Assessing The Rationale Of Fdc Containing Ofloxacin And Azoles: Dissolution, Permeation And Antimicrobial Studies

Objective: To study fixed-dose combinations (FDC) of antibacterial and antiprotozoal products (ofloxacin and azoles), prescribed for the treatment of diarrhea. Methods: Rationality of these FDC products was verified by assessing parameters such as drug content and release by assay and dissolution tests, respectively mentioned in the Indian Pharmacopoeia (IP). Amount of drug solubilized and permeated as per the Biopharmaceutics Classification System (BCS) was determined. Ex vivo permeation study was performed on the gut of goat using the everted gut sac technique. Antimicrobial efficacy in terms of minimum inhibitory concentration (MIC) was assessed using agar well diffusion method against Shigella boydii, the causative agent for diarrhea. Comparative studies were performed on an individual as well as combination doses of antibacterial and antiprotozoal products for the synergistic effects to assess the rationale of these FDC. Results: The BCS solubility of ciprofloxacin (CPX), norfloxacin (NFX) and tinidazole (TNZ) was high in acidic medium (pH 1-5) and decreased at pH above 5. The assay studies showed that the individual drug contents of FDC were within the IP limits. In vitro dissolution results for both, individual drugs and their combination illustrated 99 % drug release within 30 min in 0.01N HCl. Ex vivo permeation of TNZ was higher than CPX and NFX in individual drugs. No significant change in the permeation rate was observed for individual drugs and their FDC. CPX and NFX exhibited more antimicrobial activity in terms of inhibitory zones than their FDC with antiprotozoal TNZ, above 2.5 µg/ml MIC. The pharmaceutical, biopharmaceutical and antimicrobial evaluation study showed the similarity of FDC with the individual drugs. Conclusion: The study showed no significant data to justify the therapeutic advantage of FDC over individual drugs.

Interface healing and its correlation with visual recovery and quality of vision following small incision lenticule extraction

Purpose: To study the time course of interface healing and its correlation with visual acuity, modulation transfer function (MTF), and aberrations after myopic small-incision lenticule extraction (SMILE) correction. Methods: Seventy-eight eyes of 78 patients (1 eye per patient) with a mean age of 25.7 years and mean spherical equivalent (SE) of ?3.74D, undergoing bilateral SMILE procedure, were included in this study. On postoperative day 1, 2 weeks, and 3 months, dilated retroillumination photographs were taken and morphology of corneal interface was graded by comparing them with 5 standard templates representing 5 grades of interface roughness (IRG): IRG � 0 (clear), IRG � 1 (mild), IRG � 2 (moderate), IRG � 3 (severe), and IRG � 4 (severe IRG with Bowman's folds in visual axis). Pearson's correlations were computed to study correlation associations, and Wilcoxon signed-rank test was used for intragroup comparison of means. P ? 0.05 was considered statistically significant. Results: At 3 months, 90.70% eyes were Grade 0 while 9.30% eyes still had Grade 2 interface granularity. Mean IRG significantly improved from 2.47 � 0.57 at day 1 to 0.62 � 0.53 at 3 months (P = 0.00). At day 1, pre-SE showed a significant positive correlation with IRG; however, mean postoperative corrected distant visual acuity (CDVA, in decimal), corneal Strehl ratio (SR), and MTF showed weak but significant negative correlation with IRG (r2 = 0.28 for SE, ?0.052 for CDVA, ?0.017 for SR, and ?0.39 for MTF, respectively, P < 0.05 for all correlations). At 2 weeks and 3 months, corneal MTF continued to show a significant negative correlation, whereas other parameters did not show any correlation with IRG. Conclusion: Visual quality and corneal MTF may be significantly affected by the IRG in the immediate postoperative period after SMILE and may take 3 months or more for complete recovery.

Implications of HLA sequence-based typing in transplantation.

Serology-based conventional microlymphocytotoxicity HLA typing method, which has been regarded as the gold standard in organ and hematopoietic stem cell transplantation, has been replaced now by DNA-based typing. Many laboratories all over the world have already switched over to molecular methods. Microlymphocytotoxicity-based tissue typing was done using commercial sera, while the molecular typing by genomic DNA based. DNA quality and its quantity obtained using various DNA extraction protocols was found to be an important factor in the molecular method of tissue typing in transplant outcome. Many polymerase chain reaction-based molecular techniques have been adopted with far reaching clinical outcome. The sequence-based typing (SBT) has been the ultimate technique, which has been of the highest reliability in defining the HLA alleles. The nonavailability of specific HLA antisera from native populations, large number of blank alleles yet to be defined and comparable low resolution of HLA alleles in SSP or SSOP technique, suggests that highly refined DNA-based methods like SBT should be used as an adjunct to HLA serology and/or low/intermediate/high resolution HLA typing in order to achieve a better transplant outcome.

