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Objective: To evaluate the persistence of antibodies three years after primary vaccination with typhoid conjugate vaccine (TCV) of either Cadila Healthcare Ltd. (Cadila-TCV) or Bharat Biotech International Ltd. (Bharat-TCV) administered in a previous phase II/III study, and to study the booster dose response to Cadila-TCV. Methods: This was an open-label, phase IV extension study conducted in tertiary care and multispecialty hospitals in India. 112 subjects (Cadila-TCV-57, Bharat-TCV-55) who had participated in previous study were enrolled. Of these, eligible subjects received a single-dose of Cadila-TCV and were followed-up for 28 days post-booster. Primary outcome was persistence of antibodies 3 years after primary vaccination and seroconversion (?4-fold rise in antibody titre from baseline) 28 days postbooster. Safety was based on reported adverse events (AEs) post-booster. Results: The baseline GMT reported in the current study was significantly higher than pre-vaccination GMT reported in the previous study. 89/112 (79.5%) subjects had antibody titer ?10 IU/mL at baseline; eligible subjects (n=17) who had baseline antibody titre <10 IU/mL were administered booster dose. All the vaccinated subjects showed seroconversion post-booster. The GMTs reported at 10 days and 28 days post-booster were significantly higher as compared to GMTs reported after primary vaccination in previous study. 4 (23.5%) vaccinated subjects reported 9 AEs; all were solicited and of mild/moderate intensity. Conclusion: There was a significant persistence of immunogenicity after primary vaccination with both the TCVs, and robust immune response after booster vaccination with Cadila-TCV.
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Background: The aim of the study was to determine the distribution of oropharyngeal malignancies in terms of age, sex,personal habits, symptoms, site, histopathological type, and differentiation; and the modes of treatment adopted and its results.Materials and Methods: A total of 68 patients treated previously in the Department of Ear, Nose, and Throat of MNR MedicalCollege and Hospital were included in this study. Patients of all age groups and gender were included in the study. Patients withpersistent mass of the neck or throat or with symptoms suggesting oropharyngeal cancer were included in the study. Patientswith symptoms of chronic throat pain, difficulty swallowing, weight loss, earache, voice change, and blood-tinged saliva wereincluded in the study. Patients with severe cardiac, renal and pulmonary diseases were excluded from the study. Patientswith immunodeficiency diseases were excluded from the study. All the patients were initially evaluated by a detailed medicalhistory and comprehensive head and neck examination, which included flexible endoscope examination of the pharynx andlarynx in an outpatient department setting. Patients with suspicious looking lesions (tumors) of the oropharynx were biopsiedfor histopathological evaluation. All patients with a confirmed diagnosis of oropharyngeal squamous cell carcinoma weresubjected to evaluation by a multidisciplinary treatment team. Imaging was done to evaluate the primary tumor, involvementof lymph nodes in the neck, and for evidence of metastatic cancer spread beyond the head and neck. The patients weresubjected to either computed tomography scan or magnetic resonance imaging of the neck to evaluate the pharynx and lymphnodes in the neck.Observations and Results: Among the 68 patients, there were 41 males (60.29%) and 27 females (39.70%), with a male tofemale ratio of 1.51: 1. The mean age was 55.63 ± 5.70 years. Thirty-seven patients (54.41%) were in 55–65 years, 24 patients(35.29%) in 45–55 years, and 7 patients (10.29%) were aged above 65 years. Malignant tumors of the tonsil were observedin 21/68 (30.88%), posterior one-third of the tongue in 17/68 (25%), soft palate in 10/68 (14.70%), valleculae in 10 (14.70%),and suprahyoid epiglottis in 6 (8.82%), and posterior pharyngeal wall in 4 (105.88%) of the patients.Conclusions: Oropharyngeal cancers are one of the most common malignant tumors of the aero-digestive tract. Males aremore commonly affected than females and usually in the 5th–6th decade of life. The incidence is rising in females also becauseof using smokeless tobacco products. The most common site was tonsil followed by posterior one-third of the tongue; the leastcommon site was posterior pharyngeal wall. Well-differentiated carcinoma was the most common histopathological finding.
