Comparative Study Of Efficacy Research Articles

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.

Comparative study of efficacy and safety profile of topical preparations of alcaftadine 0.25% and olopatadine 0.2% eye drops in patients of allergic conjunctivitis – A prospective cohort study

Background: Allergic conjunctivitis, causing eye inflammation and redness, requires effective treatment with alcaftadine 0.25% and olopatadine 0.2% eye drops. Aims and Objectives: The aim of the study was to compare the efficacy and safety of alcaftadine and olopatadine ophthalmic medications in mild-to-moderate allergic conjunctivitis. Materials and Methods: A prospective, open-label, comparative study of 60 patients randomized into two study groups of 30 patients each. Each group was assigned to receive either olopatadine or alcaftadine ophthalmic solutions. Patients were followed through at regular intervals with a reduction of signs and symptoms documented using total ocular symptom scoring (TOSS) and hyperemia scale systems. Results: Baseline (1st visit) mean TOSS scores for the alcaftadine group and olopatadine groups were (6.12±1.92) and (6.32±1.80), respectively, as compared to the corresponding TOSS scores on 14th Day (4th visit) which were (0.5±0.11) and (0.9±0.40), respectively. The resolution of conjunctival symptoms in the alcaftadine group was significantly profoundly as comparison to olopatadine group (P = 0.004). Baseline (1st visit) mean hyperemia scores for alcaftadine group and olopatadine groups were (2.1±1.71) and (2.2±1.52), respectively, as comparison to the corresponding hyperemia scores on 14th day (4th visit) which were (0.08±0.01) and (0.6±0.32), respectively. The resolution of hyperemia symptoms in the alcaftadine group was significantly profound as compared to the olopatadine group (P = 0.002). Conclusion: Two topical medications utilized in the study were effective and safe for the therapy of allergic conjunctivitis. However, alcaftadine appears to surpass olopatadine in alleviating the symptoms of allergic conjunctivitis while having a lower side effect profile.

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.

A prospective comparative study of efficacy of intravenous magnesium sulfate infusion versus placebo, as an adjuvant to nebulized salbutamol in the management of acute exacerbations of chronic obstructive pulmonary disease

Background: Acute exacerbations of chronic obstructive pulmonary diseases (AECOPD) are a frequent cause of hospitalization, morbidity, and mortality and require serious medical attention. Much research has demonstrated the beneficial effects of intravenous and nebulized magnesium sulfate (MgSO4) as a bronchodilator, in the management of acute severe asthma. Nevertheless, the extent of the benefits of intravenous MgSO4 as an adjuvant to bronchodilators in AECOPD remains uncertain. Therefore, the current study aims to address this gap in knowledge. Aims and Objectives: The study aimed to compare the effectiveness of intravenous magnesium sulfate (MgSO4) versus placebo when used as an adjuvant to nebulized salbutamol in managing AECOPD. Materials and Methods: In this comparative prospective interventional, parallel-group, placebo-controlled study, a total of 60 subjects were assigned to two groups consisting of 30 individuals each. The allocation was non-randomized and open-label, with one group receiving intravenous MgSO4 as an adjuvant to nebulized salbutamol, while the other group received a placebo in the same manner. The evaluation of MgSO4 efficacy involved measuring the peak expiratory flow rate (PEFR), which served as the primary outcome parameter. PEFR measurements were taken at 0, 15, 30, and 45 min to assess the effectiveness of MgSO4. Safety and tolerability of MgSO4 were assessed based on changes in heart rate, blood pressure, deep tendon reflexes, and respiratory rate. Results: At 45 min, the mean change in PEFR was significantly higher (P = 0.061) in the MgSO4 group (178.33 ± 49.18) compared to the placebo group (155.43 ± 41.86). Moreover, the mean difference in PEFR between the two groups was consistently higher in the MgSO4 group at every observation. MgSO4 showed considerable safety and tolerability in subjects based on the postmedication monitoring of hypermagnesemia symptoms. Conclusion: Administering intravenous magnesium sulfate (MgSO4) as an adjuvant to bronchodilators in AECOPD led to the improvement of both clinical condition and PEFR. In AECOPD, MgSO4 exhibits enhanced early bronchodilator response when combined with other drugs, demonstrating significant efficacy, good safety, and tolerability at the prescribed dosage.

