6th Month Of Treatment Research Articles

Response to treatment and low serum vitamin D levels in North Indian patients with treatment-naive category I and multi-drug resistant pulmonary tuberculosis

Background Tuberculosis (TB) is a bacterial infection that usually affects the lungs, although it can also affect other parts of the body. Vitamin D deficiency and response to treatment have been demonstrated in patients with active TB in several studies, but not in MDR-TB patients, which is a new observation in the present study. Objective To study the time to initial sputum culture conversion and to associate baseline vitamin D levels and response to treatment in patients with PTB Cat I and MDR-TB. Methods A total of 897 North Indian participants were recruited and divided into three groups: treatment-naïve PTB Cat I, MDR-TB, and healthy controls. Serum biochemistry, including 25-hydroxyvitamin D and calcium, was measured in all participants with PTB, Cat I, and MDR-TB. Results PTB Cat I patients had high bacillary load grading at baseline compared to 2nd month followed by 6th month of treatment. More severe chest radiographic features, such as cavitation and the presence of bilateral disease at baseline. Mean sputum smear conversion times were 0.95 ± 0.7 months and culture conversion to negative occurred at a mean time of 0.8 ± 0.7 in PTB Cat I patients compared to MDR-TB patients on average sputum smear and time of 2.4 ± 3 months. Significantly lower mean serum 25-hyroxyvitamin D concentration was found in the 6th month than in the 2nd month and baseline in PTB Cat I. Conclusion Low serum vitamin D deficiency was observed in both groups during treatment and is one of the important factors responsible for susceptibility to TB in both groups; however, its significance is uncertain. Patients with continuous positive sputum for multidrug-resistant tuberculosis (MDR-TB) had a worse prognosis than those with sputum bacteriology conversion. Two months into a treatment regimen, sputum smear conversions may be a useful indicator of an MDR-TB patient’s prognosis.

Liraglutide in the management of obesity: real world data (Portugal).

Overweight and obesity are major public health issues with increasing incidence and prevalence, affecting more than 50% of the population in developed countries. Due to its complex pathophysiology and multifactorial etiology, disease understanding, diagnostic approach and management remain suboptimal. Together with a structured nutritional intervention and physical activity plan, pharmacological treatment has the potential to magnify weight loss and health related benefits. Liraglutide is one of the most effective and frequently prescribed weight loss medication. Its efficacy and safety have been demonstrated in randomized clinical trials, however, real world data in Portugal is scarce. The authors report on the experience of a University Hospital Endocrine Clinic in the management of patients with overweight and obesity with liraglutide on top of lifestyle intervention. The aim of the study was to evaluate the effectiveness of liraglutide in the management of overweight and obesity. Retrospective, longitudinal observational study. Inclusion criteria were adult patients (>18 years old) with obesity (BMI>30 kg/m2) or overweight (≥27 kg/m2) with at least one obesity related co-morbidity (hypertension, dyslipidemia, obstructive sleep apnea, non-alcoholic fatty liver disease) with at least three months of liraglutide treatment. Diabetes diagnosis and prior bariatric surgery were exclusion criteria. Demographic and clinical variables were included and weight was recorded before and after at least 3 months of liraglutide treatment. One hundred forty-eight patients (85.8% females) with a mean age of 48.7±11.9 years were treated with liraglutide. Mean baseline BMI was 33.8±5.2 kg/m2 and median follow-up was 13 months. At the last appointment, 85.8% were still taking liraglutide. Among patients still taking liraglutide, mean weight loss was 7.6 kg (7.9%), with significantly greater losses in patients treated for more than 6 months (8.6kg vs. 6.2 kg, P=0.016). Patients with obesity lost significantly more weight than overweight patients (8.3 kg vs. 4.5 kg, P=0.028), despite similar treatment duration. The reasons for liraglutide withdrawal were gastrointestinal intolerance (7), medication cost (2), inefficacy (10) and physician instructions (1). The present study documents the long-term efficacy of liraglutide in the treatment of patients with overweight and obesity, with a low rate of drug withdrawal. Mean weight loss was significant and more evident from the 6th month of treatment on. Liraglutide, along with lifestyle intervention, is a good option for weight management in the majority of patients with obesity.

Efficacy and safety of the type I interferon receptor inhibitor anifrolumab in patients with systemic lupus erythematosus (results of a 6-month study)

