ABSTRACT
BACKGROUND@#Pulmonary arterial hypertension (PAH) is a chronic, debilitating disease affecting millions of adults worldwide. With improved knowledge on PAH and better management, long-term survival in patients has significantly increased in the past 20 years. Bosentan is a nonselective, dual endothelin receptor antagonist used in the treatment of PAH. While the drug has already been established to improve exercise capacity and patient survival globally, no study has investigated its clinical effectiveness and safety among Filipino patients yet. A post marketing study was conducted to determine the efficacy and safety of bosentan (125 mg administered twice daily) among adult Filipino patients with PAH.@*METHODS@#A non-randomized, non-comparative, open-label trial was conducted involving adult patients at a tertiary government hospital in Metro Manila. Study duration was from March to September 2012. Primary end points of the study were patients' response to efficacy and safety.@*RESULTS@#A total of 14 patients were enrolled in the study and 13 included in the analysis. Mean age of the participants was 34 ± 11.54 years. Remarkable changes were observed for 6WMD and small improvements noted for Borg dyspnea index and CPET. There was no difference between baseline and 12th week WHO functional classification. FEVl /FVC, MVV, RV /TLC and sRaw showed modest improvement; there was a notable difference in the systolic PAP vs baseline; PVR, PVRI, SVR and SVRI demonstrated the largest changes via cardiac catherization and iloprost. Four patients experienced at least one serious adverse event, with one reported as suspected unexpected serious adverse reaction. Out of 13 patients, 1 O (76.9%) considered bosentan as effective while 11 (84.6%) considered it safe.@*CONCLUSION@#Bosentan improved exercise capacity, pulmonary function and cardiopulmonary hemodynamics among study participants. The drug is generally well-tolerated and effective. Bosentan is among the useful options for treatment of adult Filipino patients with PAH.
ABSTRACT
Background@#Accessibility, cost-effectiveness and consistency in identifying pelvic masses made ultrasonography one of the first imaging modality used by clinicians in evaluating women with ovarian disease. Scoring systems to differentiate a benign or malignant lesion has been formulated for many years and the International Ovarian Tumor Analysis (IOTA) group has developed several evidenced-based algorithms for classifying adnexal diseases. This research performs prospective validation using IOTA Simple Descriptors and IOTA Simple Rules, compared with Sassone scoring system to differentiate benign and malignant disease.@*Objective@#To determine and compare diagnostic performance of IOTA Simple descriptors, IOTA Simple rules and Sassone Scoring System in classifying benign and malignant masses.@*Study Design@#A cross-sectional study was done on patients assessed to have adnexal mass or tumors either by symptoms or by physical examination and confirmed by ultrasound using two-dimensional gray-scale with Doppler studies. The classification by sonographic features was based on the IOTA Simple Descriptors, IOTA Simple Rules and Sassone Scoring System and correlated with the histopathologic result as the gold standard.@*Results@#A total of eighty-two cases were analyzed in the study, seventy three of which was benign. Of those with malignancy, sixty one percent belonged to ages 31-50 years old. The most common benign histopathologic diagnoses were dermoid, endometrial cyst and serous cyst, while Adenocarcinoma is the most frequent type of ovarian carcinoma. The results showed high sensitivity for IOTA simple descriptors for benign tumors at 95%. On the other hand, specificity was 85% for both IOTA Simple Rule and Sassone scoring index with low sensitivity at 58% and 44% respectively.@*Conclusion@#Accuracy of the different sonologic indexes ranges from 72 to 83%. Comparing IOTA Simple Rules and Sassone Score, specificity was comparable at 85%, however with lower sensitivity for Sassone Score System.