Period In Adult Patients Research Articles

P320 Comparing faecal elastase, pancreatic enzyme doses, HbA1c and insulin doses in adult cystic fibrosis patients pre- and 6 months postcommencement of Kaftrio®

To evaluate the effect of Kaftrio on units of lipase/kg/day, faecal elastase level, HbA1c, insulin doses (primary outcome measures) and weight (secondary outcome measure) after a 6 month period in adult patients with cystic fibrosis (CF).

A prospective observational single center study evaluating emergence agitation in the early postoperative period in adult patients undergoing elective craniotomies under general anesthesia.

Emergence agitation is a significant clinical issue during recovery from general anesthesia. Patients after intracranial operations are even more vulnerable to the stress resulting from emergence agitation. Due to the limited data available in neurosurgical patients, we evaluated the incidence, risk factors, and complications of emergence agitation. 317 consenting eligible patients undergoing elective craniotomies were recruited. The preoperative Glasgow Coma Scale (GCS)) and pain score were recorded. Bispectral Index (BIS) guided balanced general anesthesia was administered and reversed. Immediate postoperatively, the GCS and the pain score were noted. The patients were observed for 24 hours following extubation. The levels of agitation and sedation were evaluated by the Riker's Agitation-Sedation Scale. Emergence Agitation was defined as Riker's Agitation score of 5 to 7. In our subset of the patient population, the incidence was 5.4%, mildly agitated in the first 24 hours and none required sedative medication as therapy. The sole risk factor identified was prolonged surgery beyond 4 hours. None of the patients in the agitated group had any complications. Early objective assessment of risk factors in the preoperative period with objective validated tests and shorter duration of surgery maybe the way forward in patients at high risk for emergence agitation, to reduce the incidence and mitigate the undesirable consequences.

Five-Year Estimated Glomerular Filtration Rate in Adults with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study.

IntroductionChronic hypoparathyroidism is associated with higher risk of developing chronic kidney disease compared with the general population. This study evaluated changes in estimated glomerular filtration rate (eGFR) over a 5-year period in adult patients with chronic hypoparathyroidism treated with recombinant parathyroid hormone (1-84), rhPTH(1-84), compared with a historical control cohort of patients who did not receive rhPTH(1-84).MethodsThis retrospective cohort study included patients with chronic hypoparathyroidism treated with rhPTH(1-84) in the REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309), and HEXT (NCT01199614 and continuation study NCT02910466) clinical trials. A historical control cohort who did not receive parathyroid hormone but who had enrollment criteria similar to those for the clinical trials was selected from the IBM® Explorys electronic medical record database (January 2007–August 2019). Outcomes of interest were the annual rate of change in eGFR from baseline (i.e., eGFR slope) and the predicted eGFR change from baseline at years 1 through 5.ResultsThe study comprised 72 adult patients with chronic hypoparathyroidism treated with rhPTH(1-84) and 176 control patients who did not receive rhPTH(1-84). Over 5 years, eGFR remained stable in the rhPTH(1-84) cohort, whereas eGFR declined at a rate of 1.67 mL/min/1.73 m2 per year in the control cohort (P < 0.001 for eGFR slope in the control cohort). At 5 years, predicted eGFR in the rhPTH(1-84) cohort increased from baseline by 1.21 mL/min/1.73 m2, whereas eGFR in the control cohort declined by 10.36 mL/min/1.73 m2, after adjusting for baseline variables. The difference in eGFR slopes between the cohorts over 5 years was 1.37 mL/min/1.73 m2 per year (95% CI 0.62–2.13; P < 0.001).ConclusionLong-term treatment with rhPTH(1-84) was associated with stable eGFR compared with eGFR decline in the controls not treated with rhPTH(1-84). Preservation of renal function conferred by rhPTH(1-84) may benefit patients with chronic hypoparathyroidism by reducing risk of long-term renal complications.

Progression of Bone and Joint Destruction During the Perinatal Period in Patients With Rheumatoid Arthritis and Juvenile Idiopathic Arthritis in the Last Decade.