Health status of hotel workers with special reference to high risk practices and STDs.

A cross sectional study was conducted on health status of hotel workers of Pune city. Out of estimated 1000 hotel workers 516 were selected by stratified random sampling technique. The study revealed that 71.5% hotel workers were suffering from one or other type of morbid condition. Anemia was the commonest morbidity with prevalence of 40.3%. 187 (36.2%) of hotel workers had extramarital sexual relations. A total of 77 (14.9%) hotel workers were having STDs at the time of study.

Rapid assessment survey of earthquake affected Bhuj block of Kachchh District, Gujarat, India.

RESEARCH QUESTIONS: How much human loss would have caused by the earthquake in Bhuj block? What is the environmental sanitation status? OBJECTIVES: (1) To assess human loss and injuries after the earthquake in Bhuj block.(2) To study the status of some relief activities.(3) To study the environmental sanitation status of the earthquake affected Bhuj block. Study design: Cross-sectional study. SETTINGS: Bhuj block. Participants: All villages excluding Bhuj city of Bhuj block. STATISTICAL ANALYSIS: Proportions, chi-square test, chi-square for trend. RESULTS: Survey was done in 144 villages; there were total 541 deaths with death rate of 3.18 per 1000 population. Death rate was significantly associated with distance of village from epicenter (chi-square for trend significant, P < 0.001). Among victims, majority were children 171 (45.4%) and women 107 (28.4%). Relief work was significantly associated with accessibility of village (P < 0.001) and few interior pockets were deprived of help. Total 56 (38.9%) villages were entirely dependent on water tanker for water supply and in 61 (42.4%) villages drinking water was used without chlorination. In 142 (98.6%) villages open-air defecation was practiced. Diseases such as URTIs, diarrheal diseases, fever and conjunctivitis were commonly observed in the field area.

Baroreceptor mediated blood pressure regulation is not affected during dose dependent inhibition of prostatic contractions by terazosin.

Benign prostatic hyperplasia (BPH), common in aging males is often treated with alpha1-adrenoceptor (AR) antagonists. In view of known hypotensive effect of most of the alpha1-AR antagonists, this work examined the effect of a selected alpha1-AR antagonist, terazosin on the baroreceptor mediated regulation of blood pressure. The three doses of terazosin (10, 100, 300 microg/kg body weight) used in anesthetized dogs inhibited in a dose-dependent manner the prostatic contractions and rise in blood pressure induced by phenylphrine. Impairment of arterial baroreflex, an important neural regulatory mechanism for the maintenance of normal arterial pressure, by alpha1-AR antagonist (prazosin) has been suggested in an earlier study. Hence, the effects of terazosin in doses 10, 100 and 300 microg/kg on baroreflex sensitivity (calculated as the ratio of heart rate change to acute increase in blood pressure by phenylephrine) were investigated. Terazocin did not produce any change in the baroreflex sensitivity. Therefore, in the absence of any adverse effect on the baroreceptor mediated regulation of the blood pressure, terazosin can be treated as a safer drug for the symptomatic treatment of BPH.

Facilitating behavioral change for acceptance of oral polio vaccine.

A child aged 26 months could not be vaccinated initially during pulse polio immunisation due to parental fear of untoward side effects. Owning responsibility of child's welfare, in-depth counseling and involvement of community leaders are crucial in this regard.

Anti-myeloperoxidase antibodies in patients with microscopic polyangiitis.

