阿瑞匹坦联合托烷司琼预防顺铂化疗引起呕吐的临床观察

目的:观察阿瑞匹坦联合托烷司琼方案预防顺铂化疗引起呕吐的疗效及不良反应。方法:采用随机、自身交叉对照的方法,将60例接受两周期含顺铂联合化疗的患者,随机分为AB、BA组。AB组第1周期应用阿瑞匹坦联合托烷司琼,第2周期应用托烷司琼;BA组第1周期应用托烷司琼,第2周期应用阿瑞匹坦联合托烷司琼。结果:可评价疗效的59例患者中,阿瑞匹坦联合托烷司琼方案和托烷司琼方案对急性呕吐的完全缓解率分别为74.6%和57.6%,有效控制率分别为91.5%和81.4%(Z=-2.017,P=0.044);对延迟性呕吐的完全缓解率分别为69.5%和42.4%,有效控制率分别为86.4%和71.2%(Z=-3.112,P=0.002)。两种方案的主要不良反应为呃逆、便秘、头痛、头晕、口干等,不良反应发生率比较差异无统计学意义(P>0.05)。结论:阿瑞匹坦联合托烷司琼方案对顺铂化疗引起急性呕吐与延迟性呕吐均有很好的疗效,不良反应可以耐受。     

阿瑞吡坦联合昂丹司琼及地塞米松防治直肠癌患者术后化疗相关性恶心呕吐临床观察

摘 要 目的：探讨阿瑞吡坦联合昂丹司琼及地塞米松防治直肠癌患者术后mFOLFOX6方案化疗相关性恶心呕吐的临床疗效。方法：122例接受术后mFOLFOX6方案化疗的直肠癌患者随机分入观察组（阿瑞吡坦+昂丹司琼+地塞米松）和对照组（昂丹司琼+地塞米松）进行预防性止吐。记录患者恶心、呕吐及其他不良反应,并评估化疗相关性恶心呕吐对患者生活质量的影响。结果：观察组急性呕吐和延迟性呕吐控制有效率分别为80.0%和83.3%,均显著优于对照组（P<0.05）。两组恶心控制有效率差异无统计学意义（P >0.05）。观察组患者生活质量评分显著高于对照组（P＜0.01）,且观察组对生活质量产生负面影响的人数明显少于对照组（P＜0.01）。结论：阿瑞吡坦联合昂丹司琼及地塞米松对术后mFOLFOX6方案化疗的直肠癌患者发生呕吐的控制作用显著,同时能改善患者的生活质量,且未造成更多不良反应。     

阿瑞匹坦用于乳腺癌患者化疗的止吐效果观察

目的观察分析阿瑞匹坦用于乳腺癌患者化疗的止吐效果及安全性。方法选取我院经病理确诊的68例初诊化疗的乳腺癌患者,随机分为试验组及对照组。试验组34例,给予阿瑞匹坦联合托烷司琼、地塞米松;对照组给予安慰剂、格拉司琼、地塞米松,用药剂量及用法与试验组相同。观察两种治疗方案对化疗所致恶心、呕吐的疗效。结果 68例患者均纳入分析,阿瑞匹坦组患者完全缓解率明显优于对照组(61.8%vs.31.3%,P=0.029);阿瑞匹坦组与对照组的急性呕吐完全缓解率分别为85.3%和67.6%(P=0.086),呈降低趋势,但差异无统计学意义;阿瑞匹坦组迟发性呕吐的完全缓解率明显高于对照组(70.6%vs.44.1%,P=0.027),迟发性呕吐的发生率明显低于对照组(5.9%vs.29.4%,P=0.011)。本研究中未观察到阿瑞匹坦相关中重度不良反应,药物安全性良好。结论阿瑞匹坦对于乳腺癌化疗患者止吐效果良好,在迟发性呕吐的缓解方面尤其突出,且不良反应较轻,患者可耐受。     

阿瑞匹坦和托烷司琼及柠檬皮片联合使用防治卵巢癌化疗患者恶心呕吐的效果分析

目的：探讨阿瑞匹坦联合柠檬皮片和托烷司琼防治卵巢癌化疗患者恶心呕吐的效果。方法：选择2021年6月—2023年6月收治的卵巢癌化疗患者110例,随机分为对照组和观察组,每组55例。对照组给予托烷司琼注射液联合柠檬皮片闻味治疗,观察组在对照组基础上口服阿瑞匹坦,比较两组的化疗相关性恶心、呕吐的预防效果及用药不良反应。结果：治疗后,观察组患者的恶心预防有效率、急性呕吐预防有效率和延迟性呕吐预防有效率均高于对照组,差异有统计学意义(P<0.05);两组用药不良反应发生率比较,差异无统计学意义(P>0.05)。结论：阿瑞匹坦、托烷司琼及柠檬皮片联合使用可提高卵巢癌患者化疗期间恶心呕吐预防效果,改善患者化疗耐受性,且不会加重止吐药的不良反应。     

