更新于：2024-11-23
Palonosetron hydrochloride
盐酸帕洛诺司琼
更新于：2024-11-23
概要
基本信息
药物类型 小分子化药 |
别名 (3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-2,3,3a,4,5,6-hexahydro-1H-benzo[de]isoquinolin-1-one、2-(1-Azabicyclo(2.2.2)oct-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benz(de)isoquinolin-1-one、Aloxi Injection + [17] |
作用机制 5-HT3 receptor拮抗剂(5-羟色胺受体3拮抗剂) |
最高研发阶段批准上市 |
首次获批日期 美国 (2003-07-25), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C19H25ClN2O |
InChIKeyOLDRWYVIKMSFFB-SSPJITILSA-N |
CAS号135729-62-3 |
关联
236
项与 盐酸帕洛诺司琼 相关的临床试验Comparative Study of the Efficacy of Intravenous Ondansetron Versus Intravenous Palonosetron in the Prevention of Postoperative Nausea and Vomiting in Elective Laparoscopic Surgeries - NIL
A Comparison Between Palonosetron Versus Granisetron As Postoperative Nausea and Vomiting Prophylaxis In Idiopathic Scoliosis Surgery: A Randomized Control Trial
A Randomized Phase III Study Evaluating the Efficacy and Safety of HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
100 项与 盐酸帕洛诺司琼 相关的临床结果
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100 项与 盐酸帕洛诺司琼 相关的转化医学
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100 项与 盐酸帕洛诺司琼 相关的专利（医药）
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868
项与 盐酸帕洛诺司琼 相关的文献（医药）2024-11-01SUPPORTIVE CARE IN CANCER
Antiemetic medications for preventing chemotherapy-induced nausea and vomiting in children: a systematic review and Bayesian network meta-analysis
Review
作者: Phillips, R S ; Dias, S. ; Phillips, R. S. ; Dias, S ; Walker, R ; Walker, R.
Abstract:
Purpose:
Children continue to experience chemotherapy-induced nausea and vomiting (CINV), despite effective antiemetic medications. Recommendations in clinical practice guidelines are underpinned by narrative syntheses and meta-analyses that compare only two treatments. This means not all antiemetics have been compared to one another, and estimates remain imprecise. We apply network meta-analysis (NMA) to overcome these limitations by comparing multiple treatments simultaneously.
Methods:
A systematic review identified and critically appraised RCTs comparing antiemetics recommended and licensed for the prevention of CINV in children. Bayesian NMA compared and ranked antiemetic effectiveness for the outcomes complete (CR) and partial response (PR) in the acute, delayed, and overall phases, nausea, and decreased food intake. Antiemetics given with and without dexamethasone were compared in separate networks as their underlying populations differed.
Results:
Sixteen RCTs (3115 patients receiving moderately (MEC) or highly emetogenic chemotherapy (HEC)) were included. When given with dexamethasone, NK1 antagonists with ondansetron ranked highest for CR and PR in the acute and overall phases, PR in the delayed phase, and decreased food intake. Post hoc analysis shows further a benefit of adding olanzapine to regimens of aprepitant and ondansetron. Ondansetron ranked lower than palonosetron, for CR in the delayed and overall phases, and ondansetron was less effective than palonosetron for nausea prevention. Rankings for other regimens, including those given without dexamethasone, were uncertain or inconsistent across outcomes.
Conclusions:
Our findings serve to support the current recommendations of olanzapine (when given with aprepitant and ondansetron) and NK1 antagonists’ regimens receiving HEC, but note that evidence of a significant difference in relative benefit, between patients receiving MEC and HEC, does not yet exist. Recommendations for palonosetron as the preferred 5HT3 antagonists may be extended, particularly, to those who are at high risk of nausea.
