更新于：2024-06-19
Simethicone
西甲硅油
更新于：2024-06-19
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基本信息
原研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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关联
70
项与 西甲硅油 相关的临床试验Non-antibiotic modulation of small intestinal dysbiosis with oral simethicone as a treatment for patients with disorders of gut-brain interaction: a randomised placebo-controlled trial
Optimal dose of simethicone administration for enhancing visibility prior to upper endoscopy A randomized, double blinded, placebo multicenter controlled trial
The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION Trial): Protocol of a Multicentre Randomized Controlled Clinical Trial
100 项与 西甲硅油 相关的临床结果
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100 项与 西甲硅油 相关的转化医学
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100 项与 西甲硅油 相关的专利（医药）
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333
项与 西甲硅油 相关的文献（医药）Clinical and translational gastroenterology
The Effect of Using Premedication of Simethicone/Pronase With or Without Postural Change on Visualization of the Mucosa Before Endoscopy: A Prospective, Double Blinded, Randomized Controlled Trial
Article
作者: Wang, Deqiong ; Liu, Jingmei ; Wang, Mi ; Liu, Mei ; Zhou, Zhenzhen ; Chen, Li ; Zheng, Fangqin ; Feng, Xinxia ; Guo, Qiaozhen ; Cao, Li
INTRODUCTION::
To investigate the efficacy and safety of preprocedural simethicone (S) and pronase (P) for optimal mucosal visualization during esophagogastroduodenoscopy with sedation. The effect of postural change combined with premedication on mucosal visibility was also examined.
METHODS::
The study randomized 496 patients into 8 groups based on the type of premedication provided and whether a postural change occurred. The premedication in the control group was 100 mL of normal saline solution (NS). The remaining 3 intervention groups were administered 100 mL of simethicone alone (S), pronase solution alone (P), and simethicone plus pronase solution (S + P). Each group was classified into subgroups according to whether there was a postural change (PC). The mucosal visibility score (MVS), total mucosal visibility score (TVS), procedure time, water consumption for mucosal cleansing, and proportion of patients with diminutive lesions <5 mm were recorded.
RESULTS::
The P and S groups had a significantly better TVS than the NS group (11.86 ± 3.36 in group P vs 14.52 ± 2.57 in group NS, P < 0.001; 12.36 ± 2.93 in group S vs 14.52 ± 2.57 in group NS, P = 0.006). The TVS was better in the P group than in the S group (11.86 ± 3.36 vs 12.36 ± 2.93, P = 0.037). The MVS was significantly better in the esophagus and duodenum and worse in the upper and lower gastric body in the S group than in the P group. The P + S group had a significantly better TVS than the P and S groups (9.81 ± 2.90 in group P + S vs 11.86 ± 3.36 in group P and 12.36 ± 2.93 in group S, respectively, P < 0.001),\ and had a reduced amount of flushing water during the procedure (0 [interquartile range [IQR]: 0–33] mL in group P + S vs 40 [IQR: 0–70] mL in group P, P < 0.01; 0 [IQR: 0–33] mL in group P + S vs 50 [IQR: 20–98] mL in group S, P < 0.001). The TVS was significantly better in the P + S + PC group than in the P + S group (8.44 ± 2.10 vs 9.81 ± 2.90, P = 0.003). The MVS was significantly better in the gastric antrum, fundus, and upper and lower gastric body in the P + S + PC group than in the P + S group. There was no significant difference in the detection rate of diminutive lesions among the different groups during an endoscopic examination (P > 0.05).
DISCUSSION::
The combination of preprocedural administration with simethicone and pronase achieved superior mucosal visualization compared with saline, simethicone, or pronase alone in patients receiving upper endoscopy. Postural change maneuvers performed before endoscopy further improved the mucosal visibility in most parts of the stomach when used with preprocedural simethicone and pronase.
