Proportion Of Patients In Group Research Articles

Evaluating the effectiveness and adverse effects of oral versus transdermal estradiol for endometrial preparation in frozen-thawed embryo transfer: a randomized controlled trial

BackgroundEndometrial preparation significantly influences the success of embryo transfer procedures. Although both oral and transdermal estradiol are common methods for endometrial priming, their efficacy and potential side effects remain uncertain. This randomized controlled trial aims to compare the effectiveness of oral and transdermal estradiol in endometrial preparation, while also evaluating their respective side effects in patients undergoing assisted reproduction treatments.MethodThis randomized clinical trial (ISRCTN15301227) was conducted at Hung Vuong Hospital between July 2020 and March 2022. Among 550 eligible patients undergoing frozen embryo transfer cycles, we included 380 patients for the study. The study protocol and all materials received approval from the Ethics Committee of Hung Vuong Hospital (1315/CN-HĐĐĐ). Participants were randomly assigned to one of two groups: Group A (n =190) received oral estradiol at an initial dose of 4 mg per day for 7 days, with the dose increased according to clinical response. Group B (n =190) received transdermal estradiol at an initial dose of 2 measures of 2.5 g estradiol gel per day for 7 days, with the dose similarly increased according to clinical response. Treatment in both groups began on days 2–3 of the menstrual cycle, with the maximum duration of estradiol administration being 27 days. We compared estradiol levels on the day of progesterone administration, duration of treatment, total estradiol dose, endometrial thickness, pregnancy outcomes, and any observed side effects between the two groups.ResultsGroup A exhibited significantly higher estradiol levels on the day of progesterone administration compared to Group B (270.5 pg/ml versus 186.5 pg/ml, p < 0.001). However, the comparison revealed no significant difference in endometrial thickness between the two groups (10.5 mm versus 10.6 mm, p = 0.85). Furthermore, pregnancy rates including positive human chorionic gonadotropin, clinical pregnancy, ongoing pregnancy, live birth, and pregnancy failure were also found to be similar between the two groups. Notably, a greater proportion of patients in Group A experienced mild side effects compared to those in Group B (20.3% versus 10.1%, respectively; n =37 versus n =18), and this discrepancy was found to be statistically significant (p = 0.007).ConclusionTransdermal estradiol offers comparable endometrial thickness and pregnancy outcomes, along with improved patient compliance and fewer side effects compared to oral estradiol.

Role of Probiotic in Vulvovaginal Candidiasis: A Randomised Controlled Non-blinded Trial from India

Abstract Background: Vulvovaginal candidiasis (VVC) is a prevalent form of vaginitis, and most patients show improvement when treated with antifungal medications. However, recurrence may affect a minority. It has been found through previous research that the concomitant utilisation of probiotics during acute VVC leads to early relief of symptoms and signs and offers a preventive measure against recurrences. Objectives: This study aimed to assess the efficacy of the combination of oral probiotics with conventional antifungal treatment as compared to conventional antifungal treatment alone. Methods: Sixty patients who were newly diagnosed with VVC were enrolled in a randomised controlled trial. They were divided into two groups. Group A included 30 cases treated with conventional antifungal medication (oral fluconazole 150 mg single dose), while Group B included 30 cases treated with conventional antifungal medication (oral fluconazole 150 mg single dose) alongside oral probiotic capsules (Lactobacillus rhamnosus, L. crispatus, L. gasseri, L. jensenii) for 2 months. The clinical and mycological findings were recorded before and after treatment. The relapse rate and side effects were recorded during the period of our study. Results: No significant difference between the clinical cure rate, mycological cure, and relapse rate was seen between the two groups. (P &lt; 0.05). However, a larger proportion of patients in Group B (97%) achieved complete remission compared to Group A (90%). No side effects were noted in either of the groups. Conclusion: Based on the findings, it can be concluded that the addition of probiotics to conventional antifungal treatment led to better rates of clinical and mycological cure and a lower likelihood of relapse compared to conventional antifungal treatment alone.

Outcomes of balloon-assisted maturation with large-diameter balloons.

