Prospective Randomized Cohort Study Research Articles

Rationale and design of a prospective randomized study of the effect of ferric carboxymaltose therapy on quality of life and clinical picture of heart failure with preserved ejection fraction in patients with iron deficiency

Introduction. The prevalence of iron deficiency (ID) among patients with chronic heart failure (CHF) ranges from 50% to 80%. It has been established that ID is a significant predictor of adverse outcomes and mortality in CHF, and is also associated with a decrease in exercise tolerance. The use of oral iron preparations for the purpose of its correction is limited by the high frequency of adverse events and, in some cases, their ineffectiveness in CHF. Ferric carboxymaltose has a high potential in the correction of ID, which has proven itself well in the cohort of patients with CHF, but its effectiveness has not been precisely established in CHF.Aim: To evaluate the effect of ferric carboxymaltose therapy on the quality of life, functional status, and clinical picture of CHF in patients with diagnosed iron deficiency.Material and Methods. It is a prospective randomized cohort study. It is planned to include 70 adult patients with CHF (NYHA II-III) and diagnosed ID: group 1 (n = 35) – group of drug therapy with ferric carboxymaltose, group 2 (n = 35) – without drug therapy. A control group of patients without ID (n = 30) will also be recruited. The prospective part involves the observation of patients with repeated visits after 6, 12 months, during which the indicators of quality of life, functional status, clinical picture of CHF, structural and functional echocardiographic indicators of LV and right heart, as well as the presence of repeated hospitalizations for CHF and death from all causes will be evaluated.

Efficacy of etonogestrel subcutaneous implants versus the levonorgestrel-releasing intrauterine system in the conservative treatment of adenomyosis.

To evaluate the clinical efficacy of etonogestrel subcutaneous implant (ENG-SCI) with that of the levonorgestrel-releasing intrauterine system (LNG-IUD) for adenomyosis treatment. A prospective randomized cohort study was conducted including 108 patients (50 patients in ENG-SCI group and 58 in the LNG-IUD group) with adenomyosis from January 2019 to July 2021. After 3 months of treatment, both ENG-SCI group and LNG-IUD group showed significant improvement in patients' visual analog scale, pictorial blood loss assessment chart (PBAC), and uterine volume (P ＜ 0.05). The uterine volume of patients in LNG-IUD group decreased more significantly than that in the ENG-SCI group since 3 months of treatment. The PBAC score in the LNG-IUD group improved better than that in the ENG-SCI group since 6 months of treatment (P ＜ 0.05). No significant difference in the occurrence rate of ideal vaginal bleeding patterns and the hemoglobin levels between the two groups was observed. The ENG-SCI group had a higher probability of weight gain and progesterone-related side effects (P ＜ 0.05). Both ENG-SCI and LNG-IUD were effective in treatment of adenomyosis. However, LNG-IUD had a more significant effect in treating adenomyosis-related dysmenorrhea, excessive menstrual flow, anemia, and uterine enlargement, with relatively fewer side effects.

Does topical vancomycin prevent fracture-related infections in closed fractures undergoing open reduction and internal fixation? A randomised controlled trial

PurposeThe role of topical vancomycin in fracture-related infection (FRI) is debatable. Very few studies have reported their efficacy in open and high-risk extremity fractures. This study aimed to assess topical vancomycin's role in reducing FRI in closed fractures undergoing open surgical intervention with an implant. MethodsThis prospective randomized cohort study was carried out between February 2021 to January 2022. Patients with isolated closed fractures, who were planned for open reduction and internal fixation within 2 weeks from the time of injury were included for this study. The data collected included age, gender, socioeconomic status, mechanism of injury, diagnosis, Tscherne classification, and time interval to take up for surgery. Patients were randomized into the intervention and control groups using the block randomization technique. The control group received only systemic antibiotic prophylaxis, whereas the intervention group received topical application of vancomycin powder in the surgical wound alongside systemic antibiotic prophylaxis. The primary outcome measure was the incidence of FRI among these individuals. Clinical and radiological findings and culture reports (in cases with infection) were recorded during the post-operative period and at 6 weeks of follow-up. All relevant statistical calculations were done using STATA statistical/data analysis-parallel edition version 16.0 (StataCorp LLC). The quantitative variables like age and duration of the surgery were assessed for normalcy by Shapiro-Wilk W test. An independent samples t-test with equal variances was applied to the age data. Fisher's exact test was used for the analysis of the primary outcome measure (presence of FRI following surgery), and “Risk of FRI” and “Risk difference” between the 2 groups was calculated. The strength of the association between qualitative variables was assessed using the Fisher's exact and Chi-square tests, respectively. ResultsThere were 88 patients included in this study. No statistical significance was found about FRI between both groups (p = 0.494). At 6 weeks following surgery, no incidence of infection was observed in the intervention group. Two infections (4.5%) were found in the control group, with positive cultures reported in one of them but none in the treatment group. Radiologically, 15.9% of patients in the control group showed lysis around the implant compared to 2.3% in the intervention group. Impaired fracture healing was observed in 22.7% of patients in the intervention group compared to 15.9% in the control group. ConclusionApplying topical vancomycin in closed fractures undergoing open reduction and internal fixation does not significantly reduce the incidence of FRI until the end of 6 weeks following surgery.

