Correlation of severity & clinical outcomes of COVID-19 with virus variants: A prospective, multicentre hospital network study.

BACKGROUND OBJECTIVES: The clinical course of COVID-19 and its prognosis are influenced by both viral and host factors. The objectives of this study were to develop a nationwide platform to investigate the molecular epidemiology of SARS-CoV-2 (Severe acute respiratory syndrome Corona virus 2) and correlate the severity and clinical outcomes of COVID-19 with virus variants. METHODS: A nationwide, longitudinal, prospective cohort study was conducted from September 2021 to December 2022 at 14 hospitals across the country that were linked to a viral sequencing laboratory under the Indian SARS-CoV-2 Genomics Consortium. All participants (18 yr and above) who attended the hospital with a suspicion of SARS-CoV-2 infection and tested positive by the reverse transcription-PCR method were included. The participant population consisted of both hospitalized as well as outpatients. Their clinical course and outcomes were studied prospectively. Nasopharyngeal samples collected were subjected to whole genome sequencing to detect SARS-CoV-2 variants. RESULTS: Of the 4972 participants enrolled, 3397 provided samples for viral sequencing and 2723 samples were successfully sequenced. From this, the evolution of virus variants of concern including Omicron subvariants which emerged over time was observed and the same reported here. The mean age of the study participants was 41 yr and overall 49.3 per cent were female. The common symptoms were fever and cough and 32.5 per cent had comorbidities. Infection with the Delta variant evidently increased the risk of severe COVID-19 (adjusted odds ratio: 2.53, 95% confidence interval: 1.52, 4.2), while Omicron was milder independent of vaccination status. The independent risk factors for mortality were age >65 yr, presence of comorbidities and no vaccination. INTERPRETATION CONCLUSIONS: The authors believe that this is a first-of-its-kind study in the country that provides real-time data of virus evolution from a pan-India network of hospitals closely linked to the genome sequencing laboratories. The severity of COVID-19 could be correlated with virus variants with Omicron being the milder variant.

Comparative yield of transbronchial cryo-nodal biopsy, transbronchial intra-nodal forceps biopsy, and transbronchial needle aspiration for mediastinal lesions at a tertiary care center in India (COLD-FORCEPS study).

Endobronchial ultrasound (EBUS) guided mediastinal cryobiopsy, and intranodal forceps biopsy are newer modalities for sampling mediastinal lymph nodes. The data regarding the diagnostic yield of both modalities is scarce. Patients were recruited retrospectively from our existing database. Patients who had undergone both an EBUS guided mediastinal cryobiopsy and an intranodal forceps biopsy were enrolled in the study. The final diagnosis was made with a clinical-pathological-radiological assessment and clinico-radiological follow-up after one month. A total of 34 patients were enrolled in the study who had undergone both EBUS guided mediastinal cryobiopsy and intranodal forceps biopsy and had complete data available, including 1-month follow-up data. The sample adequacy rate of EBUS-transbronchial needle aspiration (EBUS-TBNA), EBUS-TBNA with mediastinal cryobiopsy, and EBUS-TBNA with intranodal forceps biopsy was 94.11%, 97.05%, and 94.11%, respectively (p=0.56). The diagnostic yield achieved in EBUS-TBNA, EBUS-TBNA with mediastinal cryobiopsy, and EBUS-TBNA with intranodal forceps biopsy was 73.52%, 82.35%, and 79.41%, respectively (p=0.38). No major complications were seen in any patient. To conclude, adding EBUS guided mediastinal cryobiopsy and intranodal forceps biopsy to EBUS-TBNA may not be superior to routine EBUS-TBNA.

Chronic hyperglycemia drives alterations in macrophage effector function in pulmonary tuberculosis.