Background: Rheumatoid arthritis (RA) is a disease that can cause joint destruction and multiple arthritis. We retrospectively investigated bone and joint destruction during the perinatal period in adult patients with RA and juvenile idiopathic arthritis (JIA) in our hospitals in the last decade.Methods: The study included 15 women, with 20 pregnancies, 19 childbirths, and one fetal death recorded between 2009 and 2018. We analyzed patient characteristics, disease activity, the modified total Sharp score (mTSS), and ΔmTSS from prepregnancy to delivery and from delivery to one year after delivery in the biologics (BIO) group (biologics used before pregnancy) and non-BIO group (not using biologics).Results: There were five preterm births and seven low-birth-weight infants. The Clinical Disease Activity Index (CDAI) before pregnancy and postdelivery worsened from 12±1.8 to 19.9±2.7 (p<0.05). The mTSS at prepregnancy and postdelivery was 47.7±12.2 and 57.3±11.1 in the BIO group, respectively, and 58.9±11.9 and 75.0±13.1 in the non-BIO group, respectively. In addition, the ΔmTSS value from prepregnancy to delivery and from delivery to one year after delivery was 14.5±4.8 and 9.2±1.7 in the BIO group, respectively (p<0.05), and 16.1±5.2 and 8.3±4.0 in the non-BIO group, respectively.Conclusion: The disease activity worsened, and bone and joint destruction progressed in both the BIO and non-BIO groups during the perinatal period in adult patients with RA and JIA in the last decade.

Sublingual microcirculatory alterations during the immediate and early postoperative period: A systematic review and meta-analysis.

The incidence of postoperative microcirculatory flow alterations and their effect on outcome have not been studied extensively. This systematic review and meta-analysis were designed to investigate the presence of sublingual microcirculatory flow alterations during the immediate and early postoperative period and their correlation with complications and survival. A systematic search of PubMed, Scopus, Embase, PubMed Central, and Google Scholar was conducted for relevant articles from January 2000 to March 2021. Eligibility criteria were randomized controlled and non-randomized trials. Case reports, case series, review papers, animal studies and non-English literature were excluded. The primary outcome was the assessment of sublingual microcirculatory alterations during the immediate and early postoperative period in adult patients undergoing surgery. Risk of bias was assessed with the Ottawa-Newcastle scale. Standard meta-analysis methods (random-effects models) were used to assess the difference in microcirculation variables. Thirteen studies were included. No statistically significant difference was found between preoperative and postoperative total vessel density (p = 0.084; Standardized Mean Difference (SMD): -0.029; 95%CI: -0.31 to 0.26; I2 = 22.55%). Perfused vessel density significantly decreased postoperatively (p = 0.035; SMD: 0.344; 95%CI: 0.02 to 0.66; I2 = 65.66%), while perfused boundary region significantly increased postoperatively (p = 0.031; SMD: -0.415; 95%CI: -0.79 to -0.03; I2 = 37.21%). Microvascular flow index significantly decreased postoperatively (p = 0.028; SMD: 0.587; 95%CI: 0.06 to 1.11; I2 = 86.09%), while no statistically significant difference was found between preoperative and postoperative proportion of perfused vessels (p = 0.089; SMD: 0.53; 95%CI: -0.08 to 1.14; I2 = 70.71%). The results of the non-cardiac surgery post-hoc analysis were comparable except that no statistically significant difference in perfused vessel density was found (p = 0.69; SMD: 0.07; 95%CI: -0.26 to 0.39; I2 = 0%). The included studies investigate heterogeneous groups of surgical patients. There were no randomized controlled trials. Significant sublingual microcirculatory flow alterations are present during the immediate and early postoperative period. Further research is required to estimate the correlation of sublingual microcirculatory flow impairment with complications and survival.