Angle Kappa and angle Alpha agreement between Pentacam Scheimpflug system, swept source optical coherence tomography and ray-tracing aberrometry

PurposeTo compare the consistency of Pentacam Scheimpflug system (Pentacam® HR), ray-tracing aberrometry (iTrace), and swept source optical coherence tomography (IOLMaster 700) measurements for Angle Kappa and angle Alpha. MethodsA prospective randomized cohort study. 86 individuals (86 eyes) aged 19–45 years with best corrected vision of 4.9 or better were randomly selected from January 2022 to December 2022 in a tertiary-level hospital. Angle Kappa and angle Alpha were measured or calculated using Pentacam, iTrace, and IOLMaster 700, respectively. ResultsThe mean difference of angle Kappa between any two instruments was not statistically significant, but the mean difference of angle Alpha between both Pentacam and iTrace, Pentacam and IOLMaster 700, and iTrace and IOLMaster 700 was statistically significant (p value <0.001, 0.003, <0.001). The highest consistency of angle Kappa and the narrowest 95% LoA (-0.20 to 0.21) were found between Pentacam and iTrace according to Bland Altman plots, but between Pentacam and IOLMaster 700 according to Mountain plots. Both Bland Altman plots and Mountain plots showed the highest consistency of angle Alpha and the narrowest 95% LoA (-0.14 to 0.24) between Pentacam and iTrace. ConclusionThe mean angle Kappa among Pentacam® HR, iTrace, and IOLMaster 700 had good agreement, and the value of angle Kappa could be output directly, making it more convenient for clinical application. The measured or calculated angle Alpha had poor agreement, and ophthalmologists could refer to measurements from multiple instruments.

Comparison of Honey & Povidone Iodine dressings in Post-Cesarean Surgical Site Wound Infection Healing.

To compare the healing of post-cesarean infected wounds by a combination of honey and povidone iodine & povidone-iodine alone dressings using ASEPSIS Score. This prospective randomised cohort study was carried out at at OBGYN Department Jinnah Postgraduate Medical Center from 1st August 2022 till 31st December 2022. Patients were randomly allocated into groups A and B. Group-A was dressed with honey povidone-iodine, while Group-B only had povidone-iodine. The ASEPSIS score was calculated in both groups on day fifth, 7th, 9th, and 10th day. Patients were followed till full recovery of the wound. A total of 70 women were included and equally allocated into two groups A & B (35 each). On day five mean ASEPSIS score in Group-A was 36.14 and that in Group- B was 37.74. No significant difference in scores were noted on day five [t (68) = -.753, p = .454] & day seven Group-A 28.63 vs Group-B 32.11 [t (68) = -1.302, p = .197]. Significant improvements in ASEPSIS scores were noted on days ninth & tenth. On day nine ASEPSIS score of Group-A was 21.54 and that of Group-B was 27.14 [t (68) = -2.056, p = .044]. On day tenth the mean ASEPSIS score of Group-A was 18.26, while that of Group-B was 23.86 [t (68) = -2.021, p = .047]. The mean time required for the wound to heal in Group-A and Group-B was eighteen & twenty-one days respectively. Significant improvements in ASEPSIS score occurred with the use of honey with povidone-iodine combination.

Tek kat ve çift kat onarımın rezidüel miyometriyal kalınlık, istmosel oluşumu ve jinekolojik bozukluklar üzerine etkisi: Prospektif Randomize Kontrollü Bir Çalışma.

