The purpose of this study is to assess the target occupancy (TO) of scopolamine at M1 Muscarinic Receptors in the brain after single I.V. doses of scopolamine, in healthy control subjects, using the radiotracer [11C]EMO (also known as [11C]LSN3172176).

开始日期2025-03-01

申办/合作机构

Yale University

[+1]

ChiCTR2500097562

/ Suspended临床4期IIT

Prognostic impact of scopolamine hydrobromide injection in patients with hyperlactate septic shock: a prospective, multicentre, randomised, double-blind, placebo-parallel controlled clinical study

开始日期2025-02-22

申办/合作机构

上海交通大学医学院附属瑞金医院

PACTR202407805328722

/ Suspended临床4期IIT

Effect of hyoscine N-Butyl bromide on progress of labour and pregnancy outcome; A randomized control trial

开始日期2023-10-01

申办/合作机构-

100 项与氢溴酸东莨菪碱相关的临床结果

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100 项与氢溴酸东莨菪碱相关的转化医学

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100 项与氢溴酸东莨菪碱相关的专利（医药）

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1,208

项与氢溴酸东莨菪碱相关的文献（医药）

2025-03-01·ChemistryOpen

Synergistic Antiemetic Effects of Nerolidol on Domperidone, Hyoscine, and Ondansetron: In Vivo and in Silico Investigations on Receptor Binding Affinity

Article

作者: Torequl Islam, Muhammad ; Bhuia, Md. Shimul ; Ghosh Situ, Sharmita ; Al Hasan, Sakib ; Akber Ansari, Siddique ; Chowdhury, Raihan ; Aamer Ansari, Irfan ; Ali, Arman

AbstractThe present study was designed to measure the potential antiemetic properties of nerolidol (NDL) via in vivo and in silico studies. To induce emesis copper sulfate pentahydrate (CuSO4.5H2O) was administered at a dose of 50 mg/kg (orally) to 2‐day‐old chicks. The test sample (NDL) was given at two doses of 50 and 100 mg/kg. b.w. orally. Additionally, aprepitant (16 mg/kg), domperidone (6 mg/kg), hyoscine (21 mg/kg), ondansetron (5 mg/kg), and diphenhydramine (10 mg/kg) were given also orally as positive controls. To observe the modulatory effects of the test sample, combination therapies with reference drugs were also administered to three different groups of animals. Molecular docking and visualization of ligand‐receptor interaction were performed against several emesis‐inducing receptors (5HT3, D2, D3, H1, and M1‐M5) using diverse computational tools. Pharmacokinetics and drug‐likeness of the selected ligands were also calculated. Findings demonstrated that NDL significantly (p <0.05) dose‐dependently lessens the mean number of retches and delays the emetic onset in the chicks. The combined drug therapy with ondansetron exposed better antiemetic activity. In addition, in silico analysis, NDL has greater binding affinity (−7.3 kcal/mol) against M2 and M3 receptors. In conclusion, NDL exerted mild antiemetic activity with synergistic properties through muscarinic receptors.

2025-01-01·Gut

Combined MRI, high-resolution manometry and a randomised trial of bisacodyl versus hyoscine show the significance of an enlarged colon in constipation: the RECLAIM study

Article

作者: Gowland, Penny ; Knowles, Charles H ; Dinning, Philip ; Taylor, Stuart A ; Wilkinson-Smith, Victoria ; Wiklendt, Lukasz ; Marciani, Luca ; Hoad, Caroline Louise ; Scott, Mark ; Corsetti, Maura ; Spiller, Robin C ; Sansone, Stefano ; Atkinson, David ; Zdanaviciene, Ausra ; Coupland, Carol ; Menys, Alex

BackgroundColonic motility in constipation can be assessed non-invasively using MRI.ObjectiveTo compare MRI with high-resolution colonic manometry (HRCM) for predicting treatment response.DesignPart 1: 44 healthy volunteers (HVs), 43 patients with irritable bowel syndrome with constipation (IBS-C) and 37 with functional constipation (FC) completed stool diaries and questionnaires and underwent oral macrogol (500–1000 mL) challenge. Whole gut transit time (WGTT), segmental colonic volumes (CV), MRI-derived Motility Index and chyme movement by ‘tagging’ were assessed using MRI and time to defecation after macrogol recorded. Left colonic HRCM was recorded before and after a 700 kcal meal. Patients then proceeded to Part 2: a randomised cross-over study of 10-days bisacodyl 10 mg daily versus hyoscine 20 mg three times per day, assessing daily pain and constipation.ResultsPart 1: Total CVs median (range) were significantly greater in IBS-C (776 (595–1033)) and FC (802 (633–951)) vs HV (645 (467–780)), p<0.001. Patients also had longer WGTT and delayed evacuation after macrogol. IBS-C patients showed significantly reduced tagging index and less propagated pressure wave (PPW) activity during HRCM versus HV. Compared with FC, IBS-C patients were more anxious and reported more pain. Abnormally large colons predicted significantly delayed evacuation after macrogol challenge (p<0.02), impaired manometric meal response and reduced pain with bisacodyl (p<0.05).Part 2: Bisacodyl compared with hyoscine increased bowel movements but caused more pain in both groups (p<0.03).ConclusionAn abnormally large colon is an important feature in constipation which predicts impaired manometric response to feeding and treatment responses. HRCM shows that IBS-C patients have reduced PPW activity.Trial registration numberThe study was preregistered on ClinicalTrials.gov, Reference:NCT03226145.

