A randomized, non-inferiority clinical trial on the safety and efficacy of midazolam oral solution combined with dexmedetomidine for sedation in children undergoing magnetic resonance imaging examinations

开始日期2026-03-31

申办/合作机构

嘉兴市妇幼保健院服务部

CTR20253105

/ Active, not recruiting临床1期

SH081012口服用浓溶液在中国健康受试者中单中心、开放、随机、单剂量、交叉的药代动力学比较研究

主要研究目的评价在健康受试者中空腹单次给予山东百诺医药股份有限公司提供的受试制剂SH081012口服用浓溶液500 mg（规格：3 mL：1 g）与特丰制药有限公司生产的参比制剂水合氯醛/糖浆组合包装500 mg[规格：水合氯醛浓缩液1.342 g：1 g/糖浆（稀释液）9 mL]药代动力学（PK）特征的相似性，评价其相对生物利用度。次要研究目的评估山东百诺医药股份有限公司提供的受试制剂SH081012口服用浓溶液的安全性、药效动力学、口感、刺激性。

开始日期2025-08-18

申办/合作机构

山东百诺医药股份有限公司

[+1]

NCT06606899

/ CompletedN/AIIT

A Comparative Study Between Efficacy of Combined Oral Melatonin With Nasal Sevoflurane Versus Combined Oral Chloral Hydrate With Nasal Sevoflurane in Sedation of Pre-school Children Undergoing Brain Magnetic Resonance Imaging

The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.
Group A: will receive oral Melatonin and nasal Sevoflurane. Group B: will receive oral Chloral Hydrate and nasal Sevoflurane. In group A, Approximately 45 to 60 min prior to the intended scan time, the children will be given syrup melatonin 3 mg. Before starting the MRI scan, nasal sevoflurane will be started after positioning of the child at a concentration of 1%.
In Group B, the child will receive oral chloral hydrate (50 mg/kg, maximum 2 g) in syrup form was given to patients requiring sedation. Before starting the MRI scan, nasal sevoflurane will be started after positioning of the child at a concentration of 1% and will be increased gradually as needed to achieve adequate level of sedation.
The child will wait on a general hospital bed in a darkened room with its parents/carers at the rest room. When the radiology technicians decide; the child could be scanned, the child will then be transported in the arms of the parents/carers. Prior to entering the scanning room, the children and parents/carers will be checked for metal to ensure safe entrance. The child will then be lifted from the bed onto the MRI scanning table. Children will be scanned with headphones. If children did not fall asleep or if they woke up.
The MRI scan will be started. After the scanning procedure, the child and its parents/carers will be allowed to go home if the child feels well. All scans will be done on a 1.5 Tesla MR system, using a regular head coil. The MRI studies will be performed during daytime, the protocol duration will range from approximately 10 to 30 min, including positioning of the patient on the scan table. In case children move, radiology technicians could pause the study till the patients is adequately sedated and stops movement. An MRI scan will be considered to have failed when; the entire MRI scan was not assessable because of movement or in the presence of moved scans

开始日期2024-09-20

申办/合作机构

Ain Shams University

100 项与水合氯醛相关的临床结果

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100 项与水合氯醛相关的转化医学

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100 项与水合氯醛相关的专利（医药）

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3,235

项与水合氯醛相关的文献（医药）

2026-04-01·ARCHIVES OF TOXICOLOGY

Immune effects of trichloroethylene: key findings of occupational hypersensitivity syndrome and its pathogenesis

Review

作者: Ito, Yuki ; Wang, Hailan ; Naito, Hisao ; Nakajima, Tamie ; Kamijima, Michihiro

Trichloroethylene (TCE) remains a versatile organic solvent used globally. In recent years, immunological occupational diseases such as hypersensitivity syndrome (HS) and systemic sclerosis (SSc) have attracted attention in terms of the number of patients and the life-threatening consequences. This review summarizes mechanisms underlying HS pathogenesis based on the available literature. TCE-HS is a disease attributable to anti-CYP2E1 autoantibodies and HLA-B13:01 as susceptibility gene and is characterized by systemic skin lesions, severe-to-moderate liver damage, fever above 38 °C, leukocytosis, lymphadenopathy, and human herpesvirus 6 (HHV6) reactivation with elevated inflammatory cytokines, which are all similar to the characteristics of drug-induced HS. TCE-HS occurs on average 1 month after the commencement of exposure to TCE, which is shorter than the corresponding period for SSc. Recent epidemiological and animal studies have clarified the mechanism of pathogenesis: the oxidative metabolites chloral hydrate, dichloroacetyl chloride, and trichloroethanol, which are produced by CYP2E1, amplify the methylation of CD4⁺ T cells and activate them, resulting in the upregulation of cytokines such as TNF-α. Subsequently, some unidentified but oxidized metabolite haptens are assumed to activate CD8⁺ T cells with HLA-B*13:01, resulting in the production of anti-CYP2E1 autoantibodies. Subsequently, HHV6 is reactivated, leading to the development of skin and hepatic injuries. Whether skin lesions develop through a pathophysiological mechanism originating from hepatic lesions or by the same mechanism as the development of hepatic lesions remains unclear. Although disease contours have been clarified, further studies are required to elucidate its pathogenesis.

