一项比较新型口服缓释利托君与传统片剂的前瞻性随机临床试验。

A prospective randomized clinical trial comparing a new oral sustained-release ritodrine with conventional tablets.

作者信息

Hagay Z J, Epstein M, Goldchmit R, Gotlib Z, Blickstein I, Zalel Y, Weissman A

机构信息

Department of Obstetrics and Gynecology, Kaplan Hospital, Rehovot, Israel.

出版信息

Eur J Obstet Gynecol Reprod Biol. 1994 Aug;56(2):83-7. doi: 10.1016/0028-2243(94)90261-5.

DOI:10.1016/0028-2243(94)90261-5

PMID:7805972

Abstract

OBJECTIVES

Evaluation of maternal metabolic and cardiovascular responses to treatment with the new sustained-release oral ritodrine as compared with the conventional tablets.

METHOD

Thirty-two pregnant patients who had successful intravenous tocolysis were randomly assigned to treatment with either ritodrine tablets or sustained-release capsules. After 5 days of the randomly determined first oral treatment each patient was shifted to the alternate ritodrine formulation for a further 5-day course. Each patient underwent metabolic and non-invasive hemodynamic evaluation.

RESULTS

Echocardiographic parameters during treatment with ritodrine tablets were not significantly different from during sustained-release capsules. Mean systolic blood pressure increased significantly during peak drug activity in patients treated with ritodrine tablets and not during treatment with the sustained-release form. Fasting plasma glucose levels were higher in patients on conventional tablets therapy than in patients on sustained-release ritodrine therapy (88.9 +/- 9 mg/dl vs. 78.7 +/- 8 mg/dl, P < 0.05) while levels following a 50-g oral glucose challenge test did not differ significantly (135 +/- 32 mg/dl vs. 124.5 +/- 27 mg/dl)

CONCLUSIONS

Because of fewer metabolic and cardiovascular side-effects, the new oral therapy offers some advantages over the presently available tablets.

摘要

目的

评估新型口服缓释利托君与传统片剂相比，对母体代谢及心血管系统的治疗反应。

方法

32例静脉注射保胎成功的孕妇被随机分配接受利托君片或缓释胶囊治疗。在随机确定的首次口服治疗5天后，每位患者换用另一种利托君剂型再进行5天的疗程。每位患者均接受代谢及无创血流动力学评估。

结果

服用利托君片治疗期间的超声心动图参数与服用缓释胶囊期间无显著差异。服用利托君片的患者在药物活性峰值时平均收缩压显著升高，而服用缓释剂型时则未出现此情况。接受传统片剂治疗的患者空腹血糖水平高于接受缓释利托君治疗的患者（88.9±9mg/dl对78.7±8mg/dl，P<0.05），而口服50g葡萄糖耐量试验后的血糖水平无显著差异（135±32mg/dl对124.5±27mg/dl）。