Динаміка маркерів запалення у хворих після протезування клапанів серця

Мета: оцінити вплив штучного кровообігу на рівні маркерів запалення та виявити їх діагностичну значущість щодо перебігу раннього післяопераційного періоду у дорослих пацієнтів, яким проводилися кардіохірургічні операції. Матеріал та методи. У дослідження, що проводилося за відкритим дизайном, було включено 37 хворих із патологією клапанів серця, які були оперовані в умовах штучного кровообігу. На автоматичному гематологічному аналізаторі виконували кількісний підрахунок клітин крові. Лейкоцитарний індекс інтоксикації розраховували за формулою Кальф-Каліфа. Рівень цитокінів (інтерлейкін (IL) 1α, IL-6, фактор некрозу пухлини α, IL-10) у сироватці крові визначали методом імуноферментного аналізу. Точки контролю: до операції; після закінчення штучного кровообігу; 24 години після операції. Результати. Штучний кровообіг та операційна травма активують системну запальну відповідь, що проявляється у вигляді лейкоцитозу, підвищення рівнів цитокінів IL-6, IL-10 та IL-1α. Встановлено позитивний взаємозв’язок між кількістю лейкоцитів після штучного кровообігу та летальністю, концентрацією IL-6 у сироватці крові та часом перетискання аорти, індексом IL-6/IL-10 та тривалістю штучного кровообігу.

Significance of plasma fibrinogen and malondialdehyde in the post-inflammatory period in patients with cystic fibrosis.

Evaluation of selected inflammatory parameters and serum malondialdehyde (MDA) significance in the post-inflammatory period in adult patients with cystic fibrosis. Laboratory biomarkers can be integrated into clinical practice as part of monitoring the effectiveness of treatment. After recovery from an acute exacerbation of lung infection, selected inflammatory parameters (fibrinogen, IL-1, IL-6, SAA, hs-CRP) and serum MDA were examined in 30 adult patients with cystic fibrosis. Their correlation with FEV1, frequency and duration of subsequent hospitalizations and 6-year prognosis in terms of mortality or need for lung transplantation was evaluated. FEV1 negatively correlated with fibrinogen, but positively with MDA. No significant correlation with hs-CRP, IL-1, IL-6 and SAA was recorded. Plasma fibrinogen predicted the frequency and duration of subsequent hospitalizations. The 6-year prognosis was negatively associated with plasma fibrinogen whereas its association with MDA was positive. However, the prognosis of patients in the multivariate analysis was significantly associated only with FEV1. Plasma fibrinogen examined in the post-inflammatory period is a marker of lung damage in patients with cystic fibrosis and can be used to predict the prognosis. The positive correlation of serum MDA with FEV1 in the post-inflammatory period may be important to the interpretation of treatment interventions (Tab. 3, Fig. 2, Ref. 17).

Change in Estimated Glomerular Filtration Rate in Adult Patients With Chronic Hypoparathyroidism Treated With rhPTH(1–84) Compared With a Historical Control Cohort

Abstract Chronic hypoparathyroidism (HypoPT) is associated with impaired renal function.1 This study evaluated change in estimated glomerular filtration rate (eGFR) over a 5-yr period in adult patients (pts) with chronic HypoPT treated with or without recombinant human parathyroid hormone (1–84), rhPTH(1–84). The rhPTH(1–84)-treated pt cohort was derived from NCT01297309 (RACE) and NCT01199614 (HEXT) clinical trials. A historical control pt cohort with HypoPT who did not receive rhPTH(1–84) or rhPTH(1–34) were from the large national US Explorys electronic medical record database (Jan 2007−Aug 2019) using criteria similar to the trial enrollment criteria. The index date was the day after treatment initiation for the rhPTH(1–84) cohort and the day after the first calcitriol prescription for the control. The analysis included pts with eGFR ≥60 mL/min/1.73 m2 at the closest eGFR measurement during the 6 months before index date, ≥2 eGFR measurements ≥3 months apart during the 5 yrs on or after the index date and ≥1 eGFR measurement at 5 yrs (±6 months). For pts from RACE, baseline and study visit data after rhPTH(1–84) initiation were collected from the antecedent trials. Changes in eGFR were assessed in linear mixed and multivariable models (adjusted for age/sex/race, baseline eGFR value, history of hypercalciuria/hypertension/type 2 diabetes (T2D)/acute HypoPT manifestations/cardiovascular condition). There were 72 pts in the rhPTH(1–84) cohort and 174 in the control cohort. Before the index date, pts in the rhPTH(1–84) cohort, compared with the control, were younger (mean±SD, 47.5±11.0 vs 53.9±15.5 yrs; P&amp;lt;0.01), and a lower proportion had acute manifestations of HypoPT (22.2% vs 69.0%; P&amp;lt;0.001) and T2D (2.8% vs 17.8%; P&amp;lt;0.001). Over the 5-yr period, the difference in the rate of eGFR change between the 2 cohorts was 1.45 mL/min/1.73 m2 per yr and 1.33 mL/min/1.73m2 per yr, in the unadjusted and adjusted linear mixed models respectively (both P&amp;lt;0.001); eGFR remained higher in the rhPTH(1–84) cohort at all times. Over 5 yrs, eGFR was relatively stable in the rhPTH(1–84) cohort, but eGFR declined in the control at a rate of −1.58 mL/min/1.73 m2 per yr (unadjusted model, P&amp;lt;0.001), and by −1.57 mL/min/1.73 m2 per yr (adjusted model, P&amp;lt;0.001). By yr 5, pts in the rhPTH(1–84) and control cohort were predicted to have eGFR changes from baseline of +1.51 mL/min/1.73 m2 and −10.48 mL/min/1.73 m2, respectively. Data interpretation is limited by the differing pt management (ie, predefined trial protocols and clinical practice for the control). In pts with chronic HypoPT, the annual rate of eGFR decline over a 5-yr period was significantly lower in pts treated with rhPTH(1–84) compared with controls not treated with rhPTH(1–84). These results support the Chen et al1 analysis of data from the same trials and a regional US health record database. 1. Chen KS, et al. JCEM 2020;105(10)dgaa490

