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约旦一家门诊糖尿病诊所中2型糖尿病患者临床药学管理的随机对照试验

Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan.

作者信息

Jarab Anan Sadeq, Alqudah Salam Ghazi, Mukattash Tareq Lewis, Shattat Ghassan, Al-Qirim Tariq

机构信息

AIZaytoonah University of Jordan, Pharmacy, P.O. Box 130, Amman, Jordan 11733.

出版信息

J Manag Care Pharm. 2012 Sep;18(7):516-26. doi: 10.18553/jmcp.2012.18.7.516.

DOI:10.18553/jmcp.2012.18.7.516
PMID:22971205
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10437536/
Abstract

BACKGROUND

Glycemic goals (hemoglobin A1c < 7%) are often not achieved in patients with type 2 diabetes despite the availability of many effective treatments and the documented benefits of glycemic control in the reduction of long-term microvascular and macrovascular complications. Several studies have established the important positive effects of pharmacist-led management on achieving glycemic control and other clinical outcomes in patients with diabetes. Diabetes prevalence and mortality are increasing rapidly in Jordan. Nevertheless, clinical pharmacists in Jordan do not typically provide pharmaceutical care; instead, the principal responsibilities of pharmacists in Jordan are dispensing and marketing of medical products to physicians.

OBJECTIVE

To assess the primary clinical outcome of glycemic control (A1c) and secondary outcomes, including blood pressure, lipid values, self-reported medication adherence, and self-care activities for patients with type 2 diabetes in an outpatient diabetes clinic randomly assigned to either usual care or a pharmacist-led pharmaceutical care intervention program.

METHODS

Patients with type 2 diabetes attending an outpatient diabetes clinic of a large teaching hospital were recruited over a 4-month period from January through April 2011 and randomly assigned to intervention and usual care groups using the Minim software technique. The intervention group at baseline received face-to-face objective-directed education from a clinical pharmacist about type 2 diabetes, prescription medications, and necessary lifestyle changes, followed by 8 weekly telephone follow-up calls to discuss and review the prescribed treatment plan and to resolve any patient concerns. The primary outcome measure was glycemic control (A1c), and secondary measures included systolic and diastolic blood pressure, complete lipid profile (i.e., total cholesterol, low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], serum triglycerides), and self-reported medication adherence (4-item Morisky Scale) and self-care activities (Summary of Diabetes Self-Care Activities questionnaire). Data were collected at baseline and at 6 months follow-up. Changes from baseline to follow-up were calculated for biomarker values, and between-group differences in the change amounts were tested using the t test for independent samples. A P value of < 0.05 was considered statistically significant.

RESULTS

A total of 77 of 85 patients (90.6%) randomly assigned to the intervention group and 79 of 86 patients (91.9%) assigned to usual care had baseline and 6-month follow-up values. Compared with baseline values, patients in the intervention group had a mean reduction of 0.8% in A1c versus a mean increase of 0.1% from baseline in the usual care group (P = 0.019). The intervention group compared with the usual care group had small but statistically significant improvements in the secondary measures of fasting blood glucose, systolic and diastolic blood pressure, total cholesterol, LDL-C, serum triglycerides, self-reported medication adherence, and self-care activities. Between-group differences in changes in the secondary measures of HDL-C and body mass index were not significant.

CONCLUSIONS

Patients with type 2 diabetes who received pharmacist-led pharmaceutical care in an outpatient diabetes clinic experienced reduction in A1c at 6 months compared with essentially no change in the usual care group. Six of 8 secondary biomarkers were improved in the intervention group compared with usual care.

摘要

背景

尽管有多种有效治疗方法,且血糖控制对减少长期微血管和大血管并发症的益处已有文献记载,但2型糖尿病患者往往无法实现血糖目标(糖化血红蛋白<7%)。多项研究已证实,药剂师主导的管理对糖尿病患者实现血糖控制及其他临床结局具有重要的积极作用。约旦的糖尿病患病率和死亡率正在迅速上升。然而,约旦的临床药剂师通常不提供药学服务;相反,约旦药剂师的主要职责是向医生分发和销售医疗产品。

目的

在一家门诊糖尿病诊所中,对随机分配至常规护理或药剂师主导的药学服务干预项目的2型糖尿病患者,评估血糖控制的主要临床结局(糖化血红蛋白)以及次要结局,包括血压、血脂值、自我报告的用药依从性和自我护理活动。

方法

2011年1月至4月的4个月期间,在一家大型教学医院的门诊糖尿病诊所招募2型糖尿病患者,并使用Minim软件技术将其随机分配至干预组和常规护理组。干预组在基线时接受临床药剂师关于2型糖尿病、处方药和必要生活方式改变的面对面目标导向教育,随后进行8次每周一次的电话随访,以讨论和审查规定的治疗计划并解决患者的任何疑虑。主要结局指标是血糖控制(糖化血红蛋白),次要指标包括收缩压和舒张压、完整血脂谱(即总胆固醇、低密度脂蛋白胆固醇[LDL-C]、高密度脂蛋白胆固醇[HDL-C]、血清甘油三酯)以及自我报告的用药依从性(4项Morisky量表)和自我护理活动(糖尿病自我护理活动问卷摘要)。在基线和6个月随访时收集数据。计算生物标志物值从基线到随访的变化,并使用独立样本t检验检验变化量的组间差异。P值<0.05被认为具有统计学意义。

结果

随机分配至干预组的85名患者中有77名(90.6%)以及分配至常规护理组的86名患者中有79名(91.9%)有基线和6个月随访值。与基线值相比,干预组患者的糖化血红蛋白平均降低0.8%,而常规护理组从基线平均升高0.1%(P = 0.019)。与常规护理组相比,干预组在空腹血糖、收缩压和舒张压、总胆固醇、LDL-C、血清甘油三酯、自我报告的用药依从性和自我护理活动等次要指标方面有虽小但具有统计学意义的改善。高密度脂蛋白胆固醇和体重指数次要指标变化的组间差异不显著。

结论

在门诊糖尿病诊所接受药剂师主导药学服务的2型糖尿病患者在6个月时糖化血红蛋白有所降低,而常规护理组基本无变化。与常规护理相比,干预组的8项次要生物标志物中有6项得到改善。

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