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硝酸甘油贴片治疗早产的效果:一项单盲随机临床试验

The Effects of Glyceryl Trinitrate Patch on the Treatment of Preterm Labor: A Single-blind Randomized Clinical Trial.

作者信息

Nankali Anisodowleh, Jamshidi Parnian Kord, Rezaei Mansour

机构信息

Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.

Biostatistics and Epidemiology Department, Social Development and Health Promotion Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.

出版信息

J Reprod Infertil. 2014 Apr;15(2):71-7.

Abstract

BACKGROUND

Preterm labor (PTL) is one of the main causes of neonatal mortality and morbidity. PTL leads to serious complications especially in the gestational age prior to 24-26 weeks. The aim of this study was to investigate the effect of glyceryl trinitrate (GTN) patch on the treatment and complications of PTL.

METHODS

In this clinical trial, 84 singleton pregnant women with gestational age of 27-35 weeks were surveyed. PTL was clinically diagnosed and the patients were randomly divided into two groups who were treated with GTN or placebo for 48 hr. The consequences, complications and changes in some parameters in both groups were compared. Data were analyzed with chi square test, paired and unpaired t tests by SPSS software and p<0.05 was considered significant.

RESULTS

No significant difference was observed between two groups in terms of successful tocolysis, receiving full dose of corticosteroids and the mean prolongation of the pregnancy. However, delivery times in patients who delivered during the hospitalization were 31±4.4 and 18.3±2.2 hr (p=0.01), respectively. Headache was more severe in control group (p=0.007). The systolic and mean arterial blood pressure decrease (p<0.001) and maternal heart rate increase (p=0.01) were significant in GTN group. The changes of vital signs were not significant in placebo group.

CONCLUSION

The effect of GTN in the treatment of PTL is similar to the placebo without any serious complication. However, GTN delays the delivery time in delivery during the primary hospitalization. Thus, further studies with larger sample size are needed to evaluate the exact effects of GTN on PTL.

摘要

背景

早产是新生儿死亡和发病的主要原因之一。早产会导致严重并发症,尤其是在孕24 - 26周之前的孕周。本研究的目的是探讨硝酸甘油(GTN)贴片对早产治疗及并发症的影响。

方法

在这项临床试验中,对84名单胎妊娠、孕周为27 - 35周的孕妇进行了调查。临床诊断为早产,患者被随机分为两组,分别用GTN或安慰剂治疗48小时。比较两组的结果、并发症及一些参数的变化。数据用SPSS软件进行卡方检验、配对和非配对t检验,p<0.05被认为具有统计学意义。

结果

两组在成功抑制宫缩、接受全剂量皮质类固醇治疗及妊娠平均延长时间方面无显著差异。然而,住院期间分娩的患者的分娩时间分别为31±4.4小时和18.3±2.2小时(p = 0.01)。对照组头痛更严重(p = 0.007)。GTN组收缩压和平均动脉压下降(p<0.001)以及母体心率增加(p = 0.01)显著。安慰剂组生命体征变化不显著。

结论

GTN治疗早产的效果与安慰剂相似,且无任何严重并发症。然而,GTN可延迟初次住院期间的分娩时间。因此,需要进一步进行更大样本量的研究来评估GTN对早产的确切影响。

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