格拉司琼与恩丹西酮预防顺铂所致呕吐的疗效及费用-效果分析

目的 :了解格拉司琼与恩丹西酮的费用 -效果比。方法 :对36例接受顺铂化疗的患者 ,采用随机自身对照的方法 ,比较国产格拉司琼与恩丹西酮的止吐效果和毒性 ,并进行费用 -效果分析。结果 :格拉司琼能有效预防顺铂所致的恶心、呕吐 ,其止吐效果与恩丹西酮相似。两药防治恶心平均有效率分别为75 9 %和77 8 % ;两药止吐平均有效率分别为79 7 %和75 0% ,疗效无统计学差异 ,毒副作用小。格拉司琼费用 -效果比优于恩丹西酮。结论 :盐酸格拉司琼为肿瘤化疗安全、有效、经济的止吐药物之一 ,值得推广应用。     

Current pharmacotherapy for chemotherapy-induced nausea and vomiting in cancer patients

Introduction: Nausea and vomiting are two of the most frequent and troubling side effects patients experience during chemotherapy, interfering with compliance with cancer therapies and quality of life. While newly available treatments have improved our ability to manage nausea and vomiting, anticipatory and delayed nausea and vomiting are still major problems for patients receiving chemotherapy. Many cancer patients consider delaying future chemotherapy cycles and some contemplate stopping chemotherapy altogether because of their fear of experiencing further nausea and vomiting.

Areas covered: The purpose of this article is to provide an overview of the pathopsychophysiology of chemotherapy-induced nausea and vomiting (CINV), the recommended guidelines for treatment, and current agents in late-stage clinical trials, and future research needs to address the continued challenges of treatment-related nausea and vomiting.

Expert opinion: Despite advances in pharmaceutical and behavioral therapies, and the provision of standard clinical guidelines for effectively managing CINV, patients continue to experience it. Moreover, control of nausea, acute and delayed, and anticipatory nausea and vomiting remains an important, unmet need among cancer patients. It is critical to focus attention on better understanding the mechanisms underlying nausea, anticipatory symptoms and delayed symptoms.     

昂丹司琼对比托烷司琼预防上腹部分割放疗所致恶心呕吐的临床研究

目的 比较昂丹司琼和托烷司琼预防上腹部分割放疗所致恶心呕吐的有效性与安全性。方法 选择84例接受上腹部分割放疗的肿瘤患者为研究对象,采用随机数字表法分为昂丹司琼组（O组）和托烷司琼组（T组）,每组42例。记录两组患者放疗期间恶心呕吐及其他不良反应的发生情况。结果 O组急性期恶心的完全缓解（CR）率显著低于T组（81.0% vs. 57.1%, P=0.018）;两组延迟期和全期恶心的CR率（61.9% vs. 50.0%, P=0.272; 61.9% vs. 45.2%, P=0.126）比较,差异无统计学意义。两组急性期、延迟期及全期呕吐的CR率（71.4% vs. 64.3%, P=0.483; 59.5% vs. 57.1%, P=0.825; 66.7% vs. 57.1%, P=0.369）比较,差异均无统计学意义。两组头晕、头痛、疲乏、腹泻和便秘的发生率比较,差异均无统计学意义（P>0.05）。结论 昂丹司琼和托烷司琼预防上腹部分割放疗所致恶心呕吐具有相似的疗效和安全性,昂丹司琼预防急性恶心的效果优于托烷司琼。     

Ondansetron antiemetic therapy for chemotherapy and radiotherapy induced vomiting in children.

