Comparative Study Of Efficacy Research Articles

Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments.

The Japanese biosimilar guideline requires that the sponsors conduct clinical studies such as comparative pharmacokinetic (PK), pharmacodynamic (PD), or efficacy studies. In each biosimilar development, the sponsors consider the clinical data package, and thus clinical data packages vary among biosimilar developments. The aim of this study was to elucidate the clinical data packages for the biosimilars approved in Japan. The details of clinical data packages and sample size for the regulatory approvals of biosimilars in Japan was reported. We surveyed the clinical data packages and sample size based on the Pharmaceuticals and Medical Devices Agency (PMDA) website review reports between 2009 and 2023. Twenty-four biosimilars have been approved based on the comparative PK and efficacy studies, 10 biosimilars have been approved based on the comparative PK/PD study, and one biosimilar has been approved based on the comparative efficacy study. Regarding the sample size, comparative PK studies were conducted in healthy volunteers or patients for up to 300 cases, although the majority enrolled only 1-100 cases (68.1%, 32/47). Comparative PD studies enrolling 1-30, 31-60, and 61-90 cases totaled 4, 7, and 4 cases, respectively. Finally, comparative efficacy studies enrolling 1-300, 301-600, and 601-900 totaled 6, 10, and 11 cases, respectively. In particular, the oncology and rheumatology areas were the first and second disease areas recruiting 601-900 patients. Large numbers of patients were enrolled to conduct a comparative efficacy study. Efficient biosimilar development should be considered on the basis of the accumulation of scientific understanding of comparable features of biosimilars and their development.

Comparative study of the bronchodilator efficacy and adverse effects of salbutamol and hyoscine butylbromide in horses with severe asthma.

Salbutamol and hyoscine butylbromide (HBB) are commonly used bronchodilators in horses with severe asthma (SA). To compare the bronchodilation potency, duration, and adverse effects of salbutamol and HBB in SA. Six horses in exacerbation of SA. The effects of inhaled salbutamol (1000 μg) and HBB (150 mg, IV) were compared in a randomized, blinded, crossover experiment. Lung function, intestinal borborygmi and heart rate were assessed before and sequentially until 180 minutes after drug administration, and analyzed with 2-way repeated-measures ANOVA and Dunnett's multiple comparison tests. Both treatments caused a similar improvement in lung function. Pulmonary resistance and reactance returned to baseline values within 30 minutes after HBB administration, whereas salbutamol improved reactance until 180 minutes (mean improvement at 180 minutes of 0.040 Kpa/L/s, 95% CI = 0.004 to 0.076; P = .02 for salbutamol and of 0.009 Kpa/L/s, 95% CI = -0.028 to 0.045; P = .98 for HBB for the resistance at 3 Hz and of 0.040 Kpa/L/s, 95% CI = 0.007 to 0.074; P = .01 for salbutamol and of 0.009 Kpa/L/s, 95% CI = -0.024 to 0.042; P = .97 for HBB for the reactance at 7 Hz). From 5 to 30 minutes after HBB administration, the heart rate accelerated (mean increase of 3.3 beats per minute, 95% CI = -6.6 to 13.1; P = .92 for salbutamol, and of 13.0 beats per minute, 95% CI = 3.6 to 22.4; P = .002 for HBB at 30 minutes) and the gut sounds decreased (mean reduction of 1.3, 95% CI = -0.1 to 2.8; P = .09 for salbutamol and of 2.8 for the gastrointestinal auscultation score, 95% CI = 1.4 to 4.3; P < .0001 for HBB at 30 minutes). Both drugs have a similar bronchodilator potency but with a longer duration for salbutamol. Gastrointestinal and cardiovascular effects were noted only with HBB, suggesting the preferential use of salbutamol to relieve bronchoconstriction in horses with asthma.

