Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions in Gynecological Laparoscopic Surgery

At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.
The main questions it aims to answer are:
whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;
whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.
Participants will:
Induction of anesthesia with the experimental drug or placebo；
5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；
To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded.

开始日期2024-06-01

申办/合作机构

华中科技大学同济医学院附属同济医院

100 项与异戊巴比妥钠相关的临床结果

登录后查看更多信息

100 项与异戊巴比妥钠相关的转化医学

登录后查看更多信息

100 项与异戊巴比妥钠相关的专利（医药）

登录后查看更多信息

1,889

项与异戊巴比妥钠相关的文献（医药）

2024-08-01·Pain and Therapy

Effect of Intravenous Sodium Pentobarbital on Pain and Sensory Abnormalities in Patients with Chronic Non-Cancer Pain: Narrative Literature Review, Research Study, and Illustrative Case Reports

Article

作者: Lakha, Shehnaz Fatima ; Mailis, Angela

INTRODUCTION:

Sodium pentobarbital (SP), a short- to intermediate-acting barbiturate, has limited information in the existing literature. The objectives of this study are to describe (a) the effect of intravenous (IV) SP infusion on pain and sensory abnormalities, and (b) its utility in the diagnosis and management of patients with chronic pain.

METHODS:

A narrative review of barbiturate applications for chronic pain was followed by a pragmatic study of 176 consecutive patients admitted to an inpatient pain unit (2004-2009). We collected demographic information upon admission, diagnoses retrieved from chart review, and pain ratings and sensory abnormalities at baseline and after blinded infusion of normal saline (NS) followed by SP.

RESULTS:

The study group consisted of 83 men and 93 women (mean age 41 ± 11 years); the mean NS dose was 7.8 ± 2.3 (range 2-10 ml), the SP dose was 223.8 ± 88 mg (range 40-420), and the numeric rating scale (NRS) baseline pain score was 6.0 ± 2. The mean reduction in NRS reached both statistical and clinical significance in 150 responders to either NS/SP or SP only. Collectively, we found (a) an extremely high rate of response to IV SP irrespective of the underlying pathology, (b) greater response for pain than for sensory abnormalities (sensory gains or deficits), (c) greater response for sensory gain than for sensory deficit, and (d) greater response for allodynia than for pinprick hyperalgesia. Illustrative case reports are also presented.

DISCUSSION:

IV SP infusion is a diagnostic tool that assists in elucidating pain generators and the nature of sensory abnormalities (central vs. peripheral), with effects similar to those of IV sodium amytal. The test cannot be viewed as a tell-all diagnostic modality and must be used in conjunction with clinical judgment, investigations, and psychological reports.

2024-05-01·Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery

Super-selective Wada test for pre-surgical leg motor function assessment: A case report

Article

作者: Dashti, Shervin ; Sah, Jeetendra ; Kuruvilla, Alexander ; Mutchnick, Ian ; Stilp, Rebecca ; Karakas, Cemal ; Sadle, Charles J ; Karia, Samir

INTRODUCTION:

Wada test is well-known to assess lateralization of memory and language functions; however, super-selective Wada (ss-Wada) to evaluate motor leg function is rare. We present a ss-Wada test within the anterior cerebral artery (ACA) to assess the motor function of the leg.

METHODS:

Retrospective chart review.

RESULTS:

Comprehensive phase-I/II surgical evaluation revealed an ictal focus around the left post-central gyrus with immediate involvement around the left para-central regions. To avoid potential right leg motor dysfunction with the surgery, the patient underwent a ss-Wada procedure. Angiography revealed bilateral ACAs were supplied by the left A1 segment. Super-selective microcatheter injection of amobarbital into the left ACA was performed to avoid cross-filling the contralateral ACA. The ss-Wada test confirmed no right leg motor impairment. Afterward, a craniotomy with direct cortical stimulation confirmed that the left-sided ictal/peri-ictal zone had no clear leg motor function. The patient underwent disconnection of that region and remained seizure-free at 10-month post-op follow-up without any motor or sensory deficits in the right limbs.