阿瑞匹坦在预防肺癌含铂化疗方案所致化疗相关性恶心呕吐的疗效研究

目的分析研讨阿瑞匹坦在预防肺癌含铂化疗方案所致化疗相关性恶心呕吐的疗效。方法随机抽取我院2015年9月~2017年10月期间收治的肺癌含铂化疗方案治疗而引发恶心呕吐患者80例,根据其所使用止吐药物进行分组,对照组40例接受地塞米松+托烷司琼治疗,研究组40例接受阿瑞匹坦+地塞米松+托烷司琼治疗,观察比较两组患者治疗疗效、不良反应,以及患者生活质量等。结果研究组治疗总有效率为90%高于对照组的72.50%,P0.05。研究组不良反应总发生率15%虽略低于对照组12.50%,P0.05。对比两组患者FLIE评分,治疗前P0.05,治疗后,研究组评分均高于对照组,P0.05。研究组首次呕吐时间晚于对照组,P0.05,表明阿瑞匹坦药物在预防化疗相关性恶心呕吐方面有应用价值。结论临床治疗肺癌含铂化疗而造成的恶心呕吐症状可在地塞米松联合托烷司琼治疗基础上,给予阿瑞匹坦药物,止吐效果更好,且可确保给药安全性,进而提升患者生活质量。     

两种止吐药物预防CINV的循证药物经济学评价

目的:采用循证方法对奥氮平与阿瑞匹坦联合5-HT_3拮抗剂和地塞米松预防化疗所致恶心呕吐(chemotherapy-induced nausea and vomiting, CINV)进行药物经济学评价。方法:计算机检索Pubmed、 Central、 Embase、CNKI、和Wanfang数据库,查找有关奥氮平与阿瑞匹坦比较其在CINV预防方面的随机对照试验(RCT),检索时限均为建库时间至2018年3月。同时手检相关期刊与会议论文。采用RevMan 5.3软件进行meta分析。结果:共纳入4个RCT,包括患者447例。有效性方面:两种预防方案的全程CINV缓解率相当(P>0.05),奥氮平组急性期呕吐缓解率(OR=1.87, 95%CI:1.08～3.27,P<0.05)、延迟期恶心控制率(OR=2.78, 95%CI:1.85～4.19),P<0.05)优于阿瑞匹坦组;安全性方面:阿瑞匹坦组患者呃逆症状发生率更高(RD=-0.20, 95%CI:-0.37～-0.03),P<0.05);经济性方面:奥氮平组成本明显低于阿瑞匹坦组,具有较大经济学优势。结论:奥氮平联合5-HT3拮抗剂和地塞米松三联止吐方案安全、有效、经济,适合临床推广。     

帕洛诺司琼不同给药频次预防大剂量顺铂化疗致胃肠道反应的临床观察

目的 探讨帕洛诺司琼不同给药频次预防大剂量顺铂化疗致胃肠道反应的临床疗效。方法 上海市奉贤区中心医院2010年4月—2014年1月收治的行大剂量顺铂化疗的恶性肿瘤患者,随机分为对照组（42例）和治疗组（42例）。对照组化疗第1天治疗前30 min静脉点滴盐酸帕洛诺司琼注射液0.25 mg/次;治疗组于化疗第1、3、5天治疗前30 min静脉点滴盐酸帕洛诺司琼注射液0.25 mg/次。所有患者仅观察1个化疗周期。比较两组患者呕吐、恶心、食欲减退的发生情况。结果 对照组急性期呕吐有效控制率为78.57%,治疗组为83.33%,两组比较差异无统计学意义;延迟期对照组呕吐有效控制率为52.38%,治疗组为61.90%,两组比较差异有统计学意义（P<0.01）。治疗后,急性期对照组恶心有效率为61.90%;治疗组有效率为76.19%;延迟期对照组恶心有效率为52.38%,治疗组为66.67%,两组比较差异有统计学意义（P<0.01）。急性期对照组食欲减退有效控制率为88.10%,治疗组为92.86%;延迟期对照组有效控制率为85.71%,治疗组为90.48%,两组比较差异无统计学意义。两组不良反应发生率比较差异无统计学意义。结论 对大剂量顺铂化疗致胃肠道反应可适当增加盐酸帕洛诺司琼用药频次进行预防,但应警惕增加不良反应的风险。     