Objective: to evaluate the efficacy and safety of the type I interferon (IFN) receptor inhibitor anifrolumab (AFM, Safnelo®) in patients with systemic lupus erythematosus (SLE) in real-life clinical practice over an observation period of 6 months.Material and methods. The prospective 6-month study included 21 patients with SLE fulfilling the 2012 SLICC criteria, predominantly women (n=17,81%), median age – 31 [27; 46] years, disease duration – 9 [6.0; 11.0] years. Standard laboratory values and immunological markers of SLE were examined in all patients. The SLEDAI-2K index was used to determine the activity of SLE, and the severity of the mucocutaneous syndrome was assessed using the Cutaneous Lupus Disease Area and Severity Index (CLASI) index. Organ damage was assessed using the SLICC/ACR Damage Index (DI). After 6 months, the achievement of low activity was assessed according to the Lupus Low Disease Activity State (LLDAS) indexResults and discussion. At the time of inclusion in the study, the mean SLEDAI-2K activity index for the group was 8 [6.0; 10.0] points, the median CLASI index – 8.6±8.2 points, 81% of patients had skin and mucosal lesions, 66% had non-erosive polyarthritis, and high immunological activity was observed in all cases. Various irreversible organ damage was observed in 86 of patients. The average DI was 2.2±1.5 points. At the start of AFM therapy, all patients received glucocorticoids (GCs) at a mean dose of 10.7±5.6 mg/day, 52% of patients received a dose above 10 mg/day, 76% of patients continued to take hydroxychloroquine, and 33% of patients took immunosuppressants. Significant positive dynamics were observed with AFM therapy. The average CLASI index for the group after 3 months of treatment was 1.2±4.1 points, after 6 months – 0.3±1.2 points (p<0.0001). The SLEDAI-2K index fell significantly in the group on average from 8 [6.0; 10.0] to 2 [2.0; 4.0] points from the 3rd month of treatment (p<0.0001) and remained at the same level after 6 months. At month 6 of treatment, 13 (62%) of 21 patients met the LLDAS criteria for low disease activity. After the 3rd month of treatment, a significant decrease in antibodies against dsDNA was observed, which persisted for 6 months after the start of treatment. In the group as a whole, there were no significant changes in complement fractions values during the observation period. There was no increase in irreversible organ damage (DI – mean 2.2±1.5 points). The mean daily dose of GCs was significantly reduced from 10.7±5.6 mg/day to 7.5±4.0 mg/day (p<0.01) by the 3rd month and to 5.2±2.1 (p<0.001) by the 6th month of treatment. No infusion reactions were observed in any case. Adverse events occurred in 9 (42%) out of 21 patients, mainly herpes infections of varying severity, mainly after the 1st to 3rd infusions. In one case, severe herpes zoster was observed, so the drug was discontinued.Conclusion. At a dose of 300 mg intravenously monthly AFM is a highly effective drug with a relatively good safety profile in patients with active SLE in whom autoantibodies are present and who do not respond adequately to standard therapy.

Pre-pregnancy preparation of women with hypoandrogenism and female sexual dysfunction

The onset of pregnancy in the natural cycle is a task that requires the coordinated work of both central and peripheral levels of regulation of hypothalamic‑pituitary hormones. An analysis of the reproductive health of women with a menstrual cycle disorder against the background of hypoandrogenism indicates an unsatisfactory course of the early stages of the pregnancy process with the subsequent formation of infertility against the background of a reduced ovarian reserve. Hypolubrication is considered a clinical marker of hypoandrogenism in women of reproductive age.
 Objective — Optimization of pre‑pregnancy training in women with hypoandrogenism, menstrual cycle disorders and early pregnancy losses in the anamnesis.
 Materials and methods. A comprehensive clinical, laboratory and instrumental examination involved 90 women with menstrual cycle disorders and hypoandrogenism, from them 45 women received the proposed therapy (group Ia), and 45 patients traditional therapy (group IIa). The control group consisted of 30 healthy women at the stage of pre‑gravid examination. The age of women was 18 to 35 years. Hormonal reproductive background was determined on the 5 ‑ 7th day of the menstrual cycle in all examined women, as well as levels of thyroid‑stimulating hormone (TSH), thyroid peroxidase antibody, vitamin D, homocysteine. The proposed algorithm of pre‑gravid measures included: 1) optimization of thyroid gland function (after consultation with an endocrinologist); 2) restoration of pituitary‑ovarian relationships in case of functional central hypogonadism; 3) therapy aimed at optimizing the prolactin level (target value 12.5ng/ml); 4) reduction of homocysteine level (target level 5.6 mmol/l); 5) normalization of vitamin D level (norm is 75—125 nM/l, insufficiency defined as 50—75 nM/l, and deficiency <50 nM/l). The target control parameters included restoration of lubrication, ovulatory menstrual cycle, onset and progression of pregnancy. IBM SPSS Statistics version 25.0 software was used for statistical processing of the obtained data. The control periods of therapy were 3, 6 and 9 months.
 Results. In women with proposed treatment algorithm, therapy resulted in the recovery of vitamin D levels, starting from the 6th month of therapy, and complete normalization was recorded at the 9th month of treatment. This indicates the need for long‑term supplementation of vitamin D in women with hypoandrogenism. A decrease in the homocysteine levels was also noted on the 6th month of treatment, and its normalization after 9 months of treatment. Elevated homocysteine levels and vitamin D insufficiency/deficiency were observed throughout the follow‑up period in the conventional therapy group. In women with the proposed therapy, the levels of follicle‑stimulating hormone (FSH), TSH, luteinizing hormone (LH) and prolactin tend to normalize already from the 3rd month of therapy, while the highest positive increase was noted in the LH indicator on the 3rd‑6th month of treatment. Ovarian steroidogenesis approached the indicators of the control group after 6—9 months of therapy. Proandrogenic steroidogenesis began to increase on the 3rd month of therapy, reaching maximum on the 9th month. Unsatisfactory indicators of changes in free testosterone and dehydroepiandrosterone sulfate (DHEA‑C) were noted in women from the group of the traditional pre‑pregnancy preparation even after 9 months.
 The specified features of steroid support of the hormonal background of women’s reproductive health demonstrated the following: signs of female sexual dysfunction in the group with the proposed therapy completely disappeared after the 9th month of treatment, and in the group of traditional therapy they continued to bother 91.1% of women. At the end of the observation period, the regular menstrual cycle was gained in 40.0% of women with the proposed therapy and in 6.7% with the traditional one. Progressive pregnancies in the group with the proposed algorithm were achieved in 37.5% of women (successfully overcame the luteoplacental barrier), and in 8.8% in the group of the traditional approach (ended by early termination of pregnancy).
 Conclusions. The period of formation of the luteal phase insufficiency is the specific feature of the restoration of menstrual cycle fullness in women with hypoandrogenism, which requires additional therapy to ensure the conditions for a full‑fledged secretory endometrium transformation. The pregnancy process takes place in unfavorable conditions, which can lead to early pregnancy losses. The period of pre‑pregnancy measures in this group of patients should last at least 6—9 months. Traditional pre‑pregnancy preparation does not contribute to the restoration of the central mechanisms of menstrual cycle regulation in women with hypoandrogenism, nor does it contribute to the restoration of full‑fledged ovarian steroidogenesis, it is accompanied by anovulation and insufficiency of the luteal phase, early pregnancy losses. Symptoms of female sexual dysfunction do not disappear under the influence of traditional treatment.