Comparative Efficacy Study on Treatment of Synaptamide (SYN) and Its Analog, Dimethylsynaptamide (DMS) in the Reduction of Murine Experimental Allergic Encephalomyelitis (EAE) (P7-6.013)

Comparative Efficacy Study on Treatment of Synaptamide (SYN) and Its Analog, Dimethylsynaptamide (DMS) in the Reduction of Murine Experimental Allergic Encephalomyelitis (EAE) (P7-6.013)

Comparative study of treatment efficacy in severe intraepithelial squamous cell lesions and preinvasive cervical cancer by conization and chlorin e6-mediated fluorescence-assisted systemic photodynamic therapy

BackgroundCervical cancer (CC) occupies a leading position in incidence among young women of reproductive age. In this connection, it is urgent to search for the most effective approaches to the diagnosis and treatment of this pathology.The purpose of the study was to evaluate the effectiveness of the PDT method using Cе6 with the control of the photobleaching using video and spectral fluorescence diagnostic methods, to develop the method of fluorescence-assisted systemic photodynamic therapy mediated with chlorin e6 for treatment CIN 3 and CIS. Materials and methodsA randomized comparative clinical study was conducted involving 94 women aged 18 to 49 years with histologically verified severe intraepithelial squamous cell lesions of the cervix or preinvasive cervical cancer. The patients were included in 2 groups: in the first group conization of the cervix was performed with curettage of the remaining part of the cervical canal; patients in the second group underwent the chlorin e6-mediated fluorescence-assisted systemic photodynamic therapy. ResultsThe absolute majority of patients in the main group after the first course of chlorin e6-mediated fluorescence-assisted systemic photodynamic therapy showed normalization of cytological parameters and colposcopic picture, while women from the comparison group showed signs of cervical lesions statistically significantly more often. These changes corresponded to the dynamics of the proliferation markers expression in the cells of intraepithelial squamous cell lesions. Also, patients of the second group who were planning a pregnancy had better reproductive outcomes after treatment compared to those of the first group. ConclusionIn general, higher clinical efficacy and safety of the use of the chlorin e6-mediated fluorescence-assisted systemic photodynamic therapy in the treatment of intraepithelial squamous cell lesions and preinvasive cervical cancer have been established compared to the use of standard treatment methods.

A Prospective Randomised Comparative Four-arm Intervention Study of Efficacy and Safety of Saroglitazar and Vitamin E in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH)-SVIN TRIAL

Background and AimVitamin E is widely prescribed for Non-alcoholic steatohepatitis (NASH).Saroglitazar, a novel dual PPAR ɑ/γ agonist, is approved in India for Non-alcoholic fatty liver disease(NAFLD).No head-to-head comparative study for vitamin E and saroglitazar is available. We studied the efficacy and safety of saroglitazar and vitamin E in NAFLD/NASH. Materials and MethodsWe prospectively randomised 175 NAFLD patients into four arms as; Saroglitazar 4mg daily alone (n=44),vitamin E 800IU daily alone (n=41), vitamin E and saroglitazar combination(n=47) and control arm (n=43). All the baseline variables including Liver stiffness measurement (LSM) and Controlled attenuation parameter (CAP) were recorded.Reassessment was done after 24 weeks of treatment. ResultsThe mean age and BMI was 45±11 years and 26±3.6 kg/m2 respectively. Compared to control, the decrease in ALT levels with saroglitazar, vitamin E and combination therapy was significant (95% CI, 6.27-28.25,p=0.002, 95% CI, -3.39-18.88, p=0.047 and 95% CI 8.10-29.54,p=0.001 respectively).The reduction in CAP was significant with saroglitazar and combination therapy (95% CI, -31.94-11.99,p=0.015 and 95% CI, -10.48-30.51,p=0.026 respectively).Only combination therapy shows significant reduction in LSM (95% CI, 0.41-1.68,p=0.001).Among glycaemic parameters, both saroglitazar alone and combination therapy significantly improved HBA1C levels (P=0.001 and P=0.015) and only combination therapy significantly improved HOMA-IR (P=0.047).Saroglitazar alone showed significant reduction in TG and LDL levels (P=0.038 and P=0.018), and combination therapy showed significant increase in HDL levels (P=0.024). ConclusionsCombination of Saroglitazar and vitamin E showed statistically significant reduction of LSM and CAP along with biochemical, glycaemic and lipid parameters. Clinical Trial Registry India no(CTRI/2022/01/039538).

