Significant Intergroup Differences Research Articles

Transcatheter aortic valve replacement with balloon-expandable and self-expandable valves in Japanese patients with large annulus: the OCEAN-TAVI registry

Abstract Background East Asians have smaller aortic valve complexes than individuals from Western countries, and few studies have reported transcatheter aortic valve replacement (TAVR) outcomes in Asian patients with a large annulus. Purpose We aimed to compare the acute and long-term outcomes of TAVR using balloon-expandable valves (BEVs) and self-expandable valves (SEVs) in Asian patients with a large annulus. Methods We retrospectively analyzed the data from the Optimized transCathEter vAlvular interveNtion Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. A large annulus was defined by annular area ≥ 500 mm2 and average diameter ≥ 25 mm in computed tomography scans. The primary endpoint was the 3-year all-cause mortality. Secondary endpoints were 3-year heart-failure rehospitalization (HFR) after TAVR, acute outcomes of TAVR, and changes in valve function on echocardiography 2 years after TAVR. Results Among 773 patients, 671 (86.8%) underwent BEV-TAVR. The SEV-TAVR group showed a significantly higher incidence of above-moderate perivalvular leakage (2.1% vs. 7.8%; P < 0.001), and included a significantly greater percentage of patients who required postoperative pacemaker implantation (6.1% vs. 11.8%; P = 0.035). The incidence of moderate-to-severe prosthesis–patient mismatch did not differ between the two groups. The Kaplan–Meier curve showed no significant intergroup differences in the 3-year all-cause mortality and HFR rates (log-rank P = 0.900), and the echocardiography-indexed effective orifice area and mean transaortic valve pressure gradient at 2 years post-TAVR did not differ significantly between the two groups. Conclusions The benefits of BEV-TAVR may outweigh those of SEV-TAVR in patients with a large annulus.

Effectiveness of Implant Therapy in Patients With and Without a History of Periodontitis: A Systematic Review With Meta-Analysis of Prospective Cohort Studies.

This systematic review investigates the effectiveness of implant therapy in patients with and without a history of periodontitis in terms of implant loss, peri-implant marginal bone loss (MBL), and occurrence of peri-implant diseases. The protocol of the present meta-analysis was registered on PROSPERO (CRD42021264980). An electronic search was conducted up to April 2024. All prospective cohort studies reporting implant loss, MBL, and occurrence of peri-implant diseases in both patients with a history of periodontitis (HP) and patients with no history of periodontitis (NHP) after at least 36-month follow-up were included. The risk of bias was evaluated using the Newcastle-Ottawa Scale and the quality of the evidence was also assessed. A meta-analysis was performed on the selected outcomes at the available follow-up time points. Subgroup analyses were conducted based on follow-up time, rate of progression and severity of periodontitis, and implant surface characteristics. Publication bias was evaluated using the Funnel plot and Egger's test. From 13 761 initial records, 14 studies (17 articles) were finally included. Eight studies had a low risk of bias level, and six had a medium risk of bias level. Meta-analysis showed that HP patients had a significantly greater risk for implant loss (HR: 1.75; 95% CI: 1.28-2.40; p = 0.0005; I2 = 0%), MBL (MD: 0.41 mm; 95% CI 0.19, 0.63; p = 0.0002; I2 = 54%), and peri-implantitis (3.24; 95% CI: 1.58-6.64; p = 0.001; I2 = 57%) compared to NHP, whereas no significant intergroup difference for peri-implant mucositis was found. Subgroup analyses revealed a particularly greater risk for implant loss for HP patients over a ≥ 10-year follow-up (HR: 2.02; 95% CI: 1.06-3.85; p = 0.03; I2 = 0%) and for patients with a history of grade C (formerly aggressive) periodontitis (HR: 6.16; 95% CI: 2.53-15.01; p < 0.0001; I2 = 0%). A greater risk for implant loss for stages III-IV (severe) periodontitis, and implants with rough surfaces was also found. Within the limits of heterogeneous case definitions and methods of assessment, a history of periodontitis has been proved to significantly increase the risk for implant loss, particularly at long follow-up (≥ 10 years) and in case of rapidly progressive forms (grade C), and for MBL and peri-implantitis.

Unilateral and Bilateral Transcutaneous Tibial Nerve Stimulation in Women With Overactive Bladder Syndrome: A Randomized Controlled Study (UBTTNS-OAB Study).

