结构化临床算法对印度尼西亚合并结核和糖尿病患者血糖控制的影响：一项随机试验。

The effect of a structured clinical algorithm on glycemic control in patients with combined tuberculosis and diabetes in Indonesia: A randomized trial.

机构信息

Infectious Disease Research Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia; Department of Biomedical Science, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.

Infectious Disease Research Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia; Department of Internal Medicine, Radboud Institute of Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.

出版信息

Diabetes Res Clin Pract. 2021 Mar;173:108701. doi: 10.1016/j.diabres.2021.108701. Epub 2021 Feb 18.

DOI:10.1016/j.diabres.2021.108701

PMID:33609618

Abstract

AIMS

Diabetes mellitus (DM) is associated with worse tuberculosis (TB) treatment outcomes, especially among those with poor glycemic control. We examined whether a structured clinical algorithm could improve glycemic control in TB patients with DM.

METHODS

In an open label randomized trial, TB-DM patients were randomized to scheduled counselling, glucose monitoring, and adjustment of medication using a structured clinical algorithm (intervention arm) or routine DM management (control arm), with glycated hemoglobin (HbA1c) at month 6 as the primary end point.

RESULTS

We randomized 150 pulmonary TB-DM patients (92% culture positive, 51.3% male, mean age 53 years). Baseline mean HbA1c was 11.0% in the intervention arm (n = 76) and 11.6% in the control arm (n = 74). At 6 months, HbA1c had decreased more in the intervention arm compared with the control arm (a difference of 1.82% HbA1c, 95% CI 0.82-2.83, p < 0.001). Five patients were hospitalized in the intervention arm and seven in the control arm. There was more hypoglycemia (35.0% vs 11.8%; p = 0.002) in the intervention arm. Two deaths occurred in the intervention arm, one due to cardiorespiratory failure and one because of suspected septic shock and multiorgan failure.

CONCLUSION

Regular monitoring and algorithmic adjustment of DM treatment led to improved glycemic control.

摘要

目的

糖尿病（DM）与结核病（TB）治疗结局较差相关，尤其是在血糖控制不佳的患者中。我们研究了结构化临床算法是否可以改善合并 DM 的 TB 患者的血糖控制。

方法

在一项开放性标签随机试验中，TB-DM 患者被随机分为常规咨询、血糖监测以及使用结构化临床算法调整药物治疗组（干预组）或常规 DM 管理组（对照组），以 6 个月时糖化血红蛋白（HbA1c）作为主要终点。

结果

我们随机纳入了 150 例肺结核合并 DM 患者（92%培养阳性，51.3%为男性，平均年龄 53 岁）。干预组（n=76）和对照组（n=74）的基线平均 HbA1c 分别为 11.0%和 11.6%。6 个月时，干预组 HbA1c 下降幅度明显大于对照组（HbA1c 差值为 1.82%，95%CI 0.82-2.83，p<0.001）。干预组中有 5 例患者住院，对照组中有 7 例患者住院。干预组发生低血糖的患者更多（35.0% vs 11.8%；p=0.002）。干预组有 2 例死亡，1 例死于心肺衰竭，1 例疑似感染性休克和多器官功能衰竭。