3种止吐药物在晚期食管癌患者化疗中的药物经济学评价

目的：前瞻性研究本院帕洛诺司琼、阿扎司琼和托烷司琼对化疗引起恶心和呕吐的影响及对不同止吐方案进行成本-效果分析。方法：选取2018年1月~2019年12月间124例采用多西他赛+顺铂（DP）方案化疗的晚期食管癌患者作为研究对象,均签署知情同意书。将其随机分为3组（帕洛诺司琼组、阿扎司琼组和托烷司琼组）。在化疗前,分别给予相应药物预防止吐,通过MAT量表与FLIE量表对化疗相关恶心呕吐（CINV）情况进行评估,并基于医疗提供者角度,开展成本-效果分析。结果：3组抑制急性呕吐与恶心、延迟性呕吐与恶心方面,疗效比较无统计学差异（P>0.05）。住院期间抑制呕吐与恶心的药物成本,三种方案有统计学差异（P<0.05）。采用最小成本法,帕洛诺司琼成本最低,具有经济性。敏感性分析结果显示：缓解恶心和呕吐,帕诺洛司琼具有经济性概率始终最高。结论：帕诺洛司琼具有较好的经济性。     

盐酸帕洛诺司琼预防硬膜外自控镇痛所致恶心呕吐的分析

【摘要】　目的 观察盐酸帕洛诺司琼预防术后硬膜外腔自控镇痛引起恶心呕吐副作用的效果。方法 选取择期硬膜外麻醉下开腹胆囊切除术后施行硬膜外腔自控镇痛(PCEA)的患者60例,PCEA采用吗啡6 mg+0.125%布比卡因混合液(100 mL)。将患者分为盐酸帕洛诺司琼组,氟哌啶组和对照组(每20例),在术前静脉给予盐酸帕洛诺司琼0.25 mg,氟哌啶2.5 mg和生理盐水100 mL。术后记录使用PCEA镇痛期间的恶心例数及其严重程度;呕吐例数及次数;出现呕吐后给予胃复安,非那根,地塞米松等药物止吐的控制率。结果 对照组13例出现Ⅰ~Ⅲ级恶心呕吐的不良反应,盐酸帕洛诺司琼组患者1例1级恶心呕吐的发生,与其他两组相比P<0.001;氟哌啶组出现5例Ⅰ~Ⅱ级恶心呕吐的,与对照组相比P=0.022。结论 术前预防性给予盐酸帕洛诺司琼可显著降低胆囊切除术后PCEA引起恶心呕吐副作用的发生。     

Postoperative nausea and vomiting prophylaxis: The efficacy of a novel antiemetic drug (palonosetron) combined with dexamethasone

BackgroundPalonosetron is a new, potent, and long-acting 5HT3-receptors antagonist that had been approved by the FDA for use in postoperative nausea and vomiting (PONV) prophylaxis. This study is designed to evaluate its efficacy combined with dexamethasone in PONV prophylaxis in highrisk patients scheduled for laparoscopic surgeries.MethodsIn this double-blind, active-controlled study, 150 patients aged 20–55 years, ASA I–II, and with Apfel’s PONV score 2–4 were equally randomized to receive dexamethasone 8 mg before anesthesia induction and saline 30 min before the end of surgery (group D + S), dexamethasone 8 mg before anesthesia induction and metoclopramide 25 mg 30 min before the end of surgery (group D + M), or dexamethasone 8 mg combined with palonosetron 0.075 mg before anesthesia induction and saline 30 min before the end of surgery (group D + P). Incidences of early and late PONV, complete response, adverse events from antiemetics used, and overall patients’ satisfaction were recorded.ResultsThe incidence of PONV was comparable in the three groups 0–6 h postoperatively. Palonosetron–dexamethasone and dexamethasone–metoclopramide combination therapies significantly reduced the incidence of PONV at 6–12 h postoperatively compared to dexamethasone monotherapy (12% and 16%, vs. 36%, respectively, with P < 0.05). Moreover, palonosetron–dexamethasone combination therapy significantly reduced the incidence of PONV at 12–24 h postoperatively compared to both dexamethasone monotherapy (16% vs. 48%, P < 0.01), and dexamethasone–metoclopramide combination therapy (16% vs. 40%, P < 0.05). The incidence of adverse drug effects was comparable in the three groups. The overall patients’ satisfaction was significantly higher in palonosetron–dexamethasone combination therapy compared to other groups.ConclusionPalonosetron–dexamethasone combination is effective and safe in PONV (early and late) prophylaxis in high-risk patients undergoing laparoscopic surgeries with known high-risk of PONV.     