A comparative study of efficacy and safety of drugs in stage I hypertensive patients attending cardiac OPD at tertiary care hospital

To study the efficacy and safety profile of Azilsartan 40 mg and Olmesartan 40 mg in stage I systemic Hypertension among patients attending cardiac OPD in a tertiary care center. All patients with stage I systemic hypertension of either sex, aged 20-65 years, with blood pressures of &gt;140/90 mmHg or diabetes mellitus attending the cardiac outpatient. After initial screening, diagnosed cases of essential hypertension were randomly allocated to either group 1 (Tablet Azilsartan 40 mg or group 2 (Tablet Olmesartan 40 mg). The patients were advised to report for follow-up for review on the 4th, 8th, 12th, and 24th week.The mean decrease in the systolic blood pressure in both groups was statistically significant with a P value of &lt;0.0000001. Both drugs controlled blood pressure at similar proportions. However, the mean of SBP and DBP for the Azilsartan group was lower than the Olmesartan Group. Both drugs were tolerated well, and no significant adverse effects were noted during the study.

Comparative Clinical Study of Efficacy of Seethodaka Oil and Dashanga Lepa in the Management of Chronic Ulcers

Comparative Clinical Study of Efficacy of Seethodaka Oil and Dashanga Lepa in the Management of Chronic Ulcers

A comparative study of efficacy and safety in stage I hypertensive patients visiting the cardiac OPD at a tertiary care hospital

To investigate the efficacy and safety of Azilsartan 40 mg and Olmesartan 40 mg in patients with stage I systemic hypertension undergoing cardiac OPD at a tertiary care facility. A 6-month open-label comparison study was undertaken in the Department of Cardiology at Acsr Government Medical College and Hospital. All patients visiting the cardiac outpatient clinic at Acsr Government Medical College who have stage I systemic hypertension of any sex, aged 20-65, with blood pressures &gt;140/90 mmHg, or glucose intolerance. Diagnoses for essential hypertension were made, and patients were randomised to receive either group 1 (40 mg of Azilsartan) or group 2 (40 mg of Olmesartan) after the initial screening. The individuals receiving care were instructed to come back for a fourth, eighth, twelveth, as well as twenty-fourth weeks. Both groups showed a statistically significant drop in systolic blood pressure (P value &lt; 0.0000001). Both medicines regulated blood pressure in similar ways. However, the Azilsartan group had a lower mean SBP and DBP than the Olmesartan group. Both medicines were well tolerated, and no severe side effects were observed throughout the research.

A Comparative Study of Postoperative Analgesic Efficacy of Suprainguinal versus Infrainguinal Approach of Ultrasound-guided Fascia Iliaca Compartment Block using 0.2% Ropivacaine in Patients Undergoing Surgery for Hip Fracture under Spinal Anesthesia

Abstract Context: Fascia iliaca compartment block (FICB) is a useful modality to provide postoperative analgesia in patients with hip fracture undergoing surgery. Aims: The aims of this study were to compare the analgesic efficacy of suprainguinal versus infrainguinal approach of ultrasound-guided FICB using 0.2% ropivacaine in patients undergoing surgery for hip fracture under spinal anesthesia. Settings and Design: It was a prospective, randomized, controlled study. Subject and Methods: Group A (n = 25) received ultrasound-guided FICB by suprainguinal approach and Group B (n = 25) received ultrasound-guided FICB by infrainguinal approach. The primary objective was to compare 24-h postoperative analgesic efficacy using Numeric Rating Scale (NRS) score. Statistical Analysis: For data analysis, t-test, Mann–Whitney test, and Chi-square test were applied. Results: NRS score after 30 min of FICB in Group A was 2.36 ± 1.11 which was lower in comparison to 3.28 ± 0.94 in Group B (P = 0.002). NRS score during positioning in Group A was 2.16 ± 0.90, which was lower than Group B 3.08 ± 0.81 (P = 0. 0004). Greater block coverage was achieved in obturator nerve distribution in Group A 0.76 ± 0.52 compared to 0.16 ± 0.37 in Group B (P &lt; 0.001). The total duration of analgesia was 493.40 ± 214.83 min, which was more in Group A than in Group B 367.48 ± 63.92 min (P = 0.007). Quality of recovery (QoR) score out of 150 in Group A was 120.60 ± 8.91 compared to 110.40 ± 7.59 in Group B (P &lt; 0.001). Conclusion: FICB by suprainguinal approach provides better analgesia, sensory block coverage, and conditions for positioning for spinal anesthesia and also has a higher time to first rescue analgesic requirement with better QoR compared to infrainguinal approach.