Comparative study of efficacy of fetal Admission test alone and non-stress test done antenatally with fetal Admission test to evaluate fetal outcome

Aim. Current study evaluated the efficacy of fetal admission test alone and nonstress test (NST) antenatally with fetal admission test in both low and high risk pregnant in relation to fetal outcome to decrease the fetal morbidity and mortality. Methods and material. Study included 240 pregnant women after 34 weeks of pregnancy who were categorized into low and high risk groups. The fetal outcome following Antenatal NST and Admission test studied based on Apgar score of &lt;7 at 5 minutes, Meconium stained liquor, NICU requirement, and mortality. Result. Apgar score &lt;7 at 5 min seen in 8 babies (13.33%), meconium stained liquor in 14(23.33%) and NICU admission in 11 (18.33%) cases in whom both antenatal NST and fetal admission tests were done together. Apgar score &lt;7 at 5 min seen in 14 (23.33%) babies, meconium stained liquor in 18 (30%) and NICU admission in 19 (31.66%) cases in whom only admission test was done. The Antenatal NST for antenatal fetal surveillance shows 96.88% of specificity, 29.17% of sensitivity, 70% of positive predictive value (PPV) and 84.55% of negative predictive value (NPV). The admission test for intrapartum fetal distress shows 99.38% of specificity, 32.91% sensitivity, 75.12% NPV and 96.3% PPV. Both NST and fetal admission test done together significantly decreased the incidence of fetal distress as early intervention was taken to prevent further fetal compromise in high-risk pregnant. NST strongly correlate with admission test result in high-risk pregnant. Conclusion. NST and fetal admission test in high risk pregnant helps for early detection of fetal distress and help to take necessary intervention to improve fetal outcome.

Connective Tissue Dysplasia As A Predictor Of Premature Skin Aging

Background — One of the manifestations of connective tissue dysplasia (CTD) is premature skin aging. The latter can have different etiological factors. The objective of our study was to investigate the effect of predictors of premature skin aging, especially CTD, on the severity of involutional changes in the skin, as well as to develop the approach for the management of patients with premature aging. Material and Methods — We included in our study 78 women 35-45 years of age with no substantial anti-aging treatment procedures in their anamneses. We considered genealogical and cosmetological anamneses, and life history (including somatic pathology), physical examination; determined prevailing type of facial skin aging; identified predictors of CTD, assessed psychoemotional state of the patient, and performed sonography of the skin and biochemical examination of patient serum. At a clinical stage, we conducted a randomized comparative study of biorevitalizant efficacy in patients with normal and premature patterns of skin aging. Results — Our study established the role of CTD in assessing the risk of premature skin aging. In addition to the presence of CTD, the importance of identifying isolated phenotypic manifestations of CTD (such as arachnodactyly, hypermobility syndrome, low relative weight of the patient, and skin manifestations of CTD) was shown. Other predictors were also analyzed; their identification can help assessing the risk of premature skin aging. Among them, somatic pathology (varicose veins, herniated discs, visceroptosis, autonomic vascular dystonia) and physical examination data (such as pallor of the facial skin, swelling, skin hyperelasticity) were noted. When assessing the clinical efficacy of biorevitalization, the greatest satisfaction of patients with premature skin aging regarding its results was characteristic for the group of patients after 7% collagen treatment. The clinical efficacy according to sonography and histological examination in patients with premature skin aging was significantly higher after the use of collagen or a complex hyaluronic acid (HA) preparation, compared with native HA. Patients with premature skin aging exhibited high level of anxiety and/or depression, which in turn increased the risk of underestimating the outcome of procedures. Conclusion — The presented study confirmed the role of CTD in assessing the risk of premature skin aging. Predictors were revealed (somatic pathology, type of facial aging, physical examination data of the patient, etc.) that could be used to assess the risk of premature skin aging. In patients with premature aging, preparation with native HA (as a biorevitalizant) had a low clinical efficacy comparable to using placebo. A collagen-based preparation and a complex HA-based preparation exhibited high clinical efficacy. Also, patients with premature aging of the skin had a higher score of anxiety and depression, while patients with high levels of anxiety and depression were more likely to underestimate the satisfaction with the results of their aesthetic treatment.