CONCLUSION:

This case demonstrates the proof of concept for ss-Wada in assessing lower extremity motor function. The ss-Wada procedure accurately predicted no motor deficits in the right leg, consistent with preserved motor function post-surgery.

2024-01-01·Methods in molecular biology (Clifton, N.J.)

Analysis of Barbiturates in Urine by LC-MS/MS

Article

作者: Horne, Hunter ; Ketha, Hemamalini ; Janis, Gregory ; Campbell, Matthew

In the method described here, an aliquot of a urine sample is analyzed to detect barbiturates through dilution and ultra-high-performance chromatography-tandem mass spectrometry (UPLC-MS/MS) using deuterated internal standards. This assay detects the presence of nine barbiturate drugs-amobarbital, barbital, butalbital, butabarbital, mephobarbital, secobarbital, pentobarbital, phenobarbital, and thiopental. This protocol describes two LC separation methods-first LC method (2.2 min/sample) is intended to be used as a first step of the analysis that does not separate amobarbital and pentobarbital, and a second, longer (2.7 min/sample) LC method is intended to be used only for samples which have a peak in the amobarbital/pentobarbital retention time on the shorter LC method. Since the frequency at which amobarbital and pentobarbital are observed in clinical populations is low, the shorter LC method helps gain efficiency in a high-volume laboratory environment. Additional features of this protocol that help in efficiency gain are automated extraction using Hamilton™ liquid handling system and algorithmic data review using Ascent™ software.

