Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.
Arch Gynecol Obstet. 2021 Aug;304(2):345-353. doi: 10.1007/s00404-020-05950-3. Epub 2021 Jan 16.
PURPOSE: To compare 3 consecutive days of hyperglycemic response following antenatal dexamethasone regimens of 12-mg or 6-mg doses 12 hourly in diet-controlled gestational diabetes. METHODS: A randomized controlled trial was carried out in a university hospital in Malaysia. Women with lifestyle-controlled gestational diabetes scheduled to receive clinically indicated antenatal corticosteroids (dexamethasone) were randomized to 12-mg 12 hourly for one day (2 × 12-mg) or 6-mg 12-hourly for two days (4 × 6-mg). 6-point (pre and 2-h postprandial) daily self-monitoring of capillary blood sugar profile for up to 3 consecutive days was started after the first dexamethasone injection. Hyperglycemia is defined as blood glucose pre-meal ≥ 5.3 or 2 h postprandial ≥ 6.7 mmol/L. The primary outcome was a number of hyperglycemic episodes in Day-1 (first 6 BSP points). A sample size of 30 per group (N = 60) was planned. RESULTS: Median [interquartile range] hyperglycemic episodes 4 [2.5-5] vs. 4 [3-5] p = 0.3 in the first day, 3 [2-4] vs. 1 [0-3] p = 0.01 on the second day, 0 [0-1] vs. 0 [0-1] p = 0.6 on the third day and over the entire 3 trial days 7 [6-9] vs. 6 [4-8] p = 0.17 for 6-mg vs. 12-mg arms, respectively. 2/30 (7%) in each arm received an anti-glycemic agent during the 3-day trial period (capillary glucose exceeded 11 mmol/L). Mean birth weight (2.89 vs. 2.49 kg p < 0.01) and gestational age at delivery (37.7 vs. 36.6 weeks p = 0.03) were higher and median delivery blood loss (300 vs. 400 ml p = 0.02) was lower in the 12-mg arm; all other secondary outcomes were not significantly different. CONCLUSION: In gestational diabetes, 2 × 12-mg could be preferred over 4 × 6-mg dexamethasone as hyperglycemic episodes were fewer on Day-2, fewer injections were needed and the regimen was completed sooner. CLINICAL TRIAL REGISTRATION: http://www.isrctn.com/ISRCTN16613220 .
目的:比较经饮食控制的妊娠期糖尿病患者接受 12 小时 12 毫克或 6 毫克剂量的产前地塞米松方案后连续 3 天的高血糖反应。 方法:在马来西亚的一所大学医院进行了一项随机对照试验。计划接受临床指示的产前皮质激素(地塞米松)的生活方式控制的妊娠期糖尿病女性被随机分为 12 小时 12 毫克 1 天(2×12 毫克)或 12 小时 6 毫克 2 天(4×6 毫克)。在第一次地塞米松注射后,开始进行长达 3 天的每日 6 点(餐前和餐后 2 小时)毛细血管血糖监测。高血糖定义为餐前血糖≥5.3 或餐后 2 小时血糖≥6.7mmol/L。主要结局是第 1 天(第 1 次 6 次 BSP 点)的高血糖发作次数。计划每组 30 名患者(N=60)。 结果:中位数[四分位距]第 1 天的高血糖发作次数为 4[2.5-5]与 4[3-5](p=0.3),第 2 天为 3[2-4]与 1[0-3](p=0.01),第 3 天为 0[0-1]与 0[0-1](p=0.6),在整个 3 天试验期间,第 6 毫克组为 7[6-9]与第 12 毫克组为 6[4-8](p=0.17)。在 3 天的试验期间,每个手臂的 2/30(7%)接受了抗血糖药物治疗(毛细血管血糖超过 11mmol/L)。第 12 毫克组的平均出生体重(2.89 与 2.49kg,p<0.01)和分娩时的胎龄(37.7 与 36.6 周,p=0.03)较高,中位分娩失血量(300 与 400ml,p=0.02)较低;所有其他次要结局均无显著差异。 结论:在妊娠期糖尿病中,2×12mg 可能优于 4×6mg 地塞米松,因为第 2 天的高血糖发作次数较少,需要的注射次数较少,且治疗方案完成得更早。 临床试验注册:http://www.isrctn.com/ISRCTN16613220。
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