盐酸利托君(Ritodrine Hydrochloride) - 药物靶点：β2-adrenergic receptor_在研适应症：先兆流产，早产_专利_临床

概要

基本信息

药物类型

小分子化药

别名

p-Hydroxy-alpha-(1-((p-hydroxyphenethyl)amino)ethyl)benzyl alcohol、Ritodrine、Ritodrine Hydrochioride

+ [8]

靶点

β2-adrenergic receptor

作用机制

β2-adrenergic receptor激动剂(β2-肾上腺素能受体激动剂)

治疗领域

泌尿生殖系统疾病

在研适应症

先兆流产早产

非在研适应症-

原研机构-

在研机构

台湾生研股份有限公司

Kissei Pharmaceutical Co., Ltd.

非在研机构

AstraZeneca LP

最高研发阶段批准上市

首次获批日期

(1972-08-01),

早产

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C17H22ClNO3

InChIKeyIDLSITKDRVDKRV-JSUROZADSA-N

CAS号23239-51-2

关联

9

项与盐酸利托君相关的临床试验

CTR20241135 / Active, not recruitingN/A

一项在健康成年女性受试者中于餐后情况下进行的关于盐酸利托君片（利托君，10 mg，口服片剂）和Utemerin®（利托君，5 mg，口服片剂）的单剂量、随机、开放性、三周期、三序列、部分重复交叉的生物等效性研究

主要研究目的在健康成年女性受试者中于餐后情况下评价盐酸利托君片和Utemerin®的吸收速度和吸收程度，评价两制剂间是否具有生物等效性。次要研究目的评估受试制剂盐酸利托君片和参比制剂Utemerin®在健康成年女性受试者中的安全性。

开始日期2024-04-21

申办/合作机构

北京信东联创生物技术有限公司

CTR20202691 / CompletedN/A

一项在健康成年女性受试者中于餐后情况下进行的关于盐酸利托君片（利托君，10 mg，口服片剂）和Utemerin®（利托君，5 mg，口服片剂）的单剂量、随机、开放性、双周期、双交叉的生物等效性研究

主要研究目的在健康成年女性受试者中于餐后情况下评价盐酸利托君片和Utemerin®的吸收速度和吸收程度，评价两制剂间是否具有生物等效性。次要研究目的评估受试制剂盐酸利托君片和参比制剂Utemerin®在健康成年女性受试者中的安全性。

开始日期2021-01-20

申办/合作机构

北京信东联创生物技术有限公司

CTR20202690 / CompletedN/A

一项在健康成年女性受试者中于空腹情况下进行的关于盐酸利托君片（利托君，10 mg，口服片剂）和Utemerin®（利托君，5 mg，口服片剂）的单剂量、随机、开放性、双周期、双交叉的生物等效性研究

主要研究目的在健康成年女性受试者中于空腹情况下评价盐酸利托君片和Utemerin®的吸收速度和吸收程度，评价两制剂间是否具有生物等效性。次要研究目的评估受试制剂盐酸利托君片和参比制剂Utemerin®在健康成年女性受试者中的安全性。

开始日期2021-01-18

申办/合作机构

北京信东联创生物技术有限公司

100 项与盐酸利托君相关的临床结果

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100 项与盐酸利托君相关的转化医学

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100 项与盐酸利托君相关的专利（医药）

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1,016

项与盐酸利托君相关的文献（医药）

2024-10-01·International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics

Risks of maternal cardiopulmonary events associated with ritodrine for tocolysis: A national database linkage study in 1 831 564 pregnant women

Article

作者: Huang, Wei‐I ; Chen, Wen‐Wen ; Chen, Yi‐Yung ; Chao, Pi‐Hui ; Hsiao, Fei‐Yuan ; Liang, Hsun‐Yin ; Chan, K. Arnold ; Lin, Chih‐Wan

Abstract:

Objective:

Real‐world data on cardiopulmonary events among pregnant women receiving β‐agonist therapy are scarce. In the present study, we aimed to examine the absolute and relative risks of maternal cardiopulmonary events associated with the use of β‐agonist ritodrine during pregnancy.