2024-11-17·Cureus

Esophagogastroduodenoscopy Quality Improvement and the Role of Topical Antiperistaltic Agents: A Systematic Review and Meta-Analysis

Review

作者: Burke, Eoghan ; Harkins, Patricia ; Arumugasamy, Mayilone

Gastric cancer (GC) represents one of the most lethal forms of cancer. When identified at an early stage, conventional treatment can be curative. The key to identifying GC at an early stage is high-quality esophagogastroduodenoscopy (EGD). This has led to an increased focus on quality standards in EGD to improve the detection rates of early GC and its premalignant lesions (PMLs), such as atrophic gastritis. In Asia, the routine use of antiperistaltic (antispasmodic) agents is advocated to improve the quality of mucosal visualization during diagnostic EGD. The rationale is that the cessation of peristalsis should yield a more stable intragastric visual field to enhance the detection of early GC. Hyoscine and glucagon are commonly used as antiperistaltic agents. Both, however, must be given either intravenously or via intramuscular injection. They both also have potentially serious systemic side effects, which can limit their routine use, particularly in the elderly or co-morbid patients. As a result of these side effects, there is growing interest in using peppermint oil or L-menthol topically as anti-peristaltic agents. As these agents are applied topically (either via direct spraying during the EGD or consumed as a premedication before the EGD), they are associated with fewer adverse events than systemically applied agents. This study aimed to synthesize, for the first time, the available data on the use of topically applied anti-peristaltic agents to decrease or stop peristalsis during diagnostic EGDs. This study is a systematic review and meta-analysis of published randomized controlled trials. Its reporting is per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. This study was registered prospectively with the PROSPERO register, registration number CRD42024601488. This systematic review and meta-analysis encompassed five high-quality randomized controlled trials with a low risk of bias. All included studies were conducted in Asian countries between 2011 and 2022. They comprised 538 patients, with a mean age of 62.7. Four of the included studies look at topically applied L-menthol at 160 mg, while one study looked at the role of 160 mg of phloroglucinol administered as a 20 mL oral premedication liquid 15 minutes before the EGD. All included trials involved diagnostic EGDs and reported their primary outcomes using the same scoring systems. The primary outcome of interest for this study was the efficacy of the antiperistaltic agents at stopping peristalsis for the duration of a diagnostic EGD. We found an odds ratio of 4.22 with a 95% confidence interval ranging from 2.47 to 7.21, favoring the antiperistaltic agents in terms of attaining a peristalsis score of 1 after administration. This systematic review and meta-analysis represent the most up-to-date review on topical antiperistaltic agents during diagnostic EGD. We found that topical antiperistaltic agents effectively decrease or stop peristalsis during an EGD, and these effects persist for the duration of the EGD. Larger-scale studies will be required to determine whether their routine use translates into increased detection rates of early GC and its PMLs.

项与氢溴酸东莨菪碱相关的新闻（医药）

2025-03-05

·药筛

丁、东，654-1、2，几个关键数据后的玄机

前几天的一篇文章，我分享了氢溴酸山莨菪碱注射液的简单数据。（没有参比，独家原料，绝对的第一) 今天再简单说一下这个品种，以及相关同类品种情况。山莨菪碱算是中国式原创新药了，最早由中国医学科学院药物研究所、青海省医学科学研究所的研究人员，从我国特产茄科植物唐古特莨菪中提取的一种生物碱，分子结构、药理作用和阿托品相似，属于抗M胆碱药。据说，产品成功提取的日期是在1965年4月，因此，取名代号就是654-1。 1975年，研究人员又人工合成消旋山莨菪碱，代号654-2。由于654-2的合成成本低，容易开发，后来就有多个药品批文上市，成为了临床常用的药物。早些年，消旋山莨菪碱年销售数量五千多万支，远高于山莨菪碱。但这几年的数量差距越来越小。而山莨菪碱的注射液价仅有一个企业在生产，价格较高，这些年随着销售数量的大幅上涨，销售金额已经远远超越654-2，成为一个重磅产品。山莨菪碱和消旋山莨菪碱都没有参比制剂，因此，暂时不存在国采的风险。而同类品种，东莨菪碱就不怎么乐观了。东莨菪碱最早于1880年，由德国科学家阿尔贝特·拉登堡，首次从植物中分离纯其盐形式，目前，临床用药的剂型，主要是氢溴酸盐和丁溴酸盐两种形式。国内市场，氢溴酸东莨菪碱注射液这几年的销售额快速上涨，年销接近2亿元，远远超过了丁溴东莨菪。原因不复杂，大家可以多对比数据，就能找到。最后，附上4个品种的关键特性、数据对比，大家能看出哪些玄机呢？本文数据来源：摩熵医药，摩熵药筛小程序。用摩熵药筛小程序，快速快速评估产品！

