Terms Of Efficacy Research Articles

Long term improvement of knee osteoarthritis after injection of single high/very high volume of very pure PRP: A retrospective analysis of patients optimally managed in dedicated centers

IntroductionPRP is gaining increasing interest for pain relief and improvement of joint function in patients with knee osteoarthritis (KOA) but practices and results remain heterogeneous limiting its adoption as standard of care. Current international recommendations are to collect real-life evidence of efficacy with a systematic monitoring of PRP quality and patients' outcomes. We aimed to analyze the response of patients presenting KOA and treated with standardized PRP injection in routine care. We also investigated the potential contributing factors including patient's phenotype and PRP characteristics. MethodsPatients with symptomatic KOA and that failed first-line therapy received a single injection of a qualified PRP prepared using medical devices allowing to recover a high/very high volume of very pure PRP. Visual analogue scale (VAS) and Western Ontario and McMaster Osteoarthritis Index (WOMAC) score were recorded at baseline and during 18 months follow-up. Results431 patients had available follow-up data at 3 months, 291 at 6 months, 137 at 12 months and 44 at 18 months. PRP induced a significant decrease of WOMAC score at all follow up endpoints (29.2 ± 19.2 at 3 months, p < 0.001 and 25.9 ± 19.7 at 12 months, p < 0.01, compared to 39.7 ± 18.9 at baseline). Similar results were observed for pain VAS (38.9 ± 23.3 at 3 months, p < 0.001 and 35.3 ± 24.1 at 12 months, p < 0.05, compared to 56.0 ± 20.7 at baseline). Changes at 12 months were correlated to baseline scores and to the level of improvement at 3 months. The proportion of OMERACT OARSI responders reached 56.2 % for the total cohort and 60.4 % for severe patients at 6 months. Treatment failure occurred for 8.4 % of patients. Age, BMI or Kellgren–Lawrence grade did not impact on efficacy. ConclusionThis real-life study evidences the clinical benefit of a standardized high or very high-volume injection of very pure PRP in patients with KOA, including those with a severe grade. It opens perspectives in the positioning of such strategy to delay arthroplasty and provide insights on factors able to anticipate long term efficacy.

Parental Experiences with Newborn Screening and Gene Replacement Therapy for Spinal Muscular Atrophy.

Spinal muscular atrophy (SMA) is a genetic neurodegenerative disorder with onset predominantly in infants and children. In recent years, newborn screening and three treatments, including gene replacement therapy (Onasemnogene abeparvovec-xioi), have become available in the United States, aiding in the diagnosis and treatment of children with SMA. To evaluate parents' experiences with newborn screening and gene replacement therapy and to explore best practices for positive newborn screen disclosure and counseling of families. We conducted semi-structured interviews (n = 32) and online surveys (n = 79) of parents whose children were diagnosed with SMA (on newborn screening or symptomatically) and treated with gene replacement therapy. Gene replacement therapy was most parents' first treatment choice, although concerns regarding long term efficacy (65%) and safety (51%) were common. Information provided during the newborn screening disclosure was quite variable. Only 34% of parents reported the information provided was sufficient and expressed need for more information about treatment. Although many parents experienced denial of the diagnosis at initial disclosure, 94% were in favor of inclusion of SMA on newborn screening. Parents were almost universally anxious following diagnosis and over half remained anxious at the time of study participation with uncertainty of the future being a key concern. Many parents had difficulty processing information provided during their first clinic appointment due to its complexity and their emotional state at the time. Utilizing this data, we provide a recommendation for the information provided in newborn screening disclosure, propose adjustments to education and counseling during the first clinic visit, and bring awareness of parents' mental health difficulties.

Micropulse cyclophotocoagulation compared to continuous wave cyclophotocoagulation for the management of refractory pediatric glaucoma.

Micropulse cyclophotocoagulation (MPCPC) has been shown in adults to offer a favorable post-operative safety profile compared to continuous wave transscleral cyclophotocoagulation (CWCPC) in the management of glaucoma. The purpose of this study is to evaluate the long term efficacy, safety, and effectiveness of MPCPC in the management of pediatric glaucoma when compared to CWCPC. IRB approved retrospective chart review of patients with pediatric glaucoma that underwent MPCPC and CWCPC at 2 separate institutions. Success was defined as intraocular pressure (IOP) between 5 and 21mmHg on any number of topical glaucoma medication without requiring additional surgical intervention or oral IOP lowering medication. Of the 48 patients in the study, 22 (26 eyes) underwent MPCPC and 26 (30 eyes) underwent CWCPC. At 1 year, 7 out of 26 eyes (26.9%) achieved success in the MPCPC group compared to 13 out of 30 eyes (43.3%) in the CWCPC group. Survival analysis unveiled a statistically significant difference in success between the two groups (p = 0.03). In pediatric glaucoma patients undergoing cyclophotocoagulation procedures, CWCPC outperformed MPCPC using default settings in terms of achieving long-term IOP control. Additional studies are required to evaluated augmented MPCPC settings in pediatric glaucoma patients.