不同疗程地塞米松联合阿瑞匹坦、托烷司琼预防蒽环类药物引起乳腺癌患者恶心及呕吐的临床研究

目的:探讨不同疗程的地塞米松联合5-HT3受体拮抗剂和NK-1受体拮抗剂对预防乳腺癌患者接受蒽环类药物和环磷酰胺化疗方案(AC或EC)引起高度恶心呕吐(CINV)的疗效。方法:采用前瞻性研究方法选择2018年1月1日-2018年6月30日接收AC或EC的乳腺癌患者84例,随机分为对照组48例(第1~3天受地塞米松10 mg),观察组36例(第1天接受地塞米松10 mg)。在整个研究期间通过患者研究日志记录其对治疗的反应。主要研究终点为完全缓解率(CR),次要研究终点包括急性期CR、延迟期CR;完全控制率(CC)、急性期CC、延迟期CC,以及这种止吐治疗的安全性。结果:2组患者均接受6个化疗周期,且其一般临床资料均无显著性学差异。观察组与对照组急性期及延迟期CINV的CR分别是(94.4%vs 87.5%,P>0.05),(88.9%vs 91.7%,P>0.05);CINV的总CR为(80.6%vs 81.3%,P>0.05);观察组与对照组急性期及延迟期CINV的CC分别是(55.6%vs 60.4%,P>0.05),(63.9%vs 68.8%,P>0.05);CINV的总CR为(47.2%vs 54.2%,P>0.05);且各组间无显著性差异。治疗期间2组不良反应均为轻度,观察组头痛,关节酸痛的发生率(8.3%)稍低于对照组(14.6%),有显著性差异(P<0.05);便秘及皮疹的发生率无显著性差异。且期间未出现与止吐方案相关的严重不良反应。结论:阿瑞匹坦及托烷司琼联合地塞米松(第1天)的预防性止吐作用可实现与地塞米松(第1~3天)相似的疗效,特别是对于延迟性化疗相关性恶心呕吐疗效更佳,且安全性更好,值得临床推广。     

阿瑞匹坦预防顺铂化疗所致恶心和呕吐的疗效分析

目的:为明确阿瑞匹坦在预防含顺铂的化疗方案所致的化疗相关性恶心呕吐的临床疗效。方法:选取我院2014年1月1日–2014年10月1日接受含顺铂(75 mg·m-2)化疗方案的患者100例,接受阿瑞匹坦、5-HT3受体拮抗剂和地塞米松的患者为阿瑞匹坦组,同期使用5-HT3受体拮抗剂和地塞米松的患者为对照组,观察两组患者急性期(第1天)、延迟期(第2~5天)完全有效率(CR)及化疗期间(5 d)无严重恶心呕吐的发生率。结果:阿瑞匹坦组与对照组治疗急性呕吐的CR分别为70%和54%(P=0.149);而治疗迟发性呕吐两组有效率分别为78%和46%(P=0.002),阿瑞匹坦组显著优于对照组。化疗期间阿瑞匹坦组与对照组患者无严重恶心呕吐的发生率分别为86%、62%(P=0.012),阿瑞匹坦组优于对照组。两组止吐药物相关不良反应无明显差异。结论:阿瑞匹坦三联方案在预防顺铂诱发恶心和呕吐的疗效及耐受性方面表现良好,为提高患者生活质量提供了较好的选择方式。     

阿瑞匹坦用于肺腺癌紫杉醇联合顺铂化疗引起恶心呕吐的临床研究

目的观察阿瑞匹坦在肺腺癌紫杉醇联合顺铂方案化疗中的急性期及延迟期止吐疗效和安全性。方法 50例肺腺癌患者,均接受紫杉醇联合顺铂的TP方案化疗,随机分为实验组及对照组,每组25例。对照组患者接受5-HT3受体拮抗剂托烷司琼、地塞米松预防止吐,实验组在对照组基础上联合应用阿瑞匹坦预防止吐。完成1个周期化疗后,评估两组患者在化疗后急性期及延迟期恶心呕吐情况及不良反应。结果 50例患者均按期完成1个周期的TP方案化疗,实验组和对照组急性恶心、呕吐完全缓解率(CR)分别为44%和32%(χ~2=0.764,P>0.05),有效率(RR)分别为80%和72%(χ~2=0.439,P>0.05),差异无统计学意义。实验组和对照组延迟性恶心呕吐CR分别为52%和24%(χ~2=4.160,P<0.05),RR分别为76%和44%(χ~2=5.333,P<0.05),差异有统计学意义。两组患者不良反应主要包括头晕、乏力、呃逆、腹胀、便秘,均为轻度,差异无统计学意义。结论阿瑞匹坦联合托烷司琼、地塞米松方案预防肺腺癌紫杉醇联合顺铂化疗引起的急性期及延迟期恶心呕吐疗效确切,安全性高,值得临床进一步应用推广。     

