Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices

Drug Safety - Pharmacovigilance is the science of monitoring the effects of medicinal products to identify and evaluate potential adverse reactions and provide necessary and timely risk mitigation...     

Protective effect of aqueous extract of Oroxylum indicum Linn. (root bark) against DNBS-induced colitis in rats

Objective:

Aqueous root extract of Oroxylum indicum was evaluated in rats against dinitrobenzene sulfonic acid (DNBS) induced colitis.

Materials and Methods:

Rats were pre-treated orally for seven days and continued for four days after the induction of colitis with OI_aq (100, 200, and 400 mg/kg) or vehicle. Colitis was induced by intracolonic instillation of 25 mg of DNBS per rat dissolved in 50% alcohol and 4 days later, the colonic mucosal damage was analyzed along with food intake, body weight, colon weight, spleen weight, histological damage, myeloperoxidase (MPO) activity, malondialdehyde (MDA) levels, reduced glutathione (GSH), and nitric oxide levels in colonic tissue homogenate.

Results:

Significant reduction in gross damage area, weight loss and increase in colonic and spleen weight were evident in test substance-pretreated animals’ dose dependently as compared to vehicle treated control. These effects were confirmed biochemically by a reduction in colonic myeloperoxidase activity, malondialdehyde levels, nitric oxide levels, and increase in reduced glutathione (GSH) levels. Furthermore, microscopic examination revealed diminution of inflammatory cell infiltration and submucosal edema in colon segments of rats treated with OI_aq.

Conclusion:

The results demonstrate the protective effect of OI_aq in the animal model of acute colitis possibly through an antioxidant, anti-lipoperoxidative or due to reduction in nitric oxide generation.KEY WORDS: Oroxylum indicum, DNBS, colitis, rats     

Extracting biomarkers of autism from MEG resting-state functional connectivity networks

The present study is a preliminary attempt to use graph theory for deriving distinct features of resting-state functional networks in young adults with autism spectrum disorder (ASD). Networks modeled neuromagnetic signal interactions between sensors using three alternative interdependence measures: (a) a non-linear measure of generalized synchronization (robust interdependence measure [RIM]), (b) mutual information (MI), and (c) partial directed coherence (PDC). To summarize the information contained in each network model we employed well-established global graph measures (average strength, assortativity, clustering, and efficiency) as well as graph measures (average strength of edges) tailored to specific hypotheses concerning the spatial distribution of abnormalities in connectivity among individuals with ASD. Graph measures then served as features in leave-one-out classification analyses contrasting control and ASD participants. We found that combinations of regionally constrained graph measures, derived from RIM, performed best, discriminating between the two groups with 93.75% accuracy. Network visualization revealed that ASD participants displayed significantly reduced interdependence strength, both within bilateral frontal and temporal sensors, as well as between temporal sensors and the remaining recording sites, in agreement with previous studies of functional connectivity in this disorder.     

Detecting Social and Non-Social Changes in Natural Scenes: Performance of Children with and Without Autism Spectrum Disorders and Typical Adults

We probed differences in the ability to detect and interpret social cues in adults and in children and young adolescents with and without autism spectrum disorders (ASD) by investigating the effect of various social and non-social contexts on the visual exploration of pictures of natural scenes. Children and adolescents relied more on social referencing cues in the scene as compared to adults, and in the presence of such cues, were less able to use other kinds of cues. Typically developing children and adolescents were no better than those with ASD at detecting changes within the various social contexts. Results suggest children and adolescents with ASD use relevant social cues while searching a scene just as typical children do.     

Overactive Bladder and Pain: Management Strategies

Overactive bladder associated with pain (ie, interstitial cystitis/bladder pain syndrome [IC/BPS]) is a prevalent condition that can be very difficult to diagnose and even more difficult to treat. In this paper, we review the studied therapies for IC/BPS, including non–medication-based therapies, oral and intravesical-based medications, and surgical treatments for interstitial cystitis. We also review an approach to the treatment of a patient with IC/BPS using the previously published UPOINT clinical phenotyping template.     

Adapting to an aftereffect

We report a new type of orientation-contingent color aftereffect in which the color aftereffect is opposite to the classical McCollough effect, i.e., the perceived color of the aftereffect is the same as the inducer's color. Interleaved exposure to red, horizontal and achromatic (gray), horizontal gratings led to a long-lasting aftereffect in which achromatic horizontal gratings appeared reddish. The effect, termed the anti-McCollough effect, although weaker than the classical aftereffect, remained stable for a moderate duration of time (24 hours). Unlike the classical aftereffect, which is known to not transfer interocularly, the new after-aftereffect transferred 100%, suggesting that its locus in the brain was downstream of the classical effect. It is likely that neurons in a higher-order area adapted to the classical color aftereffect that was represented in a lower-order area, thus forming an aftereffect of an aftereffect, i.e., an after-aftereffect. Our finding has implications as to how neural activity in lower- and higher-level areas in the brain interacts to yield conscious visual experience.     

Bone conduction improvement after surgery for conductive hearing loss

The objective is to evaluate change in post-operative bone conduction in patients who underwent surgery for conductive/mixed hearing loss due to various reasons. The study design is of retrospective case review and tertiary referral center setting. Five-hundred patients with unilateral conductive/mixed hearing loss were divided into five equal groups (each representing different causes for pre-operative hearing loss), who underwent appropriate surgical correction and had a follow-up audiogram available. The intervention comprises surgery (like myringoplasty and ossiculoplasty with closed or open cavity mastoidectomy for chronic otitis media, stapes mobilization for tympanosclerosis and stapedotomy for otosclerosis) for conductive/mixed hearing loss. Significant improvement or worsening in bone conduction was defined as 15?dB or more improvement or worsening of bone conduction threshold at least in two frequencies between 500 and 4000?Hz. All the other groups also showed a consistent pre-operative bone conduction reduction with an equally consistent improvement in post-operative bone conduction improvement to a varying degree with otosclerosis group having maximum percentage of patients with post-operative bone conduction improvement (60%). The measurement of bone conduction is not necessarily a true reflection of the function of the inner ear. Middle ear makes a contribution to bone conduction and correction of a middle ear conductive lesion causes an apparent improvement in inner ear function. The apparent inner ear hearing loss caused in this way may be reversible to some extent.