Rzepecki P, Pielichowski W, Oborska S, Barzal J, Mlot B
Bone Marrow Transplantation Unit, Military Institute of Health Services, 128 Szaserow Street; 00-909 Warsaw, Poland.
Transplant Proc. 2009 Oct;41(8):3247-9. doi: 10.1016/j.transproceed.2009.07.071.
A clinical study of palonosetron was performed to evaluate its efficacy in preventing both acute and delayed emesis after high-dose chemotherapy (HDC) before hematopoietic stem cell transplantation (HSCT) using a historical control group of patients treated with ondansetron as the comparative drug.
Among the 46 evaluated patients 20 with lymphoma received BEAM as the conditioning regimen; 16 has relapsed germ cell tumors treated with CARBOPEC; and 10 with acute myeloid leukemia received BuCY. Increasing severity of nausea was evaluated according to the following 4-grade scale: none (no nausea); mild (slight nausea but no disruption to daily activities); moderate (nausea and some disruption to daily activities); and severe (extreme nausea and severe disruption to daily activities). The emetic response rate was evaluated using the criteria: complete (no emetic episode); major (1-2 episodes); minor (3-5 episodes); and failure (>5 episodes). The response rate of the study drugs was evaluated by the following 4-grade scale based on the condition of nausea and vomiting: highly effective, moderately effective, slightly effective, and not effective.
Patients treated with palonosetron showed significantly greater response rates than those receiving ondansetron during the both the acute and the delayed phases: highly and moderately effective: acute phase 15% versus 5% CARBOPEC; 70% versus 35% BEAM and 32% versus 20% BuCY; delayed phase: 60% versus 30% BuCY; 100% versus 50% BEAM and 25% versus 10% CARBOPEC.
Single-dose palonosetron was more effective than ondansetron treatment to prevent acute and delayed nausea and vomiting following HDC before HSCT.
进行一项关于帕洛诺司琼的临床研究，以评估其在造血干细胞移植（HSCT）前大剂量化疗（HDC）后预防急性和迟发性呕吐的疗效，使用以昂丹司琼治疗的患者作为历史对照组进行比较。
在46例接受评估的患者中，20例淋巴瘤患者接受BEAM作为预处理方案；16例复发性生殖细胞肿瘤患者接受CARBOPEC治疗；10例急性髓系白血病患者接受BuCY治疗。根据以下4级量表评估恶心严重程度的增加：无（无恶心）；轻度（轻微恶心但不影响日常活动）；中度（恶心并对日常活动有一定影响）；重度（极度恶心并严重影响日常活动）。使用以下标准评估呕吐反应率：完全缓解（无呕吐发作）；主要缓解（1 - 2次发作）；次要缓解（3 - 5次发作）；未缓解（>5次发作）。根据恶心和呕吐情况，通过以下4级量表评估研究药物的反应率：高效、中效、低效、无效。
在急性和迟发性阶段，接受帕洛诺司琼治疗的患者的反应率均显著高于接受昂丹司琼治疗的患者：高效和中效：急性期，CARBOPEC方案中分别为15%对5%；BEAM方案中为70%对35%；BuCY方案中为32%对20%；迟发性期：BuCY方案中为60%对30%；BEAM方案中为100%对50%；CARBOPEC方案中为25%对10%。
单剂量帕洛诺司琼在预防HSCT前HDC后的急性和迟发性恶心及呕吐方面比昂丹司琼治疗更有效。
