6th Month Of Treatment Research Articles

Effect of an increased dose of colchicine on microalbuminuria in children with Familial Mediterranean Fever

Aim of workFamilial Mediterranean Fever (FMF) is an autosomal recessive condition causing recurrent attacks of fever and polyserositis and may result in amyloidosis of the kidney. The aim of the present work was to investigate the response to an increased dose of colchicine in a group of Egyptian children suffering from FMF and albuminuria. Patients and methods40 FMF patients with microalbuminuria were prospectively followed up in the Pediatric Rheumatology Outpatient Clinic of Children’s Hospital, Cairo University, for a period of one year. All children were in an attack-free period and had no clinical evidence of renal disease. Colchicine doses were increased by 50%. ResultsPatients' mean age was 9.8 ± 3.08 years (5–17 years), disease duration was 3.96 ± 2.21 years (1–10 years) and were 15 males and 25 females. The mean dose of colchicine was 0.96 ± 0.46 mg/day and increased to 1.36 ± 0.46 mg/day during the study period. The new dose of colchicine was well tolerated by most patients with a few minor complaints of diarrhea and no affection of liver functions. The number of annual attacks decreased significantly with the increased doses of colchicines from 39.9 ± 22.43 attacks/year to 7.92 ± 4.92 attacks/year (p = 0.0001). Resolution of the microalbuminuria occurred in 50% within 3 months; another 30% responded within 6 months, and the remaining 20% responded after the 6th month of treatment. There was no significant association between the types of mutations and microalbuminuria. ConclusionIncreased doses of colchicine are effective in treating microalbuminuria of FMF and should be given to children with frequently recurring attacks. All patients with FMF should be regularly screened for microalbuminuria.

Effect of short-term orthokeratology lens or ordinary frame glasses wear on corneal thickness, corneal endothelial cells and vision correction in adolescents with low to moderate myopia

BackgroundWe aimed to investigate the effect of short-term orthokeratology lens or frame glasses wear on corneal thickness, corneal endothelial cells and vision correction in adolescents with low to moderate myopia.MethodsData of 100 adolescents with low to moderate myopia were retrospectively analyzed. The patients were assigned into two groups. The experimental group were treated with night-wear orthokeratology lens, and control group were treated with ordinary frame glasses. Follow up was carried out at the 3rd, 6th and 12th months of treatment. The naked-eye vision, diopter, corneal curvature, intraocular pressure, axial length, endothelial cell count and central corneal thickness were examined. Complications within 12 months were observed, and corneal fluorescein staining was graded.ResultsThe naked-eye vision of the experimental group was significantly higher than that of the control group at the 3rd, 6th and 12th months, while the diopter of the experimental group was significantly lower than that of the control group at these time points. The corneal curvature of the experimental group was significantly decreased when comparing with that of the control group at the above 3 time points. The increase of axial length in the experimental group was significantly less than that in the control group at the 6th and 12th months.ConclusionsShort-term orthokeratology lens wear can effectively improve the naked-eye vision in adolescents with low to moderate myopia without significant impact on the central corneal thickness and corneal endothelial cells. It is a relatively safe method to correct myopia.

P4558Hemodynamic management of resistant hypertension

Abstract Background Hypertension is the most prevalent chronic disease worldwide and is is related with high probability of cardiac disease, kidney disease and cerebrovascular events. Blood pressure measurement was used in the last decades to diagnose and guide antihypertensive therapy; however blood pressure is the result of interaction of more complex hemodynamic parameters previously reserved to experimental studies or critical care patients management using invasive methods. Since 1996 few studies has proposed the use of hemodynamic parameters to classify and guide hypertension therapy with good results. Purpose The present study purpose was to measure hemodynamic parameters in patients with non-controlled resistant hypertension and use it to guide pharmacologic treatment in order to archive control blood pressure values according to the European Society of Cardiology guidelines. Methods A total of 84 patients between 32 and 95 years old diagnosed with non-controlled primary resistant hypertension were recruited and after previous therapy washout hemodynamic parameters were measured using noninvasive methods: preload by central venous pressure (CVP) using inferior vena cava diameter, cardiac index and systemic vascular resistance using Lyljestrand & Zander modified formula. Patients were classified in 3 basic groups depending on which parameter was above normal value: hyperdynamic (HD) for high cardiac index >3.5 L/min/m2, fluid overload (FO) for CVP >8cmH2O and high systemic vascular resistance index (HSVRi) >2500 dynes/sec/m2/cm–5, also 3 combined groups were a patient had 2 simultaneous hemodynamic alterations (HD+FO, HD+HSVRi and FO+HSRVi), according to this classification pharmacotherapy was guided indicating Bisoprolol in HD group, Amlodipine to HSVR patients and Hydrochlorothiazide to FO patients, in combined groups, combined therapy was given. Patients were observed for 6 months period taking as primary endpoint blood pressure control, acute cardiovascular events and hypotension. Results A significant reduction of hemodynamic parameters and blood pressure was observed since the first month of treatment obtaining a 100% hemodynamic and blood pressure goals in all patients at the third month of therapy without hypotension or acute cardiovascular event during this period, the HD+FO group reach goals at the 6th month of treatment without reported complications. Conclusions In this preliminary studied we observed that hemodynamic guided high blood pressure control may be a useful tool to a better understanding, classifications and treatment in patients with resistant hypertension; however a larger outcome studies to confirm this hypothesis.

