Effectiveness of a novel, fixed dose combination of netupitant and palonosetron in prevention of chemotherapy induced nausea and vomiting: A real-life study from India

BACKGROUND A new,oral fixed dose combination of highly selective neurokinin-1 receptor antagonist,netupitant with 5HT3 receptor antagonist,netupitant and palonosetron(NEPA)was approved in India for prevention of chemotherapy induced nausea and vomiting(CINV).AIM To assess effectiveness of NEPA in real-world scenario.METHODS We retrospectively assessed the medical records and patient dairies of adult patients who received highly emetogenic or moderately emetogenic chemotherapy(HEC/MEC)and treated with NEPA(Netupitant 300 mg+Palanosetron 0.50 mg)for prevention of CINV.Complete response(CR)was defined as no emesis or no requirement of rescue medication in overall phase(0 to 5 d),acute phase(0-24 h)and delayed phase(2 to 5 d).RESULTS In 403 patients included in the analysis,mean age was 56.24±11.11 years and 55.09%were females.Breast cancer(25.06%)was most common malignancy encountered.HEC and MEC were administered in 54.6%and 45.4%patients respectively.CR in overall phase was 93.79%whereas it was 98.01%in acute CINV and 93.79%in delayed CINV.Overall CR in HEC and MEC groups was 93.63%and 93.98%respectively.CR was more than 90%in different chemotherapy cycles except in group of patients of cycle 4 where CR was 88.88%.CONCLUSION NEPA is a novel combination that is effective in preventing CINV in up to 93%cases treated with highly emetogenic or moderately emetogenic chemotherapy.This study brings the first real-life evidence of its effectiveness in India population.

Palonosetron versus Ondansetron as Prophylaxis against Postoperative Nausea and Vomiting (PONV) after Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial

Introduction: Postoperative nausea and vomiting (PONV) are prevalent symptoms after laparoscopic surgeries with an incidence rate of (54% - 79%) in bariatric procedures. Despite its popularity, limited studies assessed the effect of antiemetics for PONV prophylaxis after laparoscopic sleeve gastrectomy (LSG). The aim of this trail is to compare the effectiveness of a single pre-induction intravenous dose of Palonosetron versus Ondansetron for prophylaxis of PONV, 24 hours after LSG. Subjects and Methods: This prospective randomized controlled double-blind parallel-group study was conducted from May till December 2019. Recruited patients were consented and randomized using a closed envelop method into two groups with fifty patients each. The total number of nausea and vomiting attacks in the 24 hours postoperatively was considered as a primary end point. The secondary end points were the frequency of nausea, retching and vomiting attacks in the 24 hours post-surgery. The severity of nausea was evaluated using a 10 cm visual analogue scale (VAS). Results: This RCT included 100 patients divided into 2 groups of 50 patients each. Patients received either 75 mcg Palonosetron (Group I) or Ondansetron 4 mg (group II). Group I had statistically significant fewer episodes of nausea, retching and vomiting in the first 4 hours (P = 0.022) and from 4 to 12 hours (P = 0.024) but not after 12 hours post LSG. Total episodes of nausea, retching and vomiting in 24 hours postoperative were significantly less in group I (P = 0.021). Conclusion: A single dose of intravenous 75 mcg Palonosetron is superior to Ondansetron 4 mg in preventing PONV for patients after LSG.

Comparison of nutritional status and inflammatory stress levels after gastric cancer patients with chemotherapy received palonosetron hydrochloride injection and tropisetron

Objective:To study the nutritional status and inflammatory stress levels after gastric cancer patients with chemotherapy received palonosetron and tropisetron.Methods: 94 patients with advanced gastric cancer undergoing FOLFOX4 intravenous chemotherapy in our hospital between May 2014 and March 2016 were selected and randomly divided into observation group (n=47) and control group (n=47) who received palonosetron and tropisetron for chemotherapy anti-emesis respectively. After four cycles of chemotherapy, serum samples were collected from two groups of patients to determine nutritional status, inflammatory reaction and stress reaction indexes.Results:After four cycles of chemotherapy, serum albumin (ALB), prealbumin (PAB), transferrin (TFN), immunoglobulin A (IgA), IgG and IgM content of observation group were significantly higher than those of control group (P<0.05). After four cycles of chemotherapy, serum Keap1 content of observation group was significantly higher than that of control group (P<0.05), while Nrf2, ARE, NQO1, HO-1, interferon-γ (IFN-γ), tumor necrosis factorα (TNF-α), interleukin-4 (IL-4) and IL-10 content were significantly lower than those of control group (P<0.05).Conclusions:Palonosetron has better antiemetic effect than tropisetron for gastric cancer patients with chemotherapy, and after chemotherapy, the nutritional status is better and the inflammatory stress level is lighter.