Balloon-assisted maturation (BAM) is a well-established technique for maturation of inadequate arteriovenous fistulas (AVF). The objective of this study was to evaluate outcomes of initial BAM using large-diameter angioplasty balloons. Charts of patients who underwent BAM between 2018 and 2021 at a single academic institution were reviewed. AVF maturation rate was the primary outcome. Secondary outcomes included procedural complications, re-intervention rates, post-procedure vein diameter, and time to catheter-free hemodialysis (HD). Outcomes of patients that underwent initial BAM with ⩾7 mm diameter balloons (Group I) were compared to those of patients that had initial BAM with <7 mm balloons (Group II). Group I (n = 149) was a significantly younger cohort and had more men compared to Group II (n = 90). There were no significant differences associated with procedural details and complication rates. Median vein diameter was larger (5.9 mm, IQR: 5-6.4) in Group I compared to Group II (5.1 mm, IQR: 4.2-5.9; p = 0.03) on post-procedure Duplex ultrasound. There was also a higher incidence of vein stenosis in Group II. The overall maturation rate was higher in Group I (97% vs 88%, p = 0.003), and a larger proportion of patients in Group II required more than one BAM to achieve maturation (33% vs 16%, p = 0.002). The median time to catheter-free HD after first BAM was 29 days (IQR: 19-47) in Group I and 42 days (IQR: 24-75) in Group II (p = 0.002). At 60 days after first BAM, the incidence of catheter-free HD was 83% in Group I versus 67% in Group II (p = 0.001). Our study demonstrates that the ability to utilize large angioplasty balloons during initial BAM is associated with higher rates of AVF maturation with fewer re-interventions and shorter time to catheter-free dialysis. AVFs that can tolerate this procedure often have more favorable baseline characteristics.

Changes in intraocular pressure following intravitreal dexamethasone implant in patients with history of glaucoma filtration surgery.

This study aimed to evaluate changes in intraocular pressure following intravitreal dexamethasone implant injection, specifically in patients undergoing glaucoma filtration surgery. The degree of increase in intraocular pressure was compared retrospectively among three groups. Group 1 comprised patients who underwent prior glaucoma filtration surgery (54 eyes). Group 2 included patients with or suspected glaucoma without such surgical history (20 eyes). Group 3 included patients without glaucoma (33 eyes). Pressure measurements were taken before the injection and at 1, 2, 3, and 6months post-injection. A subgroup analysis was performed for pressure > 35mmHg, > 30mmHg, > 25mmHg, and a difference > 10mmHg between the peak and baseline pressure. Group 1 consistently displayed lower pressures compared with Group 2, with significant difference at both 1- and 6-month post-injections (15.09mmHg vs. 18.10mmHg, P = 0.042 and 13.91mg vs. 17.25mmHg, P = 0.040). The proportion of patients in Group 1 and Group 3 with pressures > 25mmHg, > 30mmHg, and a difference > 10mmHg did not significantly differ (15.6% vs. 9.5%, P = 0.231; 3.1% vs. 2.3%, P = 0.867; and 17.1% vs. 7.1%, P = 0.231). Notably, Group 2 exhibited a significantly higher proportion within each category (> 25mmHg, 24.0%; > 30mmHg, 20.0%; > 10mmHg difference, 28.0%). Intravitreal dexamethasone implant did not increase the risk of elevated intraocular pressure in patients with a history of glaucoma filtration surgery compared with patients with suspected glaucoma; the risk was similar to those without glaucoma.

Efficacy of tacrolimus capsules in patients undergoing high-risk keratoplasty

Purpose: To evaluate the efficacy of tacrolimus capsules in patients undergoing high-risk keratoplasty.&#x0D; Methods: 40 high-risk patients who underwent penetrating keratoplasty at The Third Hospital of Hebei Medical University, China between January 2016 and December 2021 were included in this study. These patients were divided into two groups based on the specific immunosuppressant administered post-surgery. Twenty patients were administered oral tacrolimus capsules in conjunction with 0.1 % tacrolimus eye drops, constituting the combination with systemic treatment group (group 1), while another twenty patients were solely administered 0.1 % tacrolimus eye drops, forming the topical treatment group (group 2). The occurrence of rejection, corneal neovascularization, corneal graft edema and visual acuity were documented in both groups.&#x0D; Results: In comparison to patients in group 2, patients in group 1 exhibited a significant reduction in rejection rate (p &lt; 0.05). Additionally, the average time of neovascularization in group 1 was delayed and the number of cases was lower (p &lt; 0.05). Furthermore, a smaller proportion of patients in group 1 experienced corneal graft edema (25 vs 60 %, p &lt; 0.05), while a higher percentage of patients in group 1 demonstrated improved visual acuity (90 vs 60 %, p &lt; 0.05).&#x0D; Conclusion: Concurrent administration of tacrolimus eye drops and capsules orally effectively mitigates anti-rejection reactions, regulation of neovascularization, management of graft edema and enhancement of visual acuity in high-risk keratoplasty patients when compared to the use of tacrolimus eye drops as a standalone treatment. These results have the potential to stimulate novel avenues of investigation in future clinical research.

Dexmedetomidine vs Dexamethasone as an Adjuvant to Levobupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomies.

