国产与进口昂丹司琼预防顺氯氨铂所致呕吐的费用效果分析

目的：对进口昂丹司琼（枢复宁）与国产昂丹司琼预防顺氯氨铂所致呕吐的临床疗效与治疗费用进行分析。方法：使用含顺铂化疗方案的肿瘤病人，随机自身对照，交替使用进口和国产昂丹司琼，评价其止呕效果及其安全性，计算每一周期止吐药的总费用。结果：急性止呕有效率进口昂丹司琼组为７０％，国产昂丹司琼组为７５％，在一个治疗周期内，两药的止呕有效率无显著差别。药物不良反应的发生频率也近似且程度较轻，但进口昂丹司琼的费用     

脱品司琼和昂丹司琼治疗化学疗法所致恶心,呕吐和厌食的比较

目的：观察恶性肿瘤病人应用脱品司琼或昂丹司琼控制化学疗法（化疗）所致胃肠道反应的效果。方法：５８例恶性肿瘤病人采用随机交叉性研究，脱品司琼（５ｍｇ）和昂丹司琼（８ｍｇ）分别在同一病人前后２个化疗周期的ｄ１给药前３０ｍｉｎ，ｉｖ１次，并用地塞米松１０ｍｇ，ｉｖ滴注，结果：２药控制急性及迟发性恶心，呕吐的疗效均可达８１％～１００％，２药的有效率无差别（Ｐ〉０．０５），对改善厌食情况亦基本相似，结论：脱     

脱品司琼和昂丹司琼治疗化学疗法所致恶心、呕吐和厌食的比较

目的：观察恶性肿瘤病人应用脱品司琼或昂丹司琼控制化学疗法（化疗）所致胃肠道反应的效果。方法：５８例恶性肿瘤病人采用随机交叉性研究，脱品司琼（５ｍｇ）和昂丹司琼（８ｍｇ）分别在同一病人前后２个化疗周期的ｄ１给药前３０ｍｉｎ，ｉｖ，１次，并用地塞米松１０ｍｇ，ｉｖ滴注。结果：２药控制急性及迟发性恶心、呕吐的疗效均可达８１％～１００％，２药的有效率无差别（Ｐ＞０．０５），对改善厌食情况亦基本相似。结论：脱品司琼和昂丹司琼１次用药均可很好地控制化疗所致的胃肠道反应，２药的疗效及不良反应均无差别。     

昂丹司琼单用或联用预防食管癌术后化疗所致呕吐的临床观察

目的:观察昂丹司琼单用或联用的止吐效果及不良反应,寻找经济实用的止吐方案。方法:对40例食管癌术后接受顺铂联合化疗的患者,采用随机对照的方法,比较单用常规剂量昂丹司琼及1/3常规剂量昂丹司琼联合甲氧氯普胺和地塞米松的疗效及毒性。结果:昂丹司琼组、联合组止吐有效率分别为82.5%及95.0%,完全缓解率分别为72.5%、87.5%;其止吐效果两组间无统计学差异,但联合组不良反应较轻。结论:小剂量昂丹司琼、甲氧氯普胺、地塞米松联合应用可获得常规剂量昂丹司琼一样的止吐效果,且前者是廉价实惠的止吐方案。     

枢丹预防消化系统肿瘤化疗后恶尽呕吐？…

目的：旨在了解枢丹（盐酸昂丹司琼）在消化道肿瘤病人接受化疗期间的止呕疗效及其不良反应。材料和方法：７８例消化道肿瘤并接受化疗的病人,连续观察２个疗程,以胃复安（甲氧氯普胺）作为对照组,化疗方案包括动脉插管化疗、腹腔化疗、静脉化疗,恶心呕吐分级采用ＷＨＯ标准,临床有效以完全缓解和部分缓解计算。结果：３种不同化疗途径枢丹的总有效率为８６．０２％,与对照组相比有显著差异（Ｐ〈０．００１）;无论何种化疗途     