AIM: To evaluate ondansetron as the sole antiemetic in children treated with emetogenic chemotherapy and irradiation. METHODS: Fifteen children aged 3-11 years were studied. Seven had acute lymphoblastic leukaemia, two acute myeloid leukaemia, two lymphoma and four had other tumours. Ondansetron 5 mg/m2 IV or 4 mg by mouth was given immediately before chemotherapy or radiation treatment and continued eight hourly for 24 hours. Nausea and vomiting was assessed during treatment and for the next 48 hours, and graded using WHO criteria. RESULTS: Thirty-eight courses of chemotherapy were assessed, 27 severely emetogenic and 11 moderately emetogenic. Two included total body irradiation. The most severe nausea and vomiting was grade 2 (transient vomiting) reported in six children. Nausea and vomiting was abolished on subsequent courses in four of these children by increasing the ondansetron dose frequency to six hourly. The remaining children experienced no nausea or vomiting (n = 7) or only nausea (n = 2). Nausea and vomiting were each completely controlled in 27 courses. CONCLUSIONS: Ondansetron is a cost effective and safe antiemetic in children receiving chemotherapy and total body irradiation, minimises weight loss on treatment and enables outpatient chemotherapy in some cases.     

Randomised clinical trial: ghrelin agonist TZP-101 relieves gastroparesis associated with severe nausea and vomiting--randomised clinical study subset data

Aliment Pharmacol Ther 2011; 33: 679–688

Summary

Background Limited therapeutic options exist for severe gastroparesis, where severe nausea and vomiting can lead to weight loss, dehydration and malnutrition due to inadequate caloric and fluid intake. TZP‐101 (ulimorelin) is a ghrelin receptor agonist that accelerates gastric emptying and improves upper gastrointestinal symptoms in diabetic patients with gastroparesis. Aim To assess effects of TZP‐101 in diabetic gastroparesis patients with severe nausea/vomiting and baseline severity scores of ≥3.5 (range: 0–5) on the Gastroparesis Cardinal Symptom Index (GCSI) Nausea/Vomiting subscale. Methods Patients were hospitalised and received four single daily 30‐min infusions of one of six TZP‐101 doses (range 20–600 μg/kg) or placebo. Efficacy was assessed by symptom improvement. Results At baseline, 23 patients had a mean severity score for GCSI Nausea/Vomiting of 4.45 ± 0.44. Statistically significant improvements over placebo occurred in the 80 μg/kg group for end of treatment changes from baseline in GCSI Nausea/Vomiting subscale (reduction in score of ?3.82 ± 0.76, P = 0.011) and the GCSI Total score (?3.14 ± 0.78, P = 0.016) and were maintained at the 30‐day follow‐up assessment (?2.02 ± 1.63, P = 0.073 and ?1.99 ± 1.33, P = 0.032 respectively). The proportion of days with vomiting was reduced significantly (P = 0.05) in the 80 μg/kg group (mean of 1.2 days of vomiting for four treatment days) compared with placebo (mean of 3.2 days of vomiting across 4 treatment days). Conclusions TZP‐101 substantially reduced the frequency and severity of nausea and vomiting as well as overall gastroparesis symptoms. The results are consistent with gastrointestinal motility effects of TZP‐101, supporting further investigation of TZP‐101 in the management of severe gastroparesis.

     

Intestinal obstruction in pregnancy by ondansetron

BackgroundOndansetron use for nausea and vomiting during pregnancy has increased in the last years, although its maternal and fetal safety is not conclusive.CaseWe describe a case of intestinal obstruction in a pregnant woman with severe nausea and vomiting of pregnancy treated with ondansetron, which is known to slow gut motility.ConclusionThe spontaneous reporting system of WHO confirms that this potentially life threatening complication is more common than what the peer review literature may suggest and needs to be looked into carefully, especially in view of the wide spread off-label use for NVP.     

Ondansetron. Therapeutic use as an antiemetic.

Ondansetron (GR 38032F) is a highly selective 5-HT3 receptor antagonist, one of a new class of compounds which may have several therapeutic applications. Animal and clinical studies show that ondansetron reduces the 24-hour incidence and severity of nausea and vomiting induced by cytotoxic drugs, including cisplatin, and by single exposure, high dose radiation. Ondansetron is more effective than high dose metoclopramide in the 24 hours following chemotherapy, and preliminary clinical evidence suggests that it is equally effective in the following 4 days. It is also more effective than the 'moderate' doses of metoclopramide used to suppress emesis following radiotherapy. The antiemetic efficacy of ondansetron is enhanced by dexamethasone in cisplatin-treated patients. Importantly, extrapyramidal effects have not been reported with ondansetron. Further comparisons are required with standard combination antiemetic therapy to complement the data presently available. Thus, ondansetron is a promising new agent for prophylaxis against nausea and vomiting in chemotherapy and radiotherapy. It may be particularly useful in young and elderly patients who are more susceptible to extrapyramidal symptoms induced by high dose metoclopramide. With its improved tolerability and clinical response profiles, ondansetron represents an important advance in a difficult area of therapeutics.     