昂丹司琼、格拉司琼和帕洛诺司琼预防食管癌术后化疗所致恶心、呕吐的效果观察

目的 比较昂丹司琼、格拉司琼和帕洛诺司琼预防食管癌术后化疗所致恶心、呕吐的临床效果及安全性.方法 将60例食管癌术后患者随机分为昂丹司琼组、格拉司琼组和帕洛诺司琼组,各20例,均行顺铂等药物化疗,并分别给予昂丹司琼、格拉司琼和帕洛诺司琼预防恶心、呕吐反应;观察3组患者恶心、呕吐的控制效果及不良反应.结果 昂丹司琼组、格拉司琼组和帕洛诺司琼组患者恶心、呕吐控制急性期有效率分别为55％、60％、75％,帕洛诺司琼组与其他两组比较,差异有统计学意义（P＜0.05）;延迟期有效率分别为40％、45％、75％,帕洛诺司琼组与其他两组比较,差异有统计学意义（P＜0.05）.结论 帕洛诺司琼预防化疗所致恶心、呕吐效果较昂丹司琼、格拉司琼更优,安全性相似,且临床应用方便.     

固相萃取-HPLC法同时测定盐酸帕洛诺司琼注射液中6种杂质

目的：固相萃取—高效液相色谱法同时测定盐酸帕洛诺司琼注射液中差向异构体、对映异构体、氮氧杂质等6种杂质的含量。方法：样品经1 mol·L-1氢氧化钠溶液调节pH,经Agilent Bond Elut C8固相萃取柱（200 mg,3 mL）去除大部分基质干扰,实现净化与富集,再用乙醇洗脱得到富集物。采用USP40盐酸帕洛诺司琼原料药已知杂质测定方法,以Astec CHIROBIOTIC?誖V（250 mm × 4.6 mm,5 μm）为色谱柱对其进行分离检测。结果：6种杂质在0.2~4.3 μg·mL-1范围内线性良好,相关系数r≥0.999 5,方法的检测限为0.056~0.065 μg·mL-1,低、中、高3个浓度的加样回收率为90.60%~105.7%。结论：本方法可用于同时检测盐酸帕洛诺司琼注射液中的6种杂质。     

气相色谱法同时测定帕洛诺司琼中的8种有机溶剂残留量

[目的]测定帕洛诺司琼中甲醇、甲苯、乙酸乙酯、乙醇、四氢呋哺、丙酮、异丙醇、正己烷的含量。[方法]采用毛细管气相色谱法，色谱系统：HP-5色谱柱、程序升温、载气为氮气、检测器为FID，外标法计算含量。[结果]在选定的色谱条件下，测得各有机溶剂的线性良好（r〉0．99）；平均回收率96．35％～103．67％，RSD1．37％～3．04％，最低检出限0．27～0．38ng，3批样品中8种有机溶剂残留量均符合要求。[结论]经方法学试验验证，该方法灵敏、准确、可靠，适用于本品有机溶剂残留量的测定。     

A phase II trial of olanzapine,dexamethasone, and palonosetron for the prevention of chemotherapy-induced nausea and vomiting: a Hoosier oncology group study

Objective The purpose of this study is to determine the control of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) with the combined use of palonosetron and olanzapine, and dexamethasone with the dexamethasone given on day 1 only. Materials and methods Forty chemotherapy-naive patients received on the day of chemotherapy, day 1, an anti-emetic regimen consisting of dexamethasone, palonosetron, and olanzapine. Patients continued olanzapine for days 2–4 after chemotherapy administration. Patients recorded daily episodes of emesis, daily symptoms utilizing the M.D. Anderson Symptom Inventory, and the utilization of rescue therapy. Results For the first cycle of chemotherapy, the complete response (no emesis, no rescue) for the acute period (24 h post-chemotherapy) was 100%, the delayed period (days 2–5 post-chemotherapy) 75%, and the overall period (0 120 h post-chemotherapy) 75% in 8 patients receiving HEC and was 97, 75, and 72% in 32 patients receiving MEC. Patients with no nausea for the acute period was 100%, the delayed period 50%, and the overall period 50% in 8 patients receiving HEC and was 100, 78, and 78% in 32 patients receiving MEC. Discussion The complete response and control of nausea in subsequent cycles of chemotherapy were not significantly different from cycle one. Conclusion Olanzapine combined with a single dose of dexamethasone and a single dose of palonosetron was very effective in controlling acute and delayed CINV in patients receiving both HEC and MEC.     

