胃库尔膳食补充剂联合泮托拉唑治疗幽门螺杆菌的疗效及安全性评价

D. Bordin, I. Voynovan
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摘要

本文介绍了一项关于幽门螺杆菌患者服用膳食补充剂Gastrokur联合泮托拉唑的疗效和安全性的临床研究结果。材料和方法。经13c -脲酶呼吸试验证实幽门螺杆菌感染的患者10例,连续4周给予膳食补充剂Gastrokur 2粒,每日3次,联合泮托拉唑40 mg,每日1次。一个特殊的条件是符合Gastrokur储存温度从+40到+100 С。治疗结束后30天用13C脲酶呼气试验评估根除效果。结果。根据ITT标准,10例患者中有2例(20%)幽门螺杆菌根除,根据PP标准,9例患者中有2例(22.2%)幽门螺杆菌根除。到治疗的第14天,80%的患者完全停止了消化不良症状,治疗结束后效果持续一个月。在治疗的前两周,3名患者出现腹胀,5名患者出现糊状大便,每天不超过3次。这些现象不明显,不需要中断治疗。1例患者在治疗第21天因粉红色地衣恶化退出研究,该情况在停药后2天独立过去。结论。用生物活性食物补充剂Gastrokur联合泮托拉唑进行一个疗程的治疗,20%的幽门螺杆菌被根除。在治疗的背景下,观察到良好的积极临床动态。除一名患者出现粉红色地衣恶化外,未见严重不良事件报告。
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Efficacy and Safety Evaluation of Gastrokur Dietary Supplement in Combination with Pantoprazole in Patients with Helicobacter pylori
The results of a clinical study of the efficacy and safety of taking a dietary supplement Gastrokur in combination with pantoprazole in patients with Helicobacter pylori are presented. Material and methods. 10 patients with H. pylori infection confirmed according to 13C-urease respiratory test for four weeks received the dietary supplement Gastrokur two capsules three times a day in combination with pantoprazole 40 mg once a day. A special condition was the compliance with Gastrokur temperature regime of storage from +40 to +100 С. The efficacy of eradication was evaluated using a 13C urease breath test 30 days after completion of treatment. Results. H. pylori eradication was achieved in two out of 10 (20%) patients according to the ITT criterion and in two out of nine (22.2%) patients according to the PP criterion. By the 14th day of therapy, 80% of patients had completely stopped symptoms of dyspepsia with the effect remaining for a month after the end of therapy. During the first two weeks of therapy, three patients had bloating, five had mushy stools no more than three times a day. These phenomena were not pronounced and did not require interruption of treatment. One patient dropped out of the study due to an exacerbation of pink lichen on the 21st day of therapy, which independently passed two days after discontinuation of treatment. Conclusion. A course of therapy with a biologically active food supplement Gastrokur in combination with pantoprazole led to the eradication of H. pylori in 20%. Against the background of therapy, a good positive clinical dynamics was observed. No serious adverse events have been reported, with the exception of an exacerbation of pink lichen in one patient.
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