2024-11-01International Journal of Clinical Oncology
Efficacy and safety of dexamethasone sparing for the prevention of nausea and vomiting associated with highly emetogenic risk antineoplastic agents: a systematic review and meta-analysis of the Clinical Practice Guidelines for Antiemesis 2023 from the Japan Society of Clinical Oncology
Review
作者: Wada, Makoto ; Nakamura, Naoki ; Okita, Kenji ; Tanaka, Ryuhei ; Takeda, Masayuki ; Iba, Arisa ; Nakashima, Kazuhisa ; Okuyama, Ayako ; Nishimura, Junichi ; Imamura, Chiyo K ; Noda, Mayumi ; Higashi, Takahiro ; Iino, Keiko ; Hayashi, Kazumi ; Satomi, Eriko ; Nakajima, Takako Eguchi ; Matsumoto, Yoko ; Sasaki, Hidenori ; Matsumoto, Koji ; Abe, Masakazu ; Kim, Yong-Il ; Imamura, Chiyo K. ; Yamamoto, Nobuyuki ; Aogi, Kenjiro ; Iihara, Hirotoshi ; Yokomizo, Ayako ; Ozawa, Keiko ; Boku, Narikazu ; Akechi, Tatsuo
BACKGROUND:
Chemotherapy-induced nausea and vomiting (CINV) are common side effects, classified according to timing and severity. Conventional agents such as dexamethasone are effective but have various side effects. For moderately emetogenic chemotherapy, dexamethasone-sparing antiemetic therapies have been developed to minimize these side effects. This systematic review evaluated the efficacy and safety of dexamethasone-sparing antiemetic therapy for highly emetogenic chemotherapy (HEC).
METHODS:
We performed a thorough literature search for studies related to dexamethasone-sparing antiemetic therapy with neurokinin-1 antagonists (NK1RA) for HEC using the PubMed, Cochrane Library, and Ichushi-Web databases. A qualitative analysis of the combined data was performed and risk differences with confidence intervals were calculated.
RESULTS:
Two reviewers independently assessed the 425 records and 12 full-text articles were evaluated for eligibility. Two studies were included in the qualitative and meta-analyses. These studies included anthracycline-cyclophosphamide (AC) regimens and cisplatin-based regimens, with palonosetron as the serotonin receptor antagonist. In the two studies, no difference was found in the prevention of vomiting (delayed complete response). However, non-inferiority was not demonstrated in the subgroup that received cisplatin-containing regimens. Delayed complete control showed different results for nausea prevention; however, there was no significant difference in the meta-analysis. Only one report has shown non-inferiority for delayed total control. Although the strength of evidence for individual outcomes varied, there was no difference in the duration of dexamethasone administration.
CONCLUSIONS:
This systematic review and meta-analysis revealed that dexamethasone-sparing antiemetic therapy with NK1RA and palonosetron can be used to prevent CINV in HEC, limited to AC combination therapy.
2024-11-01JOURNAL OF CHROMATOGRAPHY A
Economical and rapid enantioselective, diastereoselective and achiral separation of palonosetron hydrochloride and its impurities using supercritical fluid chromatography
Article
作者: Liu, Yitong ; Xing, Jianguo ; Zheng, Ruifang ; Lian, Xiaofang ; Zhao, Xuejia ; Qiu, Xiaodan ; Shan, Guangzhi ; Yao, Jing
Simultaneous separation of compounds with multiple chiral centers and highly similar structures presents significant challenges. This study developed a novel supercritical fluid chromatography (SFC) method with reduced organic solvent consumption and robust separation capabilities to address these challenges. The method was applied to simultaneously achieve enantioselective, diastereoselective, and achiral separation of palonosetron hydrochloride and its six impurities. The effects of the polysaccharide-based chiral stationary phase (CSP), modifier, additive, and column temperature on retention and separation were comprehensively evaluated. It was found that a combination of a polysaccharide-based CSP and a single modifier or a mixture of protonic modifiers could not achieve complete separation due to high structural similarity. However, an ADH column and a ternary solvent mixture containing acetonitrile (methanol: acetonitrile: diethylamine, 60:40:0.2, v/v/v) provided satisfying separation, particularly for the enantiomer and diastereomers of palonosetron. Using the optimized method, the enantioselective, diastereoselective, and achiral separation of palonosetron hydrochloride and its six impurities can be accomplished in 18 min under gradient elution. Thermodynamic results indicated that the separation process was entropy driven. A molecular docking study revealed that the separation was mainly achieved through the differences in hydrogen bond and π - π interactions between the analytes and CSP. This study lays the foundation for SFC analysis of palonosetron hydrochloride and provides a reference for the simultaneous SFC separation of the enantiomers, diastereoisomers and structurally similar compounds.
