Davidov M I, Bunova N E
E.A. Vagner Perm State Medical University of Minzgrav of Russia, Perm, Russia.
Urologiia. 2018 Oct(4):24-32.
The study aimed to compare the efficacy and safety of Canephron N and ciprofloxacin as monotherapy in the management of mild forms of acute uncomplicated cystitis in women of working age.
A prospective, randomized study of Canephron N and ciprofloxacin for treating mild forms of acute uncomplicated cystitis (ACSS score less or equal 10) comprising 160 women aged 18-55 years was conducted from 2015 to 2017. Group I consisted of 80 women, who received oral Canephron N 2 tablets 3 times daily for 30 days. Group II included 80 women who took oral ciprofloxacin 0.5 g twice daily for 3 days. The results were assessed using the ACSS scale, urinalysis by microscopy, bacteriological examination of urine, etc. The outcomes were evaluated at 3, 6 and 30 days, and one year after the treatment initiation.
In group I, monotherapy with Canephron NH resulted in a marked improvement in symptoms, a decrease in the ACSS scores from 7.9 at baseline to 0.1 at day 30. The indicator of clinical efficacy (recovery) was 93.75%, bacteriological efficiency was 91.3%, relapse of cystitis within one year was observed in 5% of patients; no side effects were registered. In group II, the symptoms and bacteriuria decreased more rapidly in the early periods, but after 30 days the results of clinical and bacteriological efficacy did not differ from the group I (93.75 and 91.3%, respectively). Side effects and cystitis relapses were noted in 18.8% and 12.5% of patients, respectively.
The findings of the study show that Canephron N is an effective and safe alternative to treating mild forms (ACSS score less or equal 10) of acute uncomplicated cystitis in women, allowing the use of antibiotics to be reduced. In our opinion, patients with more severe forms of acute uncomplicated cystitis should be treated with traditional antibiotic therapy.
本研究旨在比较卡内普龙N(Canephron N)与环丙沙星作为单一疗法治疗工作年龄女性轻度急性单纯性膀胱炎的疗效和安全性。
2015年至2017年,对卡内普龙N和环丙沙星治疗轻度急性单纯性膀胱炎(ACSS评分小于或等于10)进行了一项前瞻性随机研究,纳入160名年龄在18 - 55岁的女性。第一组由80名女性组成,她们每天口服卡内普龙N 2片,每日3次,共30天。第二组包括80名女性,她们每天口服环丙沙星0.5克,每日2次,共3天。使用ACSS量表、显微镜下尿液分析、尿液细菌学检查等评估结果。在治疗开始后的3天、6天、30天及1年后评估结果。
在第一组中,卡内普龙N单一疗法使症状明显改善,ACSS评分从基线时的7.9降至第30天时的0.1。临床疗效(康复)指标为93.75%,细菌学有效率为91.3%,5%的患者在1年内出现膀胱炎复发;未记录到副作用。在第二组中,早期症状和菌尿减少更快,但30天后临床和细菌学疗效结果与第一组无差异(分别为93.75%和91.3%)。分别有18.8%和12.5%的患者出现副作用和膀胱炎复发。
研究结果表明,卡内普龙N是治疗女性轻度急性单纯性膀胱炎(ACSS评分小于或等于10)的一种有效且安全的替代疗法,可减少抗生素的使用。我们认为,患有更严重形式急性单纯性膀胱炎的患者应采用传统抗生素疗法治疗。