项与异戊巴比妥钠相关的新闻（医药）

2024-11-24

·药事纵横

药物溶解度影响因素在药物研发过程中的应用

溶解度作为化合物的一个基本的理化性质，在药物的研发中起着举足轻重的地位。通常在拿到一个新的药物分子，我们会进行处方前的研究，而对于溶解度的测定又是研发工作的重中之重。根据化合物结构特点和溶解度数据，就可以判定是pH依赖，还是非pH依赖，并绘制pH-溶解度曲线。对弱酸或弱碱性药物辅助以其pKa，我们可以知道这个化合物在某个pH条件下，化合物离子型与分子型存在的大致比例，以此可以判断这个化合物的亲水与亲脂性情况（LogD），与人体复杂的pH微环境联系起来，可能研究更加有意义。药物分子制备成一定的制剂形式，通过口腔或者其他的胃肠道给药，药物只有溶解成分子（也有说法说离子形式也可以跨膜），才能渗透到胃肠道内，进入毛细血管，经历肝的首过效应，进去体循环，然后向靶组织，靶细胞分布，最后才能发挥作用。获取化合物的溶解度，基于BCS分类系统，大致可以判断此化合物溶解性情况（对于创新药的研发早期，最高剂量单位的药物即为目前研究的规格），大致可以判断这个化合物在某个pH条件下可能存在有区分力的溶出曲线（暂时的有区分力，保证批次间产品质量一致，区分力与否需要临床数据来验证）的可能；当然基于药物属于不同BCS分类，其制剂处方工艺开发的策略也是不尽相同的。溶解度是我们在药物开发过程中需要格外关注的药物的理化性质，它很重要，但是它又受很多的影响因素的影响，比如自身结构特征，pH，温度，多晶型等。所以这篇文章，我们向简单通过多个案例向大家介绍一下：化合物溶解度的影响因素们。 a.化合物结构结构决定性质。化合物的结构特征是决定化合物理化性质的基本。一般来说，能与水形成氢键的基团越多，化合物的水溶性越强，这样就要多多关键化合物的氢键受体（O和N）与氢键的供体（NH和OH）。当然，疏水键越多，效果反之。案例1.同一母核，不同的结构修饰造就不同的溶解度。异戊巴比妥与巴比妥结构的母核相同，异戊巴比妥多了一条更长的烃基链溶解度急剧降低。在化合物筛选的过程，为了保持药效与药物理化性质的平衡，在满足一定药效的前提下，我们可以就可能使我们候选化合物有一个比较好的类药性。 b.溶液中引入化合物的物理状态化合物可以以多种物理状态所存在。在制剂研发阶段，基本已经选定了确定的开发的晶型，一般为热力学最稳定的形式。因为热力学最稳定的形式才不容易发生转晶，一旦晶型转变，我们制剂的物理稳定性，化学稳定性，原辅料相容性，溶解性甚至相关机械性能都会发生变化。所以必须保证研发过程及药物货架期晶型稳定，以保证药物的质量符合要求。案例2：转晶导致溶出降低，造成生物利用度降低。利托那韦由雅培开发，是一种新型蛋白酶抑制剂，用于治疗获得性免疫缺陷综合症（AIDS）。1995年12月进行了新药申报，1996年3月通过FDA批准，以半固体胶囊和液体制剂的形式上市。但仅仅上市两年后，产品由于质量问题被迫全部撤市。经排查，原因是生成了之前从未发现的另一种晶型Form II。与已经上市的亚稳晶型Form I相比，Form II的溶解度显著下降，因此出现了药物大量析出和溶出测试不合格的情况。1999年，利托那韦最终重新开发了制剂并获得批准，然后重新投放市场。据估计，该公司的收入损失超过2.5亿美元。案例3 药物分子以无定型形式存在制备固体分散体提高药物溶解度。同种物质可能有多种不同晶型，但在一定的温度和压力条件下，多晶型中最稳定的一种称为稳定型，而其它的晶型都划归为亚稳定型。相同化学结构的药物既能形成不同晶型的结晶，也能够成为无结晶性的状态，即无定形粉末或简称无定形。无定形固体分散体药物可以提高溶出速率，其原理基于3个因素:晶体破格能量，空化能量以及溶解能量。晶体破格能量可以将排列整齐的晶体分裂成单个分子，然后空化能量在水分子中制成一个能够容纳单个小分子的洞穴，最后溶解能量可以让溶质与溶剂能够比较好的结合在一块。相比而言，晶体破格能量在3种因素中是最为重要的，是增加溶解度的主要驱动力。而无定形固体分散体的形成可以破坏传统的晶格，最小化晶体破格所需能量，增加药物溶解度，使药物迅速溶出。但是固体分散体仍旧存在难以避免的问题-老化。因为难溶药物的无定型态是高能态，高能态必向低能态转化，也就是析晶或转晶。尽管如此目前已经30以上以固体分散体技术上市的药物。 c.溶剂的种类溶解的基本原理是相似相溶，不同的溶剂对于药物来说，相似性肯定是不尽相同的，那么，我们药物在不同的溶剂条件下，溶解度一定也是不一样的。与其更多的关注化合物在有机溶剂如乙醇，丙酮等的溶解度，我们似乎还可以考虑一下生物相关溶出介质。