Diabetes mellitus (DM) alters immune responses and given the rising prevalence of DM in tuberculosis (TB) endemic countries; hyperglycemia can be a potential risk factor for active TB development. However, the impact of hyperglycemia on TB-specific innate immune response in terms of macrophage functions remains poorly addressed. We assessed macrophage effector functions in uncontrolled DM patients with or without TB infection (PTB+DM and DM), non-diabetic TB patients (PTB), and non-diabetic-uninfected controls. Phagocytic capacity against BCG and surface expression of different pattern recognition receptors (PRRs) (CD11b, CD14, CD206, MARCO, and TLR-2) were measured via flow cytometry. Effector molecules (ROS and NO) required for bacterial killing were assessed via DCFDA and Griess reaction respectively. A systematic dysregulation in phagocytic capacity with concurrent alterations in the expression pattern of key PRRs (CD11b, MARCO, and CD206) was observed in PTB+DM. These altered PRR expressions were associated with decreased phagocytic capacity of macrophages. Similarly, ROS was aberrantly higher while NO was lower in PTB+DM. These altered macrophage functions were positively correlated with increasing disease severity. Our results highlight several key patterns of immune dysregulation against TB infection under hyperglycemic conditions and highlight a negative impact of hyperglycemia with etiology and progression of TB.

Seizure EEG Quality in Right Unilateral Ultrabrief ECT.

OBJECTIVE: The aims of this study were to compare threshold and suprathreshold ictal electroencephalograms (EEGs) in right unilateral (RUL) ultrabrief (UB) electroconvulsive therapy (ECT) and to identify the differences between these EEGs. METHODS: This study is a retrospective review of 125 pairs EEGs from titration and subsequent sessions across a 2-year period. All EEGs were independently rated for by 2 assessors using a scale based on qualities of an EEG used to guide ECT treatment dose adequacy, for example, midictal amplitude, regularity, interhemispheric coherence, seizure end point, and postictal suppression. The scores of threshold and suprathreshold EEGs were compared within and between groups based on 2 ECT types, that is, RUL UB ECT and RUL brief pulse (BP) ECT. RESULTS: Paired t tests showed a statistically significant difference in between threshold and suprathreshold EEG scores in RUL UB ECT. There were no statistically significant differences between corresponding scores for RUL UB ECT and RUL BP ECT threshold and suprathreshold EEGs. CONCLUSIONS: There is a significant difference between the quality of threshold and suprathreshold EEGs in RUL UB ECT when measured with an EEG rating scale. Visual rating of ictal EEGs is as reliable in discriminating between threshold and suprathreshold seizure in RUL UB ECT as it is in RUL BP ECT.

Post-extubation high-flow nasal cannula oxygen therapy versus non-invasive ventilation in chronic obstructive pulmonary disease with hypercapnic respiratory failure.

The sequential use of non-invasive ventilation (NIV) for weaning in hypercapnic respiratory failure patients is a recommended practice. However, the effectiveness of weaning on High flow nasal cannula (HFNC) is unclear. Chronic obstructive pulmonary disease patients with hypercapnic respiratory failure who received invasive ventilation were screened for enrolment. This study was a single-centre, prospective, randomized comparative study. The primary outcome was treatment failure within 72 hours after extubation. Patients who were screened positive for extubation were enrolled in the study and randomized into the HFNC group and NIV group using a computer-generated simple randomization chart. The treatment failure was defined as a return to invasive mechanical ventilation, or a switch in respiratory support modality (i.e., changing from HFNC to NIV or from NIV to HFNC). Of 72 patients, 62 patients were included in the study. Treatment failure occurred in 8 patients (26.67 %) in HFNC group and 8 patients in NIV group (25%) (p=0.881). The mean duration of ICU stay in HFNC group was 5.47±2.26 days and 6.56±3.39 in NIV group (p=0.376). In the current study, HFNC was non-inferior to NIV in preventing post-extubation respiratory failure in COPD patients, while HFNC had better treatment tolerance.

Comparison of immediate withdrawal and stepwise reduction in duration of non-invasive ventilation in chronic obstructive pulmonary disease patients presenting with acute hypercapnic respiratory failure.