合用昂丹司琼、地塞米松与甲氧氯普胺控制由顺铂引起的胃肠道反应

１０４例接受由顺铂为主的化疗，分昂丹司琼组（男性４５例，女性９例，年龄５０±ｓ１６ａ）与甲氧氯普胺组（男性４３例，女性７例，年龄４６±１８ａ）。昂丹司琼组：昂丹司琼加地塞米松及甲氧氯普胺；甲氧氯普胺组：甲氧氯普胺加地塞米松。控制由顺铂引起的胃肠道反应。昂丹司琼组止吐完全缓解率达８５％。甲氧氯普胺组２６％，疗效有显著性差别（Ｐ＜０．０５）。     

合用昂丹司琼、地塞米松与甲氧氯普胺控制由顺铂引的胃肠道反应

１０４例接受由顺铂为主的化疗，分昂丹司琼组（男性４５例，女性９例，年龄５０±ｓ１６ａ）与甲氧氯普胺组（男性４３例，女性７组，年龄４６±１８ａ。昂丹司琼组：昂丹司琼加地塞米松及甲氧氯普胺；甲氧氯普胺组：甲氧氯普胺加地塞米松。控制由顺铂引起的胃肠道反应。昂丹司琼组止吐完全缓解率达８５％。甲氧氯普胺组２６％，疗效有显性差别（Ｐ＜０．０５）。     

止吐膏穴位贴敷预防肿瘤化疗时呕吐的观察

目的：探讨止吐膏穴位贴敷预防肿瘤化疗后呕吐的效果。方法将98例恶性肿瘤化疗患者随机分为治疗组49例和对照组49例。治疗组采用穴位贴敷结合静脉注射昂丹司琼治疗,对照组单纯静脉注射昂丹司琼治疗,观察两组预防化疗后呕吐的临床疗效。结果治疗组化疗后呕吐总有效控制率为93．9％,对照组为79．6％,治疗组疗效明显高于对照组（P＜0．05）。结论止吐膏穴位敷贴联合静脉注射昂丹司琼预防化疗后呕吐疗效显著,操作简便,值得临床推广应用。     

观察昂丹司琼防治肿瘤化疗引起呕吐的临床疗效分析

目的：观察新一代止吐药昂丹司琼对防治肿瘤患者化疗引起的恶心呕吐胃肠道反应的疗效,以保证化疗顺利进行。方法：60例患者采用自身交叉对照法随机分为A、B两组,化疗第一周期,A组应用昂丹司琼8mg静滴,化疗前20分钟应用,每日一次,d1～d5天,B组应用胃复安20mg肌注,每日二次,并加用吗叮啉片10mg,每日三次口服,d1～d5天。第二周期化疗,A、B两组止吐药物交换,两组止吐药均与化疗日期同步。采用1990年欧洲临床肿瘤会议推荐的恶心呕吐标准,对两组止吐药物的疗效进行对比和评价。结果：两组药物的有效率有显著的统计学差异（P〈0.005）。在控制化疗引起的恶心呕吐方面,昂丹司琼的疗效明显优于胃复安加吗叮啉。结论：新一代止吐剂昂丹司琼能够有效控制以顺铂为主的不同联合化疗方案引起的恶心呕吐胃肠道反应,其疗效明显优于传统的常规止吐药物,并且副作用小,使用安全,有效作用时间长,这对提高肿瘤化疗的疗效,延长患者的生存期,提高患者的生活质量有重要作用。因此,昂丹司琼应作为化疗辅助用药的首选药物之一。     

穴位指针法联合静脉滴注昂丹司琼治疗化疗所致恶心、呕吐的效果观察

目的：观察穴位指针法联合静脉滴注昂丹司琼治疗化疗所致恶心、呕吐的效果。方法将240例肿瘤化疗患者随机分成两组,治疗组采用穴位指针法联合静脉滴注昂丹司琼,对照组单纯静脉滴注昂丹司琼,观察两组预防、减轻恶心、呕吐的效果。结果治疗组的有效率明显高于对照组（P〈0.01）。结论穴位指针法联合静脉滴注昂丹司琼治疗化疗所致恶心、呕吐的效果优于单纯静脉滴注昂丹司琼。     

Granisetron. A pharmacoeconomic evaluation of its use in the prophylaxis of chemotherapy-induced nausea and vomiting