Abstract:&#x0D; Physicians are making great efforts to decrease the long-term complications of the cesarean section such as placental adherent syndromes, uterine scar pregnancies, uterine rupture, abnormal menstrual bleeding, or isthmocele. There is a controversy about the closure technique of the cesarean incision. The purpose of that study was to compare the impact of single layer versus double-layer closure of the hysterotomy incision on the residual myometrial thickness, isthmocele, menstrual disorders, dysmenorrhea, and dyspareunia.&#x0D; Material and Method&#x0D; A prospective randomized cohort study has been performed in a tertiary center named Bursa Yuksek İhtisas Training Research Hospital between July – October 2021. Patients were randomly assigned to each procedure (1:1) to the Single Layer Locked Continuous group and Double-layer Continuous un-locked group as uterine closure technique. Patients were examined via transvaginal ultrasound to evaluate the isthmocele occurrence, residual myometrium thickness, and inquired about menstrual properties, dysmenorrhea, and dyspareunia. Patients were also divided into groups via underwent first cesarean and more than one cesarean. &#x0D; Results:&#x0D; The numbers of the women whose hysterotomy incision was closed by single-layer locked continuous( SLLC) technique and double-layer un-locked continuous(DLUC) technique 68 and 71 respectively. There was no statistically significant difference in terms of demographic variables, obstetric history, post-operative complications, neonatal outcomes. The comparison of these groups revealed that there was no significant difference in terms of post-menstrual bleeding, heavy menstrual bleeding, post-coital bleeding, dysmenorrhea, dyspareunia. The incisional residual myometrial thickness was higher in the DLUC group with a p-value of 0,007. Six patients in SLLC and 5 patients in the DLUC group have detected isthmocele (p: 0,941). &#x0D; Patients have also been categorized as women who undergone their first cesarean section (SLLC n: 33 versus DLUC, n:33) and more than one cesarean section (SLLC n: 35 versus DLUC, n:38). Comparing the patients in these subgroups also did not differ significantly in terms of isthmocele occurrence, menstrual disorders, or residual myometrial thickness. &#x0D; Conclusion:&#x0D; No significant difference had occurred in terms of isthmocele incidence, or menstrual disorders comparing the single layer versus double-layer closure. However, women whose hysterotomy insicions were closed with double-layer un-locked continuous technique have a thicker resudial myometrium than single layer closure group especially women who underwent repeated cesarean.

Comparison of Reproductive Outcomes in ICSI Cycles Using Sperm Chip Technique and Density Gradient Technique in Men with Normal Semen Analysis

Background: Microfluidic sperm sorting procedure or sperm chip technique is a chemical-free method of selecting sperm using a disposable chip. It is a new gentle alternative for sperm processing which has been produced to obtain sperm with higher rates of motility and better morphology, as well as to reduce DNA fragmentation in sperm with high DNA fragmentation to nearly undetectable levels. We aimed to evaluate sperm chip techniques on clinical pregnancy rates in patients who underwent intracytoplasmic sperm injection (ICSI). Methods: The patients in whom fresh embryo transfer (ET) on Day-3 or 5 after ICSI had been performed were analyzed in this prospective randomized cohort study. Results: Of those, 102 patients underwent ICSI with sperm isolated using sperm chip technique (study group) while 111 patients underwent ICSI with sperm isolated using swim-up technique (control group). No significant difference was observed between the groups in terms of fertilization rate in patients who underwent ET on the 3rd or 5th day. In the patients having ET on Day-3, Grade 1 embryos were obtained similarly between the sperm chip group and the control group. Grade 1 embryos transferred on Day-5 were observed significantly more frequently in the study group (p = 0.050). However, clinical pregnancy rates did not show significant differences between the groups in patients who were transferred on both the 3rd and 5th days. Conclusions: Although sperm selection using by sperm chip technique provides advantage in terms of blastocyst quality, use of this technique does not enhance success in terms of clinical pregnancy. Clinical Trial Registration: Approval was obtained from ClinicalTrials.gov with NCT03355937 approval number.

Comparison of clinical safety and efficacy of dexmedetomidine, remifentanil, and propofol in patients who cannot tolerate non-invasive mechanical ventilation: A prospective, randomized, cohort study.

Background and objectivesNon-invasive ventilation (NIV) is used in intensive care units (ICUs) to treat of respiratory failure. Sedation and analgesia are effective and safe for improving compliance in patients intolerant to NIV. Our study aimed to evaluate the effects of dexmedetomidine, remifentanil, and propofol on the clinical outcomes in NIV intolerant patients.MethodsThis prospective randomized cohort study was conducted in a tertiary ICU, between December 2018 and December 2019. We divided a total of 120 patients into five groups (DEXL, DEXH, REML, REMH, PRO). IBM SPSS Statistics 20 (IBM Corporation, Armonk, New York, USA) was used to conduct the statistical analyses.ResultsThe DEXL, DEXH, REML, and REMH groups consisted of 23 patients each while the PRO group consisted of 28 patients. Seventy-five patients (62.5%) became tolerant of NIV after starting the drugs. The NIV time, IMV time, ICU LOS, hospital LOS, intubation rate, side effects, and mortality were significantly different among the five groups (P = 0.05). In the groups that were given dexmedetomidine (DEXL, and DEXH), NIV failure, mortality, ICU LOS, and hospital LOS were lower than in the other groups.ConclusionIn this prospective study, we compared the results of three drugs (propofol, dexmedetomidine, and remifentanil) in patients with NIV intolerance. The use of sedation increased NIV success in patients with NIV intolerance. NIV failure, mortality, ICU LOS, IMV time, and hospital LOS were found to be lower with dexmedetomidine.

