PLATIPUS is an adaptive platform trial aimed at improving the health of infants born preterm (before 37 weeks' gestation). PLATIPUS will compare how different treatments and care provided to pregnant women and people at risk of preterm birth and infants born preterm affect infant health.
The main questions PLATIPUS aims to answer are:
1. What effect/s do different treatments/care provided to pregnant women and people at risk of preterm birth have on the health of their infants? (Pregnancy domains)
2. What effect/s do different treatments/care given to infants born preterm have on their health ? (Neonatal domains).
This registration record relates to the PLATIPUS Core (or 'master') protocol which provides guidance for the overall running of the trial. Additional appendices will outline the aims, questions, treatments, and activities for each separate research question (domain). Each Domain-Specific Appendix will be registered separately on ClinicalTrials.gov and will link to this record.

开始日期2025-02-01

申办/合作机构

University of Melbourne

[+10]

NCT06518603 / Not yet recruiting临床4期IIT

Randomized Controlled Trial of Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia

The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age.
Our research questions are:
1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits?
2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age?
Researchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits.
Parents of participants will:
1. Administer caffeine citrate 20mg/kg/day or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge
2. Keep a diary of symptoms and any apneic events
3. Check in with researchers via telephone call once a week
4. Return to clinic for infant physical examination at 28 days
5. Return to the clinic for infant physical examination at 2 months
5. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age

开始日期2024-10-01

申办/合作机构

The University of Alabama at Birmingham

[+1]

NCT06538584 / Recruiting临床1/2期IIT

Caffeine Facilitates the Recovery of Dexmedetomidine Sedation for MRI in Pediatric Patients: a Randomized, Double-blinded and Placebo-controlled Pilot Study

Dexmedetomidine (Dex), a selective α2-adrenergic receptor agonist, is the most used sedative for procedural sedation in children and in pediatric Intensive Care Unit (PICU) because it is associated with less respiratory depression and also less neurotoxicity; rather Dex appears neuroprotective. Unfortunately, Dex is associated with very long emergence times and may cause bradycardia and hypotension. However, using sedation dosing guidelines (by consensus among SPS members) 1-3 mcg/kg bolus and a 1-2 mcg/kg/hour infusion, hemodynamic compromise is less significant and rarely requires intervention in these patients. With this Dex sedation protocol, these pediatric patients usually take an average of 45 minutes (30-60 minutes) to wake and become alert and up to 2 hours to be discharged.
Without reversal agents, emergence times from Dex sedation are slow. The prolonged recovery after Dex sedation for non-surgical procedures negatively affects throughput, thus increasing the cost of care. Patient safety and satisfaction suffer as a result. The children wake feeling tired and sluggish. The children don't feel back to normal for an extended period of time, which is not surprising given that the half-life for Dex metabolism in 2-3 hours in humans. However, using sedation dosing guidelines (by consensus among SPS members) 1-3 mcg/kg bolus and a 1-2 mcg/kg/hour infusion, hemodynamic compromise is less significant and rarely requires intervention in these patients. In humans, it has been found that caffeine at 7.5 mg/kg (15 mg caffeine citrate equivalent to 7.5 mg caffeine base) sped emergence from isoflurane anesthesia with minimal hemodynamic effects in healthy human volunteers.
The goal of this clinical trial is to determine whether caffeine will facilitate the recovery of Dex sedation after a Magnetic Resonance Imaging (MRI) procedure by measuring the time from the end of Dex infusion to the time meeting the discharge criteria.

开始日期2024-09-09

申办/合作机构

The University of Chicago

100 项与枸橼酸咖啡因相关的临床结果

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100 项与枸橼酸咖啡因相关的转化医学

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100 项与枸橼酸咖啡因相关的专利（医药）

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1,009

项与枸橼酸咖啡因相关的文献（医药）

2024-11-01·JOURNAL OF ETHNOPHARMACOLOGY

Investigating the involvement of the NLRP3/ASC/caspase-1 and NF-κb/MAPK pathways in the pathogenesis of gouty arthritis: Insights from irradiated and non-irradiated Trifolium alexandrium L. extracts and some metabolites

Article

作者: Seif-Eldein, Noha A ; Elariny, Hemat A ; Mohammed, Hala Sh ; Mahgoub, Sebaey ; Abu El Wafa, Salwa A ; El-Said, Nermin T ; Taha, Eman Fs

ETHNOPHARMACOLOGICAL RELEVANCE:

Trifolium alexandrinum L. (TA), has traditionally been used in folk medicine for its anti-inflammatory properties against hyperuricemia and gout. However, the specific mechanisms of action of TA have not been thoroughly studied.

