恩丹西酮加安定防治顺铂所致呕吐60例

目的 比较恩丹西酮加安定与恩丹西酮加地塞米松防治顺铂引起呕吐的疗效。方法 采用自身交叉随机对照方法，观察顺铂3d化疗期间（急性）及随后2d（延迟性）恶心呕吐发生的情况。结果 顺铂化疗中恩丹西酮加安定控制急性及延迟性恶心呕吐疗效与恩丹西酮加地塞米松的疗效相似，两组均有效，两组比较无显著差异。结论 恩丹西酮加安定能有效控制顺铂化疗所致的恶心呕吐反应，尤其适应于合并有糖皮质激素禁忌证的肿瘤患者，较恩丹西酮加地塞米松更具有临床应用前景。     

国产甲孕酮加强预防化疗消化道反应的效果比较

目的 :比较恩丹西酮、恩丹西酮 地塞米松、恩丹西酮 地塞米松 国产甲孕酮 (倍恩胶囊 )三种止吐方案预防化疗消化道反应的疗效。方法 :以中等剂量顺铂或阿霉素为主化疗的患者 90例 ,随机分成三组 ,每组 30例 ,分别使用上述止吐方案 ,观察其预防化疗消化道反应的效果。结果 :对于呕吐 ,单用恩丹西酮、恩丹西酮 地塞米松、恩丹西酮 地塞米松 倍恩胶囊三个方案的有效率相近 ,分别为 80 %、87%、90 % ;对于恶心 ,三个方案的有效率分别为 6 3%、80 %、90 % ,差别具有显著性 (χ2 =6 .3,P <0 0 5 ) ;对于食欲不振 ,三个方案的有效率分别为 17%、5 3%、80 % ,有极显著差异 (χ2 =2 4 .2 7,P <0 0 0 5 )。结论 :单独使用恩丹西酮不足以完全预防化疗消化道反应 ,加用地塞米松后效果有所提高 ,但以恩丹西酮 地塞米松 倍恩胶囊最好 ,特别是预防化疗恶心和食欲不振明显优于单用恩丹西酮或恩丹西酮 地塞米松     

雷莫司琼预防肺癌顺铂化疗所致恶心呕吐效果的随机对照临床研究

背景与目的顺铂对各种恶性肿瘤都有明显疗效,是肺癌联合化疗的常用药物。但它所引起的严重的恶心、呕吐成为临床应用顺铂的一个剂量限制因素。新一代止吐药物5-HT3受体拮抗剂雷莫司琼可以减轻顺铂化疗引起的恶心呕吐。为了观察雷莫司琼注射剂预防顺铂化疗所致恶心呕吐的临床疗效,我们进行了临床观察,并与恩丹西酮进行对照。方法采用随机平行对照方法,100例患者随机分为雷莫司琼组50例和恩丹西酮组50例。雷莫司琼0.3mg化疗前30min静脉冲入,恩丹西酮8mg化疗前15min和化疗结束时静脉冲入。结果雷莫司琼对顺铂所致恶心的控制率在第1~3天分别为82%、72%、84%,恩丹西酮分别为84%、70%、76%,两药疗效相似。雷莫司琼对呕吐控制的有效率在第1~3天分别为88%、86%、90%,恩丹西酮分别为80%、76%、86%,雷莫司琼对呕吐的有效率高于恩丹西酮,但无统计学上差异。两药不良反应的发生率相似。结论雷莫司琼能有效预防顺铂化疗引起的恶心呕吐,其疗效略优于恩丹西酮。     