Duodenal tuberculosis with gastric outlet obstruction: a case report of successful diagnosis and treatment, with review of literature

BackgroundDuodenal tuberculosis (TB) is extremely rare, and its diagnosis is challenging owing to the lack of specific symptoms and radiological or endoscopic findings. When it leads to gastric outlet obstruction (GOO), diagnosing it accurately and providing appropriate treatment is crucial. However, this is often overlooked.Case presentationA 35-year-old man presented with abdominal pain, fullness, vomiting, and weight loss. Upper gastrointestinal endoscopy and radiography revealed nearly pinpoint stenosis with edematous and reddish mucosa in the D1/D2 portion of the duodenum. Computed tomography (CT) showed the duodenal wall thickening, luminal narrowing, multiple enlarged abdominal lymph nodes, and portal vein stenosis. Conventional mucosal biopsy during endoscopy revealed ulcer scars. We initially suspected stenosis due to peptic ulcers; however, chest CT revealed cavitary lesions in both lung apices, suggesting tuberculosis. Due to the suspicion of duodenal TB and the need to obtain deeper tissue samples, endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) was performed. The tissue sample showed caseating granulomas with multinucleated giant cells, and acid-fast bacilli were positive by Ziehl–Neelsen staining. The patient was diagnosed with duodenal TB and subsequent GOO. Because the patient had difficulty eating, surgical intervention was prioritized over antitubercular drugs, and laparoscopic gastrojejunostomy was performed. The patient started an oral diet on the 3rd postoperative day and began antitubercular treatment immediately after discharge on the 11th day. During the 6th month of treatment, endoscopic examination revealed residual duodenal stenosis; however, the bypass route functioned well, and the patient remained asymptomatic.ConclusionsAn aggressive biopsy should be performed to diagnose duodenal TB. EUS-FNA has proven to be a useful tool in this regard. Both nutritional improvement and antitubercular treatment were achieved early and reliably by performing laparoscopic gastrojejunostomy for duodenal TB with GOO.

Dolutegravir based therapy showed CD4+ T cell count recovery and viral load suppression among ART naïve people living with HIV AIDS: a pilot evaluation

Recently, dolutegravir (DTG)-based combined therapy, a more effective and safer first-line antiretroviral therapy (ART), has been recommended by the World Health Organization for the treatment of Human Immunodeficiency Virus (HIV) since July 2018. However, its effectiveness in CD4+ T-cells count recovery and viral load suppression has not been studied yet in Ethiopia, where HIV is endemic. Therefore, we aimed to conduct a pilot assessment on the effect of DTG-based therapy on CD4+ T-cell count and viral load count among people living with HIV (PLWH) in Ethiopia. A longitudinal prospective cohort study was conducted from July 2020 to February 2021. 109 PLWH who are ART naive but plan to initiate DTG-based therapy were recruited. HIV viral ribonucleic acid (RNA) copies were determined using polymerase chain reaction. To compute the difference in viral load and CD4+ T-cell counts between the baseline, 3rd, and 6th months, a Friedman test was used. The study included 109 PLWH who had never received antiretroviral medication. Participants taking DTG-based treatment showed significantly decreasing median (IQR) values of viral load count (copies/mL) from 446,812 (237649.5–732994.5) at baseline to 34 (23.5–46) at 3 months and 0.0 (0–19) at 6 months of treatment follow-up. Although the treatment increases the proportion of participants with HIV-1 RNA 50 copies/mL from 0 (0% at baseline) to 87 (79.8%) and 100 (91.7%) at the 3rd and 6th months of treatment, respectively, On the other hand, the CD4+ T-cell count increased significantly during treatment: median (IQR): 209 (81.5–417.5) versus 291 (132–522) versus 378 (181–632.5) cells/L at baseline, the 3rd and 6th months of the treatment follow-up period, respectively. We found dolutegravir-based therapy was a promising option with high virological suppression rates and CD4+ T-cell count recovery, demonstrating a restoration of cellular immunity. Moreover, Viral load suppression rates were high after the initiation of the treatment. We recommend further research should be conducted with a larger number of participants to acquire greater awareness of the treatment outcomes.