AIM OF THE WORK:

This study aimed to evaluate the protective effects of irradiated (TR25) and non-irradiated (TR0) Trifolium alexandrinum L. aqueous extract (TAAE), along with two isolated compounds, caffeine (CAF) and saponin (SAP), in a rat model of acute gouty arthritis (GA).

MATERIALS AND METHODS:

The GA model was established by injecting a monosodium urate (MSU) suspension into the knee joint. Synovial tissue pathology was assessed, and levels of TNF-α, IL-6, IL-1β, NF-κB, mTOR, AKT1, PI3K, NLRP3, and ASC were measured by ELISA. mRNA expression of ERK1, JNK, and p-38 MAPK was detected using qRT-PCR, and Caspase-1 protein expression was assessed by immunohistochemical analysis. Knee swelling, uric acid levels, liver and kidney function, and oxidative stress markers were also evaluated.

RESULTS:

TAAE analysis identified 170 compounds, with 73 successfully identified using LC-HR-MS/MS, including caffeine citrate and theasapogenol B glycoside as the main constituents. The studied materials demonstrated significant protective effects against GA. TR25 administration significantly mitigated knee joint circumference compared to other treatments. It demonstrated potential in alleviating hyperuricemia, renal and hepatic impairments induced by MSU crystals. TR25 also alleviated oxidative stress and reduced levels of IL1β, IL-6, TNF-α, and NF-κB. Weak Caspase-1 immune-positive staining was observed in the TR25 group. TR25 decreased NLRP3 and ASC expression, reducing inflammatory cytokine levels in GA. It effectively inhibited the PI3K, AKT, and mTOR signaling pathways, promoting autophagy. Additionally, TR25 suppressed ERK1, JNK, and p-38 MAPK gene expression in synovial tissue. These effects were attributed to various components in TAAE, such as flavonoids, phenolic acids, tannins, alkaloids, and triterpenes.

CONCLUSION:

Importantly, irradiation (25 KGy) enhanced the antioxidant effects and phtchemical contents of TAAE. Additionally, TR0, TR25, CAF, and SAP exhibited promising protective effects against GA, suggesting their therapeutic potential for managing this condition. These effects were likely mediated through modulation of the NLRP3/ASC/Caspase-1 and ERK/JNK/p-38 MAPK signaling pathways, as well as regulation of the PI3K/AKT/mTOR pathway. Further research is warranted to fully elucidate the underlying mechanisms and optimize their clinical applications.

2024-10-01·JOURNAL OF HOSPITAL INFECTION

The CATERPILLAR study: an assessor-blinded randomized controlled trial comparing a taurolidine–citrate–heparin lock solution to a heparin-only lock solution for the prevention of central-line-associated bloodstream infections in paediatric oncology patients

Article

作者: Fiocco, M ; van de Wetering, M D ; van der Bruggen, J T ; Frakking, F N J ; van de Ven, C P ; van der Steeg, A F W ; van den Bosch, C H ; Loeffen, Y G T ; Wijnen, M H W A

BACKGROUND:

Taurolidine-citrate(-heparin) lock solutions (TCHL) are suggested as a promising and safe method for the prevention of central line-associated bloodstream infections (CLABSI).

AIM:

To investigate the efficacy TCHL for the prevention of CrLABSI in paediatric oncology patients.

METHODS:

An assessor blinded randomized controlled trial at the Princess Máxima Centre for paediatric oncology, the Netherlands, was performed from 2020-2023. Paediatric oncology patients receiving a tunnelled central venous access device (CVAD) were eligible. A total of 462 patients was required to compare the TCHL to the heparin-only lock (HL). Patients were followed-up for the first 90 days after CVAD insertion. The primary outcome was the incidence of the first CLABSI from CVAD insertion until the end of follow-up. Intention-to-treat and per-protocol analyses were performed.

