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[使用大肠杆菌Nissle 1917株(EcN)进行益生菌药物治疗:对3807例患者记录的前瞻性研究结果]

[Probiotic drug therapy with E. coli strain Nissle 1917 (EcN): results of a prospective study of the records of 3,807 patients].

作者信息

Krammer H J, Kämper H, von Bünau R, Zieseniss E, Stange C, Schlieger F, Clever I, Schulze J

机构信息

Praxis für Gastroenterologie am Enddarmzentrum Mannheim.

出版信息

Z Gastroenterol. 2006 Aug;44(8):651-6. doi: 10.1055/s-2006-926909.

Abstract

INTRODUCTION

Living microorganisms that enter the gut in an active state and exert a positive influence on the host are called probiotics. Numerous experimental and clinical studies were performed recently and confirm both the efficacy and modes of action of probiotic drugs.

PATIENTS AND METHODS

In a post-marketing-surveillance study with the probiotic Escherichia Coli strain Nissle 1917 (EcN) data on the range of indications as well as on efficacy and tolerance were gathered prospectively in 446 centres. The intended treatment duration was limited to a maximum of 12 weeks.

RESULTS

EcN was used in 3,807 patients with more than 20 different indications, n = 3,511 of whom had gastrointestinal complaints: Among others, 1,067 patients presented with chronically recurring (n = 728) or protracted diarrhoea (n = 339), 415 with inflammatory bowel disease, 679 with irritable bowel syndrome, and 253 with chronic constipation. The overall efficacy was assessed as good to very good by an average of 81.4 % of the therapists. The stool frequency and consistency as well as the symptoms of meteorism and abdominal pain were improved in very many patients. Suspected cases of side effects were documented in only 2.8 % of the patients.

CONCLUSION

EcN is frequently used in practice for the treatment of various, mostly gastrointestinal, complaints and is well tolerated.

摘要

引言

以活跃状态进入肠道并对宿主产生积极影响的活微生物被称为益生菌。最近进行了大量实验和临床研究,证实了益生菌药物的疗效和作用方式。

患者与方法

在一项关于益生菌大肠杆菌菌株Nissle 1917(EcN)的上市后监测研究中,前瞻性地收集了446个中心关于适应证范围以及疗效和耐受性的数据。预期治疗持续时间最长限制为12周。

结果

3807例患者使用了EcN,适应证超过20种,其中3511例有胃肠道不适:其中,1067例患者表现为慢性复发性(n = 728)或持续性腹泻(n = 339),415例患有炎症性肠病,679例患有肠易激综合征,253例患有慢性便秘。平均81.4%的治疗医生评估总体疗效为良好至非常好。很多患者的大便频率和稠度以及腹胀和腹痛症状都有所改善。仅2.8%的患者记录了疑似副作用病例。

结论

EcN在实践中常用于治疗各种(主要是胃肠道)不适,且耐受性良好。

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