A prospective, randomized, parallel group, double blind, multicenter study to compare the efficacy, safety and immunogenicity of Lupin’s Ranibizumab with Lucentis® in patients with neovascular age-related macular degeneration

Purpose: The present study compares the efficacy, safety, and immunogenicity of Lupin’s biosimilar ranibizumab with that of Lucentis® in patients with neovascular age-related macular degeneration. Methods: This prospective, double-blind, multi-centric phase-III study was conducted across 19 centers in India. A total of 202 patients with neovascular age-related macular degeneration were randomized (1:1) to receive either Lupin’s biosimilar ranibizumab or Lucentis®, 0.5 mg, as an intravitreous injection once every month for 3 months. The primary efficacy endpoint was the proportion of patients who lost fewer than 15 letters from baseline in best-corrected visual acuity. The safety profile included assessment of adverse events, ophthalmic examination, physical and systemic examination, and vital parameters. The immunogenicity assessment was based on evaluation of anti-drug antibodies. Results: Overall, 174 patients (87 [86.14%] in each group) completed the study. The demographics and baseline characteristics were comparable between the treatment groups. The proportion of patients losing fewer than 15 letters from baseline best corrected visual acuity score in the study eye was comparable between two groups. The difference between Lupin’s ranibizumab and Lucentis® for the proportion of patients who lost fewer than 15 letters was within the predefined equivalence margin (intention-to-treat population: 1.0%; 95% confidence interval [CI], ?3.3% to 5.4% and per protocol population: 1.2%; 95% CI, ?3.2% to 6.4%). The incidence of treatment-emergent adverse events was comparable, and 11 (10.89%) patients in Lupin’s ranibizumab and 19 (18.81%) patients in Lucentis® group had at least one treatment-emergent adverse event. The immunogenicity incidence as assessed by proportion of patients with positive anti-drug antibodies was numerically lower in Lupin’s ranibizumab (4.95%) than Lucentis® (12.87%). Conclusion: Lupin’s biosimilar ranibizumab demonstrated therapeutic equivalence, desirable safety, and favorable immunogenicity profile compared to Lucentis

Study of Acute Febrile Encephalopathy among Children in Tertiary Care Centre

Acute febrile encephalopathy (AFE) in children is a medical emergency and could be a manifestation of many systemic and central nervous system pathologies. The clinical features of AFE are nonspecific and etiological spectrum variable depending on the studied population. Methods: A prospective, observational study was carried out including children aged between 1 month and 12 years with AFE admitted to the Pediatric Intensive Care Unit of a tertiary care hospital in B.J medical college. The primary objective was to assess the clinical presentation and etiology of AFE while the secondary objectives were to correlate the clinical and etiological findings and to determine the risk factors associated with mortality. Results: Out of the ninety children with AFE included in this study, male: female ratio was 1.2:1; most of them were aged between 1 and 5 years and came with a history of < 7 day (82.2%). All of them had altered sensorium, about 2/3rd had seizures and 47.8% having a Glasgow Coma Score (GCS) <8. Etiology remained elusive in about 40% of the cases, and viral infections were the most common among the ones with an identifiable cause. Conclusion: AFE, though a rare diagnosis in children, is associated with significant morbidity and high mortality in a developing country like India.

Non Surgical Management of Self Inflicting Gingival Injury In Schizophrenic Patient.

Schizophrenia is a brain disorder that affects the way a person acts and sees the world. People with schizophrenia have an altered perception of reality, often a significant loss of contact with the reality. Some of the most common early warning signs of schizophrenia includes extreme reaction to criticism, deterioration of personal hygiene, depression, odd or irrelevant statement etc. A 24-year old female patient with similar features came to the department with the chief complaint of bleeding and receding gums; upon examination it was found that gingival mucosa in relation to maxillary right canine to first molar was lacerated. Detailed history of the patient showed that she was suffering from schizophrenia and was undergoing treatment for the same; she deliberately brushed hard on the respective region causing recession and laceration. Following diagnosis, non surgical management of the lesion was done including scaling and root planning. Four weeks after treatment, the patient was reviewed and in the follow up it was observed that the gingival lesion had resolved

Comparative Study of Pulmonary Function Tests in Smokers and Non-Smokers.

Objective : The present study was aimed to evaluate the influence of smoking on pulmonary functions. To study the differences in pulmonary function test values in smokers and non-smokers and their variation from other reported values for smokers by other studies. Materials and Methods : In cross sectional study spirometry data of 51 smokers & 54 non-smokers were collected by RMS Medispiror computerized spirometer. Expiratory flow volume curves were recorded & FVC, FEF „„, PEFR, FEV„ FEV,/FVC ratio were obtained. The data were compared between smokers and non-smokers group. Results : PFT parameters FVC, FEV„ PEFR, FEF„, and MW were significantly reduced in smokers group compare to non-smokers group (p< 0.05). The PFT parameters markedly decrease with increase no. of cigarette smoked per day as well as increase duration of smoking. Conclusion : The present study brings out substantial variation in most of the parameters of PFTs between smokers and non-smokers confirming PFT values are less in smokers due to toxic effects of tobacco smoking on respiratory system & is the major cause of obstructive lung disease in Indian population.