IMPACT OF PHARMACOLOGICAL TREATMENT ON CARDIOVASCULAR AUTONOMIC FUNCTION TESTS IN PATIENTS OF OCD AND ITS CLINICAL RELEVANCE: A FOLLOW-UP STUDY

Objectives: Obsessive-compulsive disorder (OCD) is associated with increased mortality due to coronary artery disease. Autonomic dysfunction has been associated with an increased risk of developing cardiovascular illness. Thus, this study examined that autonomic dysfunction is inherent in the disease process and it improves with early initiation of treatment. Methods: A total of 50 drug-naive patients meeting the ICD-10 criteria for OCD were subjected to autonomic function tests at baseline and then follow-up assessments were done at the 3rd and 6th month of treatment. The follow-up parameters were compared statistically with the baseline parameters. Results: Difference of time domain parameters of heart rate variability at baseline and second follow-up were statistically significant (p<0.05). Difference of frequency domain parameters of HRV at baseline and second follow-up were also statistically significant (p=0.000). Conclusion: OCD is characterized by inherent autonomic dysfunction. Thus, physicians should carefully monitor metabolic and cardiovascular health in patients with OCD early in the course of the disorder and early initiation of treatment can further prevent these cardiovascular events.

Clinical Efficacy and Safety of Flumatinib in the Treatment of Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

To explore the clinical efficacy and safety of flumatinib mesylate produced in China in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). 32 newly diagnosed CML-CP patients admitted to the Hematology Department of the Affiliated Hospital of Southwest Medical University from March 1, 2020 to March 31, 2022, who had never received any tyrosine kinase inhibitor (TKI) were included in the study. The patients were treated by flumatinib mesylate 600mg once daily. The hematologic, cytogenetic and molecular responses were assessed at 3-, 6- and 12-month, and adverse effects of the drug were evaluated. 31 patients were treated with flumatinib for≥3 months, of which 24 patients were treated for ≥6 months and 14 patients were treated for≥12 months. At 3rd month of treatment, 30 out of 31 patients achieved complete hematologic response (CHR); 24 patients underwent cytogenetic testing and 22 cases achieved major cytogenetic response(MCyR), of which 21 cases achieved complete cytogenetic response (CCyR); Among 25 patients who underwent molecular testing, 22 patients had BCR-ABLIS≤10%, including 10 patients with BCR-ABLIS≤0.1%, and 6 patients with BCR-ABLIS≤0.01%. At 6th month of treatment, 23 out of 24 patients achieved CHR; 17 patients underwent cytogenetic testing and all achieved CCyR; Among 23 patients who underwent molecular testing, 20 patients had BCR-ABLIS≤1%, including 16 patients with BCR-ABLIS≤0.1% and 12 patients with BCR-ABLIS≤0.01%. At 12nd month of treatment, all 14 patients achieved CHR and CCyR; Among them, 10 patients had BCR-ABLIS≤0.1%, including 9 patients with BCR-ABLIS≤0.01%. The grade Ⅲ/Ⅳ leukopenia, thrombocytopenia and anemia rates in the patients were 13.3%, 20.0% and 3.3%, respectively. One patient stopped flumatinib therapy due to severe and persistent hematologic toxicity. The major non-hematologic adverse events were abnormal liver function (20%), diarrhea (10%), bone/joint pain (10%), muscle spasm (10%), rash (6.7%), acute kidney injury (6.7%) and nausea(3.3%), most of which were grade I-II. No patient experienced grade Ⅳ non-hematologic adverse events. No drug toxicity-related death occurred. Flumatinib mesglate, as the first-line treatment for newly diagnosed CML-CP, can enable the patients to achieve early and deep molecular and cytogenetic responses, and shows good safety.

Artificial intelligence for predicting orthodontic patient cooperation: Voice records versus frontal photographs

Objectives: The purpose of this study was to compare the predictive ability of different convolutional neural network (CNN) models and machine learning algorithms trained with frontal photographs and voice recordings. Material and Methods: Two hundred and thirty-seven orthodontic patients (147 women, 90 men, mean age 14.94 ± 2.4 years) were included in the study. According to the orthodontic patient cooperation scale, patients were classified into two groups at the 12th month of treatment: Cooperative and non-cooperative. Afterward, frontal photographs and text-to-speech voice records of the participants were collected. CNN models and machine learning algorithms were employed to categorize the data into cooperative and non-cooperative groups. Nine different CNN models were employed to analyze images, while one CNN model and 13 machine learning models were utilized to analyze audio data. The accuracy, precision, recall, and F1-score values of these models were assessed. Results: Xception (66%) and DenseNet121 (66%) were the two most effective CNN models in evaluating photographs. The model with the lowest success rate was ResNet101V2 (48.0%). The success rates of the other five models were similar. In the assessment of audio data, the most successful models were YAMNet, linear discriminant analysis, K-nearest neighbors, support vector machine, extra tree classifier, and stacking classifier (%58.7). The algorithm with the lowest success rate was the decision tree classifier (41.3%). Conclusion: Some of the CNN models trained with photographs were successful in predicting cooperation, but voice data were not as useful as photographs in predicting cooperation.