格拉司琼与恩丹西酮防治食管癌术后化疗所致恶心呕吐的疗效对比

目的：比较格拉司琼与恩丹西酮防治食管癌术后患者化疗引起恶心、呕吐的作用及毒副反应。方法：回顾性研究439例食管癌术后化疗患者的临床资料，比较格拉司琼和恩丹西酮的治疗效果及毒副反应。结果：吻合VI位于颈部患者比位于胸内患者易发生恶心、呕吐。格拉司琼对化疗后急性（1d）恶心、呕吐有效率为81．6％，延迟性恶心呕吐（2—5d）的有效率分别为75．0％、64．2％、60．8％、56．1％。恩丹西酮对化疗后急性恶心、呕吐有效率为71．4％，延迟性恶心、呕吐的有效率分别为68．7％、57．7％、52．0％、47．1％，两组差异显著（P〈0．05），格拉司琼治疗效果优于恩丹西酮。两者不良反应基本相似。结论：格拉司琼对于防治食管癌术后患者化疗所致恶心、呕吐效果较好。     

恩丹西酮防治顺铂所致呕吐的疗效观察

目的:观察恩丹西酮对顺铂化疗所致呕吐的疗效。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:对急性呕吐止吐有效率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呕吐止吐有效率(P<0.05),但对迟发性呕吐,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。     

阿扎司琼与恩丹西酮预防化疗性恶心呕吐的对照研究

目的 :比较阿扎司琼和恩丹西酮对预防恶性肿瘤化疗性呕吐的临床疗效。方法 :35例患者分为阿扎司琼组(A组 )和恩丹西酮组 (B组 )。阿扎司琼组 13例 ,化疗前静脉推注阿扎司琼 10mg ,隔日应用 1次 ;恩丹西酮组 2 2例 ,化疗前静脉推注恩丹西酮 8mg,每日 1次。结果 :阿扎司琼和恩丹西酮止吐的总有效率相近 (76 9%和 72 7% ) ,两组对比无明显差异 (P>0 0 5 ) ;但完全控制率分别为 5 3 8%和 4 0 9% ,两组比较差异有显著性 (P <0 0 5 )。对平均呕吐次数和初次呕吐时间也进行了比较 ,阿扎司琼和恩丹西酮有显著性差异 (P <0 0 5 )。结论 :阿扎司琼是一种预防化疗所致恶心呕吐的高效药物 ,不良反应很轻     

胃复安联合苯海拉明预防顺铂所致迟发性呕吐38例

[目的]探讨胃复安联合苯海拉明在治疗以顺铂为主的化疗所致迟发性恶心、呕吐的临床疗效。[方法]70例患者在顺铂化疗前30min用恩丹西酮8mg静注预防急性呕吐,24h后随机分成两组,A组38例:用胃复安20mg联合苯海拉明25mg肌注,连用3d;B组32例:继续用恩丹西酮8mg静注,连用3d。[结果]A组迟发性恶心、呕吐完全控制率(CR)分别为10.5%、52.6%,基本控制率(CR PR)为73.7%、86.8%。B组迟发性恶心、呕吐完全控制率(CR)分别为15.6%、50.0%,基本控制率(CR PR)为71.9%、81.3%。两组比较无显著性差异(P>0.05)。[结论]胃复安联合苯海拉明在治疗顺铂所致迟发性恶心、呕吐中疗效与恩丹西酮相当,但前者较后者明显价廉。     

恩丹西酮与灭吐灵加地塞米松控制化疗所致恶心呕吐的临床观察

目的对照观察恩丹西酮预防化疗所致急性及延迟性恶心呕吐的作用，比较其对含顺铂方案和5-氟尿嘧啶 醛氢叶酸方案的止吐作用。方法采用自身交叉随机对照方法，观察化疗后24小时(急性)及5日内(延迟性)恶心呕吐发生的情况。结果大剂量顺铂化疗中恩丹西酮控制急性及延迟性恶心呕吐疗效明显好于对照组，而5-氟尿嘧啶 醛氢叶酸方案化疗中两组结果无显著差异。结论恩丹西酮能有效控制化疗所引起的恶心呕吐反应，在用顺铂时疗效尤为突出，5-氟尿嘧啶 醛氢叶酸化疗则可考虑用较经济的灭吐灵加地塞米松处理。     

