Ainuddin Jahan Ara, Karim Nasim, Zaheer Sidra, Ali Syed Sanwer, Hasan Anjum Ara
Department of Obstetrics and Gynecology, Dow University of Health Sciences, Karachi 74400, Pakistan.
Department of Pharmacology, Medical and Dental College, Bahria University, Karachi 75500, Pakistan.
J Diabetes Res. 2015;2015:325851. doi: 10.1155/2015/325851. Epub 2015 Mar 22.
To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability.
In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma.
Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain (P < 0.001) and pregnancy induced hypertension (P = 0.029) were observed in metformin treated group. Small for date babies were more in metformin group (P < 0.01). Neonatal hypoglycemia was significantly less and so was NICU stay of >24 hours in metformin group (P < 0.01). Significant reduction in cost of treatment was found in metformin group.
Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763.
评估二甲双胍的疗效，并将其与胰岛素治疗妊娠2型糖尿病患者的围产期结局、母体并发症、额外胰岛素需求及治疗可接受性进行比较。
在这项随机、开放标签研究中，从产前诊所选取了206例符合入选标准的妊娠2型糖尿病患者。必要时在二甲双胍治疗中加用胰岛素，以维持目标血糖控制。对患者进行随访直至分娩。在一份表格上记录母体和围产期结局以及药物治疗特征。
二甲双胍组和胰岛素治疗组的母体特征具有可比性。二甲双胍组84.9%的患者在平均孕周26.58±3.85周时需要加用胰岛素治疗。二甲双胍治疗组观察到母体体重增加较少（P<0.001）和妊娠高血压较少（P=0.029）。二甲双胍组小于胎龄儿较多（P<0.01）。二甲双胍组新生儿低血糖明显较少，入住新生儿重症监护病房>24小时的情况也较少（P<0.01）。二甲双胍组治疗费用显著降低。
单独使用二甲双胍或加用胰岛素对妊娠2型糖尿病患者是一种有效且廉价的治疗选择。本试验已在临床试验注册中心注册，注册号为：Clinical trials.gov NCT01855763。