Enantioseparation of Palonosetron Hydrochloride and Its Related Enantiomeric Impurities by Computer Simulation and Validation

A rapid, simple and single stereo selective high-performance liquid chromatographic (HPLC) method was developed and validated for enantiomers of palonosetron hydrochloride (PALO) and its process related chiral impurities. A computer simulating software was used for the development of chiral method. The developed method was able to separate not only the enantiomers of palonosetron hydrochloride but also its process related chiral impurities within 12 min. The chromatographic separation was carried out by normal phase chromatography using a 3 μm column of cellulose based chiral stationary phase (Chiralcel-OD 250mm × 4.6mm) with a mobile phase comprised of n-hexane: ethanol: methanol: heptafluoro butyric acid: diethyl amine (70:15:15:0.05:0.1, v/v) at a flow rate of 1.0 mL/min. The effects of additive concentration as well as nature of polar organic modifier, flow rate, and temperature on enantioselectivity were investigated. The limit of detection (LOD) and limit of quantification (LOQ) of the palonosetron isomers and its related chiral impurities were found to be in the range 0.06-0.10 μg/mL and 0.14 - 0.24 μg/mL respectively. The method showed excellent linearity (R2 > 0.998) over a range of 0.14 to 1.125 μg/mL. The percentage recovery of the isomers in bulk drug samples ranged from 87.0 to 116.0.

The use of aprepitant and palonosetron in preventing chemotherapy-related nausea and vomiting inlung cancer patients

Objective The aim of this study was to explore the clinical efficacy and toxicity of a combination aprepitant and palonosetron hydrochloride therapy in preventing chemotherapy-induced nausea and vomiting associated with a cisplatinum-based regimen in patients with lung cancer. Methods Sixty-eight patients with lung cancer were randomly assigned to receive either aprepitant plus palonosetron hydrochloride(group A, n = 38) or tropisetron(group B, n = 30). Acute(0–24 h) and delayed(2–5 d) emetic episodes, nausea, vomiting, constipation, and dizziness were compared between the two groups in the five days following cisplatinum-based chemotherapy.Results Group A had a higher complete control rate for both acute and delayed emetic episodes than Group B(36.8% vs. 13.3% and 31.6% vs. 13.3%, respectively; P < 0.05 for both). There was no significant difference in the constipation rate between the two groups. Conclusion Aprepitant combined with palonosetron hydrochloride is active and well tolerated in both acute and delayed emetic episodes in patients with lung cancer treated by a cisplatinum-based regimen.

奈妥匹坦帕洛诺司琼预防化疗引起的恶心呕吐:从临床试验到日常临床实践

化疗引起的恶心呕吐(CINV)是众多抗癌药物治疗中常见的不良事件,不仅会对患者生活质量带来负面影响,还有可能影响化疗效果。目前,指南建议的止吐方案可以预防大部分癌症患者的CINV。但临床医师并不能始终遵循指南建议,患者也常常难以坚持医师处方的治疗。因此需要采取一些提高指南依从性的方法。奈妥匹坦帕洛诺司琼(NEPA)是首个也是唯一一个固定剂量复方止吐药,由奈妥匹坦(口服)/福奈妥匹坦(静脉给药)与帕洛诺司琼(PALO)组成。NEPA可以联合地塞米松组成三联止吐方案,这是用于高致吐性化疗(HEC)患者和部分中致吐性化疗(MEC)患者预防CINV的推荐方案。因此,NEPA止吐治疗操作简单便捷,可能有助于提高指南依从性。本综述对CINV进行了概括,评价了在临床试验和真实实践中积累的NEPA止吐效果及安全性方面的证据,同时也评价了在关键临床试验之外的环境下,即日常临床环境中使用NEPA进行止吐的初步证据。此外,本文还评述了化疗期间使用NEPA控制恶心症状和提高患者生活质量,这是癌症患者管理中面临的两个大挑战。