帕洛诺司琼和恩丹西酮预防化疗诱发恶心呕吐的临床对比研究

目的:对比观察帕洛诺司琼和恩丹西酮预防化疗诱发恶心和呕吐的作用及其不良反应。方法:采用随机自身对照方法对36例接受中～高度致吐化疗药物的恶性肿瘤患者使用帕洛诺司琼进行止吐治疗,并与恩丹西酮作对照,于化疗第1个周期或第2个周期使用帕洛诺司琼止吐,同一患者于另1个周期使用恩丹西酮作自身对照。结果:帕洛诺司琼于急性呕吐期(化疗后24h内)止吐完全有效率为94.4%,恩丹西酮组为83.3%,帕洛诺司琼控制急性呕吐的疗效优于恩丹西酮,但两组比较差异无统计学意义,P>0.05。帕洛诺司琼于延迟呕吐期(化疗后d2～d5)止吐的有效率(完全有效率+部分有效率)均高于恩丹西酮,但两组差异均无统计学意义,P>0.05。帕洛诺司琼的不良反应主要为头痛和便秘,与恩丹西酮比较,两组主要不良反应发生率差异无统计学意义,P>0.05。结论:帕洛诺司琼能有效预防中、高度致吐化疗药物所致的恶心和呕吐反应,对于急性和延迟性呕吐反应相比恩丹西酮有较好疗效。     

Anti-emetic effect and safety of ondansetron tablet in double-blind comparison with placebo]

Ondansetron, a selective 5-HT3 receptor antagonist, has already been reported to have a marked effect to alleviate or prevent nausea and vomiting associated with cancer chemotherapy, after its intravenous administration. The present study was planned to examine the usefulness of its tablet form, which was prepared for the convenient use in outpatients receiving chemotherapy. In order to make an objective evaluation of anti-emetic effect and safety of ondansetron 4 mg tablet, this study was conducted in double-blind comparison versus placebo in patients receiving cisplatin at a single dose of 50mg/m2 or higher. Either 4 mg of ondansetron or placebo (lactose tablet) was administered orally once at 2 hrs prior to administration of cisplatin. If any satisfactory anti-emetic effects were not obtained, 4 mg of ondansetron injection was given once intravenously as a rescue medication. The inhibitory effect on nausea and vomiting was assessed in 4 grades as "excellent", "good", "fair" and "poor" based on severity of nausea and number of vomiting that occurred during the first 24hrs after administration of cisplatin. When rescue medication was conducted, the case was assessed as "poor". Ondansetron was significantly superior to placebo in inhibition of nausea and vomiting, in which efficacy rates (excellent+good) of ondansetron and placebo groups were 58.1% (25/43 cases) and 16.7% (7/42 cases), respectively. Number of cases requiring rescue medication with ondansetron injection was obviously greater in placebo group (31 cases) than that in ondansetron group (12 cases). In those patients given ondansetron injection as the rescue medication, satisfactory effects were obtained in 5 cases in ondansetron group and in 18 cases in placebo group. Although side effects including chest itching (ondansetron group), headache and dull headache (placebo group) were observed after the rescue medication with ondansetron injection, these symptoms were not severe and disappeared after 1-2 days. As mentioned above, ondansetron tablet was shown to possess excellent anti-emetic effect on nausea and emesis induced by high dose of cisplatin and to have no problem in safety. Hence ondansetron was proven to be clinically very useful anti-emetic.     

Evaluation of the anti-emetic effectiveness of two drug formulations of Ondansetron in combined chemotherapy for children with malignant tumors]

A double-blind randomized comparison (protocol S3AB4003, Glaxo Wellcome, Great Britain) carried out in a group of 52 children showed that the 5-HT3-receptor antagonist ondansetron (in syrup) effectively prevented vomiting, nausea and loss of appetite caused in combination chemotherapy with highly- or moderately emetogenic cytostatic drugs in 92.3; 69.3 and 81.0%, respectively. Treatment was given to patients who were on dexamethasone. With intravenous injection of ondansetron plus dexamethasone, per os, said indices were 88.5; 73.2%; 73.2%, respectively, thus showing no significant differences. No side-effects were observed with either regimen.     