BLOOD PRESSURE AND ARTERIAL STIFFNESS DYNAMICS DEPENDING ON THE DURATION OF CPAP NIGHT SESSIONS IN PATIENTS WITH SEVERE OBSTRUCTIVE SLEEP APNEA

Background: Numerous studies on the pathophysiological mechanisms of obstructive sleep apnea discover the relationship between obstructive sleep apnea and cardiovascular diseases, its contribution to the development of resistant hypertension and endothelial remodeling. Continuous Positive Airway Pressure (CPAP) is the only reasonable pathogenetic therapy in these patients. This treatment regimen implies the creation of a “pneumatic stent” with a given level of positive pressure on the inhalation and exhalation of the patient, allowing to stabilize the lumen of the upper respiratory tract and prevent the pharyngeal collapse. However, the effects and the required duration of CPAP of night sessions to achieve the target values of blood pressure and restore arterial stiffness in patients with severe obstructive sleep apnea with resistant hypertension remain poorly understood. Objective: to study the dynamics of blood pressure, arterial stiffness and endothelial dysfunction in patients with severe obstructive sleep apnea with resistant hypertension, depending on the duration of auto-adjusting CPAP (A-Flex therapy). Methods: the prospective single-center study enrolled 168 patients with obstructive sleep apnea with resistant hypertension (139 males, 46,6 ± 9,0 y. o.) with apnea-hypopnea index >30 events /hour. The night polygraphy study was performed to calculate AHI, oxygen desaturation index, mean nocturnal saturation (SpO2 ) according to the requirements of American Academy of Sleep Medicine. Endothelial function of blood vessels was assessed manually to peripheral arterial tone. The reactive hyperemia index and augmentation index was calculated. Blood pressure was monitored by office measurement, daily monitoring of blood pressure, and by individual patient diaries. Optimal level of CPAP-treatment was adjusted at home. Apnea-hypopnea index, the level of air leakage, average pressure and compliance to CPAP-therapy were established in accordance with international requirements. Results: In the group of patients, treated with night sessions of A-Flex > 6 h/night, significant dynamics was observed by the 6th month of treatment. That is, a decrease in RHI by -1.33 (95% CI from -2.25 to -0.41; P = 0.002), a decrease in AI by -12.4% (95% CI from -18.42 to -6.38; P = 0.001), a decrease in mean SBP (24 h) by -33.6 mm Hg (95% CI from -44.1 to -23.2; P = 0.002) and decrease in mean DBP (24 h) by -20.2 mm Hg (95% CI from -29.4 to -11.1; P = 0.001), with a decrease in rate of morning rise of SPB by -22.4 mm Hg/h (95% CI from -24.7 to -20.1; P = 0.002) and a decrease in rate of morning rise of DPB by -17.4 mm Hg/h (95% CI from -19.5 to -15.3; P = 0.003). The best target values were achieved by the 12th month of treatment: a decrease in RHI by -2.11 (95% CI from -2.57 to -1.65; P = 0.001), a decrease in AI by -28.5% (95% CI from -37.06 to -19.94; P = 0.002), a decrease in mean SBP (24 h) by -39.7 mm Hg (95% CI from -48.9 to -30.5; P = 0.001) and decrease in mean DBP (24 h) by -26.8 mm Hg (95% CI from -36.1 to -17.5; P = 0.001), with a decrease in rate of morning rise of SPB by -22.5 mm Hg/h (95% CI from -23.6 to -21.4; P = 0.001) and a decrease in rate of morning rise of DPB by -19.4 mm Hg/h (95% CI from -20.7 to -18.1; P = 0.002). Conclusions: in patients with severe obstructive sleep apnea and resistant hypertension only CPAP-therapy in the A-Flex mode > 6 h/night allows to achieve target blood pressure, restores endothelial function and arterial stiffness, therefore reducing the risks of cardiovascular complications.

Treatment of rheumatoid arthritis: csDMARDS versus bDMARDS. Prospective study to evaluate disease activity