盐酸帕洛诺司琼用于麻醉术后止吐的效果观察

目的:观察盐酸帕洛诺司琼用于麻醉术后出现的急性及迟发性呕吐的疗效和不良反应。方法:选择腹腔镜胆囊切除手术的60例患者,随机分为试验组与对照组,每组30例,在麻醉诱导前,试验组给予盐酸帕洛诺司琼0.25mg,对照组给予盐酸托烷司琼5mg,分别记录2组麻醉术后72h内止吐效果和不良反应。结果:试验组与对照组对麻醉术后出现急性呕吐的完全控制率分别为80.0%、70.0%(P>0.05),急性呕吐发生率均为13.3%,但迟发性呕吐发生率分别为6.7%、16.7%(P<0.05);2组主要不良反应为腹胀、头痛及便秘,试验组与对照组的总不良反应发生率分别为23.3%、20.0%(P>0.05)。结论:2种5-羟色胺3(5-HT3)受体拮抗药均有较好的止吐作用,而盐酸帕洛诺司琼对于迟发性呕吐效果更好。     

帕洛诺司琼联合小剂量地塞米松治疗顺铂致恶心呕吐的临床观察

目的 探讨帕洛诺司琼联合小剂量的地塞米松在防治顺铂引起的恶心、呕吐中的疗效和安全性.方法 采用随机信封方法将60例采用顺铂化疗的肿瘤患者分为对照组(29例)和联合组(31例).对照组用药为盐酸帕洛诺司琼注射液0.25 mg,第1、3天静脉注射;联合组在对照组基础上联合地塞米松5 mg/d,第1～3天静脉推注.对化疗后恶心呕吐疗效进行评价,并观察地塞米松所致的不良反应.结果 化疗期间,对照组急性呕吐有效22例(75.9％),无效7例(24.1％),延迟性呕吐有效20例(69.0％),无效9例(31.0％).联合组急性呕吐有效24例(77.4％),无效7例(22.6％);延迟性呕吐有效26例(83.9％),无效5例(16.1％).联合组对于延迟性呕吐疗效优于对照组(P＜0.05).地塞米松应用期间,发生血压和血糖升高2例,兴奋1例,失眠1例,皮疹1例,但均可控制.结论 盐酸帕洛诺司琼注射液联合小剂量的地塞米松能够预防化疗引起的延迟性恶心、呕吐,疗效和安全性较好.     

帕洛诺司琼联合地塞米松预防中度致吐化疗引起恶心呕吐的临床研究

目的 观察和评价帕洛诺司琼联合地塞米松预防中度致吐化疗方案所致恶心、呕吐(CINV)的临床疗效和不良反应.方法 60例患者采用中度致吐方案化疗,按随机抽样法随机分为帕洛诺司琼组和昂丹司琼组,各30例.帕洛诺司琼组给予盐酸帕洛诺司琼0.25 mg,第1天化疗前30 min静脉注射.昂丹司琼组给予盐酸昂丹司琼8 mg,化疗前30 min缓慢静脉滴注,连用3d.2组均联合地塞米松5 mg静脉注射.观察5d内恶心、呕吐等不良反应发生情况并作比较.结果 帕洛诺司琼组与昂丹司琼组急性CINV完全缓解率分别为80.0％ (24/30)和76.7％(23/30),有效控制率分别为93.3％(28/30)和86.7％(26/30),差异无统计学意义(P＞0.05);延迟性CINV完全缓解率分别为76.7％ (23/30)和63.3％(19/30),差异无统计学意义(P＞0.05),有效控制率分别为93.4％(28/30)和73.3％(22/30),差异有统计学意义(P＜0.05).2组不良反应发生率均较低,组间差异无统计学意义(P＞0.05).结论 帕洛诺司琼预防中度致吐化疗方案所致急性CINV 疗效与昂丹司琼相当,对延迟性CINV 的疗效优于昂丹司琼,不良反应程度较轻、安全性好.