Low-Dose IL-2 for Treating Moderate to Severe Alopecia Areata: A 52-Week Multicenter Prospective Placebo-Controlled Study Assessing its Impact on T Regulatory Cell and NK Cell Populations

Low-Dose IL-2 for Treating Moderate to Severe Alopecia Areata: A 52-Week Multicenter Prospective Placebo-Controlled Study Assessing its Impact on T Regulatory Cell and NK Cell Populations

Effects of Relaxation Techniques on Acute Postlaminectomy Pain: A Three-Arm Randomized Controlled Clinical Trial

PurposeThis study compared the effects of Benson relaxation with progressive muscle relaxation on pain severity after laminectomy. DesignThree-arm randomized, nonblinded, and parallel group trial. MethodsThe study was conducted with 93 patients who underwent lumbar laminectomy. Patients were randomly assigned to three groups of Benson relaxation + routine care (n = 31), progressive muscle relaxation + routine care (n = 31), and routine care (n = 31). The two relaxation methods were performed at 2 (time 1), 12 (time 2), and 24 (time 3) hours after patients' regaining full consciousness in postoperative wards. Pain severity was assessed using the visual analog scale once before laminectomy, before and also 20 minutes after each relaxation session. In the control group, pain severity was measured at the same times as in the two relaxation groups. FindingsBoth Benson relaxation and progressive muscle relaxation resulted in a significant reduction in pain severity in comparison with the control group at all three measurement times (except at time 1 in the progressive muscle relaxation group). However, no significant differences were found between Benson relaxation and progressive muscle relaxation in any of the three times. ConclusionsThe results suggest that both Benson and progressive muscle relaxation techniques can decrease acute postlaminectomy pain in the immediate postoperative period in adult patients.

Awareness and concern towards anesthesia among patients undergoing surgical procedure: A cross-sectional study at pre-anesthetic clinic of a Teaching Hospital

Background: With the advent of anesthesia, surgery is no longer a race against the clock and surgeons. Many studies in the past have demonstrated limited knowledge among patients about various aspects of anesthesia.Objectives: To assess the awareness and concern of elective surgical patients towards anesthesia.Methodology: A cross-sectional questionnaire survey was conducted over two months’ period in adult patients of age eighteen years and above. Two hundred surgical patients accessing services at the pre-anesthesia check-up clinic were interviewed using 12 questions assessing demographic characteristics, educational status and their knowledge about anesthesia.Results: Out of 200 patients, only 32% knew that anesthesiologists provide anesthesia. It was found that 63% didn’t have any knowledge about the types of anesthesia. The most common fear among the participants about anesthesia was the fear of pain during surgery.Conclusion: The study showed poor knowledge of patients regarding anesthesia.