Efficacy of dupilumab plus topical corticosteroids in children with atopic dermatitis: Ameta-analysis of randomized controlled trials.

Children with atopic dermatitis (AD) bear a significant burden of illness that adversely affects their quality of life. To determine the efficacy of dupilumab and topical corticosteroids for the treatment of pediatric AD. A comprehensive literature search was conducted using three prominent databases: Web of Science, PubMed, and Embase. Using a fixed-effects or random-effects model, the standard mean differenceor risk ratioswith 95% confidence intervals were calculated, and the trial protocol was listed as CRD42023408546. A total of 3 studies were included, and 896 participants met the inclusion criteria. The combined estimate showed that dupilumab plus topical corticosteroids had numerically greater efficacy in terms of Eczema Area and Severity Index(EASI)-50, EASI-75, EASI-90, and Investigator Global Assessment (IGA) score of 0 or 1. Children who received topical corticosteroids and dupilumab achieved significantly higher Children's Dermatological Life Quality Index scores compared to those who received placebo. The number of individuals who achieved IGA 0/1 increased with the use of dupilumab and topical corticosteroids. Dupilumab and topical corticosteroids can be used to treat symptoms in children with AD. However, given the substantial variation in treatment outcomes among studies, the findings should be interpreted with caution.

Intravenous versus intramuscular oxytocin injection for preventing uterine atonic primary postpartum haemorrhage in third stage of labour: A double-blind randomised controlled trial.

To compare the efficacy and safety of intravenous and intramuscular oxytocin in preventing atonic primary postpartum haemorrhage in the third stage of labour. A double-blind randomised clinical study on consenting women without risk factors for primary postpartum haemorrhage in labour at term. Two hundred and thirty-two women were randomly allotted into intravenous (n = 115) and intramuscular (n = 117) oxytocin groups in the active management of the third stage of labour. All participants received 10 IU of oxytocin, either IV or IM, and 1 ml of water for injection as a placebo via a route alternate to that of administration of oxytocin within 1 min of the baby's delivery. The primary outcome measures were mean postpartum blood loss and haematocrit change. Trial Registration No.: PACTR201902721929705. The baseline socio-demographic and clinical characteristics were similar between the two groups (p > 0.05). There was no statistically significant difference between the two groups with regards to the mean postpartum blood loss (254.17 ± 34.85 ml versus 249.4 ± 39.88 ml; p = 0.210), haematocrit change (2.4 (0.8%) versus 2.1 (0.6%); p = 0.412) or adverse effects (p > 0.05). However, the use of additional uterotonics was significantly higher in the intravenous group (25 (21.73%) versus 17 (14.53%); p = 0.032). Although oxytocin in both study groups showed similar efficacy in terms of preventing atonic primary postpartum haemorrhage, participants who received intravenous oxytocin were more likely to require additional uterotonics to reduce their likelihood of having an atonic primary postpartum haemorrhage. However, both routes have similar side effect profiles.

A Review of Lateral Epicondylitis Injection: Drugs Used, Injection Techniques and Guidance Method

Abstract This article aimed to study the most suitable drug for injection, injection techniques and guidance method for treating tennis elbow. The words ‘injection technique’, ‘lateral epicondylitis’ and ‘tennis elbow’ were keyed into PubMed search base, and 145 full-text English language articles were obtained, from which 22 articles were deemed suitable for review based on content and relevance. One article was added from the author’s collection. The eligibility was (a) patients with tennis elbow or lateral epicondylitis, (b) patients who had undergone injection therapy and (c) studies that had done a comparison between two or more agents or two techniques or used comparison between using or not using imaging guidance for injection. It was found that corticosteroid injections in tennis elbow produce a short-term improvement in symptoms, while prolotherapy, autologous blood and platelet-rich plasma (PRP) injections may show more efficacy in the long term. In terms of technique, peppering seems to be a better alternative to tender point injections. The use of ultrasound guidance does not seem to have any effect on the overall efficacy of the injection treatment. The evidence in this study shows that it is better to use corticosteroids for short-term improvement, whereas bioactive agents like PRP injections may work better in the long term.