上市批准

2025-01-08

·echemi

80 batches of drugs recalled urgently! A major decision by the National Medical Products Administration

Recently, the National Medical Products Administration announced an important decision to stop the production, sale, and use of Hyoscine Butylbromide Tablets, and to revoke its drug registration certificate. According to the announcement issued by the National Medical Products Administration on January 3, titled “Announcement on the Revocation of the Drug Registration Certificate for Hyoscine Butylbromide Tablets (2025 No. 2)”, Hyoscine Butylbromide Tablets, an antibacterial drug also known as Loperamide, will no longer circulate in the market of our country. This decision is effective immediately, and the products already on the market will be recalled by the marketing authorization holder and supervised by provincial drug regulatory authorities for destruction or other harmless disposal measures. A total of 80 batches of Hyoscine Butylbromide Tablets are involved. In addition, in another announcement issued by the National Medical Products Administration on December 2, 2024, it was also announced that 58 drug registration certificates, including 11 batches of Hyoscine Butylbromide Tablets, have been revoked. Based on Article 83 of the Drug Administration Law of the People's Republic of China and other relevant regulations, these drugs have been required to stop production and sale due to unclear efficacy, serious adverse reactions, or other hazards to human health. Hyoscine Butylbromide Tablets are a compound preparation, with the main active ingredients including Hyoscine Tincture, Sulfamethoxazole, and Trimethoprim, primarily used to treat dysentery caused by Shigella and other sensitive pathogenic bacteria causing enteritis. However, with the withdrawal of this drug from the market, other drugs such as Montmorillonite Powder will take on the responsibility for treating diarrhea. According to data from Miiine, the incidence of gastrointestinal diseases is on the rise and is becoming more prevalent among younger populations. In the first three quarters of 2022, the sales of anti-diarrheal drugs and intestinal anti-inflammatory/infection drugs in public hospitals in key provinces and cities in China exceeded 1.2 billion yuan, a year-on-year increase of 6.30%. The sales scale of Montmorillonite Powder in the three major terminal markets in China has exceeded 1 billion yuan, with the outpatient market being the main sales channel, rising by 60%, making it the Top 2 product in anti-diarrheal and intestinal anti-inflammatory/infection drugs. Statistics from Cyborg Blue show that 145 drug registration certificates were revoked in 2024. In the announcement on December 2, 2024, in addition to Hyoscine Butylbromide Tablets, it also included 3 batches of Losartan Potassium Tablets, 2 batches of Phenazone Tablets, 2 batches of Amlodipine Besylate Tablets, 2 batches of Entecavir Tablets, 2 batches of Compound Snake Gall and Chuan Bei Powder, and 2 batches of Rifampicin Capsules. Phenazone, as a pyrazolone analgesic and antipyretic, was launched early in our country, but its injection and nasal drops have severe adverse reactions, with risks outweighing benefits, and alternative medications are available, leading to its registration certificate being revoked in 2020. Although oral preparations like Phenazone Tablets still have certain clinical value, the National Medical Products Administration has implemented risk control measures by revising the instructions to add safety warnings, restricting applicable populations and indications. In the domestic market for antipyretic and analgesic drugs, Phenazone has a low market share and is declining. Data from Cyborg Blue shows that there are 861 approvals for "Phenazone Tablets," involving many companies and intense market competition. As related drug approvals are revoked, this market will face further fragmentation. Finally, according to the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, the National Medical Products Administration decided on April 11, 2024, to revoke the registration certificates for 87 drugs, including Pancreatin Injection. Cyborg Blue’s analysis found that drugs such as 7 batches of Iohexol Injection, 6 batches of Insulin Glargine Injection, 4 batches of Detemir Insulin Injection, 4 batches of Vardenafil Hydrochloride Tablets, and 3 batches of Brain Protein Hydrolysate Injection were also revoked. Please note that the number of drugs counted in the text has not been deduplicated. No. Marketing Authorization Holder Approval Number 1 Shijiazhuang Lesheng Pharmaceutical Co., Ltd. SFDA H13023949 2 Jiangzhong Pharmaceutical Co., Ltd. SFDA H36022316 3 Shijiazhuang Fourth Pharmaceutical Co., Ltd. SFDA H13023932 4 Shijiazhuang Grey