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一项比较盐酸屈他维林和溴戊乙奎醚在引产中的应用的随机对照研究。

A randomised controlled study comparing Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour.

机构信息

Government Medical College, Miraj, Maharashtra, India.

出版信息

Arch Gynecol Obstet. 2010 Jul;282(1):11-5. doi: 10.1007/s00404-009-1188-8. Epub 2009 Jul 31.

DOI:10.1007/s00404-009-1188-8
PMID:19644697
Abstract

OBJECTIVES

Cervical dilatation is a poorly understood process. Various drugs have been used to facilitate this process and reduce the duration of labour and thereby reduce feto-maternal complications. The present study is an attempt to compare and evaluate the efficacy of Drotaverine hydrochloride and Valethamate bromide in the process of cervical dilatation and labour augmentation.

STUDY DESIGN

A prospective randomised trial of 146 low-risk women in spontaneous labour was conducted. 49 women were given Drotaverine (Group 1), 49 women were given Valethamate (Group 2) and 48 women were given placebo (Group 3). At 4 cm of cervical dilatation, elective amniotomy was done and the injection was given intramuscularly, and repeated every hour for a maximum of three doses.

RESULTS

There was a statistically significant difference in the mean injection-delivery times (time from first injection to delivery of the baby), which was 183.2 min (SD 78.8) in the Drotaverine group compared to 206.5 min (SD 69.7) in the Valethamate group, and 245 min (SD 70.9) in the control group. The mean cervical dilatation rate (cm/h) was 3 (SD 1.4), 2.4 (SD 0.9) and 1.9 (SD 0.6) in groups 1, 2 and 3, respectively, and these differences were statistically significant. There were no statistically significant differences in the duration of second and third stage of labour. Transient side effects such as foeto-maternal tachycardia, flushing of the face and dryness of mouth were noted with Valethamate. A few patients complained of headache in the Drotaverine group.

CONCLUSIONS

Both Drotaverine and Valethamate appear to significantly help cervical dilatation and augment first stage of labour. But, Drotaverine is superior to Valethamate with fewer side effects.

摘要

目的

宫颈扩张是一个尚未被充分了解的过程。各种药物已被用于促进这个过程,减少分娩的持续时间,从而减少母婴并发症。本研究旨在比较和评估盐酸屈他维林和溴戊乙奎醚在宫颈扩张和分娩增强过程中的疗效。

设计

对 146 名自然分娩的低危妇女进行前瞻性随机试验。49 名妇女给予屈他维林(第 1 组),49 名妇女给予溴戊乙奎醚(第 2 组),48 名妇女给予安慰剂(第 3 组)。在宫颈扩张 4cm 时,选择性行羊膜切开术,并肌肉注射药物,最多每小时重复一次,最多 3 次。

结果

从第一次注射到分娩的平均注射时间(从第一次注射到分娩的时间)有统计学上的显著差异,屈他维林组为 183.2 分钟(SD 78.8),溴戊乙奎醚组为 206.5 分钟(SD 69.7),对照组为 245 分钟(SD 70.9)。平均宫颈扩张率(cm/h)分别为 1 组 3cm(SD 1.4)、2 组 2.4cm(SD 0.9)和 3 组 1.9cm(SD 0.6),这些差异具有统计学意义。第二产程和第三产程的持续时间无统计学差异。溴戊乙奎醚组出现胎儿-母体心动过速、面部潮红和口干等短暂的副作用。屈他维林组少数患者有头痛。

结论

屈他维林和溴戊乙奎醚都能显著促进宫颈扩张和第一产程,但屈他维林的副作用比溴戊乙奎醚少,效果更好。

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