The efficacy of granisetron in preventing acute nausea and vomiting during the 24 hours following chemotherapy in patients with cancer is equivalent to that of other serotonin 5-HT3 receptor antagonists (ondansetron and tropisetron) and similar to or greater than that of conventional antiemetic regimens such as metoclopramide plus dexamethasone. Like other 5-HT3 receptor antagonists, granisetron is generally well tolerated by most patients and its antiemetic efficacy is enhanced when used concomitantly with dexamethasone. To date, pharmacoeconomic evaluations of granisetron have involved intravenous administration of the drug to adult patients with cancer receiving single-dose or fractionated chemotherapy of moderate to high emetogenic potential. In economic analyses conducted in France, a single dose of granisetron 3mg was associated with a mean direct treatment cost per patient (or per well-controlled patient) approximately 50% lower than that for ondansetron 8mg intravenously followed by 8mg orally every 8 hours for 3 days, in patients receiving single-dose chemotherapy. Direct costs per patient were approximately 20 to 30% lower with granisetron (usually 3 mg/day) than ondansetron (usually 24 to 32 mg/day intravenously) in patients receiving chemotherapy fractionated over several days. Sensitivity analysis showed that the results, were robust to variations in the acquisition costs of the antiemetics. Granisetron also remained more cost effective than ondansetron with variations in the antiemetic dosage regimens, except when the granisetron dosage remained unchanged while the ondansetron dosage was reduced to a single 8mg intravenous dose on each day prior to chemotherapy (and no change in efficacy was assumed). Other economic evaluations suggest that granisetron may be more cost effective than a combined antiemetic regimen of high dose metoclopramide plus dexamethasone, and selected use of granisetron or ondansetron in patients receiving emetogenic chemotherapy can be implemented with relatively small incremental increases to the total cancer treatment budget, albeit with a marked increase in antiemetic acquisition costs. In conclusion, granisetron is an effective and well tolerated agent for the prophylaxis of acute chemotherapy-induced nausea and vomiting, and its selective use in this clinical setting can provide cost-effective antiemetic therapy.     

Cost and cost-effectiveness analysis of ondansetron versus metoclopramide regimens: a hospital perspective from Italy

In a large double-blind study of antiemetic therapy conducted in Italy, 289 patients underwent 3 consecutive cycles of cisplatin chemotherapy. Antiemetic treatment with ondansetron plus dexamethasone was more efficacious and better tolerated, but also more expensive, than treatment with metoclopramide plus both dexamethasone and diphenhydramine. To evaluate the different costs of the 2 antiemetic regimens, we conducted a retrospective cost-effectiveness analysis from a hospital perspective. Direct costs of antiemetic therapy (acquisition cost of drugs, materials and time spent by nurses to prepare and administer therapies), cleanup after emesis, rescue medication and adverse events were evaluated. Antiemetic drug acquisition costs per patient were 5.23-fold higher for the ondansetron regimen than for the metoclopramide regimen. However, when the costs of materials and nursing time required to prepare and administer the antiemetic regimens were included, this ratio was 3.77. Furthermore, including the cost of emesis, rescue antiemetic treatments and medication used to treat adverse events, hospital costs per patient were 3.21-fold higher with the ondansetron regimen during the first cycle, 3.08-fold higher during second cycle and 2.89-fold higher during third cycle of chemotherapy. Complete protection from vomiting and from both vomiting and nausea with ondansetron occurred, respectively, in 78.7 and 69.1% of patients in the first cycle, 73.8 and 57.3% in the second cycle, and 74.2 and 58.1% in third cycle of chemotherapy. Corresponding figures for the metoclopramide regimen were 59.5 and 50.4%, 53.6 and 37.1%, and 46.8 and 27.3%, respectively. Thus, the cost per successfully treated (completely protected) patient was 2.43- and 2.34-fold higher, respectively, for ondansetron at the first cycle, 2.23- and 1.99-fold higher, respectively, at second cycle, and 1.82- and 1.36-fold higher, respectively, at third cycle. In conclusion, the study demonstrates that, while ondansetron has a greater acquisition cost than metoclopramide, the ondansetron regimen costs per successfully-treated patient substantially decrease when all direct hospital costs are taken into account.     