Comparison of the short and medium term efficacy of ortholox UHMWPE sternal cerclage band system and figure-of-8 wire sternum closure technique in patients at risk for sternal dehiscence

Aim: In this retrospective study, it was aimed to compare the short and medium term efficacy of Sternal Cerclage Band System and Figure-of-8 wire closure technique in open heart surgery patients with risk for sternal dehiscence. Material and Methods: In total, 320 open heart surgery patients with risk for sternal dehiscenceattempting to Kahramanmaraş Sütçü Imam University Medical Faculty Hospital between 28.12.2017 and 11.12.2021were subjected to this restrospective study. Since the study is retrospective, randomization and randomization procedures are not in question.The patients included in the study were divided into 2 groups as Steel Wire (standard procedureFigure 8 wiretechnique), and the Sternal Cerclage (sternum was closed with the Ortholox® Sternal Cerclage Band System). Baseline characteristics and outputs of patient groups were compared. Results: Age and body mass index (BMI) means were significantly higher in Cerclage Band group (p&lt;0.05). 53.8% of Cerclage Band group and 38.1% of Steel Wire group had obesity, and the difference was significant (p&lt;0.05). Diabetes mellitus (DM) rate was 36.3% in Steel Wire group and 48.4% in Cerclage Band with statistically significant differences (p&lt;0.05). In Cerclage Band group, 42.5% of patients were smoker, whereas 3.8% of Steel Wire group were smokers (p&lt;0.05). Length of hospital stay, sternal stability and infection after surgery rates were similar between patient groups with statistically insignificant differences (p&gt;0.05). Conclusion: Although there are differences between Cerclage Band and Steel Wire, results and outputs were similar, and showed that Sternal Cerclage Band System is a safe and useful technique in open heart surgery patients with risk for sternal dehiscence.

A PROSPECTIVE STUDY OF EFFICACY AND OUTCOME ANALYSIS OF ROLE OF PRP INJECTION IN OSTEOARTHRITIS OF KNEE JOINT 40 CASES PROSPECTIVE ANALYSIS

Background: Knee osteoarthritis is a progressive debilitation degenerative disease of the cartilage of the knee. In severe conditions, the patient is unable to do basic activities of daily living also. The pain associated with severe cartilage degeneration is excruciating. Platelet rich plasma being autologous in nature, the chances of disease transmission are also very less. This study aims to evaluate the efficacy in terms of pain relief and functional outcome of platelet rich plasma in patients with knee osteoarthritis with Kellgren-Lawrence Grade I, II and III. Material and Method: This study was conducted in the Department of Orthopedics, Arihant Hospital and Research Centre, Indore during the study period of 2 years. We included 29 patients with primary osteoarthritis of knee with age more than 35 years and who were willing to undergo this procedure. After preliminary evaluation of the knee with radiograph and confirming the fitness of the patient for the procedure, these patients were given injection of PRP and were instructed on post procedure precautions. The second injection was given at 3rd week and 3rd injection at 6th week, and these patients were followed up till 12 months. At each follow-up WOMAC score and VAS scores were evaluated. Pairedt test was applied to evaluate the change in mean WOMAC and VAS scores at each follow-up. A p value of &lt; 0.05 was taken as statistically significant. Result and Conclusion: We had included 40 knees (29 patients) with a mean age of 55.89 ± 9.14 years. Female predominance was seen in our study (75.9%). Only Kellgren-Lawrence osteoarthritis grades I, II and III were included and Grade IV were excluded. The left knee involvement (52.5%) was slightly higher in comparison to the right knee. The mean WOMAC score preinjection was 75.65 ± 5.54, at 3 weeks it was 66.23 ± 6.95 and at 6 weeks and 43.93 ± 14.11 at 6 months. There was a significant improvement (P&lt;0.05) in WOMAC scores over the follow-up till 6 months. The mean WOMAC score along with its 3 subscales showed significant deterioration at 12 months in comparison to 6 months, scores (P&lt;0.05). Likewise, the mean VAS preinjection was 7.18 ± 0.93, which significantly decreased at postinjection (at 6 months) to 3.90 ± 1.19 (P&lt;0.05), but by 12 months the mean VAS showed significant increase to 6.38 ± 1.01 (P&lt;0.05). No major complications were noted, except for pain and swelling at the site of injection. These were managed conservatively and responded well to the given treatment.

DrCORRECT: An Algorithm for the Preventive Administration of Postprandial Corrective Insulin Boluses in Type 1 Diabetes Management.

