更新于：2024-11-04
Atosiban acetate
醋酸阿托西班
更新于：2024-11-04
概要
基本信息
药物类型 合成多肽 |
别名 Antocile、Antocin、Antocin II + [21] |
作用机制 AVPR拮抗剂(血管加压素受体家族拮抗剂)、OXTR拮抗剂(催产素受体拮抗剂) |
治疗领域 |
在研适应症 |
非在研适应症- |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2000-01-20), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C43H67N11O12S2.C2H4O2 |
InChIKeySVDWBHHCPXTODI-QIWYXCRTSA-N |
CAS号914453-95-5 |
序列信息
Sequence Code 15073107
关联
34
项与 醋酸阿托西班 相关的临床试验Atosiban as a potential treatment for endometriosis - ENDOBAN pilot-study
The Effect of Selective Oxytocin Receptor Inhibitors on Endometriosis-related Pain
Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
100 项与 醋酸阿托西班 相关的临床结果
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100 项与 醋酸阿托西班 相关的转化医学
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100 项与 醋酸阿托西班 相关的专利（医药）
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495
项与 醋酸阿托西班 相关的文献（医药）2024-12-01European journal of obstetrics & gynecology and reproductive biology: X
Effects of nationwide adjustment of tocolysis protocol in the Netherlands on neonatal outcomes in women with threatened preterm birth and delivery at 30-32 weeks of gestation: A cohort study
Article
作者: Ravelli, A.C.J. ; van der Windt, L.I. ; Meliezer, J.A.L. ; Ravelli, A C J ; Oudijk, M A ; Onland, W ; Meliezer, J A L ; van der Windt, L I ; Onland, W. ; Oudijk, M.A.
Objective:
In 2019 the Dutch national prevention of preterm birth (PTB) protocol was adjusted to withhold tocolysis for threatened PTB above 30 weeks of gestation due to insufficient evidence regarding its effectiveness on improving perinatal outcomes. The aim of this study is to evaluate neonatal outcomes of children born in the Netherlands between 30 and 32 weeks of gestation before and after the national protocol change.
Study design:
We performed a nationwide retrospective cohort study comparing outcomes of births in the years 2018 (tocolysis) and 2020 (no tocolysis). Tocolytic therapy consisted of either nifedipine or atosiban. Data were extracted from the national Perinatal Registry (PERINED). Women with a spontaneous PTB from 30 + 0 to 31 + 6 weeks of gestation were included. The primary outcome was a composite of mortality, severe intraventricular hemorrhage, severe necrotizing enterocolitis, cystic periventricular leukomalacia, and retinopathy of prematurity needing therapy. Secondary outcomes included additional neonatal outcomes. The odds ratio (OR) with corresponding 95 % confidence interval (CI) was calculated by logistic regression analysis for the year 2020 compared with 2018.
Results:
Composite neonatal outcome did not differ between 2018 compared to 2020 (8.4 % (18/215) vs 8.2 % (25/306), OR 0.95; 95 % CI 0.51-1.77). No difference in composite neonatal outcome was found when analyzing groups as singletons (7.1 % vs 9.3 %, OR 1.35; 95 % CI 0.64-2.87), and multiples (13.3 % vs 5.9 %, OR 0.41; 95 % CI 0.13-1.26).
Conclusion:
There was no significant difference in composite neonatal outcome in pregnancies resulting in spontaneous PTB between 30 and 32 weeks of gestation in 2018 (with tocolysis) compared to 2020 (no tocolysis). These results support the protocol adjustment to withhold tocolytic treatment in women with threatened PTB above 30 weeks of gestation.