A comparative study of the analgesic efficacy of intraperitoneal instillation of diluted bupivacaine versus non-diluted bupivacaine after laparoscopic cholecystectomy, a prospective single-blinded controlled randomized study

ABSTRACT Intraperitoneal (IP) bupivacaine instillation for postoperative analgesia after laparoscopic cholecystectomy (LC) has been reported in many studies as either diluted or non-diluted, with conflicting results and no standard recommendations. Objective Our study aims to compare the analgesic efficacy of intraperitoneal instillation of diluted versus non-diluted bupivacaine after laparoscopic cholecystectomy. Methods In this prospective, single-blinded, controlled and randomized study, we included 50 patients undergoing LC. They were randomly divided into two groups, with 25 patients each. At the end of surgery, the first group received intraperitoneal 20 ml bupivacaine 0.5% (100 mg), added to 480 ml normal saline, diluted bupivacaine group (DBG) and the second group received intraperitoneal 20 ml bupivacaine 0.5% (100 mg); non-diluted bupivacaine group (NBG). Pain was assessed and recorded using the visual analog scale (VAS) for 24 h. Time to the first analgesic request, total analgesic consumption in 24 h, incidence of negative effects after LC, such as nausea, vomiting and shoulder pain, any side effects due to local anesthetic used as hypotension, bradycardia or respiratory depression and hemodynamic parameters were also recorded. Results Postoperative VAS values were significantly lower in DBG than NBG in the 1st 24 h (P value ≤ 0.003). The duration of analgesia (the 1st time analgesic request) was significantly longer in DBG (20.16 ± 3.52 h) than that in NBG (6.19 ± 2.93 h) (P value = 0.0001). Also, the total amount of postoperative analgesic consumption (tramadol) was less in DBG (7.2 ± 19.9 mg) than NBG (63 ± 31.16 mg) (P value = 0.0001). In relation to negative effects after LC, side effects due to analgesic drugs and hemodynamic parameters, the results were comparable in both groups. Conclusion Intraperitoneal instillation of diluted bupivacaine at the end of laparoscopic cholecystectomy decreases postoperative pain, delays request for rescue analgesia and reduces the amount of analgesics in the 1st 24 h postoperatively, more than non-diluted bupivacaine, with comparable results in incidence-negative effects after LC, side effects due to analgesic drugs and comparable hemodynamic parameters.

An Open-Labelled Randomized Comparative Efficacy Study of Unani Formulations and Hijama Bila Shart in Tashanuji Usr al-Tamth (Spasmodic Dysmenorrhea)

An Open-Labelled Randomized Comparative Efficacy Study of Unani Formulations and Hijama Bila Shart in Tashanuji Usr al-Tamth (Spasmodic Dysmenorrhea)

Comparative Study of efficacy of various solvent systems in extraction of morphine from viscera

Morphine, the main alkaloid of opium, was first obtained from poppy seeds in 1805. It is a potent analgesic, though its use is limited due to tolerance, withdrawal, and the risk of abuse. Morphine is still routinely used today, though there are a number of semi-synthetic opioids of varying strength such as codeine, fentanyl, methadone, hydrocodone, hydromorphone, meperidine, and oxycodone. Morphine is used for the management of chronic, moderate to severe pain. Opioids, including morphine, are effective for the short term management of pain. Patients taking opioids long term may need to be monitored for the development of physical dependence, addiction disorder, and drug abuse.

A novel hydrogel-based moisturizing cream composed of hyaluronic acid for patients with xerosis: An intraindividual comparative analysis.

Hyaluronic acid (HA) is mainly used to treat xerosis. It also exerts wound-healing, moisturizing, and antiaging effects. Although HA is considered an effective and safe ingredient in cosmetics, there is a constant demand for a more money-saving and effective formulation. This study aimed to evaluate the safety and efficacy of a novel hydrogel-based moisturizer containing HA cross-linked with silicone polymers, produced solely through irradiation without the use of cross-linking agents. A safety study enrolled 30 participants with healthy skin to perform patch and photopatch tests while recording adverse events. For the efficacy study, 30 participants with xerosis were compared before and after using the novel hydrogel, evaluating the cutaneous barrier function, xerosis severity scale (XSS) score, participant's satisfaction, and Investigator's Global Assessment (IGA). Furthermore, the efficacy of the novel hydrogel-based moisturizer was evaluated by comparing it with a conventional moisturizer, Physiogel, in another 30 participants with xerosis. In the safety study, no serious adverse events were observed. In the efficacy study before and after use, skin hydration and skin surface lipid increased (p<0.05) whereas the XSS scores decreased (p<0.05) with time. In the comparative efficacy study with Physiogel, skin hydration increased whereas the XSS scores decreased (p<0.05) over time in both groups. Furthermore, IGA improved in 100% of participants in both groups. Also, 100% and 93% of participants were satisfied with the novel hydrogel-based moisturizer and Physiogel, respectively. The novel hydrogel-based moisturizer proved to be safe and effective for xerosis, showing comparable results to the conventional moisturizer.