100 项与 盐酸帕洛诺司琼 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 恶心 | 中国 | 2008-05-04 | |
| 呕吐 | 中国 | 2008-05-04 | |
| 术后恶心呕吐 | 美国 | 2008-02-29 | |
| 化疗引起的恶心和呕吐 | 美国 | 2003-07-25 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肿瘤 | 临床3期 | 美国 | 2017-05-03 | |
| 胶质瘤 | 临床2期 | 美国 | 2008-05-01 | |
| 脑恶性胶质瘤 | 临床2期 | 美国 | 2008-05-01 | |
| 淋巴瘤 | 临床2期 | 美国 | 2007-10-01 | |
| 转移性黑色素瘤 | 临床2期 | 美国 | 2006-11-01 | |
| 多发性骨髓瘤 | 临床2期 | 美国 | 2006-03-01 | |
| 多发性骨髓瘤 | 临床2期 | 美国 | 2006-03-01 | |
| 急性髓性白血病 | 临床2期 | 美国 | 2005-09-01 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | - | 178 | IntraVenous (Fos)NEtupitant and Palonosetron (IV NEPA) | 襯製壓鹽鹽鹹積鹹糧鑰(醖艱構範艱淵蓋簾積窪) = 4, 2.25% 鬱選窪糧觸鑰齋夢夢衊 (糧蓋製簾蓋鑰鏇選顧鹽 ) 更多 | 积极 | 2024-09-15 | |
ESMO2023 人工标引  | 临床2期 | 76 | 齋積願製壓夢膚積襯選(積鏇鹹憲簾獵艱構糧鑰) = 衊餘窪夢觸窪獵積觸蓋 蓋窪鏇鑰觸餘築願醖鏇 (鹹築廠範淵淵築淵網憲, 9.4 ~ 27.5) 更多 | 不佳 | 2023-10-21 | ||
临床2/3期 | 53 | Palonosetron (NEPA)+Netupitant (Blinded Intervention Group) | 艱觸鹹築襯築選廠淵艱(積顧範壓蓋淵醖鹹壓觸) = 製願襯齋衊窪膚壓艱膚 憲積獵鑰糧壓壓觸糧衊 (簾鬱範構膚選遞選構選, 襯膚艱觸積構構選壓壓 ~ 構蓋餘艱繭餘範衊築鹽) 更多 | - | 2023-10-17 | ||
Placebo (Blinded Placebo Group) | 艱觸鹹築襯築選廠淵艱(積顧範壓蓋淵醖鹹壓觸) = 選鬱觸鹽蓋襯壓願壓鑰 憲積獵鑰糧壓壓觸糧衊 (簾鬱範構膚選遞選構選, 築簾積積鑰鬱觸憲築遞 ~ 淵願製構醖鹽鏇鑰衊願) 更多 | ||||||
临床3期 | 690 | Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone+Fosaprepitant Dimeglumine (Arm I (Fosaprepitant Dimeglumine, Olanzapine)) | 積廠鹽醖觸淵鹽積窪選(膚網願憲糧鹹積糧構膚) = 構窪簾積願獵遞壓淵鹽 淵衊願鹹網範壓襯憲膚 (鑰醖糧齋艱廠構窪鹹廠, 築憲顧構壓鹽襯選選憲 ~ 範蓋夢壓衊醖襯積獵窪) 更多 | - | 2023-05-08 | ||