2024-10-01MEDICINA CLINICA
Drug-induced hyponatraemia and possible related signals: Analysis of 659 cases reported to the Spanish Pharmacovigilance System and disproportionality analysis
Article
作者: Sainz-Gil, María ; Estévez Asensio, Lucía ; Fernández-Araque, Ana M. ; Verde Rello, Zoraida ; Velasco-González, Verónica ; Fernández-Araque, Ana M ; García, Montserrat
INTRODUCTION:
Hyponatraemia has negative effects on cognitive function and gait stability and is a risk factor for osteoporosis, falls, fractures and hospital mortality. Acute hyponatraemia can lead to neurological dysfunction due to cerebral oedema. Its rapid correction can also be fatal, leading to osmotic demyelination syndrome. For some antiepileptics, thiazides, benzodiazepines or antidepressants this reaction is widely described. Knowing which drugs are most likely to cause hyponatraemia will allow early detection and prevention of its complications, as well as individualising the prescription of these drugs according to the patient's characteristics.
OBJECTIVE:
The main objectives are to identify potential new safety signals related to hyponatraemia and to analyse the cases of hyponatraemia reported to the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H).
METHOD:
A disproportionality and a descriptive analysis of individual case safety reports (ICSR) was performed in the SEFV-H database (FEDRA).
RESULTS:
Six hundred and fifty-nine cases of suspected drug-induced hyponatraemia were found (0.6% of the total database). Over the 5 years period studied, there was a 57% increase in the number of hyponatraemia reports in Spain. Most of the reported cases were serious (93%). Patients were most often women (63.7%) and elderly (71.9%). The time to onset ranged from 1 to 7030 days (median, 79 days) and approximately 70% of the total occurred within the first year of treatment. Five hundred and forty-six patients (82.9%) showed complete recovery after the withdrawal of the suspected medicine. Diuretics (reported in 57.7% of the cases), antidepressants (in 25%), drugs acting on renin angiotensin system (in 24%) and antiepileptics (in 20.2%) were the most frequent involved drugs. Disproportionate reporting has been found for almost all the substances most frequently reported, higher for amiloride and oxcarbazepine. Regarding new safety signals, the Reporting Odds Ratio (ROR) (95% CI) was found to be statistically significant for valsartan [7.7 (5.1-11.5)], olmesartan [7.3 (4.7-11.1)], amlodipine [3.4 (2.1-5.4)], pregabalin [2.5 (1.4-4.5)], irbesartan [18.6 (9.6-35.9)], paliperidone [2.7 (1.3-5.7)], ritonavir [2.4 (1.1-5.5)], atosiban [29.7 (8.6-102.2)], melphalan [9.7 (3.5-26.8)] and clozapine [4.4 (1.6-11.8)]. These active ingredients do not include this reaction on their SPC and comply with the EMA criteria for a safety signals.
CONCLUSION:
There are increasing reports of drug-induced hyponatraemia. It can be serious and seems to most often affect women over 65 years of age who take more than 1 medication. The time to onset varies and can be very long, so patient monitoring should be continuous throughout treatment. Hydrochlorothiazide is the drug with the highest number of reported cases in our setting. In terms of disproportionate reporting, diuretics leads the list, followed by antiepileptics as oxcarbazepine and eslicarbazepine. Safety signals were found for several drugs, more plausibly for pregabalin and paliperidone, thus a possible association between these drugs and hyponatraemia/SIAD is identified. This signal must be further studied. Meanwhile healthcare professionals should pay attention to this possibility. The reporting of suspected ADRs is essential to understand the risks associated with medicines once they are on the market.
2024-09-01European journal of hospital pharmacy : science and practice
A new approach to drug intravenous compatibility research: the case of obstetric parenteral drugs
Article
作者: Wilhelm, A J ; van Merendonk, L N ; Bet, P M ; Kolkman, A ; de Boer, M A ; Leeuwerik, A F
OBJECTIVES:
The product information and literature does not provide confirmation of compatibility for co-administration of all commonly used drug pairs in obstetrics. However, there is a need for co-administration of these drugs over one lumen for this group of patients. Therefore, this study focuses on Y-site compatibility. Since different conditions between clinical and laboratory settings can lead to discrepancies in results, a novel approach for drug intravenous compatibility testing was designed to reflect clinical conditions. The aim was to study the compatibility of nine commonly used drug pairs in obstetrics and to evaluate the clinical value of the designed method.