There is no universally acceptable protocol for the withdrawal of non-invasive ventilation (NIV) in chronic obstructive pulmonary disease (COPD) patients presenting with acute hypercapnic respiratory failure (AHcRF). This study was carried out to evaluate immediate against stepwise reduction in NIV. Sixty COPD patients with AHcRF who were managed with NIV were randomized into two groups - immediate NIV withdrawal (Group A), and stepwise reduction of NIV duration (Group B). The rate of successful NIV withdrawal, time to recurrence of hypercapnic respiratory failure, total duration of NIV use, and hospital length of stay (LOS), were compared among the 2 groups. NIV was successfully withdrawn in 51/60 (85%) patients. NIV was successfully withdrawn in 24/30 (80%) patients in Group A and 27/30 (90%) patients in Group B (p=0.472). The total duration of NIV use was significantly lower in Group A (38.97±17 hours) as compared to Group B (64.3±7.74 hours) (p<0.0001). The hospital LOS was significantly lower in group A (5.8±1.6 days) as compared to Group B (7.7±0.61 days) (p<0.0001). To conclude, immediate withdrawal of the NIV after recovery of respiratory failure among patients with exacerbation of COPD is feasible and does not increase the risk of weaning failure.

Prediction of Weaning Outcome from Mechanical Ventilation Using Ultrasound Assessment of Parasternal Intercostal Muscle Thickness.

Background: Monitoring the function of parasternal intercostal muscles provides information on respiratory load and capacity and thus can be a weaning monitoring tool. Objective: The goal was to study the diagnostic accuracy of parasternal intercostal muscle thickness fraction (PICTF%) as a predictor of weaning. Materials and methods: A prospective observational study on consecutively admitted patients who were intubated and mechanically ventilated for a duration of at least 48 hours was carried out. When an SBT was planned by the treating physician, the study examiner performed the ultrasound measurements of parasternal intercostal muscle thickness (inspiration and expiration) and thickening fraction using M-mode ultrasonography (USG). The PICTF% was calculated as "(peak inspiratory thickness - end-expiratory thickness)/end-expiratory thickness) × 100." Weaning failure was defined if the patient had a failed spontaneous breathing trial (SBT) or the need for a reintubation within 48 hours following extubation. The SBT failure was defined as the need to connect the patient back to the ventilator prior to its completion due to any reason as decided by the clinician. Results: Of 81 screened patients, 60 patients met the inclusion criteria, of whom 49 patients had successful SBT, and 48 patients could be successfully extubated. The PMTF% cut-off value more than or equal to 15.38% was associated with the best sensitivity (75%) and specificity (87.8%) in predicting extubation failure. Conclusion: The PICTF% has a good diagnostic accuracy in predicting weaning failure. How to cite this article: Ramaswamy A, Kumar R, Arul M, Ish P, Madan M, Gupta NK, et al. Prediction of Weaning Outcome from Mechanical Ventilation Using Ultrasound Assessment of Parasternal Intercostal Muscle Thickness. Indian J Crit Care Med 2023;27(10):704-708.

Effect of COVID-19 vaccination status on outcome of adult patients admitted at a tertiary care centre in India.

COVID-19 vaccination was initially started in India on 16th January 2021 after approval from national authorities. This study was carried out to assess the effect of vaccination status on the severity and clinical outcome among patients infected with COVID-19. The study included all adult COVID-19 patients admitted to our hospital from 1st April to 30th June 2021. A total of 819 patients were enrolled in the study out of which only 183 (22.3%) were vaccinated. The study documented a statistically significant reduction in the severity of illness among the vaccinated (single/double dose) (33% severe COVID-19) against the unvaccinated (43% severe COVID-19) groups; along with a reduction in mortality. On univariate and multivariate analysis, age, severity of illness and lack of COVID-19 vaccination status were associated with a statistically significant increased mortality. To conclude, this study demonstrates the role of vaccination in decreasing the severity and mortality of COVID-19 infection.

