EVALUATION OF EXPERIENCE WITH A COMBINATION PHYTOTHERAPEUTIC DRUG IN PREGNANT WOMEN (A multicenter retrospective observational study)
Objective. To evaluate experience with the combination phytotherapeutic drug Canephron N in pregnant women Design. This was a multicenter retrospective observational study. Subjects and methods. The study enrolled 550 patients whose pregnancy ended in a delivery. Group 1 included 480 women who used Canephron N in different periods of pregnancy (a study group) and Group 2 consisted of 70 women who did not take the drug (a comparison group). Their medical records were analyzed just on pregnancy completion. The pregnant women were given Canephron N prophylactically and as part of combination therapy for different types of kidney and urinary tract infections. Canephron N tablets and drops were used in 402 and 51 pregnant women, respectively; 27 patients received tablets and drops sequentially. All the patients underwent comprehensive clinical and laboratory examination including full blood and urine tests, Nechiporenko urinalysis, kidney ultrasound, and urine bacteriological study. The fetal status was assessed using dynamic ultrasound biometry, Doppler blood flow study in the uterine, placental, and umbilical cord vessels, and cardiac monitoring. Results. Effective Canephron N treatment without antibiotic use was performed in 12 of 32 women with asymptomatic bacteriuria (a study group). There was no relapsing bacteriuria. Thirty patients with acute cystitis and 48 women with an exacerbation of recurrent cystitis took Canephron N together with antimicrobial agents. Canephron N treatment reduced the symptoms of an exacerbation of cystitis in all the patients; moreover, the results suggest that there is a significant (p < 0.05) reduction in reinfection rates and an increase in interrecurrence periods. Even if recurrences occurred, they were taking their milder course with the use of Canephron N. Fifty-six pregnant women with gestational pyelonephritis and 132 women with an exacerbation of chronic pyelonephritis received Canephron N (a study group) together with antibiotic therapy. Incorporation of Canephron N into pyelonephritis therapy in pregnant women substantially enhanced its efficiency: the prompter the exacerbations abated, the fewer number of recurrences was. This could reduce the number of repeat courses of antibacterial therapy during pregnancy and, possibly, the rate of renal infection chronization after prior gestational pyelonephritis. The study also evaluated the safety of Canephron N to the fetus and newborn infant. The rate of developmental anomalies of the babies born to the mothers who had taken Canephron N proved to be slightly lower than that in the population. Conclusion. This study has revealed no signs of the fetotoxic effect of Canephron N, which makes possible the use of the drug in all pregnancy periods. The total effects of Canephron (in improving renal blood flow and enhancing glomerular filtration, positively affecting urodynamics, antibacterial and anti-inflammatory properties, and stimulating restorative processes in the renal epithelium) along with its high safety permits the use of Canephron N in pregnant women for the treatment and prevention of relapses of chronic and acute urinary system infections.