恩丹西酮（齐鲁）预防顺铂所致呕吐的Ⅱ期临床研究

１６７例病人，随机对照观察恩丹西酮（齐鲁）的止吐作用。顺铂为３０ｍｇ／次×５天、５０ｍｇ／次×３天或５０ｍｇ／ｍ￣２×１～２天。化疗第１周期用恩丹西酮或用对照药－胃复安或枢复宁，第２周期交换。结果恩丹西酮对控制急性呕吐的有效率高达８６．６％，而胃复安仅为３５．４％。第１天平均呕吐次数两药分别为１．１次／日和５．７次／日（Ｐ＜０．００１）。恩丹西酮对迟发性呕吐也较胃复安为好。恩丹西酮与枢复宁比较，止吐效果相似。恩丹西酮对顺铂所致呕吐效果甚佳，副作用小，是肿瘤化疗的良好止吐药。     

恩丹西酮（齐鲁）预防非顺铂化疗所致呕吐的II期临床研究

本组采用随机对照方法观察恩丹西酮（齐鲁）的止吐作用。凡第１次接受含环磷酰胺、阿霉素的联合方案后出现呕吐的患者入组，第２次化疗时随用恩丹酮酮或用对照药（胃复安或枢复宁），第３次化疗时交换。共１５５例患者入组。结果显示，恩丹西酮第１天的止吐有效率为８７．７％，胃复安为６１．６％；平均呕吐次数分别为０．８次／日和２．７次／日（Ｐ〈０．０１）。恩丹西酮与枢复宁比较止吐效果相似。恩丹西酮对非顺铂化疗引起的呕     

恩丹西酮（齐鲁）预防非顺铂化疗所致呕吐的Ⅱ期临床研究

本组采用随机对照方法观察恩丹西酮（齐鲁）的止吐作用。凡第１次接受含环磷酰胺、阿霉素的联合方案后出现呕吐的患者入组，第２次化疗时随机用恩丹西酮或用对照药（胃复安或枢复宁），第３次化疗时交换。共１５５例患者入组。结果显示，恩丹西酮第１天的止吐有效率为８７．７％，胃复安为６１．６％；平均呕吐次数分别为０．８次／日和２．７次／日（Ｐ＜０．０１）。恩丹西酮与枢复宁比较止吐效果相似。恩丹西酮对非顺铂化疗引起的呕吐具有很好的止吐效果，副作用小。     

恩丹西酮（齐鲁）预防顺铂所致呕吐的II期临床研究

１６７例病人，随机对照观察恩丹西酮（齐鲁）的止吐作用。顺铂为３０ｍｇ／次×５天、５０ｍｇ／次×３天或５０ｍｇ／ｍ＾２×１￣２天。化疗第１周期用恩丹西酮或用对照药－胃复安或枢复宁，第２周期交换。结果恩丹西酮对控制急性呕吐的有效率高达８６．６％，而胃复安仅为３５．４％。第１天平均呕吐次数两药分别为１．１次／日和５．７次／日（Ｐ〈０．００１）。恩丹西酮对迟发性呕吐也较胃复安为好。恩丹西酮与枢复宁比较，止     

盐酸恩丹西酮与胃复安治疗以顺铂或阿霉素联合化疗诱发恶心呕吐──311例Ⅱ期临床试验随机自身对照疗效比较

３１１例以顺铂和阿霉素联合方案化疗的恶性肿瘤患者，采用国产盐醚恩丹西酮与胃复安进行自身随机对照止吐研究。结果表明，恩丹西酮对顺铂联合方案引起的急性呕吐治疗，第１、２、３天有效率分别为９２．５％、８８．９％及８２．９％，明显优于胃复安的４２．２％、５６．３％及５９．３％（Ｐ＜０．０５）；恩丹西酮对阿霉素联合方案化疗引起的急性呕吐治疗，第１、２、３天有效率分别为９７．７％、９３．８％及９５．８％，而胃复安有效率为９２．０％、８４．１％及８１．３％。在副作用方面，恩丹西酮治疗组除便秘（４５例次．１１．７％）高于胃复安治疗组（且７例次，４．４％）外，无其它明显毒副反应；相反，胃复安治疗组中有７例（１．８％）发生锥体外系反应．而恩丹西酮治疗组中无一例出现。我们认为，恩丹西酮止吐疗效好，使用安全，尤其适合治疗顺铂类药物化疗所致的急性严重呕吐。     