FINDINGS:

In total, 232 were randomized in the HL and 231 in the TCHL-group. A total of 47 CLABSIs were observed. The intention-to-treat analysis showed that a CLABSI was observed in 26 (11.2%) of the HL-group patients versus 21 (9.1%) of the TCHL-group patients; incidence rate ratio (IRR) of 0.81 (CI95%0.46-1.45), in favour of the TCHL-group. The per-protocol analysis showed that a CLABSI was observed in 10 (7.9%) of the HL-group patients versus 6 (4.8%) of the TCHL-group patients; IRR of 0.59 (CI95%0.21-1.62) in favour of the TCHL-group. Adverse events were more common in the TCHL-group but rarely reported.

CONCLUSION:

No difference was detected between the TCHL and HL in the incidence of CLABSI in paediatric oncology patients.

TRIAL REGISTRATION NUMBER:

ClinicalTrials.gov NCT05740150.

2024-09-01·Nursing in critical care

Comparison of diluted vs concentrated regional citrate anticoagulation in continuous renal replacement therapy: A quasi‐experimental study

Article

作者: Mateos‐Dávila, Almudena ; Guix‐Comellas, Eva Maria ; Betbesé Roig, Antonio Jorge ; Santos Rodríguez, José Alberto

Abstract:

Background:

The incidence of coagulation of continuous renal replacement therapy circuits remains high. To the best of our knowledge, no scholar has published a protocol to avoid management errors when different types of citrates coexist in the same Intensive Care Unit.

Aim:

To assess the safety and efficacy of the unification of two protocols with different concentrations of citrate solution.

Study Desing:

A prospective, quasi‐experimental study was carried out in the intensive care unit of a tertiary referral hospital (in Barcelona, Spain), over 3 years. Consecutive adult patients requiring continuous renal replacement therapy with citrate were included. The sample was divided into two groups, a control group (concentrated citrate) and an intervention group (diluted citrate). The decision to initiate anticoagulation with diluted (18 mmol/L) or concentrated (136 mmol/L) citrate was made based on the machine available and the decision of the doctor responsible for the patient. It was not possible to randomize the sample. Both protocols were matched with a starting citrate dose of 3.5 mmol/L, and a dialysis solution was used. Post‐filter replacement was not used, and the citrate solution was the only fluid administered pre‐filter.

Results:

The analysis included 59 circuits in the concentrated citrate group and 40 circuits in the diluted citrate group. An increased need for electrolyte replacement was observed in the diluted group (p < .001). The concentrated citrate group had a longer filter life (p < .05), and there was a slight trend toward alkalosis.

Conclusion:

The diluted citrate group had a higher incidence of electrolyte replacement. The concentrated citrate group had longer circuit lifespan and a trend toward metabolic alkalosis, although this was not statistically significant. If these conclusions are considered, the protocol can be unified.

Relevance to Clinical Practice:

The present work aims to provide information on the differences in the use of regional anticoagulation with diluted or concentrated citrate. The objective is to pay special attention to aspects that can lead to complications. The unified protocol proposed in this paper could be extrapolated to any machine on the market that uses either of these two types of citrate concentration.

