V.P. Stus, I.M. Antonian
Evaluation of the effectiveness and safety of the drug urolesan in treatment of patients with acute cystitis
The purpose of this study is a comparative evaluation of the effectiveness and tolerability Urolesan, fluid production of AO "Halichfarm" in patients with acute cystitis. PURPOSE: To prove the effectiveness of the group exceeds Urolesan (study group) compared with the efficiency and standard antibiotic therapy (control group), the acknowledgment is not as effective in the group Urolesan compared with standard therapy.
This clinical study was conducted as an open, comparative, randomized, parallel. The study included 130 men and women aged 18 to 65 years with a diagnosis of acute cystitis. All patients in a 1:1 ratio were divided into two groups, the primary group (Urolesan) - 65 patients and a control group (standard therapy only) - 65 patients by simple randomization. Patients in the study were treated: basic therapy . fluoroquinolones II.III generation, as well as symptomatic therapy (diuretics desensebiliziruyuschie funds, antispasmodics). And also, the main group received the study drug Urolesan, fluid production of AO "Halichpharm" (in addition to standard therapy), which was administered in 8-10 drops on a piece of sugar or on toast under the tongue 3 times a day before meals. The course of treatment was 10 days. Patients of the control group received only standard therapy. The study patients of all groups recommended regime and diet.
In the study, each patient was physical examination (measurement of heart rate, blood pressure and body temperature, physical examination, palpation of the suprapubic area, survey the meatus) a registration of subjective complaints, including on a scale of symptoms in patients with pain in the pelvis (The Pelvic and Urinary / Frequency (PUF) Patient Symptom Scale); perfomed: complete blood count, urinalysis, bacteriological analysis of urine, blood chemistry, ultrasound. All survey data were introduced into the patient case report form (CRF) test and medical history. Safety assessment was made on the basis of measurement of vital signs, data on adverse events, laboratory data of blood and urine.
Based on the results of research can be stated as follows:
1. Revaluation of symptoms (for PUF) was statistically significantly greater in the primary group compared with the control at visit 5 (p = 0.047), which proves the effectiveness of excess on this indicator in the study group compared to the control.
2. The effectiveness of therapy in the study group than in the control group performance assessment of discomfort (for PUF) (downgrade discomfort is significantly greater in the intervention group compared with the control at visit 3 (p = 0.020), visit 4 (p = 0.046) for visit 5 (p = 0.001) and at visit 6 (p = 0.024)).
3. Effectiveness in the primary group than the efficiency in the control on the overall assessment of the scale of PUF (reducing the total assessment is statistically significantly greater in the intervention group compared with the control at visit 3 (p = 0.037) and visit 5 (p = 0.007).
4. According to the analysis of the effectiveness of therapy statistically significantly higher in the primary group (p = 0.003) than in the control group at the time of recovery of patients. So in the primary group of Me recovery time of patients was 4 days (NC = 2 days, VC = 6 days), and in the control group, Me = 6 days (NC = 4 days, VC = 9 days).
5. It is recommended to use Urolesan, fluid production of AO “Halichpharm", in the treatment of acute cystitis.