Comparison of the efficacy and side-effects of ondansetron and metoclopramide-diphenhydramine administered to control nausea and vomiting in children treated with antineoplastic chemotherapy: a prospective randomized study

Nausea and vomiting following antineoplastic therapy in patients receiving chemotherapy remains a problem. To prevent nausea and vomiting due to antineoplastic therapy, many types of drugs have been used. Ondansetron and the combination metoclopramide-diphenhydramine have been widely used in children. In this prospective randomized study these drugs were compared both for their efficacy and side-effects in children treated with antineoplastic chemotherapy (with and without cisplatin) the number of chemotherapy courses being equal in both groups. Ondansetron gave complete anti-emetic cover in five of nine courses in patients treated with cisplatin. Metoclopramide-diphenhydramine gave complete anti-emetic cover in one out of nine courses, and 17 out of 23 courses in patients treated without cisplatin. Metoclopramide-diphenhydramine produced side effects in nine courses whereas ondansetron produced side-effects in three courses. Conclusion Ondansetron appeared to be superior to metoclopramide-diphenhydramine in the control of emesis induced by chemotherapy regimens containing cisplatin. The results of the present prospective randomized study indicate that ondansetron is a useful anti-emetic in the treatment of chemotherapy-induced emesis. Received: 17 May 1996 / Accepted in revised form: 23 December 1997     

恩丹西酮（齐鲁）预防顺铂所致呕吐的：Ⅲ期临床研究

目的进一步确定恩丹西酮（齐鲁）的临床应用价值及改进的用药方案。方法多中心协作研究,观察单用恩丹西酮和恩丹西酮合并地塞米松对顺铂（每次３０ｍｇ～２００ｍｇ）所致呕吐的预防效果。结果３３０例接受恩丹西酮、４４３例接受恩丹西酮加地塞米松治疗。结果对急性恶心有效率分别为７３．３％和８０．８％,对急性呕吐有效率分别为８６．７％和９４．８％,第１天平均呕吐次数分别为０．９和０．５次,表明加用地塞米松可显著提高对急性恶心呕吐有效率。但对迟发性呕吐的疗效相似。此外,单用恩丹西酮８ｍｇ静脉注射也能取得疗效。结论该药对预防顺铂所致呕吐疗效突出,改进的方案用法简便,可减少用药次数,疗效好。     

昂丹司琼联合地塞米松对比昂丹司琼单药预防腹腔镜胆囊切除术后恶心呕吐的荟萃分析

目的:系统评价昂丹司琼联合地塞米松与昂丹司琼单药预防腹腔镜胆囊切除术(laparoscopic cholecystectomy,LC)术后恶心呕吐(postoperative nausea and vomiting,PONV)的疗效及安全性,以期为临床用药提供参考。方法:系统检索与筛选Cochrane Library、Pub Med、EMBASE、SCI、CNKI、维普、万方数据库中对比昂丹司琼单药与联合用药预防LC术后PONV的随机对照试验。使用Google学术、百度学术等搜索引擎进一步补充检索。按照纳入与排除标准纳入文献后,由两位作者独立进行质量评价、数据提取,交叉核对后,使用Rev Man 5.3软件统计分析,合并效应量中计数资料采用相对危险度(relative risk,RR)及95%可信区间(confidence interval,CI)描述。结果:纳入12项随机对照试验,共1 156例患者。Meta分析结果显示,相较昂丹司琼单药组,联合地塞米松用药组LC术后24 h内PONV发生率显著下降[RR=0.45,95%CI(0.35,0.57)]。依据药物用量行亚组分析时发现,4 mg、8 mg昂丹司琼联合用药组均可显著降低术后24 h PONV发生率,而在8 mg时较单药组可显著降低总的呕吐发生率[RR=0.40,95%CI(0.23,0.71)]。安全性方面,两组术后其他并发症发生率差异无统计学意义。结论:昂丹司琼联合地塞米松相较昂丹司琼单药能更好地预防LC术后的PONV,有效降低术后不适症状,同时临床应用时应注意昂丹司琼剂量的选择。     

Delivery of doxorubicin across the blood–brain barrier by ondansetron pretreatment: a study in vitro and in vivo

Doxorubicin (Dox) has got a limited efficacy in the treatment of central nervous system tumors because of its poor penetration through blood–brain barrier mediated by MDR efflux transporters. We investigated the possibility that ondansetron (Ond) enhances Dox cytotoxicity in cell lines interfering with P-glycoprotein and increases Dox concentration in rat brain tissues.     