Pharmaceutical Co., Ltd. SFDA H13023934 5 Handan Bailin Pharmaceutical Co., Ltd. SFDA H13023945 6 Hebei Yongfeng Pharmaceutical Co., Ltd. SFDA H13023943 7 China National Pharmaceutical Group Wuhan Zhonglian Fourth Pharmaceutical Co., Ltd. SFDA H42022497 8 Jiangsu Enhua Pharmaceutical Co., Ltd. SFDA H32025932 9 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022013 10 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022244 11 Jiangsu Chenpai Pharmaceutical Group Co., Ltd. SFDA H32025935 12 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024102 13 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024073 14 Hebei Hengli Group Pharmaceutical Co., Ltd. SFDA H13024253 15 Hebei Tianzhi Pharmaceutical Co., Ltd. SFDA H13024245 16 Hebei Dongfeng Pharmaceutical Co., Ltd. SFDA H13024170 17 Hebei Jinzhuan Pharmaceutical Co., Ltd. SFDA H13024269 18 Tianjin Baihai Pharmaceutical Co., Ltd. SFDA H12021099 19 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41024876 20 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41025013 21 Shanxi Xinxing Pharmaceutical Co., Ltd. SFDA H14023068 22 Jiangxi Jiminke Pharmaceutical Co., Ltd. SFDA H36022305 23 Suzhou Hongsun Pharmaceutical Co., Ltd. SFDA H32025897 24 Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd. SFDA H32026256 25 Guangxi Tiantianle Pharmaceutical Co., Ltd. SFDA H45021319 26 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021120 27 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021117 28 Shanghai Modern Harsen (Shangqiu) Pharmaceutical Co., Ltd. SFDA H41024989 29 Tianjin Pacific Pharmaceutical Co., Ltd. SFDA H12021100 30 Hebei Guojin Pharmaceutical Co., Ltd. SFDA H13023940 31 Hebei Kaiwei Pharmaceutical Co., Ltd. SFDA H13023920 32 Hebei Sanshi Pharmaceutical Co., Ltd. SFDA H13023928 33 Yuanda Pharmaceutical (China) Co., Ltd. SFDA H42022649 34 Shanxi Tongda Pharmaceutical Co., Ltd. SFDA H14023309 35 Shanxi Guorun Pharmaceutical Co., Ltd. SFDA H14023402 36 Shanxi Fenhe Pharmaceutical Co., Ltd. SFDA H14023200 37 Shanxi Wanhui Pharmaceutical Co., Ltd. SFDA H14023333 38 Jilin Wantong Pharmaceutical Co., Ltd. SFDA H22025288 39 Changchun Overseas Pharmaceutical Group Co., Ltd. SFDA H22026726 40 Shijiazhuang Xiehe Pharmaceutical Co., Ltd. SFDA H13024084 41 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023541 42 Kuihua Pharmaceutical Group (Hengshui) Defier Co., Ltd. SFDA H13023979 43 Shijiazhuang Kanghewai Pharmaceutical Co., Ltd. SFDA H13024261 44 Shandong Xinhua Pharmaceutical Co., Ltd. SFDA H37023523 45 Hebei Yuzhilin Pharmaceutical Co., Ltd. SFDA H13024426 46 Xinhai Yansheng Pharmaceutical Co., Ltd. SFDA H41024907 47 Fu'an Pharmaceutical Group Yantai Zhichu Pharmaceutical Co., Ltd. SFDA H37023543 48 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025139 49 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025174 50 Changchun Changqing Pharmaceutical Group Co., Ltd. SFDA H22025234 51 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41024840 52 Changzhou Kangpu Pharmaceutical Co., Ltd. SFDA H32025910 53 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41025575 54 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41024862 55 Hebei Ruicen Pharmaceutical Co., Ltd. SFDA H13023953 56 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020588 57 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020604 58 Yaodu Pharmaceutical Group Co., Ltd. SFDA H13023951 59 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023939 60 Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. SFDA H13023952 61 Tianfang Pharmaceutical Co., Ltd. SFDA H41024887 62 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41025576 63 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022412 64 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022411 65 Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. SFDA H41024834 66 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41024896 67 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41025009 68 Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. SFDA H13023994 69 Handan Furong Pharmaceutical Co., Ltd. SFDA H13024077 70 Hebei Tiancheng Pharmaceutical Co., Ltd. SFDA H13024056 71 Hebei Kangtai Pharmaceutical Co., Ltd. SFDA H13024041 72 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44025328 73 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44024963 74 Zhengzhou Furuitang Pharmaceutical Co., Ltd. SFDA H41025579 75 Chongqing Kerui Pharmaceutical (Group) Co., Ltd. SFDA H50021730 76 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41024872 77 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41024895 78 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41025012 79 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41025008 80 Tianfang Pharmaceutical Co., Ltd. SFDA H41025010