In the postoperative period, open total abdominal hysterectomy (TAH) surgeries induce considerable pain. Multimodal strategies are being used to alleviate pain. This study aimed to examine the efficacy and safety of dexamethasone and dexmedetomidine as an adjuvant to levobupivacaine in ultrasound-guided transversus abdominis plane (TAP) blocks for postoperative pain in TAH patients. A total of 72 patients with ASA grade I and grade II were randomly and equally assigned to two groups. After the completion of surgery with a subarachnoid block (SAB), patients in group 1 received a mixture of 20 mL of 0.25% levobupivacaine and 4 mg of dexamethasone on each side of the TAP block. Patients in group 2 received a mixture of 20 mL of 0.25% levobupivacaine and dexmedetomidine, with a total dose of 1 µg/kg body weight evenly distributed bilaterally in the TAP block. Patients were evaluated for pain using the Visual Analog Scale (VAS), total tramadol consumption as rescue analgesia, time to first rescue analgesia, any adverse effects, and patient satisfaction. When comparing VAS scores for pain assessment, we observed that the mean VAS score was initially comparable between the two groups for the first hour. However, at 6, 9, and 12 h, VAS scores were significantly lower in group 2. The mean total tramadol consumption was higher in group 1 than in group 2 (213.33 ± 44.08 vs 161.11 ± 37.93 mg, P-value 0.027). The time to the first rescue analgesia after the TAP block in the postoperative period was significantly longer in group 2 (47.5 ± 62.76 vs 77.22 ± 56.14 min, P-value 0.002). No significant side effects were noted, and a greater proportion of patients in group 2 expressed satisfaction with their overall pain treatment. The addition of dexmedetomidine to levobupivacaine is superior to the addition of dexamethasone, as it prolongs the duration of the block in the dexmedetomidine group. However, the use of dexamethasone as an adjuvant is a good alternative option, particularly due to its lower cost and reduced incidence of adverse effects such as postoperative nausea and vomiting.

Perinatal Outcome in Overweight Women: An Audit.

Obesity in pregnancy is associated with a myriad of well-documented complications. However, the outcomes of pregnancy in overweight females, who are not classified as obese, have not been studied. The aim of the study was to assess foeto-maternal outcomes in primigravida who are overweight and compare them to normal-weight patients. This was a prospective observational cohort study and included primigravida with full-term gestation (between 38 and 42 weeks), with a single live foetus in vertex presentation, who were admitted for labour induction. Based on pre-pregnancy weight, patients were divided into normal weight (body mass index, BMI<23kg/m2) and overweight (BMI≥23kg/m2 and<25kg/m2) categories labelled as groups A and B, respectively. Data was collected for gestational age, demographics (age, education, occupation), and obstetric and labour-related parameters per pre-designed proforma. Parameters included were the reason for induction, number of doses of prostaglandin E2 (PGE2) gelused, duration of labour, induction to delivery interval, and mode of birth- operative/ non-operative. Data was also collected for peri-partum maternal complications, neonatal Apgar score, and need for Neonatal Intensive Care Unit (NICU) admissions. One hundred and fifty patients were recruited in the study and divided based on weight into two groups- 115 in Group A (normal weight) and 35 in Group B (overweight). Compared to Group A, a higher proportion ofpatients in Group B needed a third dose of PGE2 gel (n=24, 20.8%vs n=18, 51.4%). Also, more patients in Group B had an induction to delivery time of longer than 30 hours (n=7, 20% vs n=5, 4.3%)and had a higher incidence of failed induction needing caesarean section (n=9, 25.7% vs n=13, 11.3%).Neonates born to overweight mothers had a poor Apgar score at 1 min. However, on reassessment, Apgar improved at 5 minutes, and no statistically significant difference was seen for admission to NICU- 5.7% (n=2) in Group B vs 1.7% (n=2) in Group A Conclusion: Pregnancy in overweight females is associated with prolonged labour, higher instances of failed induction, and poor neonatal outcomes at initial assessment. Thus, perinatal counselling and management should focus on weight control while also planning appropriate strategies for monitoring and treating pregnancy-related complications if weight control measures fail. Although obesity is the main focus of research, we suggest including overweight but non-obese females in such studies as they have similar adverse outcomes and complications.

IINCIDENCE OF POST-OPERATIVE NAUSEA AND VOMITING IN LAPAROSCOPIC CHOLECYSTECTOMY WITH A SINGLE DOSE OF PREOPERATIVE DEXAMETHASONE

and vomiting (PONV). Dexamethasone, a synthetic glucocorticoid with potent anti-inflammatory, immune-modulating, analgesic, and anti-emetic effects, effectively reduces the incidence of PONV after laparoscopic cholecystectomy. In this double-blind, placebo-controlled study, we aimed to investigate the efficacy of a single 8 mg dose of dexamethasone in preventing PONV in patients undergoing laparoscopic cholecystectomy. Sixty patients were randomized into two groups: group A, who received an 8 mg dexamethasone injection in a 2-ml preparation, and group B, who received normal saline during induction. Both groups received standardized anesthesia. Post-operatively, the incidence of nausea and vomiting was observed in both groups. Our study's findings indicate that no substantial variances were observed between the two cohorts in terms of medical or demographic factors. However, a lower proportion of patients in group A exhibited post-operative nausea and vomiting (PONV), while group B had a higher demand for anti-emetic medications to alleviate PONV symptoms. Thus, we can infer that administering a solitary dose of dexamethasone before laparoscopic cholecystectomy can reduce the risk of post-operative complications in patients.

