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复发性尿路感染的口服免疫疗法:一项双盲安慰剂对照多中心研究。

Oral immunotherapy of recurrent urinary tract infections: a double-blind placebo-controlled multicenter study.

作者信息

Schulman C C, Corbusier A, Michiels H, Taenzer H J

机构信息

Department of Urology, Erasmus University Hospital, University of Brussels, Belgium.

出版信息

J Urol. 1993 Sep;150(3):917-21. doi: 10.1016/s0022-5347(17)35648-3.

DOI:10.1016/s0022-5347(17)35648-3
PMID:8345609
Abstract

We treated 166 patients suffering from recurrent urinary tract infections under double-blind conditions for 3 months with 1 capsule daily of either the immunostimulating bacterial extract (85) or a placebo (81), followed by a 3-month observation period without the test drugs. The bacterial extract exerted a significant beneficial curative action and long-term consolidative effect on the frequency of recurrent urinary tract infections with marked improvements in the characteristic signs and symptoms. It was significantly superior to placebo for the majority of the assessed parameters: number of recurrent urinary tract infections, bacteriuria, leukocyturia, erythrocyturia, nitrituria, albuminuria and casts in urine. Consumption of antibiotics, chemotherapeutics, urinary antiseptics or disinfectants was significantly less under active drug therapy compared to placebo. Tolerance was good with only 2 side effects reported in 2 patients (2%) in the active group compared to 11 among 5 (6%) in the placebo group. Therefore, the bacterial extract can be considered an efficient and well tolerated drug for the treatment of urinary tract infections, and their accompanying signs and symptoms, as well as for decreasing the risk of recurrences and the need for antibiotics and other antibacterial drugs.

摘要

我们对166例复发性尿路感染患者进行了为期3个月的双盲治疗,每天服用1粒免疫刺激细菌提取物胶囊(85例)或安慰剂(81例),随后是为期3个月的无试验药物观察期。细菌提取物对复发性尿路感染的频率产生了显著的有益治疗作用和长期巩固效果,特征性体征和症状有明显改善。在大多数评估参数方面,它显著优于安慰剂:复发性尿路感染的次数、菌尿、白细胞尿、红细胞尿、亚硝酸盐尿、蛋白尿和尿沉渣。与安慰剂相比,活性药物治疗下抗生素、化疗药物、尿路防腐剂或消毒剂的消耗量显著减少。耐受性良好,活性组仅有2例患者(2%)报告了2例副作用,而安慰剂组5例中有11例(6%)。因此,细菌提取物可被认为是一种治疗尿路感染及其伴随的体征和症状、降低复发风险以及减少对抗生素和其他抗菌药物需求的有效且耐受性良好的药物。

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Oral immunotherapy of recurrent urinary tract infections: a double-blind placebo-controlled multicenter study.复发性尿路感染的口服免疫疗法:一项双盲安慰剂对照多中心研究。
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