Teaching veterinary surgical skills: Comparison of massed versus spaced instruction.

To determine the effect of massed instruction (MI) versus spaced instruction (SI) of veterinary surgical skills on students' cognitive load and skill retention. Prospective randomized cohort study STUDY POPULATION: First-year veterinary students from Louisiana State University (LSU; n=47) and Lincoln Memorial University (LMU; n=101). Students were randomized to MI (two skills in a single session of twice the duration) or SI (one skill per session on two consecutive days). Instructors, instructional ratio, and total educational time was equivalent. Following instruction, students completed a cognitive load questionnaire and underwent a structured assessment immediately after (LMU only), 1day after, and 3-4 weeks after learning the second skill. Students completed two supervised practice sessions one and 2 weeks after the initial laboratory session(s). Overall cognitive load did not differ between groups (p > .05), although LMUs MI group reported higher physical and time demands, effort, and frustration. At initial assessment, SI students scored higher than MI students for the first skill at both LSU (mean checklist score=27.7 vs. mean=24; p=.004) and LMU (mean global rating score=4.76 vs. mean=4.55; p=.029). Differences between groups were no longer evident by 3-4 weeks after instruction. SI may lead to improved immediate performance; however, supervised practice was sufficient to overcome the initial disparity. SI may be beneficial for initial skill performance. However, SI and MI students had similar performance after 3 weeks, suggesting the more convenient curricular design of MI may be sufficient as long as practice sessions are incorporated.

Novel Method for Early Prediction of Clinically Significant Drug-Drug Interactions with a Machine Learning Algorithm Based on Risk Matrix Analysis in the NICU.

Aims: Evidence for drug–drug interactions (DDIs) that may cause age-dependent differences in the incidence and severity of adverse drug reactions (ADRs) in newborns is sparse. We aimed to develop machine learning (ML) algorithms that predict DDI presence by integrating each DDI, which is objectively evaluated with the scales in a risk matrix (probability + severity). Methods: This double-center, prospective randomized cohort study included neonates admitted to the neonatal intensive care unit in a tertiary referral hospital during the 17-month study period. Drugs were classified by the Anatomical Therapeutic Chemical (ATC) classification and assessed for potential and clinically relevant DDIs to risk analyses with the Drug Interaction Probability Scale (DIPS, causal probability) and the Lexicomp® DDI (severity) database. Results: A total of 412 neonates (median (interquartile range) gestational age of 37 (4) weeks) were included with 32,925 patient days, 131 different medications, and 11,908 medication orders. Overall, at least one potential DDI was observed in 125 (30.4%) of the patients (2.6 potential DDI/patient). A total of 38 of these 125 patients had clinically relevant DDIs causing adverse drug reactions (2.0 clinical DDI/patient). The vast majority of these DDIs (90.66%) were assessed to be at moderate risk. The performance of the ML algorithms that predicts of the presence of relevant DDI was as follows: accuracy 0.944 (95% CI 0.888–0.972), sensitivity 0.892 (95% CI 0.769–0.962), F1 score 0.904, and AUC 0.929 (95% CI 0.874–0.983). Conclusions: In clinical practice, it is expected that optimization in treatment can be achieved with the implementation of this high-performance web tool, created to predict DDIs before they occur with a newborn-centered approach.

Angle Kappa agreement between Scheimpflug tomography, combined placido Scheimpflug and combined slit scanning placido systems

PurposeTo compare the measured or calculated angle Kappa using Oculus pentacam HR, Sirius and Orbscan III devices.Patients and methodsA prospective randomized cohort study, conducted on 47 eyes of 47 healthy orthotropic individuals, with an age range of 18–50 years and a corrected Snellen’s distance visual acuity (CDVA) of 0.8 decimal or better. Angle Kappa is assessed directly using Orbscan® III software version 1.8.165.1. (Bausch and Lomb Rochester, New York, United States), while Pentacam® HR 1.21r.65 (Oculus Optikgeräte GmbH, Wetzlar, Germany) and Sirius device (CSO, version 3.2.1.60, Costruzione Strumenti Oftalmici, Florence, Italy) were used to calculate angle kappa indirectly.ResultsLeast mean difference of estimated angle Kappa was between Orbscan and Pentacam devices (− 0.18° ± 1.8), and it was statistically insignificant (p value = 0.1294). Differences between both Orbscan and Sirius, and Pentacam and Sirius were statistically significant (p value = 0.0004 and < 0.0001 consecutively). Bland Altman analysis showed a 95% confidence interval between Orbscan III and Pentacam of − 3.76 to 3.4 and between Orbscan III and Sirius of − 3.79 to 2.26.ConclusionPentacam parameters can be used as a reliable method to calculate angle kappa indirectly, without usage of any additional measurements from other machine. Sirius device parameters could also be used, but with less accurate results. A simple modification to those devices’ software to calculate it, and incorporate it in the printout is possible, and highly recommended.