我们通常会仔细的研究化合物在缓冲液溶液中的溶解度，而我们的药物最终是需要进入人体去挥发作用的，如何真实反应化合物在人体的情况，我们不妨去研究一下化合物在人工肠液人工胃液中化合物的溶解度，一般情况，在在人工肠液人工胃液中化合物的溶解度的药物溶解度要大于在对应的缓冲溶液中的溶解度。案例4：在小肠中，从胆囊分泌的胆汁进入十二指肠导致肠道中胆酸盐和磷脂的浓度增高，即使在空腹状态下，也会形成混和胶束，改善固体颗粒的润湿性并通过胶束提高药物的溶解度。进食可以进一步刺激胆酸盐和磷脂的释放，显著的影响药物的溶出速率。 d．溶液成分（例如盐、离子、蛋白质、脂类、表面活性剂）化合物添加到不同的溶液中，因为溶液的组成不同也会影响化合物的溶解度情况。比如药物进入血液循环，药物将会与血浆蛋白结合，高结合率将会限制有利药物在组织中的浓度，在一定意义上，药物溶解度是不是降低了。当然，添加表面活性剂、脂类或者化合物制备成盐型，通常可以提高化合物的溶出速率。案例5：同离子效应降低药物的溶解度。若药物的解离型或盐型是限制药物溶解的组分,则溶液中相关离子的浓度则可影响药物的溶解度。通常向难溶性盐类饱和溶液中加入含有相同离子的化合物时,其溶解度降低,称为同离子效应(common-ion effect)。如许多盐酸盐类药物在0.9%氯化钠溶液中的溶解度比在水中低。同离子效应通常表现为药物在某溶液中溶解度的降低或升高、弱酸弱碱性药物解离度的变化以及药物透膜速度的变化等。盐酸普萘洛尔本身为一种盐酸盐,所以可以认为,在0.1moL盐酸溶液中药物释放之所以缓慢,是与同离子效应的影响有关，即与溶液中氯离子的作用有关，药物溶解度降低，进而减缓药物的溶出速率。 e.pH 药物分子中20%为酸性药物，75%为碱性药物或者两性药物，仅仅5%的药物为中性药物。对于弱酸弱碱性药物来说，在不同pH的溶液中可以发生不程度的解离，其将呈现不同比例的离子化状态与分子状态。一般情况，化合物发生解离后，可以通过离子作用力与溶剂分子结合，一般的相互作用力(强度)大小排序:离子键>共价键(配位键)>氢键>分子间作用力，故解离态的化合物溶解度要大于分子态化合物的溶解度。也就是化合物解离态的比例越大，其溶解度越大。所以，对于碱性药物，当pH>pKa，分子态比例增多，离子态比例减少，化合物溶解度降低。酸性药物，反之。案例6：pH依赖药物溶解度随pH的变化而变化。 f.其他（温度，平衡时间，分离技术，检测手段）有些化合物溶解度受温度影响比较大，我们测定其溶解度就要刻意保证取样，测定这个过程中温度保持恒定，以免化合物出现沉淀；在我们进行平衡溶解度测定时，我们通常会平衡24h，48h甚至72h，一般情况下，认为在两个时间点，化合物溶解度测定数据不再发生变化，认为化合物达到了动态平衡；分离技术有的时候也会对溶解度产生影响，比如离心或者过滤，离心过程难以保证温度，过滤难以保证化合物会不会发生吸附，这个都需要我们去验证与摸索；不同的检测仪器可能灵敏度不同，也会对检测结果产生些许影响。新药研发过程中，除了关注药物的安全性，稳定性，提高药物在体内的生物利用度将将是我们首要目标。但是，面对越来越多的溶解度比较差的化合物，无形中增加了药物研发的难度。那么，我们更加需要更多的关注影响溶解度的因素，从全局谋划策略，以达到溶解度测定准确（温度，平衡时间，分离技术，检测手段）；从顶层设计平衡药效与药物性质的关系（化合物结构）；万般无奈可以选择固定分散体技术（化合物物理状态），提高药物溶解度；更加关注人体内胃肠道药物的溶解情况（pH，生物相关介质）。从上面的案例，我们可以知道，化合物的溶解度，并不是测个数值那么容易。从前期化合物的筛选直道化合物进去人体，无不需要仔细考量与关注。文章最后，以一小诗作结：纸上得来终觉浅,绝知此事要躬行。参考文献： 1 抗病毒药利托那韦的晶型与药效 2 药物固体分散体技术回顾与展望。 3 现代药剂学，平其能. 4 同离子效应对盐酸普萘洛尔渗透泵片释药速率的影响. 5 口服固体制剂研发理论与实践 6 生物药剂学在药学研发中的应用 7 多个重磅品种年销售额超10亿美元！浅析固体分散体品种分类及市场前景 8 类药性质：概念、结构设计与方法从ADME到安全性优化 9 Dealingwith the Impact of Ritonavir Polymorphs on the Late Stages of Bulk Drug ProcessDevelopment. 10 OralLipid-Based Formulations: Enhancing the Bioavailability of Poorly Water-SolubleDrugs. 药事纵横征稿启事