2026-04-01·INTERNATIONAL DENTAL JOURNAL

Drug-Related Halitosis: A Narrative Review

Review

作者: Iranitalab, Mina ; Ouanounou, Aviv

INTRODUCTION:

This article provides a current narrative review of the medications that may cause halitosis as a side effect. Halitosis is frequently associated with important social, psychological, and emotional aspects of life; therefore, it is crucial for health care providers to be able to diagnose and manage it effectively.

METHODS:

A literature review was conducted using the PubMed and EMBASE/OVID databases between January 2015 and December 2024 to find the latest relevant articles, focusing on systematic reviews and literature published between 2020 and 2025.

RESULTS:

Medications can lead to halitosis (bad breath) either intra- or extra-orally. Research has identified several medications that may cause extra-oral halitosis as a side effect. These include ranitidine, cysteamine, certain antifungals, peppermint oil, aspirin and other NSAIDs, PX-12, silybin, disulfiram, suplatast tosilate, dimethyl sulfoxide, levocarnitine, nitrates and nitrites, paraldehyde, chloral hydrate, and iodine-containing medications. Intra-oral halitosis is mostly related to medications that cause xerostomia and MRONJ as side effects.

DISCUSSION:

Multiple groups of medications can cause intra- or extra-oral halitosis. prior knowledge about these medications and their underlying mechanisms that will lead to halitosis will enable clinicians to diagnose and manage this condition more effectively. It is also wise for clinicians to consider recreational drugs like crack, cocaine, and smokeless tobacco when looking for the underlying reason for halitosis.

SUMMARY:

Multiple groups of medications can act as an underlying cause for halitosis. However, more research is needed to monitor halitosis as an independent side effect and to investigate the mechanism by which each medication causes halitosis.

2026-01-01·BMJ Open

Midazolam oral solution for neonatal MRI: study protocol of a randomised controlled trial

Article

作者: Lu, Zhuo ; Song, Ting ; Xu, Li ; Wang, Hao ; Cheng, Zhangqin ; Cui, Yu

Introduction:

Current medications used for neonatal MRI sedation may lead to complications such as decreased oxygen saturation, apnoea and bradycardia. There has been no study investigating the application of midazolam oral solution in neonatal MRI examinations. Therefore, this study aims to observe the safety and efficacy of midazolam oral solution for sedation during neonatal MRI examinations, providing a reference for clinical application.

Methods and analysis:

We designed a double-blind randomised controlled trial. A total of 140 neonates who underwent MRI are included. The neonates are randomly assigned into two groups of n=70 each to receive either midazolam oral solution or chloral hydrate oral solution. The primary outcome indicator of the study is the success rate of sedation as assessed by the University of Michigan Sedation Scale (UMSS). In addition, the time to a UMSS score of 2 or greater after drug administration, the number of sedation remedies, the behavioural scores of the children while taking the drug and the movement scores during the MRI performed are collected as secondary outcome indicators.

Ethics and dissemination:

Ethical approval for the study was obtained from the Ethics Committee of the Chengdu Women’s and Children’s Central Hospital (Approval No. 2023 (18)−2). The study findings will be submitted for peer-reviewed publication in a scientific journal.

Trial registration number:

ChiCTR2300069996.