Toxic Epidermal Necrolysis in Pregnancy due to Ondansetron with a Favorable Outcome: A Case Report and Review of the Literature

Toxic epidermal necrolysis (TEN) is an uncommon, life-threatening hypersensitivity drug reaction with a high mortality rate that involves the skin and mucous membranes. Most reported cases involving pregnant patients were seen in those with human immunodeficiency virus. Here, we discuss a 21-year-old Iranian woman who presented at 18 weeks’ gestation with extensive TEN following the administration of ondansetron with no any other risk factors.     

Combining ondansetron and naltrexone effectively treats biologically predisposed alcoholics: from hypotheses to preliminary clinical evidence

BACKGROUND: Individuals considered to be early onset alcoholics (EOA) are characterized by an early onset age, a broad range of antisocial behaviors, high familial loading, and presumed biological disease predisposition. Ondansetron, a 5-HT3 antagonist, improves drinking outcomes and increases abstinence rates among EOA. Individuals with high familial loading for developing alcoholism have lower levels of beta-endorphin and demonstrate a more pronounced increase in beta-endorphin levels in response to alcohol administration compared with individuals who do not have alcoholic relatives. The propensity for naltrexone (a mu opioid antagonist) to reduce alcohol's rewarding effects and drinking in humans is greatest in individuals with high familial loading. Predicated on the added knowledge that 5-HT3 receptors may themselves mediate alcohol reward via activation of the endogenous opioid system, we hypothesized that the combination of ondansetron and naltrexone would act synergistically and would be an effective treatment in EOA. METHODS: We conducted an 8-week double-blind placebo controlled clinical trial in which 20 EOA were randomized to receive ondansetron (4 microg/kg twice a day) + naltrexone (25 mg twice a day) or placebo as an adjunct to weekly standardized group Cognitive Behavioral Therapy. RESULTS: At endpoint, subjects who received ondansetron + naltrexone (n = 10), compared with those who received placebo (n = 10), had fewer drinks/day (covariate adjusted mean 0.99 +/- 0.60 vs. 3.68 +/- 0.63; F1, 16 = 9.35,p = 0.008; effect size = 1.42), drinks/drinking day (covariate adjusted mean 3.14 +/- 0.87 vs. 6.76 +/- 0.71; F1, 13 = 10.45, p = 0.007; effect size = 1.71), and a trend toward increased percent days abstinent (covariate adjusted mean 69.76 +/- 8.64 vs. 48.24 +/- 9.12; F1, 16 = 3.58, p = 0.08; effect size = 0.88). CONCLUSIONS: Ondansetron plus naltrexone seems to synergistically improve the drinking outcomes of EOA. Larger scale studies that test these medications, both alone and together, among various alcoholic subtypes are needed to establish and extend these promising findings.     

曲马多联合昂丹司琼预防剖宫产麻醉后寒颤的效果观察

目的：观察曲马多联合昂丹司琼预防蛛网膜下腔麻醉后寒颤的临床效果。方法将120例行剖宫产的产妇随机分为观察组A、观察组B和对照组。麻醉开始前,观察组A缓慢静脉注射曲马多1mg／kg,观察组B缓慢静脉注射曲马多1mg／kg＋昂丹司琼4mg,对照组给予生理盐水4ml。观察麻醉开始至手术结束4h内产妇寒颤、恶心呕吐、眩晕、低血压、呼吸抑制等不良反应情况和新生儿Apgar评分情况。结果观察组A和观察组B产妇寒颤发生率均低于对照组,差异均有统计学意义（P＜0．05）,观察组A恶心呕吐发生率高于观察组B和对照组,差异均有统计学意义（P＜0．05）,观察组B与对照组恶心呕吐发生率差异无统计学意义（P＞0．05）。3组均未发生眩晕、呼吸抑制等,且术中低血压发生率3组间差异无统计学意义（P＞0．05）,3组新生儿Apgar评分组间差异无统计学意义（P＞0．05）。结论曲马多联合昂丹司琼能有效预防蛛网膜下腔麻醉后的寒颤反应,且恶心呕吐的发生率较低。     

昂丹司琼不同时间及不同剂量给药在预防妇科腹腔镜手术PONV的临床效果

目的探讨昂丹司琼不同时间及不同剂量给药预防妇科腹腔镜手术术后恶心呕吐的临床效果。方法选择全麻下行妇科腔镜手术的患者100例为研究对象,分为四组,每组25例。第一组在麻醉诱导前5rain昂丹司琼8mg静脉注射;第二组手术结束时昂丹司琼8mg静脉注射;第三组麻醉诱导前5min昂丹司琼4mg静脉注射;第四组整个麻醉期间未使用任何抗呕吐药物。比较四组术后24h内恶心呕吐的发生率及程度。结果第一组、第二组、第三组无效例数显著低于第四组,差异均有统计学意义（P〈0．05）。结论昂丹司琼能有效降低术后恶心呕吐的发生率,且临床效果与不同时间和不同剂量无明显关系。