Clinico-epidemiological profile of COVID-19 patients admitted during third wave of pandemic in a tertiary care hospital in New Delhi, India.

Even nearly two years after the first reported case, the novel coronavirus (SARS-CoV-2) continues to ebb and flow around the world. A retrospective cohort study was carried out to determine the clinico-epidemiological profile and outcome of the cases. The study analyzed secondary data from 827 patients who presented to our center with COVID-19-related illnesses between December 15, 2021, and February 15, 2022 (third wave in India). There was a significant difference in the vaccination status of patients treated at home and those admitted, with 87.9% having received two doses compared to 74% in the second group being unvaccinated. Patients who were isolated at home recovered at a rate of 99.4%, while hospitalized patients died at a rate of 26.5%. Vaccination reduces the severity of COVID-19; however, constant vigilance for new variants, precautionary measures, and increased vaccination drives are critical moving forward.   *Other members of the Safdarjung Hospital COVID-19 working group: B. Lal (Medicine), Harish Sachdeva (Anaesthesiology), Santvana Kohli (Anaesthesiology), Amandeep Jaswal (Anaesthesiology), Sumitra Bachani (Obstetrics and Gynecology), Ajay Kumar (Pediatrics), Rohit Kumar (Pulmonary Medicine), Vidya Sagar Chaturvedi (Surgery), Vinod Chaitanya (Medicine).

Role of Regulatory Proteins Involved in Iron Homeostasis in Pulmonary Tuberculosis Patients and Their Household Contacts.

Early identification and treatment of active tuberculosis disease among high risk household contacts could limit new transmission and better clinical outcome, thus decreasing TB burden. Host iron homeostasis is an important yet underevaluated factor in pathophysiology of tuberculosis (TB). One such protein is hepcidin which internalizes ferroportin (membrane iron transporter), thus inhibiting iron export from macrophages which is utilised by bacteria leading to disease severity. Iron homeostasis markers were evaluated in 50 pulmonary tuberculosis patients (PTB) and their household contacts to assess their utility as biomarkers for TB development. Altered iron homeostasis with significantly lower haemoglobin levels despite optimum serum iron levels was observed in PTB compared to household contacts and healthy controls pointing towards anaemia of inflammation. Higher serum hepcidin with lower ferroportin expression and hence higher ferritin levels was seen in PTB compared to both household contacts and healthy controls due to IL-6 induced hepcidin production in TB. Transferrin levels were found to be significantly lower in PTB and household contacts as compared to healthy controls owing to higher ferritin levels in PTB group. Upon infection, regulation of iron absorption is disturbed via increased hepcidin levels leading to ferroportin internalization and thus inhibition of iron export from macrophages which may lead to favourable M.tb. survival and multiplication leading to tuberculosis. Some of these markers could be assessed for early identification and treatment of active tuberculosis among high risk household contacts limiting new transmission and better clinical outcome, thus decreasing TB burden.

A middle-aged lady with near-fatal respiratory failure.

Tuberculosis is an uncommon cause of acute hypoxemic respiratory failure. We present a case of a middle-aged women with near-fatal respiratory failure due to underlying tuberculosis with favorable clinical recovery. Early diagnosis and treatment are imperative to prevent morbidity, mortality, and disease transmission.

Mortality among adult hospitalized patients during the first wave and second wave of COVID-19 pandemic at a tertiary care center in India.