上市批准申请上市

2024-12-30

·梅斯医学

震惊！医生不能再擅自使用西地兰了？未告知患者医疗风险，多名医生被立案处罚！医生困惑：抢救时也要问患者？西地兰难道不是成品药？

医生不能再擅自使用西地兰了？未告知患者医疗风险，多名医生被立案处罚！ 12月12日，永州市公布了第二批2024年非法行医行政处罚典型案例，其中易医生、欧医生、刘医生等多名医生的处罚案件引起讨论，一时之间令很多医生不知所措，十分茫然。仔细查看这几名医生的案由，可以发现一个共同点。根据官方通报，卫生健康委卫生监督员在某县某医院检查发现，该院三名医生在为患者使用毒性药品去乙酰毛花苷（俗称西地兰）时，未向患者告知医疗风险、替代方案及未取得患者书面同意。通报表示，有一定危险性，可能产生不良后果的检查和治疗为“特殊治疗”，在以上案件中为患者使用西地兰被认定为特殊治疗（使用毒性药品），三名涉事医生违反了《医疗纠纷预防和处理条例》第十三条第一款的规定，依据《医疗纠纷预防和处理条例》第四十七条第(二)项的规定，结合《湖南省卫生健康行政处罚裁量权基准》，卫生行政部门给予该医院警告、罚款人民币壹万伍仟元整（15000.00元）的行政处罚，同时责令立即改正上述违法行为。对于以上3名医师的违法违规行为依据《中华人民共和国医师法》的有关规定对其进行另案查处。典型案例一经发出，立刻引起了医生同行们的讨论。 12月24日，陕西一名重症医学科的医生表示：“西地兰是我们常用的药物，我也曾用过西地兰抢救心衰病人，似乎都没有单独签过字。现在，你告诉我使用西地兰不签字会受到行政处罚，我以后不敢用了。西地兰这个药，都是危急情况用来抢救的，有时候需要用就赶紧用了，难道用的时候还要去找患者单独征得同意并签字吗？” 浙江一名麻醉科医生也认为：“这个药的使用，我们科室没有单独签过字，照这样说，以后使用西地兰、阿托品，是不是用一个药就要单独签一个知情同意书呢？用之前给家属照着说明书读一下这个药物的危害，强调这个药物的毒性，家属不让用，那就不用了是不是？心衰时强心最常用西地兰，如果抢救时需要详细告知药物说明、需要和家属拉扯并签写知情同意书，那耽误了时间，患者都不一定能救得过来。抢救时可能会用到多种药物，私以为，是药三分毒，哪一个药没有副作用呢，何况在这种抢救的情况下，等告知完风险后，病人都没了，还用什么药。”西地兰到底是不是毒性药品？可以肯定的是，西地兰不是原料药！众所周知，西地兰是一种快速强心药，用药后强心作用的时间比较快，在体内的代谢及排泄也快，蓄积性小，作用持续时间也短。西地兰通常采用静脉注射，适用于危重的急症患者，在短时期内可以反复、多次使用。它可快速减轻急性心衰患者的症状，是目前唯一可以减慢心率的正性肌力药物，可以快速减低房颤患者的心室率，可较好地维持心衰患者稳态。西地兰常用，有效，被视为毒性药品又是怎么一回事呢？让我们一点一点梳理有关这方面的规定，来一个清晰的认识。 1988年，中华人民共和国国务院令（国务院令第23号）正式发布《医疗用毒性药品管理办法》，其中给出了定义，医疗用毒性药品系指毒性剧烈、治疗剂量与中毒剂量相近，使用不当会致人中毒或死亡的药品。医疗用毒性药品管理品种目录具体包括：一、毒性中药品种（28种）：砒石（红、白）、砒霜、水银、生马钱子、生川乌、生草乌、生白附子、生附子、生半夏、生南星、生巴豆、斑蝥、青娘虫、红娘子、生甘遂、生狼毒、生藤黄、生千金子、生天仙子、闹羊花、雪上一枝蒿、红升丹、白降丹、蟾酥、洋金花、红粉、轻粉、雄黄。二、毒性西药品种（11种）：去乙酰毛花甙丙(去乙酰毛花苷C)、阿托品、洋地黄毒甙、氢溴酸后马托品、三氧化二砷、毛果芸香碱、升汞、水杨酸毒扁豆碱、亚砷酸钾、氢溴酸东莨菪碱、士的年。毒性药品的包装容器上必须印有毒药标志，即黑底白字的一个“毒”字，在运输毒性药品的过程中，应当采取有效措施，防止发生事故。因此，想判断一种药品是否属于毒性药品，最直观的方法就是看一看包装盒和包装瓶。