Alidjanov Jakhongir F, Naber Kurt G, Pilatz Adrian, Wagenlehner Florian M
Clinic for Urology, Pediatric Urology and Andrology, Justus Liebig University, Rudolf-Buchheim-Str. 7, 35392 Giessen, Germany.
Department of Urology, Technical University of Munich, 81675 Munich, Germany.
Antibiotics (Basel). 2020 Dec 19;9(12):929. doi: 10.3390/antibiotics9120929.
The diagnosis of acute uncomplicated cystitis (UC) is usually based on clinical symptoms. The study aims to develop and validate the American-English Acute Cystitis Symptom Score (ACSS), a self-reporting questionnaire for diagnosis and patient-reported outcome in women with acute uncomplicated cystitis (UC). After certified translation into American-English and cognitive assessment, the clinical validation of the ACSS was performed embedded in a US phase-II trial. 167 female patients with typical symptoms of UC were included in the study following US Food and Drug Administration (FDA) guidance. At Day 1 (diagnosis), the mean (SD) sum score of the six ACSS typical symptoms reached 10.60 (2.51). Of 100 patients followed-up last time on Day 5 or 6 (End-of-treatment, EoT), 91 patients showed clinical success according to the favored ACSS criteria (sum score of typical symptoms 0.98 (1.94)). There was no correlation between the severity of symptoms on Day 1 or between clinical success rate at EoT and level of bacteriuria on Day 1. The American-English ACSS showed high predictive ability and responsiveness and excellent levels of reliability and validity. It can now be recommended as the new master version in clinical and epidemiological studies, in clinical practice, or for self-diagnosis of women with symptoms of UC.
急性单纯性膀胱炎（UC）的诊断通常基于临床症状。本研究旨在开发并验证美国英语版急性膀胱炎症状评分（ACSS），这是一种用于诊断急性单纯性膀胱炎（UC）女性患者并报告患者预后的自我报告问卷。在翻译成美国英语并进行认知评估后，在美国一项II期试验中对ACSS进行了临床验证。根据美国食品药品监督管理局（FDA）的指导方针，167名有UC典型症状的女性患者被纳入研究。在第1天（诊断时），ACSS六个典型症状的平均（标准差）总分达到10.60（2.51）。在第5天或第6天（治疗结束，EoT）最后一次随访的100名患者中（根据最有利的ACSS标准），91名患者显示临床成功（典型症状总分0.98（1.94））。第1天症状的严重程度之间，或EoT时的临床成功率与第1天的菌尿水平之间均无相关性。美国英语版ACSS显示出较高的预测能力和反应性，以及出色的信度和效度水平。现在可以推荐将其作为临床和流行病学研究、临床实践中，或有UC症状女性自我诊断的新主版本。