帕洛诺司琼联合地塞米松对腹腔镜手术术后恶心呕吐预防效果的Meta分析

目的系统评价帕洛诺司琼联合地塞米松对比单用帕洛诺司琼治疗腹腔镜手术术后恶心呕吐(PONV)的有效性和安全性。方法计算机检索CNKI、WanFang Data、VIP、PubMed、EMbase、the Cochrane Library数据库,补充检索Google学术,搜集帕洛诺司琼联合地塞米松(联合用药组)对比单用帕洛诺司琼(单独用药组)治疗腹腔镜手术PONV的随机对照试验(RCT),检索时限均由建库至2021年10月31日,由两位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果共纳入9个RCT,包括830例患者。Meta分析结果显示,联合用药组的0~2 h PONV发生率[RR=0.63,95%CI(0.44,0.91),P=0.01]和0~24 h PONV发生率[RR=0.61,95%CI(0.43,0.86),P=0.006]、止吐救援需求率[RR=0.58,95%CI(0.41,0.84),P=0.004]以及药品不良反应的发生率[RR=0.62,95%CI(0.42,0.92),P=0.02]均显著低于单独用药组,而两组0~6 h PONV发生率、2~6 h PONV发生率、0~48 h PONV发生率、24~48 h PONV发生率以及0~72 h PONV发生率相当(P>0.05)。结论当前证据显示,相较于单用帕洛诺司琼,帕洛诺司琼联合地塞米松并不能完全降低腹腔镜手术PONV发生率,但能够显著降低止吐救援需求率和药品不良反应的发生率。受纳入研究数量和质量的限制,上述结论尚待更多大样本、高质量研究予以验证。

5-HT_(3)受体抑制剂预防成人术后恶心呕吐的研究进展

术后恶心呕吐(PONV)是常见的术后并发症之一。PONV增加了患者痛苦、医疗费用及术后风险。临床中多种因素可导致PONV的发生,如吸入性麻醉药、阿片类药物、腹腔镜所建立的气腹等,可通过5-HT_(3)受体等各种受体等介导恶心或呕吐的发生。因此阻滞5-HT_(3)受体神经传导通路是预防PNOV的重要方法。本文综述了5-HT_(3)受体抑制剂应用于预防成人PONV研究进展,为提高围手术期患者就医体验、缩短住院时间提供一定的参考。

经皮穴位电刺激联合帕洛诺司琼对腹腔镜非胃肠手术患者术后早期恢复质量的影响

目的探讨经皮穴位电刺激(TEAS)联合帕洛诺司琼对腹腔镜非胃肠手术患者术后恶心呕吐和早期恢复质量的影响。方法选择择期全麻下行腹腔镜非胃肠手术患者648例,男28例,女620例,年龄18~50岁,BMI 15~40 kg/m^(2),ASAⅠ—Ⅲ级。采用随机数字表法将患者分为两组:TEAS组(T组,n=330)和对照组(C组,n=318)。两组患者均在麻醉诱导时预防性使用地塞米松和帕洛诺司琼,T组于麻醉苏醒后和术后第1天上午TEAS双侧内关穴和足三里穴,持续30 min;C组穴位选择同T组,患者连接电针刺激仪,但不给予通电刺激。记录术后24 h内恶心呕吐发生情况、40项恢复质量评分(QoR-40)、止吐补救和术后并发症发生情况。结果与C组比较,T组术后24 h内恶心、持续恶心、呕吐和呕吐累积发生率、恶心和呕吐最高VAS评分、止吐补救率和术后并发症发生率均明显降低(P<0.05),QoR-40总评分、身体舒适、情绪状态、心理支持、身体独立和疼痛评分均明显升高(P<0.05)。结论术后TEAS双侧内关穴和足三里穴联合帕洛诺司琼可降低腹腔镜非胃肠手术患者PONV和术后并发症发生率,提高术后早期恢复质量。

