不同止吐方案预防化疗所致呕吐的对比研究

目的 从几组化疗止吐剂中筛选出经济有效，便于基层医院应用的抗癌止吐方案。方法 胃复安为对照组，恩丹西酮或欧必亭综合防治用药为观察组，进行自身前后对照，以止吐效果为主要指标的多侧面观察比较。结果 止恶心有效率，急性期和延迟期呕吐防治有效率分别为：胃复安组38．88％，36．41％，33．33％，恩丹西酮或欧必亭组78．34％，86．67％，76．67％；综合防治组74．50％，83．33％，91．18％。未见严重副反应。结论 以胃复安，苯海拉明，地塞米松，安定联合按需用药是基层医院较理想的抗癌化疗止吐方案。     

不同止吐方案预防化疗所致呕吐的对比研究

目的　从几组化疗止吐剂中筛选出经济有效 ,便于基层医院应用的抗癌止吐方案。方法　胃复安为对照组 ,恩丹西酮或欧必亭综合防治用药为观察组 ,进行自身前后对照 ,以止吐效果为主要指标的多侧面观察比较。结果　止恶心有效率、急性期和延迟期呕吐防治有效率分别为 :胃复安组 38 88%、36 41%、33 33% ;恩丹西酮或欧必亭组 78 34 %、86 67%、76 67% ;综合防治组 74 5 0 %、83 33%、91 18% ;未见严重副反应。结论　以胃复安、苯海拉明、地塞米松、安定联合按需用药是基层医院较理想的抗癌化疗止吐方案     

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。     

康泉预防化疗引起呕吐的疗效观察

对96例肿瘤病人随机分为3组，各组均为32例，分别应用康泉、盐酸恩西酮、胃复安联合地塞米松进行抗呕吐治疗疗效的观察，化疗第一天控制呕吐有效率3组依次分别为87．5％、84．4％、59．4％，康泉组与盐酸恩丹西酮组在控制急性呕吐的效果上无明显差异，但均明显于胃复安联合地塞米松组，对延迟性呕吐的止吐效果则优于盐酸恩丹西酮及胃复安联合地塞米松组，康朱不良反应甚少且停药后可自缓解，是效果佳且安全可靠的化疗止吐剂。     

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     

托烷司琼联用预防化疗呕吐临床研究

目的 观察托烷司琼联用地塞米松及胃复安防止化疗所致呕吐的临床疗效和毒性作用。同时选恩丹西酮联用等量地塞米松、胃复安作对照组进行分析。方法 45例接受顺铂或环磷酰胺加阿霉素联合化疗者随机分为两组,于每组化疗两个周期中交叉用药,自身对照。观察第1～5天患者恶心、呕吐控制的有效率(CR PR)并作出比较。结果 含顺铂化疗组托烷司琼联用,急性期止吐有效率93.8％,CR87.5％。恩丹西酮联用有效率96.7％,CR81.3％。迟发期有效率84.4％～90.6％,两药相似。结论 托烷司琼与恩丹西酮疗效相同,防止化疗呕吐效果显著,无严重毒性作用。联用地塞米松和胃复安可以提高两药疗效,尤其对迟发期呕吐取得较为满意的作用。     

恩丹西酮加用胃复安、苯海拉明防治化疗呕吐52例观察

目的　寻找化疗呕吐的高效低毒止吐方法。方法　采用前瞻性病例自身对照方法。观察化疗病人恩丹西酮和胃复安 (±苯海拉明 )的止吐效果。结果　对急性呕吐和迟发性呕吐的有效率分别为 96.0 %和 75.0 % ,与单用恩丹西酮的 96.1 %和 66.6%无统计学差异 (P >0 .0 5)。但是 ,其毒副作用减轻 ,所需费用减少 49%。结论　恩丹西酮加用胃复安、苯海拉明是一个高效低毒且较经济的化疗止吐方法。     

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。     

恩丹西酮与其它止吐剂在化疗中的疗效观察

目的 观察恩丹西酮和其他止吐药物的疗效及毒副作用。方法 采用随机双盲对照法对318例接受顺铂、阿霉素联合化疗的恶性肿瘤病人采用恩丹西酮、胃复安、枢复宁进行止吐效果和毒副作用的比较分析。结果 用恩丹西酮、胃复安、枢复宁化疗后3天内病人无恶心和轻度恶心分别为88.7%、51.3%、83.3%,对急性呕吐的止吐作用分别为95.3%、52.5%、92.3%。3种止吐药的毒副作用以胃复安较大,多以头晕、困倦为主,尤其是有7.5%椎外系统症状,恩丹西酮以便秘轻重。结论 国产盐酸恩丹西酮的疗效与进口枢复宁疗效相似,明显优于胃复安,无锥外系统的副作用,且能口服,使用安全方便,价格便宜。     

