MATERIALS AND METHODS: This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2- period crossover study with a washout period of 7 days. All 28 adult male subjects were required to fast for at least 10 hours prior to drug administration and they were given access to water ad libitum during this period. Thirty minutes prior to dosing, all subjects were served with a standardized high-fat and high-calorie breakfast with a total calorie of 1000 kcal which was in accordance to the EMA Guideline on the Investigation of Bioequivalence. Subsequently, subjects were administered either the test or reference preparation with 240mL of plain water in the first trial period. During the second trial period, they received the alternate preparation. Plasma levels of glibenclamide and metformin were analysed separately using two different high performance liquid chromatography methods.
RESULTS: The 90% confidence interval (CI) for the ratio of the AUC0-t, AUC0-∞, and Cmax of the test preparation over those of the reference preparation were 0.9693-1.0739, 0.9598- 1.0561 and 0.9220 - 1.0642 respectively. Throughout the study period, no serious drug reaction was observed. However, a total of 26 adverse events (AE)/side effects were reported, including 24 that were definitely related to the study drugs, namely giddiness (n=17), while diarrheoa (n=3), headache (n=2) and excessive hunger (n=2) were less commonly reported by the subjects.
CONCLUSION: It can be concluded that the test preparation is bioequivalent to the reference preparation.
MATERIALS AND METHODS: This was a prospective interventional study with convenient sampling (n = 10). Thirty patients aged between 18 and 40 years, who needed noncomplicated tooth extraction of mandibular premolar tooth, were sequentially divided equally into three groups. In Group I, simple extraction was done and the empty extraction socket left to heal conventionally. In Group II, extraction sockets were filled with lyophilized bovine granules only. In Group III, immediate implants were placed into extraction sockets, and the buccal gap was also filled with bovine granules. All groups were subjected to cone beam computed tomography scan for radiological evaluation. Assessment of biomechanical stability (radiofrequency analysis [RFA] was performed at 9 months postoperative for Group III to assess the degree of secondary stability of the implants using Osstell. Repeated measure analysis of variance (ANOVA) test was applied when comparing within each group at three different time intervals, whereas one-way ANOVA was applied followed by post hoc-tukey test when comparing between groups. P < 0.05 was considered statistically significant.
RESULTS: Radiological assessment reveals a significant difference of bone resorption in alveolar dimension within Group I; 1.49 mm (P = 0.002), and 0.82 mm (P = 0.005), respectively, between day 0 and 3 months. Comparison between Group I and III showed a highly significant difference of bone resorption in ridge width at 3 months 2.56 mm (P = 0.001) and at 9 months interval 3.2 mm (P < 0.001). High RFA values demonstrating an excellent biomechanical stability were observed in Group III at 9 months postoperatively.
CONCLUSION: The insertion of immediate implants in extraction sockets with bovine bone augmentation of the buccal gap was able to preserve a greater amount of alveolar ridge volume.
OBJECTIVES: This review aims to provide insights regarding the FOXP3 Tregs involved and their mechanisms in breast cancer prognosis.
METHODS: The literature study method is used from primary and secondary libraries. The library search used online-based search instruments such as NCBI-PubMed, Google Scholar, and Elsevier. The data obtained were then arranged according to the framework, data on the relationship between FOXP3 Regulatory T Cells and breast cancer, and writing a journal review was carried out according to the given format. Regulators (Tregs) can inhibit anti-tumor immunity and promote tumor growth. Tregs also play a role in inhibiting cytotoxic T lymphocyte cells by inhibiting the release of granules from CD8+, where CD8+ is important in killing tumor cells. FOXP3 is a Treg-specific biomarker and plays an important role in the development and function of Tregs.
RESULTS: Studies on the presence of FOXP3+ Tregs in tumors have shown controversial results. Studies in some tumors reported the presence of FOXP3+, indicating a poor prognosis, whereas studies in other tumors found that FOXP3+ correlated with a good prognosis.
CONCLUSION: Regulatory T lymphocytes and TILs in invasive breast carcinoma are still not established. Therefore, further research on the Effect of FOXP3 expression of regulatory T lymphocytes on breast cancer is still important.