The assessment of disease activity is an essential component in the selection of therapeutic approach for the prevention of disability of patients with RA. The current study was conducted to evaluate the disease activity in patients on csDMARDs and bDMARDs after 6 months to 1-year of treatment and to determine whether the benefits of different therapies were sustained over time. For the purpose of the study were selected 220 patients with a mean age 55.05 ± 10.63 SD years, meeting the 1987 ACR classification criteria for RA. Patients were stratified according to treatment regimens into 2 age-matched treatment groups: 96 on csDMARDs and 124 on bDMARD therapy. Patient‘s assessment of disease related pain, global health and physician assessment of global health was made by visual analogue scale (VAS) – 100 mm. Disease activity was the primary outcome domain. Independent joint assessor evaluated 28 joints on baseline, 6th and 12th month of the follow-up period. C-reactive protein (CRP) was used to measure the infl ammation process. DAS28-CRP, CDAI and SDAI were calculated according to the standard formulas. Comparison was performed by analysis variance ANOVA. On baseline, patients on bDMARDs had a significantly higher mean time-averaged 28-joint disease activity score (5.03 ± 0.84 SD vs. 4.35 ± 1.20 SD, p < 0,001), CDAI (25.06 ± 7.32 SD vs. 20.83 ± 10.53 SD, p < 0.001) and SDAI (28.27 ± 8.74 SD vs. 23.19 ± 11.89 SD, p < 0.001) compared to those on csDMARDs. On the 6th month in both groups (bDMARDS and csDMARDs) we found significant decrease in mean DAS28 (p < 0.001, p < 0.001), although no significant difference in disease activity between the groups was measured by this indicator (3.75 ± 2.49 SD vs 3.90 ± 1.10 SD, p = 0.566). Patients on bDMARDs had significantly lower disease activity compared to those on csDMARDs after 6th and 12th month of treatment assessed by CDAI (13.43 ± 4.98 SD vs 16.81 ± 9.94 SD, p = 0.001; 8.65 ± 4.53 SD vs 15.86 ± 10.02 SD, p < 0.001), and SDAI (14.63 ± 5.42 SD vs 18.38 ± 10.49 SD, p < 0.001; 9.39 ± 4.92 SD vs 16.79 ± 10.5 SD, p < 0.001). Unlike results reported by DAS28-CRP which showed no change between the 6th and 12th month in patients receiving csDMARDs (3.90 ± 1.10 SD, 3.82 ± 1.12 SD, p = 0.156), we observed a statistically significant difference in all three time intervals (0, the 6th, 10th month) of the follow up period regarding to CDAI and SDAI. After a year prospective follow-up, therapy with biologic DMARDs results in sustained suppression – minimal disease activity assessed by DAS28-CRP, CDAI and SDAI, compared to patients receiving DMARDs who had moderate disease activity according to these tools. The therapy with bDMARDs was superior to csDMARDs therapy for suppressing disease activity (assessed by DAS28-CRP, CDAI and SDAI) of rheumatoid arthritis (RA) on the 6th and 12th month of the follow-up period.

Real World Experience of Disease Activity in Patients With Rheumatoid Arthritis and Response to Treatment With Varios Biologic DMARDs.

The current study investigate the disease activity and effectiveness of treatment in patients with RA on biological disease modifying antirheumatic drugs (bDMARDs) in combination with a conventional synthetic DMARD (csDMARD) and determine whether or not the benefits of different therapies were sustained over a follow up period of 1 year. 124 patients were selected with a mean age 55.26 ± 13, 18SD years, meeting the 1987 ACR and /or ACR/ EULAR (2010) classification criteria for Rheumatoid arthritis (RA). Patients were arranged according to treatment regimens: Tocilizumab (TCL) – 30 patients, Certolizumab (CZP) – 16, Golimumab (GOL) – 22, Etanercept (ETN) 20, Adalimumab (ADA) 20, Rituximab (RTX) – 16. Disease activities was the primary concern. Independent joint assessor evaluated 28 joints on baseline, 6th and 12th month’s thereafter. C-reactive protein (CRP) was used to measure the inflammatory process. DAS28-CRP, clinical disease activity index (CDAI) and simplified disease activity index (SDAI) were calculated. On baseline all of the patients’ groups had severe disease activity (mean DAS28-CRP > 5.2, mean CDAI > 22, mean SDAI > 26. It was noted that, during the 6th month follow-up period all of the treatment groups significantly decreased DAS28-CRP, CDAI, SDAI and reach moderate disease activity. After 6th and 12th months of treatment all of the groups on bDMARDs had significantly lower disease activity. The GOL group reach remission only according to DAS28-CRP: 2.49 ± 0.76, and low disease activity as measured by CDAI: 6.78 ± 4.51 and SDAI 7.80 ± 5.67. The other 5 groups after 12 months reach the level of low disease activity according to the three activity parameters: DAS28-CRP (TCL 3.07 ± 0.73, CZP 3.06 ± 0.65, ETN 2.85 ± 0.55, ADA 3.15 ± 0.82, RTX 2.90 ± 0.70), CDAI (TCL 9.80 ± 4.91, CZP – 9.33 ± 4.22, ETN 7.97 ± 3.80, ADA 10.00 ± 5.25, RTX 7.48 ± 2.99) and SDAI (TCL 10.45 ± 5.14, CZP 9.94 ± 4.43, ETN 9.03 ± 4.25, ADA 10.50 ± 5.61, RTX 8.08 ± 3.24). The therapy with different bDMARDs added to a csDMARD led to very similar results – a minimal disease activity and a state of remission in the GOL treatment group only as per DAS28-CRP.

Assessment of auditory function and lipid levels in patients receiving oral isotretinoin (13-cis retinoid) therapy for acne vulgaris.

IntroductionIsotretinoin (13-cis retinoid) is a synthetic retinoid. It was approved by the FDA in 1982 for use of oral isotretinoin in severe acne. It is also used in moderate-severe acne that does not respond to conventional treatments. Isotretinoin is the only available drug that affects all stages of acne pathogenesis.AimTo prospectively investigate whether there is an effect of isotretinoin therapy on auditory function and, if so, to demonstrate its association with simultaneous blood lipid levels.Material and methodsThirty patients (60 ears) with acne vulgaris, who received 0.5 mg/kg of isotretinoin therapy, were included in the study. Distortion product otoacoustic emissions (DPOAEs) and pure tone audiometry tests were performed to evaluate auditory function at the beginning of the procedure and the 6th month of treatment. In addition, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total cholesterol, triglyceride, high-density lipoproteins (HDL) and low-density lipoproteins (LDL) cholesterol levels were recorded.ResultsThere was no statistically significant difference between pre-treatment and post-treatment mean pure tone audiometry threshold and DPOAE values; however, the increase in total blood cholesterol, triglyceride and LDL levels and the decrease in HDL levels were statistically significant.ConclusionsAccording to our study findings, isotretinoin did not cause worsening of the bilateral hearing threshold, but increased blood lipid levels. There is no need for follow-up auditory functions in routine practice during therapy, but blood lipid levels should be monitored.