101

项与水合氯醛相关的新闻（医药）

2026-04-24

·中金财富证券

苑东生物公司信息更新报告：利润稳健增长创新研发驱动成长

苑东生物（688513）主要从事化学原料药和化学药制剂的研究、生产与销售。利润稳健增长，创新研发驱动成长，维持“买入”评级。 2025年公司收入13.31亿元（同比-1.36%）；归母净利润2.84亿元（同比+19.24%）；扣非归母净利润2.0亿元（同比+19.02%）。2026Q1公司收入3.26亿元（同比+6.75%，环比+4.49%）；归母净利润0.51亿元（同比-16.11%，环比-20.45%）；扣非归母净利润0.38亿元（同比-17.81%，环比+9.11%）。基于公司当前持续加大创新管线投入力度，开源证券下调2026-2027年并新增2028年盈利预测，预计2026-2028年归母净利润为3.00、3.29、3.67亿元（2026-2027年原预测为3.19、3.79亿元），EPS为1.70元、1.86元和2.08元，当前股价对应PE为39.3、35.9以及32.2倍，开源证券持续看好公司创新管线潜力，维持“买入”评级。公司高端制剂矩阵扩容，精麻特药优势巩固。公司目前已有75个高端化学药品产业化，近年新获批产品陆续贡献公司业绩增量，包括纳布啡、布托啡诺、水合氯醛糖浆、奥沙西泮、麻黄碱等，氨酚羟考酮有望近期获批贡献业绩增量。同时，原料制剂出海稳步推进，单剂量鼻喷生产线零缺陷通过FDA现场检查，原料药生产基地通过FDA现场检查；亚甲蓝注射液ANDA获得美国FDA批准，盐酸尼卡地平注射液常态化出口；EP-0216I提交美国ANDA申报，海外产品放量有望提速。创新药研发多点突破，具备全球开发潜力。公司全面布局分子胶、PROTAC、ADC、DAC、RIPTAC等核心技术平台，支撑创新发展。HP-001目前正推进Ib期单药剂量拓展和Ila期联合地塞米松联合用药，有望进击IKZF1/3分子胶领域的BIC；HP002是可透脑口服BTK-PROTAC降解剂，目前已获IND申请受理；YLSH003（靶向TF）正在进行I期剂量探索爬坡实验。自免领域，EP-0210单抗（靶向TL1A）正进行IBD的I期临床。麻醉镇痛领域，Cav2.2钙离子通道a2δ亚基调节剂EP-0226片正进行神经病理性疼痛的I期临床。公司创新平台价值有望进一步抬升公司估值。风险提示：集采降价的风险；药品研发失败的风险；产品竞争加剧的风险等。

2026-04-24

·新浪财经

苑东生物(688513)：利润稳健增长创新研发驱动成长

利润稳健增长，创新研发驱动成长，维持“买入”评级2025 年公司收入13.31 亿元（同比-1.36%）；归母净利润2.84 亿元（同比+19.24%）；扣非归母净利润2.0 亿元（同比+19.02%）。2026Q1 公司收入3.26 亿元（同比+6.75%，环比+4.49%）；归母净利润0.51 亿元（同比-16.11%，环比-20.45%）；扣非归母净利润0.38 亿元（同比-17.81%，环比+9.11%）。基于公司当前持续加大创新管线投入力度，我们下调2026-2027 年并新增2028 年盈利预测，预计2026-2028 年归母净利润为3.00、3.29、3.67 亿元（2026-2027 年原预测为3.19、3.79 亿元），EPS 为1.70 元、1.86 元和2.08 元，当前股价对应PE 为39.3、35.9以及32.2 倍，我们持续看好公司创新管线潜力，维持“买入”评级。　　公司高端制剂矩阵扩容，精麻特药优势巩固　　公司目前已有75 个高端化学药品产业化，近年新获批产品陆续贡献公司业绩增量，包括纳布啡、布托啡诺、水合氯醛糖浆、奥沙西泮、麻黄碱等，氨酚羟考酮有望近期获批贡献业绩增量。同时，原料制剂出海稳步推进，单剂量鼻喷生产线零缺陷通过FDA 现场检查，原料药生产基地通过FDA 现场检查；亚甲蓝注射液ANDA 获得美国FDA 批准，盐酸尼卡地平注射液常态化出口；EP-0216I 提交美国ANDA 申报，海外产品放量有望提速。　　创新药研发多点突破，具备全球开发潜力　　公司全面布局分子胶、PROTAC、ADC、DAC、RIPTAC 等核心技术平台，支撑创新发展。HP-001 目前正推进Ib 期单药剂量拓展和Ila 期联合地塞米松联合用药，有望进击IKZF1/3 分子胶领域的BIC；HP002 是可透脑口服BTK-PROTAC降解剂，目前已获IND 申请受理；YLSH003（靶向TF）正在进行I 期剂量探索爬坡实验。自免领域，EP-0210 单抗（靶向TL1A）正进行IBD 的I 期临床。麻醉镇痛领域，Cav2.2 钙离子通道a2δ亚基调节剂EP-0226 片正进行神经病理性疼痛的I 期临床。公司创新平台价值有望进一步抬升公司估值。　　风险提示：集采降价的风险；药品研发失败的风险；产品竞争加剧的风险等。