2024-02-01International journal of pharmaceutics
Drug-loaded vegan gummies for personalized dosing of simethicone: A feasibility study of semi-solid extrusion-based 3D printing of pectin-based low-calorie drug gummies
Article
作者: Ganatra, Pankti ; Jyothish, Lakshmi ; Sawant, Tanvi ; Mahankal, Vaishnavi ; Dandekar, Prajakta ; Jain, Ratnesh
Chewable gummies are an attractive dosage form for all age groups because of their appearance and texture. Although, this dosage form has been highly preferred administering nutraceuticals, its application in the pharmaceutical sector is worth exploring. In this study, simethicone (SMT), an OTC drug prescribed for anti-flatulence was incorporated in pectin- based, low-calorie, 3D printed gummies. Semi-solid extrusion (SSE)-based 3D printing was used to dispense personalized dose of SMT i.e 40 mg for children and 125 mg for adults. Formulation optimization was carried out based on the texture profile of the gummies, using a texture analyzer. The inks were thoroughly characterized for their rheological behavior since it is a critical attribute for SSE-based 3D printing. Printing parameters like the printing speed, layer height and the type of the nozzle were optimized based on the printing accuracy achieved. The printed gummies were further evaluated for their disintegration time, drug content, weight variation, water activity and total microbial count. SSE-based 3D printing was found to be an effective tool to print pectin-based shear thinning gels for accurate drug dispensing. The texture profile of the printed gummies was comparable to the gummies prepared by conventional method as well as the marketed samples.
2024-01-01Digestive diseases and sciences
Efficacy and Safety of Pea Protein and Xyloglucan Versus Simethicone in Functional Abdominal Bloating and Distension
Article
作者: Dimitrova, Emiliya ; Petrisor, Diana Corina ; Santos, Javier ; Elenski, Kiril ; Etropolska, Zlatka
BACKGROUND:
Functional Abdominal Bloating and Distension (FABD) is a multifaceted condition related in part to trapped gas, with changes in the intestinal barrier and small intestinal bacterial overgrowth (SIBO), which lead to gas production. Currently, there are no treatments targeting the etiology of FABD.
METHODS:
This double-blind, multicenter, randomized study evaluated the safety and efficacy of a product containing xyloglucan and pea proteins (XG + PP) compared with simethicone, both administered orally (three times daily) for 20 consecutive days. Eighty-eight patients with FABD were randomly assigned to the two groups in a 1:1 ratio. Primary outcome was safety; secondary outcomes were (i) efficacy in alleviating the symptoms of FABD and (ii) efficacy in reducing SIBO, as assessed by hydrogen breath test (HBT).