Extrusion of hydrogel exoplant into upper eyelid 16 years after a scleral buckle procedure.

Sixteen years after scleral buckle surgery with a hydrogel episcleral exoplant, a 43-year-old woman presented with progressive binocular diplopia, ptosis, and an expanding mass in her upper eyelid. She underwent surgical removal of the hydrogel exoplant through an anterior approach. The exoplant proved to be friable, fragmented, and encapsulated in a fibrous tissue; the exoplant was removed in its entirety. Postoperatively, the eyelid mass resolved, while her diplopia and ptosis improved slightly.

An epidemiological study in Gujarat by community periodontal index of treatment needs (CPITN).

3696 subjects (15 to 44 yrs.) attending Govt. Dental College and Hospital were screened for their periodontal treatment needs using the Community Periodontal Index of Treatment Needs (CPITN). Calculus predominated as the most frequently recorded CPITN score and affected over 70 % of the population. On the other hand, only a few persons below 20 years had CPITN score 4. The assessed treatment need was predominately scaling and oral hygiene education. (TN2) The need for deep scaling and/or surgery (TN3) was very low.

Diabetic retinopathy: A comprehensive review.

Diabetic retinopathy (DR) remains one of the leading risk factors and causes of blindness worldwide. Tight metabolic and blood pressure control has been shown to significantly decrease the risk of development as well as progression of retinopathy and remains a cornerstone in the medical management of DR. Laser photocoagulation and vitrectomy are important tools for preventing severe visual loss from sight-threatening DR and its complications. New pharmacological therapies to target the underlying biochemical mechanisms that cause DR are also being evaluated in order to overcome the limitations of current treatment modalities. In this context, the role of protein kinase C inhibitors, intravitreal injections of steroids, vascular endothelial growth factor inhibitors, angiotensin converting enzyme inhibitors such as candesartan, and growth hormone inhibitors is promising. Although treatment can help prevent blindness in a majority of cases, the key variable in the success of therapy lies in identifying patients with retinopathy before their vision is affected. This calls for timely eye examination of diabetic patients. The present article is a comprehensive review of DR with special emphasis on its pathophysiology and management aspects.

Adherence to high activity antiretrovial therapy (HAART) in pediatric patients infected with HIV: issues and interventions.

It has been proven that HAART is effective in suppressing human immunodeficiency virus (HIV) replication, decreasing morbidity and mortality associated with HIV and improving quality of life in adults as well as children infected with HIV. However, drugs don't work in patients who don't take them and in the management of HIV infection it is now well established that optimum adherence to HAART is critical to successful outcome of patients receiving therapy. At least 95% adherence to HAART is optimum and studies have shown that 50%. Important factors that influence adherence to HAART such as regimen related complexities, patient/family related issues and factors related to healthcare delivery system makes adherence to HAART challenging. Although numerous interventions to improve adherence have been investigated in developed as well as developing countries, majority of work in this area is focused on adherence in adults and data in children is limited. Therefore, in order to facilitate adherence and improve outcome of HAART in pediatric population, it is necessary to have a deep understanding of the factors influencing adherence and interventions that can improve adherence in children.

Progesterone receptors on human spermatozoa.

Progesterone, primarily recognized as a female steroid hormone, is reported to affect several sperm functions especially capacitation, motility and acrosome reaction. These effects of progesterone on the spermatozoa are mediated via the progesterone binding sites/progesterone receptor (PR) on the acrosomal membrane. These receptors in response to progesterone increase the intercellular Ca2+ levels and stimulate Ca2+ influx in the mature human spermatozoa via non-genomic mode of actions. Characterization of this receptor reveals that the sperm PR is masked protein and is exposed to the surface by some non-ionic detergents. Localized on to the acrosome region of the spermatozoa, these receptors are recognized by most antibodies directed towards the C-terminal region of the conventional PR. The estimated molecular weight of PR on spermatozoa varies from 27 kDa to 85 kDa. At the molecular level, sequences encoding for the entire DNA and hormone binding domains of the conventional PR are detected in the mRNA derived from spermatozoa. No insertions, deletions or mutations are detected in this region. These results are suggestive of the fact that at least the C terminal region of the conventional PR is conserved in the sperm. It is hypothesized that post-translational modifications or peptide splicing of the conventional PR in spermatozoa may possibly lead to the variant of the steroid hormone receptor. Detailed characterization of the sperm PR will be important in understanding the alternate non-genomic mode of action of steroid hormone receptors.

Evaluation of sparfloxacin eye drop in the management of conjunctival and corneal infection.

Sparfloxacin 03% eye drop was evaluated in consecutive culture proven cases of conjunctivitis and corneal infection. Sparfloxacin 03% eye drop was found to provide 100% cure rate clInIcally as well as bacteriologically. This can be due to better ocular penetration and higher therapeutic index of sparfloxacin 03% eye drops. Sparfloxacin seems to be a better antibiotic for topical application for themanagement of external ocular Infections like conjunctivitis, keratitis and corneal ulcers.