A clinical study of Guizhi-Fuling pill combined with conventional therapy for the patients with oviduct obstructive infertility

Objective In order to evaluate the clinical curative effect of Guizhi-Fuling pill combined with conventional therapy for the patients with oviduct obstructive infertility. Methods In this study, 102 patients with oviduct obstructive infertility (OOI) that accorded with the inclusion criteria were randomly divided into two groups according to the order of treatment. During the study, a total of 5 patients were lost in the two groups, and so 49 in the treatment group and 48 in the control group completed the protocol. The control group was given fallopian tube recanalization under the hysteroscopy, and the treatment group was given oral Guizhi-Fuling pill at day 2 after surgery on the basis of the control group treatment. Both groups were observed for 6 months. Before and after treatment, TCM symptom score was conducted, and IL-6 level was determined by radioimmunoassay; the uterine fallopian tube was examined after the 6th month of treatment, and pregnancy rate was observed and recorded. Results After treatment, abdominal pain degree (0.6 ± 0.1 vs. 1.3 ± 0.1, t=3.612), the low back pain (0.9 ± 0.2 vs. 1.6 ± 0.2, t=2.553), abdominal distension (0.5 ± 0.0 vs. 1.0 ± 0.8, t=2.364), menstrual blood clots (0.5 ± 0.1 vs. 1.0 ± 0.1, t=2.331) in the treatment group were significantly lower than those in the control group (Ps<0.05). After treatment, the rate of oviduct patency was 75.5% (37/49) in thetreatment group, 50.0% (24/48) in the control group, and the comparison difference between the two groups was statistically significant (χ2=8.075, P=0.044). After 6 months of treatment, the pregnancy rate of the treatment group was 63.3% (31/49), and that of the control group was 37.5% (18/48), the difference of pregnancy rate between the two groups was statistically significant (χ2=6.724, P=0.035). After treatment, serum IL-6 (31.04 ± 2.47 ng/ml vs. 42.71 ± 2.52 ng/ml, t=7.593) in the treatment group was signicantly lower than the control group (P<0.05). Conclusions Guizhi-Fuling pill combined with conventional therapy can reduce IL-6 level, promote fallopian tube recanalization, improve the intrauterine pregnancy rate, and improve the clinical symptoms of OOI patients. Key words: Infertility, female; Fallopian tube obstruction; Gui Zhi Fu Ling Wan; Hysteroscopes; Interventional

Effect and Safety of Huannao Yicong Formula (还脑益聪方) in Patients with Mild-to-Moderate Alzheimer’s Disease: A Randomized, Double-Blinded, Donepezil-Controlled Trial

To assess the effect and safety of Huannao Yicong Formula (, HYF) in the treatment of patients with mild-to-moderate Alzheimer's disease (AD). Sixty patients with mild-tomoderate AD were evenly randomized into HYF group and donepezil group with the random number method. Patients in the HYF group took 5 g of HYF granules twice daily and 5 mg placebo of donepezil once daily. Patients in the donepezil group took 5 mg donepezil once daily and 5 g placebo of HYF granules twice daily. The intervention lasted for 6 months. Clinical researchers, participants and statisticians were blinded to the treatment assignment throughout the study. The primary outcomes were scores of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and Chinese Medicine Symptom Scale (CM-SS). The secondary outcomes were scores of Montreal Cognitive Assessment (MoCA) test and Mini-Mental State Exam (MMSE). The serum levels of acetylcholinesterase (AchE) and amyloid-β protein 42 (Aβ42) were detected with enzymelinked immunosorbent assay kits. The scale assessments were conducted at baseline, the 3rd and 6th months of treatment, respectively. Biochemistry tests were conducted at baseline and the 6th month of treatment. A total of 52 patients completed the trial, 28 in HYF group and 24 in donepezil group. Compared with the baseline, HYF and donepezil signifificantly decreased the total scores of ADAS-Cog and CM-SS, and signifificantly increased the scores of MoCA and MMSE after 6-month treatment (all P<0.01). Both treatments remarkably reduced the serum levels of AchE and Aβ42 (both P<0.05). The CM-SS total effective rate of HYF was signifificantly higher than donepezil [75.00% (21/28) vs. 54.17% (13/24), P<0.05]. No severe adverse events were observed in both groups. HYF is effective and safe for improving the cognitive function in mildto-moderate AD patients. [Trial registration: Chinese Clinical Trial Registry (Reg No. ChiCTR-IOR-17011746)].

