Background: A herbal medicinal product (HMP) with centaury, lovage, and rosemary as active ingredients (brand name: Canephron® N) has been widely used for treatment and prevention of urinary tract infections (UTIs) and other urinary system disorders. Non-clinical in vitro and in vivo data indicate its diuretic, spasmolytic, anti-inflammatory, antioxidative and analgesic effects. The purpose of this non-interventional, prospective, multicenter study was to collect data on the use of the HMP in the Russian pediatric outpatient population. Results: In total, 636 outpatients aged 1-17 years were enrolled. Of these, 634 received at least one dose of the HMP and were included in the safety set, which was used for analysis. 61 patients were 12-23 months, 227 were 2-5 years, 234 were 6-11 years and 112 were 12-17 years of age. The oral solution of the HMP was prescribed in 66.4%, and tablets (dragées) in 33.6% of the patients. For 48% of the patients the HMP was prescribed to treat an acute or chronic disease, 25% of the patients received it for prophylaxis, and 27% for both. More than half of the patients (53%) received the HMP as monotherapy. Main treatment indications were UTIs (34.1%) and pyelonephritis (30.0%). The proportion of UTIs was the highest within the youngest age group (51%), while the proportion of different cystitis forms increased in patients older than 2 years. Relevant proportions of different nephritis forms and urolithiasis were only observed in patients aged 12-17 years. Forms of cystitis were more frequent in female than in male patients (15% vs. 1%), while forms of nephritis, urolithiasis, and dysmetabolic nephropathy / crystalluria were more frequent in male patients. At the end of the observational period, 20% of the patients were reported as recovered from their disease, and 65% were reported to show improvements. For 91% of all patients with HMP monotherapy the investigators evaluated the effectiveness of the HMP as 'good' or 'very good'. Nearly all patients (99%) evaluated the tolerability as 'good'or 'very good'. Five adverse drug reactions were observed. Conclusions: The treatment of children aged 1-17 years with the HMP is safe and well tolerated. The study results support the use of the HMP for treatment and prophylaxis of urinary system diseases.
В обзоре представлены данные о недостатках антимикробных мероприятий, с которыми связываются дефекты эффективности лечения инфекций мочевой системы, -высокая вероятность рецидивов заболевания, стабильная доля вторичного пиелонефрита среди причин хронической почечной недостаточности. Уязвимость подобного подхода заключается в ускорении темпов приобретения уропатогенами резистентности к современным антибиотикам, которые, кроме того, дают ряд побочных эффектов, в том числе включающихся в патогенез инфекций мочевой системы. Трудности проведения адекватной этиотропной терапии также связаны с некоторыми субъективными факторами, в значительной мере затрудняющими персонифицированную диагностику возбудителей патологии.
Background and aimsA non-interventional study (NIS) was performed by Bionorica LLC company to collect data on the use of the herbal medicinal product (HMP) Canephron® N in routine paediatric practice in Russia.MethodsChildren of 1–17 years of age with confirmed diagnoses of urinary system disease and who were prescribed treatment with the HMP participated in the study at 26 polyclinics and out-patient departments. Exclusion criteria comprised hypersensitivity to any components of HMP, unsigned informed consent form, gastric ulcer and duodenal ulcer in the acute stage, participation in another clinical trial simultaneously or during 3 months before enrolment. Observational period included study treatment and follow-up period and was limited to a maximum of 6 weeks. Key parameters were prescribed indications, prescribed/actual treatment regimen, duration of treatment, co-medications, global assessments of HMP effectiveness and tolerability by physician and patient/parent, analysis of Adverse Events/Adverse Drug Reactions (AE/ADR). The NIS was approved by the local ethics committees and conducted with site monitoring by a contract research organisation.Results636 children aged 1–17 years were enrolled and 634 (470 girls) of them comprised Safety Set: 61 in the age of 1–2 years, 227 in 2–5 years, 234 in 6–11 years and 112 in 12–17 years. The main indications for HMP prescription were urinary tract infection (34.1%), pyelonephritis (30.0%), dysmetabolic nephropathy (18.9%), cystitis (11.5%), urolithiasis (4.1%) and nephritis (3.6%). HMP was prescribed for treatment in 307 (48.3%) patients, for prophylaxis in 157 (24.7%) and both for treatment and prophylaxis in 172 (27%) of patients. HMP in oral solution was prescribed in 66.4% of patients and tablets in 33.6%. Any concomitant medication was reported in 61.8% of patients. Effectiveness assessments by physician and patient/parent at visit 2 were ‘good’ and ‘very good’ in 88.2% and 87.9% and at visit 3 in 89.1% and 89.1%, correspondingly. Tolerability assessments as ‘good’ and ‘very good’ at visits 2 and 3 varied from 98.1% to 99.2%. In total, 100 AEs were registered and 5 AEs were evaluated as ADRs (including 1 serious ADR (renal colic)).ConclusionsEffectiveness and good tolerability of the HMP in the treatment and prophylaxis of urinary diseases in children of 1–17 years was confirmed. According to registered safety data, the HMP can be considered safe and well tolerated for children of the studied age.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.