The similarities and differences between the mortality patterns of the two waves in India remain largely unknown. This was a retrospective study of medical records conducted in the COVID data center of our hospital This study analyzed data of patients who died in the month of August, 2020 to October 2020 (one month before and after the peak of first wave i.e., 16th September, 2020) and April 2021 to June 2021 (one month before and after the peak of second wave i.e., 6th May, 2021), corresponding to an equal part of the pandemic during first (2020) and second (2021) wave. Out of 1893 patients in the study, 764 patients were admitted during the first wave and 1129 patients during the second wave of pandemic. In total, 420 patients died during the entire study period. Of those, 147 (35%) deaths occurred during the first wave and 273 (65%) during the second wave, reflecting a case fatality rate (CFR) of 19.2% during the first wave and a CFR of 24.18%. There were no significant differences in the age group, gender, presenting complaints, duration of stay and comorbidities. However, the deceased COVID-19 patients had an increase in case fatality rate, average duration of symptoms from onset to hospital admission (DOSHA) and a major shift from MODS to ARDS being the cause of death during the second wave of pandemic. This study demonstrates increased CFR, average DOSHA and a paradigm shift to ARDS as cause of mortality during the second peak of the pandemic. It is necessary to remain vigilant of newer COVID-19 variants of concern, follow COVID-19 appropriate behaviors and keep emphasizing on care of high-risk groups including patients with comorbidities and elderly population to prevent mortality.

Chest percussion, a common yet underutilized art.

Dear Editor Long years of respiratory medicine practice lets one develop a clinical instinct which certainly aids in diagnostic acumen...

Development of double crosslinked sodium alginate/chitosan based hydrogels for controlled release of metronidazole and its antibacterial activity.

Double network sodium alginate/chitosan hydrogels were prepared using calcium chloride (CaCl2) and glutaraldehyde as the crosslinking agents by the ionotropic interaction method for controlled metronidazole release. The effect of polymer ratios and CaCl2 amount is investigated by the developing porosity, gel fraction, and extent of swelling in simulated physiological fluids. Interaction between the polymers with the formation of crosslinked structures, good stability, phase nature, and morphology of the hydrogels is revealed by Fourier-transform infrared spectroscopy, thermogravimetric analysis, X-ray diffraction, and scanning electron microscopy. A sodium alginate/chitosan hydrogel (weight ratio of 75:25) crosslinked with two percent CaCl2 is chosen for the in-situ loading of 200 mg of metronidazole. The drug release kinetics using different models show that the best-fit Korsmeyer-Peppas model suggests metronidazole release from the matrix follows diffusion and swelling-controlled time-dependent non-Fickian transport related to hydrogel erosion. This composition displays enhanced antimicrobial activity against Staphylococcus aureus and Escherichia coli.

Clinical utility of intrabronchial antifungal instillation in a complicated case of chronic pulmonary aspergillosis: case report and systematic review of literature.

Chronic pulmonary aspergillosis (CPA) is a progressive, debilitating clinical condition associated with significant morbidity. Surgery is the mainstay of treatment for life-threatening hemoptysis in symptomatic patients with simple aspergillomas. However, in patients with chronic cavitary pulmonary aspergillosis, surgical removal of aspergillomas is fraught with difficulty due to debilitating nature of the illness. Here we present a case showcasing the utility of intrabronchial voriconazole instillation in controlling hemoptysis in a patient unfit for surgery followed by systematic review of literature involving 11 clinical studies after screening a total of 5572 studies from PubMed and Google Scholar database. Data gathered from these studies addresses the concerns regarding the efficacy, safety of the procedure as well as draws attention regarding several lacunae in our existing knowledge. A 53-year-old male with chronic pulmonary aspergillosis who had recurrent episodes of hemoptysis despite bronchial artery embolization and was unfit for surgery due to limited lung reserve, patient underwent single session of intrabronchial voriconazole instillation which resulted in dramatic symptomatic and radiological improvement. Intrabronchial antifungal instillation may be a safe and effective option for hemoptysis control in patients with chronic pulmonary aspergillosis.

Tuberculosis with discordant drug resistance patterns- A diagnostic dilemma.