Analysis of clinical efficacy of comprehensive nursing intervention on elderly patients with hypertension combined with hyperuricemia.

To evaluate the clinical efficacy of the comprehensive nursing intervention on elderly patients with hypertension combined with hyperuricemia. This was a retrospective study. One hundred elderly patients with hypertension combined with hyperuricemia admitted to the Baoding No.1 Central Hospital from May 2019 to May 2020 were included and randomly divided into two groups. Patients in the control group were treated with conventional nursing intervention, while those in the experimental group were treated with comprehensive nursing intervention based on the therapy in the control group. The improvement of compliance behavior, clinical efficacy, quality of life and satisfaction with hypertension combined with hyperuricemia before and after treatment were compared and analyzed between the two groups. The proportion of patients in both groups who developed gout or renal insufficiency was recorded, and their long-term treatment outcomes were compared and analyzed. After the comprehensive nursing intervention, the number of cases of compliance behaviors in the experimental group was significantly higher than that in the control group(p<0.05). The systolic and diastolic blood pressure and uric acid levels were significantly lower in the experimental group compared to the control group after the intervention(p=0.00). The scores of physical function, psychological function, social function and material life status improved significantly in the experimental group compared to the control group after the intervention(p=0.00). The satisfaction rate of the experimental group was significantly higher than the control group(p=0.02). The proportion of patients in the experimental group who developed gout was significantly lower than that in the control group(p=0.03). Comprehensive nursing intervention plays a vital role in the treatment and prognosis of hypertension combined with hyperuricemia.

Long-term efficacy and safety of different corticosteroid courses plus mycophenolate mofetil for autoimmune encephalitis with neuronal surface antibodies without tumor.

To compare the efficacy and safety of different-course corticosteroids plus mycophenolate mofetil (MMF) as maintenance therapy in autoimmune encephalitis (AE) with neuronal surface antibodies (NSAbs) without tumor and explore the optimal course of corticosteroids. Fifty-five patients with definite AE without tumor were enrolled consecutively between June 2015 and November 2020 and retrospectively divided three groups according to the course of treatment with corticosteroid, i.e., a group of patients with a course of 3-6 months (Group 3-6mo), 6-12 months (Group 6-12mo), and >12 months (Group >12mo). Demographic data, clinical manifestation and ancillary tests results were recorded. The dosage and courses of corticosteroid treatment, the recovery of neurological function, the occurrence of adverse effects, and relapses were followed up. A total of 55 patients were included in the final analysis. The numbers of patients in Group 3-6 mo, Group 6-12 mo, and Group >12 mo was 14, 17, and 24, respectively. A significantly higher proportion of patients in Group >12 mo showed a decreased level of consciousness at the onset (12, 50%) than in Group 3-6 mo and Group 6-12 mo (2,14.3%; 3, 17.6%) (p = 0.033). The incidence of MRI abnormalities was significantly higher in Group 6-12 mo and Group >12 mo (10, 58.8%; 16, 66.7%) than in Group 3-6 mo (3, 21.4%) (P=0.023). Ordinal regression analysis indicated that decreased level of consciousness was associated with the course of corticosteroid (OR=3.838, 95% CI: 1.103-13.323, P=0.035). No significant difference was observed between the three groups regarding the cumulative dose of corticosteroids administered during the first three months of long-term treatment (P>0.05). Additionally, no significant difference in the cumulative dosage of corticosteroids was found between patients in Group 6-12 months and Group >12 months during the first 6 months after beginning long-term treatment. The mRS scores of the three groups were not statistically significant before and after first-line treatment or at the last follow-up. Bonferroni multiple comparison test indicated that the mRS scores of patients in Group 6-12 months and Group >12 months were not statistically significant at 3 months and 12 months after the start of long-term treatment. During the follow-up, 50 (90.9%) patients achieved satisfactory neurological function (mRS score ≤2). Five patients (9.1%) experienced a first relapse and 2 of them were overlapped with both anti-NMDA receptor and glial antibodies. The incidence of adverse effects was significantly higher in Group >12 mo (17, 70.8%) than in Group 3-6 mo (3, 21.4%) and Group 6-12 mo (5, 29.4%) (P=0.003). The beneficial effects of oral corticosteroid treatment may do not persist beyond 12 months and may even contribute to an increased incidence of adverse effects. In order to optimize the effectiveness and safety of treatment, we recommend a corticosteroid course of 3-12 months. Patients with reduced levels of consciousness may be more inclined to choose longer courses of corticosteroids for long-term treatment. Patients with an "overlapping syndrome" may require more intense immunotherapy to prevent relapse.