1250. Prevalence and Risk Factors for Acquiring Carbapenem-Resistant Enterobacteriaceae in an Intensive Care Unit at a Tertiary Hospital

BackgroundActive surveillance testing of carbapenem-resistant Enterobacteriaceae (AST-CRE) is recommended in high-risk settings, such as intensive care units (ICUs), to prevent CRE outbreaks or invasive infections. This study aimed to investigate the effects of AST-CRE by analyzing the prevalence and risk factors for acquiring CRE during the ICU care.MethodsWe conducted AST-CRE on rectal swabs of patients admitted to the ICU in the emergency room at a tertiary hospital in South Korea for 12.5 months. AST-CRE was performed upon admission and weekly thereafter. To assess the risk factors of acquiring AST-CRE during the admission period in adult patients, those colonized with CRE upon admission and aged <18 years were excluded. AST-CRE was performed using Centers for Disease Control and Prevention methods. A polymerase chain reaction assay was performed to detect five carbapenemase genes (NDM, KPC, VIM, IMP, and OXA).ResultsA total of 810 patients were admitted during the study period. The acquisition rate and carbapenemase-producing CRE were 2.6% (21/810) and 42.9% (9/21), respectively. No invasive infection due to CRE was found. The most common species were Klebsiella pneumoniae (71.4%, 15/21), and eight KPC and one NDM genes were detected. In CRE-positive patients, in-hospital mortality and length of hospitalization were higher (P = 0.003) and longer (P < 0.001), respectively. Multivariate analyses showed that male gender (adjusted odds ratio [aOR] 8.0; 95% confidence interval [CI] 1.7–36.8), previous hospitalization in the last year (aOR 5.1; 95% CI 1.6–16.4), co-colonization with multidrug-resistant Acinetobacter species (aOR 18.3; 95% CI, 4.2–79.2) and extended-spectrum β-lactamase-producing bacteria (aOR 3.4; 95% CI, 1.1–10.9), and length of ICU admission until CRE detection for ≥10 days (aOR 6.5; 95% CI 2.2–19.2) were independently associated with CRE acquisition.ConclusionTo prevent CRE outbreak or invasive infections, patients admitted in the ICU should be screened using AST-CRE.Disclosures All authors: No reported disclosures.

Presentation and survival in patients with hematologic malignancies in Jos, Nigeria: A retrospective cohort analysis.

Haematologic malignancies cause significant morbidity and mortality and are not uncommon in resource-limited-low income countries. However, the types, pattern of presentation and treatment outcomes vary across regions. We assessed the presentation and overall survival over an 11-year period in adult patients presenting with haematologic cancers in Jos, North Central Nigeria. This retrospective outcome study evaluated patients who presented with haematologic malignancies between 2005-2015 at the Jos University Teaching Hospital (JUTH), Jos. Variables of interest were abstracted through chart reviews. Descriptive statistics were used to evaluate baseline and follow-up parameters. Overall survival (OS) was assessed using Kaplan-Meier method. Sixty patients, contributing 25,994 person-days of follow-up were evaluated. The mean age was 43+17 years and 61.7% were males. Thirty-one patients (51.7%) presented with leukemia, 45.0% with lymphoma, and 3.3% with multiple myeloma. Forty-two (70.0%) presented with advanced disease, 5 (5.2%) were HIV positive and 4 (6.7%) had died at the end of follow-up. OS was 84.3% (95% CI: 58.1-94.7). Survival differed by disease group (p=0.01) and having fever at presentation (p=0.02). We found long-term OS to be impacted by disease type and status of fever at presentation. Disease-specific Strategies to improve early diagnosis and therapies are needed to ensure optimal outcomes in Nigerian patients.

A 3-year prognostic score for adults with cystic fibrosis

BackgroundTherapeutic progress in patients with cystic fibrosis (CF) has resulted in improved prognosis over the past decades. We aim to reevaluate prognostic factors of CF and provide a prognostic score to predict the risk of death or lung transplantation (LT) within a 3-year period in adult patients. MethodsWe developed a logistic model using data from the French CF Registry and combined the coefficients into a prognostic score. The discriminative abilities of the model and the prognostic score were assessed by c-statistic. The prognostic score was validated using a 10-fold cross-validation. ResultsThe risk of death or LT within 3years was related to eight characteristics. The development and the validation provided excellent results for the prognostic score; the c-statistic was 0.91 and 0.90 respectively. ConclusionThe score developed to predict 3-year death or LT in adults with CF might be useful for clinicians to identify patients requiring specialized evaluation for LT.