The efficacy of unilateral versus bilateral Transcutaneous Tibial Nerve Stimulation (TTNS) for women with Overactive Bladder Syndrome (OAB) remains uncertain. To compare the efficacy of unilateral and bilateral TTNS in the tibial region in women with OAB. This randomized, controlled, triple-blind clinical trial included women with OAB or urgency-predominant urinary incontinence (UUI). Participants were randomized (1:1) into the Unilateral Tibial Group or Bilateral Tibial Group. Before treatment, they underwent a pre-assessment including peripheral sensitivity examination and completion of sociodemographic data and seven validated questionnaires on urinary symptoms, quality of life, sleep, and psycho-emotional aspects. TTNS interventions were administered twice weekly (12 sessions, 30 min each). Posttreatment, participants underwent another physical examination and completed the same questionnaires, with a 30-day follow-up. Categorical variables were analyzed using Chi-square or Fisher's Exact Test, while numerical variables were assessed with the Mann-Whitney test. Group comparisons over time utilized intention-to-treat ANOVA (p < 0.05). Thirty-five women participated: 17 in the unilateral group and 18 in the bilateral group. Mean ages were 55.1 (±14.7) years and 52.7 (±12.6) years, respectively (p = 0.680). Initial OAB severity (ICIQ-OAB) did not differ significantly between groups (p = 0.561). Both groups showed significant improvement in ICIQ-OAB scores: unilateral group from 10.1 (±3.4) to 5.8 (±3.4) (p < 0.001), bilateral group from 9.3 (±3.3) to 5.1 (±4) (p < 0.001), with no intergroup difference (p = 0.395). Improvement in UUI symptoms was observed: unilateral group from 2.2 (±1.4) to 0.7 (±1.5), bilateral group from 1.5 (±1.9) to 0.2 (±0.5), without significant intergroup difference (p = 0.645). Quality of life scores improved similarly between groups (p = 0.055). TTNS appears to be effective in improving bladder storage and UUI symptoms in women with OAB, with no difference between unilateral and bilateral applications. Brazilian Registry of Clinical Trials (REBEC) (RBR: 96f2fgkn).

Physiologic Preoperative Knee Hyperextension Is Not Associated With Postoperative Laxity, Subjective Knee Function, or Revision Surgery After ACL Reconstruction With Hamstring Tendon Autografts.

There is concern that physiologic knee hyperextension may be associated with inferior outcomes after anterior cruciate ligament reconstruction (ACLR) using hamstring tendon (HT) autografts. To assess whether there is an association between contralateral passive preoperative knee hyperextension (≤-5°) and postoperative anterior knee laxity, subjective knee function, or revision surgery after ACLR using HT autografts. Cohort study; Level of evidence, 3. Patients without concomitant ligament injuries who underwent primary ACLR using an HT autograft at Capio Artro Clinic, Stockholm, Sweden, between January 1, 2005, and December 31, 2018, were identified. The cohort was dichotomized into the hyperextension group (≤-5°) and the no hyperextension group (>-5°) depending on preoperative contralateral passive knee extension degree. Anterior knee laxity (KT-1000 arthrometer; 134 N) was assessed preoperatively and at 6 months postoperatively. The Knee injury and Osteoarthritis Outcome Score (KOOS) was collected preoperatively and at 1, 2, and 5 years postoperatively. Patients who underwent revision ACLR at any institution in Sweden within 5 years of the primary surgery were identified in the Swedish National Knee Ligament Registry. A total of 6104 patients (53.5% male) for whom knee range of motion measurements were available were identified (hyperextension group [≤-5°]: 2350 [38.5%]; mean extension, -6.1°± 2.3° [range, -20° to -5°]; no hyperextension group [>-5°]: 3754 [61.5%]; mean extension, 0°± 1.4° [range, -4° to 15°]). There were no intergroup differences in anterior knee laxity preoperatively (hyperextension group, 3.6 ± 2.8 mm; no hyperextension group, 3.7 ± 2.7 mm; P = .24) or postoperatively (hyperextension group, 1.8 ± 2.3 mm; no hyperextension group, 1.8 ± 2.2 mm; P = .41). The only significant but nonclinically relevant intergroup differences were seen in the KOOS Symptoms subscale at the 1-year follow-up (hyperextension group, 81.4 ± 16.0; no hyperextension group, 80.3 ± 16.5; P = .03) and in the Sport and Recreation subscale at the 5-year follow-up (hyperextension group, 73.0 ± 25.6; no hyperextension group, 75.7 ± 24.3; P = .02). No other significant intergroup differences were noted preoperatively or at 1, 2, or 5 years postoperatively in any of the KOOS subscales. The overall revision ACLR rate at ≤5 years after the primary surgery was 4.9% (302 of 6104 patients). The hazard for revision ACLR in the no hyperextension group (4.5%; 170 of 3754 patients) was not significantly different from that in the hyperextension group (5.6%; 132 of 2350 patients) (hazard ratio, 0.89; 95% CI, 0.71 to -1.12; P = .34). A subsequent subanalysis showed that the hazard of revision ACLR in patients with no hyperextension was not significantly different from that of patients with ≤-10° of extension (5.8%; 27 of 467 patients) (hazard ratio, 0.91; 95% CI, 0.61 to 1.36; P = .65). Preoperative passive contralateral knee hyperextension (≤-5°) was not associated with postoperative anterior knee laxity, subjective knee function, or revision surgery ≤5 years after ACLR using HT autografts. Therefore, the presence of knee hyperextension alone should not be considered a contraindication per se for the use of HT autografts in ACLR.