Comparative pharmacogenetic study of disulfiram or cyanamide efficacy for alcohol dependence: the key role of dopamine neurotransmission gene polymorphisms

The actual direction of increasing the efficacy of alcohol dependence (AD) treatment is the search for opportunities for individualization of therapy using pharmacogenetic markers to stratify patients in order to select the most optimal therapeutic tactics.Aims. To test an associations of possible pharmacogenetic markers with indicators of the efficacy of disulfiram and cyanamide to stabilize remission in patients with AD.Materials and methods. A pharmacogenetic study was conducted on the basis of a double-blind, randomized, comparative, placebo-controlled clinical study of the efficacy and tolerability of disulfiram and cyanamide in the treatment of alcohol dependence syndrome. The main outcome: the duration of retention of patients in the treatment program (in remission), and withdrawal from the treatment program for any reason was considered a negative outcome. Secondary outcomes: time to relapse to alcohol use and time to recurrence to AD. 150 patients with AD (ICD-10 criteria) (av. age - 40.65±1.09 y.o., 19.3% females) were randomly assigned to one of three treatment groups (50 subjects in each): Disulfiram, Cyanamid and Placebo. All patients had weekly (12 weeks) visits to research clinic for brief counselling session. The genetic panel of the study consisted of 15 polymorphic loci in 9 genes: dopamine receptors 2 (DRD2) and 4 (DRD4) types, transmembrane dopamine transporter (DAT), enzymes dopamine-beta-hydroxylase (DBH) and catechol-ortho-methyl-transferase, as well as a two polymorphisms in the genes of the endogenous opioid system and the aldehyde dehydrogenase enzyme gene cluster.Results. For disulfiram, the DBH rs1108580 is associated with a longer remission (p=0.053, trend), and DRD4 VNTR 48 bp is associated with a shorter remission (p=0.006). For cyanamide, DAT VNTR 40 bp was associated with shorter remission (p=0.006) and rapid recurrence to AD (p=0.045). DAT rs27072 has an effect simultaneously in two treatment groups, while the direction of the effect is opposite. For cyanamide, the marker is slightly associated with a longer remission (p = 0.082, trend), a longer time to relapse (p = 0.063, trend) and a longer time to recurrence to AD (p = 0.083, trend). For placebo, DAT rs27072, on the contrary, is associated with a shorter time to to recurrence to AD (p = 0.066, trend). For placebo, DRD2 rs1799732 was associated with a shorter remission (p = 0.001), a shorter time to relapse (p = 0.018), and a shorter time to recurrence to AD (p = 0.001).Conclusion. Preliminary pharmacogenetic markers of the efficacy of alcohol dependence treatment have been identified in genes that control dopaminergic neurotransmission. After independent validation, the obtained genetic markers may be used for pharmacogenetic stratification of patients in order to select the optimal treatment options for alcohol dependence.

Comparative Study of the Short-Term Efficacy and Safety between DEB-TACE and C-TACE in the Treatment of Unresectable Hepatocellular Carcinoma, a Retrospective Study.