Efficacy of prednisone combined with mycophenolate mofetil for immunoglobulin A nephropathy with moderate-to-severe renal dysfunction.

Immunoglobulin A nephropathy (IgAN) is a common form of chronic glomerulonephritis. Currently, IgAN is one of the main causes of chronic renal failure in China; its prognosis varies greatly between patients, with renal function at the time of diagnosis and prognosis being strongly correlated. Mycophenolate mofetil (MMF) is a drug with a good immunomodulatory effect and is commonly used clinically. However, its effects in IgAN have not yet been clearly demonstrated. Therefore, herein, we retrospectively compared the effectiveness and safety of prednisone alone or combined with MMF for the treatment of primary IgAN with moderate-to-severe renal impairment. To evaluate the effectiveness and safety of prednisone and MMF in treating IgAN with moderate-to-severe renal dysfunction. Between January 2011 and December 2020, 200 patients with moderate-to-severe IgAN were included in this study, all of whom were admitted to Wuxi People's Hospital affiliated with Nanjing Medical University. All patients underwent a renal puncture biopsy, which revealed primary IgAN with a glomerular filtration rate (GFR) of 30-60 mL/min. The patients were divided into a glucocorticoid therapy group (GTG) and an immunosuppressive therapy group (ITG) according to the different treatment regimens, with 100 patients in each group. Based on general treatments, such as angiotensin-converting enzyme inhibitors/ angiotensin receptor blockers, patients in the GTG were administered prednisone 0.5-0.8 mg/ (kg·d-1) for 4-8 wk, which was reduced by 5 mg every two weeks until the maintenance(30 mg/d) dose was reached and maintained for 12 mo. In the ITG, MMF was administered at 1.0 g/d for 6-12 mo, followed by a maintenance dosage of 0.5 g/d for 12 mo. Age, sex, blood pressure, 24-h urinary egg white measurement, serum creatinine (Scr), blood uric acid, blood albumin, blood potassium (K), hemoglobin, GFR, alanine aminotransferase, total cholesterol (T-CHO), fasting blood glucose, and body mass index were recorded. The 24-h urinary protein, Scr, and GFR levels were recorded 3, 6, 9, and 12 mo after treatment. Follow-up data were also collected. No discernible differences existed between the two groups in terms of age, sex, blood pressure, creatinine, 24-h urinary protein level, GFR, or other biochemical indicators at the time of enrollment. Both regimens significantly reduced the 24-h urinary protein quantitation and stabilized renal function. Nine months after treatment, the 24-h urinary protein and Scr of the ITG decreased more significantly than those of the GTG. By the 12th month of treatment, the 24-h urinary protein and Scr in both groups continued to decrease compared to those by the 9th month. In addition, the overall response rate in the ITG was significantly higher than that in the GTG. The occurrence of side effects did not vary significantly between the two regimens; however, endpoint events were significantly more common in the GTG than in the ITG. The follow-up time for the GTG was noticeably lower than that for the ITG. Prednisone combined with MMF was effective for the treatment of IgAN with moderate-to-severe renal dysfunction.

Effectiveness of a novel hydrolysate collagen formulation in the complex treatment and rehabilitation of patients with symptomatic knee osteoarthritis

BACKGROUND: Knee osteoarthritis is a chronic disease that can eventually lead to surgical arthroplasty. Overuse, inflammation, metabolic disorders, and hormonal changes play important roles in the pathogenetic development of osteoarthritis of the knee. Recent studies have shown that collagen hydrolysate slows down the degenerative processes in cartilage tissue and has analgesic and anti-inflammatory effects.
 AIMS: To examine the effect of a dietary supplement of collagen hydrolysate (COLLA GEN) on the treatment and rehabilitation of patients with symptomatic knee osteoarthritis.
 MATERIALS AND METHODS: This prospective, blinded, placebo-controlled study included 99 patients diagnosed with radiographic knee osteoarthritis. All patients were randomly divided into two groups. Both groups were prescribed a course of therapeutic exercises. Group I was also prescribed a food supplement of collagen hydrolysate (COLLA GEN), whereas group II received placebo. The effectiveness of collagen hydrolysate in symptomatic osteoarthritis was evaluated based on the comparison of the WOMAC and VAS scores before the treatment and rehabilitation process and after 1, 3, and 6 months.
 RESULTS: Daily intake of 40 g of collagen hydrolysate dietary supplement of collagen hydrolysate («COLLA GEN») for 3 months, in combination with exercise therapy, in patients with symptomatic osteoarthritis, allowed statistically significant (p 0.05), compared with the placebo group, to improve such indicators on the WOMAC scale as «pain» (3.9±1.5 in group I and 5.4±1.8 in group II), «physical function» (8.7±3.2 in group I and 13.7±2.9 in group II), and «total score» (14.5±5.2 in group I and 21.5±4.9 in group II) by 6 months of observation. When analyzing the indicators on the VAS scale at the end of the 3rd and 6th month of treatment, a statistically significant difference (p 0.05) was observed between the indicators of regression of pain symptoms, which were 2.17 and 3.72 points in group I and 0.83 and 2.03 points in group II, respectively.
 CONCLUSION: The use of a novel hydrolysate collagen formulation in the complex treatment and rehabilitation of patients with symptomatic knee osteoarthritis has potential therapeutic effects.

