Maev I V, Mkrtumyan A M, Bektemirova L G, Andreev D N, Dicheva D T
Yevdokimov Moscow State University of Medicine and Dentistry.
Ter Arkh. 2022 Feb 15;94(2):209-215. doi: 10.26442/00403660.2022.02.201372.
Evaluation of the efficacy and safety of eradication therapy of infection Helicobacter pylori in patients with H. pylori- associated pathology of the upper gastrointestinal tract and concomitant type 2 diabetes mellitus (DM).
The prospective randomized study involving 180 patients (87 men and 93 women) with H. pylori- associated pathology of the upper gastrointestinal tract was carried out. The patients were divided into four groups of 45 people: 1 patients without diabetes who received the classic triple eradication therapy; 2 patients with type 2 DM who received the classic triple eradication therapy; 3 patients without DM who underwent quadrotherapy with bismuth preparations; 4 patients with type 2 DM who underwent quadrotherapy with bismuth preparations. Eradication therapy was carried out for 14 days. Evaluation of the effectiveness of eradication using a breath test was carried out 4 weeks after completion of the course of treatment. Eradication success was assessed separately for ITT and PP analyzes.
The effectiveness of classical triple eradication therapy in patients with concomitant type 2 DM is 64.4% in the ITT group and 69.05% in the PP: quadrotherapy 73.34 and 80.49%, respectively. The effectiveness of first line eradication therapy is higher in patients without DM compared with groups of patients with concomitant type 2 DM: ITT 83.33%, PP 88.23% and ITT 68.89%, PP 74.70%, respectively. The incidence of side effects in patients with type 2 DM: with the use of classical triple therapy 22.23%, quadrotherapy 31.12%.
The data of the study of the efficacy and safety of line I eradication therapy make it possible to recommend the four-component therapy based on bismuth for use in clinical practice, especially in patients with DM.
评估根除幽门螺杆菌治疗对幽门螺杆菌相关上消化道疾病合并2型糖尿病（DM）患者的疗效及安全性。
对180例（87例男性和93例女性）幽门螺杆菌相关上消化道疾病患者进行前瞻性随机研究。患者被分为四组，每组45人：1组为未患糖尿病且接受经典三联根除疗法的患者；2组为2型糖尿病且接受经典三联根除疗法的患者；3组为未患糖尿病且接受铋剂四联疗法的患者；4组为2型糖尿病且接受铋剂四联疗法的患者。根除治疗持续14天。治疗疗程结束4周后，采用呼气试验评估根除效果。分别对意向性分析（ITT）和符合方案分析（PP）进行根除成功率评估。
在ITT组中，经典三联根除疗法对合并2型糖尿病患者的有效性为64.4%，PP组为69.05%；四联疗法的ITT组和PP组分别为73.34%和80.49%。与合并2型糖尿病的患者组相比，未患糖尿病患者的一线根除治疗有效性更高：ITT组分别为83.33%、PP组为88.23%，而合并2型糖尿病患者组的ITT组为68.89%、PP组为74.70%。2型糖尿病患者的副作用发生率：使用经典三联疗法为22.23%，四联疗法为31.12%。
关于一线根除治疗疗效和安全性的研究数据使得推荐基于铋剂的四联疗法用于临床实践成为可能，尤其是在糖尿病患者中。