The efficacy and safety of the biosimilar product (Inflectra®) compared to the reference drug (Remicade®) in rescue therapy in adult patients with ulcerative colitis.

IntroductionThe biosimilar product Inflectra® has been approved by the European Medicine Agency (EMA) for the same indications as its reference drug, infliximab, based on studies in patients with rheumatic diseases. Thus far, there have not been enough data regarding its efficacy and safety in ulcerative colitis (UC).AimTo assess the efficacy and safety of the biosimilar product Inflectra® in comparison with its reference biological agent (Remicade®) in rescue therapy in adult patients presenting with severe exacerbation of UC, as well as to evaluate recurrence rate during a 6-month observation after finish of treatment.Material and methodsIn a single-centre retrospective study, a cohort of 83 adult patients with severe UC treated at the Department of Gastroenterology with Inflammatory Bowel Diseases Subdivision of the Central Clinical Hospital of MSWiA, Warsaw was investigated. All patients received three induction doses of Remicade® (28 individuals) or Inflectra® (55 individuals) based on the same criteria of the National Health Fund (NFZ) Therapeutic Program (total Mayo score > 6). Activity of the disease was evaluated on the Mayo scale at qualification, after finishing the rescue treatment (after 14 weeks), and after a 6-month observation period. In all patients, sigmoidoscopy was performed at qualification and after induction (after three doses).ResultsThe studied groups were similar with respect to age and sex distribution, duration of the disease, extent of the disease (left-sided type, pancolitis), additional pharmacotherapy, and smoking. Clinical response following three induction doses was noted in 81% of patients receiving Remicade® compared to 77% receiving the biosimilar product, Inflectra® (NS); while clinical remission was observed in 42% receiving Remicade® and 32% receiving Inflectra® (NS), respectively. Endoscopic remission assessed as 0 on the Mayo scale was achieved in 4 (15%) patients on Remicade® and in 7 (13%) patients on Inflectra® (p = 0.45). Relapse occurred in 68% of all patients, while 51% presented with exacerbation of the disease 3 months after finishing biological treatment. In 93%, exacerbation occurred within 12 months. The recurrence rate was similar in both groups (75% with Remicade®, 64% with Inflectra®, respectively). Side effects occurred with similar frequency in both groups.ConclusionsIn the study, it was established that the biosimilar drug (Inflectra®) has a similar efficacy and safety as the reference biological agent (Remicade®), not only in rescue therapy, but also during a 6-month observation period in adult patients with severe UC. Low mucosal healing rate in both groups and high recurrence rate of the disease soon after finishing induction treatment indicate the need for prolonged therapy with infliximab in patients with severe UC.

Uvular injury during the perioperative period in patients undergoing general anesthesia

The purpose of this study was to evaluate the incidence and causes of uvular injury in the patients that received general anesthesia in the perioperative period. A 4-year retrospective review of cases of uvular injury and their resolution was conducted in adult patients who received general anesthesia at our institution. An extensive review was conducted of the quality assurance (QA) database maintained by the Department of Anesthesiology at our tertiary academic medical center. The database was searched for cases of uvular injury that occurred in adult patients undergoing general anesthesia that between January 2007 and December 2010. The medical records of identified patients were then obtained to evaluate the presentation, treatment and ultimate resolution of injury. Ten cases of uvular injury were reported in the 28,788 general anesthetics conducted over a 3-year period in adult patients. This correlates to an incidence of 0.034%. Uvular injury occurred in mostly male patients (80%) during elective cases in the supine position. All cases were associated with endotracheal intubation. Additional objects, such as gastric tubes and esophageal temperature probes, were placed in the pharynx of 80% of these patients. Urologic procedures were associated with 50% of reported cases. Treatment ranged from observation to medical therapy. There were no permanent symptoms in any of the patients. Uvular injury is a relatively rare complication that occurs in patients during the perioperative period who receive general anesthesia. While endotracheal intubation is closely associated with this type of injury, further study is required to elucidate the mechanism and other associated etiologic factors.

