1型糖尿病患者的一项随机试验分析

在近日的ADA年会中，来自纽卡斯尔大学细胞医学研究所的Stuart A等，针对长期患有1型糖尿病（T1DM）并伴有低血糖意识受损(IAH)和严重低血糖（SH）并发症的患者进行了一项胰岛素泵(CSII)/持续血糖监测(RT)和每日多次注射（MDI）/自我监测血糖(SMBG)的对比分析，这是针对这一高危组首次进行该类试验分析。

该研究组在T1DM患者和IAH患者（黄金得分≥4）中进行一项2×2析因随机对照试验（RCT），主要变量为24周黄金得分的差别。全组均进行2个小时的HypoCOMPaSS标准教育，随机分为CSII组（诺和锐）和 MDI（诺和锐/甘精胰岛素），而患者监测血糖的方法则根据实验中心和糖化血红蛋白HbA1c(<64 ≥64mmol/mol)单独分为RT组和SMBG组。全组给予同等的支持治疗避免生化性低血糖(BH)和总体HbA1c降低。全组共96例，年龄49±12岁（平均值±标准差）、糖尿病史29±12年、HbA1c66±12mmol/mol，63%为女性。24周后全组黄金得分的中位数从5（4-6）提升到了4(3-5)。24周后BH（每24小时血糖≤3 mmol/l分钟）从53±63分钟（基本值）减少到了24±56分钟。SH从9±13次/患者·年 减少到了1±2次/患者·年。RCT前92%有明显症状影响生活，RCT中19%的患者有明显症状影响生活。平均HbA1c未变。治疗组之间在24黄金周评分SH或糖化血红蛋白的差异无统计学意义。治疗满意度（采用DTSQ评估）显著高于无检测区别随机分为CSII组和MDI组的试验（32±5 、28±6 p<0.001）。平均每周使用RT3.6 (1.9-5.3)天。

对于长期患有1型糖尿病患者（T1DM）在没有导致HbA1c降低的同时，成功降低IAH的并发率，同时成功预防了SH的发生。尽管CSII的满意度较高，但在给予同等教育和关注时，相对于CSII/RT联合治疗方案来说MDI和SMBG方案也取得了相同的治疗结果。

Impaired awareness of hypoglycemia (IAH) affects 20% of people with type 1 diabetes (T1DM) and is associated with a 6-fold increased risk of severe hypoglycemia (SH). Definitive comparison of insulin pump (CSII) and real-time continuous glucose monitoring (RT) with multiple daily injections (MDI) / self-monitoring of blood glucose (SMBG) has not previously been undertaken in this high-risk group.

A 2x2 factorial RCT was conducted in adults with T1DM and IAH (Gold score ≥4). Primary outcome was difference in 24-week Gold score. All received standardised 2 hour HypoCOMPaSS education and were randomized to CSII (aspart) or MDI (aspart / glargine) with RT or SMBG alone stratified by center and HbA1c (<64 ≥64mmol/mol). All received equal support with treatment goal being rigorous avoidance of biochemical hypoglycemia (BH) without relaxation of overall HbA1c. We recruited 96 participants (mean±SD age 49±12 years diabetes duration 29±12 years HbA1c 66±12mmol/mol; 63% women).

Overall at 24 weeks median (IQR) Gold score improved from 5(4-6) to 4(3-5). BH (minutes ≤3 mmol/l per 24 hours) decreased from 53±63 (baseline) to 24±56 minutes (24 wks). SH reduced from 9±13 to 1±2 episodes/patient year; 92% participants affected pre-RCT vs 19% during RCT. Mean HbA1c was unchanged. There were no statistically significant differences in 24 week Gold score SH or HbA1c between treatment arms. Treatment satisfaction (measured with DTSQ) was significantly higher in those randomized to CSII vs MDI (32±5 vs 28±6 p<0.001) with no difference by monitoring arm. RT use was variable: 3.6 (1.9-5.3) days per week.

IAH was improved and recurrent SH prevented without relaxation of HbA1c in adults with long standing T1DM. When provided with equal education and attention equivalent biomedical outcomes were attained with conventional MDI and SMBG regimens compared with CSII / RT although satisfaction was higher in CSII users.

编辑： 吴楠    来源：丁香园