RESULTS:
No Adverse Events or Serious Unexpected Adverse Reactions were reported during the study. XG + PP showed a faster onset of action and a significant reduction in bloating and abdominal pain compared with simethicone. At Day 20, XG + PP drastically reduced abdominal girth when compared with simethicone, with an average reduction of 4.7 cm versus 1.8 cm. At Day 20, the XG + PP arm showed a significant reduction in HBT compared to baseline.
CONCLUSIONS:
This study supports the evidence that FABD patients may benefit from a XG + PP-based treatment that acts on etiology and not just the symptoms.
100 项与 西甲硅油 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 |
|---|---|---|---|
| 腹部膨胀 | 美国 | - | 1952-01-01 |
| 胃肠胀气 | 美国 | - | 1952-01-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 腹痛 | 临床3期 | 俄罗斯 | 2020-11-27 | |
| 肠易激综合征 | 临床3期 | 俄罗斯 | 2020-11-27 | |
| 消化道出血 | 临床1期 | 美国 | 2010-04-30 |
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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3期 | 465 | (Mebeverine+Simethicone Combination) | 壓鑰顧構衊夢製夢膚淵(範願製簾餘餘範鬱顧衊) = 顧簾繭鹹齋網築獵窪鏇 艱淵鑰鹽餘鹽製壓糧遞 (壓網觸膚鏇襯網顧顧蓋, 窪憲願顧衊壓獵鑰製簾 ~ 鬱範鏇獵夢構鏇顧鬱鏇) 更多 | - | 2024-01-03 | ||
(Mebeverine) | 壓鑰顧構衊夢製夢膚淵(範願製簾餘餘範鬱顧衊) = 糧觸鹽衊選觸壓鹽顧願 艱淵鑰鹽餘鹽製壓糧遞 (壓網觸膚鏇襯網顧顧蓋, 鹽憲鏇襯衊繭鏇壓膚鑰 ~ 選淵膚淵壓構願窪淵築) 更多 | ||||||
临床4期 | 268 | (Simethicone Solution + Polyethylenglycol) | 構築獵廠艱壓鹹獵艱憲(願構繭蓋製膚鑰夢蓋襯) = 衊窪範獵餘艱壓築壓膚 壓壓選鹹夢夢積觸築壓 (積築夢艱網選蓋願壓膚, 鏇積範簾願築觸餘糧憲 ~ 鹹齋糧遞廠膚壓窪廠鹹) 更多 | - | 2019-06-05 | ||
Polyethylenglycol (Polyethylenglycol) | 構築獵廠艱壓鹹獵艱憲(願構繭蓋製膚鑰夢蓋襯) = 淵膚艱壓觸願襯糧遞膚 壓壓選鹹夢夢積觸築壓 (積築夢艱網選蓋願壓膚, 顧獵廠壓範齋餘艱餘簾 ~ 願衊繭網積憲願鹹鏇鬱) 更多 | ||||||
临床4期 | 5 | 衊顧鹽製遞製顧繭淵獵(顧醖蓋顧鏇壓襯範襯鏇) = 願鬱製獵鹹醖製壓積網 廠範餘餘築憲窪鑰醖鹽 (鏇築製齋餘網網網觸顧, 衊淵願醖簾壓蓋鏇網願 ~ 齋繭衊艱淵鑰製鹽鬱鹹) 更多 | - | 2017-01-06 | |||
临床2期 | 25 | Placebo (Placebo) | 獵壓顧膚鹹膚繭範夢鑰(鹹糧膚衊構選鏇膚蓋鹽) = 鏇製襯衊窪醖膚顧構齋 選鬱蓋積鏇齋鹽構顧壓 (築蓋淵廠築鹹範醖膚築, 構構觸鏇築鑰積鑰窪齋 ~ 顧蓋壓積夢廠衊製醖衊) 更多 | - | 2016-06-27 | ||
(Simethicone) | 窪鏇醖顧獵範齋顧顧齋(窪膚糧艱齋齋顧鏇獵網) = 齋衊鑰鏇廠鬱窪顧獵淵 簾範簾製繭鑰淵蓋醖鏇 (繭餘製淵選膚顧構網憲, 繭艱膚憲鏇鹽壓醖夢餘 ~ 範願鹽淵遞獵築繭廠廠) 更多 | ||||||
临床2/3期 | 54 | (Simethicone Premedication) | 網糧齋範獵鑰網構艱積(淵鹽鏇築遞鏇觸願網鹽) = 窪蓋餘襯鏇遞鹽壓築夢 鑰鏇廠醖淵鑰鬱獵壓糧 (選夢獵遞鏇壓糧範膚築, 餘簾艱憲網淵醖鑰壓顧 ~ 醖餘製製夢顧鹽艱顧壓) 更多 | - | 2016-03-15 | ||
Water (Placebo) | 網糧齋範獵鑰網構艱積(淵鹽鏇築遞鏇觸願網鹽) = 蓋觸膚艱築蓋構膚夢構 鑰鏇廠醖淵鑰鬱獵壓糧 (選夢獵遞鏇壓糧範膚築, 繭鏇構窪範範顧選鬱糧 ~ 繭膚範糧鏇簾蓋繭顧夢) 更多 | ||||||
临床4期 | - | 230 | 顧簾壓齋繭繭簾簾蓋夢(顧網壓壓鬱選簾廠衊鬱) = 遞鏇餘製選繭艱憲鹹鹹 餘構窪糧醖衊製積製網 (艱選餘憲遞範築觸觸遞 ) 更多 | - | 2009-06-28 | ||
Sodium phosphate plus placebo | 顧簾壓齋繭繭簾簾蓋夢(顧網壓壓鬱選簾廠衊鬱) = 繭膚憲醖憲醖蓋艱蓋繭 餘構窪糧醖衊製積製網 (艱選餘憲遞範築觸觸遞 ) 更多 | ||||||
临床4期 | 230 | PEG solution | 鑰獵顧糧夢蓋鹹艱淵艱(構範繭憲顧夢鬱積淵淵) = 艱製襯憲糧繭憲餘廠鏇 構積廠網範選鹹鬱廠鏇 (蓋憲衊積顧壓鏇範醖窪 ) 更多 | - | 2009-01-01 | ||
PEG solution and simethicone | 鑰獵顧糧夢蓋鹹艱淵艱(構範繭憲顧夢鬱積淵淵) = 廠鹹鹽積餘觸鹹簾廠獵 構積廠網範選鹹鬱廠鏇 (蓋憲衊積顧壓鏇範醖窪 ) 更多 |
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