Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting over multiple cycles of moderately or highly emetogenic chemotherapy

ObjectiveRolapitant, a novel neurokinin-1 receptor antagonist (RA), was shown to protect against delayed chemotherapy-induced nausea and vomiting (CINV) during the first cycle of moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) in randomized, double-blind trials. This analysis explored the efficacy and safety of rolapitant in preventing CINV over multiple cycles of MEC or HEC.Patients and methodsPatients in one phase III MEC, one phase II HEC, and two phase III HEC clinical trials were randomized to receive oral rolapitant (180 mg) or placebo in combination with a 5-hydroxytryptamine type 3 RA and dexamethasone. Regardless of response in cycle 1, patients could continue the same antiemetic treatment for up to six cycles. On days 6−8 of each subsequent chemotherapy cycle, patients reported the incidence of emesis and/or nausea interfering with normal daily life. Post hoc analyses of pooled safety and efficacy data from the four trials were performed for cycles 2–6.ResultsSignificantly more patients receiving rolapitant than control reported no emesis or interfering nausea (combined measure) in cycles 2 (p = 0.006), 3 (p < 0.001), 4 (p = 0.001), and 5 (p = 0.021). Over cycles 1−6, time-to-first emesis was significantly longer with rolapitant than with control (p < 0.001). The incidence of treatment-related adverse events during cycles 2–6 was similar in rolapitant (5.5%) and control (6.8%) arms. No cumulative toxicity was observed.ConclusionsOver multiple cycles of MEC or HEC, rolapitant provided superior CINV protection and reduced emesis and nausea interfering with daily life compared with control and remained well tolerated.     

美国妇产科医师学会“妊娠期恶心呕吐指南2015版”要点解读

正妊娠期恶心、呕吐是一种影响孕妇及其胎儿健康的常见疾病。早孕期轻度的恶心、呕吐是一种生理性反应;中度(和)或重度或病情迁延(和)或加重的妊娠期恶心、呕吐,会严重影响孕妇的生活质量,乃至危及母胎生命安全,需及时诊治。美国妇产科医师学会(ACOG)近年来针对妊娠期呕吐,颁布了一系列指南,并提出一些与妊娠期恶心、呕吐诊治有关的新观念及循证医学证据。本文对2015年颁布的第153号《妊娠期恶心     

Economic and clinical burden of opioid-induced nausea and vomiting

Opioids are the standard of care for treating moderate-to-severe pain; however, their efficacy can be limited by adverse events (AEs), including nausea and vomiting. Opioid-induced nausea and vomiting (OINV) is an inherent adverse effect of opioid treatment, exerting effects centrally and peripherally. Opioid-related AEs can impact treatment adherence and discontinuation, which can result in inadequate pain management. OINV may persist long-term, negatively affecting patient functional outcomes, physical and mental health, patient satisfaction, and overall costs of treatment. Multiple factors may contribute to OINV, including activation of opioid receptors in the chemoreceptor trigger zone, vestibular apparatus, and gastrointestinal tract. Prophylactic or early treatment with antiemetics may be appropriate for patients who are at high risk for OINV.     

Reviewing current and emerging antiemetics for chemotherapy-induced nausea and vomiting prophylaxis