Total knee arthroplasty versus unicompartmental knee arthroplasty in management of anteromedial knee osteoarthritis: a randomized clinical trial

Background: Both total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA) are options to manage anteromedial knee osteoarthritis. This study’s aim was to determine the functional outcome, time taken to walk without support, and postoperative complications after either TKA or UKA in treatment of anteromedial knee osteoarthritis. Methods: A prospective randomized cohort study was performed at a level 1 academic center on 60 patients with a mean age of 56.2 yr who had isolated anteromedial knee osteoarthritis. Thirty patients were managed by UKA (group 1), and the other 30 patients were managed by TKA (group 2). Diagnosis was confirmed by plain radiographs (anteroposterior standing, lateral, skyline, stress varus, and valgus views). Follow-up was done for at least 12 mo postoperatively. Results: Mean preoperative functional Knee Society Score (KSS) was 65.83 and 62.67 for group 1 and group 2, respectively. Mean functional KSS after 1 yr was 86.3 for group 1 and 84.6 for group 2. In group 1, one patient developed lateral joint line pain, and another patient developed postoperative blood loss of more than 400 mL. In group 2, one patient developed patellofemoral pain, and another patient developed postoperative blood loss of more than 400 mL. The mean time that it took for patients to walk without support was 1.6 wk in group 1 and 1.93 wk for group 2. Conclusions: Both UKA and TKA have the same functional outcome for treatment of anteromedial knee osteoarthritis and the same rate of complications, but early postoperative rehabilitation is better in patients managed by UKA. Level of Evidence: Level I.

Effect of early feeding regimen in pre-terms with abnormal antenatal dopplers: a prospective analytical COHORT study

Background: Enteral feeding in preterm neonates with intrauterine growth restriction (IUGR) and absent or reversed end diastolic flow (AREDF) on umbilical artery (UA) Doppler is delayed owing to an increased risk of necrotizing enterocolitis (NEC). Delaying enteral feeding with longer duration of parenteral nutrition (PN) carries an increased risk of various neonatal morbidities.Methods: It was a prospective observational non randomized cohort study. Data was collected prospectively from the NICU records. Neonates fulfilling the inclusion criteria were classified as early feeding regimen and late feeding regimen. A strict feeding regimen was followed. Data was analyzed for primary and secondary outcomes.Results: The 50 neonates were enrolled. Baseline characteristics were comparable. A significantly higher time to full feeds was recorded in the delayed feeding regimen by a mean of 3.9 days. The duration of hospital stay was significantly higher for delayed feeding regimen (+12.7 days). Days of mechanical ventilation were also significantly higher (+1.6 days) in the neonates in delayed feeding group. There was no difference in the incidence of feed intolerance, NEC, incidence of culture positive sepsis and mortality across the two regimens, however neonates in the delayed feeding group needed longer support with parenteral nutrition.Conclusions: Early feeding will lead to earlier time to full feeds and decreased duration of hospital stay without additional increase the incidence of feeding intolerance and NEC in neonates with AEDF/REDF. Individualized feeding strategy in these compromised neonates should be the primary objective to optimize outcomes.

Efficacy of the early treatment with tocilizumab-hydroxychloroquine and tocilizumab-remdesivir in severe COVID-19 Patients

BackgroundThe effectiveness of the best combination between different antiviral and anti-inflammatory drugs stills an interest in the treatment of COVID19 infection. Patients and methodsA prospective randomized cohort study comprised 108 adult patients with confirmed PCR COVID 19 infection with systemic hyper inflammation state, divided into two groups according to the treatment regimen, 56 in the tocilizumab- hydroxychloroquine (TCZ-HCQ) treatment, and 52 in the tocilizumab-remdesivir (TCZ-RMV) treatment. The first group received a combination of I.V. TCZ (400–800 mg every 24 h for only two doses) and HCQ (400 mg twice in the first day then 200 mg twice for 5 days) while the second group of patients received I.V. RMV of 200 mg on day 1 followed by 100 mg once daily infused over 60 min for 5 days with the same TCZ regimen used in the first group. All clinical parameters and laboratory investigations were assessed before and after treatment. ResultsThe CRP was significantly decreased while PaO2/FiO2 (P/F) ratio post-treatment was significantly improved in both treatment groups. TCZ-HCQ group showed a significant decrease in the ferritin, LDH, and D. Dimer levels. The median days of hospitalization with interquartile range (IQR) were 10 (6–16) and 8 (5–12) for TCZ-HCQ and TCZ-RMV groups, respectively. The numbers of mechanically ventilated patients were 25 and 43 for TCZ-HCQ and TCZ-RMV groups, respectively. Therapeutic failure was about 26.8% in the TCZ-HCQ group and 30.8% in the TCZ-RMV group but there was no significant difference between both groups. Some complications were recognized only in TCZ-RMV following treatment including secondary bacterial infections (42.3%), myocarditis (15.4%), and finally pulmonary embolism (7.7%). ConclusionEfficacy of both TCZ-RMV and TCZ-HCQ combinations are observed in the treatment of severe COVID-19 patients; however the increased need for ICU or mechanical ventilation in the TCZ-RMV arm contributed to the appearance of cardiac and thrombotic events.The study was registered at the Clinical Trials registry (ClinicalTrials.gov; NCT04779047).