Distraction osteogenesis for management of obstructive sleep apnoea in temporomandibular joint ankylosis patients before the release of joint

AimTo evaluate the effects of distraction osteogenesis in management of obstructive sleep apnoea patients secondary to temporomandibular joints ankylosis. MethodsFifteen patients were included in study. Preoperatively the patients were worked up for polysomnography and CT scans. Only those patients with Apnoea–hypopnoea index >15 events/h denoting moderate to severe obstructive sleep apnoea were included in the study. Distraction osteogenesis was followed with 5 days latency period in adult patients and 0 days for children. Rate of distraction was 1 mm/day for adults and 2 mm/day for children till the mandibular incisors were in reverse overjet. After 3 months post distraction assessment was done using polysomnography and CT scan.TMJ ankylosis was released by doing gap arthroplasty after distraction osteogenesis. ResultsPost distraction improvement was seen in clinical features of OSA like daytime sleepiness and snoring. Epworth sleepiness scale improved from a mean of 10.25 to 2.25. Polysomnographic analysis also showed improvement in all cases with apnoea–hypopnoea index from 57.03 to 6.67 per hour. Lowest oxygen saturation improved from 64.47% to 81.20% and average minimum oxygen saturation improved from 92.17% to 98.19%. Body mass index improved from a mean of 18.26 to 21.39 kg/m2. ConclusionDistraction osteogenesis is a stable and beneficial treatment option for temporomandibular joint ankylosis patients with obstructive sleep apnoea.

519 Predictors of Mortality in Individuals With Nonalcoholic Fatty Liver Disease (NAFLD) in the United States: Results From the Third National Health and Nutrition Examination Survey (NHANES III)

Background: Previous cross-sectional studies have shown that serum levels of cytokeratin fragments (CK18) are associated with the presence of steatohepatitis in individuals with nonalcoholic fatty liver disease (NAFLD). However, it is unknown if serial serum CK18 levels can predict longitudinal changes in liver histology in NAFLD. Aim: To determine the degree to which changes in serum CK18 associate with changes in liver histology over a 96-week period in adult patients with nonalcoholic steatohepatitis (NASH). Methods: Serum CK18 levels were measured at baseline and 16, 48, and 96 weeks in 231 of the 247 adults with NASH who participated in the PIVENS trial which investigated the efficacy of pioglitazone vs. vitamin E vs. placebo in non-diabetic individuals with histologically confirmed NASH over a 96-week period. Liver biopsies at baseline and after 96 weeks of treatment were centrally evaluated by the NASH CRN Pathology Committee. Multiple logistic (for categorical outcomes) and linear (for continuous outcome variables) regression models were used to determine the association between changes in histological features, ALT, and % collagen assessed by Sirius red staining, and change in CK18 levels, controlling for baseline CK18 levels and treatment group. Results: At baseline, CK18 levels among the 3 treatment groups were similar (placebo: 440± 350 U/L, vit E: 510± 350 U/L, and pioglitazone: 490± 410 U/L). Compared to placebo, serum CK18 levels among individuals treated with vit E were reduced at week 16 (mean change from baseline -160± 300 vs. -50 ±380 U/L, p= 0.02), week 48 (-220± 390 vs. -10± 370 U/L, p=0.009), and week 96 (-200± 400 vs. 30± 400 U/L, p=0.009). Similarly, compared to placebo, serum CK18 levels among individuals treated with pioglitazone were reduced at week 16 (mean change from baseline -240 ± 390 vs. -50± 380 U/L, p,=0.001), week 48 (-180± 370 vs. -10± 370 U/L, p=0.001, and week 96 (-260 ±400 vs. 30 ± 400 U/L, p=0.001). Strong correlations were seen with change in CK18 levels and the primary histologic endpoint, resolution of NASH, and individual histologic features of NASH (Table 1). In addition, change in CK18 levels strongly correlated with change in ALT levels (b=0.06, 95% CI: 0.04, 0.08; P,0.001).Percent collagen measurements were not related to change in CK18 (b=-0.17 %/100*U/L , 95% CI:-0.70, 0.37; P= 0.54). Summary: (1) Compared to placebo, treatment with vit E or pioglitazone had significant reduction in serum CK18 levels. (2) Changes in serum CK18 correlated with histologic improvement in non-diabetic adults with NASH treated with vitamin E or pioglitazone. Conclusion: Serum CK18 is a potential useful surrogate marker for detection of improvement in clinical trials.

