doxorubicin regimens, betamethasone-dixyrazine gave full protection in 80% compared to 40% for metoclopramide. Cisplatin regimens were a greater challenge and protection against nausea and vomiting was achieved only in 27% with betamethasone-dixyrazine and in 18% with metoclopramide. Adverse reactions were a significant problem with metoclopramide: restlessness 33%, akathisia 19%, parkinsonism 16%, and acute dystonia 3%. Sedation was the same with the two regimens (80%).
在一项前瞻性随机双盲交叉研究中，将一种由倍他米松（1×8毫克）和二苯拉嗪（一种吩噻嗪衍生物）（4×10毫克）组成的新的止吐方案与标准高剂量甲氧氯普胺（4×1毫克/千克）方案进行比较，用于多柔比星和顺铂化疗中的止吐治疗。100名连续患者（62名无化疗经验，38名有化疗经验）进入研究，并在1至4个化疗疗程中接受随访。使用视觉模拟量表进行量化，在患者和护士的问卷上记录疗效和副作用参数。对于疗效变量（恶心和呕吐）以及不良反应（镇静和锥体外系反应），两种记录方式（自我评分与护理人员记录）之间的相关性非常高。每位患者的疗程中位数为3.0（范围1 - 4），总共研究了299个疗程。无论患者既往经验或所使用的细胞毒性药物如何，倍他米松 - 二苯拉嗪方案使58%的患者获得完全止吐保护，高剂量甲氧氯普胺方案使34%的患者获得完全止吐保护。在多柔比星治疗方案中，倍他米松 - 二苯拉嗪使80%的患者获得完全保护，而甲氧氯普胺为40%。顺铂治疗方案面临更大挑战，倍他米松 - 二苯拉嗪仅使27%的患者免受恶心和呕吐困扰，甲氧氯普胺为18%。甲氧氯普胺的不良反应是一个严重问题：不安33%、静坐不能19%、帕金森综合征16%、急性肌张力障碍3%。两种方案的镇静发生率相同（80%）。