Background: This is a retrospective study aimed at comparing the clinical efficacy and safety between drug-eluting bead transcatheter arterial chemoembolization (DEB-TACE) and conventional TACE (C-TACE) in the treatment of unresectable hepatocellular carcinoma. Methods: From July 2019 to April 2021, we enrolled 282 patients with unresectable hepatocellular carcinoma who were admitted to our hospital, of which 179 and 103 were in the DEB-TACE and C-TACE groups, respectively. General information was collected, and treatment effects were evaluated following the modified Response Evaluation Criteria in Solid Tumors. To compare the indexes of liver and kidney function, routine blood and coagulation were collected before treatment, and 1 day, 1 month, 3 months, and 6 months postoperatively. Postoperative adverse reactions (ie, fever, nausea, vomiting, anorexia, abdominal pain) were recorded to evaluate the safety of treatment. The two groups' progression-free survival and overall survival were also calculated to assess the treatment effect. Results: Preoperatively, the bilirubin, transaminase, and absolute neutrophil values between the two groups were not statistically significant (P > .05). At 1 month postoperatively, the absolute neutrophil values were significantly higher in the DEB-TACE group than those in the C-TACE group (P < .05). At 3 months postoperatively, AST, total bilirubin, and direct bilirubin levels were significantly elevated in the DEB-TACE group (P < .05), compared with the C-TACE group. However, at 6 months postoperatively, total and direct bilirubin levels in the C-TACE group were higher than those in the DEB-TACE group, showing a statistically significant difference (P < .05). For patients undergoing DEB-TACE, the survival risk was lower compared to those undergoing C-TACE. The survival risk of patients undergoing DEB-TACE was lower than that of C-TACE within 20 months postoperatively. The survival risk of patients undergoing DEB-TACE was lower than that of patients undergoing C-TACE. Conclusion: DEB-TACE may be superior to C-TACE in terms of safety and efficacy in the treatment of unresectable hepatocellular carcinoma.

A Comparative Study of Occupational Stress, Coping Style, Self Efficacy and Life Satisfaction among Public and Private Sector Employees

The present study intended to compare occupational stress , coping style, self efficacy, life satisfaction among Public and private sector and to study the interrelationship among these variables for each sectors. This sample consisted of 100 individuals, 50 public sector employees and 50 private sector employees between the age group 35-50 years. A detailed information schedule, a occupational stress index scale by Srivastava and Singh(1984), Brief-Cope Questionnaire by Carver, C.S(1997), General self efficacy scale by Schwarzer, R et al(1995), Satisfaction with life scale by Diener, E, Emmons et al(1985) were administered on the subjects individually. Data were quantitatively analyzed by doing Independent t-test and Pearson’s Product moment correlation. The result signifies that there is significant difference between the two employee groups in terms of occupational stress, self efficacy and life satisfaction and in case of coping styles, the two groups only differ in terms of avoidance coping style

Comparison of atezolizumab plus bevacizumab and lenvatinib for hepatocellular carcinoma with portal vein tumor thrombosis.

Atezolizumab plus bevacizumab and lenvatinib are currently available as first-line therapy for the treatment of unresectable hepatocellular carcinoma (HCC). However, comparative efficacy studies are still limited. This study aimed to investigate the effectiveness of these treatments in HCC patients with portal vein tumor thrombosis (PVTT). We retrospectively included patients who received either atezolizumab plus bevacizumab or lenvatinib as first-line systemic therapy for HCC with PVTT. Primary endpoint was overall survival (OS), and secondary endpoints included progressionfree survival (PFS) and disease control rate (DCR) determined by response evaluation criteria in solid tumors, version 1.1. A total of 52 patients were included: 30 received atezolizumab plus bevacizumab and 22 received lenvatinib. The median follow-up duration was 6.4 months (interquartile range, 3.9-9.8). The median OS was 10.8 months (95% confidence interval [CI], 5.7 to not estimated) with atezolizumab plus bevacizumab and 5.8 months (95% CI, 4.8 to not estimated) with lenvatinib (P=0.26 by log-rank test). There was no statistically significant difference in OS (adjusted hazard ratio [aHR], 0.71; 95% CI, 0.34-1.49; P=0.37). The median PFS was similar (P=0.63 by log-rank test), with 4.1 months (95% CI, 3.3-7.7) for atezolizumab plus bevacizumab and 4.3 months (95% CI, 2.6-5.8) for lenvatinib (aHR, 0.93; 95% CI, 0.51-1.69; P=0.80). HRs were similar after inverse probability treatment weighting. The DCRs were 23.3% and 18.2% in patients receiving atezolizumab plus bevacizumab and lenvatinib, respectively (P=0.74). The effectiveness of atezolizumab plus bevacizumab and lenvatinib was comparable for the treatment of HCC with PVTT.