Anticonvulsants impacting bone metabolism: interim results from a cross-sectional study

Background. Despite a wide range of antiepileptic drugs (AEDs) with an improved pharmacological profile, patients often experience a variety of side effects during long-trem anticonvulsant therapy, among which are osteoporotic disorders. Currently, the mechanisms of AED effect on bone metabolism remain poorly understood, which creates certain difficulties in prevention and treatment of AED-induced osteoporosis.Objective: to study bone mineral density and laboratory parameters of bone metabolism in patients with epilepsy and longterm AED administration.Material and methods. A cross-sectional study included two comparison groups: 100 adult patients with epilepsy receiving AEDs for more than 12 months and 58 healthy volunteers without taking AEDs. All participants underwent general clinical examination, computed tomography (CT) densitometry at three time points (L1, L2 and femoral neck) and laboratory tests of mineral metabolism.Results. According to CT-densitometry results, a decrease in bone mineral density was detected in the majority of participants from both study groups. While assessing an impact of osteoporosis risk factors on bone tissue in epileptic patients, low motor activity and duration of AED therapy were the most significant, which was associated with lower bone mineral density indices. The study of laboratory mineral metabolism indicators revealed significant inter-group differences in indicators such as ionized calcium, 25-hydroxy-calciferol, free thyroxine and prolactin (p(U)=0.044, p(U)=0.040, p(U)=0.001, p(U)=0.003, respectively).Conclusion. The intermediate study results showed that long-term anticonvulsant use negatively affected bone metabolism in patients suffering from epilepsy. The data obtained point at need for further in-depth study of AED therapy effect on mineral metabolism.

Anesthetic Effects of Dexmedetomidine Combined with Nalbuphine in Patients Undergoing Laparoscopic Cholecystectomy and its Impact on Nutritional Status.

Laparoscopic cholecystectomy (LC) is a common surgical procedure for the removal of the gallbladder. Effective anesthesia is crucial for ensuring patient comfort and safety during LC. Dexmedetomidine, a selective α2-adrenergic agonist, is widely used as an adjunct to anesthesia due to its sedative and analgesic properties. Nalbuphine, a synthetic opioid analgesic, is also employed for pain management during various surgical procedures. This study aimed to determine the anesthesia effects of dexmedetomidine combined with nalbuphine on patients undergoing LC and its impact on their nutritional status. The clinical records of 100 patients who underwent LC at Wuhan No.1 Hospital between January 2021 and January 2022 were analyzed retrospectively. Forty-six patients who received intravenous dexmedetomidine (0.4 µg/kg) were assigned to the control group, while fifty-four patients who received intravenous nalbuphine (0.2 mg/kg) and dexmedetomidine (0.4 µg/kg) were assigned to the study group. The outcomes compared between the two groups included heart rate (HR), mean arterial pressure (MAP), Riker sedation-agitation scale (RSAS) scores, visual analogue scale (VAS) scores, duration of operation, awakening time from anesthesia, extubation time, adverse reactions, and nutrition-related indicators before and after surgery. There were no significant differences in MAP between the groups at the same time point (p > 0.05). However, at T1 and T3, the study group had significantly lower HR compared to the control group (p < 0.05), with no significant differences in HR at other time points (p > 0.05). The study group exhibited significantly lower RSAS scores compared to the control group (p < 0.01). No significant differences were observed between the groups in terms of duration of operation, awakening time from anesthesia, and extubation time (p > 0.05). At 6 hours post-operation, there were no significant differences in VAS scores between the groups (p > 0.05), but at 12, 24, and 48 hours post-operation, the study group had significantly lower VAS scores compared to the control group (p < 0.0001). No significant inter-group difference was observed in the total incidence of adverse reactions (p = 0.180). Additionally, one week after surgery, the study group exhibited significantly higher levels of albumin, prealbumin, transferrin, and total protein compared to the control group (p < 0.0001). Dexmedetomidine combined with nalbuphine provides a superior anesthetic effect compared to dexmedetomidine alone in patients undergoing LC. This combination effectively controls hemodynamic fluctuations during the recovery period and reduces agitation without affecting the awakening time from anesthesia. These findings suggest that this combination is beneficial and worth promoting.

Three Therapy Regimens and Their Cost-effectiveness for Girls With Central Precocious Puberty: A Real-World Clinical Study.

The objective of this study was to evaluate the effectiveness and cost-effectiveness of different therapy regimens for girls with central precocious puberty (CPP). This study retrospectively analyzed CPP girls from 2013 to 2021 and grouped them into GnRHa, Mixed, and GnRHa+GH based on therapy regimen. While comparing the differences among these groups, initial age and bone age of GnRHa group girls were significantly lower than Mixed and GnRHa+GH groups, but their growth level was significantly higher (P < .05). In the Mixed group, starting with GnRHa alone, the predicted adult height improvement (ΔPAH) decreased to -1.0 cm in the second year, prompting addition of growth hormone (GH) therapy in the third year, resulting in a ΔPAH increase to 3.0 cm. At therapy completion, final predicted adult heights (PAHs) were similar among the groups at 155.6 to 156.7 cm, with ΔPAH between 5.8 and 6.5 cm and no significant intergroup differences (P > .05). Younger CPP girls with greater height can begin therapy with GnRHa alone. Consideration of combining GH therapy depends on growth velocity and PAH during treatment.