“胃三针”针刺联合中药膏摩防治化疗相关性恶心呕吐的临床研究

目的:观察“胃三针”针刺联合中药膏摩(平胃散加减)防治化疗相关性恶心呕吐(CINV)的临床疗效。方法:80例于2021年11月—2022年11月接受含铂化疗方案治疗的恶性肿瘤患者,采用随机数字表法分为西医组(40例)和联合组(40例)。西医组化疗前予以盐酸帕洛诺司琼注射液+地塞米松磷酸钠注射液治疗,联合组在西医组的基础上予以“胃三针”针刺联合中药膏摩(平胃散加减)治疗,两组均治疗7 d。观察并对比两组患者恶心呕吐时间发生情况及缓解率、中医症状评分、卡式功能状态(KPS)评分、不良事件发生情况及治疗前后血清5-羟色胺3(5-HT_3)受体和P物质(SP)水平。结果:联合组总有效率(87.5%,35/40)高于西医组(77.5%,31/40),且联合组急性期及延迟期恶心呕吐事件发生率均低于西医组,差异具有统计学意义(P<0.05);治疗后两组中医症状评分、KPS评分及血清5-HT_3受体和SP水平均有所改善,且相较于西医组,联合组中医症状评分及血清5-HT_3受体、SP下降水平及KPS评分上升水平更明显,差异具有统计学意义(P<0.05)。两组在治疗期间均未出现明显不良反应。结论:“胃三针”针刺联合中药膏摩(平胃散)防治CINV疗效好,能有效减少血清因子的释放,减少使用含铂类方案化疗患者急性期及延迟期CINV的发生情况,改善患者生活质量,安全有效,值得临床推广应用。

帕洛诺司琼治疗剖宫产围术期使用卡前列素氨丁三醇所致恶心呕吐的效果

目的探讨帕洛诺司琼治疗剖宫产围术期使用卡前列素氨丁三醇所致恶心呕吐的临床效果。方法选取2022年1—9月淄博市妇幼保健院收治的剖宫产围术期出现恶心呕吐者80例,按照随机数表法分为对照组及观察组,各40例。所有入组者均接受腰硬联合麻醉下剖宫产手术,观察组静脉滴注帕洛诺司琼,对照组静脉滴注甲氧氯普胺。比较两组患者恶心、呕吐评分缓解时间,治疗前后恶心呕吐评分,给药后30 min患者生命体征变化情况及其他不适情况。结果观察组恶心缓解时间和呕吐缓解时间分别为(2.3±0.2)h和(4.1±0.5)h均显著早于对照组,差异有统计学意义(t=11.437、7.569,P<0.05)。治疗后观察组恶心呕吐评分为(0.5±0.1)分,低于对照组,差异有统计学意义(t=20.000,P<0.05)。观察组给药后30 min心率和呼吸频率分别为(85.2±12.1)、(15.2±3.3)次/min均慢于对照组,差异有统计学意义(t=6.687、12.098,P<0.05),平均动脉压和血氧饱和度分别为(85.5±5.5)mmHg和(98.8±1.1)%,均高于对照组,差异有统计学意义(t=13.276、15.283,P<0.05)。观察组发生胸闷、呼吸困难、面色潮红和低血压的总比例为1例(2.5%)低于对照组的10例(25.0%),差异有统计学意义(χ^(2)=8.538,P<0.05)。结论帕洛诺司琼可快速的缓解使用卡前列素氨丁三醇后导致的恶心呕吐不适,更好地维持患者术中生命体征平稳,同时对降低使用卡前列素氨丁三醇后的其他不适症状亦有一定帮助。