THE STUDY OF BIOCHEMICAL INDIXES OF ORAL FLUID IN ORTHODONTIC TREATMENT

The work is devoted to the study of the reactivity of the biochemical composition of saliva in children with SCI, which was used for the treatment of non-removable and removable OA. There was a decrease in the activity of the α-amylase enzyme during orthodontic treatment in both experimental groups: in patients in the experimental group, which used non-removable equipment 3 months after starting treatment at 16.5% and 6 months after starting treatment it was 16%. There was a decrease in the activity of saliva α-amylase after 3 months at 11% and in samples of saliva taken after 6 months at 10% during treatment of patients of the experimental group with removable orthodontic equipment. The total calcium level after 3 months of observation was 15% lower compared to the start of treatment. The phosphorus level was 9% lower at this moment of observation. After 6 months of observation, the trace elements were different from the original ones: calcium was 27% lower, and the level of phosphorus was lower comparing to the baseline by 15%. Treatment of SCI with removable orthodontic equipment impaired the mineral balance: the calcium level after 3 months of observation was lower by 12%, and the level of phosphorus was lower by 6% compared to the beginning of the study. After 6 months of observation, the traced elements differed from the original ones: the level of calcium was 21% lower than the previous values, and the level of phosphorus was lower by 13% compared to the start of treatment. The evaluation of alkaline phosphatase activity in mixed unstimulated saliva using non-removable orthodontic equipment showed that the level of alkaline phosphatase after 3 months of treatment was 3% lower compared to the beginning of treatment, and after 6 months of observation activity of the investigated enzyme was less than the initial by 10%. Treatment of dental anomalies with removable equipment inhibited the enzyme activity: after 3 months of treatment, the activity of alkaline phosphatase was less than 7% compared to the beginning of the study, and after 6 months of observation activity of the investigated enzyme differed from the initial by 20%. The use of non-removable orthodontic equipment led to a significant increase in the activity of IL-1β. Three months after starting the study, IL-1β was 4-fold higher compared to the start of treatment, and after 6 months of treatment, it became 9-fold higher. Treatment of dental abnormalities with removable equipment showed that the activity of IL-1β after 3 months of treatment increased 4-fold, and after 6 months of observation the researched index was different from the initial 9-fold.&#x0D; At the 3rd month of observation in children using non-removable OA, the activity of lysozyme decreased by 21%; reduction of lysozyme activity during the 6th month of treatment constituted 23%. Patients in the experimental group treated with detachable OA observed an increase in lysozyme activity at the 3rd month of observation by 27%, and 6 months after the start of treatment, the activity of lysozyme was less than 29% compared to the data of the 3rd month of the use of non-removable orthodontic equipment it led to a significant increase in the level of anti-inflammatory cytokine: after 3 months of observation was 2.5 times more than at the beginning of treatment, and after 6 months of observation, they differed from the initial in 4 times. Treatment of dental anomalies with removable orthodontic equipment also contributed to an increase in anti-inflammatory cytokine: IL-4 levels were higher after 3 months of treatment compared to baseline data by 1,8, and after 6 months of follow-up, the study figure was in 4 times higher than the previous values.&#x0D; The obtained results of the study of the reactivity of biochemical changes in oral fluid using removable and non-removable OA in children can be used in planning of orthodontic treatment as diagnostic markers for the further selection of tactics and assessment of the oral cavity in children on the background of treatment of JFA by removable and non-removable OA.

COMPARISON OF INFLUENCE OF VARIOUS REGIMENS OF DRUG INTAKE ON 24 HOUR bLOOD PRESSURE, CENTRAL AORTIC PRESSURE AND VASCULAR WALL STIFFNESS IN SYSTEMIC HYPERTENSION PATIENTS WITH ISCHEMIC STROKE

Aim. To assess and compare the efficacy of combination antihypertension drugs influence with various dosage regimens during 24 hour, on the parameters of daily blood pressure (BP) profile, central aortic pressure (CAP) and vessel wall stiffness in arterial hypertension (AH) patients with ischemic stroke (IS).Material and methods. To the study, 177 AH patients included, with IS within last 4 weeks. All patients were randomized to 3 groups depending on the regimen of antihypertensive drugs combination intake during 24 hours. At baseline and in 12 months of therapy all patients underwent 24 hour BP monitoring (ABPM), CAP measurement and vessel wall stiffness evaluation. Results. In 8 weeks of antihypertension therapy, target pressure level achievement was significantly more common in b. i.d. valsartan (group 3) comparing to once daily in the morning (group 1) or evening (group 2) (p&lt;0,05). In all groups there were statistically significant positive changes in ABPM, CAP and stiffness. Also, in the group 2 there was significantly (p&lt;0,05) more prominent decrease of the main ABPM, CAP and stiffness parameters than in the group 1. Valsartan b. i.d. led to significantly more prominent (p&lt;0,05) improvement of the main ABPM, CAP and stiffness parameters improvement comparing to both variants of its once daily regimens. In 12 months of chronopharmacotherapy, in all groups, there was significant (p&lt;0,05) increase of “dipper” 24 hour BP profile patients. Differences of the groups of “dippers” and “non-dippers” by the 12th month of treatment were significant for 3rd and 1st (p=0,0004), 3rd and 2nd (p=0,04) groups with the benefit for group 3.Conclusion. Two times a day or only evening intake of valsartan with thiazidelike diuretic in the morning facilitated more significant improvement of the main parameters of ABPM, CAP and vascular wall rigidity comparing to just morning intake. B.i.d. valsartan regimen led to significantly (p&lt;0,05) more commonly reached target BP level, improved normalization of 24 hour BP in most of patients, led to more significant improvement of the main ABPM, CAP and vascular stiffness parameters comparing to once daily morning or evening regimen.

