Purpose of the study. To determine the safety and efficacy of 20% azelaic acid cream in the treatment of patients with papulopustular acne vulgaris. Materials and methods. 65 patients with acne vulgaris were examined. The control group consisted of 30 healthy individuals. Acne severity was evaluated according to G. Michaelsson et al. scale, Cook’s scale, absolute number of papules and pustules. Assessment of quality of life was performed. Facial skin microbiocenosis was assessed. All patients with acne vulgaris applied 20% azelaic acid cream during 15 ± 2 days. Results and discussion. The use of 20% azelaic acid cream contributed to the rapid regression of inflammatory acne. After 10 days of treatment, the number of papulopustular elements decreased in 3 times. After 10 days of therapy acne score according to G. Michaelsson et al. decreased in 1,5 times and after 15 days of treatment – in 1,9 times. After 10 days of therapy the acne score on the Cook’s scale decreased in 1,4 times. At the end of the study the acne score on the Cook’s scale was 2,4 points. There was a significant decrease in the total number of bacteria, the number of coagulase-positive staphylococci, quantity of Propionibacterium acnes on facial skin in 15 days after the start of therapy. A significant difference in the average value of the DLQI was fixed before (18,9 ± 0,31) and at the end (8,1 ± 0,54) of treatment. Conclusions. The high effectiveness of 20% azelaic acid cream in treatment of papulopustular acne vulgaris was proved. 20% azelaic acid cream provides a rapid regression of inflammatory forms of acne, reduction of total quantity of bacteria and Propionbacterium acnes on skin.
Study question To assess the efficacy of Relugolix-CT vs placebo in women who were surgically diagnosed with endometriosis <5 and > = 5 years ago. Summary answer Treatment outcomes did not differ for dysmenorrhea and daily functioning between subgroups of patients with <5 years or ≥ 5 years since surgical diagnosis. What is known already Time since clinical manifestation and diagnosis of endometriosis may influence the treatment success of patients with endometriosis-associated pain. SPIRIT 1 and 2 were randomized, double-blind, placebo-controlled Phase 3 studies of Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) in premenopausal women (age 18–50 years) with surgically diagnosed endometriosis and a history of moderate-to-severe dysmenorrhea and non-menstrual pelvic pain (NMPP). These studies previously demonstrated that Relugolix-CT significantly reduced dysmenorrhea and NMPP, and improved daily functioning measured by the Endometriosis Health Profile-30 (EHP-30) pain domain score vs placebo over 24 weeks. Study design, size, duration Premenopausal women with surgically diagnosed endometriosis and moderate-to-severe dysmenorrhea and NMPP at baseline were randomized 1:1:1 to 24 weeks of treatment with once daily oral Relugolix-CT, delayed Relugolix-CT (relugolix 40 mg monotherapy for 12 weeks followed by Relugolix-CT for 12 weeks), or placebo. The proportion of dysmenorrhea and NMPP responders at Week 24/End-of-Treatment (EoT), based on daily Numerical Rating Scale (NRS), and analgesic use status were co-primary endpoints. Participants/materials, setting, methods Pooled SPIRIT 1 and 2 data of patients who received 24 weeks of treatment with once daily Relugolix-CT (N = 418) or placebo (N = 416) are presented. Outcomes for the delayed Relugolix-CT group were only for the safety assessment and therefore not reported here. Analyses of NRS scores for dysmenorrhea, NMPP, and EHP-30 pain domain score were carried out in the subgroups of patients with time since diagnosis of < 5 years (N = 579) and ≥5 years (N = 255). Main results and the role of chance Baseline demographics and clinical characteristics were comparable between the time since diagnosis subgroups except for a numerically higher mean age in the ≥5-years subgroup. Mean time since diagnosis (standard deviation) was 2.1 (1.5) years with both Relugolix-CT and placebo for <5-years subgroup, and 8.0 (2.8) and 7.8 (2.3) years, respectively, for ≥5-years subgroup. In Relugolix-CT-treated patients, mean NRS score for dysmenorrhea decreased from 7.5 (severe) to 1.8 (mild) in the <5-years subgroup and from 6.9 (moderate) to 1.8 (mild) in the ≥5-years subgroup with a significant difference to placebo (p < 0.0001, both subgroups), and demonstrating 74.8% and 72.7% reduction in pain from baseline to Week 24/EoT, respectively. Mean NRS score for NMPP decreased from 6.0 (moderate) to 3.0 (mild) with a significant difference compared with placebo (p < 0.0001), equating to 48.8% pain reduction in the <5-years subgroup, and from 5.6 (moderate) to 2.7 (mild) equating to 51.5% pain reduction (p = 0.089) in the ≥5-years subgroup. Improvement of daily functioning as measured by EHP-30 pain domain score was significantly greater with Relugolix-CT vs placebo in both subgroups, with decrease in EHP-30 pain score from 59.1 to 24.0 in the <5-years subgroup, and from 57.4 to 21.1 in the ≥5-years subgroup (p < 0.0001, both