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: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
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
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...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。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: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。