Вплив блокатора мінералокортикоідних рецепторів еплеренону на динаміку структурно-функціонального стану міокарда в пацієнтів із не Q-інфарктом міокарда через 3 та 6 місяців лікування

Aim.&nbsp;Assessment of the dynamics of the structural and functional state of the myocardium in patients with non Q-wave myocardial infarction in 3 and 6 months depending on the use of the blocker of the mineralocorticoid receptors eplerenone. Material and Methods.&nbsp;We examined 77 patients (63.6% males) with non Q-wave myocardial infarction aged from 50 to 79 (mean 64.1±1.0) years. Hospital management strategy was elaborated in accordance with modern standards for the treatment of acute coronary syndrome without ST-elevation, which envisaged stratification of risk on the GRACE scale (estimated risk of mortality in the near future) and the choice of adequate procedure of the invasive strategy. The structural and functional state of the myocardium was evaluated using echocardiography, which was performed in the M-, B- and D-modes. Results and Discussion.&nbsp;A substantial increase in the total score of echocardiographic dynamics at the 6th month was demonstrated, as compared to the 3rd month of treatment, indicating a certain association of positive hemodynamic changes with the duration of basic treatment. An analysis of the total score of echocardiographic dynamics during the 3rd and 6th months of treatment indicated a significant increase in the indicator for all periods of observation in the eplerenone group, which showed a more convincing anti-remodeling effect in the group of patients with non-Q myocardial infarction who were administered the drug. Conclusions.&nbsp;The use of eplerenone in addition to basic treatment is associated with more convincing anti-remodeling and hemodynamic effects during the 3rd and 6th months of treatment. Positive hemodynamic effects of the drug exhibit a certain dependence on the duration of treatment, which is characterized by more powerful dynamics of most echocardiographic parameters on the 6th compared to the 3rd month of observation.

ПЕРСПЕКТИВЫ ПРИМЕНЕНИЯ ТАРГЕТНОЙ ХИМИОТЕРАПИИ ДЕЛАМАНИДОМ В СХЕМАХ ЛЕЧЕНИЯ БОЛЬНЫХ ТУБЕРКУЛЕЗОМ С МНОЖЕСТВЕННОЙ/ШИРОКОЙ ЛЕКАРСТВЕННОЙ УСТОЙЧИВОСТЬЮ ВОЗБУДИТЕЛЯ. УСПЕХИ, ВОЗМОЖНОСТИ ИЛИ НЕОПРЕДЕЛЕННОСТЬ?

The article presents the review of current publications, clinical recommendations and guidelines written by foreign authors and devoted to treatment of drug resistant tuberculosis with delamanid. According to the publications, delamanid and its combinations with other anti-tuberculosis are highly effective when used for treatment of respiratory MDR tuberculosis: 74.5% of patients achieved the complete sputum conversion by the 6th month of treatment.

ЭФФЕКТИВНОСТЬ ВКЛЮЧЕНИЯ ИММУНОРЕПАРАНТА В СОВРЕМЕННЫЕ РЕЖИМЫ ЛЕЧЕНИЯ БОЛЬНЫХ ТУБЕРКУЛЕЗОМЛЕГКИХ С ЛЕКАРСТВЕННОЙ УСТОЙЧИВОСТЬЮ ВОЗБУДИТЕЛЯ

The single prospective study was conducted in order to assess clinical efficiency of adding the immune restorative agent of deoxyribonucleat sodium (Derinat) to the current chemotherapy regimens of 102 patients (new cases or relapses) with destructive pulmonary tuberculosis with multiple or extensive drug resistance; the patients were divided into two groups: the main group included 30 patients who were prescribed with intramuscular injections of Derinat, 5 ml, every 24 hours with 48 hours interval, 10 injections in total; and nebulizer inhalations with mixture of Derinat and saline solution in the proportion of 1:1 (2 ml of Derinat and 2 ml of saline solution), once a day, 20 inhalations in total; the comparison group included 72 patients, who had no Derinat prescribed. When compared to the control group, the group of patients treated with the immunomodulator had a shorter period of clinical manifestations elimination, increase in the frequency of sputum conversion (by 28.6% by the 4th month of treatment), reduction in the rate of eradication of bronchial tree mucus inflammations, increase in the frequency of cavity healing (by 20% by the 6th month of treatment).

ЭФФЕКТИВНОСТЬ ХИМИОТЕРАПИИ ТУБЕРКУЛЕЗА ЛЕГКИХ У ВПЕРВЫЕ ВЫЯВЛЕННЫХ ПАЦИЕНТОВ ПРИ РАЗНЫХ СРОКАХ ОПРЕДЕЛЕНИЯ МНОЖЕСТВЕННОЙ ЛЕКАРСТВЕННОЙ УСТОЙЧИВОСТИ ВОЗБУДИТЕЛЯ

The objective of the study is to compare the efficiency of chemotherapy in new pulmonary tuberculosis patients depending on the time when multiple drug resistance was detected. Materials and subjects : 89 new patients with pulmonary tuberculosis were enrolled into the study, they all had a positive result of sputum test (at least, culture). All patients were divided into 3 groups: Group 1 (55 persons) included those with mycobacteria susceptible to rifampicin (as per the cartridge test and culture), Group 2 (16 persons) - patients resistant to rifampicin (as per the cartridge test and culture), and Group 3 (18 persons) was formed retrospectively and included patients with MDR (confirmed by culture). Results. The structure of clinical forms of tuberculosis among new cases does not depend on the drug resistance of mycobacteria. High treatment efficiency can be achieved in the new pulmonary tuberculosis cases if the initial treatment regimen was prescribed based on the results of the cartridge test with consequent correction depending on the results of the proportional method on liquid media in the automated system detecting growth of mycobacteria. If the above is provided the time of destruction healing did not depend on the drug resistance of mycobacteria, and sputum conversion was achieved in all patients of Groups 1 and 2, 71 (100 ± 1.6% ) by the 6th month of treatment.

