Yarboro C H, Wesley R, Amantea M A, Klippel J H, Pucino F
National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Bethesda, MD 20892, USA.
Ann Pharmacother. 1996 Jul-Aug;30(7-8):752-5. doi: 10.1177/106002809603000708.
To evaluate the antiemetic efficacy of a modified regimen of oral ondansetron and dexamethasone in patients with lupus nephritis undergoing treatment with cyclophosphamide whose conventional antiemetic regimen had failed.
A before-after prospective observational pilot project.
A federal research hospital.
Fourteen outpatients with lupus nephritis receiving intravenous cyclophosphamide 0.75-1.0 g/m2 had previously experienced chemotherapy-induced emetic events (vomiting or retching) while receiving a standard combination intravenous antiemetic regimen. The regimen consisted of four doses of thiethylperazine 10 mg and diphenhydramine 25 mg every 6 hours, and two doses of lorazepam 0.5 mg every 6 hours starting at 1 hour prior to cyclophosphamide. A subset of 8 patients previously completed a blinded study in which they received the intravenous formulation of ondansetron (4 doses of 4-16 mg q4h) administered orally beginning 30 minutes prior to the cyclophosphamide infusion.
The number of emetic events and cost of drug administration were assessed for the modified ondansetron intervention and compared with those of the standard antiemetic regimen. The incidence of emetic events and visual analog nausea scores for the subset of eight patients were also evaluated.
To account for the delayed onset of emesis associated with cyclophosphamide, patients received both ondansetron 8 mg orally every 4 hours (3 doses) and dexamethasone 10 mg orally (1 dose) beginning 4 hours after the cyclophosphamide infusion. This is different from the manufacturer's recommended dose schedule, in which ondansetron is administered prior to chemotherapy.
No emetic events were observed following the administration of oral ondansetron/dexamethasone. The 95% confidence interval for the true rate of emesis was 0% to 19.3%. There was a significant difference in efficacy between ondansetron/dexamethasone and the triple antiemetic regimen (p < 0.0002). None of the patients experienced adverse effects while receiving the ondansetron/dexamethasone regimen. Cost comparisons (including admixture and nursing administration times) for standard combination therapy and oral ondansetron/dexamethasone were $109.09 and $70.24, respectively. No difference in emetic events or nausea ratings was observed between oral ondansetron/dexamethasone tablets and oral administration of ondansetron using the intravenous formula.
This study suggests that a modified oral ondansetron/dexamethasone regimen is safe and efficacious, and costs less than alternative regimens to prevent cyclophosphamide-induced emesis in patients with lupus nephritis.
评估口服昂丹司琼和地塞米松改良方案对常规止吐方案治疗失败的狼疮性肾炎患者在接受环磷酰胺治疗时的止吐疗效。
前后瞻性观察性试点项目。
一家联邦研究医院。
14名接受静脉注射环磷酰胺0.75 - 1.0 g/m²的狼疮性肾炎门诊患者，在接受标准静脉联合止吐方案时曾经历化疗引起的呕吐事件（呕吐或干呕）。该方案包括每6小时4剂10 mg硫乙拉嗪和25 mg苯海拉明，以及从环磷酰胺前1小时开始每6小时2剂0.5 mg劳拉西泮。8名患者的一个亚组此前完成了一项盲法研究，他们在环磷酰胺输注前30分钟开始口服静脉用昂丹司琼（4剂，4 - 16 mg，每4小时1剂）。
评估改良昂丹司琼干预措施的呕吐事件数量和药物给药成本，并与标准止吐方案进行比较。还评估了8名患者亚组中的呕吐事件发生率和视觉模拟恶心评分。
为了应对与环磷酰胺相关的呕吐延迟发作，患者在环磷酰胺输注后4小时开始每4小时口服8 mg昂丹司琼（3剂）和口服10 mg地塞米松（1剂）。这与制造商推荐的剂量方案不同，在该方案中昂丹司琼在化疗前给药。
口服昂丹司琼/地塞米松后未观察到呕吐事件。呕吐真实发生率的95%置信区间为0%至19.3%。昂丹司琼/地塞米松与三联止吐方案在疗效上有显著差异（p < 0.0002）。在接受昂丹司琼/地塞米松方案时，没有患者出现不良反应。标准联合疗法与口服昂丹司琼/地塞米松的成本比较（包括混合和护理给药时间）分别为109.09美元和70.24美元。口服昂丹司琼/地塞米松片与使用静脉制剂口服昂丹司琼在呕吐事件或恶心评分上没有差异。
本研究表明，改良的口服昂丹司琼/地塞米松方案安全有效，且在预防狼疮性肾炎患者环磷酰胺引起的呕吐方面成本低于替代方案。