Dynamics of clinical manifestations and cytokine levels in patients with rheumatoid arthritis associated with upadacitinib therapy

BACKGROUND: Recently, it has become evident that despite extensive data obtained from randomised placebo-controlled trials, which are still the golden standard for assessing the efficacy and safety of therapy, there are still some fundamentally important questions regarding the optimal management of patients with rheumatoid arthritis. In this regard, it is extremely relevant to assess the results of therapy in real clinical practice. Currently, much attention is paid to the study of the level of proinflammatory cytokines, both as markers of inflammatory activity of rheumatoid arthritis and monitoring the prognosis of anti-inflammatory therapy efficacy. In Russia, there are no works devoted to the study of cytokine concentration dynamics in patients with rheumatoid arthritis on the background upadacitinib therapy, which proves the relevance of the following study.
 AIM: To investigate the dynamics of clinical and laboratory values of inflammatory activity of the disease and cytokines in patients with rheumatoid arthritis associated with upadacitinib therapy.
 MATERIALS AND METHODS: We examined 10 patients with a reliable diagnosis of rheumatoid arthritis: patients’ age was 46.30 ± 10.20 years and disease duration was 12.00 (3.00–21.00) years. All the patients had moderate to high disease activity: Disease Activity Score-28 with erythrocyte sedimentation rate 5.48 (4.50–5.80), Clinical Disease Activity Index 28.00 (19.50–32.00) and Simple Disease Activity Index 29.18 (19.51–33.05). All the patients included in the study were treated with upadacitinib at a dose of 15 mg once a day against the background of the therapy with methotrexate, leflunomide, non-steroidal anti-inflammatory drugs and glucocorticoids. Observation was carried out before treatment and after 3, 6 months of therapy. Serum levels of 15 cytokines: interleukin-1β, -4, -6, -10, -17A, -17F, -21, -22, -23, -25, -31, -33, tumor necrosis factor-alpha, interferon gamma, soluble СD40 ligand were studied using multiplex xMAP technology.
 RESULTS: After 3 and 6 months of upadacitinib therapy, there was a significant decrease in Disease Activity Score-28 with erythrocyte sedimentation rate 3.78 (2.53–4.20) and 3.5 (2.00–3.68), Clinical Disease Activity Index 12.00 (5.00–17.34) and 9.0 (3.00–11.00), Simple Disease Activity Index 12.38 (5.02–17.00) and 9.61 (3.06–11.60), erythrocyte sedimentation rate 19.0 (11.0–26.0), 7.0 (4.0–18.0), CRP 0.56 (0.50–1.99), 0.71 (0.51–1.1). The values of erythrocyte sedimentation rate decreased after 3 months of treatment (baseline 21.0 (15.0–25.0) mm/hour, after 3 months 14,0 (11,0–17,0) mm/hour. After 6 months of upadacitinib therapy, there was a significant decrease in interleukin-10 (p 0.05) and interleukin-33 (p 0.01) levels compared to baseline. On the contrary, the level of interleukin-25 increased by the 6th month of treatment (p 0.01).
 CONCLUSIONS: The results of the study indicate the effectiveness of upadacitinib in rheumatoid arthritis, and also provide grounds for further study of the pathogenetic mechanisms of cytokine-dependent inflammation in this disease.

Distinct long-term disease activity trajectories differentiate early on treatment with etanercept in both rheumatoid arthritis and spondylarthritis patients: a prospective cohort study

To characterize disease activity trajectories and compare long-term drug retention between rheumatoid (RA) and spondylarthritis (SpA) patients initiating tumor necrosis factor inhibitor (TNFi) treatment (etanercept). Prospective observational study of RA, axial (AxSpA) and peripheral SpA (PerSpA) patients initiating etanercept during 2004–2020. Kaplan–Meier plots were used for drug retention comparisons and multivariable Cox regression models for predictors of discontinuation. Long-term disease activity trajectories were identified by latent class growth models using DAS28-ESR or ASDAS-CRP as outcome for RA and AxSpA respectively. We assessed 711 patients (450 RA, 178 AxSpA and 83 PerSpA) with a median (IQR) follow-up of 12 (5–32) months. At 5 years, 22%, 30% and 21% of RA, AxSpA and PerSpA patients, respectively, remained on therapy. Etanercept discontinuation was independent of the diagnosis and was predicted by gender and obesity in both RA and SpA groups. Four disease activity (DA) trajectories were identified from 6th month of treatment in both RA and AxSpA. RA patients in remission-low DA groups (33.7%) were younger, had shorter disease duration, fewer comorbidities and lower baseline disease activity compared to moderate (40.6%) & high DA (25.7%) groups. In AxSpA 74% were in inactive-low DA and they were more often males, non-obese and had lower number of comorbidities compared to higher ASDAS-CRP trajectories. In RA and AxSpA patients, disease activity trajectories revealed heterogeneity of TNFi treatment responses and prognosis. Male gender, lower baseline disease activity and fewer comorbidities, characterize a favourable outcome in terms of disease burden accrual and TNFi survival.