Oral Ondansetron 8 mg Twice Daily is as Effective as 8 mg Three Times Daily in the Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

The efficacy and safety of ondansetron 8 mg BID compared with 8 mg TID for 3 days in the prevention of nausea and vomiting in 402 patients on cyclophosphamide (≧500 mg/m²)-based chemotherapy were evaluated in a multicenter, randomized, double-blind, stratified study. The percentage of patients with no emetic episodes over the 3-day study period was 61% in the ondansetron BID group compared with 58% in the ondansetron TID group. Among patients with at least one emetic episode, the mean time to emesis was 14 hr and 17 min in the ondansetron BID group compared with 12 hr and 48 min in the ondansetron TID group. Patients' daily appetite ratings and nausea scores were not significantly different between groups. Clinical laboratory and adverse event profiles were similar between groups. This study is the first large-scale, double-blind trial to demonstrate that ondansetron 8 mg BID for 3 days, a dosing regimen that may enhance patient convenience and compliance, is as effective as ondansetron 8 mg TID for 3 days in the prevention of nausea and vomiting associated with cyclophosphamide-based chemotherapy.     

A multicentre, double-blind, randomised trial comparing ondansetron versus ondansetron plus dexamethasone in the prophylaxis of cisplatin-induced delayed emesis

The aim was to compare the efficacy of ondansetron and a combination of ondansetron plus dexamethasone in the prophylaxis of cisplatin-induced delayed emesis over three consecutive courses of chemotherapy. Cancer patients scheduled to receive for the first time cisplatin (>50 mg/m(2)) in combination with other cytotoxic agents, were recruited in a multicentre, randomised, double-blind study and treated with ondansetron 8 mg i.v. and dexamethasone 20 mg i.v. Twenty-four hours after the start of chemotherapy, patients were randomised to treatment either with oral ondansetron 8 mg bd plus placebo on days 2-5 (group A) or with oral ondansetron 8 mg bd plus oral dexamethasone 8 mg bd on days 2-3, and 4 mg bd on days 4 and 5 (group B). Two hundred and thirty-six cancer patients were recruited into the study. Complete protection from delayed vomiting/nausea in group A and group B was Obtained in 50/39% and in 63/42% of patients, respectively in the first course; in 55/34% and in 64/40% in the second and in 49/31% and 60/37% in the third. Logistic regression analysis reveals a statistically significant difference in incidence of emesis between the combination of ondansetron plus dexamethasone and ondansetron alone (P<0.05). The same model, however, shows no difference in incidence of nausea between the two treatment regimens. Ondansetron plus dexamethasone reduces the risk of delayed emesis following cisplatin chemotherapy as compared to ondansetron alone.     

奥氮平预防高致吐性化疗方案致恶心呕吐的临床观察

目的评价奥氮平预防含顺铂、表阿霉素的高致吐性化疗方案所致恶心呕吐(CINV)的有效性和安全性。方法对符合纳入标准的52例恶性肿瘤患者应用高致吐性方案化疗2个周期,随机交叉应用A→B方案或B→A方案进行预防性止呕处理。A方案(空白对照组):盐酸帕洛诺司琼0.25 mg d_1+地塞米松10 mg d_1~d_3,静推;B方案(奥氮平组):A方案基础上,加用奥氮平10 mg d_(-1)~d_5,睡前口服。主要研究指标为患者化疗后5天内急性(0~24 h)及延迟性(25~120 h)恶心、呕吐的完全缓解(CR)率,同时评估奥氮平治疗的安全性。结果最终完成2个周期化疗并可评价疗效的患者共50例,脱落2例。奥氮平组与空白对照组比较,在急性恶心(88.0%vs.52.0%,P<0.05)、延迟性恶心(72.0%vs.20.0%,P<0.05)、延迟性呕吐(86.0%vs.64.0%,P<0.05)方面CR率更高的,而在急性呕吐方面两组CR率的差异无统计学意义(94.0%vs.86.0%,P>0.05)。奥氮平止呕相关不良反应包括头晕、嗜睡、口干、疲劳、便秘、直立性低血压等,均少见且程度较轻,组间差异无统计学意义(P>0.05)。结论在盐酸帕洛诺司琼和地塞米松的基础上,加入奥氮平可以有效地提高高致吐性化疗方案致急性恶心、延迟性恶心与呕吐的疗效,且安全性较好。     