恩丹西酮预防化疗所致呕吐Ⅲ期临床研究

作观察了经顺铂类和非顺铂类药物化疗的95例患应用恩丹西酮的止吐作用。顺铂组共68例。顺铂40mg／次×3天(23例)，50mg／次×3天(27例)。80mg／次×2天(18例)；非顺铂组27例．均系接受含环磷酰胺和／或阿霉素联合方案化疗用胃复安后出现呕吐患，A组后接受同一方案治疗。结果显示，恩丹西酮对控制顺铂不同剂量组所致急性呕吐的CR率依次为87.0％，85.2％和66.7%，总有效率分别为91．3％，96．3％和94．4％;而对非顺铂组控制急性呕吐的CR率为88．9%。有效率为96.3％。上述结果表明恩丹西酮对控制顺铂类和非顺铂类药物所致的呕吐反应均有较强的止吐作用。     

恩丹西酮（Ondansetron）预防由顺铂引起恶心呕吐Ⅱ期临床研究报告

本文报告４３例接受顺铂化疗肿瘤患者，使用国产恩丹西酮与胃复安随机自身对照止吐研究，结果表明在化疗的第１～３天恩丹西酮组的进食情况及恶心呕吐程度均好于胃复安组、在控制呕吐方面第１、２天恩丹西酮组亦明显的优于胃复安组，ＣＲ＋ＰＲ分别为８１．４％、５８．１％和２７．９％、３２．６％。结果与进口柩复宁疗效相同，能有效地预防顺铂所致的胃肠道反应，尤其在控制顺铂所致的急性呕吐方面，疗效满意，可望取代柩复宁。     

小剂量恩丹西酮联合方案预防化疗所致的胃肠道反应

目的研究小剂量恩丹西酮联合方案预防化疗引起的胃肠道反应。方法对３５例病人采用自身对照随机进行，用小剂量恩丹西酮、苯海拉明、氟美松、胃复安等药联合方案，与常规止吐方案（不用恩丹西酮）对比。结果小剂量恩丹西酮联合止吐方案控制急性恶心、呕吐的有效率为９５％，明显优于常规止吐方案（Ｐ＜０．０１）。对迟发性呕吐的有效率也高于常规止吐方案，但差异无显著性（Ｐ＞０．０５）。与应用单药恩丹西酮相比，第１～５天控制恶心、呕吐的有效率均有所提高。结论认为小剂量恩丹西酮联合止吐方案既获得了较好的止吐疗效又节省了医疗费用，便于基层医院推广。     

恩丹西酮（Ondanstron）预防顺铂呕吐Ⅱ期临床研究

采用自身随机交替对照方法，观察了恩丹西酮的止吐作用。４４例患者入组，顺铂剂量为５０ｍｇ／次，连用３天，患者在第一周期随机接受恩丹西酮或胃复安止吐方案，在第二周期时交替止吐方案。结果显示，恩丹西酮控制急性恶心呕吐优于胃复安方案，９５％的患者有效，而对照组仅５０％有效。恩丹西酮组没有观察到锥体外系症状，而对照组中有３例出现锥体外系症状。     

恩丹西酮防治顺铂所致哎吐的疗效观察

目的：观察恩丹西酮对顺铂化疗所致哎吐的疗效。方法；随机将１８６例恶性肿瘤患者分为两组。９０例单用恩丹西酮（Ａ组），９６例恩丹西酮加地塞米松治疗（Ｂ组）。结果：对急性哎吐止吐有效率Ａ、Ｂ组分别为８５．６％和９６．９％。结论：恩丹西酮加地塞米松可显著提高对急性哎吐止吐有效率（Ｐ〈０．０５），但对迟发性哎吐，两组止吐疗效无明显差异（Ｐ〉０．０５）．     

恩丹西酮和胃复安预防顺铂化疗呕吐反应的疗效分析

采用自身对照方法，观察了１０６例恶性肿瘤病人以顺铂为主联合化疗，于第１，２周期分别使用胃复安，恩丹西酮。预防恶心呕吐反应，有效率分别为：４３．３９％，９２．４５％，二者差异显著。胃复安组８例发生椎体外系反应，恩丹西酮均未出现椎体外系症状。     

Phase III double-blind comparison of intravenous ondansetron and metoclopramide as antiemetic therapy for patients receiving multiple-day cisplatin-based chemotherapy.

