背景：尿路感染（UTI）在日常实践中通常通过给予抗胆碱能药治疗作为膀胱过度活动症（OAB），OAB的推荐治疗方案。然而,用于缓解UTI症状的抗胆碱能应用从未被研究过。据我们所知,本研究是首个研究抗胆碱能治疗UTI的随机试验.这项研究旨在评估额外的抗胆碱能药物是否与经验性抗生素治疗一起有益，以减轻症状，并且对于患有简单UTI的女性可以耐受。
方法：这是一项随机双盲对照试验，纳入年龄>18岁的女性，无并发症的UTI较低。除了经验性左氧氟沙星500mg治疗3天之外，患者还被随机分配到琥珀酸索利那新5mg（第1组）或安慰剂（第2组）。排除泌尿道结构和/或功能异常以及过敏反应史的患者。我们观察到膀胱过度活动症症状评分（OABSS）的变化，患者对膀胱状况的感知（PPBC）评分，患者报告的症状和不良事件.
结果：共126名患者，每组63人，开始试验的年龄中位数为44岁(19-67岁)。OABSS,基线时两组间PPBC评分。我们发现两组在治疗结束时OABSS和PPBC评分显著降低(p<0.05);然而,两组之间的降低量没有差异。在第1组中，我们发现22.2％的患者抱怨口干和25.4％，4.7%，3.2%的患者抱怨恶心，分别为嗜睡和便秘。在第2组中，我们发现20.0%，21.7％和3.3％的患者抱怨口干，恶心,和嗜睡。第2组的一名患者出现过敏反应并退出。
结论：我们发现，对于无并发症UTI的女性患者，通过在抗生素治疗中加入抗胆碱能药物治疗，OABSS和PPBC评分降低没有显著差异。没有严重不良事件记录。
BACKGROUND: urinary tract infection (UTI) is often treated in daily practice as overactive bladder (OAB) by giving anticholinergic, the recommended treatment options of OAB. However, anticholinergic application for UTI symptoms relief has never been investigated. To our knowledge, this
study was the first randomized
trial which investigate anticholinergic use for UTI treatment. This
study aimed to evaluate whether additional anticholinergic is beneficial alongside an empiric antibiotic therapy in reducing symptoms and tolerable for females with uncomplicated UTI.
METHODS: this was a randomized double-blind controlled
trial that included female aged >18 y.o with uncomplicated lower UTI. Patients were randomly assigned to either solifenacin succinate 5 mg (group 1) or placebo (group 2) in addition to empiric levofloxacin 500 mg treatment for 3 days. Those with structural and/or functional abnormalities of the urinary tract and allergic reaction history were excluded. We observed changes in overactive bladder symptom score (OABSS), patient perception of bladder condition (PPBC) score, patient-reported symptoms and adverse events.
RESULTS: a total of 126 patients, 63 for each group, initiated the
trial with median age of 44 (19-67) y.o. There were no differences of age, OABSS, and PPBC score between the 2 groups at baseline. We found significant (p<0.05) reduction of OABSS and PPBC score in both groups at the end of therapy; however the amount of reduction were not different between groups. In group 1 we found 22.2% of patients complained of dry mouth and 25.4%, 4.7%, 3.2% of patients complained of nausea, somnolence and constipation respectively. In group 2 we found 20.0%, 21.7% and 3.3% patients who complained of dry mouth, nausea, and somnolence respectively. One patient in group 2 experienced allergic reaction and was dropped out.
CONCLUSIONS: we found no significant difference in OABSS and PPBC score reduction by adding anticholinergic to antibiotic therapy for females with uncomplicated UTI. There was no serious adverse event recorded.
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