项与枸橼酸咖啡因相关的新闻（医药）

2024-05-14

·米内网

华润双鹤厉害了！拿下34个重磅品种，75个过评品种亮眼，4款新药、38个新品在路上

精彩内容近日，华润双鹤产品线进展不断：盐酸利多卡因注射液获批上市、吡拉西坦注射液过评、司美格鲁肽注射液获批临床……2021年至今，华润双鹤已有34款新品获批上市，产品线步入密集收获期。目前公司有75个品种过评（7个首家），20个品种中标国采；38个新分类报产品种在审，4款新药研发推进中。仿制药大爆发！拿下34个重磅品种5月7日，华润双鹤公告称，全资子公司双鹤利民的盐酸利多卡因注射液获批上市并视同过评。盐酸利多卡因注射液为局麻药及抗心律失常药，是华润双鹤（含子公司，下同）今年以来第8个获批上市的品种。近年来华润双鹤的产品线步入密集收获期，年度获批新品数从屈指可数发展至突破两位数。2020年华润双鹤仅有3个品种获批上市，与2019年持平。进入2021年，公司年度获批品种数显著增长，2021年、2022年分别有6个、9个品种获批上市；2023年获批品种一举站上两位数——12个。2021年至今华润双鹤获批品种自2021年以来，华润双鹤已有34个品种获批上市（不含补充申请），进一步丰富了公司的产品线。2024年至今，华润双鹤已有8个品种获批上市并视同过评，包括格列吡嗪控释片、阿哌沙班片、左乙拉西坦缓释片、甲磺酸多沙唑嗪缓释片、丙戊酸钠注射用浓溶液、米拉贝隆缓释片、利奈唑胺葡萄糖注射液、盐酸利多卡因注射液。其中，甲磺酸多沙唑嗪缓释片为国产第4家，左乙拉西坦缓释片为国产第5家。75个品种过评，猛攻4大千亿市场5月13日，华润双鹤公告称，全资子公司双鹤利民的吡拉西坦注射液，以及全资子公司上海长征富民金山制药的腹膜透析液(乳酸盐-G1.5%)、腹膜透析液(乳酸盐-G2.5%)、腹膜透析液(乳酸盐-G4.25%)通过仿制药一致性评价，有利于未来的市场销售和市场竞争。截至目前，华润双鹤已有75个品种通过/视同通过一致性评价。其中，7个品种为国内首家过评，包括厄贝沙坦分散片、非那雄胺片、格列喹酮片、枸橼酸咖啡因注射液、氯氮平口崩片、盐酸特拉唑嗪片、氧氟沙星氯化钠注射液。华润双鹤通过/视同通过一致性评价品种75个过评品种涵盖11个治疗大类，主要集中在心脑血管系统药物（15个）、神经系统药物（14个）、全身用抗感染药物（13个）、消化系统及代谢药（12个）。米内网数据显示，2023年中国城市公立医院、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）化学药终端全身用抗感染药物、消化系统及代谢药销售额均超过1000亿元，神经系统药物、心脑血管系统药物销售额均接近1000亿元。在已落地执行的八批化药集采中，华润双鹤累计有20个品种（不含续约）中选。随着公司更多“光脚”产品进入集采，在一定程度上弥补了存量产品集采降价的损失。一致性评价补充申请方面，目前华润双鹤还有11个品种在审，包括维生素B6注射液、碳酸氢钠注射液、氯化钾注射液、黄体酮注射液、法莫替丁注射液、白消安注射液、氨茶碱注射液、喷他佐辛注射液等10个注射剂。其中，维生素B6注射液、黄体酮注射液冲刺首家过评。华润双鹤一致性评价补充申请在审品种来源：米内网一致性评价进度数据库38个新品在路上！抢攻$139亿大品种近年来华润双鹤加大力度支持药品研发创新，2022年研发费用4.82亿元，同比增长17.80%；2023年研发费用5.61亿元，同比增长16.37%。在仿制药方面，目前华润双鹤还有38个新注册分类品种上市申请在审，获批生产后将视同通过一致性评价，进一步丰富公司各领域产品组合。38个品种中，培哚普利氨氯地平片(Ⅲ)在国内暂无仿制药获批上市，公司有望夺得首仿；注射用吲哚菁绿、非诺贝特酸胆碱缓释胶囊、氨氯地平贝那普利胶囊均仅有一款仿制药在国内获批上市，公司有望实现首批上市。华润双鹤主要在研新药在新药研发方面，华润双鹤的巯嘌呤微片（治疗儿童白血病）、八氟丙烷脂质微球注射液（肝脏超声微泡造影剂）已提交上市申请；1类新药CX2101A（治疗新型冠状病毒感染）处于Ⅰ期临床研究阶段；司美格鲁肽注射液（用于成人2型糖尿病）已获批临床，2023年诺和诺德的司美格鲁肽注射液Ozempic（2型糖尿病）收入139亿美元，同比增长60%。资料来源：米内网数据库、公司公告注：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