ИЗМЕНЕНИЯ БИОХИМИЧЕСКИХ ПОКАЗАТЕЛЕЙ КРОВИ ПРИ ЛЕЧЕНИИ БЫСТРОПРОГРЕССИРУЮЩЕГО ПАРОДОНТИТА

Importance The urgency of the problem of inflammatory periodontal diseases is due to its high prevalence among the population. For many years there is a tendency to an earlier occurrence of this disease and its aggressive course. The target of the research is to study progress of the blood chemistry values of the patients suffering from the rapidly progressive periodontitis and treated with calcium-based drugs. Research Materials and Methods Our research has covered 42 persons aged 25 to 45 years. The first group consisted of 15 patients suffering from the rapidly progressive periodontitis and treated with ‘Calcemin’, the second group included 15 patients suffering from the rapidly progressive periodontitis and treated with ‘Tevabone’, and the control group consisted of 12 persons. The results of the blood chemistry values of the patients has shown fluctuations of the content of total calcium, ionized calcium and phosphorus in blood within the normal limits both before and after the treatment of the patients of both groups. However, firmly significant changes in the level of calcium, phosphorus and parathyroid hormone have been found out in the patients of the second group by the third, sixth and 12th month of treatment, while the first group showed a similar trend. This confirms positive progress of the inflammation process in the patients suffering from the rapidly progressive periodontitis and treated with the drugs influencing the calcium and phosphoric metabolism, especially ‘Tevabone’. Thus, application of ‘Tevabone’ in complex treatment of the rapidly progressive periodontitis brings the blood chemistry values into the normal limits. Conclusion Based on the research results, we can recommend including ‘Tevabone’ into the regimen of treatment of the patients suffering from the rapidly progressive periodontitis.

The influence of rifaximin on diverticulitis rate and quality of life in patients with diverticulosis.

Diverticulosis, its associated symptoms and complications are one of the most common pathologies of the gastrointestinal tract in more economically developed countries. Presence of diverticuli and their clinical consequences can be divided into four categories: 1) diverticulosis, i.e. an asymptomatic presence of diverticuli that are usually found by accident 2) symptomatic uncomplicated diverticulosis 3) diverticulitis (acute uncomplicated diverticulitis) 4) complications of diverticulitis (conditions requiring hospital stay). The aim of this study was to retrospectively analyze the efficacy of rifaximin in preventing diverticulitis in patients visiting proctology clinics. The diagnostic criterium for diverticulosis was confirmation by colonoscopy, barium enema or CT colography (virtual colonoscopy) as well as history of at least one documented episode of diverticulosis. History of diverticulosis was evaluated based on medical records, clinical symptoms, elevated level of CRP (&gt;5.0) and/or diagnostic imaging (ultrasound, CT). After setting strict exclusion criteria, 248 patients were qualified for the study out of 686, and they were later divided into two groups: control group (group I - 145 patients) and studied group (group II - 103 patients receiving rifaximin prophylaxis). Diverticulitis rate was comparable in both groups over a period of 6 months before study (p = 0.1306) and 6 months of treatment (p=0.3044). Between the 6th and 12th month of treatment, a significantly lower rate of diverticulitis was noted in the group receiving rifaximin compared to control group (p&lt;0.0001). Patients receiving rifaximin reported higher quality of life (which was assessed using the VAS scale) compared to control group after 12 months. The results confirmed the efficacy of riaximin in prevention of diverticulitis, even in the scheme of repeated courses every 3 months. Not only did application of rifaximin lower the rate of diverticulitis and its complications in patients after an episode of diverticulitis, but also it improved the patients' quality of life. It seems that diverticulitis prophylaxis based on rifaximin can be economically efficient, however, it requires further research.

Preliminary assessment of neck circumference in benign prostatic hyperplasia in patients with metabolic syndrome

ABSTRACTObjectivesTo investigate the impact of neck circumference (NC) in the treatment of bening prostatic hyperplasia (BPH) patients with metabolic syndrome (MtS). Additionally, we determined dose response to alpha-blockers and cut-off values for NC and waist circumference (WC), in these patients.Materials and MethodsNon-randomized, open-labelled, and multi-centre study was conducted between March 2014 and September 2015. The BPH patients were enrolled and were divided into 2 groups: with MtS (Group 1; n=94) and without MtS (Group 2; n=103). Demographic data, anthropometric measurements, blood analyses, uroflowmetric parameters, post voiding residual urine (PVR), prostate volume, quality of life (QoL) index, NC and WC were recorded. Both groups were administered oral alpha-blockers and response to treatment was evaluated. Receiver-operating characteristic (ROC) curves were obtained and significant p was p<0.05 . ResultsIn total, 197 patients were enrolled with mean age of 60.5±8.1 years. Mean NC and WC were higher in MtS patients (p<0.001). Uroflowmetry parameters and QoL indexes were comparable between groups before treatment. International prostate symptom score, uroflowmetry parameters, and QoL significant improved in Group 2 than Group 1, at 1 st and 6 th months of treatment with alpha-blockers. Success rate of treatment was significant higher in Group 2 than Group 1 (p<0.001). Cut-off values were 42.5cm and 113.5cm for NC and WC respectively, for response to alpha-blockers in BPH patients with MtS.ConclusionsMtS can be related with BPH and can negatively affect the response to alpha-blocker treatment. NC can be used for predicting response to alpha-blocker treatment in BPH patients with MtS.