Nutritional diagnoses in people with type 2 diabetes: association with metabolic, anthropometric, and dietary parameters

BackgroundNutritional diagnosis involves identifying a nutritional problem, its cause, and the signs that indicate it to guide appropriate treatment. Few studies report on the most prevalent nutritional diagnoses in people living with type 2 diabetes (T2D).ObjectiveTo define nutritional diagnoses across different domains and their association with metabolic, anthropometric, and dietary parameters in individuals with T2D.MethodsA personalized nutritional intervention was conducted using the Nutrition Care Process (NCP) model, which encompasses assessment, diagnosis, intervention, and evaluation, utilizing standardized terminology from the Nutrition Care Process Terminology (NCPT). Two dietitians, trained and standardized in applying the NCP and NCPT, performed patient assessments and established the diagnoses. Patients over 18 years old with a diagnosis of T2D for less than 5 years were included.ResultsData from 2,050 patients were analyzed, of whom 55.3% were women, and 44.7% were men, with a median age of 57 and 54 years, respectively. The most prevalent nutritional diagnosis was excessive energy and carbohydrate intake. Diagnoses were distributed across domains: Intake (55.9%), Behavioral/Environmental (32.7%), Clinical (10.2%), and 1.2% without nutritional diagnosis. Significant intergroup differences were observed in anthropometric variables such as BMI, waist circumference, and body fat percentage (p &amp;lt; 0.05). HbA1c and glucose levels were significantly higher in the Intake and Behavioral groups (p &amp;lt; 0.001). Albumin/creatinine ratio (ACR) was higher in the ingestion group (p = 0.007). Caloric and carbohydrate intake were higher in the ingestion group, while protein and fat intake were higher in the clinical and behavioral groups (p &amp;lt; 0.001).ConclusionNutritional diagnoses in the intake domain, followed by behavioral/ environmental and clinical domains, are highly prevalent in people with T2D and are associated with worse metabolic control, higher BMI, and increased energy and carbohydrate intake. Timely identification of issues in these domains can support targeted nutritional therapy to improve disease management and promote a healthy lifestyle.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT02836808?term=caipadi&amp;amp;rank=2, Identifier (NCT02836808).

Comparison of Revision Techniques for Rod Fracture after Adult Spinal Deformity Surgery: Rod Replacement Alone or Coupled with Lateral Lumbar Interbody Fusions or Accessory Rods.

Background: Rod fracture (RF) is the most common cause of revision in adult spinal deformity (ASD) surgery, and various treatment strategies for preventing RF are reported in the literature. This retrospective study, involving 139 ASD patients (aged ≥65 years and a minimum 2-year follow-up) who underwent long-segment fixation from T10 to sacrum with pedicle subtraction osteotomy (PSO), analyzed long-term results, including radiographical parameters and the incidence of recurrent RF (re-RF), to determine the most effective revision method for preventing RF. Methods: Patients were classified into three groups according to the revision method performed for RF: simple rod replacement (RR group, n = 17), lateral lumbar interbody fusion around the PSO site (RR + LLIF group, n = 8), and accessory rod insertion (RR + AR group, n = 22). Baseline characteristics and radiographical and clinical parameters were analyzed. Results: RF occurred in 47 patients (34%) at an average of 28 months following primary deformity correction. Re-RF occurred in six patients (13%) at an average of 37 months. Re-RF occurred most commonly in the RR group (p = 0.048). Every re-RF in the RR group occurred at the PSO site; none occurred in the RR + LLIF group, and one in the RR + AR group occurred near the L4-5. After both primary deformity correction and revision surgery, spinopelvic parameters had shown favorable results, and clinical outcomes had improved in all three groups without significant intergroup differences. Conclusions: Accessory rod insertion or an additional LLIF around the PSO site seems to provide greater strength and stability to the previously fused segments than a simple rod replacement, which demonstrates the need for additional support in revision surgery for RF after a PSO.

Comparison of ilioinguial/iliohyphogastic nerves block with wound-infiltration on postoperative pain – a randomised controlled trial

Objective: To compare postoperative pain scores at rest and on movement in patients undergoing open inguinal hernia repair between those receiving illioinguinal/illiohypogastric nerve block with ropivacaine or wound infiltration with ropivacaine. Method: The randomised clinical trial was conducted at the Department of Anaesthesiology, Aga Khan University Hospital a tertiary care centre from March to August 2019 and comprised patients of either gender scheduled for elective unilateral open inguinal hernia repair under general anaesthesia. They were randomised into illioinguinal/illiohypogastric nerve block group A, and wound infiltration group B. In group A, 20ml of 0.25% ropivacaine was infiltrated in the vicinity of the nerves under ultrasound guidance, while group B received wound infiltration with ropivacaine 10ml 0.25% at the end of surgery. Postoperative static and dynamic pain was assessed at 0, 2, 6, 12 and 24 hours using visual analogue scale. Total usage of opioids in 24 hours postoperatively in both groups, patient satisfaction and complications were recorded. Data was analysed using SPSS 19. Results: Of the 60 patients, 30(50%) were in each of the 2 groups. There were 29(96.7%) males and 1(3.3%) female in group A with mean age 45.63±17.43 years, and 28(93.3%) males and 2(6.7%) females in group B with mean age 49.33±15.39. The mean pain score at rest was not significantly different between the groups (p&gt;0.05). On movement, the mean pain score between the groups was different only at 6 hours (p=0.02). There were no significant intergroup difference in total usage of opioids in 24 hours postoperatively and patient satisfaction (p&gt;0.05). Conclusion: Illioinguinal/illiohypogastric nerve block and wound infiltration with ropivacaine were found to be equally effective methods in controlling postoperative pain. ClinicalTrials.gov ID: NCT04462510. Key Words: Local anaesthesia, Inguinal hernia, Pain management, Patient satisfaction.

