Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India.
Eur J Obstet Gynecol Reprod Biol. 2021 May;260:42-47. doi: 10.1016/j.ejogrb.2021.02.017. Epub 2021 Feb 19.
To compare efficacy of myoinositol as an adjuvant to dietary modification for treatment of gestational diabetes mellitus in Asian Indian women compared to controls.
Setting: This pilot randomized open label trial was conducted in a single antenatal clinic in India.
One hundred women with singleton pregnancy and gestational diabetes diagnosed between 14-28 weeks' gestation were included. Overt diabetes, twin pregnancy, pre-existing renal disease, heart disease and other chronic medical disorders were exclusions.
Participants were randomized in two groups (1:1 ratio) by opaque envelope method. Individualized nutrition counseling with dietary modification and routine antenatal care was provided to all. Fifty women received myoinositol 1000 mg twice daily; 50 controls did not receive myoinositol. Fasting and postprandial glucose levels were assessed after two weeks. Women not achieving glycemic targets (fasting glucose <95 and postprandial glucose <120 mg/dL) were given pharmacologic therapy. Contributory factors in women requiring additional pharmacologic therapy, maternal and fetal outcomes were noted.
Between group comparisons reported relative risk and mean difference. To assess predictive factors for need for pharmacologic therapy, univariate and multivariable logistic regression analysis were used.
Baseline characteristics were comparable in both groups. Except one woman in the myoinositol group, all women provided glycaemia data throughout their pregnancy. Glycemic control was achieved in 44/ 49 (89.8 %) women in myoinositol group which was significantly higher than 34/50 (68 %) in the controls ((relative risk 0.31, 95 % confidence interval 0.13 to 0.80, p = 0.008). Mean duration of myoinositol treatment was 17.6 weeks (standard deviation 5.3). Additional treatment with metformin/insulin was needed in all women failing to achieve glycaemic control. The mean (range) dose of insulin was 25.3 units in myoinositol group compared to 14.27 units in controls (p = 0.058). Secondary outcomes were similar in two groups except baby weight which was higher in controls (p = 0.018).
Oral supplementation with myoinositol in dose of 1 gm twice-daily, when started soon after the diagnosis of GDM, is effective in achieving glycemic control and decreasing the need for additional pharmacological therapy in Asian Indian women.
比较肌醇作为辅助饮食治疗对印度裔女性妊娠期糖尿病的疗效，与对照组相比。
本研究为单中心、开放性、随机对照临床试验。
纳入 100 例 14-28 周诊断为妊娠期糖尿病的单胎妊娠印度裔妇女。排除标准：显性糖尿病、双胎妊娠、既往肾脏疾病、心脏病和其他慢性疾病。
采用信封法将参与者随机分为两组（1:1 比例）。所有患者均给予个体化营养咨询、饮食调整和常规产前护理。50 例患者服用肌醇 1000mg，每日 2 次；50 例对照组未服用肌醇。治疗 2 周后检测空腹和餐后血糖水平。血糖未达标（空腹血糖<95mg/dL，餐后血糖<120mg/dL）者给予药物治疗。记录需要额外药物治疗的患者的相关因素、母婴结局。
组间比较采用相对危险度和均数差值。采用单因素和多因素逻辑回归分析评估需要药物治疗的预测因素。
两组患者的基线特征相似。除 1 例肌醇组患者外，所有患者均在整个孕期提供血糖数据。肌醇组 49 例（89.8%）患者血糖控制达标，显著高于对照组 50 例（68%）（相对危险度 0.31，95%置信区间 0.13-0.80，p=0.008）。肌醇组的平均治疗时间为 17.6 周（标准差 5.3）。血糖控制不佳的所有患者均需要加用二甲双胍/胰岛素治疗。肌醇组胰岛素平均（范围）剂量为 25.3 单位，对照组为 14.27 单位（p=0.058）。两组的次要结局相似，除对照组新生儿体重较高外（p=0.018）。
在诊断为 GDM 后不久开始口服肌醇 1g，每日 2 次，可有效控制血糖，减少印度裔女性对额外药物治疗的需求。