BACKGROUND. Ondansetron hydrochloride is a selective serotonin subtype 3 (5HT3) receptor antagonist that has been shown to be an effective antiemetic in patients receiving cisplatin chemotherapy. METHODS. This double-blind study compared the safety and efficacy of intravenous ondansetron with metoclopramide in patients receiving a 4- or 5-day regimen of cisplatin (20-40 mg/m2/day) combination chemotherapy. Forty-five patients were enrolled, and efficacy of the drug therapy could be studied for all 45. Patients were randomly assigned (1:1) to receive three daily intravenous doses of either 0.15 mg/kg ondansetron or 1 mg/kg metoclopramide. All patients were monitored daily for the number of emetic episodes (vomiting or retching), severity of nausea, adverse events, and laboratory safety parameters. RESULTS. Seven (30%) patients who received ondansetron had no emetic episodes throughout the entire study period compared with two (9%) who received metoclopramide (P = 0.077). The greatest difference in antiemetic efficacy was seen on day 1, when 18 (78%) patients who received ondansetron had no emetic episodes compared with 3 (14%) patients who received metoclopramide (P < 0.001). Significantly fewer antiemetic treatment failures (more than five emetic episodes or withdrawal from the study) occurred with patients given ondansetron (9%) than with those given metoclopramide (50%) during the entire study period (P = 0.002). The most commonly reported adverse event associated with ondansetron therapy was headache (controlled with acetaminophen), whereas diarrhea and restlessness were the most commonly reported adverse events associated with metoclopramide therapy. Extrapyramidal symptoms were judged to have occurred in 13 patients who received metoclopramide and 1 patient who received ondansetron. However, the patient who received ondansetron subsequently was judged to have had an anxiety attack. In patients with low or normal baseline transaminase values, a greater percentage who received ondansetron had transient increases as great as twice the upper limit of normal in aspartate transaminase (5% versus 0%) and alanine transaminase (17% versus 6%) than those who received metoclopramide. CONCLUSIONS. Ondansetron is superior to metoclopramide as antiemetic therapy for multiple-day cisplatin-based chemotherapy.     

Efficacy of ondansetron against nausea and vomiting caused by dacarbazine-containing chemotherapy.

BACKGROUND AND METHODS. The antiemetic activity of ondansetron (Zofran, Glaxo Pharmaceuticals, Research Triangle Park, NC) was evaluated in 25 patients with recurrent melanoma who were treated sequentially with dacarbazine (DTIC), vinblastine, and cisplatin. The antiemetic regimen included ondansetron alone in 11 patients; ondansetron plus lorazepam (Ativan, Wyeth-Ayerst, Philadelphia, PA) in 9 patients; and ondansetron plus lorazepam plus metoclopramide (Reglan, A. H. Robins Co., Richmond, VA) in 5 patients. Twenty-one patients had no prior exposure to chemotherapy, whereas 4 patients had previously received the same chemotherapy regimen and had severe vomiting despite administration of standard antiemetics. RESULTS. The antiemetic efficacy of ondansetron was impressive. Administration of a single dose of 10 mg resulted in complete control of nausea and vomiting in 22 patients, and the remaining 3 patients had only mild vomiting. CONCLUSIONS. Ondansetron is highly effective in controlling the nausea and vomiting caused by dacarbazine.     

三种5—羟色胺受体阻滞剂预防化疗药物所致消化道毒性的临床分析

目的探讨恩丹西酮、枢复宁、康泉预防化疗药物引起恶心呕吐的临床效果。方法采用随机对照法观察了对以顺铂为主化疗药物的止吐作用,选择病例分别为４０例、３２例及９５例。结果恩丹西酮、枢复宁、康泉对控制急性呕吐的有效率（ＣＲ＋ＰＲ）分别为：８５％、８４．４％、９６．８％,康泉与恩丹西酮、枢复宁比较均有统计学意义（Ｐ＜０．０５）,而恩丹西酮与枢复宁两者比较无统计学意义（Ｐ＞０．０５）。呕吐完全控制率（ＣＲ）三者分别为６５％、７５％及８１．１％,康泉与恩丹西酮比较有统计学意义（Ｐ＜０．０５）,而康泉与枢复宁及恩丹西酮与枢复宁比较均无统计学意义（Ｐ＞０．０５）。结论恩丹西酮与枢复宁对预防化疗药物引起的呕吐有效,而康泉的效果优于枢复宁及恩丹西酮。但是,康泉的价格昂贵,临床应用受到限制。     

枢复宁防止由非顺铂化疗所致呕吐的疗效观察

本文报道用枢复宁十地塞米松与灭吐灵十地塞米松随机对照,控制非顺铂化疗诱发的呕吐。58例病人经随机分组后,28例用枢复宁加地塞米松,30例按本院常用剂量灭吐灵加地塞米松治疗。枢复宁十地塞米松对急性恶心和呕吐的完全控制率均显著高于灭吐灵十地塞米松(分别为87％比72％,P<0.05,94％比67％,P<0.001)。对延缓性呕吐的完全控制。枢复宁十地塞米松也高于灭吐灵十地塞米松,分别为85％—94％比58％—82％(P<0.05)。枢复宁十地塞米松副作用轻,主要有头痛(13％)和便秘(9％),不引起锥体外系反应。因此,枢复宁十地塞米松是一个较为有效的联合止吐方案。     