In type 1 diabetes therapy, precise tuning of postprandial corrective insulin boluses (CIBs) is crucial to mitigate hyperglycemia without inducing dangerous hypoglycemic events. Several heuristic formulas accounting for continuous glucose monitoring (CGM) trend have been proposed in the literature. However, these formulas suggest a lot of quantized CIB adjustments, and they lack personalization. drCORRECT algorithm proposed in this work employs a patient-specific time parameter and the "dynamic risk" (DR) measure to determine postprandial CIB suggestion. The expected benefits include the reduction of time in hyperglycemia, thanks to the preventive action exploited through DR. drCORRECT has been assessed retrospectively vs the literature methods proposed by Aleppo et al (AL), Bruttomesso et al (BR), and Ziegler et al (ZI) using a data set of 49 CGM daily traces recorded in free-living conditions. Retrospective evaluation of the algorithms is made possible by the use of ReplayBG, a digital twin-based tool that allows assessing alternative insulin therapies on already collected glucose data. Efficacy in terms of glucose control was measured by temporal, risk indicators, and dedicated hyperglycemic/hypoglycemic events metrics. drCORRECT significantly reduces time spent in hyperglycemia when compared with AL and BR (33.52 [24.16, 39.89]% vs 39.76 [22.54, 48.15]% and 36.32 [26.91, 45.93]%, respectively); significantly reduces daily injected insulin (5.97 [3.80, 8.06] U vs 7.5 [5.21, 10.34] U), glycemia risk index (38.78 [26.58, 55.39] vs 40.78 [27.95, 70.30]), and time spent in hypoglycemia (0.00 [0.00, 1.74]% vs 0.00 [0.00, 10.23]%) when compared with ZI, resulting overall in a safer strategy. The proposed drCORRECT algorithm allows preventive actions thanks to the personalized timing configuration and the introduction of the innovative DR-based CIB threshold, proving to be a valid alternative to the available heuristic literature methods.

Efficacy (In Terms of Avoiding Hysterectomy) of the Triple P Procedure in Managing Morbidly Adherent Placenta

Objective: To determine the efficacy (in terms of avoiding hysterectomy) of the Triple P procedure in managing morbidly adherent placenta. Study Design: Case series. Place and Duration of the Study: Department of Obstetrics &amp; Gynaecology, Combined Military Hospital, Peshawar Pakistan, from Dec 2018 to Mar 2020. Methodology: A total of 56 pregnant women of gestational age ≥32 weeks with the morbidly adherent placenta were included. Caesarean section was done in each patient by the consultant gynaecologist, and then the Triple P procedure was done. Efficacy in each patient was noted. Results: The mean age of the study participants was 30.79±4.42 years. In our analysis, the mean parity was 3.05±0.88. The mean number of caesarean sections was 2.00±1.11. The Triple P procedure was effective (in avoiding hysterectomy) in managing morbidly adherent placentas in 53(94.64 %) participants. Conclusion: This study concluded that the Triple P procedure's efficacy (in terms of avoiding hysterectomy) in managing morbidly adherent placenta is very high.

Autologous platelet-rich plasma for the treatment of interstitial cystitis/bladder pain syndrome in women: evaluation of clinical efficacy

Introduction. The pathogenetic theory of interstitial cystitis/bladder pain syndrome (IC / BPS) development declares that due to vascular changes and trophic disorders in the bladder wall, a complex of dystrophic, necrobiotic and sclerotic processes develops, involving all layers of the bladder wall with the subsequent development of fibrosis. Therapy of moderate-to-severe symptoms of IC/BPS that recommended in EAU guidelines is not so effective.Objective. To evaluate the results of intradetrusor autologous platelet-rich plasma (PRP) injections in female IC / BPS-patients.Matherials &amp; methods. A single-centre controlled randomized prospective trial that includes 85 women from 20 to 79 years old and with average disease duration of 4.8 ± 2.1 years. They were divided into two groups: group 1 — 35 patients were treated with total of five cystoscopies and hydrodistension, each once in two weeks for 10 weeks; group 2 — 50 patients were treated with total of 5 intradetrusor PRP-injection (mean platelet concentration was 982 х 103/l) into 20 – 22 points, each once in two weeks. We assessed pain (VAS-scale), urgency and frequency (PUF-scale, IUS-scale), bladder urinary, Global Response Assessment (GRA), bladder diary and bladder capacity before treatment, after one and 12 months.Results. Conventional IC/BPS therapy leads to a significant reduction in symptoms one month after its completion, and a similar pattern of symptoms and signs is observed in the PRP-treatment group. However, in group 1, negative dynamics is further determined up to 12 months, but the indicators do not reach the initial values. In contrast, in group 2, we found stabilisation of pain severity and improvement of all other symptoms and signs by 12 months compared to baseline and one month after the completion of PRP-therapy.Conclusion. The developed method of PRP-therapy of IC/BPS has high efficacy not only at the treatment completion, but also at monitoring of patients for 24 months. PRP-therapy combined with classical treatment will probably have a higher level of efficacy both in terms of symptoms and signs of the disease over a long-term monitoring.