Safety profile of HTX-019 administered as an intravenous push in cancer patients: a retrospective review

ABSTRACT

Objectives: HTX-019 (Cinvanti®) is a novel injectable emulsion formulation of the neurokinin 1 receptor antagonist (RA) aprepitant, approved (as 30-min infusion and 2-min injection) for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV). This retrospective analysis evaluated the safety of HTX-019 administered by 2-min injection in patients with cancer.

Methods: At a single center, HTX-019 was evaluated as a 2-min injection within a guideline-recommended three-drug regimen for CINV prophylaxis in patients receiving highly (HEC) or moderately emetogenic chemotherapy (MEC). Treatment-emergent adverse events (TEAEs) were assessed 0-60 minutes following initiation of HTX-019 administration, focusing on infusion-site adverse events and hypersensitivity reactions.

Results: Among 600 patients (78 MEC, 522 HEC), the most common diagnoses were lung (172) and breast (129) cancer. Patients received a 2-min injection of HTX-019, followed by a 5-hydroxytryptamine type 3 RA intravenously (IV) (palonosetron or ondansetron), dexamethasone IV, and chemotherapy regimen (most common was cisplatin-containing) via a central (76%) and peripheral line (24%). No TEAEs occurred within 60 min after start of HTX-019 administration.

Conclusion: HTX-019 administered by 2-min injection has a tolerable safety profile in patients with cancer, representing a viable method of HTX-019 administration for CINV prevention.     

Emesis control by aprepitant in children and adolescents with chemotherapy

Background Chemotherapy-induced nausea and vomiting (CINV) is a feared adverse reaction during cancer treatment. Aprepitant has shown to be effective for CINV in adults, but little is known on its effect in pediatrics. So far, the drug is not licensed in this population. Objective To investigate efficacy of aprepitant in children and young adolescents with high or moderate emetogenic courses, with uncontrollable emesis in previous cycles. Method Retrospective, observational study in children and adolescents treated with aprepitant at Ghent University Hospital, Belgium. Antiemetic regimens and emesis control were analyzed. Results Twenty patient charts representing 104 chemotherapy cycles were reviewed. Complete vomiting control was observed in 10 patients (50 %), representing 89/104 (85.6 %) episodes. Incomplete vomiting control was observed in 10 patients (50 %), representing only 15 episodes (14.4 %). Of these episodes with incomplete vomiting control, 6 were in acute phase (40 %), 7 in delayed phase (46.7 %) and 2 in both acute and delayed phase (13.3 %). Conclusion Aprepitant might be effective in preventing or reducing vomiting in children. When combined with standard antiemetics, aprepitant was well tolerated. In attendance of results of on-going international clinical trials, our results encourage us to continue the use of aprepitant after failure of emesis control in previous cycles.     

Aprepitant: a review of its use in the prevention of chemotherapy-induced nausea and vomiting

Aprepitant (Emend) is the first commercially available drug from a new class of agents, the neurokinin NK(1) receptor antagonists. Oral aprepitant, in combination with other agents, is indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with highly emetogenic chemotherapy in adults.In three randomised, double-blind, placebo-controlled trials comparing aprepitant (125 mg day 1, 80mg once daily on days 2 and 3 or 2-5) plus standard therapy (intravenous ondansetron and oral dexamethasone) with standard therapy plus placebo, overall complete responses (primary endpoint, defined as no emesis and no rescue therapy) were seen in significantly more patients in the aprepitant arms (63-73% versus 43-52%, p < 0.01 for all comparisons).Complete responses and complete protection during the acute and delayed phase, and overall complete protection were also observed in significantly more patients in the aprepitant arms. The difference between treatment groups was more marked in the overall and delayed phases than in the acute phase.The antiemetic efficacy of aprepitant plus standard therapy in the prevention of CINV was maintained for up to six cycles of chemotherapy.Where assessed, more patients in the aprepitant plus standard therapy arms than the standard therapy plus placebo arms reported no impact of CINV on daily life, as assessed by the Functional Living Index-Emesis.Aprepitant is generally well tolerated. The most common adverse events in randomised trials were asthenia or fatigue. Other adverse events experienced by aprepitant recipients include anorexia, constipation, diarrhoea, nausea (after day 5 of the study) and hiccups. In addition to being a substrate for cytochrome P450 (CYP) 3A4, aprepitant is also a moderate inhibitor and inducer of this isoenzyme as well as an inducer of CYP2C9. Thus, aprepitant has the potential to interact with other agents metabolised by hepatic CYP isoenzymes. In one trial, there was a higher incidence of serious infection or febrile neutropenia in the aprepitant plus standard therapy arm than the standard therapy plus placebo arm; this was attributed to a pharmacokinetic interaction between aprepitant and dexamethasone. In subsequent trials, a modified dexamethasone regimen was used.In conclusion, when added to standard therapy (a serotonin 5-HT(3) receptor antagonist and a corticosteroid), aprepitant is effective and generally well tolerated in the prevention of CINV associated with highly emetogenic chemotherapy in adults. Despite marked advances in the prevention of CINV, standard therapy does not protect all patients. The addition of aprepitant to standard therapy provides an advance in the prevention of both acute and delayed CINV in adults with cancer.     