Total intravenous anesthesia for geriatric hip fracture with severe systemic disease

PurposeOur study aimed to determine the impact of a novel technique of anesthesia administration on the clinical outcomes and complications in geriatric patients with severe systemic disease undergoing hip surgery.MethodsWe retrospectively identified patients aged > 65 years with severe systemic disease that was a constant of life [American Society of Anesthesiologists (ASA) IV] who underwent surgery for hip fracture between January 2018 and January 2020. The patients were divided into two groups: Group I [fascia iliaca compartment block plus propofol-based total intravenous anesthesia (FICB + TIVA)] and Group II [general anesthesia (GA)]. The primary outcomes were 30-day and 1-year mortality. The secondary outcomes included length of hospital stay, length of intensive care unit (ICU) stay, postoperative morbidity, Visual Analog Scale score, and consumption of analgesics.ResultsThere was no significant difference in the 30-day mortality (5 vs. 3.8%, p = 0.85) and 1-year mortality (15 vs. 12%, p = 0.73) between the groups. Group I had significantly lower ICU requirements (p = 0.01) and shorter lengths of ICU stay (p < 0.001) and hospital stay (p < 0.001). Moreover, a smaller proportion of patients in Group I required postoperative morphine or oral opiates.ConclusionGeriatric patients who underwent hip surgery under FICB + TIVA required fewer ICU admissions, shorter lengths of ICU and hospital stay, and had lesser postoperative opioid consumption than those who were under GA. Hence, we recommend the novel FICB + TIVA technique for hip fracture surgery in geriatric patients with poor general health status and high surgical risks (ASA IV).

Community-centered Disease Severity Assessment of Metabolic Dysfunction-associated Fatty Liver Disease.

Disease severity across the different diagnostic categories of metabolic dysfunction-associated fatty liver disease (MAFLD) remains elusive. This study assessed the fibrosis stages and features of MAFLD between different items. We also aimed to investigate the associations between advanced fibrosis and risk factors. This multicenter cross-sectional study enrolled adults participating in liver disease screening in the community. Patients were stratified following MAFLD diagnostic criteria, to group A (395 patients) for type 2 diabetes, group B (1,818 patients) for body mass index (BMI)>23 kg/m2, and group C (44 patients) for BMI≤23 kg/m2 with at least two metabolic factors. Advanced fibrosis was defined as a fibrosis-4 index>2.67. Between 2009 and 2020, 1,948 MAFLD patients were recruited, including 478 with concomitant liver diseases. Advanced fibrosis was observed in 125 patients. A significantly larger proportion of patients in group C (25.0%) than in group A (7.6%) and group B (5.8%) had advanced fibrosis (p<0.01). Logistic regression analysis found that hepatitis B virus (HBV)/hepatitis C virus (HCV) coinfection (odds ratio [OR]: 12.14, 95% confidence interval [CI]: 4.04-36.52; p<0.01), HCV infection (OR: 7.87, 95% CI: 4.78-12.97; p<0.01), group C (OR: 6.00, 95% CI: 2.53-14.22; p<0.01), and TC/LDL-C (OR: 1.21, 95% CI: 1.06-1.38; p<0.01) were significant predictors of advanced fibrosis. A higher proportion of lean MAFLD patients with metabolic abnormalities had advanced fibrosis. HCV infection was significantly associated with advanced fibrosis.

First in man study: Bcl-Xl_42-CAF®09b vaccines in patients with locally advanced prostate cancer.

The B-cell lymphoma-extra-large (Bcl-XL) protein plays an important role in cancer cells' resistance to apoptosis. Pre-clinical studies have shown that vaccination with Bcl-XL-derived peptides can induce tumor-specific T cell responses that may lead to the elimination of cancer cells. Furthermore, pre-clinical studies of the novel adjuvant CAF®09b have shown that intraperitoneal (IP) injections of this adjuvant can improve the activation of the immune system. In this study, patients with hormone-sensitive prostate cancer (PC) received a vaccine consisting of Bcl-XL-peptide with CAF®09b as an adjuvant. The primary aim was to evaluate the tolerability and safety of IP and intramuscular (IM) administration, determine the optimal route of administration, and characterize vaccine immunogenicity. Twenty patients were included. A total of six vaccinations were scheduled: in Group A (IM to IP injections), ten patients received three vaccines IM biweekly; after a three-week pause, patients then received three vaccines IP biweekly. In Group B (IP to IM injections), ten patients received IP vaccines first, followed by IM under a similar vaccination schedule. Safety was assessed by logging and evaluating adverse events (AE) according to Common Terminology Criteria for Adverse Events (CTCAE v. 4.0). Vaccines-induced immune responses were analyzed by Enzyme-Linked Immunospot and flow cytometry. No serious AEs were reported. Although an increase in T cell response against the Bcl-XL-peptide was found in all patients, a larger proportion of patients in group B demonstrated earlier and stronger immune responses to the vaccine compared to patients in group A. Further, we demonstrated vaccine-induced immunity towards patient-specific CD4, and CD8 T cell epitopes embedded in Bcl-XL-peptide and an increase in CD4 and CD8 T cell activation markers CD107a and CD137 following vaccination. At a median follow-up of 21 months, no patients had experienced clinically significant disease progression. The Bcl-XL-peptide-CAF®09b vaccination was feasible and safe in patients with l hormone-sensitive PC. In addition, the vaccine was immunogenic and able to elicit CD4 and CD8 T cell responses with initial IP administration eliciting early and high levels of vaccine-specific responses in a higher number og patients. https://clinicaltrials.gov, identifier NCT03412786.