Programmatic management of drug-resistant tuberculosis (PMDT) guidelines in India specify the use of cartridge based nucleic acid amplification test (CBNAAT) and Line probe assay (LPA) for early diagnosis of drug-resistant Tuberculosis. However, discrepancy among these genotypic tests (CBNAAT and LPA) or with the phenotypic DST in real practice poses a clinical dilemma. The usual solutions are to rely on methods with short turnaround times like CBNAAT and LPA to start an initial regimen. The culture and DST results, that are typically available after at least a few weeks, are used to modify the regimen if required. This practice is based on the fact that culture and DST based sensitivity patterns are considered the gold standard for diagnosing and drug resistance. DNA sequencing by pyrosequencing, Sanger sequencing and next generation sequencing (NGS) are being evaluated; their future availability may help in early clarifications in discordant drug resistance patterns. Such tests are costly and have limited availability, however, in view of immense benefit to detect TB Drug-resistant phenotypes, national guidelines plan to scale up their use in national and well-performing intermediate TB reference laboratories.

Enrolment under of Nikshay Poshan Yojana among tuberculosis patients in a tertiary care hospital of Delhi.

To mitigate malnutrition among tuberculosis burden, Government of India launched Nikshay Poshan Yojana in 2018, providing incentive of INR500 per month to each enrolled patient. Our study tried to find out the status of the scheme and its target benefits amongst the beneficiaries in a tertiary care hospital in Delhi, and also the facilitating factors and barriers towards enrolment, and their knowledge, attitude and practice towards nutrition in TB. METHODS: A cross-sectional study was undertaken at a tertiary care hospital involving a calculated sample of 188 patients. The subjects were interviewed on a pre-designed, semi-structured, validated questionnaire and data was analysed on SPSS v.21. RESULTS: Enrolment rate for the scheme was 81.4%, of which only 10% of the participants received any benefit. Of the 35 participants who were not enrolled or were not aware of their enrolment status, 22 were interested in enrolment. The reason for non-enrolment by the 21 participants who were not enrolled were lack of awareness, lack of time or lack of a bank account. CONCLUSION: The study found that most of the patients attending DOTS treatment were enrolled under the scheme, but 90% were not receiving any incentive promised under it.

Nanostructured SiO2 material: synthesis advances and applications in rubber reinforcement.

Silica is a commercially significant material due to its extensive use in widespread applications and products. Synthetic amorphous silica (SAS) is a form of SiO2 that is intentionally manufactured and has been produced and marketed for decades without significant changes in its physico-chemical properties. The industrial production of nanostructured SiO2 is nowadays challenged by the expensive raw material use and high energy consumption. The search for non-petroleum-based fillers such as nanostructured SiO2, which are environmentally friendly, cheap, abundant, renewable, and efficient, has been initiated nowadays. Therefore, a large number of research activities have been carried out so far for the preparation of SAS from potential alternate precursors, i.e., synthetic chemicals, biogenic, and mineral ore resources. Reinforcement of rubbers with nanostructured SiO2 fillers is a process of great practical and technological importance for improving their mechanical, dynamic, and thermal properties. The efficiencies of SiO2 reinforcement correlate with different factors such as filler structure, surface area, rubber-filler interactions, and filler-filler interactions with their effects. This review paper discusses the recent synthesis advances of nanostructured SiO2 from synthetic chemicals, biogenic and mineral ore resources, their physical characteristics, and applications in rubber reinforcement, overcoming challenges. Finally, summary and future work recommendations have been mentioned well for future researchers.

A Prospective Study Evaluating Sleep Quality and Disorders in Post-ARDS Patients.