Comparison of granisetron, ondansetron and tropisetron for control of vomiting and nausea induced by cisplatin

Severe nausea and vomiting are common and one of the most feared side effects of cisplatin-based chemotherapy. A total of 106 patients were randomized to receive a single dose of 8 mg ondansetron or 3 mg granisetron or 5 mg tropisetron intravenously as prevention of cisplatin-induced acute nausea and vomiting. Antiemetic therapy was done within 30 minutes before initiating chemotherapy. A questionnaire evaluating nausea, vomiting and retches was administered to patients and the responses were categorized as complete, partial or failure. The response determination was repeated in the first 24 hours, and within 24-72 hours following cisplatin administration. The complete response rates for ondansetron, granisetron and tropisetron in the first 24 hours were 51.4%, 65.7% and 61.1% respectively. All three agents were highly effective against cisplatin-induced acute and late vomiting and the results were statistically significant. This study demonstrated no significant difference in effectiveness of these three antiemetics. 5-HT3 (5-hydroxytryptamine 3) receptor antagonists have similar efficacy in the prevention of nausea and vomiting due to cisplatin. Thus, we recommend that drug choice be based on cost-benefit and patient tolerance.     

Antagonism of serotonin S3 receptors with ondansetron prevents nausea and emesis induced by cyclophosphamide-containing chemotherapy regimens

The control of nausea and emesis in cancer patients receiving chemotherapy poses a significant management problem. In this randomized, double-blind, placebo-controlled study, we evaluated the effect of serotonin S3 receptor blockade with ondansetron (GR 38032F) on the prevention of nausea and vomiting induced by cyclophosphamide-containing chemotherapy. Cyclophosphamide was given in doses of 500 to 600 mg/m2 and ondansetron as three intravenous (IV) doses of 0.15 mg/kg. Most patients had breast cancer. Cyclophosphamide was given in combination with doxorubicin (65% of patients) or with fluorouracil (85% of patients: 50% with Adriamycin [doxorubicin; Adria Laboratories, Columbus, OH] and 35% with methotrexate). All placebo-treated patients experienced vomiting, whereas 70% of patients treated with ondansetron did not vomit (P = .008). Median nausea scores were 8 mm on ondansetron and 65 mm on placebo (P less than .001). Seventy percent of patients treated with ondansetron retained their normal appetite, compared with 10% of placebo patients. Adverse events occurred in six placebo patients and one ondansetron patient. Diarrhea and headache were the most common events, both occurring more frequently in the placebo group. There were no extrapyramidal reactions, and the only significant biochemical change occurred in a placebo-treated patient. These results suggest that serotonin S3 receptor antagonists represent a novel, effective, and safe mode of therapy for nausea and emesis induced by cyclophosphamide-containing chemotherapies. In addition, our observations are compatible with the view that serotonin, acting on S3 receptors, mediates the nausea and emesis occurring after cyclophosphamide chemotherapy.     