Ondansetron: a pharmacoeconomic and quality-of-life evaluation of its antiemetic activity in patients receiving cancer chemotherapy

Ondansetron is more effective than high-dose metoclopramide in the prevention of acute nausea and vomiting due to highly emetogenic chemotherapy, and, unlike metoclopramide, is rarely associated with extrapyramidal effects. Pharmacoeconomic analyses have demonstrated that, in specified clinical settings, ondansetron (8mg 4-hourly for 3 doses or 8mg followed by 1 mg/h for 24 hours) is equally cost-effective as high-dose metoclopramide (3 mg/kg followed by 0.5 mg/kg/h for 8 hours) in the prophylaxis of emesis in patients receiving highly emetogenic chemotherapy, at an acquisition cost 4- or 5-fold higher than that of the metoclopramide regimen. Furthermore, the combination of dexamethasone plus ondansetron has been shown to be more effective than ondansetron monotherapy in controlling emesis. In patients receiving high-dose ( greater than 50 mg/m2) cisplatin-based chemotherapy, antiemetic therapy with ondansetron (8mg intravenously as a single dose) plus dexamethasone (16mg total intravenous dose) was shown to be more cost-effective than the combination of high-dose metoclopramide (11 mg/kg total intravenous dose), dexamethasone (8mg intravenously as a single dose) plus lorazepam (1 to 1.5mg intravenously as a single dose). In a limited number of studies, quality-of-life scores, as assessed using the Rotterdam Symptom Checklist or the Functional Living Index--Emesis instrument, were significantly higher with ondansetron than with other antiemetic agents, including metoclopramide. Together, these results suggest that ondansetron, as an alternative to antiemetic regimens including high-dose metoclopramide, is appropriate cost-effective therapy for the prevention of acute nausea and vomiting in patients receiving highly emetogenic chemotherapy. Ondansetron is effective in controlling acute emesis associated with moderately emetogenic chemotherapy, and its use in this clinical setting may best be reserved for patients who have not responded well to previous antiemetic therapy with more traditional agents. However, poorly controlled emesis can lead to anticipatory nausea and vomiting in subsequent courses of chemotherapy, thus, consideration should also be given to the use of ondansetron in patients receiving moderately emetogenic chemotherapy, although further pharmacoeconomic investigations are required to clarify its use in this clinical setting.     

异丙嗪控制奥沙利铂胃肠道肿瘤化疗所致呕吐

目的:观察异丙嗪对奥沙利铂化疗胃肠道肿瘤所致呕吐的控制率。方法:采用随机对照、自身交叉方法分组,A止吐方法:使用格拉司琼及西咪替丁;B止吐方法:在A的基础上加用异丙嗪。结果:A组的呕吐控制率为83．3％,B组为91．7％(P<0．05)。结论:格拉司琼及西咪替丁加用异丙嗪后能提高奥沙利铂化疗胃肠道肿瘤所致呕吐控制率。     

Ondansetron. Therapeutic use as an antiemetic.

Ondansetron (GR 38032F) is a highly selective 5-HT3 receptor antagonist, one of a new class of compounds which may have several therapeutic applications. Animal and clinical studies show that ondansetron reduces the 24-hour incidence and severity of nausea and vomiting induced by cytotoxic drugs, including cisplatin, and by single exposure, high dose radiation. Ondansetron is more effective than high dose metoclopramide in the 24 hours following chemotherapy, and preliminary clinical evidence suggests that it is equally effective in the following 4 days. It is also more effective than the 'moderate' doses of metoclopramide used to suppress emesis following radiotherapy. The antiemetic efficacy of ondansetron is enhanced by dexamethasone in cisplatin-treated patients. Importantly, extrapyramidal effects have not been reported with ondansetron. Further comparisons are required with standard combination antiemetic therapy to complement the data presently available. Thus, ondansetron is a promising new agent for prophylaxis against nausea and vomiting in chemotherapy and radiotherapy. It may be particularly useful in young and elderly patients who are more susceptible to extrapyramidal symptoms induced by high dose metoclopramide. With its improved tolerability and clinical response profiles, ondansetron represents an important advance in a difficult area of therapeutics.     

