PDF(Pubmed)
Abstract：
BACKGROUND: Exocrine pancreatic insufficiency (EPI) can be associated with all types of diabetes. Pancreatic enzyme replacement therapy (PERT) has short and long-term benefits in subjects with EPI, but its effects on diabetes control are uncertain. We aimed to study the effects of PERT initiation on glycemic control in subjects with diabetes and EPI from any cause.
METHODS: In this retrospective study, we compared subjects with EPI and diabetes who were prescribed PERT with subjects with diabetes who had a fecal elastase-1 concentration dosage, but did not receive PERT. The primary outcome was the effect of PERT on hypoglycemia frequency and severity. The secondary outcomes were the effects of PERT on gastro-intestinal disorders, HbA1c and body mass index (BMI).
RESULTS: 48 subjects were included in each group. Overall, PERT did not have any significant effect on hypoglycemia frequency or severity, but hypoglycemia frequency tended to decrease in subjects with chronic pancreatitis. While 19% of subjects experienced mild hyperglycemia after PERT initiation, we did not report any keto-acidosis or any other severe adverse event. Gastro-intestinal disorders improved in 80% of subjects treated with PERT, versus in 20% of control subjects (p = 0.02). Gastro-intestinal disorders improved in 87% of subjects with recommended dosage of PERT, versus in 50% of subjects with underdosage (NS). HbA1c and BMI evolution did not differ between the groups.
CONCLUSIONS: PERT initiation is safe in subjects with diabetes and EPI. It does not globally decrease hypoglycemia severity of frequency, but is associated with a decrease in gastro-intestinal disorders. Trial registration Retrospectively registered. The database was registered with the Commission Nationale Informatique et Libertés (CNIL), registration number: 2203351v0. The study was approved by the local ethics committee CLEP, registration number: AAA-2023-09047.
METHODS: In this retrospective study, we compared subjects with EPI and diabetes who were prescribed PERT with subjects with diabetes who had a fecal elastase-1 concentration dosage, but did not receive PERT. The primary outcome was the effect of PERT on hypoglycemia frequency and severity. The secondary outcomes were the effects of PERT on gastro-intestinal disorders, HbA1c and body mass index (BMI).
RESULTS: 48 subjects were included in each group. Overall, PERT did not have any significant effect on hypoglycemia frequency or severity, but hypoglycemia frequency tended to decrease in subjects with chronic pancreatitis. While 19% of subjects experienced mild hyperglycemia after PERT initiation, we did not report any keto-acidosis or any other severe adverse event. Gastro-intestinal disorders improved in 80% of subjects treated with PERT, versus in 20% of control subjects (p = 0.02). Gastro-intestinal disorders improved in 87% of subjects with recommended dosage of PERT, versus in 50% of subjects with underdosage (NS). HbA1c and BMI evolution did not differ between the groups.
CONCLUSIONS: PERT initiation is safe in subjects with diabetes and EPI. It does not globally decrease hypoglycemia severity of frequency, but is associated with a decrease in gastro-intestinal disorders. Trial registration Retrospectively registered. The database was registered with the Commission Nationale Informatique et Libertés (CNIL), registration number: 2203351v0. The study was approved by the local ethics committee CLEP, registration number: AAA-2023-09047.
摘要：
背景：胰腺外分泌功能不全（EPI）可能与所有类型的糖尿病有关。胰腺酶替代疗法（PERT）对EPI患者具有短期和长期益处，但其对糖尿病控制的影响尚不确定。我们的目的是研究PERT对任何原因引起的糖尿病和EPI患者血糖控制的影响。
方法：在这项回顾性研究中，我们比较了EPI和接受PERT处方的糖尿病患者与粪便弹性蛋白酶-1浓度剂量的糖尿病患者，但没有得到PERT。主要结果是PERT对低血糖频率和严重程度的影响。次要结果是PERT对胃肠道疾病的影响，HbA1c和体重指数（BMI）。
结果：每组48名受试者。总的来说,PERT对低血糖频率或严重程度没有任何显著影响，但慢性胰腺炎患者的低血糖频率有降低的趋势。虽然19%的受试者在PERT开始后出现轻度高血糖，我们没有报告任何酮症酸中毒或任何其他严重不良事件.80%接受PERT治疗的受试者的胃肠道疾病得到改善，与20%的对照受试者(p=0.02)相比。推荐剂量PERT的受试者中，有87％的胃肠道疾病得到改善，与50％的剂量不足（NS）的受试者相比。两组之间的HbA1c和BMI演变没有差异。
结论：在患有糖尿病和EPI的受试者中启动PERT是安全的。它不会在全球范围内降低低血糖频率的严重程度，但与胃肠道疾病的减少有关。试用登记追溯登记。该数据库已在国家信息和自由委员会（CNIL）注册，注册号:2203351v0。这项研究得到了当地伦理委员会CLEP的批准，注册号：AAA-2023-09047。
方法：在这项回顾性研究中，我们比较了EPI和接受PERT处方的糖尿病患者与粪便弹性蛋白酶-1浓度剂量的糖尿病患者，但没有得到PERT。主要结果是PERT对低血糖频率和严重程度的影响。次要结果是PERT对胃肠道疾病的影响，HbA1c和体重指数（BMI）。
结果：每组48名受试者。总的来说,PERT对低血糖频率或严重程度没有任何显著影响，但慢性胰腺炎患者的低血糖频率有降低的趋势。虽然19%的受试者在PERT开始后出现轻度高血糖，我们没有报告任何酮症酸中毒或任何其他严重不良事件.80%接受PERT治疗的受试者的胃肠道疾病得到改善，与20%的对照受试者(p=0.02)相比。推荐剂量PERT的受试者中，有87％的胃肠道疾病得到改善，与50％的剂量不足（NS）的受试者相比。两组之间的HbA1c和BMI演变没有差异。
结论：在患有糖尿病和EPI的受试者中启动PERT是安全的。它不会在全球范围内降低低血糖频率的严重程度，但与胃肠道疾病的减少有关。试用登记追溯登记。该数据库已在国家信息和自由委员会（CNIL）注册，注册号:2203351v0。这项研究得到了当地伦理委员会CLEP的批准，注册号：AAA-2023-09047。