518 Changes in Serum Cytokeratin 18 Levels Significantly Predict Changes in Liver Histology in Adults With Nonalcoholic Steatohepatitis: Results From the Pivens Trial

Background: Previous cross-sectional studies have shown that serum levels of cytokeratin fragments (CK18) are associated with the presence of steatohepatitis in individuals with nonalcoholic fatty liver disease (NAFLD). However, it is unknown if serial serum CK18 levels can predict longitudinal changes in liver histology in NAFLD. Aim: To determine the degree to which changes in serum CK18 associate with changes in liver histology over a 96-week period in adult patients with nonalcoholic steatohepatitis (NASH). Methods: Serum CK18 levels were measured at baseline and 16, 48, and 96 weeks in 231 of the 247 adults with NASH who participated in the PIVENS trial which investigated the efficacy of pioglitazone vs. vitamin E vs. placebo in non-diabetic individuals with histologically confirmed NASH over a 96-week period. Liver biopsies at baseline and after 96 weeks of treatment were centrally evaluated by the NASH CRN Pathology Committee. Multiple logistic (for categorical outcomes) and linear (for continuous outcome variables) regression models were used to determine the association between changes in histological features, ALT, and % collagen assessed by Sirius red staining, and change in CK18 levels, controlling for baseline CK18 levels and treatment group. Results: At baseline, CK18 levels among the 3 treatment groups were similar (placebo: 440± 350 U/L, vit E: 510± 350 U/L, and pioglitazone: 490± 410 U/L). Compared to placebo, serum CK18 levels among individuals treated with vit E were reduced at week 16 (mean change from baseline -160± 300 vs. -50 ±380 U/L, p= 0.02), week 48 (-220± 390 vs. -10± 370 U/L, p=0.009), and week 96 (-200± 400 vs. 30± 400 U/L, p=0.009). Similarly, compared to placebo, serum CK18 levels among individuals treated with pioglitazone were reduced at week 16 (mean change from baseline -240 ± 390 vs. -50± 380 U/L, p,=0.001), week 48 (-180± 370 vs. -10± 370 U/L, p=0.001, and week 96 (-260 ±400 vs. 30 ± 400 U/L, p=0.001). Strong correlations were seen with change in CK18 levels and the primary histologic endpoint, resolution of NASH, and individual histologic features of NASH (Table 1). In addition, change in CK18 levels strongly correlated with change in ALT levels (b=0.06, 95% CI: 0.04, 0.08; P,0.001).Percent collagen measurements were not related to change in CK18 (b=-0.17 %/100*U/L , 95% CI:-0.70, 0.37; P= 0.54). Summary: (1) Compared to placebo, treatment with vit E or pioglitazone had significant reduction in serum CK18 levels. (2) Changes in serum CK18 correlated with histologic improvement in non-diabetic adults with NASH treated with vitamin E or pioglitazone. Conclusion: Serum CK18 is a potential useful surrogate marker for detection of improvement in clinical trials.

Evaluation of acute cervical spine imaging based on ACR Appropriateness Criteria®

The objectives of this study were to determine the rate of acute blunt cervical spine injury at an academic urban level 1 trauma center and to evaluate the utilization of cervical spine imaging based on the established American College of Radiology (ACR) Appropriateness Criteria®. We retrospectively reviewed all radiography and CT imaging of the cervical spine performed over a year period in adult patients presenting with acute blunt cervical spine trauma. Exclusion criteria were children ≤17years, non-acute trauma of ≥72h, and penetrating trauma. Any fracture, dislocation, or ligamentous instability demonstrated by diagnostic imaging and requiring stabilization or specialized follow-up was defined as clinically significant cervical spine injury. A total of 1,325 cervical spine studies were reviewed in 1,245 patients; 32.7% (433/1,325) were cervical spine radiographs and 67.3% (892/1,325) were CT examinations. Approximately 1.5% (19/1,245) of the patients demonstrated clinically significant acute cervical spine injury. There were 6.4% (80/1,245) patients who received both cervical spine radiographs and CT as imaging evaluation. Based on the ACR Appropriateness Criteria®, all of the cervical spine radiographs performed (433) were determined to be "inappropriate" imaging in the setting of acute cervical spine injury.