Two- versus one-bag fluid delivery in pediatric and adolescent diabetic ketoacidosis: a systematic review and meta-analysis.

Two rehydration protocols currently exist to treat diabetic ketoacidosis (DKA) in pediatric patients aged <21 years: the traditional "one-bag" system and the more recent "two-bag" system. This study aimed to evaluate the safety and efficacy of the newer two-bag system versus the well-established one-bag system. The CiNAHL, Cochrane Library, Embase, PubMed, Scopus, and Web of Science databases were comprehensively searched from inception to June 2023 by 2 independent reviewers using the Preferred Reporting Items for Systematic Reviews and Meta-analysis framework. Eligible studies were those that reported participants <21 years of age who presented to the emergency room with a clinical diagnosis of DKA. This review was prospectively registered on PROSPERO (CRD42023427551). From the initial screening of 42 studies, 8 unique studies encompassing 583 patients met the eligibility criteria. The analysis yielded no significant intergroup differences in hypoglycemia (odds ratio, 0.61; 95% confidence interval [CI], 0.20-1.87; I2=3%) or mean glucose correction rate (mean difference [MD], 0.04 mg/ dL/hr; 95% CI, -13.10 to 13.17; I2=64%). The incidence of cerebral edema was as low (0.17%) across groups, with only one case reported in the one-bag group. Notably, the mean time to DKA resolution (MD, -3.24 h; 95% CI, -5.57 to -0.91; I2=0%) and mean response time for intravenous fluid changes (MD, -32.75 min; 95% CI, -43.21 to -22.29; I2=59%) was lower for the two-bag system. This meta- analysis presents preliminary evidence suggesting that the two-bag system may confer advantages over the one-bag system for selected patients. However, further studies with greater patient stratification based on DKA severity, fluid composition, and protocol are needed to draw definitive conclusions and elucidate the extent of these advantages.

Clinical value of transperineal ultrasound in evaluating the effects of different delivery methods on the primipara pelvic floor structure and function

To evaluate the effects of different delivery methods on the pelvic floor structure and function among primiparas by transperineal ultrasound, with a view to providing guidance for early postpartum intervention. Primiparas who underwent postpartum examination with transperineal ultrasound were recruited. Subjects were divided according to mode of delivery (vaginal and cesarean delivery). General information (including age, pre-pregnancy BMI and neonatal weight) were collected, and transperineal ultrasound was performed to measure such indicators as the levator hiatus areas in resting, constrictive anal and maximum Valsalva states, the posterior vesicourethral angles and distances between vesical neck and posterior inferior margin of pubic symphysis in resting and maximum Valsalva states, as well as the vesical neck mobility and urethral rotation angle in maximum Valsalva state. The inter-group differences in ultrasound indicators between the resting and Valsalva states were compared to analyze the postpartum incidences of pelvic floor dysfunctions like stress urinary incontinence, urethral funnel formation, bladder prolapse and uterine prolapse in primiparas. The levator hiatus areas in resting, constrictive anal and maximum Valsalva states were all larger in the vaginal delivery group than in the cesarean delivery group (P < 0.05). Compared to the cesarean delivery group, the vaginal delivery group exhibited larger posterior vesicourethral angles in resting and maximum Valsalva states (P < 0.05). The distances between vesical neck and posterior inferior margin of pubic symphysis were greater in the cesarean delivery group than in the vaginal delivery group at both resting and maximum Valsalva, with that at maximum Valsalva showing significant inter-group difference (P < 0.05). The vaginal delivery group exhibited greater vesical neck mobility and urethral rotation angle at maximum Valsalva compared to the cesarean delivery group (P < 0.05). The incidences of stress urinary incontinence, urethral funnel formation, bladder prolapse and uterine prolapse were all higher in the vaginal delivery group than in the cesarean delivery group, with the stress urinary incontinence and bladder prolapse incidences showing significant inter-group differences (P < 0.05). With transperineal ultrasound, various pelvic floor indicators of primiparas can be clearly measured and, through these ultrasound indicators, the effects of different delivery methods on the pelvic floor function can be evaluated, which is conducive to early clinical detection and intervention of postpartum pelvic floor dysfunctions, thus facilitating the early postpartum treatment.