到了1990年，卫生部药政局关于《医疗用毒性药品管理办法》又做了补充规定（卫药政发[90]第92号），其中表示：《医疗用毒性药品管理办法》中所列的毒性药品，西药品种是指原料药，中药品种系指原药材和饮片。不含制剂(单方制剂地方有规定的按地方规定办理)。根据定义，原料药是指尚未经过加工的药品原始形态，因此它不包含任何辅料；成品药是经过一系列严格的制备工艺加工而成的药品，它是由原料药加上适当的辅料进行加工制成的。此后，在2008年，国家又发布将A型肉毒毒素列入毒性药品管理的通知（国食药监办[2008]405号）。把1988年的《医疗用毒性药品管理办法》和1990年的《医疗用毒性药品管理办法》补充规定综合在一起，我们就有了一个非常重要的发现：西地兰（去乙酰毛花甙注射液）是一种成熟的药品，它似乎不属于原料药，它是成品药！查阅已上市的西地兰说明书可知，西地兰的辅料包括乙醇、甘油和注射用水，这些辅料用于稀释和配制药物，以确保药物的稳定性和使用的安全性。这就突然明白了，对于西药品种，如果是毒性药品，它必须是原料药，西地兰是经过一系列工艺严格制成的成品药，它是有辅料的。同意药物抢救不就是授权医生可以用药吗？难道用一个药就得签一个知情同意书？不再讨论西地兰是否属于毒性药品了，既然有同行因为给患者使用西地兰未签知情同意书，受到了处罚，那就应该引起我们的警惕：是不是以后使用一个药，就要签一个知情同意书？对此，河南一名急诊医生表示：“如果我们反复向患者交代这些药物的副作用，患者未必能明白这些专业知识。再说，本来患者放心让你治疗，你却刻意向患者交代用药的危害，反复征求同意，这反而让患者产生恐惧，若得不到患者同意，我们就不为患者治疗了吗？作为一个成熟的医生，我难道连用药自主权也没有了吗？” 常州一名心内医生认为：“如果以后专门打一堆知情同意书，用一个药签一个字，那我感觉也没治疗的必要了。我想说的是，病重告知书里患者签了同意药物抢救，难道这不是授权医生可以自行选择使用药物吗？这又从哪来了一个西地兰的知情同意书？这不是多此一举吗？” 关于在治疗中取得患者的知情同意书，永州市通报强调：根据《医疗纠纷预防与处理条例》第十三条，医务人员在诊疗活动中应当向患者说明病情和医疗措施。需要实施手术，或者开展临床试验等存在一定危险性、可能产生不良后果的特殊检查、特殊治疗的，医务人员应当及时向患者说明医疗风险、替代医疗方案等情况，并取得其书面同意；在患者处于昏迷等无法自主作出决定的状态或者病情不宜向患者说明等情形下，应当向患者的近亲属说明，并取得其书面同意；紧急情况下不能取得患者或者其近亲属意见的，经医疗机构负责人或者授权的负责人批准，可以立即实施相应的医疗措施。现在，既然西地兰被认定为“特殊治疗”药物（毒性药品），那各位同行们以后就不要懒惰了，在给患者使用时务必要取得患者的知情同意书，医生有义务详细告知患者药物的作用、潜在风险和副作用，以确保患者知情同意。反正要签的各种知情同意书很多很多，也不差这一个，当有了处罚的先例之后，还是谨慎为好，这既是保护患者也是保护自己。撰文 | 阿拉斯加宝编辑 | 阿拉斯加宝 ● 震撼！想找的医生在休班，竟投诉医生要求回来看病！急诊医生上厕所也被投诉！主任医生：以后让机器人来当医生吧！医护委屈奖很有必要！ ● 一杯茶，竟喝下上亿颗微塑料！真实泡茶场景模拟研究揭秘：微塑料已“渗透”到茶包！且能被人类肠道吸收！你还在泡茶包吗？ ● 震撼！48岁主治却领导2个副主任医师！能力强技术好，科室重用，职称却很低！职级倒挂现象频出，主治医生也能当科主任！要学习协和经验版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」立刻下载梅斯医学APP！

医药出海

100 项与氢溴酸东莨菪碱相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	S01FA02 N05CM05 A04AD01	DB00747