This review provides background information on chemotherapy-induced nausea and vomiting (CINV) classification and pathophysiology and reviews various antiemetic agents for CINV prophylaxis, including corticosteroids, serotonin receptor antagonists (5-HT₃ RAs), tachykinin NK₁ receptor antagonists (NK₁ RAs), and olanzapine. Other less commonly used agents are briefly discussed. Practical considerations are reviewed as well, including emetogenicity of chemotherapeutic regimens, patient-specific risk factors for CINV, principles of CINV management, health economics outcome research, and quality of life. Available data on the newly FDA-approved antiemetic combination netupitant/palonosetron (NEPA) is also reviewed. Prevention of CINV is an important goal in managing patients with cancer and is especially difficult with respect to nausea and delayed CINV. Corticosteroids are a mainstay of CINV prophylaxis and are usually given in combination with other therapies. The 5-HT₃ RA palonosetron has shown increased efficacy over other agents in the same class for prevention of delayed emesis with moderately emetogenic chemotherapy and NK₁ RAs improve emesis prevention in combination with 5-HT₃ RAs and dexamethasone. Olanzapine has shown efficacy for CINV prophylaxis and the treatment of breakthrough CINV. The new combination therapy, NEPA, has been shown to be efficacious for the prevention of acute, delayed, and overall CINV. Risk factors that have been identified for CINV include gender, age, and alcohol intake. It is important to assess the emetogenicity of chemotherapy regimens as well as the potential impact of patient risk factors in order to provide adequate prophylaxis. Acute and delayed CINV are severe, burdensome side effects of chemotherapy; however, new data on prevention and the discovery of new agents can further improve CINV control.     

耳穴贴压用于预防乳腺纤维瘤摘除术后呕吐疗效观察

目的评价耳穴贴压预防喉罩辅助通气全凭静脉麻醉下乳腺纤维瘤摘除术患者术后呕吐的效果。方法选择年龄40岁以下、ASA评分Ⅰ级、乳腺纤维瘤摘除术患者80例,随机分为A组和B组,每组40例。A组在麻醉复苏阶段患者唤醒后于耳廓相应穴位寻找敏感点,采用耳穴贴压治疗。B组不予任何处理。术后不同时间随访观察两组患者恶心、呕吐次数及BP、HR、SpO2等生命体征变化。结果两组患者术后4 h和24 h BP、HR、SpO2比较,差异均无统计学意义(P0.05);A组患者术后恶心、呕吐发生率低于B组,两组比较差异具有统计学意义(P0.01)。结论耳穴贴压具有良好的预防全凭静脉麻醉下乳腺纤维瘤摘除术患者术后恶心、呕吐的作用,且无明显不良反应。     

Tropisetron versus metoclopramide for the treatment of nausea and vomiting in the emergency department: A randomized,double‐blinded,clinical trial

Aim: We aimed to compare the relative efficacy of tropisetron and metoclopramide in treating nausea/vomiting in undifferentiated ED patients. Methods: We undertook a randomized, double‐blinded, clinical trial. Adult patients requiring treatment for nausea/vomiting were randomly assigned to either tropisetron (5 mg) or metoclopramide (10 mg), by i.v. bolus. The primary end‐point was incidence of vomiting. Secondary end‐points were decrease in nausea score from baseline (0–100 VAS), the requirement of ‘rescue’ anti‐emetics, ongoing nausea over 48 h and side‐effects. Results: Fifty patients were enrolled in each group. The demographic variables, presenting complaints and nausea scores at baseline did not differ (P > 0.05). By 180 min, two (4.0%) and nine (18.0%) patients had vomited in the tropisetron and metoclopramide groups respectively (difference 14.0%, 95% CI 0.1–28.0, P= 0.05). Also, there were two and 20 episodes of vomiting respectively. Vomiting rates were 0.02 and 0.16 episodes/person‐hour (difference 0.14 episodes/person‐hour, 95% CI 0.07–0.21, P < 0.001) respectively. By 60 min and thereafter, the decrease in nausea score from baseline was greater (although not significantly so) in the tropisetron group. At 180 min, the decreases were 47.9 mm and 37.0 mm respectively (difference 10.9 mm, 95% CI ?0.7–22.6). Five (10.0%) and 13 (26.0%) patients required a rescue anti‐emetic respectively (difference 16.0%, 95% CI ?0.7–32.7, P= 0.07). Of patients followed up, 13/47 (27.7%) and 20/49 (40.8%) had ongoing nausea respectively (difference 13.2%, 95% CI ?7.7–34.0, P= 0.25). The tropisetron group had less akathisia. Conclusions: Tropisetron was associated with a significantly lower vomiting rate and shows promise as an alternative anti‐emetic in the ED.