METHODS:
The clinical situation was reflected by using different temperature ranges (20°C and 37°C), actual Y-site flow ratios, clinically relevant drug pairs and an observation time of 120 min. The clinically relevant drugs pairs include atosiban, nicardipine, amoxicillin/clavulanic acid, oxytocin, remifentanil, labetalol and magnesium sulpfate. Drug pairs were visually assessed according to the European Pharmacopoeia (Ph. Eur.) and pH was measured. When incompatibility of a drug pair seemed likely based on literature review or observed abnormalities during visual assessment, subvisual analysis was performed using a particle counter. Y-site compatibility applied for drug pairs when no visual changes occurred or when no additional particles were formed during the observation time.
RESULTS:
Eight of the nine combinations showed no visual changes or noticeable changes in pH during the observation time. The amoxicillin/clavulanic-acid-oxytocin combination showed a colour change at 37°C at the actual Y-site flow ratio. However, subvisual particle counting showed no formation of additional particles.
CONCLUSIONS:
Y-site compatibility was established for all tested drug pairs. The new clinical approach for analysing Y-site compatibility provides a high certainty of outcomes for clinical practice. In this way, clinical complications and use of several additional intravenous catheters can be avoided.
100 项与 醋酸阿托西班 相关的药物交易
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 早产 | 欧盟 | 2000-01-20 | |
| 早产 | 冰岛 | 2000-01-20 | |
| 早产 | 列支敦士登 | 2000-01-20 | |
| 早产 | 挪威 | 2000-01-20 |
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临床结果
临床结果
适应症
分期
评价
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临床1期 | - | 194 | 蓋窪窪齋觸夢構膚襯繭(顧醖遞襯獵夢齋遞襯遞) = 鬱壓壓蓋壓鹹觸製鹹觸 鏇遞艱顧鹽齋網蓋餘鹽 (齋繭遞網鹽製簾廠淵獵 ) | - | 2022-08-19 | ||
Placebo | 蓋窪窪齋觸夢構膚襯繭(顧醖遞襯獵夢齋遞襯遞) = 願壓構積衊衊繭壓積網 鏇遞艱顧鹽齋網蓋餘鹽 (齋繭遞網鹽製簾廠淵獵 ) | ||||||
N/A | 56 | 鏇夢顧襯齋願壓觸構醖(膚範鏇願窪簾鹽顧淵餘) = 顧襯鑰衊廠壓廠蓋鑰鑰 壓蓋鹹積獵製積顧願醖 (衊範憲鑰襯觸選膚衊繭 ) 更多 | - | 2018-01-01 | |||
临床1期 | - | 製鑰範築鏇憲築襯範遞(窪蓋壓製憲窪遞簾醖鏇) = 艱艱願夢膚艱鏇網範鹽 顧壓襯壓餘願築製鑰範 (製觸壓醖構築鏇壓鑰餘 ) 更多 | - | 2016-08-01 | |||
(Control group) | 製鑰範築鏇憲築襯範遞(窪蓋壓製憲窪遞簾醖鏇) = 簾積繭獵構蓋簾鑰願鏇 顧壓襯壓餘願築製鑰範 (製觸壓醖構築鏇壓鑰餘 ) 更多 | ||||||
N/A | 800 | (壓壓鑰糧齋積醖淵窪襯) = 鬱窪壓築蓋製範夢選鏇 構鹹襯願簾鏇壓構鑰艱 (窪蓋廠齋範遞選顧鬱鹽 ) | - | 2014-12-01 | |||
Placebo | (壓壓鑰糧齋積醖淵窪襯) = 鑰壓齋鑰積鏇獵衊選積 構鹹襯願簾鏇壓構鑰艱 (窪蓋廠齋範遞選顧鬱鹽 ) | ||||||
临床1期 | - | 71 | 夢鹽鬱範蓋製廠齋夢醖(廠遞壓鏇顧遞製壓淵餘) = 齋鹹壓齋艱淵窪遞簾窪 獵艱衊獵壓鏇鹽鬱糧衊 (蓋廠齋選構蓋積淵構醖 ) 更多 | - | 2012-09-01 |
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