Preventing postoperative nausea and vomiting: post hoc analysis of pooled data from two randomized active-controlled trials of aprepitant

ABSTRACT

Objective: Compared with the 5HT₃ antagonist ondansetron, the NK₁ antagonist aprepitant has been shown in two double-blind trials to provide greater protection against postoperative vomiting and comparable or greater control of nausea. Post hoc analyses of pooled data from these trials were performed to more fully characterize the efficacy profile of aprepitant in terms of nausea and use of rescue therapy.

Research design and methods: Patients (n = 1599) scheduled for major surgery under general anesthesia (primarily gynecological surgery) were assigned to receive a preoperative dose of aprepitant 40?mg PO, 125?mg PO, or ondansetron 4?mg IV. in two randomized, double-blind, clinical trials.

Main outcome measures: Post-surgery vomiting episodes, use of rescue therapy, and nausea severity (verbal rating scale).

Results: In the 24 hours after surgery, aprepitant 40?mg was more effective than ondansetron for all five endpoints evaluated: (1) no significant nausea (56.4% vs. 48.1%); (2) no nausea (39.6% vs. 33.1%); (3) no vomiting (86.7% vs. 72.4%); (4) no nausea and no vomiting (38.3% vs. 31.4%); and (5) no nausea, no vomiting, and no use of rescue (37.9% vs. 31.2%) (?p < 0.035 for the odds ratio for each comparison). Numerically more patients receiving aprepitant 125?mg also achieved these endpoints compared with ondansetron.

Conclusions: These post hoc analyses confirm the favorable efficacy profile of aprepitant for the prevention of postoperative nausea and vomiting.     

Efficacy,safety and effectiveness of ondansetron compared to other serotonin-3 receptor antagonists (5-HT3RAs) used to control chemotherapy-induced nausea and vomiting: systematic review and meta-analysis

Introduction: Chemotherapy-induced nausea and vomiting are adverse effects responsible for worsening quality of life in cancer patients. To assess the efficacy, safety and effectiveness of serotonin receptor antagonist in cancer patients undergoing chemotherapy, comparing ondansetron with granisetron, dolasetron, tropisetron and palonosetron.

Areas covered: Systematic review and meta-analysis. The data were collected using CINAHL; CENTRAL; MEDLINE/PubMed; and LILACS databases; grey literature; and manual search. The methodological quality was assessed using the modified Jadad scale; Cochrane Collaboration’s tool for assessing risk of bias in randomized clinical trials and the Newcastle-Ottawa Scale for observational studies. The search was completed in November, 2015. 26 studies were included in the meta-analysis. Ondansetron exhibited similar efficacy than granisetron and tropisetron, as well as greater efficacy than dolasetron for acute vomiting. Palonosetron exhibited greater efficacy than ondansetron for delayed nausea and acute and delayed vomiting. The comparison of granisetron with ondansetron in the cohort studies showed no difference.

Expert commentary: In this review, palonosetron had increased efficiency compared with ondansetron, except in the subgroup analysis and acute nausea. Few cohort studies have been published addressing this topic.     

3种止吐剂的临床疗效及费用—效果分析

目的：观察不同止吐剂对化疗所致恶心呕吐的临床效果。方法：93例患者,根据肿瘤部位不同,随机分为3组,分别给予昂丹司琼,格拉司琼与托烷司琼防治化疗药物所致的恶心、呕吐、用药物经济学的方法给予评价。结果：托烷司琼组与格拉司琼组,防治化疗所致恶心、呕吐效果较好。结论：托烷司琼与格拉司琼防治化疗所致恶心、呕吐、均优于昂丹司琼,但结合药物经济学的费用－效果分析,托烷司琼优于格拉司琼。