Flow diverter stents for endovascular treatment of aneurysms: a comparative study of efficacy and safety between FREDX and FRED.

The FRED X flow diverter (FREDX), as the second generation in the FRED series, aims to improve the treatment of cerebral aneurysms. This study compares the efficacy and safety of FREDX with its predecessor, FRED. This prospective registry included patients treated with FRED and FREDX devices. Efficacy was assessed using digital subtraction angiography with 3D volumetric reconstruction at immediate and 1 year follow-ups. Safety was evaluated by recording complications, analyzed through univariate contrasts, generalized mixed models, and Bayesian network analyses. We treated 287 patients with 385 aneurysms, with 77.9% receiving FRED and 22.1% FREDX. The median age was 55 years (IQR 47-65) and 78.4% were women. The FREDX group showed a higher prevalence of saccular-like aneurysms (70.6% vs 52.7%, P=0.012) and a higher rate of complete occlusion compared with FRED interventions (79.4% vs 59.3%, P=0.022). After adjusting for confounders, these differences represented a 3.04-fold increased likelihood (95% CI 1.44 to 6.41, P=0.003) of achieving complete occlusion at 1 year with FREDX interventions. Regarding safety, two (3.5%) complications (both non-symptomatic) were observed in the FREDX group and 23 (10.4%) in the FRED group (P=0.166). Bayesian network analysis suggested a trend towards fewer complications for FREDX, with a median reduction of 5.5% in the posterior distribution of the prevalence of complications compared with FRED interventions. The FREDX device shows improved complete occlusion rates at 1 year compared with the FRED device while maintaining a favourable safety profile, indicating its potential advantage in the treatment of cerebral aneurysms.

Pain management after total hip arthroplasty: comparative study of analgesic efficacy and tolerability between oral tramadol/dexketoprofen and injectable paracetamol + tramadol.

Multimodal analgesia for total hip arthroplasty (THA) is increasingly employed to reduce early postoperative pain and promote fast patient discharge. The aim of this study was to compare the efficacy and tolerability of tramadol/dexketoprofen (TRAM/DKP, Group A) versus paracetamol + tramadol (PARA+TRAM, Group B) in patients undergoing THA using minimally invasive direct anterior approach (DAA). A single-centre, randomised, single-blind, parallel, interventional study conducted in 323 patients undergoing primary THA with DAA was performed. Group A consisted of 188 patients and Group B of 135. The primary endpoints were the change from baseline (measured 2 hours postoperatively) in pain intensity (PI) during the treatment period (48 hours), assessed by visual analogue scale (VAS) at pre-specified postoperative time-points (2, 8, 24, 48 hours) and the total rescue medication (RM) use during the first 24 hours postoperatively. As early as 2 hours after baseline, Group A showed a greater PI reduction from baseline compared to Group B (-26.24% vs. -6.87%; p < 0.001). A lower mean PI (VAS) score was consistently found over the entire observation period following treatment with TRAM/DKP than with PARA+TRAM as well as more than 2-fold higher proportion of responders at the end of treatment period. More patients in Group B required RM in comparison to those in Group A (15.6% vs. 3.7%, p < 0.001). Both treatments were well tolerated. After THA, oral TRAM/DKP provides faster and greater pain relief when compared to intravenous PARA+TRAM with limited consumption of RM and favourable tolerability profile. Our study expands the use of TRAM/DKP in the setting of major orthopaedic surgeries. clinicaltrials.gov (NCT04178109).

Global research hotspots and trends in non-surgical treatment of adolescent idiopathic scoliosis over the past three decades: a bibliometric and visualization study.