地塞米松联合帕洛诺司琼预防性用药对胸腔镜食管癌根治术患者的影响

目的:分析地塞米松联合帕洛诺司琼预防性用药对胸腔镜食管癌根治术患者的影响。方法:选取2020年3月—2022年3月福建省肿瘤医院收治的86例食管癌患者。随机将其分为地塞米松组(n=29)、帕洛诺司琼组(n=28)、联合组(n=29)。所有患者均实施常规麻醉及胸腔镜食管癌根治术治疗。地塞米松组麻醉前静脉注射地塞米松磷酸钠注射液,帕洛诺司琼组麻醉前静脉注射盐酸帕洛诺司琼注射液,联合组麻醉前静脉注射盐酸帕洛诺司琼注射液0.25 mg+地塞米松磷酸钠注射液10 mg。比较三组术后24 h内胃肠道反应发生率,术前及术后24 h胃肠激素水平、炎症因子水平。结果:术后24 h,联合组胃肠道反应发生率显著低于地塞米松组、帕洛诺司琼组,差异有统计学意义(P<0.05)。术后24 h,三组胃泌素(GSA)、胃动素(MTL)水平均显著低于术前,联合组GSA、MTL水平均显著高于地塞米松组、帕洛诺司琼组,差异有统计学意义(P<0.05)。术后24 h,三组干扰素-γ(IFN-γ)、白细胞介素-6(IL-6)、白细胞介素-10(IL-10)水平均显著高于术前,联合组IFN-γ、IL-6、IL-10水平均显著低于地塞米松组、帕洛诺司琼组,差异有统计学意义(P<0.05)。结论:地塞米松、帕洛诺司琼单独预防性用药对胸腔镜食管癌根治术患者胃肠道不良反应、胃肠激素及炎症因子影响效果相近,联合用药能降低胃肠道不良反应发生率,对胃肠激素及炎症因子影响优于二者单独用药。

帕洛诺司琼联合膈神经阻滞对甲状腺术后恶心呕吐的疗效分析

目的 探讨帕洛诺司琼联合膈神经阻滞对甲状腺肿瘤术后恶心呕吐(postoperative nausea and vomiting,PONV)的疗效。方法 选择2018年6月-2020年6月赤峰市医院收治的甲状腺肿瘤患者60例为研究对象,采用随机数表法分为两组,每组30例。帕洛诺司琼组(P组)麻醉前静注帕洛诺司琼0.25 mg;帕洛诺司琼+膈神经阻滞组(P+G组)术前行膈神经阻滞且麻醉前静注帕洛诺司琼0.25 mg。比较两组患者术后0~6 h、6~24 h视觉模拟评分法(Visual Analogue Scale, VAS)评分,术后0~6 h、6~24 h、24~48 h、48~72 h恶心、呕吐发生情况。结果 术后0~6 h、6~24 h,P+G组患者VAS评分分别为(2.49±0.88)分、(1.20±0.49)分,明显低于P组(3.20±1.04)分、(2.17±0.61)分,差异有统计学意义(t=2.902、6.902,P<0.05)。P+G组患者术后0~6 h、6~24 h、24~48 h、48~72 h的PONV发生率分别为10.0%、6.7%、3.3%、0,低于P组的40.0%、33.3%、26.7%、20.0%,差异有统计学意义(χ^(2)=7.200、6.667、4.706、4.630,P<0.05)。结论 帕洛诺司琼联合膈神经阻滞较单用帕洛诺司琼预防甲状腺肿瘤术后高危患者PONV的效果更理想。

奈妥匹坦帕洛诺司琼胶囊预防高致吐性化疗所致恶心呕吐的疗效观察

目的观察奈妥匹坦帕洛诺司琼胶囊预防高致吐性化疗所致恶心呕吐(CINV)的疗效。方法收集20例恶性肿瘤患者的病历资料,均接受高致吐性化疗方案,于化疗前1h口服奈妥匹坦帕洛诺司琼胶囊进行止吐预防,评估患者的止吐效果及不良反应。结果20例患者接受高致吐性化疗前1h均口服奈妥匹坦帕洛诺司琼胶囊,所有患者均未出现急性和延迟性CINV,仅3例患者出现轻度恶心,均有晕动症病史,其中接受培美曲塞+顺铂化疗1例,接受多柔比星脂质体+环磷酰胺化疗2例。所有患者均未发生便秘或其他严重不良反应,多数患者预后良好。结论奈妥匹坦帕洛诺司琼胶囊预防高致吐性化疗药物引起的CINV疗效及耐受性良好,安全性高,是一种安全有效的止吐药物,可作为接受中高危致吐化疗方案患者的选择之一。

