高风险糖尿病患者中药师管理糖尿病诊所的疗效：一项随机对照试验——“Pharm-MD”：临床药师在糖尿病护理中的作用。
Efficacy of a pharmacist-managed diabetes clinic in high-risk diabetes patients, a randomized controlled trial - "Pharm-MD" : Impact of clinical pharmacists in diabetes care.
机构信息
General Internal Medicine Division, Beaumont Health, 3601 W 13 Mile Rd, Royal Oak, MI, USA.
Oakland University William Beaumont School of Medicine, Rochester, MI, USA.
出版信息
BMC Endocr Disord. 2022 Mar 16;22(1):69. doi: 10.1186/s12902-022-00983-y.
BACKGROUND
Diabetes mellitus affects 13% of American adults. To address the complex care requirements necessary to avoid diabetes-related morbidity, the American Diabetes Association recommends utilization of multidisciplinary teams. Research shows pharmacists have a positive impact on multiple clinical diabetic outcomes.
METHODS
Open-label randomized controlled trial with 1:1 assignment that took place in a single institution resident-run outpatient medicine clinic. Patients 18-75 years old with type 2 diabetes mellitus and most recent HbA1c ≥9% were randomized to standard of care (SOC) (continued with routine follow up with their primary provider) or to the SOC + pharmacist-managed diabetes clinic PMDC group (had an additional 6 visits with the pharmacist within 6 months from enrollment). Patients were followed for 12 months after enrollment. Data collected included HbA1c, lipid panel, statin use, blood pressure control, immunization status, and evidence of diabetic complications (retinopathy, nephropathy, neuropathy). Intention-to-treat and per-protocol analysis were performed.
RESULTS
Forty-four patients were enrolled in the SOC + PMDC group and 42 patients in the SOC group. Average decrease in HbA1c for the intervention compared to the control group at 6 months was - 2.85% vs. -1.32%, (p = 0.0051). Additionally, the odds of achieving a goal HbA1c of ≤8% at 6 months was 3.15 (95% CI = 1.18, 8.42, p = 0.0222) in the intervention versus control group. There was no statistically significant difference in the remaining secondary outcomes measured.
CONCLUSIONS
Addition of pharmacist managed care for patients with type 2 diabetes mellitus is associated with significant improvements in HbA1c compared with standard of care alone. Missing data during follow up limited the power of secondary outcomes analyses.
TRIAL REGISTRATION
ClinicalTrials.gov , ID: NCT03377127 ; first posted on 19/12/2017.
背景
糖尿病影响了 13%的美国成年人。为了满足避免糖尿病相关发病率所需的复杂护理要求，美国糖尿病协会建议利用多学科团队。研究表明，药剂师对多种临床糖尿病治疗结果有积极影响。
方法
在一个机构的居民经营的门诊医学诊所中，进行了一项 1:1 随机分配的开放标签随机对照试验。18-75 岁的 2 型糖尿病患者，最近的糖化血红蛋白（HbA1c）≥9%，随机分为标准护理（SOC）组（继续接受常规随访）或 SOC+药剂师管理糖尿病诊所 PMDC 组（在入组后 6 个月内，与药剂师进行额外的 6 次就诊）。患者在入组后随访 12 个月。收集的数据包括 HbA1c、血脂谱、他汀类药物使用、血压控制、免疫状况以及糖尿病并发症（视网膜病变、肾病、神经病变）的证据。进行意向治疗和方案分析。
结果
SOC+PMDC 组有 44 名患者入组，SOC 组有 42 名患者入组。干预组与对照组相比，HbA1c 在 6 个月时平均下降-2.85%vs.-1.32%（p=0.0051）。此外，在干预组中，6 个月时达到 HbA1c≤8%目标的几率为 3.15（95%CI=1.18，8.42，p=0.0222），而对照组为 1.18。在其余测量的次要结果方面，没有统计学意义上的显著差异。
结论
与标准护理相比，为 2 型糖尿病患者提供药剂师管理护理与 HbA1c 的显著改善相关。随访期间缺失数据限制了次要结果分析的效力。
试验注册
ClinicalTrials.gov，ID：NCT03377127；首次于 2017 年 12 月 19 日注册。
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