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。     

单剂量康泉与枢复宁预防腹腔内化疗所致胃肠道反应的疗效比较

采用随机自身对比方法观察３６例应用和单剂量康泉（３ｍｇ）和单剂量枢复宁（８ｍｇ）预防腹腔内化疗所致胃肠道反应的效果。二者均在化疗前３０分钟静注一次，化疗方法均为ＰＤＤ６０－８０ｍｇ、５－Ｆｕ１０００－１５００ｍｇ、地塞米松１０－２０ｍｇ，一次腹腔内灌注。结果：康泉及枢复宁控制急性恶心有效率分别为９７．２％和９７．２％，没有差别（Ｐ＞０．０５），迟发性恶心ｄ２～ｄ５分别为９７．２％～１００．０％和９４．４％～１００．０％，亦无差别（Ｐ＞０．０５）；控制急性呕吐有效率分别为９７．２％和１００．０％，没有差别（Ｐ＞０．０５），迟发性呕吐ｄ２～ｄ５分别为９４．４％～１００．０％和９７．２％～１００．０％，亦无差别（Ｐ＞０．０５）；对改善进食各天均无差别。迟发性恶心发生率二者均为１１．１％，迟发性呕吐均为１３．９％。二者不良反应总发生率分别为３３．３％和３８．９％。结果显示单剂量康泉及枢复宁化疗前一次应用对预防腹腔化疗所致胃肠道反应的疗效均较好，且二者疗效及不良反应没有差别。     

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     

诱导睡眠后化疗预防含顺铂方案所致呕吐的疗效观察

目的了解睡眠后化疗对呕吐的预防作用。方法化疗前预防性使用恩丹西酮或胃复安的同时,分别选用安定或氯丙嗪或复方氯丙嗪注射液肌注。结果实验组总有效率为９３．５％,对照组为５２．７％（Ｐ＜０．００１）。实验组中恩丹西酮和胃复安的有效率分别为９６．７％和９０．６％（Ｐ＞０．０５）;对照组分别为８０．７％和４１．５％（Ｐ＜０．０１）。两组中胃复安的有效率比较差异显著（Ｐ＜０．０１）。逐日疗效比较中,两组第１～３天疗效差异显著（Ｐ＜０．０１）。结论诱导睡眠后化疗对含顺铂方案所致呕吐有预防作用。     

诱导睡眠后化疗预防含顺铂方案所致呕吐的疗效观察

目的 了解睡眠后化疗对呕吐的预防作用。方法 化疗前预防性使用恩丹西酮或胃复安的同时，分别选用安定或氯丙嗪或复方氯丙嗪注射液肌注。结果 实验组总有效率为９３．５％，对照组为５２．７％（Ｐ〈０．００１）。实验组中恩丹西酮和胃复安的有效率分别为９６．７％和９０．６％（Ｐ〉０．０５），对照组分别为８０．７％和４１．５％（Ｐ〈０．０１）。两组中胃复安的有效率比较差异显著（Ｐ〈０．０１），逐日疗效比较中，两组     

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。     

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。     

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）．     

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.     

盐酸格拉司琼止吐疗效的评价

目的　观察盐酸格拉司琼止吐效果和毒性。方法　对 60例接受化疗的肿瘤患者 ,采用随机自身对照的方法 ,比较盐酸格拉司琼和恩丹西酮的疗效和毒性。结果　格拉司琼和恩丹西酮止吐有效率分别为 81.7%和 73 .3 % ,完全缓解率分别为 65 .0 %和 5 8.3 %。两者的疗效无统计学差异 ,毒副反应均较小。结论　盐酸格拉司琼是一种安全、有效的化疗止吐药。     

Ondansetron versus granisetron, both combined with dexamethasone, in the prevention of cisplatin-induced emesis: Italian Group for Antiemetic Research