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Background: Allergic fungal sinusitis (AFS) is the most common form of fungal sinus disease with a high rate of recurrence ratedespite the advent of advanced endoscopic sinus surgery and usage of steroids. Refractory AFS is defined as a condition ofallergy due to fungal antigenic elements not amenable to surgical removal or prolonged medical management. Oral itraconazoleis an antifungal agent that seems to be benefit to the patients with refractory AFS. Hence, this study was conducted to comparethe outcome of AFS after addition of oral itraconazole to the treatment protocol.Aim of the Study: The aim of the study was to evaluate the acceptance and usefulness of itraconazole, an oral antifungaldrug, in the treatment of refractory AFRS.Materials and Methods: A total of 84 patients with refractory AFS were included in this study. The medical records of these patientswere retrieved from the medical records section and analyzed. A detail history of the AFS was elicited and demographic data weretabulated. Nasal endoscopy was done before and 3 months after the itraconazole therapy and the findings were classified according toLund-Kennedy endoscopic grading system, Scoring from 7 to 10 was graded as severe; scoring from 4 to 6 was graded as moderateand 1 to 3 as mild grade. Itraconazole was administered in the form of capsule 100 mg 2 times daily for 3 months. Prior hepaticfunction and renal function tests were undertaken for all the patients. All the data were analyzed using standard statistical methods.Observations and Results: Among the 84 patients, there were 52 (61.90%) males and 32 (38.09%) females with a male tofemale ratio of 1.6:1. The patients were aged between 18 years and 78 years with a mean age of 33.45 ± 4.15 years. Conversionof severe grade patients to mild grade following itraconazole therapy was note; post-treatment findings were severe in 5 patients,moderate in 1, and mild in 78 patients.Conclusions: Itraconazole may be useful as an adjunct in the management of AFRS. However, more studies, including aprospective randomized clinical trial, are required to determine if itraconazole is effective in the management of AFRS.
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Background: Cisplatin is a chemotherapeutic agent that is widely used to treat a variety of malignant tumors. Serious doselimiting side effects such as ototoxicity, nephrotoxicity, and neurotoxicity are likely to occur with its use.Aim of the study: The aim of the study was to do audiological evaluation of patients on cisplatin before and after chemotherapyfor squamous cell carcinomas of head and neck and analyze for hearing loss (HL).Materials and Methods: A total of 46 patients undergoing cisplatin administration were included in the study. History taking,preliminary ENT examination, and audiological evaluation with pure-tone audiometry were done. A pure-tone average (PTA) wascalculated using the speech frequencies (500, 1000, and 1500 kHz). High-frequency pure-tone audiometry was also done in allpatients to know the basal auditory threshold before starting cisplatin therapy. Baseline audiometry was done Prior to Chemotherapyor at least 24 h after administration of Cisplatin. Monitoring audiometry was done before each cycle of Cisplatin therapy. Follow-upaudiometry was done 1, 3, and 6 months after chemotherapy. Dosage of cisplatin ranged from 50 mg to 115 mg with cumulativedose ranging from 250 mg to 850 mg in all the patients. All the data were analyzed using standard statistical methods.Observations and Results: Among 46 patients, there were 33 males and 13 females (28.26%) with a male-to-female ratioof 2.53:1. Patients were aged between 45 years and 70 years and the mean age was 55.35 ± 2.70 years. 22/46 (47.82%)patients were in the range of 55–65 years age group followed by 15/46 (32.60%) patients who were in the 45–55 yearsage group. 9/46 (19.56%) patients were in the 65–75 years age group. Patients of all age groups showed high-frequency(3000 kHz–12,000 kHz) HL in the study group. The thresholds were found to be increasing from 35 dB to 59 dB with increasingfrequencies from 3000 kHz to 12,000 kHz.Conclusions: In this study, all the patients showed significant evidence of severe mixed type of HL. The HL was significant inall the age groups and in both the genders. Six months follow-up showed no recovery of HL presumable resulting in permanentHL. Very few patients showed vestibular involvement. Audiometric monitoring may help to provide early evidence of decreasedhearing ability, leading to the possible limitation of the severity of ototoxicity.