Elnour A A, El Mugammar I T, Jaber T, Revel T, McElnay James C
Al Ain Hospital, United Arab Emirates, and Clinical and Practice Research Group, School of Pharmacy, Queen's University Belfast, Belfast, UK.
J Eval Clin Pract. 2008 Feb;14(1):131-40. doi: 10.1111/j.1365-2753.2007.00819.x.
RATIONALE, AIMS AND OBJECTIVE: To investigate whether the introduction of a programme of optimising drug treatment, intensive education and self-monitoring of patients diagnosed with gestational diabetes mellitus (GDM) at an early stage (<20 gestational weeks), will improve management outcomes as determined by objective measures of patient knowledge about diabetes, glycaemia control, maternal/neonatal complications, and health-related quality of life.
The study was a randomized, controlled, longitudinal, prospective clinical trial performed at Al-Ain Hospital, Al-Ain, United Arab Emirates. Over an 18-month period, patients diagnosed with GDM were recruited and were randomly assigned to either an intervention or a control group, in a ratio of 3:2. Intervention patients received a structured pharmaceutical care service (including education and introduction of intensive self-monitoring) while control patients received traditional services. Patients were followed up from time of recruitment until 6 months postnatally at scheduled outpatient clinics. A range of clinical and humanistic outcome measures, including maternal and neonatal complications, were used to assess the impact of the intervention.
A total of 165 patients (99 intervention, 66 control) completed the study. The intervention patients exhibited a range of benefits from the provision of the programme when compared with control group patients. Statistically significant (P < 0.05) improvements were shown in the intervention group for knowledge of diabetes, health-related quality of life (as determined by the SF36), control of plasma glucose and HbA(1c), maternal complications [e.g. decreased incidence of pre-eclampsia (5.1% vs. 16.7%), eclampsia (1.0% vs. 7.6%), episodes of severe hyperglycaemia (3.0% vs. 19.7%) and need for Caesarean section (7.1% vs. 18.2%)], and neonatal complications [e.g. decreased incidence of neonatal hypoglycaemia (2.0% vs. 10.6%), respiratory distress at birth (4.0% vs. 15.2%), hyperbilirubinaemia (1.0% vs. 12.1%) and large for gestational age (9.0% vs. 22.7%)].
The research provides clear evidence that provision of pharmaceutical care adds value to the management of GDM as exemplified by improved maternal and neonatal outcomes.
原理、目的和目标：调查对妊娠20周前被诊断为妊娠期糖尿病（GDM）的患者引入优化药物治疗、强化教育和自我监测计划，是否会改善管理结果，该结果由患者对糖尿病的知识、血糖控制、母婴并发症以及健康相关生活质量的客观指标来确定。
该研究是在阿拉伯联合酋长国艾因市艾因医院进行的一项随机、对照、纵向、前瞻性临床试验。在18个月的时间里，招募被诊断为GDM的患者，并按3:2的比例随机分配到干预组或对照组。干预组患者接受结构化药学服务（包括教育和强化自我监测介绍），而对照组患者接受传统服务。患者从招募时开始随访，直至产后6个月在预定的门诊诊所进行随访。一系列临床和人文结局指标，包括母婴并发症，用于评估干预的影响。
共有165名患者（99名干预组，66名对照组）完成了研究。与对照组患者相比，干预组患者从该计划中获得了一系列益处。干预组在糖尿病知识、健康相关生活质量（由SF36确定）、血糖和糖化血红蛋白（HbA1c）控制、母体并发症[例如子痫前期发病率降低（5.1%对16.7%）、子痫发病率降低（1.0%对7.6%）、严重高血糖发作次数降低（3.0%对19.7%）以及剖宫产需求降低（7.1%对18.2%）]和新生儿并发症[例如新生儿低血糖发病率降低（2.0%对10.6%）、出生时呼吸窘迫发病率降低（4.0%对15.2%）、高胆红素血症发病率降低（1.0%对12.1%）以及大于胎龄儿发病率降低（9.0%对22.7%）]方面显示出统计学上的显著改善（P<0.05）。
该研究提供了明确证据，即药学服务的提供为GDM的管理增加了价值，改善的母婴结局就是例证。