subgroups). Limitations, reasons for caution A lower number of patients were included into the subgroup with ≥5-years since surgically diagnosed endometriosis. Five-year dichotomy was close to the mean time since surgical diagnosis in the studies and to certain extent is arbitrary. Furthermore, time since surgical diagnosis is not the same as time since symptom onset. Wider implications of the findings In women with endometriosis-associated pain, Relugolix-CT vs placebo significantly reduced dysmenorrhea and improved daily functioning in both groups: with surgical diagnosis of < 5 years or ≥ 5 years. Substantial decrease in NMPP was also observed and was significantly different to placebo in the <5-years subgroup. Trial registration number NCT03204318 and NCT03204331
Insufficient effectiveness of antibacterial and antiinflammatory therapy dictates the need to find new ways of prevention and treatment of chronic recurrent inflammatory diseases of the vagina and cervix in women with the use of new generation multiprobiotics. Objective of the study: evaluation of the effectiveness of the use of a multipropiotic drug with propolis in the treatment of recurrent bacterial vaginitis in women of reproductive age - residents of a large industrial city. Materials and methods of the study: 69 patients aged 18 - 45 years with bacterial vaginitis living in the large industrial city of Zaporizhzhya were observed. The main group consisted of 14 women with inflammatory diseases of the vagina and cervix, who received in the complex treatment of multiprobiotics with propolis 1 dose 1 time a day in the vagina for 5 days. To determine the presence of an infectious agent, microscopic and bacteriological examination of vaginal and cervical canal secretions was performed, the species composition of pathogens was determined by PCR. Results of the study and their discussion. In patients with chronic vaginitis of reproductive age living in the conditions of a large industrial city there are profound disorders of the relationship between obligate and pathogenic microorganisms, which contributes to the recurrence of the pathological process. Conclusions. The use of a multiprobiotic drug with propolis, which has a broad antiviral and antibacterial properties, containing bifido, lacto, propionic acid bacteria and propolis can effectively normalize the vaginal microflora in chronic vaginitis, shorten the development time and treatment. The results of the study give us grounds to recommend the widespread use of a propolis-based multipropiotic drug for women suffering from chronic vaginitis who are not amenable to standard anti-inflammatory therapy.
Objective. One of the most common gynecological pathologies among women of reproductive age is non-specific vaginitis. Bacterial vaginosis and aerobic vaginitis cause many obstetric and gynecological complications, and disease recurrence remains high. The aim of the study is to assess the effectiveness of complex therapy in the treatment of non-specific vaginitis in women of reproductive age. Materials and Methods. 160 women (100%) were examined, which were divided into 2 clinical groups with subgroups: the main group - 94 (58.8 %) patients with nonspecific vaginitis, who received treatment according to developed clinical diagnostic algorithms and schemes. The comparison group included 66 (41.2 %) patients with nonspecific vaginitis, who received treatment according to known protocols. Research methods: general (collection of complaints and anamnesis, gynecological examination, assessment of microscopy of vaginal smears according to the Amsel, Nugent and Donders criteria), laboratory (determination levels of follicle-stimulating, luteinizing hormones, prolactin, estradiol, adrenaline, noradrenaline, cortisol, magnesium in the blood), statistical. Results. Treatment of non-specific vaginitis according to complex schemes in the main group showed a significant decrease in the average follicle-stimulating hormone indicators – by 2.7 times, luteinizing hormone – by 2.6 times, prolactin – by 1.3 times (р<0,05) compares to the indicators before treatment. The estradiol level in the main group probably increased 1.3 times (р<0,05). The magnesium level also increased by an average of 1.4 times (р<0,05). Complex therapy in the main group significantly reduced the adrenaline levels by an average of 1.6 times, noradrenaline by 2.4 times, and cortisol by 1.8 times compared to the values before treatment (р<0,05). The proposed complex schemes are likely to improve the clinical effectiveness of drug treatment of non-specific vaginitis in the near and distant periods, which is accompanied by faster disappearance of complaints and normalization of the local condition during the gynecological examination (p<0,05), restoration of the vaginal microflora (p<0,05), a decrease frequency of recurrence in the main group of patients (c2=4,32; p<0,05). Conclusions. It is appropriate to use complex treatment of bacterial vaginosis and aerobic vaginitis in women of reproductive age.
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