一致性评价上市批准

2024-04-01

·米内网

中药OTC龙头厉害了！独家品种大涨67%，净利润猛增132%，2款中药1类新药上市可期

精彩内容近日，中药OTC龙头太极集团公布2023年业绩报告，实现营收156.23亿元（+10.58%），归母净利润8.22亿元（+131.99%）。核心品种放量明显，藿香正气口服液收入22.71亿元（+45%），急支糖浆（独家品种）收入8.81亿元（+67%）等。太极集团坚持创新驱动，研发投入大增81%，2款中药1类新药冲刺上市。净利润大涨132%！中药大单品业绩亮眼3月29日，太极集团公布2023年业绩报告，报告期内公司实现营收156.23亿元，同比增长10.58%；归母净利润8.22亿元，同比增长131.99%；扣非归母净利润7.74亿元，同比增长111.35%。从分行业看，医药工业销售收入103.88亿元，同比增长19.4%。其中，现代中药销售收入66.04亿元（+31.64%），化药销售收入37.84亿元（+2.72%）；医药商业销售收入77.26亿元，同比降低3.31%；中药材资源板块销售收入10.17亿元，同比增长118.71%。医药工业已然成为太极集团业绩增长引擎，近年来随着主品品牌力持续释放、渠道整合力持续加强等，该板块收入持续增长。从分领域收入看，消化及代谢用药为第一大品类，2023年收入28.81亿元（+36.99%）；此外，呼吸系统用药、抗感染药物、神经系统用药、大健康产品、心脑血管用药、抗肿瘤及免疫调节药分别录得收入26.42亿元（+42.21%）、18.69亿元（-0.21%）、8.98亿元（-2.36%）、8.5亿元（22.67%）、7.66亿元（10.94%）、2.46亿元（-27.26%）。2023年太极集团分领域收入情况（单位：亿元）来源：公司公告，米内网整理从细分产品收入看，核心中药产品放量明显，其中藿香正气口服液（医保甲类、OTC甲类）销售收入22.71亿元，同比增长45%；急支糖浆（独家品种，医保乙类、OTC甲类双跨）销售收入8.81亿元，同比增长67%；通天口服液（独家品种，医保乙类、OTC甲类）销售收入3.16亿元，同比增长10%；鼻窦炎口服液（独家品种，医保乙类、OTC甲类双跨）销售收入2.61亿元，同比增长22%。藿香正气口服液为太极集团OTC第一大单品，具有解表祛暑、化湿和中的功效，适用于外感风寒、内伤湿滞或夏伤暑湿所致的感冒。米内网数据显示，无论是院内市场（中国公立医疗机构终端），还是零售市场（城市实体药店+网上药店），在祛暑剂品牌排名中，太极集团的藿香正气口服液均连续多年稳居首位。太极集团另一款OTC独家大单品——急支糖浆为全国医保乙类、OTC甲类（双跨）品种，是市场上较为畅销的止咳平喘中成药。近年来在中国城市实体药店终端止咳平喘中成药产品排名中，急支糖浆均稳居第二。现代中药是太极集团战略规划重要组成部分，其目标是以现代中药智造为主，通过内生发展加外延扩张，力争“十四五”末即2025年营业收入达到500亿元，净利润率不低于医药行业平均水平，并努力成为世界一流的中药企业。为实现上述愿景，太极集团多管齐下加码中药板块：2024年3月，涪陵区与太极集团举行签约仪式，计划打造300亿级产能智造中心，即全球最大的中药提取与口服制剂智造中心、创新中药及生物医药智造中心。2023年12月，太极集团接连公布5个投资项目，包括拟对旗下中药材公司和中药饮片厂各增资4800万元；投资23亿元投建2个产能中心，分别为国药太极西南医药产业基地项目一期工程、涪陵制药厂太极医药城二期建设项目；拟以150万元在澳门投资设立全资子公司......2款中药1类新药冲刺，重磅注射剂备战第十批集采在太极集团“十四五”战略规划中，科技创新被列为发展战略之首，明确了要加快新药研发和大品种二次开发。近年来，公司不断加大研发力度，2023年研发投入2.91亿元，同比增长约81%，全年开展重点研发项目31项，其中中药16项，化药14项，生物药1项。近年来太极集团研发投入情况（单位：亿元）来源：公司公告，米内网整理截至报告期末，太极集团拥有研发人员943人，占公司总人数比例约为7.5%。在中药新药研发方面，1.1类新药芪灯明目胶囊治疗糖尿病黄斑水肿“附条件批准上市”临床试验已完成部分病例入组；治疗慢性稳定性心绞痛（血瘀证）的1.1类创新中药——丹七通脉片完成IIb期研究总结报告及专家咨询论证；改良型新药双苓止泻颗粒的研究正在开展中；华盖散颗粒、金水六君煎等3.1类古代经典名方中药复方制剂的生产注册研究正在进行中。