Pielichowski W, Gawronski K, Mlot B, Oborska S, Wasko-Grabowska A, Rzepecki P
Military Institute of Medicine, Oncology Department, Warsaw, Poland.
J BUON. 2011 Jul-Sep;16(3):541-6.
A clinical study of triple drug combination (aprepitant+palonosetron+ dexamethasone) was carried out to evaluate its efficacy in preventing both acute and delayed emesis after high-dose chemotherapy (HDC) with busulphan+cyclophosphamide (BuCy) before hematopoietic stem cell transplantation (HSCT).
The study enrolled 60 patients suffering from various hematological malignancies: 20 in the triple drug antiemetic group and 20 in each of two historical control groups that received dexamethasone plus either ondansetron or palonosetron. The groups were comparable for statistical analysis. The observation period started with the initiation of chemotherapy (0 h) and continued for 24 h after its completion for the acute phase, and during 5 days after finishing chemotherapy for the delayed phase. The response rate of the study drugs was evaluated by a 4-grade scale based on the condition of nausea and vomiting: highly, moderately or slightly effective and not effective.
Patients treated with the triple drug combination had significantly higher response rates than those receiving palonosetron or ondansetron (+ dexamethasone) during both the acute and delayed phases: highly effective in early + late phases: 55 vs. 30 vs. 20%; highly effective in early phase: 70 vs. 30 vs. 20%; highly effective in late phase: 55 vs. 55 vs. 30%; highly + moderately effective in early phase: 75 vs. 32 vs. 25%; highly + moderately effective in late phase: 85 vs. 60 vs. 40% for triple drug combination, palonosetron + dexamethasone and ondansetron + dexamethasone, respectively.
This triple drug combination was more effective than ondansetron or palonosetron (+ dexamethasone) in preventing acute (especially), and delayed nausea and vomiting following BuCy chemotherapy before HSCT.
开展一项关于三联药物组合（阿瑞匹坦+帕洛诺司琼+地塞米松）的临床研究，以评估其在造血干细胞移植（HSCT）前使用白消安+环磷酰胺（BuCy）进行大剂量化疗（HDC）后预防急性和迟发性呕吐的疗效。
该研究纳入了60例患有各种血液系统恶性肿瘤的患者：20例在三联药物止吐组，另外20例分别在两个历史对照组，这两个对照组接受地塞米松加昂丹司琼或帕洛诺司琼。这些组在统计学分析方面具有可比性。观察期从化疗开始（0小时）起，急性期在化疗结束后持续24小时，延迟期在化疗结束后持续5天。根据恶心和呕吐情况，通过4级量表评估研究药物的有效率：高度有效、中度有效、轻度有效和无效。
在急性和延迟期，接受三联药物组合治疗的患者的有效率显著高于接受帕洛诺司琼或昂丹司琼（+地塞米松）治疗的患者：在早期+晚期高度有效：分别为55%、30%和20%；在早期高度有效：分别为70%、30%和20%；在晚期高度有效：分别为55%、55%和30%；在早期高度+中度有效：分别为75%、32%和25%；在晚期高度+中度有效：分别为85%、60%和40%，分别对应三联药物组合、帕洛诺司琼+地塞米松和昂丹司琼+地塞米松组。
在预防HSCT前BuCy化疗后的急性（尤其是）和迟发性恶心和呕吐方面，这种三联药物组合比昂丹司琼或帕洛诺司琼（+地塞米松）更有效。
