[Efficacy and safety of H. pylori eradication therapy in real-world clinical practice: results of the «PAMIR» observational program].

IF 0.3 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL
N Y Alexeev, T O Astaf'eva, V V Vishnevskaya, N D Donchenko, V V Zhuravleva, P A Kruglova, A A Kurbatova, V M Pakhomova, L G Ugay, I A Filipenkova, I R Shigapova, T L Lapina, V T Ivashkin
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引用次数: 0

Abstract

Aim: To evaluate the efficacy, safety and impact on gastrointestinal symptoms of Helicobacter pylori eradication therapy with a ready-to-use set of tablets and capsules [omeprazole 20 mg × 2, clarithromycin 500 mg × 2, amoxicillin 500 mg × 4] (Pylobact® AM) in duodenal ulcer patients within the framework of an observational program.

Materials and methods: 912 H. pylori-positive patients were included (404 men and 508 women, average age - 43.8 years (43.82±11.39; 18-64 years). Symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire; patients assessed treatment satisfaction, and physicians assessed treatment efficacy and tolerability using a five-point Likert scale. The efficacy of H. pylori eradication was assessed using the results of the 13C-urea breath test, H. pylori antigen stool test, or a rapid urea test with biopsies of the gastric body and antrum obtained during upper endoscopy. A total of 870 patients completed the observational program: 538 patients in the standard triple therapy group (PAM group) and 332 patients in the group enhanced with a bismuth preparation, rebamipide, and/or a probiotic (PAMplus group). A subgroup of patients received triple therapy with bismuth and the synbiotic complex of Floriose with probiotic strains Lactobacillus acidophilus La-14, Lactobacillus rhamnosus Lr-32, Bifidobacterium lactis Bl-04, inulin and B vitamins.

Results: H. pylori eradication rates in the PAM, PAMplus, and PAM+Bi+F (ITT) groups were 90.6, 97.03, and 96.82%, respectively. Treatment significantly reduced GSRS abdominal pain scores. Physicians rated the treatment efficacy and tolerability as "very good" or "good" at the end of the program in 93.3% of patients. Patients rated 93.68% as completely or mostly satisfied with the treatment.

Conclusion: The effectiveness of H. pylori eradication with a ready-to-use set of capsules and tablets for standard triple therapy is ensured by high patient compliance. The combination of standard triple therapy with bismuth, probiotics, and/or rebamipide increases treatment efficacy.

[幽门螺杆菌根除治疗在现实世界临床实践中的有效性和安全性:«PAMIR»观察项目的结果]。
目的:在一项观察性研究中,评价一套即食片剂和胶囊[奥美拉唑20mg × 2,克拉霉素500mg × 2,阿莫西林500mg × 4] (Pylobact®AM)根除十二指肠溃疡患者幽门螺杆菌的疗效、安全性及对胃肠道症状的影响。材料与方法:纳入912例幽门螺旋杆菌阳性患者,其中男性404例,女性508例,平均年龄- 43.8岁(43.82±11.39;18-64岁)。采用胃肠症状评定量表(GSRS)进行症状评估;患者评估治疗满意度,医生使用五点李克特量表评估治疗疗效和耐受性。采用13c -尿素呼气试验、幽门螺杆菌抗原粪便试验或快速尿素试验,并在上胃镜检查中对胃体和胃窦进行活检,评估根除幽门螺杆菌的效果。共有870名患者完成了观察项目:538名患者接受标准三联治疗组(PAM组),332名患者接受铋制剂、利巴米胺和/或益生菌强化治疗组(PAMplus组)。一个亚组患者接受了铋和flororiose与益生菌菌株嗜酸乳杆菌La-14、鼠李糖乳杆菌Lr-32、乳酸双歧杆菌Bl-04、菊粉和B族维生素的合成复合物的三联治疗。结果:PAM、PAM+和PAM+Bi+F (ITT)组幽门螺杆菌根除率分别为90.6%、97.3%和96.82%。治疗显著降低GSRS腹痛评分。93.3%的患者在项目结束时,医生将治疗效果和耐受性评为“非常好”或“良好”。93.68%的患者对治疗完全满意或基本满意。结论:标准三联疗法中使用的一套即用型胶囊和片剂根除幽门螺杆菌的效果良好,患者的依从性高。标准三联疗法结合铋、益生菌和/或利巴米胺可提高治疗效果。
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来源期刊
Terapevticheskii Arkhiv
Terapevticheskii Arkhiv 医学-医学:内科
CiteScore
1.40
自引率
33.30%
发文量
171
审稿时长
3-8 weeks
期刊介绍: Терапевтический архив The journal was founded by the prominent Russian therapists M.P. Konchalovsky and G.F. Lang in 1923. Then its editors-in-chief were Professors V.N. Vinogradov and A.G. Gukasyan. Since 1972, E.I. Chazov, Academician of the Russian Academy of Sciences, has been heading the editorial board of the journal. Over 90 years, there have been more than 1000 issues where the authors and editorial staff have done their best for readers to keep abreast of current advances in medical science and practice and for physicians to master the advanced principles of recognition and treatment of a wide spectrum of visceral diseases. The papers published in the journal (editorials, original articles, lectures, reviews, etc.) cover both current scientific achievements and practical experience in diagnosing, treating, and preventing visceral diseases. The authors of publications are not only Russian, but also foreign scientists and physicians. All papers are peer-reviewed by highly qualified Russian specialists. The journal is published monthly. Traditionally, each issue has predominantly certain thematic areas covering individual therapy specializations. Every year, one of the issues is devoted to related problems in practical medicine (allergology and immunology, neurology and psychiatry, obstetrics, oncology, etc.). This all draws the attention of the reading public to the journal. The journal is indexed in RSCI (Russian Science Citation Index), PubMed/Medline, Index Medicus, Scopus/EMBASE, Web of Science Core Collection (Science Citation Index Expanded), Web of Science (Russian Science Citation Index - RSCI, Current Contents Connect, BIOSIS Previews), Google Scholar, Ulrich''s Periodicals Directory. The journal is included in the list of periodicals recommended by the Higher Attestation Committee for publishing the papers containing the basic materials of doctoral and candidate dissertations. By the decision of the Presidium of the Russian Academy of Medical Sciences, the “Therapevticheskiy Arkhiv” was awarded the Botkin medal. It was admitted to the European Association of Sciences Editors (EASE). The journal was honored with the Golden Press Fund decoration at the 13th International Press Professional Exhibition.
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