ANALGESIC EFFICACY OF TRAMADOL/ ACETAMINOPHEN COMBINATION WITH DICLOFENAC SODIUM IN MODERATE TO SEVERE LOW BACK PAIN

This prospective randomized cohort study was conducted in two parallel groups to compare the analgesic effects in conventional use of oral Diclofenac tablet, 50 mg tablet three times daily or 75 mg tablet twice daily (DIC group) with oral combination of Tramadol 37.5 mg and Acetaminophen (Paracetamol) 325 mg (T-APAP group) one tablet twice daily. The number of patients n= 150 in each group. Study data of total 300 patients of age 20 - 60 years, with moderate to severe Low back pain (LBP) was collected from the public and two private setup OPDs in Karachi, Pakistan. Patient demographic data of gender, age, BMI and socioeconomic status were collected. Numeric Pain Rating Scale (NPRS) was used to measure pain intensity and overall pain intensity at the baseline 0, 1st, 2nd, 3rd and 4th week of the treatment. The results indicated that the incidence of Low back pain (LBP) is highest 41.0 % (n = 123) in 30-39 years age group. According to Body Mass Index (BMI) classification most of the patients 63.6 % (n = 191) patients are overweight. In socioeconomic classification 47.3 % (n = 142) are from lower socioeconomic status. The duration of perceived pain was found to be shorter with 58.6 % (n = 88) recovery within one week of the treatment in the T-APAP Group, compared to 35.3 % (n = 53) recovery in DIC group (p&lt; 0.05). Oral combination of Tramadol plus Paracetamol is found to be more effective than the use of oral Diclofenac alone. 79.4 % Overall Pain Relief with 5.8 scores of Overall Pain Relief (p&lt; 0.05) were observed in the T-APAP Group. It is concluded that the oral combination of Tramadol 37.5 mg and Acetaminophen (Paracetamol) 325 mg is more effective analgesic than oral use of Diclofenac sodium alone in moderate to severe LBP.

Вплив додаткової нейропротекції Гліатиліном на перебіг септичного процесу і вираженість енцефалопатії в структурі синдрому поліорганної недостатності

Актуальність. Сепсис, як реакція організму на інфекцію, включає такий етап розвитку, як синдром поліорганної недостатності (СПОН). Мозкова дисфункція в 70 % випадків є одним з перших симптомів сепсис-асоційованого СПОН, ще до клінічних проявів в інших системах життєзабезпечення. Сепсис-асоційована енцефалопатія — мультифокальне порушення функцій головного мозку за умови наявності інфекції, що супроводжується проявами системного запалення, але без клінічних і лабораторних доказів прямої причетності інфекції до пошкодження головного мозку. Залежно від критеріїв, покладених в основу діагностики, церебральна дисфункція-недостатність може бути виявлена в усіх хворих із сепсисом. Ступінь її вираженості корелює зі зростанням тяжкості септичного процесу. Сепсис-асоційована дисфункція-недостатність може бути незалежним предиктором летального кінця. Тяжкість церебральної дисфункції-недостатності коливається від летаргії і/або дезорієнтації до коми. Мета: вивчення впливу терапії відповідно до головних положень «Міжнародного керівництва з інтенсивної терапії сепсису та септичного шоку: 2016» із додатковою нейропротекцією Гліатиліном на перебіг септичного процесу й вираженість енцефалопатії в структурі синдрому поліорганної недостатності. Матеріали та методи. За період 2010–2015 рр. нами проведено контрольоване проспективне рандомізоване когортне дослідження на клінічній базі кафедри анестезіології та інтенсивної терапії ДЗ «Дніпропетровська медична академія МОЗ України» і на базі відділення інтенсивної терапії сепсису КП «Дніпропетровська обласна клінічна лікарня ім. І.І. Мечникова» ДОР». У дослідження було включено 22 пацієнти. У всіх хворих було проведено рутинні лабораторні дослідження для визначення рівня клінічних і біохімічних маркерів системного запалення й органних дисфункцій за шкалами SOFA і LIFE. Для оцінки стану свідомості використовували шкалу коми Глазго. Концентрацію цитокінів (фактор некрозу пухлини α, інтерлейкін-1, інтерлейкін-4, інтерферон α) у сироватці крові вивчали імуноферментним методом. Базисна інтенсивна терапія здійснювалася відповідно до основних положень «Міжнародного керівництва з інтенсивної терапії сепсису та септичного шоку: 2016» з додатковим використанням нейропротекторного препарату Гліатиліну (холіну альфосцерат) 1000–3000 мг на добу внутрішньовенно, розчиненого в 0,9% розчині натрію хлориду, протягом 5–10 днів. Дослідження показників проводилося в чотири етапи: на 1-шу, 3-тю, 5-ту, 7-му добу. Результати. Узагальнюючи результати дослідження, можливо сказати, що на п’яту й сьому добу були відсутні клінічні прояви синдрому системної запальної відповіді в понад 75 % хворих; зменшилася тяжкість стану за APACHE II на 72,5 і 74,5 % (p &lt; 0,001) і ступінь вираженості синдрому поліорганної недостатності за SOFA в 9 разів (p &lt; 0,001) відповідно до етапів дослідження. Церебральна недостатність, оцінена за шкалою коми Глазго, становила 15 балів на п’яту й сьому добу дослідження, що відповідало стану ясної свідомості в понад 75 % хворих. Зазначене спостерігалося на тлі тенденції до збалансованості активності прозапальних і протизапальних ланок цитокінової системи, про що свідчили максимальні значення фактора некрозу пухлини α та інтерферону α на п’яту добу спостереження при зниженні концентрації інтерлейкіну-1 на 55,8 % щодо фону. Прогнозована летальність у пацієнтів другої групи становила 51 %, фактична летальність — 7,5 %. Отже, шляхом проведення даного варіанта інтенсивної терапії вдалося знизити передбачувану летальність на 43,5 %.