中西医结合治疗老年肿瘤化疗患者消化道素毒副反应的疗效观察

目的:观察足三里穴位注射及中药涌泉穴贴敷联合西药止吐药对老年肿瘤患者化疗引起的消化道毒副反应的临床疗效。方法:将120例确诊为老年肿瘤患者随机分为对照组60例，化疗前盐酸托烷司琼注射液滴注；治疗组60例在对照组基础上给予足三里穴位注射用甲氧氯普胺穴位注射及中药涌泉穴贴敷。结果:对照组和治疗组恶心呕吐Ⅰ-Ⅱ级发生率为60%和80%，P>0.05，两组之间无统计学差异，Ⅲ-Ⅳ级发生率为40%和20%，差异有统计学意义（P<0.05），其中急性呕吐发生率为41.7%和63.3%，迟发性呕吐发生率为36.7%和6.7%，预期性呕吐发生率为5%和0，差异有统计学意义（P<0.05）；对照组和治疗组恶心呕吐治疗总有效率（CR+PR)为61.7%和85%，差异有统计学意义（P<0.05）；其它毒副反应以头晕、头痛、口干、纳呆、腹部不适、便秘、焦虑、腹泻为主，两组经统计学处理，差异有统计学意义（P<0.05），尤其在腹部不适、便秘、焦虑、纳呆症状上有显著的差异性（P<0.01）。结论:足三里穴位注射及中药涌泉穴贴敷联合西药止吐药能有效减轻老年肿瘤患者化疗引起的消化道毒副反应，提高其化疗耐受性及生活质量，值得临床广泛应用。     

Effect of acupuncture compared with placebo-acupuncture at P6 as additional antiemetic prophylaxis in high-dose chemotherapy and autologous peripheral blood stem cell transplantation: a randomized controlled single-blind trial.

PURPOSE: The purpose is to investigate an additional antiemetic effect to ondansetron with needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture in patients undergoing high-dose chemotherapy and autologous peripheral blood stem cell transplantation. EXPERIMENTAL DESIGN: Eighty patients who were admitted to hospital for high-dose chemotherapy and autologous peripheral blood stem cell transplantation were included into a randomized placebo-controlled single-blind trial. The patients were randomized to receive acupuncture (n = 41) or noninvasive placebo acupuncture (n = 39) at the acupuncture point P6 30 min before first application of high-dose chemotherapy and the day after. All patients received 8 mg ondansetron/day i.v. as basic antiemetic prophylaxis. The main outcome measure was the rate of patients who either had at least one episode of vomiting or required any additional antiemetic drugs on the first 2 days of chemotherapy. RESULTS: The main outcome measure showed no significant difference (P = 0.82): 61% failure in the acupuncture group and 64% in the placebo acupuncture group (95% confidence interval of 3% difference: -18.1 and 24.3%). Comparing nausea, episodes of vomiting or retching and number of additionally required antiemetic drugs did not provide any discrepancy with the main result. CONCLUSIONS: This study suggests that in combination with ondansetron i.v., invasive needle acupuncture at P6 compared with nonskin-penetrating placebo acupuncture has no additional effect for the prevention of acute nausea and vomiting in high-dose chemotherapy.     

Comparison of Granisetron,Ondansetron and Tropisetron for Control of Vomiting and Nausea Induced by Cisplatin

Abstract

Severe nausea and vomiting are common and one of the most feared side effects of cisplatin-based chemotherapy. A total of 106 patients were randomized to receive a single dose of 8 mg ondansetron or 3 mg granisetron or 5 mg tropisetron intravenously as prevention of cisplatin-induced acute nausea and vomiting. Antiemetic therapy was done within 30 minutes before initiating chemotherapy. A questionnaire evaluating nausea, vomiting and retches was administered to patients and the responses were categorized as complete, partial or failure. The response determination was repeated in the first 24 hours, and within 24-72 hours following cisplatin administration.

The complete response rates for ondansetron, granisetron and tropisetron in the first 24 hours were 51.4%, 65.7% and 61.1% respectively. All three agents were highly effective against cisplatin-induced acute and late vomiting and the results were statistically significant. This study demonstrated no significant difference in effectiveness of these three antiemetics. 5-HT3 (5-hydrox-ytryptamine 3) receptor antagonists have similar efficacy in the prevention of nausea and vomiting due to cisplatin. Thus, we recommend that drug choice be based on cost-benefit and patient tolerance.