Frequency of H-Pylori Infection in Immune Thrombocytopenic Purpura

Objective: To determine the frequency of Helicobacter pylori infection in patients with Immune Thrombocytopenia (ITP) and the impact of eradication therapy on platelet counts. Study design & Setting: It was a cross-sectional study conducted at National institute of blood disease and bone marrow transplant (NIBD) hospital, Karachi, Pakistan from January 2021 to September 2022. Methodology: Adults between 18 to 70 years of either gender with thrombocytopenia (platelet count less than 100x109/L) with or without bleeding manifestation from last six months were recruited. The immunoassay was used for stool sample to detect H. pylori antigen, eradication therapy was administered and platelet counts were evaluated at 3rd and 6th month of treatment. Results: Of 120 patients with ITP, the mean age was 36.67±15.32 years, and 76.7% were female. 35.83% had H. pylori positive. The eradication treatment on platelet counts was statistically significant (p=0.001). Median platelet counts at baseline, 3 months and 6 months were 43.50(23.00- 77.00), 136.50 (57.00- 237.00), and 192.00 (130.50-275.50) patients respectively. Platelet counts were statistically different between baseline with three and six months (p=0.007 and p=0.001, respectively). Conclusion: People with ITP frequently have H. pylori infections, and eradication treatment could contribute to the increase in platelet count.

Effect of Baduanjin exercise on primary osteoporosis: study protocol for randomized controlled trial

BackgroundLack of exercise is often a major cause of chronic disease. Osteoporosis (OP) is a chronic disease with multifactorial co-morbidity. Baduanjin (BDJ) exercise may be a powerful tool for modifying risk factors. The aim is to provide more evidence about the effectiveness of BDJ exercise in improving pain and balance ability in patients with OP.MethodsIn the prospective randomized controlled trial, 160 participants will be recruited and randomized to the treatment group (BDJ exercise combined with Calcium carbonate and D3) or the control group (Calcium carbonate and D3) at 1:1 ratio. Participants in the treatment group will receive 24-week BDJ exercise for 30–60 min, 3 times a week, along with Calcium carbonate and D3 at each day, while participants in the control group will receive Calcium carbonate and D3 only. All outcome indicators will be measured at baseline, after the 6th month of treatment and 6th month after the end of treatment. The primary outcomes include pain and balance ability, as measured by the visual analogue scale (VAS) and Berg balance scale (BBS). The secondary outcomes will primarily include bone mineral density (BMD), laboratory tests (including P1NP, β-CTX, MSTN, FDF-23, NPY), the timed “up and go” (TUG) test, the morse fall scale (MFS), the five-times sit-to-stand test (FTSST).DiscussionThe study will hopefully confirm that BDJ exercise, as a non-drug intervention, should be recommended for patients with OP to prevent bone loss, falls and fractures.Trial registrationInternational standard randomized controlled trial number (ISRCTN) registry: ISRCTN76945140 registered on 07/06/2022.

Are the Goals of Therapy Achievable in Patients with Rheumatoid Arthritis Receiving Upadacitinib in Real Clinical Practice?

The aim of the study was to evaluate the effectiveness of UPA in RA patients in real clinical practice after 3 and 6 months of therapy. The study included 63 RA patients with high activity of the disease. Activity was assessed according to the DAS28(ESR), DAS28(CRP), SDAI, CDAI; functional ability to HAQ; quality of life to the EQ-5D; disease activity according to the patient’s RAPID-3 index; the level of depression and anxiety to the HADS scale. The effectiveness of therapy was evaluated after 3 (n = 45) and 6 (n = 31) months of UPA therapy. Remission or low activity of the disease by 3 months of therapy was achieved by most patients: remission of 69.8% of patients, low activity of the disease—16.3% of patients. Moderate or high activity persisted in 13.9% of patients. By the 6th month of UPA therapy, the number of remissions reached 90%, low activity 3.3%, moderate activity persisted in 6.7% of patients, high activity of the disease was not in any patient. 20% improvement in function was achieved in 71.8% of patients by the 3rd month of therapy and in 77.8% by the 6th month of treatment; the difference in average HAQ values by the 3rd month of therapy was 0.38 points, by the 6th month—0.58 points. After 3 months of follow—up, 31.1% of patients continued taking GC, by 6 months—24.2%. The dose of GC was reduced from an average of 7.23 to 5.6 mg/s. The percentage of patients requiring NSAIDs decreased from 95.2 to 35.6% and 33.3%, respectively. DMARDs continued to be received by 75.6% of patients by 3 months and 69.7% by 6 months of follow-up. Achieving remission or low activity of the disease in patients with RA receiving UPA in real clinical practice is possible in most patients. A rapid decrease in inflammatory activity is accompanied by a significant improvement in the functional state and quality of life of patients. UPA therapy reduces the need for the use of NSAIDs and reduces the dose of GC in a third of patients.

Epidemiological and clinical aspects of sporotrichosis in patients seen at a reference hospital in Madagascar.