恩丹西酮与其它止吐剂在化疗中的疗效观察

目的　观察恩丹西酮和其他止吐药物的疗效及毒副作用。方法　采用随机双盲自身对照法对 3 18例接受顺铂、阿霉素联合化疗的恶性肿瘤病人采用恩丹西酮、胃复安、枢复宁进行止吐效果和毒副作用的比较分析。结果　用恩丹西酮、胃复安、枢复宁化疗后 3天内病人无恶心和轻度恶心分别为 88 7%、5 1 3 %、83 3 % ,对急性呕吐的止吐作用分别为 95 3 %、5 2 5 %、92 3 %。 3种止吐药的毒副作用以胃复安较大 ,多以头晕、困倦为主 ,尤其是有 7 5 %椎外系统症状。恩丹西酮以便秘较重。结论　国产盐酸恩丹西酮的疗效与进口枢复宁疗效相拟 ,明显优于胃复安 ,无锥外系统的副作用 ,且能口服 ,使用安全方便 ,价格便宜     

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。     

A comparison of ondansetron with metoclopramide in the prophylaxis of chemotherapy-induced nausea and vomiting: A randomized,double-blind study

The efficacy of ondansetron was compared with metoclopramide in the prophylaxis of nausea and vomiting induced by cyclophosphamide ≥ 500 mg/m² in combination with doxorubicin ≥ 40 mg/m² or epirubicin ≥ 40 mg/m². Complete anti-emetic protection in the 24 h following chemotherapy was achieved in 26 of 40 (65%) patients treated with ondansetron compared with 17 of 42 (41%) patients treated with metoclopramide. Severe nausea was present in 3% of patients in the ondansetron group and 31% in the metoclopramide group. A worst day analysis of control of emesis and nausea on days 2 and 3 following chemotherapy also demonstrated ondansetron to be more effective than metoclopramide. Both treatments were well tolerated. Ondansetron is more effective as an anti-emetic than metoclopramide in this type of cytostatic therapy.     

A single-blind comparison of intravenous ondansetron, a selective serotonin antagonist, with intravenous metoclopramide in the prevention of nausea and vomiting associated with high-dose cisplatin chemotherapy

Ondansetron (GR 38032F), a selective antagonist of serotonin subtype 3 receptors, is effective in the prevention of emesis associated with cisplatin as well as other chemotherapeutic agents. In this randomized, single-blind, multicenter, parallel group study, we compared the efficacy and safety of intravenous (IV) ondansetron with IV metoclopramide in the prevention of nausea and vomiting associated with high-dose (greater than or equal to 100 mg/m2) cisplatin chemotherapy. Three hundred seven patients receiving their first dose of cisplatin, either alone or in combination with other antineoplastic agents, were randomized to receive ondansetron 0.15 mg/kg IV every 4 hours for three doses or metoclopramide 2 mg/kg IV every 2 hours for three doses, then every 3 hours for three additional doses. The study prohibited the concurrent administration of other antiemetics or dexamethasone. Patients receiving ondansetron had a higher rate of complete protection from emesis (40% v 30%, P = .07), a higher complete plus major response rate (65% v 51%, P = .016), a lower rate of failure (21% v 36%, P = .007), and a lower median number of emetic episodes (one v two, P = .005) than did those receiving metoclopramide. The median time to the first emetic episode was longer on ondansetron (20.5 v 4.3 hours, P less than .001). Adverse events occurred in 48% of patients receiving ondansetron and 69% of those receiving metoclopramide (P less than .001). Akathisia and acute dystonic reactions occurred only on metoclopramide; headache (controlled with acetaminophen) was significantly more frequent with ondansetron. Ondansetron is more effective, produces fewer adverse events, and is easier to administer than metoclopramide for the prevention of emesis associated with high-dose cisplatin chemotherapy.     

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。     

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.     

国产恩丹西酮预防化疗引起恶心呕吐80例临床观察

采用随机对照法观察了恩丹西酮对８０例顺铂及非顺铂类化疗药的止吐作用，化疗第１周期用恩丹西酮或胃复安，第２周期交换。结果显示，恩丹西酮对控制急性呕吐的有效率为９１．３％，而胃复安仅为５８．８％（Ｐ〈０．０１），其对非顺铂类的止吐作用，前２天优于顺铂（Ｐ〈０．０５），它对迟发性呕吐的疗效也优于胃复安，本研究认为，恩丹西酮控制顺铂及非顺铂类化疗引起的恶心呕吐均有良好的疗效，副作用少。     