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
躁郁症	中国	成都第一制药有限公司	1981-01-01
妊娠剧吐	中国	成都第一制药有限公司	1981-01-01
晕动病	中国	成都第一制药有限公司	1981-01-01
中毒	中国	成都第一制药有限公司	1981-01-01
脓毒性休克	中国	成都第一制药有限公司	1981-01-01
痉挛	中国	成都第一制药有限公司	1981-01-01
麻醉	日本	KYORIN Pharmaceutical Co., Ltd.	1961-12-01
脑炎后帕金森病	日本	KYORIN Pharmaceutical Co., Ltd.	1961-12-01

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
恶心	临床3期	美国	Defender Pharmaceuticals, Inc.	2024-01-30
呕吐	临床3期	美国	Defender Pharmaceuticals, Inc.	2024-01-30
晕动病	临床3期	美国	Repurposed Therapeutics, Inc.	2019-04-22
重度抑郁症	临床3期	美国	Repurposed Therapeutics, Inc.	2018-08-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03435003 (CTgov)	临床4期	术后恶心呕吐 \| 呕吐	83	dexmedetomidine+Compazine+Total intravenous anesthesia+scopolamine transdermal+sugammadex+Reglan+Propofol+Fentanyl+Ondansetron+Aprepitant 80 mg Oral Capsule+Dexamethasone (Intervention Arm)	範夢醖齋壓蓋鹽襯繭範(壓繭餘醖餘夢鹽鬱獵鏇) = 鬱簾製醖餘齋齋積鹹鹹網膚築鬱鹽獵鹹鑰獵糧 (選衊積廠鑰構範齋衊鬱, 廠範築築簾築獵築築範 ~ 壓範鬱餘艱壓構願鹹選) 更多	-	2024-02-14
				Compazine+sugammadex+Reglan+Sevoflurane+Desflurane+Ondansetron+Dexamethasone (Control Arm)	範夢醖齋壓蓋鹽襯繭範(壓繭餘醖餘夢鹽鬱獵鏇) = 觸繭憲簾鬱築繭廠選遞網膚築鬱鹽獵鹹鑰獵糧 (選衊積廠鑰構範齋衊鬱, 網獵選齋憲積鹹鹽鬱齋 ~ 築網壓鏇壓鏇憲獵範遞) 更多
NCT05548270 (DPI-386-MS-33, Corporate Publications) 人工标引	临床3期	晕动病	503	DPI-386	(遞構觸選範觸製鏇繭廠) = Findings showed the proportion of patients that met the primary endpoint was significantly greater in the intranasal scopolamine arm compared with the placebo arm (P <.0001). Intranasal scopolamine was also found to be significantly more effective at reducing moderate to severe nausea than placebo (P <.0001). 觸膚憲構廠願憲網糧蓋 (糧蓋鹽衊簾襯選製齋膚 ) 更多	积极	2023-06-06
				Placebo
NCT02960113 (CTgov)	临床4期	恶心 \| 呕吐	240	scopolamine patch (Scopolamine Patch)	艱願蓋鑰淵淵衊顧鏇淵(蓋醖製鏇壓鑰廠淵鏇鹹) = 製觸顧鑰膚繭鹹獵簾衊願膚顧醖構蓋獵範鹹鬱 (積積壓鹹築製壓膚夢夢, 製願網鹽鏇膚淵餘壓窪 ~ 觸窪鹽繭簾願願積鹽餘) 更多	-	2022-12-28
				acupressure point P6 (Acupressure Point P6)	艱願蓋鑰淵淵衊顧鏇淵(蓋醖製鏇壓鑰廠淵鏇鹹) = 壓選窪餘鬱壓齋顧顧憲願膚顧醖構蓋獵範鹹鬱 (積積壓鹹築製壓膚夢夢, 糧膚廠鑰顧膚餘顧蓋範 ~ 鹹範廠簾鏇壓鹽網鹹願) 更多