Comparative Study of Efficacy Between Cyclosporine and Alitretinoin in Patients With Chronic Hand Eczema.

Background: Systemic remedies such as cyclosporine, methotrexate, and retinoids are off-license treatment options that are considered for severe chronic hand eczema (CHE) that is resistant to first-line treatment. Objectives: The objective of this study was to determine the optimal treatment of CHE patients, including those with atopic Dermatitis®, and to compare the efficacy between cyclosporine and alitretinoin. Methods: This study was retrospective and included CHE patients who visited the Department of Dermatology at Hanyang University Seoul Hospital in Korea between March 2013 and February 2020. Results: A total of 95 CHE patients was included in this study. In the cyclosporine treatment group, there were more patients with severe baseline Investigator Global Assessment (IGA) (P = 0.033) and higher immunoglobulin E (IgE) level (P = 0.019). The mean recurrence duration was 15.9 weeks in the alitretinoin group and 22.9 weeks in the cyclosporine group, the difference between which was not statistically significant. In a subgroup analysis according to treatment drug, only the low IgE group showed a better recurrence profile for alitretinoin treatment compared to cyclosporine treatment (P = 0.039). When comparing the cumulative recurrence rate during the treatment period and subsequent follow-up periods, the cyclosporine group showed a greater incidence of recurrence than the alitretinoin group in all follow-up periods. The results of our study are consistent with the previously reported efficacy of alitretinoin. Despite the rapid response in the cyclosporine group, 12 weeks of CHE treatment with alitretinoin showed superior efficacy compared to cyclosporine treatment. Conclusions: Both alitretinoin and cyclosporine groups showed efficacy in patients with CHE. Cyclosporine is an alternative treatment of CHE that is refractory to alitretinoin or relapses after its use, especially in the presence of atopic Dermatitis®.

Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?

There is an increasing body of evidence supporting a more flexible approach in clinical data requirements for the approval of more complex biosimilar substances such as monoclonal antibodies (mAbs). The aim of this paper is to further analyse the role of quality/chemistry, manufacturing and controls (CMC) and clinical data for the conclusion on biosimilarity and the decision on marketing authorisation (MA). In the present study, we analysed the MA applications (MAAs) of all 33 mAbs and three fusion proteins evaluated by the European Medicines Agency (EMA) between July 2012 and November 2022 with special emphasis on all submitted rituximab (four products) and trastuzumab (seven products) biosimilar candidates, including withdrawn applications. For the two withdrawn applications, the comparative efficacy trials suggested biosimilarity, but the quality/CMC package was not accepted by EMA. We therefore investigated whether a negative MAA outcome could have been predicted based on the evidence generated in the quality/CMC packages, regardless of clinical trial data. For this purpose, we reviewed the respective European Public Assessment Reports (EPARs) or withdrawal assessment reports, and the first regulatory assessments for all these 36 MAAs (i.e. day 120 of the centralized procedure), which are not publicly available. During EMA review, where significant issues are identified which would preclude a marketing authorisation, these issues are raised as questions to the applicant and are classified as major objections (MO). In 67% of cases, the outcome of the quality and clinical assessment was the same, i.e. both the quality and clinical assessments either supported approval or did not support approval. In 11% of cases, MO were identified in the quality part of the submission but not in the clinical data. In 22% of cases, MO were raised on the clinical data package but not on the quality data. However, we found no instance where seemingly negative clinical data, including failed efficacy trials, led to a negative overall decision. In each instance, the failure to confirm similar clinical performance in all investigated aspects was eventually viewed as not being related to the biosimilar per se but as being due to imbalances in the trial arms, immaturity of secondary endpoint results, change in the reference product, or even chance findings. Furthermore, when performing an in-depth analysis of the quality and clinical packages of trastuzumab and rituximab biosimilars, we found that in no case were clinical trial data necessary to resolve residual uncertainties regarding the quality part. The results further support the argument that sufficient evidence for biosimilarity can be obtained from a combination of analytical and functional testing and pharmacokinetic studies which may also generate immunogenicity data. This calls into question the usefulness of comparative efficacy studies for the purposes of regulatory decision-making when approving biosimilar mAbs and fusion proteins.

