主要研究目的：按有关生物等效性试验的规定，选择Opella Healthcare为持证商的盐酸屈他维林片（商品名：NO-SPA；规格：40mg）为参比制剂，对石家庄四药有限公司生产并提供的受试制剂盐酸屈他维林片（规格：40mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂盐酸屈他维林片（规格：40mg）和参比制剂盐酸屈他维林片（商品名：NO-SPA；规格：40mg）的安全性。

开始日期2023-12-03

申办/合作机构

石家庄四药有限公司

CTR20232627 / CompletedN/A

盐酸屈他维林片生物等效性试验

主要研究目的评价中国健康成年受试者空腹及餐后条件下单次单剂量口服江西亿友药业有限公司生产的盐酸屈他维林片（受试制剂，规格：40mg）和Opella Healthcare France SAS持证的盐酸屈他维林片（参比制剂，商品名：NO-SPA®，规格：40mg）后的药代动力学特点和生物等效性。次要研究目的研究盐酸屈他维林片的受试制剂（规格：40mg）和参比制剂（NO-SPA®，规格：40mg）在中国健康成年受试者中的安全性。

开始日期2023-08-28

申办/合作机构

江西亿友药业有限公司

CTR20231562 / CompletedN/A

中国健康受试者空腹和餐后单次口服盐酸屈他维林片的随机、开放、两序列、两周期、双交叉设计的生物等效性试验

主要目的： 1.研究空腹单次口服盐酸屈他维林片受试制剂（40mg，江苏联环药业股份有限公司）与盐酸屈他维林片参比制剂（NO-SPA®，40mg，Sanofi-Aventis公司）后屈他维林在中国健康受试者体内的药代动力学行为，评价空腹口服两种制剂的生物等效性。 2.研究餐后单次口服盐酸屈他维林片受试制剂（40mg，江苏联环药业股份有限公司）与盐酸屈他维林片参比制剂（NO-SPA®，40mg，Sanofi-Aventis公司）后屈他维林在中国健康受试者体内的药代动力学行为，评价餐后口服两种制剂的生物等效性。次要目的：评价中国健康受试者单次口服盐酸屈他维林片受试制剂和参比制剂后的安全性。

开始日期2023-06-01

申办/合作机构

江苏联环药业股份有限公司

100 项与胆道痉挛相关的临床结果

登录后查看更多信息

100 项与胆道痉挛相关的转化医学

登录后查看更多信息

0 项与胆道痉挛相关的专利（医药）

登录后查看更多信息

114

项与胆道痉挛相关的文献（医药）

2024-09-01·Radiology Case Reports

Ascending cholangitis in a child: A rare case of biliary Ascariasis visualized by ultrasound

Article

作者: Salah, Fathia Omer ; Kebede, Assefa Getachew ; Ebsa, Yoseph Gugsa ; Tesfaye, Yenewub Muluken ; Abera, Michael Teklehaimanot ; Abdela, Abubeker Fedlu

Biliary ascariasis, resulting from the infestation of the biliary system by the roundworm Ascaris lumbricoides, is a rare but important cause of biliary blockage in children. In this case report, we present the clinical and radiological findings of a child who presented with symptoms and signs of ascending cholangitis, which followed biliary ascariasis. Double tube sign, typical for biliary ascariasis, was visualized on real time abdominal ultrasound examination.

2024-08-01·British Journal of Haematology

Comorbidities and complications in adult and paediatric patients with pyruvate kinase deficiency: Analysis from the Peak Registry

Article

作者: Yan, Yan ; McGee, Bryan ; Boscoe, Audra N. ; Glenthoej, Andreas ; Glader, Bertil ; Bianchi, Paola ; Kuo, Kevin H. M. ; Grace, Rachael F. ; Li, Junlong ; Lander, Carl ; van Beers, Eduard J.

SummaryPyruvate kinase (PK) deficiency, a rare, congenital haemolytic anaemia caused by mutations in the PKLR gene, is associated with many clinical manifestations, but the full disease burden has yet to be characterised. The Peak Registry (NCT03481738) is an observational, longitudinal registry of adult and paediatric patients with PK deficiency. Here, we described comorbidities and complications in these patients by age at most recent visit and PKLR genotype. As of 13 May 2022, 241 patients were included in the analysis. In total, 48.3% had undergone splenectomy and 50.5% had received chelation therapy. History of iron overload (before enrolment/during follow‐up) was common (52.5%), even in never‐transfused patients (20.7%). Neonatal complications and symptoms included jaundice, splenomegaly and hepatomegaly, with treatment interventions required in 41.5%. Among adults, osteopenia/osteoporosis occurred in 19.0% and pulmonary hypertension in 6.7%, with median onset ages of 37, 33 and 22 years, respectively. Biliary events and bone health problems were common across PKLR genotypes. Among 11 patients who had thromboembolic events, eight had undergone prior splenectomy. Patients with PK deficiency may have many complications, which can occur early in and throughout life. Awareness of their high disease burden may help clinicians better provide appropriate monitoring and management of these patients.