Efficacy of 5-HT3 receptor antagonists in radiotherapy-induced nausea and vomiting: a quantitative systematic review

5-HT3 receptor antagonists are used to treat radiation-induced sickness. The purpose of this study was to define anti-emetic efficacy and potential for harm of these drugs in radiotherapy. A systematic search, critical appraisal and quantitative analysis of relevant data using the number-needed-to-treat or harm (NNT/H) were conducted. Acute (0 to 24h) and delayed (beyond 24 h) anti-emetic efficacy were analysed separately. Data from 1,404 patients were found in 40 trials published in 36 reports. Data from 197 patients receiving ondansetron or granisetron in five randomised trials were regarded as valid according to preset criteria. One placebo-controlled trial had 10 patients per group and in this ondansetron was not significantly different from placebo. In a larger (n = 105) placebo-controlled trial, ondansetron was significantly more efficacious than metoclopramide for complete control of acute vomiting (NNT 2.2, 95% confidence interval (CI) 1.7-3.3) and acute nausea (NNT 3.6, 95% CI 2.2-10.2). Three trials reported delayed outcomes with ondansetron or granisetron: there was no evidence of any difference compared with placebo or other anti-emetics. Two trials reported no acute or delayed but a 'worst day' outcome; in these ondansetron's antivomiting effect was significantly better than placebo (NNT 4.4, 95% CI 2.5-23) or prochlorperazine (NNT 3.8, 95% CI 2.4-10.3), but not its antinausea effect. Constipation and headache were associated significantly with 5-HT3 receptor antagonists compared with other anti-emetics or placebo (NNH 6.4 and 17.1, respectively). Only 14% of published data enabled valid estimation of the anti-emetic efficacy of 5-HT3 receptor antagonists in radiotherapy. There was some evidence that these drugs prevent acute vomiting: 40% of treated patients will benefit (NNT approximately 2.5). The evidence for nausea was less clear. There was no evidence that these drugs are of any benefit beyond 24 h. There was evidence that they produce specific adverse effects.     

Comparative trial of oral granisetron and intravenous ondansetron in patients receiving chemotherapy for breast cancer. Study Group of Granisetron

This multicentric randomized trial compared two strategies in the prevention of acute and delayed nausea and vomiting induced by moderately emetogenic chemotherapy in patients with breast cancer. The antiemetic efficacy and side effects of oral granisetron, followed by metoclopramide, were compared to those of intravenous (IV) ondansetron followed by oral ondansetron. 198 chemonaive patients with breast cancer, treated with a moderately emetogenic chemotherapy, were randomly assigned to receive either oral granisetron 1 mg twice a day on day 1, followed by metoclopramide, 60 mg on day 2 and 3, or ondansetron, 8 mg IV on day 1, followed by ondansetron 8 mg tablet twice a day on day 2 and 3. Both treatments have shown similar control of acute emesis: complete response was achieved in 71% of granisetron group and 66% of ondansetron, and total response in respectively 49% and 53%. However, granisetron plus metoclopramide showed a trend towards better efficacy than oral ondansetron in the prevention of delayed emesis. Furthermore, during the overall study period (day 1 to 5), the percentage of complete responses in the group receiving oral granisetron followed by oral metoclopramide was significantly higher than in the group receiving ondansetron (53% versus 37%; p = 0.022). In conclusion, oral granisetron has shown similar efficacy as IV ondansetron in the prevention of acute emesis induced by moderately emetogenic chemotherapy. Oral granisetron followed by metoclopramide seems more efficient than IV plus oral ondansetron in the prevention of delayed emesis.     

Nausea and vomiting after ENT surgeries: A comparison between ondansetron, metoclopramide and small dose of propofol

Aims

To evaluate the antiemetic efficacy of ondansetron, metoclopramide or small dose of propofol following ear, nose and throat (ENT) surgery.

Materials and methods

A prospective randomized study involving 60 patients, both children and adults undergoing elective ENT surgery under standard general anesthesia. At the completion of surgery the patients received either 0.1 mg/kg of ondansetron or 0.2 mg/kg of metoclopramide or 0.5 mg/kg of propofol intravenously. The patients were observed for 24 hrs after operation for any occurrence of nausea and vomiting.

Results

The incidence of postoperative nausea and vomiting (PONV) during first 24 hrs was recorded in 20%, 70%, 50% of patients who had received ondansetron, metoclopr-amide or propofol respectively (p < 0.05). Fewer patients given ondansetron needed rescue antiemetic. The incidence of PONV was higher following middle year surgery.

Conclusion

It was concluded that ondansetron was most effective in preventing occurrence of PONV while metoclopramide was least effective. Propofol was effective only in 50% of patients, thus not recommended for routine use.