In recent years, research on the non-surgical treatment of AIS has been increasingly conducted. To the best of our knowledge, this field doesn't yet have a comprehensive and structured pulse combing analysis. In order to provide inspiration and resources for subsequent researchers, we thus reviewed the literature studies on the non-surgical treatment of AIS from the previous thirty years and highlighted the hotspots and frontiers of research in this field. Main using Citespace 6.1 software, the data from the core dataset of the WOS database pertaining to the non-surgical management of AIS from 1990 to 2022 was gathered, displayed, and analyzed. 839 papers in all were included in the literature. With 215 papers, the USA came in first place. Chinese Univ Hong Kong ranked first with 32 papers. Research hotspots are adolescent idiopathic spondylitis, Schroth-based physiotherapy-specific exercise efficacy, curve development, Cobb angle, TLSO brace-based clinical efficacy, quality of life, reliability, health-related quality of life questionnaires, finite element biomechanical models, follow-up, and clinical guidelines. There aren't many studies that compare the clinical effectiveness of various non-surgical treatments, and because of variations in inclusion eligibility standards and outcome measures, these studies cannot be directly compared. In addition, the inconsistency of existing growth potential and progression risk assessment systems further affects comparative studies of clinical efficacy; it is recommended to establish primary assessment indicators centered on patient treatment outcomes (including appearance, disability, pain, and quality of life), as well as standardized scoliosis progression risk assessment criteria.

Comparative Study of Efficacy of Corticosteroid Versus Analogues PRP in Chronic Plantar Fasciitis in Andhra Pradesh Population

Background: Plantar fasciitis is a common pathological condition of the foot and can be a challenge for cliniciansto treat successfully.Method: Out of 60 patients 30 patients were injected corticosteroid 2ml (8 mg) along with 0.5ml of plain 2% xylocaineusing 20G wide bore needle. PRP (platelet rich plasma) was prepared from the autologous blood, drawnfromcubital vein three BD vacutainer tubes which is 2.7 ml tube that contains 0.35 ml of 3.2% of sodium citrate as an anticoagulant. Blood was centrifuged twice, first time at 1200/rpm, second time 2400 rpm. The platelets were checkedrandomly by pathologist by Neubauer’s chamber method or auto analyser. PRP was injected at tenderness site,after injecting 2% of xylocaine with 20 Gauze needle and follow-up was done for a week, 6th week, 3rd month and6thmonths and outcomes of results were noted.Results: Clinical manifestations were VAS Baseline score – 7.137 in PRP group, 7.214 was in steroid group. Baselineof AOFAS was 53 (SD±5.12) in PRP group, 54.6 (SD±3.30) in steroid group. VAS score at 6th week was 2.62 in PRPgroup, 1.94 in steroid, at 3rd month 1.94 in PRP, 2.89 in steroid group, at 6th month 1.42 in PRP and 3.79 in steroidgroup. AOFAS scores was highly significant (p&lt;0.001) at 6th weeks, 3rd months and 6th months.Conclusion: Corticosteroid therapy is more effective for short duration relief but PRP therapy is more effectivefor long term relief.

A comparative study of efficacy and safety of glimepiride versus gliclazide as an add on to metformin in Type 2 diabetes mellitus at a tertiary care hospital

Background: Type 2 diabetes mellitus (T2DM) is a chronic disorder with progressive pancreatic β-cell dysfunction and insulin resistance. Hyperglycemia associated with uncontrolled T2DM leads to various diabetes-related complications. Although metformin is the most preferred first-line drug, 5–10% of patients per year subsequently fail to achieve target HbA1c levels, subsequently requiring combination therapy. While efficacy and cost favor the use of sulfonylureas, hypoglycemic episodes limit its use. Newer generation sulfonylureas such as glimepiride and gliclazide are presumed to have lower incidence of hypoglycemia. Aims and Objectives: The aim of the study was to assess the efficacy and safety of glimepiride versus gliclazide as an add-on to metformin in T2DM. Materials and Methods: A total of 60 patients with T2DM (HbA1c 7.0–10.0%, on metformin monotherapy) were recruited and randomized into two groups of 30 cases each. Group A received glimepiride 2 mg as add-on to metformin 1500 mg and Group B received gliclazide 80 mg as add-on to metformin 1500 mg. HbA1c, lipid profile, body mass index, and total blood count were assessed at baseline and at the end 12 weeks of treatment. Fasting blood sugar (FBS) and post prandial blood sugar (PPBS) were assessed at the end of 4, 8, and 12 weeks and adverse events were assessed throughout the study period. Results: There was a significant decrease in HbA1c, FBS, and PPBS scores from baseline to the end of 12 weeks in both groups (P &lt; 0.001), but the difference was not statistically significant between the two groups (P &gt; 0.05). A significant decrease in lipid levels was observed in both groups except for high-density lipoprotein, low-density lipoprotein in the metformin + gliclazide group. The treatment was well tolerated in both groups, with the most common adverse events being nausea, diarrhea, and epigastric pain. Conclusion: Glimepiride and gliclazide are both equally effective as an add-on to metformin in improving glycaemic indices and are well tolerated in the management of uncontrolled T2DM.