Nasogastric tube insertion in anesthetized intubated adult patients: A comparison between the “reverse Sellick’s maneuver with throat pack in situ” and reverse Sellick’s maneuver alone

Background: Nasogastric tube (NGT) insertion is an essential procedure in the operating room for which the anesthesiologists often take the responsibility. This simple procedure often becomes difficult in anesthetized patients. Literature reveals the flooding of studies and novel techniques are in the pipeline, indicating that quest for the best is still on. Aims and Objectives: The aim of the study was to determine the proportion of patients in whom successful NGT insertion would be possible in the first attempt using either the “Reverse Sellick’s maneuver (RSM) with throat pack in situ” technique or RSM alone; and to compare the proportions between the two groups. Materials and Methods: This interventional study was performed on 222 adult patients (≥18 years), undergoing abdominal surgeries requiring intraoperative NGT insertion. Patients received NGT insertion using the combined RSM with “throat pack in situ” technique (Group A, n=111) or RSM alone (Group B, n=111). The proportion of patients in whom successful NGT insertion was possible in the first attempt using either of the techniques and the time taken for correct placement of NGT in both the groups. In addition, the incidence of adverse events was noted. Results: Although, NGT placement was possible in higher proportions of patients in Group A in first attempt compared with Group B (91% vs. 83.8%), it was not significant on analysis (P=0.106). The procedure time in both the groups was comparable (30.0±4.0 vs. 29.9±4.3, P=0.859). Coiling was found to be significantly more in the RSM alone technique as compared to the combined method. (P=0.04). Conclusion: With comparable success rate and lesser incidence of adverse events, it can be commented that the RSM with throat pack in situ technique appears to be a better alternative to RSM alone.

A comparative analysis of distal locked and unlocked long proximal femoral nail antirotation (PFNA-II) in the fixation of stable intertrochanteric fractures

PurposeLong proximal femoral nail anti-rotation (PFNA-II) is a preferred implant in recent years for fixation of pertrochanteric fractures, especially in osteoporotic patients. The purpose of this study is to prospectively investigate the effect of distal locking in long PFNA-II fixation of stable intertrochanteric fractures. MethodsA total of 58 patients with isolated stable intertrochanteric fractures and treated in our hospital during the study period of 2017–2019 by distal locked or unlocked long PFNA-II fixation were included in this study. Patients who had multiple injuries or open fractures were excluded. There were 40 female and 18 male patients, with 33 affecting the left side and 25 the right side. Of them, 31 belonged to the distal locked group (group A) and 27 to the unlocked group (group B). Surgical procedures and implants used in both groups were similar except for the distal locking of the nails. General data (age, gender, fracture side, etc.) showed no significant difference between two groups (all p > 0.05). The intraoperative parameters like operative time, radiation exposure and follow-up parameters like functional and radiological outcomes were recorded and compared. Statistical tests like the independent samples t-test Fischer's exact and Chi-square test were used to analyze association. ResultsThe distribution of the fractures according to AO/OTA classification and 31A1.2 type of intertrochanteric fractures were most common in our study. All the included fractures united and the average functional outcome in both groups were good and comparable at the end of one year. The operative time (mL, 107.1 ± 12.6 vs. 77.0 ± 12.0, p < 0.001) and radiation exposure (s, 78.6 ± 11.0 vs. 40.3 ± 9.3, p < 0.001) were significantly less among the patients in group B. Fracture consolidation, three months after the operative procedures, was seen in a significantly greater proportion of patients in group B (92.6% vs. 67.7%, p = 0.025). Hardware irritation because of distal locking bolt was exclusively seen in group A, however this was not statistically significant (p = 0.241). ConclusionWe conclude that, in fixation of stable intertrochanteric fractures by long PFNA-II nail, distal locking not only increases the operative time and radiation exposure but also delays the fracture consolidation and increases the chances of hardware irritation, and hence is not required.