Radiological Versus Clinical 1-Year Outcomes of Dupilumab in Refractory CRSwNP: A Real-Life Study.

To provide real-life evidence on long-term radiological changes in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) treated with dupilumab, and to assess possible differences between radiological and clinical results in terms of endoscopic findings and Patient-Reported-Outcomes (PROs). Consecutive patients treated with dupilumab for recalcitrant CRSwNP were required to undergo CT scan at baseline (T0) and after 12 (T1) since first administration. A group of patients also performed CT scan at 52 weeks (T2) to assess long-term outcomes. At each timepoint, patients underwent nasal endoscopy, assessment of Nasal-Polyp-Score (NPS), Lund-Kennedy-Score (LKS), and had to fill in the 22-item Sinonasal-Outcome-Test (SNOT-22) and Visual-Analogue-Scales (VAS) for sinonasal symptoms. In fifty-three included patients, from T0 to T1 we detected a significant reduction in mean Lund-Mackay score (LM), PROs (SNOT-22, VAS) and endoscopic (NPS, LKS) scores (p < 0.05). In the subset of patients that reached T2 (n = 30), compared to T1, we observed a further significant decrease in mean LM, SNOT-22, VAS, and NPS scores, but not in LKS (p = 0.420). At T1, the highest improvement was observed in PROs (SNOT-22: 56.26%), and polyp size (NPS: 49.83%). Conversely, between T1 and T2, sinus opacification was shown to be the most improved outcome (LM: 36.86%). Our experience showed that poorly controlled CRSwNP patients treated with dupilumab experienced significant improvement in radiologic, endoscopic and clinical disease severity. While in the initial 3 months, PROs garnered attention for showing earlier effectiveness, radiological outcomes revealed sustained and gradual efficacy in a longer term. Level 4. According to the Oxford Center for Evidence-Based Medicine 2011 level of evidence guidelines, this non-randomized retrospective cohort study is classified as level 4 evidence Laryngoscope, 134:2626-2633, 2024.

Impact of Dapagliflozin Adjunctive Therapy on the Progression of Chronic Kidney Disease in Patients with Type 2 Diabetes and Chronic Kidney Disease Stages 2-5: A systematic review and meta-analysis.

This meta-analysis investigated efficacy of dapagliflozin as adjunctive therapy for patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) stages 2-5. A systematic search was conducted of selected databases for randomised controlled trials that reported the mean change in estimated glomerular filtration rate (eGFR) and urine albumin-creatinine ratio (UACR) from baseline. Out of 1,682 identified studies, 9 trials comprising 13,057 patients were included. A pooled estimate of 5 studies indicated that dapagliflozin did not affect eGFR; however, in 2 studies, it significantly reduced chronic eGFR decline compared to placebo (mean difference [MD] ± 2.74; 95% confidence interval [CI]: 1.55, 3.92; P <0.00001). Additionally, a pooled estimate of 4 studies showed that dapagliflozin significantly reduced UACR (MD -23.99%; 95% CI: -34.82--13.15; P <0.0001; I2 = 0%). Therefore, long-term use of dapagliflozin significantly attenuates eGFR decline and reduces albuminuria in patients with T2DM and CKD.

Machine Learning Analysis of the Impact of Silver Nitrate and Silver Nanoparticles on Wheat (Triticum aestivum L.): Callus Induction, Plant Regeneration, and DNA Methylation.

