n -乙酰-氨基葡萄糖- n -乙酰- muramyl二肽在新型冠状病毒感染期抗幽门螺杆菌三组分治疗中的应用

Q3 Medicine
M. R. Konorev, E. N. Tyshevich, R. A. Pavlyukov, М.Р. Конорев, Е.Н. Тышевич, Р.А. Павлюков, Roman A. Pavlyukov — Senior Lecturer
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Patients were divided into three groups according to treatment protocols: omeprazole 0.04 g/day, clarithromycin 1 g/day, amoxicillin 2 g/day (OСA; n = 103); omeprazole 0.04 g/day, clarithromycin 1 g/day, amoxicillin 2 g/day + GMDP 0.001 g/day (OCAL1; n = 61) or 0.01 g/day (OCAL10; n = 44) for 10 days. Detection of SARS-CoV-2 RNA by PCR was carried out from April 2020 to April 2022. Tracking completeness was 96.6 %.Results. The frequency of H. pylori eradication depending on “intention to treat” (ITT) and “per protocol” (PP): OCA — 79 % (95 % CI: 71-87) and 83 % (95 % CI: 75-91); OCAL1 — 95 % (95 % CI: 88-100) and 97 % (95 % CI: 92-100); OCAL10 — 96 % (95 % CI: 89-100) and 98 % (95 % CI: 93-100) respectively. The frequency of adverse reactions depending on ITT and PP: OCA — 24 % (95 % CI: 16-33) and 26 % (95 % CI: 17-35); OCAL1 — 2 % (95 % CI: 0.01-8) and 2 % (95 % CI: 0.01-8); OCAL10 — 2 % (95 % CI: 0.01-7) and 2 % (95 % CI: 0.01-7). 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引用次数: 0

摘要

目的:评价三组分幽门螺杆菌根除治疗同时服用n -乙酰-氨基葡萄糖- n -乙酰-muramyl二肽(GMDP)后COVID-19感染的发生率。材料和方法。进行前瞻性随机对照临床研究。该研究包括208例患者(147例男性,61例女性;平均年龄- 48.1±14.5岁),十二指肠溃疡伴幽门螺杆菌(H. pylori),接受根除治疗。治疗前、治疗结束及停药后6 ~ 8周分别采用形态学法和快速脲酶试验检测胃黏膜幽门螺杆菌。根据治疗方案将患者分为三组:奥美拉唑0.04 g/d、克拉霉素1 g/d、阿莫西林2 g/d (OСA;N = 103);奥美拉唑0.04 g/天,克拉霉素1 g/天,阿莫西林2 g/天+ GMDP 0.001 g/天(OCAL1;n = 61)或0.01 g/d (OCAL10;N = 44),持续10天。2020年4月至2022年4月,采用PCR方法检测SARS-CoV-2 RNA。跟踪完成度为96.6%。幽门螺杆菌根除的频率取决于“治疗意向”(ITT)和“每个方案”(PP): OCA - 79% (95% CI: 71-87)和83% (95% CI: 75-91);OCAL1 - 95% (95% CI: 88-100)和97% (95% CI: 92-100);OCAL10 - 96% (95% CI: 89-100)和98% (95% CI: 93-100)。不良反应发生频率取决于ITT和PP: OCA - 24% (95% CI: 16-33)和26% (95% CI: 17-35);OCAL1 - 2% (95% CI: 0.01-8)和2% (95% CI: 0.01-8);OCAL10 - 2% (95% CI: 0.01-7)和2% (95% CI: 0.01-7)。COVID-19感染的发生率取决于ITT和PP: OCA - 9% (95% CI: 3-14)和9% (95% CI: 3-15);OCAL1 + OCAL10 - 1% (95% CI: 0.003-1.9)和1% (95% CI: 0.001-2.9)。在幽门螺杆菌感染的患者中,在为期10天的三联根除治疗中,GMDP(一种基于保加利亚乳杆菌的免疫调节剂)剂量为1- 10mg /天,与不使用GMDP辅助治疗的10天方案相比,可以显著(p < 0.05)增加幽门螺杆菌根除的频率,并降低不良反应的发生率。用GMDP治疗幽门螺杆菌后COVID-19感染发生率显著(p < 0.05)降低。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Application of N-Acetyl-Glucosaminil-N-Acetyl-Muramyl Dipeptide during Triple Component Anti-Helicobacter Pylori Therapy in the Period of Coronavirus Infection COVID-19
Aim: evaluation of the incidence of COVID-19 infection after three-component H. pylori eradication therapy while taking N-acetyl-glucosaminyl-N-acetyl-muramyl dipeptide (GMDP).Materials and methods. A prospective randomized comparative clinical study was carried out. The study included 208 patients (147 men, 61 women; mean age — 48.1 ± 14.5 years) with duodenal ulcer associated with Helicobacter pylori (H. pylori) who underwent eradication therapy. H. pylori in the gastric mucosa was detected by a morphological method and a rapid urease test before treatment and 6-8 weeks after the end of treatment and the withdrawal of all drugs. Patients were divided into three groups according to treatment protocols: omeprazole 0.04 g/day, clarithromycin 1 g/day, amoxicillin 2 g/day (OСA; n = 103); omeprazole 0.04 g/day, clarithromycin 1 g/day, amoxicillin 2 g/day + GMDP 0.001 g/day (OCAL1; n = 61) or 0.01 g/day (OCAL10; n = 44) for 10 days. Detection of SARS-CoV-2 RNA by PCR was carried out from April 2020 to April 2022. Tracking completeness was 96.6 %.Results. The frequency of H. pylori eradication depending on “intention to treat” (ITT) and “per protocol” (PP): OCA — 79 % (95 % CI: 71-87) and 83 % (95 % CI: 75-91); OCAL1 — 95 % (95 % CI: 88-100) and 97 % (95 % CI: 92-100); OCAL10 — 96 % (95 % CI: 89-100) and 98 % (95 % CI: 93-100) respectively. The frequency of adverse reactions depending on ITT and PP: OCA — 24 % (95 % CI: 16-33) and 26 % (95 % CI: 17-35); OCAL1 — 2 % (95 % CI: 0.01-8) and 2 % (95 % CI: 0.01-8); OCAL10 — 2 % (95 % CI: 0.01-7) and 2 % (95 % CI: 0.01-7). The incidence of COVID-19 infection depending on ITT and PP: OCA — 9 % (95 % CI: 3-14) and 9 % (95 % CI: 3-15); OCAL1 + OCAL10 — 1 % (95 % CI: 0.003-1.9) and 1 % (95 % CI: 0.001-2.9), respectively.Conclusions. In H. pylori-infected patients, GMDP (an immunomodulator based on L. bulgaricus) at a dose of 1-10 mg/day, during a 10-day triple eradication therapy, allows a significant (p < 0.05) increase in the frequency of H. pylori eradication and reduce the incidence of adverse reactions compared with a 10-day protocol without adjuvant therapy with GMDP. There was a significant (p < 0.05) decrease in the incidence of COVID-19 infection after H. pylori eradication therapy with GMDP.
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CiteScore
1.90
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