洗涤菌群移植治疗脆性糖尿病的有效性及安全性观察

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目的:观察洗涤菌群移植(WMT)治疗脆性糖尿病的有效性及安全性。方法:选择2017年7月至2019年12月在南京医科大学附属逸夫医院内分泌科治疗的脆性糖尿病患者10例,完成4周导入期后开始接受WMT治疗。于治疗基线(T0),治疗后1周(T1W)、1个月(T1M)、3个月(T3M)收集患者自我血糖监测相关指标、胰岛素使用剂量、糖化血红蛋白、标准馒头餐试验血糖和C肽、血脂、低血糖以及不良事件发生情况。并在T0和T1W进行持续葡萄糖监测,在T0和T1M进行糖尿病治疗满意度问卷调查。采用配对n t检验、Wilcoxon秩和检验、Fisher精确检验、单因素方差分析或Kruskal-Wallis检验比较上述各指标的差异。n 结果:与T0比较,胰岛素使用剂量从T1W即开始降低,至T1M下降最为显著,差异具有统计学意义(n P<0.05)。自我血糖监测结果显示,与T0比较,治疗后空腹和三餐后2 h血糖、平均血糖、血糖水平标准差、血糖变异系数、平均血糖波动幅度、最大血糖波动幅度、低血糖发生频次、低血糖指数以及日间血糖平均绝对差均下降,差异具有统计学意义(均n P<0.05)。持续葡萄糖监测结果显示,与T0比较,T1W时血糖≤3.9 mmol/L和血糖≥11.1 mmol/L的时间百分比均降低[分别为1.46%(0.06%,3.08%)和0(0,0.18%),21.95%(16.02%,44.68%)和5.52%(0.57%,19.93%)],而葡萄糖目标范围内时间百分比显著增加[分别为(44.36±25.24)% 和(74.40±19.13)%],差异均具有统计学意义(均n P0.05)。治疗及随访中未出现严重不良事件。至T3M时治疗整体有效率达70%(7/10),与T0比较差异均具有统计学意义(n P<0.05或n P<0.01)。与T0比较,治疗满意度总评分在T1M时显著增加,差异具有统计学意义[分别为(26.0±2.0)和(18.0±2.0)分,n t=9.847,n P<0.01]。n 结论:WMT用于脆性糖尿病的治疗具较高的有效性、安全性及治疗满意度。“,”Objective:To observe the efficacy and safety of washed microbiota transplantation (WMT) in the treatment of brittle diabetes.Methods:Ten patients with brittle diabetes who were treated in the Department of Endocrinology of Sir Run Run Hospital, Nanjing Medical University from July 2017 to December 2019 were enrolled. After a 4-week run-in period, patients began WMT treatment. At baseline (T0), 1 week post WMT (T1W), 1 month post WMT (T1M), and 3 months post WMT (T3M), the following clinical data were collected: indicators of self-blood glucose monitoring (SMBG), insulin dose, glycated hemoglobin An 1c, blood glucose and C peptide during standard steamed bread meal test, blood lipids, the occurrence of hypoglycemia and adverse events. Continuous glucose monitoring was conducted at T0 and T1W, and diabetes treatment satisfaction questionnaire was conducted at T0 and T1M. Paired n t test, Wilcoxon matched-pairs signed rank test, Fisher exact test, One-way analysis of variance (ANOVA) test or Kruskal-Wallis test were used for data analysis.n Results:The insulin dose began to decrease from T1W, with the most significant decrease at T1M (n P<0.05). The SMBG showed that the fasting and 2-hour postprandial blood glucose, mean of blood glucose, standard deviation of blood glucose, coefficients of variation of blood glucose values, mean amplitude of glycemic excursions, the largest amplitude of glycemic excursions, episodes of hypoglycemia, low blood glucose index (LBGI) and the mean absolute difference daytime blood glucose after WMT treatment were significantly decreased than T0 (n P<0.05). In addition, continuous blood glucose monitoring data showed that the percentage of time with glucose values?≤3.9 mmol/L and the percentage of time with glucose values≥11.1 mmol/L at T1W were significantly reduced compared with T0 [1.46% (0.06%, 3.08%) vs 0 (0, 0.18%), 21.95% (16.02%, 44.68%) vs 5.52% (0.57%, 19.93%), respectively, both n P<0.05], while the percentage of time in glucose target range was significantly increased [(44.36±25.24)% vs (74.40±19.13)%,n P0.05). No serious adverse events occurred during treatment and follow-up. Up to T3M, the overall effective rate of treatment reached 70% (7/10), with a statistically significant difference compared with T0 (n P<0.05 orn P<0.01). The total score of WMT treatment satisfaction was significantly increased compared with T0 [(26.0±2.0) vs (18.0±2.0) points,n t=9.847, n P<0.01].n Conclusion:WMT for the treatment of brittle diabetes is considered to be both safe and efficient with a high patient satisfaction rate.
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