The objective of this study was to comprehend the efficiency of wheat regeneration, callus induction, and DNA methylation through the application of mathematical frameworks and artificial intelligence (AI)-based models. This research aimed to explore the impact of treatments with AgNO3 and Ag-NPs on various parameters. The study specifically concentrated on analyzing RAPD profiles and modeling regeneration parameters. The treatments and molecular findings served as input variables in the modeling process. It included the use of AgNO3 and Ag-NPs at different concentrations (0, 2, 4, 6, and 8 mg L-1). The in vitro and epigenetic characteristics were analyzed using several machine learning (ML) methods, including support vector machine (SVM), random forest (RF), extreme gradient boosting (XGBoost), k-nearest neighbor classifier (KNN), and Gaussian processes classifier (GP) methods. This study's results revealed that the highest values for callus induction (CI%) and embryogenic callus induction (EC%) occurred at a concentration of 2 mg L-1 of Ag-NPs. Additionally, the regeneration efficiency (RE) parameter reached its peak at a concentration of 8 mg L-1 of AgNO3. Taking an epigenetic approach, AgNO3 at a concentration of 2 mg L-1 demonstrated the highest levels of genomic template stability (GTS), at 79.3%. There was a positive correlation seen between increased levels of AgNO3 and DNA hypermethylation. Conversely, elevated levels of Ag-NPs were associated with DNA hypomethylation. The models were used to estimate the relationships between the input elements, including treatments, concentration, GTS rates, and Msp I and Hpa II polymorphism, and the in vitro output parameters. The findings suggested that the XGBoost model exhibited superior performance scores for callus induction (CI), as evidenced by an R2 score of 51.5%, which explained the variances. Additionally, the RF model explained 71.9% of the total variance and showed superior efficacy in terms of EC%. Furthermore, the GP model, which provided the most robust statistics for RE, yielded an R2 value of 52.5%, signifying its ability to account for a substantial portion of the total variance present in the data. This study exemplifies the application of various machine learning models in the cultivation of mature wheat embryos under the influence of treatments and concentrations involving AgNO3 and Ag-NPs.

Uric acid–reducing efficacy of Plectranthus amboinicus (Lour.) Spreng in mice with potassium oxonate-induced hyperuricemia

Plectranthus amboinicus (Lour.) Spreng is a type of Lamiaceae perennial herb that is widely used in folk treatments for respiratory and skin diseases. Notably, research on the hypouricemic effect of P. amboinicus is limited. This study investigated the uric acid–reducing efficacy of P. amboinicus in mice with potassium oxonate-induced hyperuricemia by performing an in vitro xanthine-oxidase-inhibition-activity-guided test of P. amboinicus extract (PAE) and its fractions. The ethyl acetate fraction (EAF) of PAE exhibited optimal efficacy in terms of the phenolic content, DPPH scavenging activity, and xanthine oxidase inhibition. We further demonstrated the uric acid–reducing activity of EAF in a mouse model of potassium bromate–induced hyperuricemia. The results can serve as a useful preclinical reference for researching the gout prevention effects of functional foods.&#x0D; Keywords: Plectranthus amboinicus (Lour.) Spreng, hyperuricemia, uric acid–reducing activity

INJECTION OF AUTOLOGOUS WHOLE BLOOD VERSUS CORTICOSTEROID FOR LATERAL EPICONDYLITIS: A COMPARATIVE STUDY

Objective: The objective is to compare the efficacy, in terms of pain relief and functional improvement, of autologous whole blood and corticosteroid injection in managing lateral epicondylitis (Tennis elbow). Methods: This was a comparative study conducted in Department of Orthopedics, National Institute of Medical Sciences Jaipur, Rajasthan, India. Eighty patients diagnosed to be having lateral epicondylitis were included in this study on the basis of predefined inclusion and exclusion criteria. The patients were divided into 2 groups on the basis of whether they were given autologous whole blood (Group B) or corticosteroid injection (Group S). Efficacy of both the treatment modality was compared in terms of Pain relief (as assessed by reduction in visual analogue score [VAS] score) and functional improvement (as assessed by improvement in Mayo Elbow performance score). SSPS 22.0 software was used for statistical analysis and p&lt;0.05 was taken as statistically significant. Results: A total of 80 patients were included in this study out of which there were 37 (46.25%) males and 43 (53.75%) females with a M: F ratio of 1:1.16. The mean age of patients in group B and group S was found to be found to be 52.36±9.98 years and 48.46±10.12 years, respectively. The mean age of patients in both the groups was found to be comparable with no statistically significant difference (p=0.0866). At the time of 4 weeks, 8 weeks, and 12 weeks follow–up, the mean VAS score in Group B was less as compared to group S and the difference was found to be statistically highly significant (p&lt;0.0001). At the time of 4 weeks, 8 weeks, and 12 weeks’ follow-up, the mean MEPS in Group B was more as compared to group S, and the difference was found to be statistically significant (p&lt;0.05). Conclusion: For lateral epicondylitis, whole blood injection demonstrated superior efficacy in terms of pain relief and functional improvement as compared to injection of corticosteroid.