Recurrent Endometrioma; Outcome of Medical Management with Dienogest

Background: Management of recurrent endometrioma should balance between the risk of unexpected hidden malignancy and the damaging effect of second surgery to ovarian tissue. Dienogest is a fourth generation of progestin and has been used in endometriosis with effective and save reports. Patients and methods: Between April 2015 and August 2016, the recruitment was started to include women with symptomatic recurrent endometrioma after surgery, their ages between 18 – 40 years. The adenxial masses had been evaluated by transvaginal ultrasound to prove the diagnosis which required the presence of ground glass echogenicity and one to four compartments and no papillary structures with detectable blood flow, after signing an informed consent, all patients received dienogest tablet 2 mg daily for 52 weeks. Numeric pain scale, and transvaginal ultrasound were used to evaluate all patients on monthly basis in the first three months, then every three months. Results: Twenty patients had been enrolled with minimum follow up after stopping the treatment is six months up to one year. The size of the cysts ranged from 3.2 cm up to 7 cm, with mean size 5.46 cm, after three months of treatment; mean numeric pain score was 2.5 versus 5.1 on presentation (P<0.001), and the mean of largest diameter of the cyst became 3.1 cm versus 5.45 cm on presentation (p<0.001). By the end of the 6th month of treatment, we had residual cysts (1.8cm) in two patients only which remain in their size until the end of treatment. With the end of follow up no report of recurrence of symptoms neither evidence of ultrasound features of recurrence. Conclusion: Dienogest 2mg per day is a well-tolerated therapy for recurrent endometrioma with safe side effect profile. It can make the patient pain free and reduce the size of the cyst within three months.

Influence of CYP3A5 and SLCO1 on Imatinib Response Among Egyptian Patients with Chronic Myeloid Leukemia in Chronic Phase

BackgroundImatinib (IM) was approved as a molecular target tyrosine kinase inhibitor (TKI) drug that selectively inhibits BCR/ABL1 tyrosine kinase which causes Philadelphia-positive chronic myeloid leukemia (CML) and so far has been one of the first-choice treatment option in CML with excellent results. However, only a proportion of patients achieve major molecular response. Hence, the need to find whether there are some factors that affect the response to treatment is essential. Although IM pharmacokinetics is influenced by several enzymes and transporters, little is known about the role of pharmacogenetic variation in IM metabolism. This study aimed to investigate the frequencies of mutational status of CYP3A5 and SLCO1 in CML patients undergoing imatinib treatment and to determine whether these two genes could predict the response to imatinib therapy in CML patients.Subjects and methodsWe investigated the mutational status of SLCO1 and CYP3A5 by Polymerase Chain Reaction followed by restricted fragment length polymorphism in 62 Philadelphia positive newly diagnosed Egyptian CML patients in chronic phase; 39 males (62.9%) and 23 females (37.1%). All patients received imatinib therapy and were followed up for at least one and half year. The response to imatinib therapy was evaluated by recording the hematological response, cytogenetic response at 3rd then 6th month and molecular response at 12th month according to the European Leukemia Net criteria. ResultsTwenty-eight patients (45.2%) were CYP3A5 wild versus 34 patients (54.8%) mutant while 26 patients (41.9%) were SLCO1 wild versus 36 patients (58.1%) mutant. 85.7% of patients with wild CYP3A5 had low & intermediate Sokal score versus 76.5% of mutant CYP3A5 patients had low & intermediate Sokal score with non-significant relation (p = 0.3). There was a significant relation between mutation in CYP3A5 and poor performance state (PS) of the patients at presentation; 89.3% of patients with wild CYP3A5 had good PS versus 61.8% in the mutant group with (p = 0.01). After 3 month of imatinib therapy there was no significant relation between CYP3A5 mutational state and response to therapy however, 85.7% of patients with wild CYP3A5 reached optimal & suboptimal response versus 79.4% in the mutant group with non-significant difference (p = 0.5). We had 51 patients that continued on imatinib till 6th month of therapy whereas 11 patients shifted to 2nd line TKI after imatinib failure. 87.5% of patients with wild CYP3A5 reached optimal & suboptimal response versus 66.7% in the mutant group with difference reaching significance (p = 0.07). We have 39 patients continued imatinib therapy till 12 month whereas 12 patients shifted to 2nd line TKI after imatinib failure. 71.4% of patients with wild CYP3A5 reached MMR at 12th month of treatment however only 22.2% of mutant CYP3A5 patients reached major molecular response (MMR) with significant difference (p = 0.002). Patients with wild SLCO1 were significantly had low & intermediate Sokal score (p = 0.04). However there was no significant correlation between SLCO1 mutational state and performance state or response to imatinib therapy.ConclusionCYP3A5 mutant gene was associated with poor imatinib efficacy while the SLCO1 gene was not associated with the response to imatinib treatment in Egyptian patients with CML in chronic phase. DisclosuresNo relevant conflicts of interest to declare.