Cost-effectiveness analysis of ondansetron and prochlorperazine for the prevention of postoperative nausea and vomiting

OBJECTIVE: To compare the cost-effectiveness of 2 antiemetic agents, ondansetron and prochlorperazine, for the prevention of postoperative nausea and vomiting (PONV) in patients undergoing total hip replacement or total knee replacement procedures. METHODS: The cost-effectiveness analysis model was applied to data derived from a previous clinical study conducted in 1995 and 1996. This study involved 78 adult patients (62.8% female and 37.2% male) undergoing total hip replacement or total knee replacement procedures. Patients were enrolled in a randomized, double-blind manner to receive either ondansetron 4 mg intrvenously (n=37) or prochlorperazine 10 mg intramuscularly (n=41) immediately upon completion of surgery and were monitored for occurrences of PONV during the subsequent 48 hours. In our analysis, we measured the cost-effectiveness ratio (C/E ratio), defined as the cost per successfully treated patient, for each antiemetic agent using the clinical data obtained from the previous study. RESULTS: The incidence of PONV and use of rescue antiemetics was significantly greater in the ondansetron group compared with the prochlorperazine group. The mean total costs of PONV management per patient in the prochlorperazine and ondansetron groups were dollar 13.99 and dollar 51.98, respectively (based on 2004 average wholesale prices [AWP]). The cost of successfully treating one patient with prochlorperazine and ondansetron was dollar 31.87 and dollar 275.01, respectively. One-way sensitivity analysis was performed adjusting the percent efficacy rate of each antiemetic and the drug cost of ondansetron (up to a 50% reduction in AWP). Prochlorperazine remained the dominant strategy across each scenario. CONCLUSION: The results indicate that prochlorperazine is a more cost-effective antiemetic compared with ondansetron for the prevention of PONV in a mixed gender, adult inpatient population undergoing total joint arthroplasty.     

昂丹司琼和甲氧氯普胺在肿瘤化学疗法时作为止吐剂的对比

用自身随机交替对照法，观察昂丹司琼和甲氧氯普胺对６２例（男性４３例，女性１９例：年龄４９±ｓ１２ａ）肿瘤化学疗法（化疗）患者的止吐作用。采用昂丹司琼８ｍｇ，ｉｖ，ｔｉｄ×３ｄ后改８ｍｇ，ｐｏ，ｔｉｄ×４ｄ或甲氧氯普胺２０ｍｇ，ｉｍ，ｔｉｄ×３ｄ后改１０ｍｇ，ｐｏ，ｔｉｄ×４ｄ。结果：对顺铂的止恶心和止吐，昂丹司琼优于甲氧氯普胺，有效率分别为９５％和５０％，但对阿霉素无显著差别。前者未发生锥体外系症状，后者则有３例。     

Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles

PURPOSE: Pre-clinical models have demonstrated the benefit of metronomic schedules of cytotoxic chemotherapy combined with anti-angiogenic compounds. This trial was undertaken to determine the toxicity of a low dose regimen using docetaxel and thalidomide. PATIENTS AND METHODS: Patients with advanced solid tumors were enrolled. Thalidomide 100mg twice daily was given with escalating doses of docetaxel from 10 to 30 mg/m(2)/week. One cycle consisted of 12 consecutive weeks of therapy. The maximal tolerated dose (MTD) was defined as the dose of thalidomide along with docetaxel that caused < or =grade 1 non-hematologic or < or =grade 2 hematologic toxicity for cycle one. RESULTS: Twenty-six patients were enrolled. Dose-limiting toxicities (DLTs) were bradycardia, fatigue, fever, hyperbilirubinemia, leukopenia, myocardial infarction, and neutropenia. Prolonged freedom from disease progression was observed in 44.4% of the evaluable patients. CONCLUSIONS: This anti-angiogenic regimen was well tolerated and demonstrated clinical benefit. The recommended phase II dosing schedule is thalidomide 100 mg twice daily with docetaxel 25 mg/m(2)/week.