在化药方面，目前太极集团已有15个仿制药通过或视同通过一致性评价，涵盖全身用抗感染药物、神经系统药物、呼吸系统用药、全身用激素类制剂(不含性激素和胰岛素)、消化系统及代谢药5个治疗大类。太极集团过评情况注：带*为国采中选来源：米内网一致性评价进度数据库太极集团的左氧氟沙星氯化钠注射液、氢溴酸西酞普兰片、枸橼酸咖啡因注射液、异烟肼片、地塞米松磷酸钠注射液已在国采中顺利中标。余下的过评品种中，有2个暂未纳入国采，其中盐酸格拉司琼注射液已满足5家及以上的充分竞争条件，目前有齐鲁制药、成都倍特药业、福安药业、成都普什制药、太极集团5家企业过评。格拉司琼注射剂是一种强效、高选择性的5-羟色胺受体拮抗剂，主要用于放疗、细胞毒类药物化疗等引起的恶心和呕吐，该产品2022年在中国公立医疗机构终端的销售额超过3亿元，其中福安药业主导市场，近年来占比均超过70%。此外，太极集团还有13个品种提交一致性评价补充申请在审，其中盐酸吗啡缓释片、葡萄糖酸钙片、复方甘草片等品种暂无企业过评；2个新分类报产品种在审（不含联合申报），其中盐酸羟考酮缓释片目前仅2个国产企业拥有生产批文。太极集团新分类报产且在审的品种来源：米内网中国申报进度（MED）数据库中医药利好政策不断，超7成中药企业业绩喜人在过去的2023年，中医药行业陆续迎来了多项重磅政策：国家药监局发布《中药注册管理专门规定》，进一步加强中药新药研制与注册管理；国务院办公厅印发《中医药振兴发展重大工程实施方案》，推进中医药振兴发展；八部委联合印发《“十四五”中医药文化弘扬工程实施方案》，提出12项重要任务，明确大力弘扬中医药文化；CDE发布《中药新药临床试验用药品的制备研究技术指导原则（试行）》，为中药新药临床试验用药品的制备、质量控制等研究提供技术指导......在系列利好政策催化下，2023年中药企业业绩普遍向好。截至3月30日，A股中药板块有46家上市企业披露了2023年业绩数据（含年报、业绩快报及业绩预告），其中有30余家归母净利润呈正增长，占已披露业绩数据的公司比重超过7成。白云山、云南白药、华润三九、同仁堂、太极集团、片仔癀等企业营业收入超100亿元，依次为755.15亿元、391.1亿元、247.39亿元、178.6亿元、156.2亿元、100.35亿元。白云山、华润三九、东阿阿胶、片仔癀、同仁堂、天士力、云南白药等企业净利润超10亿元，其中云南白药达40.94亿元，为目前已披露业绩的中药上市企业中，净利润最高的企业。步长制药、珍宝岛、广誉远、益佰制药、太极集团、ST康美、天士力、太龙药业等企业归母净利润同比增长超过100%。其中天士力净利润预计11.27亿～13.17亿元，同比增长521.59%～592.65%，为目前已披露业绩的中药上市企业中，净利润增速最高的企业。部分中药企业2023年业绩情况来源：东方财富网，米内网整理2024年以来，中医药行业也是政策不断：2月5日，国家药监局综合司公开征求《中药标准管理专门规定（征求意见稿）》意见，旨在进一步加强中药标准管理，建立符合中医药特点的中药标准体系，促进中医药传承创新发展；2月26日，国家卫健委等三部门联合印发《关于进一步加强新时代卫生健康文化建设的意见》。其中提到，要挖掘传承中医药文化精髓，要推动中医药文化融入生产生活；3月5日，十四届全国人大二次会议在北京开幕，政府工作报告再次提及中医药，强调要促进中医药传承创新，加强中医优势专科建设......中医药是国家顶层政策支持的板块，一方面随着审评审批制度改革等顶层设计，利好中药创新药发展，为行业提供增量；另一方面大多数中成药均聚焦OTC渠道，受集采、医保控费等影响较小，在老龄化、大众自我诊疗意识增长的社会背景下，具备长期成长空间。在系列利好政策推动下，中医药行业正在迈向高质量发展阶段，市场空间也将逐步打开。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；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3月30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

