Petrov S B, Slesarevskaya M N, Chibirov K H, Topuzov M E, Kagan O F, Voronova E N
Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.
FGBOU Saint Petersburg Scientific and Research Institute of Phthisiopulmonology of Ministry of Health of Russia, Saint Petersburg, Russia.
Urologiia. 2020 Jun(3):15-21.
to evaluate the efficiency and safety of phenazopyridine for the treatment of patients with uncomplicated lower urinary tract infection, accompanied by pain.
A multicenter double-blind, randomized, placebo-controlled study with parallel groups to evaluate the efficacy and safety of phenazopyridine in patients with acute uncomplicated cystitis was performed. A total of 60 women were divided into two groups of 30 patients. In the main group (average age 32.6+/-7.4 years) phenazopyridine was prescribed (2 tablets of 100 mg p.o., with a total dose of 200 mg, once). In the control group, patients (mean age 35.53+/-8.79 years) received a placebo according to the same scheme. To evaluate the efficiency of treatment, the severity of the main symptoms 6 hours after taking the drug was analyzed. After that, patients started antibiotic therapy. They were followed-up for the next three days. The tolerance of therapy was evaluated by the presence of adverse events.
All 30 patients taking phenazopyridine had an improvement after 6 hours, and the most frequent response was "significant improvement" (43.3%). The responses of patients in the main group significantly (p<0.05) differed from responses of patients in the control group. Six hours after taking phenazopyridine/placebo, the severity of all values according to VAS score, including the degree of general discomfort, pain during urination and increased frequency of urination improved significantly in the main group compared to the control group. The average assessment of general discomfort in the main group decreased by 53.4% in comparison with 28.8% in the control group, while the severity of pain during urination and urination frequency decreased by 57.4 vs. 35.9% and 39.6 vs. 27.6%, respectively. An analysis of the time before the complete absence of the general discomfort was performed. In the main group this period of time was significantly less than in the control group (p<0.05). There were no serious adverse events while taking phenazopyridine. Rate of adverse events was comparable between two groups.
The results of the study showed that phenazopyridine is an effective and well-tolerated drug for symptomatic therapy in patients with acute uncomplicated cystitis and can be recommended in addition to etiological therapy.
评估非那吡啶治疗伴有疼痛的单纯性下尿路感染患者的有效性和安全性。
进行了一项多中心双盲、随机、平行组安慰剂对照研究，以评估非那吡啶治疗急性单纯性膀胱炎患者的疗效和安全性。总共60名女性被分为两组，每组30名患者。主要组（平均年龄32.6±7.4岁）服用非那吡啶（口服100mg的片剂2片，总剂量200mg，一次）。对照组患者（平均年龄35.53±8.79岁）按照相同方案服用安慰剂。为评估治疗效果，分析服药6小时后主要症状的严重程度。之后，患者开始抗生素治疗。接下来的三天对他们进行随访。通过不良事件的发生情况评估治疗耐受性。
所有30名服用非那吡啶的患者在6小时后均有改善，最常见的反应是“显著改善”（43.3%）。主要组患者的反应与对照组患者的反应有显著差异（p<0.05）。服用非那吡啶/安慰剂6小时后，与对照组相比，主要组所有根据视觉模拟评分法（VAS）评分的值的严重程度均有显著改善，包括总体不适程度、排尿时疼痛和排尿频率增加。主要组总体不适的平均评估降低了53.4%，而对照组为28.8%，排尿时疼痛的严重程度和排尿频率分别降低了57.4%对35.9%和39.6%对27.6%。对完全没有总体不适之前的时间进行了分析。主要组这段时间明显短于对照组（p<0.05）。服用非那吡啶时未发生严重不良事件。两组不良事件发生率相当。
研究结果表明，非那吡啶是治疗急性单纯性膀胱炎患者症状性治疗的有效且耐受性良好的药物，除病因治疗外可推荐使用。