Examining the benefit of a higher maintenance dose of extended-release buprenorphine in opioid-injecting participants treated for opioid use disorder

BackgroundBUP-XR (SUBLOCADE®) is the first buprenorphine extended-release subcutaneous injection approved in the USA for monthly treatment of moderate-to-severe opioid use disorder (OUD). Among patients with OUD, those who inject or use high doses of opioids likely require higher doses of buprenorphine to maximize treatment efficacy. The objective of this analysis was to compare the efficacy and safety of 100-mg versus 300-mg maintenance doses of BUP-XR in OUD patients who inject opioids.MethodsThis was a secondary analysis of a randomized, double-blind, placebo-controlled study in which adults with moderate or severe OUD received monthly injections of BUP-XR (2 × 300-mg doses, then 4 × 100-mg or 300-mg maintenance doses) or placebo for 24 weeks. Abstinence was defined as opioid-negative urine drug screens combined with negative self-reports collected weekly. Each participant’s percentage abstinence was calculated after the first, second, and third maintenance doses in opioid-injecting and non-injecting participants. The proportion of participants achieving opioid abstinence in each group was also calculated weekly. Treatment retention rate following the first maintenance dose was estimated for opioid-injecting participants with Kaplan–Meier method. Risk-adjusted comparisons were made via inverse propensity weighting using propensity scores. Buprenorphine plasma concentration–time profiles were compared between injecting and non-injecting participants. The percentages of participants reporting treatment-emergent adverse events were compared between maintenance dose groups within injecting and non-injecting participants separately.ResultsBUP-XR 100-mg and 300-mg maintenance doses were equally effective in non-injecting participants. However, in opioid-injecting participants, the 300-mg maintenance dose delivered clinically meaningful improvements over the 100-mg maintenance dose for treatment retention and opioid abstinence. Exposure–response analyses confirmed that injecting participants would require higher buprenorphine plasma concentrations compared to non-injecting opioid participants to achieve similar efficacy in terms of opioid abstinence. Importantly, both 100- and 300-mg maintenance doses had comparable safety profiles, including hepatic safety events.ConclusionsThese analyses show clear benefits of the 300-mg maintenance dose in injecting participants, while no additional benefit was observed in non-injecting participants relative to the 100-mg maintenance dose. This is an important finding as opioid-injecting participants represent a high-risk and difficult-to-treat population. Optimal buprenorphine dosing in this population might facilitate harm reduction by improving abstinence and treatment retention.Trial registration: ClinicalTrials.gov, NCT02357901.

Presence and Flow as Moderators in XR-Based Sustainability Education

Virtual reality (VR) and augmented reality (AR) are emerging technologies with a variety of potential benefits for sustainability education. Here, learning processes such as flow and presence seem to determine the learning experience. Therefore, this paper presents the results of a mixed-methods study investigating a VR- and AR-based learning application on biodiversity developed by greenpeace. A total of 156 students tested the application addressing the Amazon rainforest and rated its efficacy in terms of effects on knowledge, interest, and attitude. Pre- and post-questionnaires as well as focus groups were used to uncover within-subject effects. The study results revealed that flow and presence had a moderating effect on knowledge and that this effect is strongest in learners with little prior knowledge. Presence also showed a moderating effect on one of three attitude measures. In general, the learning application was able to increase knowledge and improve attitude in this sample. The focus groups also revealed that the students engaged with environmental topics even after the experience. They also formed ideas for more environmentally friendly behavioral change. Moreover, the students described the application as impressive, captivating, and realistic. It can be concluded that presence and flow are crucial processes for learning with VR and AR technologies.

#391 : Oocyte Cryopreservation — A Five Year Follow Up Study on its Utilization and Outcome