财报

2024-03-21

·米内网

【获批】亿级畅销产品，太极集团过评了

精彩内容近日，太极集团旗下西南药业的维生素B6片通过一致性评价，成为了该集团今年首个过评产品。维生素B6片是一款临床常用药，2022年在中国三大终端六大市场（统计范围见文末）合计销售额超过1亿元。图1：西南药业最新获批的产品来源：NMPA官网维生素B6片是一种水溶性维生素，用于预防和治疗维生素B6缺乏症，如脂溢性皮炎、唇干裂，也可用于减轻妊娠呕吐。图2：维生素B6片的批文情况来源：米内网中国上市药品（MID）数据库米内网数据显示，目前有300多家国内药企获得维生素B6片的生产批文，而过评企业数量达5家，分别为杭州民生药业、宜昌人福药业、湖北广济药业、东北制药沈阳第一制药以及西南药业。图3：维生素B6片的销售情况（单位：万元）来源：米内网格局数据库近三年在中国三大终端六大市场，维生素B6片的合计销售额保持在1亿元以上，零售药店终端（城市实体药店+网上药店）已成为了该产品的销售主阵地，占比超过四成。其中在中国网上药店终端，维生素B6片2021-2022年保持双位数增速。表1：太极集团及子公司过评/视同过评的产品注：按最新的上市许可持有人统计来源：米内网中国申报进度（MED）数据库2019年太极集团旗下西南药业的异烟肼片一致性评价补充申请获批，成为该集团首个过评产品，截至目前集团过评/视同过评的产品达15个。太极集团积极参加国家集中带量采购，第二批中标了异烟肼片，第三批中标氢溴酸西酞普兰片，第五批中标了左氧氟沙星氯化钠注射液，第七批中标了枸橼酸咖啡因注射液，第九批中标了地塞米松磷酸钠注射液。资料来源：国家药监局官网、米内网数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；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

一致性评价带量采购上市批准

100 项与枸橼酸咖啡因相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D07603	枸橼酸咖啡因	N06BC01	DB00201

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
新生儿呼吸暂停	加拿大	CHIESI Farmaceutici SpA	2020-03-04
呼吸暂停	美国	Hikma Pharmaceuticals USA, Inc.	1999-09-21

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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