NCT02849639 (INCREASE, CTgov)	早期临床1期	阿尔茨海默症	90	Placebo+Scopolamine patch (Placebo)	鹹憲積積願艱膚獵餘淵(衊襯夢鬱簾糧齋糧鹽網) = 齋構餘製餘遞窪襯鏇顧壓網衊廠製壓廠壓齋選 (顧糧選夢築築鑰簾簾淵, 窪襯膚願積積築窪鬱廠 ~ 願夢衊醖衊壓鹹艱鹽齋) 更多	-	2022-08-22
				Medication Therapy Management (MTM)+Scopolamine patch (Medication Therapy Management (MTM))	鹹憲積積願艱膚獵餘淵(衊襯夢鬱簾糧齋糧鹽網) = 顧窪鹹餘糧鹽齋構獵齋壓網衊廠製壓廠壓齋選 (顧糧選夢築築鑰簾簾淵, 齋築窪範願鬱衊餘選鹽 ~ 遞襯醖積願衊範鏇襯壓) 更多
NCT03029650 (CTgov)	临床4期	-	26	Intravenous scopolamine hydrobromide+Transderm Scop® (Transderm Scop®)	築製憲餘廠醖築衊齋網(餘鬱遞壓憲觸衊淵窪獵) = 繭餘築獵襯蓋鏇鬱鹹窪築繭襯糧鏇窪鹹遞艱蓋 (鏇醖範壓製鹹簾構衊網, 範膚衊糧觸願願壓醖鹽 ~ 壓壓鹹餘糧糧糧繭積襯) 更多	-	2018-06-21
				Intravenous scopolamine hydrobromide+Transderm Scop® (Intravenous Scopolamine Hydrobromide)	築製憲餘廠醖築衊齋網(餘鬱遞壓憲觸衊淵窪獵) = 選淵蓋鬱鹽遞壓壓廠範築繭襯糧鏇窪鹹遞艱蓋 (鏇醖範壓製鹹簾構衊網, 膚遞齋襯網選膚壓構鏇 ~ 衊獵遞蓋壓觸鑰衊憲構) 更多
NCT01312844 (CTgov)	临床2期	抑郁症	7	Scopolamine (Scopolamine)	膚顧窪憲鏇膚襯鏇繭窪(衊鑰網範糧獵蓋齋窪選) = 遞選製鑰窪築壓襯鬱廠餘鏇獵艱觸淵鹹夢鏇齋 (製壓製鹹壓繭遞築艱遞, 餘製選網膚獵壓簾齋糧 ~ 選窪鏇餘網築糧積鏇廠) 更多	-	2017-04-18
				Scopolamine (Placebo)	膚顧窪憲鏇膚襯鏇繭窪(衊鑰網範糧獵蓋齋窪選) = 獵艱蓋廠齋顧鹹簾遞鑰餘鏇獵艱觸淵鹹夢鏇齋 (製壓製鹹壓繭遞築艱遞, 獵構醖鹹鹽選鑰選廠窪 ~ 鹹獵膚鏇願範積廠積淵) 更多
NCT00369915 (CTgov)	临床2期	躁郁症 \| 抑郁症	17	Scopolamine (Plac/Scop)	齋鬱襯齋醖壓選積窪鹹(願憲製憲憲廠構範網積) = 憲選襯簾夢鏇襯簾淵製鹽憲鬱夢鹽齋蓋醖蓋選 (艱簾鹽襯網構簾夢鹹鏇, 鬱鏇範膚鹽築觸壓選網 ~ 醖築餘襯壓糧鹽觸壓淵) 更多	-	2016-04-29
				Scopolamine (Scop/Plac)	齋鬱襯齋醖壓選積窪鹹(願憲製憲憲廠構範網積) = 顧築繭獵艱獵糧繭簾廠鹽憲鬱夢鹽齋蓋醖蓋選 (艱簾鹽襯網構簾夢鹹鏇, 窪築鏇簾網蓋憲獵獵繭 ~ 餘網膚遞構構糧積齋蓋) 更多
NCT00659737 (CTgov)	N/A	恶心 \| 术后恶心呕吐 \| 呕吐	115	Scopolamine	網鑰膚襯繭鬱艱構鑰衊(選鑰鬱網廠齋齋夢齋繭) = 齋範鬱廠廠簾醖觸壓鑰鬱獵淵餘範積範築餘鑰 (醖壓遞獵膚醖憲鹽衊淵, 積製餘襯醖鹽襯膚網艱 ~ 鹽範艱繭醖製艱簾齋齋) 更多	-	2014-04-29
NCT00717054 (CTgov)	N/A	恶心 \| 术后恶心呕吐 \| 呕吐	115	Scopolamine+aprepitant (Aprepitant and Scopolamine Group)	遞構鑰衊築衊顧膚製廠(糧觸網繭鏇鏇夢鬱窪窪) = 蓋蓋積獵獵積範遞壓繭廠齋艱觸製淵艱網獵壓 (繭構顧製鹹鏇繭壓築製, 淵願鹽醖積壓餘簾鏇憲 ~ 願構醖淵壓簾鹹齋觸網) 更多	-	2014-04-29
				Scopolamine (Aprepitant and Scopolamine Placebo Group)	糧繭製憲顧艱遞網艱夢(觸廠壓積膚廠鑰艱蓋願) = 齋鑰網鑰構簾構蓋選網淵醖膚選築繭鏇範鏇壓 (窪餘廠獵繭夢鹹製顧製, 獵構餘鹽壓艱觸構憲範 ~ 構鹹壓夢繭製鏇願繭夢) 更多