核酸药物

2024-05-17

·米内网

【关注】75个品种拟新增进院，华润、扬子江、华邦......

精彩内容日前，四川省成都市妇女儿童中心医院发布公告称，拟公开引进75款新药以满足临床用药需求，包括66款化学药、6款生物药和3款中成药；其中，独家品种（含独家剂型）占比超过三成，涉及扬子江药业、华润医药、华邦制药、罗氏等知名药企。来源：成都市妇儿中心医院官网按治疗大类统计，此次成都市妇儿中心医院拟引进的药物以神经系统药物为主，占据21个席位；抗肿瘤和免疫调节剂、皮肤病用药分别占8个和7个；感觉系统药物、呼吸系统用药、消化系统及代谢药以及心脑血管系统药物各有5个产品在列。75个拟引进的药品中，独家品种有23个，占比超过三成；其中化学药有16个，生物药有4个，中成药有3个，涉及扬子江药业的神曲消食口服液、华润医药的示踪用盐酸米托蒽醌注射液、重庆华邦制药的萘替芬酮康唑乳膏、四川科瑞德制药的枸橼酸坦度螺酮胶囊等。神曲消食口服液是一款儿科厌食症用药，具有消食健胃、健脾理气的功效，目前已纳入全国医保乙类药目录。近年来该药在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额逐年攀升，2023年收获超2.7亿元，同比增长17.27%，为儿科厌食症中成药TOP3产品。2023年中国公立医疗机构终端儿科厌食症中成药产品TOP10来源：米内网中国公立医疗机构药品终端竞争格局示踪用盐酸米托蒽醌注射液最早于2021年获批上市，是国内首款获批用于甲状腺癌、乳腺癌的淋巴示踪剂。2023年1月，该药通过谈判进入医保目录后市场实现快速放量，2023年在中国公立医疗机构终端销售额突破5千万元，同比增速达771.14%。此外，最新临床结果表明，示踪用盐酸米托蒽醌注射液还对肺癌、黑色素瘤、多发性骨髓瘤、肝癌、大肠癌、肾癌、前列腺癌等多个癌种有一定疗效，产品潜力在逐步释放。近年来中国公立医疗机构终端示踪用盐酸米托蒽醌注射液销售趋势（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局萘替芬酮康唑乳膏为外用抗真菌药，一般用于手癣、足癣、体癣以及花斑癣等各种原因导致的真菌感染。米内网数据显示，目前该药仅有重庆华邦制药1家企业拥有生产批文，2023年在中国公立医疗机构终端销售规模首破1亿元，同比涨逾22%，为皮肤病抗真菌化学药TOP2产品。来源：米内网一键检索此外，拟进院的独家品种中还包括国药集团的无水乙醇注射液、上海医药的注射用异戊巴比妥钠、四环医药的咪达唑仑口颊粘膜溶液、山西正来制药的潞党参口服液、罗氏的帕妥珠单抗注射液等，覆盖血液和造血系统药物、神经系统药物、补气补血类用药、抗肿瘤和免疫调节剂等多个治疗大类，进一步满足不同患者的临床用药需求。拟引进新药采购目录（带*为独家品种）资料来源：米内网数据库、成都市妇儿中心医院注：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。数据统计截至5月17日，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