NCT03913221 (CTgov)	临床1期	缺氧缺血性脑病	17	Caffeine Citrate 5 mg/kg (Low Dose Caffeine (5 mg/kg))	壓遞齋鹽繭鑰蓋鹹膚餘(淵築憲鏇鹹齋憲齋願壓) = 膚醖夢襯鹽襯膚範遞糧遞襯蓋簾齋遞衊鑰願淵 (網夢繭壓淵壓繭壓觸膚, 襯鏇膚選觸餘鏇製壓簾 ~ 鑰觸觸築簾鹹醖顧製遞) 更多	-	2024-09-19
				Caffeine Citrate 10 mg/kg (High Dose Caffeine (10 mg/kg))	壓遞齋鹽繭鑰蓋鹹膚餘(淵築憲鏇鹹齋憲齋願壓) = 鹹衊選鏇網網壓廠餘繭遞襯蓋簾齋遞衊鑰願淵 (網夢繭壓淵壓繭壓觸膚, 齋簾選鏇糧膚構範築壓 ~ 選獵鹹壓襯構選獵艱鏇) 更多
NCT03340727 (MoCHA, CTgov)	临床3期	呼吸暂停	827	Placebo	鏇鏇觸願壓鑰憲艱醖鹽(艱遞衊網蓋醖遞繭獵襯) = 壓積蓋鹹蓋憲夢壓鬱繭範鑰壓襯繭鑰願淵醖構 (廠齋遞蓋獵繭製簾網窪, 築鹽鹽蓋餘簾糧願選構 ~ 選鬱糧艱膚築糧範衊衊) 更多	-	2024-06-28
NCT03577730 (CTgov)	早期临床1期	术后疼痛	71	Caffeine Citrate (Experimental)	憲醖夢窪鏇範窪蓋鏇鬱(範觸壓艱遞遞廠憲願繭) = 範鑰艱顧顧蓋壓觸衊獵網襯鹽齋遞簾製觸顧繭 (構簾艱廠範鏇襯鏇窪網, 餘獵築夢網廠艱艱構製 ~ 糧網獵範鹽膚膚簾糧餘) 更多	-	2021-10-06
				Dextrose Water (Control)	憲醖夢窪鏇範窪蓋鏇鬱(範觸壓艱遞遞廠憲願繭) = 積憲鏇網餘鹹鬱遞齋鹽網襯鹽齋遞簾製觸顧繭 (構簾艱廠範鏇襯鏇窪網, 襯窪願壓顧蓋廠餘齋積 ~ 積餘糧艱積淵鏇鹹窪範) 更多
NCT01751724 (CTgov)	N/A	呼吸衰竭 \| 呼吸暂停 \| 早产	87	Caffeine citrate (Caffeine Arm)	範顧鏇獵鹽憲衊蓋獵窪(鏇醖糧築構艱膚獵壓廠) = 憲鹹糧齋齋鹹齋淵夢艱觸膚顧範餘齋鹽鹹積遞 (齋網繭醖餘顧衊繭獵膚, 膚鬱構衊衊構糧網築鬱 ~ 艱齋醖願願襯艱鹽餘齋) 更多	-	2017-06-19
				normal saline (Placebo Arm)	範顧鏇獵鹽憲衊蓋獵窪(鏇醖糧築構艱膚獵壓廠) = 膚製鹽膚齋蓋獵憲築壓觸膚顧範餘齋鹽鹹積遞 (齋網繭醖餘顧衊繭獵膚, 壓觸鹹蓋艱鹹範鬱窪簾 ~ 顧願醖齋鏇鑰鑰窪繭淵) 更多
NCT00182312 (CAP, Pubmed \| JAMA Pediatr)	临床3期	新生儿呼吸暂停	1,202	Caffeine citrate	(範襯齋選蓋餘願積選顧): adjusted odds ratio = 1.32 (95% CI, 0.85 ~ 2.07) 更多	-	2017-06-01
				Placebo
NCT00809055 (CTgov)	临床4期	呼吸暂停 \| 脑室内出血 \| 脑损伤	74	Caffeine citrate (High Dose Caffeine)	壓積衊範艱積艱鏇襯鹹(襯廠積醖構構襯鏇廠膚) = 選選鹹顧醖衊積糧鬱鬱蓋憲觸夢蓋顧壓網顧餘 (鹹窪鑰齋構積顧鏇鬱鹹, 觸壓遞夢簾遞衊膚襯願 ~ 遞鹹鑰夢淵獵餘製鹹蓋) 更多	-	2016-02-24
				Caffeine citrate (Standard Dose Caffeine)	壓積衊範艱積艱鏇襯鹹(襯廠積醖構構襯鏇廠膚) = 醖壓鏇鏇衊鹽壓觸鬱糧蓋憲觸夢蓋顧壓網顧餘 (鹹窪鑰齋構積顧鏇鬱鹹, 夢範廠遞簾製鑰齋齋鏇 ~ 鹽衊獵醖廠憲願夢願構) 更多
NCT01875159 (CTgov)	临床3期	缺氧	98	Caffeine citrate 6 mg/kg/day	顧醖選廠衊觸獵顧壓鏇(鏇夢醖鑰願襯齋遞鏇壓) = 選網製糧選遞夢積蓋糧醖壓鹽製顧憲鑰鏇製淵 (廠壓餘廠鑰鏇鏇鹹廠鑰, 獵網獵夢積獵積鏇願範 ~ 選糧糧繭襯願壓衊鏇簾) 更多	-	2015-03-17