Intrapulmonary electronic auscultation for asthma and chronic obstructive pulmonary disease

The aim of the study was to develop and perform clinical testing of the intrapulmonary electronic auscultation method for audio and video recording at various levels of the tracheobronchial tree for the diagnosis of asthma and chronic obstructive pulmonary disease (COPD).Methods. We examined 31 patients with moderate (n = 17) and severe (n = 14) COPD with severe symptoms outside of exacerbation and 35 patients with moderate (n = 19) and severe (n = 16) partially controlled asthma. Traditional bronchoscopy was performed, including intrabronchial recording of acoustic noise with a microphone (introduced into the instrumental channel of the bronchoscope) at various levels of the tracheobronchial tree. Video recording in various modes revealed the causes of wheezing. At the same time, pulmonary sounds were recorded in the interscapular region of the chest at the projection points of the bronchoscope in the tracheobronchial tree using a 3M™ Littmann® 3200 electronic stethoscope (USA).Results. The greatest intergroup differences between patients with moderate and severe COPD were demonstrated by intrapulmonary sound parameters (frequency and duration of wheezing, р &lt; 0.0001) and frequency response (amplitude-frequency characteristics) of wheezing in the lumen of the 4th order bronchi (р &lt; 0.0001), significantly exceeded the corresponding sound phenomena during auscultation from the surface of the chest (р &lt; 0.01). The most significant intergroup differences in the groups of BA patients with moderate and severe disease were observed in the frequency response of wheezing during intrapulmonary auscultation in the lumen of the 3rd order (р &lt; 0.0001) and 4th order (р &lt; 0.0001) bronchi; smaller differences were observed in the frequency response during auscultation from the chest surface (р &lt; 0.001).Conclusion. Intrapulmonary auscultation is a modern auscultatory method which can improve the quality and efficiency of diagnosis of asthma and COPD in pulmonology.

A study method using early dynamic acquisition of [18F]fluorodopa positron emission tomography for the differential diagnosis between progression and radionecrosis of brain metastases after radiotherapy

BackgroundIt is difficult to distinguish between the brain metastasis progression (BMP) and brain radionecrosis (BRN) on the basis of 18F-3,4-dihydroxyphenylalanine positron emission tomography/computed-tomography (18F-FDOPA PET/CT) data. The advent of silicon photomultiplier (SiPM) PET technology makes it possible to study dynamic volumes and potentially improve diagnostic accuracy. We developed a method for processing 18F-FDOPA PET/CT in the differential diagnosis between BMP and BRN. The method involves a short (3-second) sampling time during a 4-minute acquisition on a SiPM-PET/CT machine. We prospectively included 15 patients and 19 metastases. All acquisitions were performed in list mode acquisition for 25 min on a four-ring SiPM PET/CT system. We calculated the ratios between the maximum activity in the lesion’s voxel and the mean activity in the contralateral region (VOImax/CLmean) or the mean activity in the white matter (VOImax/WMmean).ResultsSeven lesions were classified as BMP and twelve were classified as BRN. Statistically significant intergroup differences in the VOImax/CLmean and VOImax/WMmean activity ratios were observed for both the clinical volume and the early acquisition. The best performing quantitative variable was the VOImax/CLmean ratio on early acquisition, with a diagnostic accuracy of 94.7%, a sensitivity of 100%, and a specificity of 91.7%.ConclusionThe 18F-FDOPA PET/CT data acquired a few minutes after the bolus injection confirms its value in differentiating between BMP and BRN, compared to the much longer classic clinical protocol.

Effect of acupuncture on the sleep quality of hemodialysis patients in a capital city in the Northeast of Brazil

Objective: Analyze the effect of auricular acupuncture on the sleep quality of hemodialytic patients with chronic pain in a capital city in the Northeast of Brazil. Methods: This study includes double-blind, randomized in blocks and allocated at a rate of 1:1, controlled trial that was conducted in two hemodialysis clinics, with 94 chronic renal patients with chronic pain (auricular acupuncture [AA]: 47, sham acupuncture [SA]: 47). Both received 12 sessions for three months. We collected data using the Pittsburg Sleep Quality Index (PSQI). Data were analyzed using t-tests, Wilcoxon test and ANOVA. Results: Comparing the SA and AA groups, there was a statistically significant difference at baseline (p &lt; 0.001), a significant intergroup difference, and the AA group had better sleep quality than the SA group during and at the end of the 12 sessions (&lt; 0.001). A high magnitude of the effect of auricular acupuncture on sleep quality was found at the end of the sessions (D= -1.94). Conclusion: The auricular acupuncture intervention proved to be effective in improving the subjective sleep classification of renal patients.

Periodontal regenerative therapy using recombinant human fibroblast growth factor (rhFGF)-2 in combination with carbonate apatite granules or rhFGF-2 alone: 12-month randomized controlled trial.