上市批准申请上市临床申请核酸药物临床3期

2023-01-30

·Business Wire

Sleep Disorder Treatment Drugs Markets in China 2023: Demand to Grow by 5% Annually Through 2032 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Sleep Disorder Treatment Drugs Markets in China" report has been added to ResearchAndMarkets.com's offering. China's demand for Sleep Disorder Treatment Drugs has grown at a fast pace in the past decade. In the next decade, both production and demand will continue to grow. The Chinese economy maintains a high speed growth which has been stimulated by the consecutive increases of industrial output, import & export, consumer consumption and capital investment for over two decades. This new study examines China's economic trends, investment environment, industry development, supply and demand, industry capacity, industry structure, marketing channels and major industry participants. Historical data (2012, 2017 and 2022) and long-term forecasts through 2027 and 2032 are presented. Major producers in China are profiled. The primary and secondary research is done in China in order to access up-to-date government regulations, market information and industry data. Data were collected from the Chinese government publications, Chinese language newspapers and magazines, industry associations, local governments' industry bureaus, industry publications, and our in-house databases. Interviews are conducted with Chinese industry experts, university professors, and producers in China. Economic models and quantitative methods are applied in this report to project market demand and industry trends. Metric system is used and values are presented in either Yuan (RMB, current price) and/or US dollars. Our market research reports provide hard-to-find market data and analyses. Today, China has the largest market in the world. Tremendous fast-growing markets for imports and business opportunities for companies around the world. If you want to expand your business or sell your products in China, our research reports provide the insights and projections into Chinese markets necessary for you to do so. Key Topics Covered: I. INTRODUCTION Report Scope and Methodology Executive Summary II. BUSINESS ENVIRONMENT Economic Outlook Key Economic Indicators Industrial Output Population and Labor Foreign Investment Foreign Trade Financial and Tax Regulations Banking System and Regulations Foreign Exchange Taxes, Tariff and Custom Duties III. SLEEP DISORDER TREATMENT DRUGS INDUSTRY ASSESSMENTS Sleep Disorder Treatment Drugs Industry Structure Market Size Market Growth Driver Sleep Disorder Treatment Drugs Sales Volume Major Producer Facility Locations and Sales Volume Market Share of Key Producers Labor Cost Potential Entrants Major Distributors Major Foreign Investments Technology Development IV. SLEEP DISORDER TREATMENT DRUGS PRODUCTION AND DEMAND Overview Sales Volume of Sleep Disorder Treatment Drugs by Region Sleep Disorder Treatment Drugs Sales Volume Western Sleep Disorder Treatment Drugs Sales Volume Barbiturates Phenobarbital Secobarbital Amobarbital Benzodiazepines Midazolam Estazolam Triazolam Others Non-benzodiazepines Zolpidem Zopiclone Zaleplon Others Chinese Traditional Sleep Disorder Treatment Drugs Sales Volume Acanthopanacis Senticosi Gastrodin Chinese Patent Medicines Sleep Disorder Treatment Drugs Imports and Exports Pricing Trends V. SLEEP DISORDER TREATMENT DRUGS MARKET OUTLOOK Sleep Disorder Treatment Drugs Markets Outlook Government Regulations Health Care Insurance Industry Overview Consumer Spending Trends Northeast North Southeast Central Southwest Northwest Demographic Trends Health Care Industry Trends Hospitals and Hospital Beds VI. MARKETING STRATEGIES China Market Entry Overview China's Distribution System Sleep Disorder Treatment Drugs Distribution Channels Transportation and Freight Infrastructure Communications China's Market Entry Export to China Indirect export Direct Export License and Contract Manufacture Assembling in China Contract Manufacturing Trade Permit Investment Equity Joint Venture Contractual Joint Venture Wholly Foreign-Owned Enterprise VII. SLEEP DISORDER TREATMENT DRUGS PRODUCER DIRECTORY Sleep Disorder Treatment Drugs Producer Profiles and Directory A selection of companies mentioned in this report includes Wusuli River Pharmaceutical Group Wandashan Pharmaceutical Factory For more information about this report visit https://www.researchandmarkets.com/r/irmoip About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

100 项与异戊巴比妥钠相关的药物交易

登录后查看更多信息