Multi-center open comparative randomized study of efficacy and safety of Akatinol Memantine 20 mg (single-doses) vs Akatinol Memantine 10 mg (double-doses) in patients with vascular dementia

Evaluation of the efficacy and safety of the drug Acatinol Memantine, 20 mg (once daily) in comparison with the drug Acatinol Memantine, 10 mg (twice daily) in patients with moderate to moderate severe vascular dementia. The study included 130 patients aged 50-85 years of both sexes with instrumentally and clinically confirmed vascular dementia. The patients were randomized into 2 groups. Group I consisted of 65 patients receiving Akatinol Memantine, 20 mg once daily, group II - 65 patients receiving Akatinol Memantine, 10 mg twice daily for 24 weeks. Clinical, parametric and statistical research methods were used. The Alzheimer's disease assessment scale, the cognitive subscale (ADAS-cog), the short mental Status Assessment Scale (MMSE) and the general clinical impression scale for patients condition and illness severity (CGI-C and CGI-S) and the Hamilton Depression Rating scale (HAM-D) were used. Adverse events were collected and analyzed. At week 24, both groups showed statistically significant positive change in ADAS-cog total score: in group I the total score was 27.2±8.76 points (absolute difference from baseline 3.5 points; p<0.01), and in group II - 26.1±7.86 points (absolute difference from baseline 2.5 points; p<0.01) with no statistically significant differences between groups. Evaluation of secondary efficacy criteria (change in ADAS-cog total score at week 12 and MMSE at weeks 4, 12, and 24) also revealed statistically significant benefit in both groups compared to baseline with no significant differences between groups. Statistically significant improvement was noticed on CGI-S and CGI-C scales in both groups. Akatinol Memantine was safe and well tolerated in both groups. The study showed no lesser efficacy and safety of Akatinol Memantine, 20 mg (once daily) compared to Akatinol Memantine, 10 mg (twice daily) in patients with moderate and moderately severe vascular dementia.

A prospective comparative study of efficacy and safety of 15% trichloroacetic acid peel, 35% glycolic acid peel and Q-switched Nd-YAG laser in patients of macular amyloidosis.

The unappealing appearance of skin in macular amyloidosis (MA) interferes with the patient's quality of life, and treating the condition has been challenging. To compare the efficacy and safety of 15% trichloroacetic acid (TCA) peel, 35% glycolic acid (GA) peel, and Q-switched Nd-YAG Laser in MA. Open, prospective study was conducted over 2 years, where after fulfilling the criteria, randomization was done into three groups. Group A: 15% TCA peel; Group B: 35% GA peel; Group C: Q-switched Nd-YAG Laser. Procedures were repeated at monthly intervals for six sittings. On each visit, patients were scored on the following parameters: color score, visual analog score (VAS), physician global assessment (PGA) scale, subjective improvement, and adverse effects. A total of 75 patients (25 patients in each group) completed the treatment. The mean age of study-population was 35.68 ± 9.8 years, with female to male ratio of 11.5:1. The mean change in color score (1.68) was more by Group A, followed by Group C (1.4), followed by Group B (1.16). Similar results were noted by subjective improvement, VAS, and PGA. Adverse events were more in Group A, followed by Group C, followed by Group B. No patient showed permanent adverse events. TCA-peel showed superior results over Nd-YAG laser and glycolic-acid peel. TCA-peel being cost-effective with excellent acceptability should be considered a treatment modality.