Sporotrichosis is a subacute to chronic fungal infection of skin and subcutaneous tissues, caused by dimorphic fungi belonging to the genus Sporothrix, commonly seen in tropical and subtropical regions like Madagascar. This study describes the epidemiological, clinical, and the treatment outcomes with itraconazole for sporotrichosis. A descriptive retrospective study on patients suffering from sporotrichosis, from March 2013 to January 2019, was conducted, in the reference center for endemic mycoses. Patients with sporotrichosis who received itraconazole for at least 3 months were included in the study. Patients received itraconazole 200 mg daily for 3 to 6 months. Therapeutic responses were evaluated at months 3 and 6 after treatment. Outcomes were classified as minor response, major response, cure, and failure. Forty-three cases of sporotrichosis were included. The median age of patients was 40 years. Most of them (62.8%) were rural workers. Men were more frequently infected (72%). At the end of 6th month of treatment, 20 patients (46.5%) were cured and a major response to itraconazole was observed in 8 patients (18.6%). The cure rate was higher in 12 patients (27.9%) who had disease durations of less than to one year than in those who had more time of disease (18.6%) (p = 0.01). Thirteen patients (30.2%) were lost to follow up. The rate of lost to follow-up was also higher (39.5%) in patients who had sporotrichosis of less than to one year than in those who had more time of disease. The cure rate found in this study was inferior to that reported in the literature. However, it was higher in patients with early symptomatology.

A Retrospective Follow-Up Study To Show The Effectiveness Of Booster Dose Of Foam Sclerotherapy Session At 3rd And 6th Months In Preventing The Recurrence Of Varicose Veins.

Injection sclerotherapy administration is known to cause a decreased recurrence of varicose vein disease. This research aimed to investigate the recurrence of varicose vein disease after giving booster doses of injection sclerotherapy. The booster doses were given at 3rd and 6th months. One hundred and fifty patients participated and all patient's included ages 30-70 in the category of 'low risk' patients. The patients were both males and females. Patients participating in the study were counselled appropriately and written consent was taken from them. Moreover, the patients selected were volunteers and agreed to be part of the study. Patients who were above 70 years of age, those who were at a high-risk due to some co-morbidities (high-risk patients), patients not willing to be part of the study, those allergic to drugs being used including sclerosant and people with any known psychiatric illness or cardiac arrhythmias, deep venous thrombosis patients, patients having arteriovenous malformation/venous ulcers were all excluded. If the patient was pregnant, the gynaecology team was taken on board and the procedure was carried out. Every procedure was carried out under the direct supervision of the supervisor. Booster dose sessions of Foam Sclerotherapy were held at 3rd and 6th months of the study time. Their effectiveness was observed and documentation was carried out. Since it was a procedure that could be done in the OPD, there was no need for specialized anaesthesia care. It is of significant notice that when a patient of varicose veins was given a booster intravenous sclerosant injection at 3rd and 6th month of treatment, chances of recurrence decreased to 50%.

Investigation the impact of liraglutide on the thyroid function tests

Aim: Liraglutide is a once-daily glucagon-like peptide-1 receptor agonist (GLP‑1 RA) which is an incretin hormone secreted from intestinal L cells in response to nutritional intake and stimulates glucose-dependent insulin secretion, decreases hepatic glucagon secretion, slows gastric emptying, provides a feeling of satiety and is the first GLP‑1 RA to be indicated for weight loss treatment for obesity. The impact of liraglutide on thyroid function tests is unknown and to the best of our knowledge, there are no studies on this regard. Our aim is to compare thyroid function tests, other biochemical and hemogram parameters before and 6 months after liraglutide treatment.
 Material and Methods: The patients, 18-65 years old, who used liraglutide for at least 6 months due to obesity treatment between January 2021 and January 2023 in Burdur State Hospital were included.
 Results: There were 51 patients (39 female, 12 male) using liraglutide without thyroid disease during the study period. Twelve patients discontinued liraglutide use before the 6th month of treatment was completed. Weight, body mass index (BMI), fasting plasma glucose (FPG), hemoglobin A1C (HbA1c), low-density lipoprotein (LDL), triglyceride and thyroid-stimulating hormone (TSH) values were significantly lower at the 6th month of treatment. Free thyroxine (FT4) and free triiodothyronine (FT3) values were similar. and there was no difference other biochemical and hemogram parameters between before and 6 months after treatment
 Conclusion: We found a significant decrease in TSH values and improvement in metabolic parameters, but no change in thyroid hormone levels.

Real-world efficacy and safety of vedolizumab in managing ulcerative colitis versus Crohn’s disease: results from an Italian multicenter study

ABSTRACT Background Vedolizumab (VDZ) can be used to treat refractory ulcerative colitis (UC) and Crohn’s disease (CD). We assessed whether there are differences in treating UC vs CD with VDZ. Research design and methods Mayo score in UC and the Harvey-Bradshaw Index (HBI) in CD scored the clinical activity. Achievement and maintenance of clinical remission during the follow-up, and safety were the primary endpoints. Results 729 patients (475 with UC and 254 with CD), median follow-up of 18 (IQR 6-36) months, were enrolled. Clinical remission at the 6th month of treatment was achieved in 488 (66.9%) patients (74.4% in CD vs 62.9% in UC, p<0.002) while, during the follow-up, no difference was found (81.5% in the UC group and 81.5% pts in the CD group; p=0.537). The clinical remission at the 6th month of treatment (p=0.001) and being naïve to biologics (p<0.0001) were significantly associated with prolonged clinical remission. The clinical response was significantly higher in UC (90.1%) vs CD (84.3%) (p=0.023), and surgery occurred more frequently in CD (1.9% in UC vs 5.1% in CD, p=0.016). Conclusion We found differences when using VDZ in UC vs CD in real life. These parameters can help the physician predict this drug’s longterm efficacy.