Aprepitant: the evidence for its place in the prevention of chemotherapy-induced nausea and vomiting

INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) represents a significant burden on patients and healthcare systems. Despite the introduction of serotonin antagonists, many patients still experience CINV, particularly delayed symptoms occurring more than 24 hours after chemotherapy. Aprepitant is a selective neurokinin-1 (NK(1)) receptor antagonist approved for use with other antiemetics to prevent CINV caused by moderately to highly emetogenic chemotherapy. AIMS: To review the evidence underlying the use of aprepitant to prevent CINV. EVIDENCE REVIEW: In patients receiving moderately and highly emetogenic chemotherapy, adding aprepitant to standard antiemetic therapy with dexamethasone and a serotonin antagonist significantly improved control of CINV. The degree of control of delayed CINV was particularly pronounced, and effectiveness was more likely to be maintained in multiple cycles compared with standard therapy. Nausea was generally less frequent among patients taking aprepitant. More patients receiving aprepitant were satisfied with their treatment and reported minimal/no impact of CINV on daily activities. Aprepitant appears to be well tolerated, with fatigue being the most commonly reported adverse event. The drug is an inhibitor and inducer of cytochrome P450 (CYP) 3A4, resulting in contraindications and caution with some concomitant medication. Limited economic evidence suggests that a proportion of the acquisition cost of aprepitant may be offset by savings in overall direct costs of managing CINV. PLACE IN THERAPY: The evidence supports the recommended use of aprepitant in clinical guidelines for the prevention of CINV due to highly emetogenic chemotherapy, and its recently approved role in regimens with moderate risk. It is particularly useful for delayed symptoms.     

Aprepitant for the prevention of nausea and vomiting associated with chemotherapy and postoperative recovery

Chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV) can negatively impact patient quality of life, functional performance and activities of daily living. Although the development of serotonin receptor antagonists has greatly improved the control of acute emesis, delayed CINV remains a significant clinical issue. Aprepitant (Emend^®) is the first commercially available drug from a new class of agents, the neurokinin-1 receptor antagonists. Elucidation of its mechanism of action has produced a greater understanding of the pathophysiology of nausea and vomiting. Oral aprepitant, in combination with a selective serotonin (5-HT₃) receptor antagonist and corticosteroids, is indicated for the prevention of acute and delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy in adults. Aprepitant alone or in combination only with dexamethasone does not optimally control acute emesis compared with triple combination therapy. By contrast, aprepitant as monotherapy is indicated for the prevention of PONV. Aprepitant represents an emerging class of agents and its addition to standard therapy provides an advanced benefit in the prevention and treatment of CINV and PONV. Investigations of aprepitant for other indications are ongoing.     

奥氮平治疗食管癌患者化疗相关性呕吐的效果及安全性

目的 探讨奥氮平治疗食管癌患者化疗相关性呕吐的效果及安全性.方法 选择82不能手术的食管癌患者,随机分为对照组和观察组,各41例.两组均应用TP方案化疗,对照组托烷司琼和地塞米松预防呕吐,观察组在对照组基础上加用奥氮平治疗.结果 对照组急性化疗所致呕吐发生率为51.2％,观察组为29.3％,差异有统计学意义(P＜0.05);对照组延迟性化疗所致呕吐发生率为31.7％,观察组为9.8％,差异有统计学意义(P＜0.05);对照组4例出现不良反应,观察组7例,差异无统计学意义(P＞0.05).结论 奥氮平可有效预防食管癌患者化疗相关性呕吐,安全有效.