2024-07-01·The American Journal of Emergency Medicine

Association of biliary distention with a diagnosis of acute cholecystitis

Article

作者: Herbst, Meghan Kelly ; Lotterman, Seth ; Cannata, David ; Anslip, Abeid ; Herbst, Timothy ; She, Trent ; Chin, Kyle A

BACKGROUNDGallbladder distention has been described in radiology literature but its value on point-of-care ultrasound (PoCUS) performed by emergency physicians is unclear. We sought to determine the test characteristics of gallbladder distention on PoCUS for cholecystitis (acute or chronic), and secondarily whether distention was associated with an obstructing stone-in-neck (SIN), acute cholecystitis on subsequent pathology report, and longer cholecystectomy operative times.METHODSThis was a dual-site retrospective cohort study of all Emergency Department (ED) patients that underwent diagnostic biliary PoCUS and were subsequently admitted from 11/1/2020 to 10/31/2022. Patients with pregnancy, liver failure, ascites, hepatobiliary cancer, prior cholecystectomy, or known cholecystitis were excluded. Gallbladder distention was defined as a width ≥4 cm or a length ≥10 cm. Saved ultrasound images were reviewed by three independent reviewers who obtained measurements during the review. Test characteristics, Cohen's kappa (κ), and strength of association between distention and our variables (acute cholecystitis on pathology report and SIN on PoCUS) were calculated using a Chi Square analysis, where intervention (cholecystectomy, percutaneous cholecystostomy, or intravenous antibiotics) was used as the reference standard for AC. A one-tail two sample t-test was calculated for mean operative times.RESULTSOf 280 admitted patients who underwent ED biliary PoCUS, 53 were excluded, and 227 were analyzed. Of the 227 patients, 113 (49.8%) had cholecystitis according to our reference standard, and 68 (30.0%) had distention on PoCUS: 32 distended by both width and length, 16 distended by width alone, and 20 distended by length alone. Agreement between investigators was substantial for width (κ 0.630) and length (κ 0.676). Distention was 85.09% (95% CI 77.20-91.07%) specific and 45.1% (95% CI 35.8-54.8%) sensitive for cholecystitis. There was an association between distention and SIN; odds ratio (OR) 2.76 (95% CI 1.54-4.97). Distention of both length and width was associated with acute over chronic cholecystitis; OR 4.32 (95% CI 1.42-13.14). Among patients with acute cholecystitis, mean operative times were 114 min in patients with distention and 89 min in patients without distention (p = 0.03).CONCLUSIONGallbladder distention on PoCUS was specific for cholecystitis (acute or chronic), and associated with SIN, acute cholecystitis on subsequent pathology report, and longer cholecystectomy operative times. Measurement of gallbladder dimensions as part of the assessment of cholecystitis may be advantageous.

项与胆道痉挛相关的新闻（医药）

2023-11-23

·米内网

【关注】联环药业冲击首仿，1600亿市场再掀波澜

精彩内容日前，CDE官网显示，江苏联环药业的盐酸屈他维林片以仿制3类报产获受理，有望拿下该产品首仿。截至目前，公司在消化系统及代谢药领域已拥有7款产品生产批文，其中，盐酸屈他维林注射液为首家过评。米内网数据显示，2022年中国公立医疗机构终端消化系统及代谢药销售规模超过1600亿元。不久前，江苏联环药业的奥美沙坦酯氨氯地平片报产获CDE受理，目前在审评审批中。来源：米内网项目进度数据库盐酸屈他维林是异喹啉衍生物，为直接作用平滑肌细胞的亲肌性解痉药。用于胃肠道平滑肌痉挛，应激性肠道综合征；胆绞痛和胆道痉挛，胆囊炎、胆囊结石、胆道炎；肾绞痛和泌尿道痉挛，肾结石、输尿管结石、肾盂肾炎、膀胱炎；子宫痉挛，痛经、先兆流产、子宫强直。2022年中国公立医疗机构终端胃肠解痉药/抗胆碱药和胃动力药通用名TOP10来源：米内网中国公立医疗机构药品终端竞争格局屈他维林近年近年在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端市场规模稳步攀升，2022年销售额超过1亿元，同比略有增长，是胃肠解痉药/抗胆碱药和胃动力药通用名TOP10，江苏联环药业的市场份额最大。屈他维林批文情况来源：米内网中国上市药品（MID）数据库米内网数据显示，屈他维林已上市产品有盐酸屈他维林注射液和盐酸屈他维林片，其中，盐酸屈他维林注射液有4家企业拥有生产批文，仅有江苏联环药业1家过评，成都倍特药业、陕西丽彩药业、北京沃邦医药3家均以仿制4类报产在审，获批后视同过评；盐酸屈他维林片仅赛诺菲1家拥有生产批文，江苏联环药业1家报产在审，有望拿下首仿。截至目前，江苏联环药业在消化系统及代谢药领域已拥有奥美拉唑肠溶胶囊、盐酸托烷司琼注射液等7款产品生产批文，其中，盐酸屈他维林注射液为首家过评。在2022年中国公立医疗机构终端消化系统及代谢药销售规模超过1600亿元，是仅次于抗肿瘤和免疫调节剂的化学药治疗大类。资料来源：CDE官网、米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

一致性评价