盐酸帕洛诺司琼预防化疗性恶心呕吐的多中心双盲随机对照临床研究

目的：奉国家SFDA文，观察和评价国产新药盐酸帕洛诺司琼注射液预防和控制抗肿瘤化疗药物引起的恶心呕吐的有效性和安全性。方法：采用双盲双模拟、随机、阳性药平行对照的多中心临床试验方法。对使用高度致吐性化疗方案的患者，于化疗前半小时缓慢静脉推注新药盐酸帕洛诺司琼注射液0．25mg（试验组）或市售的格拉司琼注射液3mg（对照组）。严格观察患者急性呕吐、延迟性呕吐以及恶心发生情况，必要时给予解救性止吐治疗（格拉司琼＋地塞米松）。结果：6个中心共人组223例患者，试验组111例，对照组112例。试验组对化疗引起的急性呕吐（24小时内）完全缓解率（CRR）与对照组相比无显著性差异（85．59％vs.78．57％，P=0．1420），但前者对化疗引起的延迟性呕吐（24小时-7天）完全控制率（CCR）明显高于对照组（63．96％vs.50．00％，P=0．0282），化疗后未出现呕吐（0—7天）的受试者比例也明显高于对照组（分别为62．16％vs．46．43％，P=0．0140）。同时，帕洛诺司琼注射液控制化疗性恶心的作用优于格拉司琼（P=0．0198）；化疗后人均呕吐发作次数也明显少于格拉司琼[（1．76±4．27）次／例vs．（3．08±6．20）次／例，P=0．0289]。试验组呕吐控制时间明显长于对照组（P=0．0377）。两组在解救治疗的时间、解救治疗的受试者比例、解救治疗人均次数以及KPS评分下降程度方面均无统计学差异（P〉0．05）。两组分别有8．11％和8．04％的受试者出现轻度便秘、腹胀及头痛等（P=1．0000），但是对照组需要服用镇静剂预防焦虑、失眠的受试者明显高于试验组（10．71％vs.0．90％，P=0．0026）。结论：国产新药盐酸帕洛诺司琼注射液预防肿瘤强烈化疗所致恶心呕吐优于盐酸格拉司琼注射液，且安全性好，建议上市应用。

盐酸帕洛诺司琼注射液预防化疗引起恶心呕吐的临床疗效观察

目的：观察盐酸帕洛诺司琼注射液预防化疗引起恶心呕吐的有效性和安全性。方法：采用多中心、分层随机、双盲双模拟、自身交叉阳性对照临床试验设计，全部入组125例患者，分为A方案（61例）和B方案（64例）。A方案为每组患者随机采用在第1周期使用盐酸帕洛诺司琼注射液、第2周期使用盐酸格拉司琼注射液，B方案与之相反。试验组为A、B方案中所有使用试验药物的患者，对照组为A、B方案中所有使用对照药物的患者。行2个疗程化疗方案的试验组和对照组的急性和延迟性呕吐的完全控制率以及不良反应比较。结果：中度致吐性化疗组中试验组的预防延迟性呕吐的完全控制率为76.92%（50/65）、对照组为55.38%（36/65），两组差异具有统计学意义（P=0.0110）。第1～5天中度致吐性化疗组中试验组的呕吐次数为（1.32±3.42）次、对照组为（1.94±3.03）次，两组之间比较差异具有统计学意义（P=0.0096）。试验、对照组不良反应发生率均较低，程度也较轻。结论：盐酸帕洛诺司琼预防中、高度致吐性化疗引起的急性及延迟性呕吐疗效确切，特别对预防中度致吐性化疗引起的延迟性呕吐，盐酸帕洛诺司琼优于盐酸格拉司琼，且盐酸帕洛诺司琼不良反应轻微，值得在临床上推广使用。

盐酸帕洛诺司琼预防中重度化疗致吐药引起恶心呕吐的Ⅱ期临床研究

目的:探讨盐酸帕洛诺司琼预防中重度化疗致吐药引起的恶心和呕吐的疗效和不良反应。方法:采用多中心、随机、双盲双模拟、自身交叉对照的研究方法。试验药为盐酸帕洛诺司琼注射液,对照药为盐酸昂丹司琼注射液。对化疗后1～5天的恶心程度、止吐疗效及不良反应进行评价。结果:共入选病例112例,104例可评价疗效。在接受以顺铂或阿霉素为主的化疗方案后,盐酸帕洛诺司琼0.25mg和盐酸昂丹司琼16mg的止吐有效率分别为77.08%和73.08%,恶心程度改善率分别为64.42%和62.50%,两药的疗效差异无统计学意义(P>0.05)。盐酸帕洛诺司琼注射液的不良反应主要为头痛和便秘。结论:盐酸帕洛诺司琼注射液能够预防化疗引起的恶心和呕吐,疗效和安全性较好。