2026-04-24

·东方财富网

公司信息更新报告：利润稳健增长，创新研发驱动成长

苑东生物(688513) 利润稳健增长，创新研发驱动成长，维持“买入”评级 2025年公司收入13.31亿元（同比-1.36%）；归母净利润2.84亿元（同比+19.24%）；扣非归母净利润2.0亿元（同比+19.02%）。2026Q1公司收入3.26亿元（同比+6.75%，环比+4.49%）；归母净利润0.51亿元（同比-16.11%，环比-20.45%）；扣非归母净利润0.38亿元（同比-17.81%，环比+9.11%）。基于公司当前持续加大创新管线投入力度，我们下调2026-2027年并新增2028年盈利预测，预计2026-2028年归母净利润为3.00、3.29、3.67亿元（2026-2027年原预测为3.19、3.79亿元），EPS为1.70元、1.86元和2.08元，当前股价对应PE为39.3、35.9以及32.2倍，我们持续看好公司创新管线潜力，维持“买入”评级。公司高端制剂矩阵扩容，精麻特药优势巩固公司目前已有75个高端化学药品产业化，近年新获批产品陆续贡献公司业绩增量，包括纳布啡、布托啡诺、水合氯醛糖浆、奥沙西泮、麻黄碱等，氨酚羟考酮有望近期获批贡献业绩增量。同时，原料制剂出海稳步推进，单剂量鼻喷生产线零缺陷通过FDA现场检查，原料药生产基地通过FDA现场检查；亚甲蓝注射液ANDA获得美国FDA批准，盐酸尼卡地平注射液常态化出口；EP-0216I提交美国ANDA申报，海外产品放量有望提速。创新药研发多点突破，具备全球开发潜力公司全面布局分子胶、PROTAC、ADC、DAC、RIPTAC等核心技术平台，支撑创新发展。HP-001目前正推进Ib期单药剂量拓展和Ila期联合地塞米松联合用药，有望进击IKZF1/3分子胶领域的BIC；HP002是可透脑口服BTK-PROTAC降解剂，目前已获IND申请受理；YLSH003（靶向TF）正在进行I期剂量探索爬坡实验。自免领域，EP-0210单抗（靶向TL1A）正进行IBD的I期临床。麻醉镇痛领域，Cav2.2钙离子通道a2δ亚基调节剂EP-0226片正进行神经病理性疼痛的I期临床。公司创新平台价值有望进一步抬升公司估值。风险提示：集采降价的风险；药品研发失败的风险；产品竞争加剧的风险等。

100 项与水合氯醛相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00265	-	N05CC01	DB01563

研发状态

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适应症	国家/地区	公司	日期
镇静	中国	特丰制药有限公司	2019-12-30

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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


NCT02239445 (Pubmed \| Paediatr Anaesth)	临床4期	镇静	158	Second oral dose chloral hydrate 25 mg/kg	鏇鹹網齋選築衊觸衊顧(衊衊襯鑰艱衊廠鏇選壓) = 齋網簾齋窪構艱壓積蓋鹽夢壓築鹹簾鹽齋膚齋 (襯齋壓範餘鏇構蓋範網 )	-	2016-03-01
				Intranasal dexmedetomidine 1 mcg/kg	鏇鹹網齋選築衊觸衊顧(衊衊襯鑰艱衊廠鏇選壓) = 壓鹽範艱簾廠鬱淵製願鹽夢壓築鹹簾鹽齋膚齋 (襯齋壓範餘鏇構蓋範網 )
NCT01255904 (CTgov)	临床4期	镇静	90	Placebo+Dexmedetomidine (Oral Placebo and Intransal Dexmedetomidine)	選觸鹹選廠齋範餘膚築(顧繭齋選鏇獵夢顧範遞) = 襯網觸願鹹淵蓋鑰選夢憲選鏇製廠顧壓簾鹹窪 (鏇醖蓋網鹽鬱觸鏇糧夢, 願憲憲蓋繭範築獵簾範 ~ 齋餘範簾憲艱鹽鹹齋鏇) 更多	-	2016-02-22
				Placebo+Chloral Hydrate (Oral Chloral Hydrate and Intranasal Placebo)	選觸鹹選廠齋範餘膚築(顧繭齋選鏇獵夢顧範遞) = 廠選餘衊淵夢範鹹繭繭憲選鏇製廠顧壓簾鹹窪 (鏇醖蓋網鹽鬱觸鏇糧夢, 衊艱網顧鬱糧餘艱壓積 ~ 簾艱衊膚衊範齋鬱鏇製) 更多
NCT01128270 (CTgov)	临床1/2期	-	27	Chloral Hydrate+DCA (2A) (Therapeutic Chloral Hydrate and DCA (2A))	願遞鑰餘構鹹襯餘蓋糧(遞鹽鑰襯淵醖醖選糧積) = 餘艱廠製繭繭顧觸糧憲淵遞鹽製膚齋觸觸製積 (襯壓積構鏇衊醖觸窪築, 0.40) 更多	-	2014-05-07
				Chloral Hydrate (Therapeutic Chloral Hydrate (2B))	繭餘選鬱憲齋窪遞範遞(衊簾鏇衊構簾選選鏇選) = 簾獵積鑰鏇齋構鏇衊簾遞構顧糧糧構觸鹽鹽窪 (鹽襯襯築顧艱繭壓憲鑰, 1403) 更多