This randomized controlled trial compared the outcomes of recombinant human fibroblast growth factor (rhFGF)-2 plus carbonate apatite (CO3Ap) granules with rhFGF-2 alone in the treatment of intrabony periodontal defects. Patients with Stage III Grade B/C periodontitis who had completed initial periodontal therapy and had intrabony defects with a depth of ≥ 3mm were included. Defects were treated solely with rhFGF-2 (control) or rhFGF-2 plus CO3Ap (test). Periodontal parameters and a patient-reported outcome measure (PROM) were assessed at baseline, at 6, 9 and 12 months postoperatively. The primary outcome was the change in clinical attachment level (CAL) from baseline to 12 months postoperatively. Using the Friedman test with Dunn's post-test, intragroup data were compared over time, and Mann-Whitney U test was used to assess intergroup data at each time point. Forty-eight sites in 38 patients were subjected to analysis. At 12 months postoperatively, CAL in both groups showed a significant improvement from baseline (p < 0.001). CAL gain was 3.4 ± 1.3mm in the test group and 3.2 ± 1.2mm in the control group, with no significant intergroup difference (p = 0.567). Radiographic bone fill in the test group (67.2%) was significantly greater than in the control group (32.4%) (p < 0.001). PROM scores showed no difference between groups. At 12 months, the outcomes including CAL gain and PROM showed no significant differences between groups, although the combination treatment enhanced radiographic bone fill. The use of rhFGF-2 (with/without CO3Ap) could lead to significant improvement in clinical parameters in the treatment of intrabony periodontal defects. The benefit of adding CO3Ap to rhFGF-2 therapy needs further evaluation. The University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) : UMIN000040783.

7625 Functional and structural neuronal changes of dulaglutide compared to placebo during smoking cessation - a randomized placebo-controlled trial

Abstract Disclosure: C.O. Sailer: None. S. Lengsfeld: None. D. Coynel: None. F. Baur: None. K. Bologna: None. T. Vukajlovic: None. N.A. Jeanloz: None. C. Bathelt: None. D. Zanchi: None. M. Christ-Crain: None. B.F. Winzeler: None. Introduction: Nicotine activates reward-related brain regions and chronic cigarette smoking can lead to functional and structural neuronal changes. Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), known for their anti-obesity effects, have emerged as potential treatments for addictive disorders. A pilot study of exenatide vs placebo revealed increased short-term smoking abstinence rates and reduce smoking craving. We previously reported the results of a clinical trial (n=255) investigating the effect of dulaglutide vs placebo on smoking cessation. Herein, we report the functional magnetic resonance imaging (fMRI) results of a subset of participants. This substudy aimed to investigate the influence of dulaglutide on smoking craving, functional and structural neuronal changes of smokers aiming to quit smoking. Methods: This single-center, randomized, double-blind, placebo-controlled trial enrolled 71 participants with at least a moderate nicotine dependence, all committed to quitting smoking. Of these, 35 participants received 12 weeks dulaglutide 1.5mg, and 36 participants placebo, alongside varenicline treatment and behavioral counselling. An fMRI session was conducted at baseline and 12 weeks. The primary outcomes included smoking craving assessed on a visual analogue scale (VAS, range 0-7), differences in blood oxygen level dependent (BOLD) signal (whole brain and regions of interests, e.g., nucleus accumbens, amygdala, thalamus) and gray matter changes between sessions and groups when exposed to smoking and neutral video cues. Secondary outcomes assessed the above in quitters vs persistent smokers. Results: In line with the primary study findings, abstinence rates at 12 weeks were comparable in the dulaglutide (54%) and placebo (68%) groups (p=0.27). In a mixed effect model, smoking craving significantly decreased at 12 weeks vs baseline (-2.13 (95% CI -2.46, -1.80), p&amp;lt;0.001) and were lower for neutral vs smoking cues (-2.02 (-2.34, 1.70,), p&amp;lt;0.001). However, no significant inter-group difference was observed (-0.09 (-0.53, 0.33), p=0.65). Persistent smokers exhibited higher smoking craving at 12 weeks vs quitters (0.48 (0.06, 0.90), p=0.028), particularly when exposed to smoking cues (2.02 (1.70, 2.34), p&amp;lt;0.001). No significant differences were found in functional or structural analyses between interventions or smoking status. Conclusions: The smoking cessation intervention led to a significant reduction in smoking craving at 12 weeks without in-between group differences in behavioral, functional, or structural outcomes. Our findings challenge the hypothesis that GLP-1 RAs modulates smoking craving and behavior. It is plausible that a potential GLP-1 effect might have been masked by varenicline treatment and the unexpectedly high abstinence rate in the placebo group. Future studies should explore more potent GLP-1 RAs or dual agonists. Presentation: 6/1/2024

6986 Efficacy and Safety of Weekly Liquid Alendronate Sodium Trihydrate in Korean Postmenopausal Women with Osteoporosis: A 12-Month, Multi-Center, Randomized Trial