High frequency jet ventilation through mask contributes to oxygen therapy among patients undergoing bronchoscopic intervention under deep sedation

BackgroundHigh frequency jet ventilation (HFJV) is an open ventilating technique to maintain ventilation for emergency or difficult airway. However, whether jet ventilation or conventional oxygen therapy (COT) is more effective and safe in maintaining adequate oxygenation, is unclear among patients with airway stenosis during bronchoscopic intervention (BI) under deep sedation.MethodsA prospective randomized cohort study was conducted to compare COT (high flow oxygen) with normal frequency jet ventilation (NFJV) and HFJV in oxygen supplementation during BI under deep sedation from March 2020 to August 2020. Patients receiving BI under deep sedation were randomly divided into 3 parallel groups of 50 patients each: the COT group (fractional inspired oxygen (FiO2) of 1.0, 12 L/min), the NFJV group (FiO2 of 1.0, driving pressure of 0.1 MPa, and respiratory rate (RR) 15 bpm) and the HFJV Group (FiO2 of 1.0, driving pressure of 0.1 MPa, and RR of 1200 bpm). Pulse oxygen saturation (SpO2), mean arterial blood pressure and heart rate were recorded during the whole procedure. Arterial blood gas was examined and recorded 15 min after the procedure was initiated. The procedure duration, dose of anesthetics, and adverse events during BI in the three groups were also recorded.ResultsA total of 161 patients were enrolled, with 11 patients excluded. The clinical characteristics were similar among the three groups. PaO2 of the COT and NFJV groups was significantly lower than that of the HFJV group (P < 0.001). PaO2 was significantly correlated with ventilation mode (P < 0.001), body mass index (BMI) (P = 0.019) and procedure duration (P = 0.001). Multiple linear regression showed that only BMI and procedure duration were independent influencing factors of arterial blood gas PaO2 (P = 0.040 and P = 0.002, respectively). The location of airway lesions and the severity of airway stenosis were not statistically correlated with PaCO2 and PaO2.ConclusionsHFJV could effectively and safely improve intra-operative PaO2 among patients with airway stenosis during BI in deep sedation, and it did not increase the intra-operative PaCO2 and the risk of hypercapnia. PaO2 was correlated with ventilation mode, BMI and procedure duration. Only BMI and procedure duration were independent influencing factors of arterial blood gas PaO2. PaCO2 was not correlated with any preoperative factor.Trial registrationChinese Clinical Trial Registry. Registration number, ChiCTR2000031110, registered on March 22, 2020.