BACKGROUND & OBJECTIVES: Anti-neutrophil cytoplasmic antibodies in active necrotizing and crescentic glomerulonephritis are associated with systemic vasculitides like Wegener's granulomatosis, Microscopic polyangitiis and Churg Strauss Syndrome. This study shows the incidence of ANCA with specificities to Myeloperoxidase and Proteinase3 in MPA cases and gives the correlation of ANCA with Birmingham Vasculitis Activity Score. MATERIAL & METHODS: Eighteen cases of MPA were diagnosed as per Chapel Hill Consensus Criteria. ANCA was detected by indirect immunofluorescence microscopy using fluorescence and Confocal Laser Scanning Microscopes. Anti-MPO and anti-PR3 were identified by commercial ELISAs and anti-MPO subclass and IgG isotypes were also detected. RESULTS: MPA patients showed a male preponderance with BVAS ranging from 17-30. Systemic involvement was seen in 88.9%, lower respiratory tract involvement in 77.8% and upper respiratory tract in only 33.3% cases. All these patients had perinuclear pattern on IIF, where titers ranged from 80-640 and ELISA showed anti-MPO; values ranging from 20-80 units/ml. IIF and ELISA showed a good correlation (r=0.77). Two patients having FPGN had dual specificities and had both anti-MPO and anti-PR3 which could be picked up only by ELISA. A good correlation (r=0.78) was observed between BVAS and ANCA levels as well. IgG ANCA was detected in 88.7% and 11.1% had IgG+IgM and IgG1+IgG4 ANCA was detected in 50% patients. CONCLUSION: p-ANCA with anti-MPO is highly specific for MPA; both IIF and ELISA should be carried out for true positivity and to identify rare cases of dual specificities. Confocal laser scanning microscopy is useful in identifying ANCA patterns especially when ANA is also positive. ANCA testing with BVAS assessment will surely help in early diagnosis and estimating the severity of this life threatening disease.

Glanzmann's thrombasthenia.

Glanzmann's thrombasthenia (GT) is an uncommon cause of bleeding in children. We diagnosed two siblings as having GT on the basis of flow cytometric studies. Both had cutaneous bleedings and epistaxis since early childhood. Hematological investigations revealed prolonged bleeding time and a normal platelet count. Both the patients had absence of aggregation of platelets with the agonist adenosine diphosphate. Absence of the GPIIb/IIIa receptor was confirmed by flow cytometry. A short review of the disorder is presented.

Transfusion transmitted diseases in haemophilics from western India.

BACKGROUND & OBJECTIVES: Transfusion related human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infections have been a major cause for morbidity and mortality in the haemophilic population in the west. The prevalence of these markers of transfusion transmitted viral diseases in severe and moderate haemophilia patients was studied. METHODS: The seropositivity for these viral markers was evaluated in 400 haemophilics (323 severe and 77 moderate) in a 5-year survey starting from 1995. First 188 of these patients were also tested for HCV. Serological tests for HIV, HBsAg and HCV were done by third generation ELISA; positive samples were also confirmed by Western blot. RESULTS: Fifteen of the 400 patients were found to be HIV positive (3.8%), 24/400 were HBsAg positive (6%) and 45/188 (23.9%) were positive for HCV (28 for both non-structural and core antigen, 13 for core only and 4 for non-structural antigen only). The lowest age of HIV positivity was 12 yr and that of HCV positivity was 8 yr. INTERPRETATION & CONCLUSION: The above study shows a reduction in blood product related HIV transmission in severe and moderately affected haemophilics but more stringent policy for blood product usage, universal hepatitis C screening, hepatitis B vaccination and continuous awareness programmes for medical staff, general public and patients is needed to reduce the incidence of these diseases in haemophilics.

Assessment of transcervical chorion villus aspiration biopsy in early pregnancy.

BACKGROUND. Chorionic villus sampling for prenatal diagnosis is a relatively new technique and variable success rates have been reported by different authors depending on the methods and instruments used. We describe our experience with chorionic villus sampling in Bombay. METHODS. The procedure was attempted on 62 women before termination of their pregnancy via the transcervical route, under constant real-time ultrasound guidance. A metallic cannula was negotiated through the cervix into the uterine cavity to reach the chorionic frondosum and chorionic villi were aspirated by creating a negative pressure in the syringe attached to the cannula. The villus tissue was checked under a dissecting microscope. We calculated the success rate for obtaining a sample depending on the site of the chorionic frondosum, the physique of the mother, the position of the uterus and the size of the cannula. RESULTS. Villus tissue was aspirated in 47 of the 62 cases. The success rates of sampling at the first and second attempts were 48% and 27% respectively. The factors which were associated with a higher success rate were when the chorionic frondosum was situated posteriorly rather than anteriorly (61% v. 48%; p < 0.01), when the patient was thin rather than fat (58% v. 25%; p < 0.001), when the uterus was anteverted rather than retroverted (53% v. 41%). The commonest complication was bleeding which occurred in 15% of patients. CONCLUSION. Transcervical chorionic villus sampling is associated with a high success rate except in fat women with a retroverted uterus and in those with the chorionic frondosum situated in the fundus.