Mavacamten induces a clinical, hemodynamic, and biomarker response beyond the primary endpoint in EXPLORER-HCM: results from a post hoc machine learning analysis

Abstract Introduction Mavacamten, a first-in-class selective inhibitor of cardiac myosin, was demonstrated in EXPLORER-HCM (NCT03470545) to be superior to placebo in achieving a primary endpoint of either (1) a ≥1.5 mL/kg/min increase in peak oxygen consumption (pVO2) and at least one New York Heart Association (NYHA) class reduction, or (2) a ≥3.0 mL/kg/min pVO2 increase without NYHA class worsening, in adults with obstructive hypertrophic cardiomyopathy (oHCM). However, the observed benefits of mavacamten were broader than the primary endpoint, suggesting a complex effect of the drug beyond improvements in these two parameters. Purpose A post hoc investigation of mavacamten clinical effects beyond the primary endpoint of EXPLORER-HCM. Methods EXPLORER data at week 30 were analyzed to evaluate improvements from baseline in primary (specified above), secondary (e.g. postexercise left ventricular outflow tract gradient and Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score) and exploratory endpoints (e.g. circulating NT-ProBNP and cardiac Troponin I). Responses were classified as improved or not improved based on published thresholds, clinical standards and analyses of the EXPLORER data. Patients were grouped according to their improvement status using unsupervised hierarchical clustering. Results The cluster analysis resulted in four main groups with the following trends (Table); Group 1 = patients who met the primary endpoint and showed improvement in secondary/exploratory endpoints; Group 2 = patients with improvement in secondary/exploratory endpoints who did not meet the primary endpoint; Group 3 = patients who met the primary endpoint without substantial secondary/exploratory endpoint responses; Group 4 = patients without appreciable improvement in any endpoint. A substantially larger proportion of patients in Group 1 received mavacamten compared with placebo (88% vs. 12%, respectively). A similar trend was observed in Group 2 patients who exhibited improvements in secondary/exploratory endpoints (85% mavacamten vs. 15% placebo). Group 3 consisted predominantly of placebo-treated patients who met the primary endpoint but had negligible responses to secondary/exploratory endpoints (5% mavacamten vs. 95% placebo). Group 4 consisted predominantly of placebo-treated patients without appreciable clinically relevant responses from this analysis (10% mavacamten vs. 90% placebo). Conclusions Mavacamten was associated with clinical improvements beyond the primary endpoint of EXPLORER-HCM and was predominantly accompanied by amelioration of other measures associated with oHCM pathophysiology. In contrast, most placebo-treated patients who met the primary endpoint did not exhibit improvement in the underlying pathophysiology. These findings suggest a potential underestimation of mavacamten clinical impact based on the primary endpoint and prompt a deeper examination of mavacamten efficacy in patients with oHCM based on other clinically relevant endpoints. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): MyoKardia, Inc., a wholly owned subsidiary of Bristol Myers Squibb

Endocapillary hypercellularity levels are associated with early complete remission in children with class IV lupus nephritis as the initial presentation of SLE

BackgroundEndocapillary hypercellularity (ECHC) is commonly seen in class IV lupus nephritis (LN), the most common and severe LN in children. Factors influencing early complete remission (CR) in pediatric class IV LN have been poorly described. We investigated the relationship between ECHC levels and early CR in pediatric class IV LN.MethodsPatients with newly, simultaneously diagnosed systemic lupus erythematosus (SLE) and class IV LN by renal biopsy from 2012 to 2021 were studied. In this retrospective study, two pathologists who were blind to clinical information reviewed all pathological data retrospectively and classified glomerular lesions according to the revised criteria of the International Society of Nephrology and the Renal Pathology Society (ISN/RPS). The demographics, baseline clinical characteristics, laboratory parameters, renal histopathological findings, treatment regimen and CR at 6 months after immunosuppressive therapy were analyzed. ECHC was categorized as: > 50% (group A), 25–50% (group B) and < 25% (group C). CR was defined as absence of clinical symptoms, 24-hour urinary protein < 0.15 g, and normal levels of serum creatinine and albumin.ResultsSixty-four patients were identified: 23, 15 and 26 in groups A, B and C, respectively. Group A had significantly higher levels of D-dimer, urine protein, and SLE disease activity index (SLEDAI) than groups B and C. Group C had a markedly higher estimated glomerular filtration rate (eGFR) than groups A and B. A substantially greater proportion of patients in group A had glomerular microthrombi and basement membrane thickening than in groups B and C. At 6 months post treatment, CR was achieved in 19 (82.6%), 5 (33.3%) and 11 (42.3%) in groups A, B and C, respectively (p < 0.05, group A vs groups B and C). Multiple logistic regression analysis revealed that ECHC and urine protein levels were significantly associated with CR.ConclusionECHC and urine protein levels may be valuable biomarkers for predicting early CR in pediatric class IV LN.