Prospects for the Use of Monofocal IOLs with Extended Depth of Focus (EDOF) Instead of Traditional Multifocal (Trifocal) IOLs in Cataract Surgery

Purpose — a literature review of comparative studies of the clinical efficacy of IOLs based on extended depth of focus technology (EDOF) and trifocal IOLs (TFIOLs). Methods. Literature analysis was performed in the international database “PubMed”.The search keywords were “IOL with extended depth of focus (EDOF)”, “Trifocal IOL”, “Contrast sensitivity”, “Aberrometry”, “Defocus curve”. The choice of sources for the review was carried out in accordance with the criteria for prospective or retrospective studies. A total of 158 sources were analyzed, further using systematic review filters and the authors’ knowledge of the topic. The duration of the retrospective analysis was 8 years (2015–2022), some of the considered works were dated 2023. Results. The values of visual acuity for distance, near and at an intermediate distance in both studied groups did not differ significantly. When analyzing the defocusing curve, the preservation of visual acuity under load conditions from +1.0 to +3.0 diopters was determined for both types of IOL, respectively. At the same time, visual acuity was significantly better in the TPIOL group than in the EDOF group in the optical load range from -2.5 to -4.0 diopters. Most studies did not report significant difference between EDOF and TFIOL in terms of contrast sensitivity, the likelihood of postoperative “halo” effects, and “independence” of spectacle correction. The stated provisions are fully consistent with the results of the medical and technical evaluation of EDOF presented in the literature. Conclusion. The development of a new type of EDOF IOL seems to be a promising direction in cataract surgery, especially taking into account the possibility of using patients whose professional activities are associated with long-term visual work at intermediate distances (for example, users of personal computers). Further accumulation of clinical material is required in the context of the role and place of EDOF in the general system of aphakia correction, taking into account the IOL model and the conditions of the patient’s professional visual activity.

Comparative Study of Efficacy Between Platelet-Rich Plasma vs Corticosteroid Injection in the Treatment of Lateral Epicondylitis

Background: Lateral epicondylitis, commonly known as "tennis elbow," is a painful condition affecting the tendons on the outer part of the elbow. Managing lateral epicondylitis is essential to relieve discomfort and improve the patient's quality of life. Various treatment options are available for lateral epicondylitis, including Platelet-Rich Plasma (PRP) therapy and corticosteroid injections. The technique if proved better in pain control would be later on preferred as it will contribute significantly to reduce indoor patient burden, earlier recovery of patients and to their overall satisfaction. Objective: To assess and comparative effectiveness of corticosteroid injections with platelet-rich plasma injections in the management of lateral epicondylitis. Study Design: Randomized controlled trial (RCT). Settings: Department of Orthopedic Surgery, PIMS, Islamabad Pakistan. Duration: From December 2019 to May 2020. Methods: Overall, 162 adult patients having clinical features of chronic lateral epicondylitis unilateral/bilateral not responding to conservative management of either gender with age between 18-60 years were included. Patients were randomly assigned into two intervention groups. Patients of Group A underwent local steroid injections, while Group B received platelet-rich plasma (PRP) injections. Patients of the PRP group, were administered 2 mL of PRP, derived from their own blood, at the most sensitive spot on the lateral epicondyle. Patients of the steroid group, were given 2 mL of methylprednisolone (40 mg/mL). Following the injections, patients were instructed to rest for 15 minutes and advised against massaging the treated area. VAS score was calculated at baseline before giving treatment in both groups and was subsequently assessed at 6th week, 3rd month and 6th month post therapy. VAS score was compared in both groups at different time intervals using student-t test for independent samples. Results: Mean age in group A was 47.4 ± 7.5 years and in group B was 48.1 ± 8.2 years. In group A, 56.8% of the participants were males, and 43.2% were females, whereas in group B, 54.3% were males, and 45.6% were females. Baseline average score of VAS was almost equal among both groups at baseline (7.69 ± 1.03 and 7.74 ± 1.06) in group A and B respectively. At 6th weeks, average score of VAS in steroid group was 3.7 ± 1.79 and in PRP group was 3.23 ± 2.05 (P=0.440). At 3 months, average score of VAS in steroid group was 2.73 ± 1.48 and it was 2.53 ± 1.82 SD in PRP group (P=0.451). At 6 months, VAS average score was noted significantly decreased 2.11±1.29 compared to steroid group was 4.83 ± 2.11 (P=0.001). Conclusion: The study revealed that PRP injections are more effective than local steroid injections for chronic lateral epicondylitis. Initial VAS scores were similar for both treatments up to three months, but PRP showed significantly better results at the 6-month follow-up, indicating its long-term effectiveness.