Blood serum and follicular fluid relaxin: a pilot study of the hormone effects on ovarian function and fertilization efficiency

Hypothesis/aims of study. To date, one of the most important avenues of research in the field of reproductive medicine is the searching for new biochemical markers of oocyte quality and the prediction of the effectiveness of in vitro fertilization (IVF) protocols. The aim of this study was to assess the effect of relaxin levels in blood serum and follicular fluid on the efficiency of ovulation stimulation, fertilization, and characteristics of the embryos.&#x0D; Study design, materials and methods. This prospective randomized cohort study included 11 patients undergoing infertility treatment in a superovulation stimulation protocol using gonadotropin-releasing hormone antagonists. Age, body mass index, hormonal status, ovarian response, endometrial thickness and structure, the number and quality of oocytes and embryos, as well as fertilization efficiency were assessed. The level of relaxin in blood serum and follicular fluid samples was determined on the day of transvaginal follicle puncture using enzyme immunoassay.&#x0D; Results. A correlation between follicular fluid relaxin levels and body mass index, age, the number of oocytes, and their fertilization efficiency (p 0.05) was established. Changes in follicular fluid relaxin level were revealed depending on the gonadotropin preparations (p 0.05) and triggers of final maturation of oocytes (p 0.05). The tendency of the effect of gonadotropin doses on circulating relaxin levels, and of the hormone itself on endometrial thickness and the quality of oocytes was determined.&#x0D; Conclusion. Determination of the relaxin concentration can be considered as a promising method for predicting the result of ovarian stimulation and the efficiency of fertilization in IVF protocols.

Prospective Randomized Cohort Study to Explore the Acceptability of Patient-Reported Outcome Measures to Patients of Hand Clinics

PurposeThe purpose of this randomized prospective cohort study was to assess the acceptability of administering patient-reported outcome measures (PROMs) in the waiting room of hand clinics.MethodsParticipants were randomly assigned to receive the Patient-Rated Wrist and Hand Evaluation (PRWHE), Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, or Michigan Hand Questionnaire (MHQ). Acceptability was measured in terms of data quality, participation, and retention rates. Data quality was determined by the number of incomplete questionnaires, unanswered questions, and unscorable questionnaires. Most frequently unanswered questions were identified. The participant-reported time taken to complete the questionnaires was collected.ResultsA total of 491 participants enrolled in this study. A participation rate of 85% with a retention rate of 94% indicated that patients found the administration of PROMs in the waiting room of the clinic to be acceptable. The proportion of missing data for each questionnaire was 4.2% for PRWHE, 3.9% for DASH and 6.3% for MHQ. Whether a questionnaire could be used to generate a score was determined by the scoring rules of each instrument. The proportion of questionnaires that were not completed sufficiently for a score to be generated was 0% for PRWHE, 9% for DASH, and 4% for MHQ. No association was found between whether a questionnaire could generate a score and participants’ sex, age, or the nature of the condition. Over 80% of participants reported taking 10 minutes or less to complete the questionnaire.ConclusionsThis study shows that hand clinic patients will complete PROMs while waiting for the clinical review. The PRWHE and MHQ groups demonstrated good usability, because less than 5% were unable to produce a score. The usability of the DASH group was lower, because 9% were unable to be scored. This indicates that PRWHE and MHQ are more suitable than DASH to application in a hand clinic setting.Type of study/level of evidenceTherapeutic III.

A prospective randomized cohort study on 3D-printed artificial vertebral body in single-level anterior cervical corpectomy for cervical spondylotic myelopathy.

BackgroundThis was a prospective randomized cohort study aiming at examining the safety and efficacy of artificial vertebral body (AVB) fabricated by electron beam melting (EBM) in comparison to conventional titanium mesh cage (TMC) used in single-level anterior cervical corpectomy and fusion (SL-ACCF).MethodsForty patients with cervical spondylotic myelopathy (CSM) underwent SL-ACCF using either the EBM-AVB or the TMC. Patients were evaluated for their demographics, radiological characteristics, neurologic function [using the Japanese Orthopaedic Association (JOA) scale], and health-related quality-of-life (HRQoL) aspects [using the Short Form 36 (SF-36)] before and after the surgery and comparison was made between the two groups both at baseline and the last follow-up. The Student t-text, paired-sample t-text, and Fisher’s exact test were used when appropriate to detect any statistical significance at the level of α=0.05.ResultsPost-operative recovery was uneventful for all patients and no revision surgery was required. There were no significant differences between the EBM-AVB group and the TMC group at baseline. Patients in both groups demonstrated significant improvement in cervical alignment, JOA score, and SF-36 score after the surgery. Six months post-operatively, patients in the EBM-AVB group were found to have significantly less loss of fusion height and lower incidence for severe implant subsidence compared with the TMC group. Patients in the two groups were comparable at the last follow-up regarding their rate of fusion, cervical alignment, JOA recovery rate, SF-36 score, and by Odom’s criteria.ConclusionsFor CSM patients undergoing SL-ACCF, the EBM-AVB group demonstrated comparable outcomes regarding patient cervical alignment, neurologic function, and HRQoL in comparison with the TMC group. Furthermore, the use of EBM-AVB was associated with decreased loss of the height of the fusion mass and a lower rate for severe implant subsidence.