Methods:

By linking Taiwan's National Birth Certificate Application Database with National Health Insurance data, 1 831 564 pregnancies at ≥20 weeks' gestation were identified. Age‐standardized incidence rates of cardiopulmonary events among pregnant women exposed to ritodrine were estimated. Nested case–control analyses were conducted to evaluate the relative risk of pulmonary edema, heart failure, and arrhythmia associated with prior ritodrine use. Cases and controls were matched using risk set sampling, and adjusted odds ratios were estimated using conditional logistic regression models.

Results:

A total of 189 cases of pulmonary edema, 126 cases of heart failure, and 162 cases of arrhythmia were identified (corresponding age‐standardized incidence rates: 20.90, 8.35, and 16.63 per 100 000 among pregnant women only exposed to oral ritodrine; 91.28, 36.01, and 14.61 per 100 000 among those ever exposed to intravenous ritodrine). Exposure to oral ritodrine was associated with a lower increased risk of pulmonary edema (aOR 1.76; 95% CI: 1.12–2.76) and arrhythmia (2.21; 1.47–3.32) whereas exposure to ritodrine injection was associated with a significantly higher risk of pulmonary edema (10.56; 6.39–17.45), arrhythmia (4.15; 1.99–8.64), and heart failure (5.58; 2.27–13.74).

Conclusions:

Pregnant women receiving intravenous ritodrine therapy had higher cardiopulmonary risks and should be intensively monitored. While the relative risk associated with oral ritodrine is not pronounced, it should be used judiciously among pregnant women as well.

2024-09-01·MATERNAL AND CHILD HEALTH JOURNAL

Association Between Atopic Dermatitis in Pregnant Women and Preterm Births: The Japan Environment and Children’s Study

Article

作者: Fukuda, Toma ; Kyozuka, Hyo ; Yasumura, Seiji ; Yamaguchi, Akiko ; Yasuda, Shun ; Fujimori, Keiya ; Kanno, Aya ; Shinoki, Kosei ; Isogami, Hirotaka ; Nishigori, Hidekazu ; Ogata, Yuka ; Imaizumi, Karin ; Hosoya, Mitsuaki ; Hashimoto, Koichi ; Sato, Akiko ; Murata, Tsuyoshi

OBJECTIVES:

This study aimed to evaluate the association between atopic dermatitis in pregnant women and preterm births, accounting for maternal ritodrine hydrochloride administration status.

METHODS:

Data of 83,796 women with singleton pregnancies at and after 22 weeks of gestation (enrolled between 2011 and 2014) were analyzed. These data were obtained from the Japan Environment and Children's Study. Atopic dermatitis was defined based on self-reported questionnaire responses obtained during the first trimester. The primary outcome measures were preterm births before 37, 32, and 28 weeks of gestation. Using a multivariable logistic regression model, odds ratios for preterm births in pregnant women with atopic dermatitis were calculated, with women without atopic dermatitis included in the reference group. This analysis considered confounding factors and maternal ritodrine hydrochloride administration.

RESULTS:

Among pregnant women with atopic dermatitis, the adjusted odds ratios (95% confidence intervals) for preterm births before 37, 32, and 28 weeks of gestation were 0.89 (0.81-0.98), 0.98 (0.74-1.30), and 0.88 (0.50-1.55), respectively. This trend remained consistent after excluding participants who received ritodrine hydrochloride.

CONCLUSIONS FOR PRACTICE:

Atopic dermatitis in pregnant women was significantly associated with a decreased incidence of preterm births before 37 weeks of gestation, even after accounting for the effects of maternal ritodrine hydrochloride administration.

2024-08-01·JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH

Response to Letter to “Relationship between maternal mortality and ritodrine hydrochloride as a tocolytic agent in Japan”

Letter

作者: Sekizawa, Akihiko ; Hasegawa, Junichi ; Nakamura, Masamitsu

100 项与盐酸利托君相关的药物交易

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