Background &amp; Aim: Oocyte cryopreservation is a boon for women undergoing Assisted reproductive technology (ART). Apart from cancer patients it is recently promoted as a mode of fertility insurance to overcome the age-related decline in fertility, endometriosis, primary ovarian insufficiency, etc. The objective of the study was to evaluate the clinical applications of oocyte freezing and its efficacy in terms of pregnancy outcome. Method: Retrospective observational study of all patients undergoing oocyte cryopreservation from 2016 to 2021 in Lilavati Hospital &amp; Research Centre, Mumbai, India. Result: 221 patients undergoing oocyte cryopreservation were included. Oocyte cryopreservation was done for different indications like azoospermia (50.2%, most common), planned oocyte freezing (41.17%), fertility preservation (1.36%), endometriosis (0.45%), ejaculatory dysfunction (1.8%), husband with active hepatitis B infection (3.62%) and unavailability of husband on the day of egg retrieval (3.62%). A total of 1715 mature oocytes were frozen. 41.17% women were normo-responder, 38.91% were poor responder and 19.90% were hyper-responder. The oocytes of 59 patients (return rate-26.7%) have been thawed and 162 women (73.3%) remain in storage. Out of 508 oocytes frozen for these 59 patients utilizing their oocytes, around 474 oocytes were recovered post-warming (recovery rate 93.3%). A total of 59.3% patients created embryos with a partner, and 40.6% used donor sperm. The mean fertilization rate was 65.8% of surviving oocytes. Of 59 patients, 44 (74.5%) planned a fresh embryo transfer, out of which 20 patients tested positive for pregnancy (pregnancy rate 45.45%). Conclusion(s): We report the outcomes of patients opting for oocyte cryopreservation, which is useful for patient counselling. Limited evidence is available in terms of utilization rate, post warming survival of oocytes, fertilization and pregnancy rate. Further studies over long period of time with larger cohorts are needed.

Evaluation of the Impact of Tocilizumab Use in Recipients of CAR T Cells for Non-Hodgkin Lymphoma

Introduction: CAR T has revolutionized the treatment of patients with relapsed or refractory (R/R) Non-Hodgkin lymphoma (NHL). Treatment of the major toxicity of cytokine release syndrome (CRS) is tocilizumab (toci) and corticosteroids based on the ASTCT grade. Real-world experiences in the United States and Europe have reported a higher rate of tocilizumab use than in pivotal trials; however, the impact of single or multiple administrations on clinical outcomes is not clear. Methods: Patients diagnosed with diffuse (DLBCL), high grade (HGBCL) and primary mediastinal B cell lymphoma (PMBL) treated at our institution with commercial CAR T were retrospectively identified. The association between the number of doses received with best overall response by day 100, PFS, and OS was investigated through a Cox regression model using a 14-day landmark analysis. Late neutropenia was defined as an ANC &amp;lt;1000/mmc for two consecutive counts beyond day 30 post CAR-T infusion and a 30-day landmark analysis was performed in this case. Results: 230 patients with R/R DLBCL (80%), HGBCL (17%) and PMBL (3%) were included in the analysis. Axicabtagene ciloleucel (Axi-cel), tisagenlecleucel (Tisa-cel), and lisocabtagene maraleucel (Liso-cel) were administered in 62%, 29% and 9% of cases, respectively. Median age at time of CAR-T infusion was 65 years (range 20-86), with a male predominance (63%). The median number of prior treatment lines was 3 (range 1-12), and 21% underwent a prior autologous hematopoietic cell transplant. Disease burden prior to CAR-T infusion can be inferred by the following: bridging therapy was deemed necessary in 77% of patients, pre-lymphodepletion LDH was elevated in 40%, and bulky disease with largest mass diameter was &amp;gt; 10 cm in 10%. CRS and ICANS were grade 2 in 107 patients (46%) and 46 patients (20%), respectively. Median time to first administration of toci was 4 days (range 1-16) with patients receiving 0 (51%), 1 (27%), 2 (14%), or 3-4 (8%) doses. Best response by day 100 for the whole cohort was CR in 138 (60%) and PR in 36 (16%) patients. In univariable analysis, factors associated with a lower likelihood of response were the administration of Tisa-cel (p=0.014), bulky disease (p&amp;lt;0.001), administration of bridging therapy (p=0.009), and being refractory to the last treatment line (p=0.006). Number of doses of tocilizumab did not impact the likelihood of response (p=0.72). In a Cox regression model for survival, number of doses of tocilizumab was not associated with worse PFS (p=0.38, Figure 1) or OS (p=0.64), while other known negative predictors of response had impact on survival, such as bulky and refractory disease. By univariable analysis, tocilizumab administration was significantly associated with prolonged neutropenia (p&amp;lt;0.001). The likelihood to observe an ANC&amp;lt;1000/mmc beyond day 30 increased accordingly to the number of doses received (Figure 2). Other factors associated with late neutropenia were bulky disease (P=0.013), need of bridging therapy (p=0.004), and corticosteroids administration (p&amp;lt;0.001). Conclusion: The number of tocilizumab infusions did not impact CAR T efficacy in terms of overall response and long-term survival, a finding that is concordant with other real-world experiences. The cumulative incidence of late neutropenia events was impacted by the number of doses received. We speculate that a severe CRS driven systemic inflammatory response, requiring several tocilizumab and corticosteroids administrations, may hinder the bone marrow function and recovery.