重复使用5-HT3受体拮抗剂预防多日化疗相关性恶心呕吐的疗效和安全性分析

目的:探讨重复使用第一代5-HT3受体拮抗剂(5-HT3RA)托烷司琼与第二代5-HT3RA帕洛诺司琼预防多日高度催吐风险化疗所致恶心和呕吐(chemotherapy-induced nausea and vomiting,CINV)的疗效和安全性。方法:在接受含有高度催吐风险药物连续多日化疗的患者中,采用随机、交叉自身对照的方法分组,A方案组为:在第1周期化疗中,帕洛诺司琼0.25 mg,静脉滴注,d1、d3(必要时d5)。地塞米松(DXM)10 mg,静脉滴注,d1;5 mg,静脉滴注,d2~d5。第2周期为托烷司琼5 mg,静脉滴注,d1~d3(必要时d4、d5);DXM用法同前。B方案组的止吐方案为第1周期使用托烷司琼,第2周期使用帕洛诺司琼(剂量、用法均同A方案组)。将A方案组第1个周期和B方案组第2个周期的患者归为帕洛诺司琼组,A方案第2个周期和B方案组第1个周期的患者归为托烷司琼组,比较帕洛诺司琼与托烷司琼预防CINV的疗效和不良反应。结果:共计入组91例患者。在d3至d5,帕洛诺司琼组每天恶心发生率分别为28.6%、30.8%和24.2%,托烷司琼组分别为42.8%、47.3%和39.6%,差异均有统计学意义(均P<0.05);在d4至d6,帕洛诺司琼组每天呕吐发生率分别为28.6%、18.7%和5.5%,托烷司琼组则为42.9%、34.1%和14.3%,差异均有统计学意义(均P<0.05);按时间段分析,帕洛诺司琼组在d4~5、d6~7和全程(d1~7)恶心和呕吐发生率均显著低于托烷司琼组(均P<0.05)。帕洛诺司琼组全程(d1~7)解救药使用率为13.2%,低于托烷司琼组的24.2%,但差异无统计学意义(P=0.057)。帕洛诺司琼组与托烷司琼组的止吐药物相关性不良反应发生率的差异均无统计学意义(均P>0.05)。结论:重复使用帕洛诺司琼预防持续多日高度催吐风险化疗相关的延迟性恶心呕吐的疗效优于托烷司琼,两者的安全性良好。

单剂量和多次重复剂量盐酸帕洛诺司琼注射液预防化疗所致恶心、呕吐的临床观察

目的观察单剂量和多次重复剂量盐酸帕洛诺司琼预防化疗所致恶心、呕吐的疗效和安全性。方法 451例患者随机进入单剂量组(A组,232例,盐酸帕洛诺司琼0.25mg化疗前静滴d1)或多次重复剂量组(B组,219例,盐酸帕洛诺司琼0.25mg化疗前静滴d1、d3、d5;化疗时间≤2天的患者,如果在化疗后第4天无呕吐、恶心发生,第5天停用盐酸帕洛诺司琼),分析两组的疗效及不良反应。结果 B组化疗全程的恶心、呕吐完全缓解率明显高于A组(52.97%vs.38.36%,P=0.002)。A、B两组在急性期恶心、呕吐完全缓解率的差异无统计学意义(58.19%vs.62.56%,P=0.340),但在延迟期B组恶心、呕吐完全缓解率明显高于A组(65.30%vs.46.98%,P<0.001)。A、B两组在急性期呕吐完全缓解率的差异无统计学意义(86.64%vs.87.21%,P=0.860),但在延迟期B组呕吐完全缓解率明显高于A组(89.95%vs.71.12%,P<0.001)。A、B两组在急性期恶心完全缓解率无明显差异(58.19%vs.62.56%,P=0.340),但在延迟期B组恶心完全缓解率明显高于A组(66.21%vs.51.72%,P=0.0018)。B组解救治疗率低于A组(11.42%vs.19.83%,P=0.014)。A、B两组的不良反应发生率分别为8.19%和10.05%(P=0.390)。结论多次重复剂量盐酸帕洛诺司琼较单剂量盐酸帕洛诺司琼可以提高化疗患者的延迟期恶心、呕吐完全缓解率,且两者不良反应发生率相似。