INTRODUCTION: Critically ill patients are predisposed to developing sleep disorders due to multiple factors like pre-existing sleep disorders, severe acute illness, sleep-altering medical interventions, and the disturbing intensive care unit (ICU) environment. In the current study, a multi-modality approach has been attempted to capture the different aspects of sleep disturbances, including insomnia (using ISI), daytime sleepiness (using ESS), sleep quality (using PSQI), sleep architecture, and SDB (using PSG). MATERIALS AND METHODS: The eligible ARDS survivor patients were updated about the study's design prior to hospital discharge. At admission, data regarding demographic details, clinical history, etiology of ARDS, and PaO2/FiO2 (P/F) ratio at presentation, Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scores was collected. All enrolled patients were evaluated twice (early-within 7 days of admission and late-after 6 weeks of discharge) by the Richards-Campbell Sleep Questionnaire (RCSQ), Insomnia severity index (ISI), and level 1 PSG. Additionally, ESS questionnaire and the Pittsburgh Sleep Quality Index (PSQI) were also recorded in late evaluation. Abnormal sleep was defined if one or more of the following characteristics met: ISI > 15, ESS > 10, global PSQI > 5, AHI ≥ 5 events/h. RESULTS: Thirty patients were recruited out of the total of 88 ARDS patients screened at admission. The median (IQR) PaO2/FiO2 ratio and APACHE II scores were 176 (151-191.5) and 14 (14-16), respectively. The median (IQR) duration of stay in the ICU was 10 (7.3-19.5) days. The median RCSQ score in the early and late evaluation was 42 and 69, respectively. The mean ISI score in the early evaluation was 16.67 ± 4.72, which decreased to 11.70 ± 5.03 in late evaluation (p < 0.05). ISI score > 15 (clinical insomnia) was found in 18 out of 30 subjects (60%) in early evaluation and 11 out of 30 (36%) in late evaluation. During the early evaluation, sleep efficiency was low (median 59.9% and predominantly N1 and N2) which improved in late evaluation (median 80.6%). Of the 30 patients, only 4 had AHI > 5 in early evaluation and none in late evaluation. Neither of P/F ratio, SOFA, and APACHE II scores did correlate with ICU events in the early and late evaluations. Regression analysis showed subjects with ICU stay more than 10 days, duration of IMV more than 7 days, Fentanyl more than 7 mg, duration of sedative use more than 7 days was independently associated with poor objective sleep quality (low sleep efficiency, low TST and high arousal index) during the early and late evaluations after ICU discharge compared to counterparts (p value < 0.05). CONCLUSION: We conclude that sleep quality in ARDS survivors was poor within 7 days of ICU discharge, characterized by severe disruption of sleep architecture and sleep-disordered breathing. After 6 weeks of ICU discharge sleep quality showed significant improvement in the N3 stage and AHI, however persistent insomnia was observed even at 6 weeks. Therefore, prior identification of risk factors and early diagnosis of sleep quality disorders in post-ARDS patients is essential.

Comparative efficacy and safety of oxcarbazepine versus divalproex sodium in the treatment of acute mania: a pilot study.

OBJECTIVE: This study compared the efficacy and safety of oxcarbazepine and divalproex sodium in acute mania patients. SUBJECTS AND METHODS: In this 12 week, randomized, double-blind pilot study, 60 patients diagnosed with acute mania (DSM-IV) and a baseline Young Mania Rating Scale (YMRS) score of 20 or more received flexibly dosed oxcarbazepine (1,000-2,400 mg/day) or divalproex (750-2,000 mg/day). The mean decrease in the YMRS score from baseline was used as the main outcome measure of response to treatment. A priori protocol-defined threshold scores were or=15 for relapse. Number of patients showing adequate response and the time taken to achieve improvement was compared. Adverse events were systematically recorded throughout the study. RESULTS: Over 12 weeks, mean improvement in YMRS scores was comparable for both the groups including the mean total scores as well as percentage fall from baseline. There were no significant differences between treatments in the rates of symptomatic mania remission (90% in divalproex and 80% in oxcarbazepine group) and subsequent relapse. Median time taken to symptomatic remission was 56 days in divalproex group while it was 70 days in the oxcarbazepine group (p=0.123). A significantly greater number of patients in divalproex group experienced one or more adverse drug events as compared to patients in the oxcarbazepine group (66.7% versus 30%, p<0.01). CONCLUSION: Oxcarbazepine demonstrated comparable efficacy to divalproex sodium in the management of acute mania. Also the overall adverse event profile was found to be superior for oxcarbazepine.