枢复宁防止肿瘤化疗所致呕吐的疗效观察

本文报道用枢复宁防止肿瘤化疗所致呕吐,共计３０例,其中１２例在使用枢复宁前曾用灭吐灵（作为自身对照）。结果发现枢复宁组防止化疗呕吐的完全控制率、有效率均显著高于灭吐灵组（分别是６３．３％１６．７％、９６．７％比５８．３％,Ｐ＜０．００）。且其副作用少而轻微。因此,枢复宁是一种安全而有效的止吐剂。     

High efficacy of a single oral dose of ondansetron 8 mg versus a metoclopramide regimen in the prevention of acute emesis induced by fluorouracil, doxorubicin and cyclophosphamide (FAC) chemotherapy for breast cancer

The aim of our single-center, prospective, randomized, open study was to evaluate the antiemetic efficacy and tolerability of a regimen based on a single oral dose of ondansetron 8 mg in comparison with a metoclopramide-based regimen, for prevention of acute FAC (fluorouracil, doxorubicin and cyclophosphamide) chemotherapy-induced emesis. A total of 149 chemotherapy-naive, female outpatients, under 50 years of age and with no history of alcohol consumption, scheduled to receive their first cycle of FAC chemotherapy, were included. The patients received either oral ondansetron (8 mg) or metoclopramide (1.5 mg/kg, i.v.), both combined with dexamethasone (16 mg, i.v.) and alprazolam (0.5 mg t.i.d. orally). No antiemetic prophylaxis was given for delayed emesis. Complete control of acute vomiting was obtained in 69/74 (93%) of patients receiving ondansetron, and in 49/75 (65%) of those receiving metoclopramide (p=0.00003). Complete control of acute nausea was obtained in 58% of patients receiving ondansetron and in 36% of those receiving metoclopramide (p=0.007). Complete prevention of delayed vomiting/nausea was achieved in 73%/20% and 60%/16% of patients, respectively. Sedation was more frequent in the metoclopramide arm (p=0.04). As far as we know this is the first study that supports the efficacy of a regimen based on a single oral dose of ondansetron 8 mg in the prevention of acute FAC chemotherapy-induced emesis. The ondansetron regimen was highly effective in female patients and was superior to the metoclopramide based regimen.     

Ondansetron Versus Metoclopramide as Antiemetic Treatment During Cisplatin-based Chemotherapy: A prospective study with special regard to electrolyte imbalance

Cancer patients selected for cisplatin-based chemotherapy were randomly divided into two groups (42 patients in each) which received either metoclopramide or ondansetron as antiemetics. Metoclopramide was given i.v. with 5 doses of 2 mg/kg starting 30 min before the cisplatin infusion and continued with one dose every 3 h. Ondansetron was given with a first injection of 8 mg i.v. 30 min before the cisplatin infusion; the patients were given 8 mg orally 5 and 10 h after the cisplatin infusion followed by 8 mg × 3 during the next two days. In the present study ondansetron was superior to metoclopramide concerning antiemetic efficacy and gave also less side-effects as diarrhea, dizziness, extrapyramidal symptoms and electrolyte imbalance (sodium, potassium, magnesum, phosphorous) during the first 24 h following the cisplatin infusion.     

Double-blind randomised trial of the antiemetic efficacy and safety of ondansetron and metoclopramide in advanced breast cancer patients treated with epirubicin and cyclophosphamide

Ondansetron was compared with metoclopramide for antiemetic efficacy in a randomised double-blind trial in 122 patients with advanced breast cancer. All patients were treated with epirubicin (> 50 mg/m²) and cyclophosphamide (> 500 mg/m²). 50 patients receiving ondansetron and 60 with metoclopramide were considered evaluable. Ondansetron was at least as effective as metoclopramide in the control of vomiting and nausea. The percentage of patients with complete plus major control was 72% (59–85%) vs. 61% (48–74%) on day 1 (P = 0.230) and 79% (67–91%) vs. 66% (53–78%) on days 2–3 after chemotherapy (P = 0.122). Over the 3-day study period, nausea was absent or mild in 60% of the patients treated with ondansetron, compared to 45% given metoclopramide (P = 0.064). No major drug-related side-effects were reported. 1 patient receiving ondansetron experienced gastrointestinal disturbance and headache. Episodes of diarrhoea, fever, hyperkinetic syndrome, fatigue, restlessness and migraine with vomiting were reported by 5 patients treated with metoclopramide. None of the changes in the biochemical or haematological parameters was attributed to the antiemetic treatments.