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 chemo...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.展开更多
<b><span style="font-family:Verdana;">Introduction:</span></b><b><span style="font-family:Verdana;"> </span></b><span style="font-family...<b><span style="font-family:Verdana;">Introduction:</span></b><b><span style="font-family:Verdana;"> </span></b><span style="font-family:Verdana;">Postoperative nausea and vomiting (PONV) are prevalent symptoms after laparoscopic surgeries with an incidence rate of (54</span><span style="font-family:Verdana;">% </span><span style="font-family:Verdana;">-</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">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</span><span style="font-family:Verdana;">. </span><b><span style="font-family:Verdana;">Subjects and Methods:</span></b><b><span style="font-family:Verdana;"> </span></b><span style="font-family:Verdana;">This prospective randomized controlled double-blind parallel-group study was</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">conducted from May till December 2019. Recruited patients were consented and randomized using a closed envelop method into two groups with fifty patients each.</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">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.</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">The severity of nausea was evaluated using a 10 cm visual analogue scale (VAS).</span><span style="font-family:Verdana;"> </span><b><span style="font-family:Verdana;">Results:</span></b><b><span style="font-family:Verdana;"> </span></b><span style="font-family:Verdana;">This RCT included 100 patients divided into 2 groups of 50 patients each. Patients received either 75</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">mcg Palonosetron (Group I) or Ondansetron 4 mg (group II).</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">Group I had statistically significant fewer episodes of nausea, retching and vomiting in the first 4 hours (P</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">=</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">0.022)</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">and from 4 to 12</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">hours</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">(P</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">=</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">0.024)</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">but not after 12 hours post</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">LSG. Total episodes of nausea, retching and vomiting in 24 hours postoperative were significantly less in group I</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">(P</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">=</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">0.021).</span><span style="font-family:Verdana;"> </span><b><span style="font-family:Verdana;">Conclusion:</span></b><b><span style="font-family:Verdana;"> </span></b><span style="font-family:Verdana;">A single dose of intravenous 75</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">mcg Palonosetron is superior to Ondansetron 4 mg in preventing PONV for patients after LSG.</span>展开更多
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 wi...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.展开更多
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 undergoi...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.展开更多
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 impurit...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.展开更多
目的观察经皮穴位电刺激(TAES)联合帕洛诺司琼对日间手术患者术后恶心呕吐(PONV)的预防效果。方法选择90例择期行半月板损伤的日间手术患者,随机分为A组、B组、C组,每组30例。A组给予TAES治疗,B组给予帕洛诺司琼治疗,C组给予TAES联合帕...目的观察经皮穴位电刺激(TAES)联合帕洛诺司琼对日间手术患者术后恶心呕吐(PONV)的预防效果。方法选择90例择期行半月板损伤的日间手术患者,随机分为A组、B组、C组,每组30例。A组给予TAES治疗,B组给予帕洛诺司琼治疗,C组给予TAES联合帕洛诺司琼治疗。比较三组患者PONV发生情况、术后视觉模拟评分法(VAS)评分及术后需应用止吐药物补救的情况。结果A组术后48 h内PONV发生率为36.7%(11/30),B组PONV发生率为26.7%(8/30),C组PONV发生率为3.3%(1/30)。C组PONV发生率低于A组和B组,存在统计学差异(P<0.05);A组PONV发生率与B组比较无统计学意义(P>0.05)。三组患者术后12、24、48 h VAS评分比较无统计学意义(P>0.05)。A组有3例(10.0%)患者术后实施补救止吐药物,B组有1例(3.3%),C组0例。三组患者术后实施补救止吐药物占比比较无统计学意义(P>0.05)。结论相较于单独TAES与单独使用帕洛诺司琼,TAES联合帕洛诺司琼对半月板损伤日间手术患者PONV的预防效果更佳。展开更多
文摘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.
文摘<b><span style="font-family:Verdana;">Introduction:</span></b><b><span style="font-family:Verdana;"> </span></b><span style="font-family:Verdana;">Postoperative nausea and vomiting (PONV) are prevalent symptoms after laparoscopic surgeries with an incidence rate of (54</span><span style="font-family:Verdana;">% </span><span style="font-family:Verdana;">-</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">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</span><span style="font-family:Verdana;">. </span><b><span style="font-family:Verdana;">Subjects and Methods:</span></b><b><span style="font-family:Verdana;"> </span></b><span style="font-family:Verdana;">This prospective randomized controlled double-blind parallel-group study was</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">conducted from May till December 2019. Recruited patients were consented and randomized using a closed envelop method into two groups with fifty patients each.</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">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.</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">The severity of nausea was evaluated using a 10 cm visual analogue scale (VAS).</span><span style="font-family:Verdana;"> </span><b><span style="font-family:Verdana;">Results:</span></b><b><span style="font-family:Verdana;"> </span></b><span style="font-family:Verdana;">This RCT included 100 patients divided into 2 groups of 50 patients each. Patients received either 75</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">mcg Palonosetron (Group I) or Ondansetron 4 mg (group II).</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">Group I had statistically significant fewer episodes of nausea, retching and vomiting in the first 4 hours (P</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">=</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">0.022)</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">and from 4 to 12</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">hours</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">(P</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">=</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">0.024)</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">but not after 12 hours post</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">LSG. Total episodes of nausea, retching and vomiting in 24 hours postoperative were significantly less in group I</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">(P</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">=</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">0.021).</span><span style="font-family:Verdana;"> </span><b><span style="font-family:Verdana;">Conclusion:</span></b><b><span style="font-family:Verdana;"> </span></b><span style="font-family:Verdana;">A single dose of intravenous 75</span><span style="font-family:Verdana;"> </span><span style="font-family:Verdana;">mcg Palonosetron is superior to Ondansetron 4 mg in preventing PONV for patients after LSG.</span>
文摘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.
文摘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.
文摘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.
文摘目的观察经皮穴位电刺激(TAES)联合帕洛诺司琼对日间手术患者术后恶心呕吐(PONV)的预防效果。方法选择90例择期行半月板损伤的日间手术患者,随机分为A组、B组、C组,每组30例。A组给予TAES治疗,B组给予帕洛诺司琼治疗,C组给予TAES联合帕洛诺司琼治疗。比较三组患者PONV发生情况、术后视觉模拟评分法(VAS)评分及术后需应用止吐药物补救的情况。结果A组术后48 h内PONV发生率为36.7%(11/30),B组PONV发生率为26.7%(8/30),C组PONV发生率为3.3%(1/30)。C组PONV发生率低于A组和B组,存在统计学差异(P<0.05);A组PONV发生率与B组比较无统计学意义(P>0.05)。三组患者术后12、24、48 h VAS评分比较无统计学意义(P>0.05)。A组有3例(10.0%)患者术后实施补救止吐药物,B组有1例(3.3%),C组0例。三组患者术后实施补救止吐药物占比比较无统计学意义(P>0.05)。结论相较于单独TAES与单独使用帕洛诺司琼,TAES联合帕洛诺司琼对半月板损伤日间手术患者PONV的预防效果更佳。