Abstract Disclosure: Y. Rhee: None. S. Ahn: None. N. Hong: None. D. Seo: None. S. Hong: None. Background: Although alendronate is the most prescribed oral bisphosphonate for osteoporosis treatment, it can lead to gastrointestinal problems, impacting treatment compliance and efficacy. This study aimed to assess the efficacy and safety of once-weekly alendronate sodium trihydrate (ALN-S), an oral solution, compared to once-weekly alendronate sodium (ALN-T), an oral tablet, in Korean postmenopausal women with osteoporosis. Methods: Conducted as a 12-month, multi-center, prospective, randomized, open-labeled, parallel trial at two hospitals in Korea, 170 postmenopausal women were randomized to ALN-S (N=85) or ALN-T (N=85). Bone mineral density (BMD) at the lumbar spine (LS), femoral neck (FN), and total hip (TH) was measured at baseline and after 12 months. Bone turnover markers, including C-telopeptide (CTX) and procollagen type 1 amino-terminal propeptide (P1NP), were assessed at baseline, 6 months, and 12 months. The primary outcome was the percentage change in LS BMD, evaluated for non-inferiority. Results: After 12 months, both ALN-S and ALN-T groups exhibited a significant increase in LS, FN, and TH BMD, with no significant intergroup differences (ALN-S: LS 5.0 ± 0.6%, FN 1.8 ± 0.6%, TH 2.2 ± 0.5%; ALN-T: LS 5.2 ± 0.6%, FN 1.6 ± 0.6%, TH 1.8 ± 0.5%). ALN-S was found to be non-inferior to ALN-T for BMD change at LS (treatment difference: -0.22%, 95% CI: -1.84 to 1.40%), excluding the predefined non-inferiority margin of -2.29%. Changes in both CTX and P1NP over time did not significantly differ between the groups. There was no significant difference in the frequency of adverse events between the groups. Conclusion: Weekly liquid alendronate sodium trihydrate demonstrated non-inferiority to weekly tablet alendronate sodium in increasing LS BMD in Korean postmenopausal women with osteoporosis. Presentation: 6/2/2024

Changes in shoulder function and muscle strength following rehabilitation exercise program in male patients with forward shoulder posture undergoing rotator cuff repair

BackgroundAbnormal posture is known to affect the efficacy of exercise therapy for musculoskeletal diseases. However, no studies to date have examined the effect of exercise programs should take into account the posture of the upper body in patients with rotator cuff disease. This study aimed to assess how rotator cuff and corrective exercises impact shoulder function and muscle strength post-arthroscopic rotator cuff repair surgery, providing tailored rehabilitation programs for patients with forward posture.MethodsNinety male patients who underwent arthroscopic rotator cuff repair participated in this study. The patients were randomly divided into three groups corrective exercise group (CEG, n = 29), rotator cuff exercise group (REG, n = 27), and control group (CG, n = 28). Each group was instructed to apply different exercise programs to correct posture and enhance rotator cuff strength. All patients were checked by the American Shoulder and Elbow Surgeons (ASES) score, Constant score and muscle strength, and range of motion preoperatively and postoperatively at 6 months and 1 year.ResultsASES shoulder function scores showed significant difference between the three groups (p = 0.002, F = 7.03), indicating that the corrective exercise program was more beneficial than rotator cuff exercises (p = 0.009, F = 3.78). A significant intergroup difference in mean Constant score was also noted (p = 0.025, F = 3.86), while a statistically significant interaction between time and group was observed (p = 0.032, F = 2.96).ConclusionsThese results suggested that a corrective exercise program can improve shoulder muscle strength and function after rotator cuff repair in male patients with a forward shoulder posture.

Efficacy of Preoperative Autologous Blood Donation for Surgical Treatment of Thoracic Spinal Stenosis: A Propensity-Matched Cohort Study.

Thoracic spinal stenosis (TSS) surgeries necessitate a substantial amount of allogeneic blood resources. However, the efficacy of preoperative autologous blood donation (PABD) in TSS surgery has not been clearly evaluated. Therefore, we aimed to evaluate the efficacy of PABD for TSS surgery. This study is a retrospective study. Totally 397 patients who underwent TSS surgeries at our institution from January 2019 to June 2023 were included. Propensity score matching (PSM) was used to make the PABD and Non-PABD groups comparable at baseline. Regarding outcome measures, the incidence and amount of allogeneic blood transfusion, changes in postoperative hemoglobin and hematocrit levels, occurrence of postoperative complications, medical costs, drainage time, length of hospital stay, and postoperative neurological function were analyzed. The outcomes were compared between the matched PABD (n = 79) and Non-PABD (n = 79) groups. Univariate analysis methods were used for statistical analysis, including independent samples t-test, Wilcoxon rank-sum test, and chi-square test. The incidence of allogeneic blood transfusion (8.9% vs. 25.3%, p = 0.006) and volume of intraoperative red blood cell (RBC) transfusion (10.12 ± 54.52 vs. 122.78 ± 275.00 mL, p < 0.001) in the PABD group were significantly lower than those in the Non-PABD group. The PABD group had significantly higher average postoperative hemoglobin and hematocrit levels than the Non-PABD group at 1, 3, and 5 days after surgery (p < 0.05). Similarly, the PABD group exhibited a smaller reduction in hemoglobin and hematocrit levels compared with the Non-PABD group on 1, 3, and 5 days postoperatively. There were no significant intergroup differences in terms of transfusion-related complications, medical expenses, neurological function, length of hospital stay, or drainage time. Notably, PABD was an independent protective factor of allogeneic transfusion in the multivariate regression analysis (OR = 0.334, 95%CI = 0.051-0.966). PABD can effectively reduce the incidence of allogeneic blood transfusion and amount of allogeneic blood in TSS surgeries with safety. It also significantly improved the postoperative hemoglobin and hematocrit levels. Under the premise of clear indications, PABD is worth promoting for the surgical treatment of TSS.