Background: Differences in pharmacodynamic and pharma-cokineticcharacteristics among serotonin-receptor antagonists have beenreported in preclinical studies. This prompted us to carry outa study to determine whether such differences are importantin terms of clinical efficacy or tolerability Patients and methods: 973 consecutive cancer patients scheduledto receive cisplatin for the first time (at doses > 50 mg²),entered a double-blind multicenter randomized study comparingintravenous ondansetron 8 mg versus granisetron 3 mg. Dexamethasone20 mg was added to both serotonin antagonists. On days 2 to4 after chemotherapy all patients received oral metoclopramideplus intramuscular dexamethasone as antiemetic prophylaxis fordelayed emesis. Nausea and vomiting were assessed daily untilday 6 after chemotherapy Results: We evaluated 966 patients (483 receiving ondansetronand 483 granisetron). Complete protection from acute vomiting/nauseawas obtained in 79.3%/72.0% of patients receiving ondansetronand in 79.9%/71.8% of those receiving granisetron. Completeprotection from delayed vomiting\nausea was obtained in 69.7%/52.9%and 70.0%/ 49.6% of patients receiving the ondansetron or granisetronregimens, respectively. Adverse effects were mild and not significantlydifferent between the two antiemetic regimens Conclusions: Ondansetron 8 mg and granisetron 3 mg, both combinedwith dexamethasone, showed similar efficacy and tolerabilityin the prevention of cisplatin-induced emesis. The choice betweenthe two regimens can be dictated by their respective purchaseprices antiemetics, cisplatin, dexamethasone, granisetron, ondansetron     

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。     

格拉司琼对恶性肿瘤化疗所致恶心、呕吐的疗效观察

目的：探讨格拉司琼和昂丹司琼防治恶性肿瘤化疗所致恶心、呕吐的疗效和安全性。方法：采用随机对照的研究方法,124例患者分为格拉司琼组（治疗组）64例,昂丹司琼组（对照组）60例。结果：格拉司琼组总有效率96．88％（62／64）;昂丹司琼组为80．00％（48／60）,差异有统计学意义（P〈0．01）。而两组不良反应差异无统计学意义（P〉0．05）。结论：格拉司琼防治恶性肿瘤化疗所致恶心、呕吐具有高效、安全的优点。     

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。     

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。     

Ondansetron versus metoclopramide in the prevention of chemotherapy-induced nausea and vomiting - a metaanalysis

Nausea and vomiting remain important clinical problems occuring in 25 to 50% of patients receiving chemotherapy for cancer. Clinical trials comparing a new antiemetic drug, ondansetron, to metoclopramide have suggested improved control of nausea and vomiting but studies disagree on the magnitude of the treatment effect and its statistical significance. We combined evidence from randomized controlled trials in a meta-analysis of the efficacy and safety of ondansetron compared to metoclopramide in the prevention of acute (less-than-or-equal-to 24 hours) nausea and emesis associated with chemotherapy. Literature search identified six randomised controlled trials of ondansetron versus metoclopramide in an adult population. Study outcomes were the observed incidence of emesis (vomiting or retching) and patient-reponed grades of nausea after chemotherapy. For meta-analysis of each outcome we defined therapeutic success as complete protection (ie. zero episodes during 24 hours following chemotherapy). The relative odds of success (ondansetron/metoclopramide) was calculated for each trial and all trials combined. Results were expressed as a relative risk (RR) for zero emesis or nausea at 24 hours. The six trials reported on 705 patients (median age range 53-59 years; 57% female). Relative odds for complete control of emesis was greater than one in all trials but was nonsignificant (p>0.05) in two trials, including the largest trial. When trials were combined, summary odds ratios for control of emesis and nausea were greater than one (p<0.05). RR of zero emesis with ondansetron was 1.72 (95% CI 1.45 to 1.97) and was similar for nausea (RR= 1.78, 95% CI 1.39 to 2.13). In trials using high-dose cisplatin chemotherapy, higher rates of extrapyramidal affects and diarrhea were associated with metoclopramide (p<0.05) while headache was frequently associated with ondansetron (p<0.05). Combined clinical trial evidence supports the conclusion. that, relative to metoclopramide, ondansetron places patients at a much lower risk of nausea and emesis following chemotherapy with moderately or highly emetogenic regimens.     

Comparison of Ondansetron with Customary Treatment in the Prophylaxis of Nausea and Emesis Induced by Non-Cisplatin Containing Chemotherapy

One hundred cancer patients receiving non-cisplatin containing chemotherapy were entered in a prospective study in which the efficacy of ondansetron was compared with standard antiemetic treatments in the prophylaxis of nausea and emesis. During the first 24 h, 77% of patients on ondansetron reported complete control of emesis compared with 56% of those on customary treatments (p = 0.03). However, no statistically significant difference was observed between ondansetron and customary treatments in control of delayed emesis on days 2-5. Nor was any statistically significant difference seen between ondansetron and customary treatments in preventing acute or delayed nausea.