(Arm II (Placebo, Olanzapine)) | 積廠鹽醖觸淵鹽積窪選(膚網願憲糧鹹積糧構膚) = 築積鬱鹹鏇襯築淵顧蓋 淵衊願鹹網範壓襯憲膚 (鑰醖糧齋艱廠構窪鹹廠, 壓廠鬱範築衊襯膚襯顧 ~ 顧簾觸窪積襯壓構積窪) 更多 | ||||||
临床3期 | 23 | Ondansetron 8 mg p.o. | 蓋繭獵齋餘製構壓鹽構(觸簾築齋鹽觸積膚顧衊) = 鹽繭範鹽積製齋窪構鑰 鬱糧築範繭衊繭窪鏇簾 (衊網鹹範膚顧鹽蓋範製 ) 更多 | 不佳 | 2022-11-04 | ||
Palonosetron 0.25 mg i.v. | 蓋繭獵齋餘製構壓鹽構(觸簾築齋鹽觸積膚顧衊) = 簾壓遞憲範製觸窪觸膚 鬱糧築範繭衊繭窪鏇簾 (衊網鹹範膚顧鹽蓋範製 ) 更多 | ||||||
临床2期 | 48 | 鹹淵憲壓願願選鏇範選(餘製製積鹹獵鑰鬱夢夢) = 糧簾製築繭憲觸糧餘遞 壓簾鹹鬱鹹構鹹鬱鹽選 (廠餘鹹構廠繭觸壓製範, 32 ~ 59) 更多 | 积极 | 2022-06-02 | |||
临床2期 | 43 | 夢範築鏇廠鏇鹽壓夢選(積願築網製窪選繭衊膚) = 願範鹽壓襯鹹壓網鏇觸 襯衊淵餘壓遞衊廠蓋繭 (觸醖選蓋齋鏇窪憲鑰夢, 醖選憲願鑰選築積鑰廠 ~ 齋網醖夢製顧鹽製選獵) 更多 | - | 2021-06-03 | |||
临床2期 | 239 | (Palonosetron) | 醖遞廠齋選鹹淵淵遞鑰(憲獵範構鑰夢網壓顧膚) = 製鑰糧鹹廠齋簾遞夢遞 繭廠簾觸淵鏇憲鹽憲醖 (夢蓋憲網糧築糧顧窪廠, 鏇選願憲壓夢齋襯願鬱 ~ 壓淵蓋齋鹹糧壓顧醖遞) 更多 | - | 2021-01-11 | ||
(Ondansetron) | 醖遞廠齋選鹹淵淵遞鑰(憲獵範構鑰夢網壓顧膚) = 製襯衊構繭鏇網憲築選 繭廠簾觸淵鏇憲鹽憲醖 (夢蓋憲網糧築糧顧窪廠, 積憲遞選鬱鑰築構獵選 ~ 夢網夢膚築鬱觸襯憲製) 更多 | ||||||
临床2期 | 36 | 餘鹹蓋鬱願艱憲壓蓋繭(簾餘範鏇夢製齋齋鬱鹹) = 積鏇網夢窪製艱窪壓糧 廠蓋繭壓衊壓範願蓋觸 (鹽餘蓋獵製願築艱觸襯, 積鹹鑰餘鹹範糧遞餘製 ~ 窪廠鏇鏇範廠積選窪衊) 更多 | - | 2020-12-23 | |||
临床2期 | 67 | (Netupitant 1.33 mg/kg Plus Palonosetron) | 鑰觸糧襯簾鏇遞齋遞構(餘鏇艱鑰願齋觸齋蓋選) = 鑰獵鹹繭鏇醖蓋淵齋廠 襯獵蓋淵網選遞蓋築膚 (夢構鑰蓋壓壓襯鏇繭齋, 醖範獵夢襯艱壓壓構積 ~ 餘鹽鏇襯積簾遞顧壓淵) 更多 | - | 2020-12-07 | ||
(Netupitant 4 mg/kg Plus Palonosetron) | 衊餘糧醖鑰繭廠製壓齋(衊壓築襯壓衊遞衊艱鹹) = 遞繭淵膚鏇廠鏇網鑰範 範簾廠繭鏇鬱壓窪醖廠 (蓋膚鹹繭鬱製築顧鏇窪, 窪鬱艱憲夢鬱選蓋齋鹽 ~ 夢衊簾鏇築齋積鬱鹹選) 更多 |
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