Synthetic Analogue of Leu-Enkephalin in COVID-19 (a Prospective Clinical Study)

One of the main problems facing intensivists when treating patients with COVID-19 is severe and critical acute respiratory distress syndrome (ARDS) with the underlying viral pneumonia. The current guidelines of the Russian Ministry of Health (Version 15 of 22.02.22) do not include drugs with a lung protective effect. This issue could be solved by administration of a synthetic analogue of leu-enkephalin.Aim. Study the efficacy of a synthetic analogue of leu-enkephalin in ARDS in patients with COVID-19.Materials and methods. The study included 35 patients divided into 2 groups. Group 1 (main) patients (n=15) in addition to standard therapy received a continuous infusion of synthetic analogue of leu-enkephalin at a rate of 5 µg/kg/hour for 5 days. Patients from group 2 (control, n=20) were treated according to the Temporary Guidelines of the Ministry of Health (V.15), but without the synthetic analogue of leu-enkephalin. The radiological data, frequency, severity and evolution of respiratory complications, changes in P/F (PaO2/FiO2) ratio, as well as changes in the scores of prognostic APACHE II, SOFA, and NEWS scales were evaluated.Results. In patients taking the studied drug, the percentage of lung damage did not change with the median (IQR) of 0 [–8; 0], while in the control group it increased by approximately 10% with the median (IQR) of +10,0 [+2; +20] (P=0.001). The proportion of patients in group 1 with positive disease evolution within 5–9 days after treatment initiation was significantly higher and reached 46.7 [24.8; 69.9]%, whereas in group 2 it was 15.0 [5.2; 36.0]% (P=0.04). Also, in group 1, starting from day 4, the median P/F ratio was significantly higher than in group 2 reaching 220 [185;245] versus 127 [111;158], respectively (P=0.014). The need for non-invasive lung ventilation in group 1 on day 7 averaged 7%, while in group 2 it was as high as 45.0%, which was significantly higher than in the main group (P=0.013).Conclusions. The use of synthetic analogue of leu-enkephalin according to the specified regimen had a significant impact on the main parameters of the viral pneumonia severity. The results serve as a rationale for the development of a novel effective treatment strategy to supplement the current standard COVID-19 management.

SPOD1 Effect of BMI on Safety of Bariatric Surgery during the COVID-19 pandemic, Procedure Choice, and Safety Protocols – an analysis from the GENEVA Study

BackgroundIt has been suggested that patients with a Body Mass Index (BMI) of >60 kg/m2 should be offered expedited Bariatric Surgery (BS) during the Coronavirus Disease-2019 (COVID-19) pandemic. The main objective of this study was to assess the safety of this approach.MethodsWe conducted a global study of patients who underwent BS between 1/05/2020 and 31/10/2020. Patients were divided into three groups according to their preoperative BMI - Group I (BMI<50 kg/m2), Group II (BMI 50–60 kg/m2), and Group III (BMI>60 kg/m2). The effect of preoperative BMI on 30-day morbidity and mortality, procedure choice, COVID-19 specific safety protocols, and comorbidities was assessed.ResultsThis study included 7084 patients (5197;73.4% females). The mean preoperative weight and BMI were 119.49±24.4 Kgs and 43.03±6.9 Kg/m2, respectively. Group I included 6024 (85%) patients, whereas Groups II and III included 905 (13%) and 155 (2%) patients, respectively.The 30-day mortality rate was higher in Group III (p=0.001). The complication rate and COVID-19 infection were not different. Comorbidities were significantly more likely in Group III (p=<0.001). A significantly higher proportion of patients in group III received Sleeve Gastrectomy or One Anastomosis Gastric Bypass compared to other groups. Patients with a BMI of >70 kg/m2 had a 30-day mortality of 7.7% (2/26). None of these patients underwent a Roux-en-Y Gastric Bypass.ConclusionThe 30-day mortality rate was significantly higher in patients with BMI >60 kg/m2. There was, however, no significant difference in complications rates in different BMI groups, probably due to differences in procedure selection.

Low recognition of attention deficit hyperactivity disorder in adult patients admitted to the Epilepsy Monitoring Unit.

IntroductionAdult patients with epilepsy (PWE) have an 18% prevalence of comorbid attention deficit hyperactivity disorder (ADHD) compared to a prevalence of 2%–5% in the general population. Recognition of this dual diagnosis is important since stimulant therapy is both safe and effective in this population.MethodsHere, we aim to determine if PWE have adequate documentation for comorbid ADHD when being admitted to the Epilepsy Monitoring Unit (EMU). A retrospective review was conducted at the Baylor St. Luke's Medical Center EMU for patients presenting between July 2017 and November 2020. Patients were divided into two groups: Group I—patients without a documented ADHD diagnosis or ADHD medications and Group II—patients with a documented ADHD diagnosis and/or taking medications indicated specifically for ADHD.ResultsOf 524 individual patients who presented to the EMU, only 25 patients (4.8%) had documentation of a diagnosis of ADHD and/or ADHD medications (Group II). The proportion of patients in Group II did not significantly differ based on the EMU diagnosis. However, there was a significantly greater number of other psychiatric diagnoses (p = .005) and a greater number of psychiatric medications prescribed (p < .001) in patients in Group II.ConclusionOur study suggests that ADHD is underrecognized and underdiagnosed in patients presenting to the EMU, and screening tools may be useful to help clinicians address seizure comorbidities such as ADHD.