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@#To evaluate bioequivalence and safety of two kinds of metformin hydrochloride sustained-release tablets (test preparation vs reference preparation) under the condition of fed and single administration.A single center, randomized, open, single-dose, two-period, two-sequence, and double-crossover design was used.32 healthy subjects took 0.5 g of test preparation or reference preparation under fed and single-dose administration.4 mL of venous blood was collected from before administration (0 h) to 1, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 12, 15, 24, 36 and 48 h after administration.The concentration of metformin in plasma samples was detected, and then the pharmacokinetic parameters were calculated by WinNonlin 7.0 software.When the 90% confidence intervals of cmax, AUC0-t and AUC0-∞ geometric mean ratio of test preparation and reference preparation were within 80.00%-125.00% equivalent intervals respectively, the bioequivalence of the two preparations was proved.One subject fell off due to adverse events.The main pharmacokinetic parameters of test preparation and reference preparation as follows: cmax were (0.68 ± 0.14) and (0.65 ± 0.11) mg/L, AUC0-t were (7.33 ± 1.65) and (7.00 ± 1.89) h·mg/L, AUC0-∞ were (7.39 ± 1.67) and (7.06 ± 1.91) h·mg/L, respectively.The 90% confidence intervals of the geometric mean ratio of the two main pharmacokinetic parameters were 101.45%-109.14%, 100.08%-112.32% and 100.24%-112.28%, respectively, which fell within the bioequivalence interval of 80.00%-125.00%.There were no serious adverse events and unexpected adverse events during the trial.The results show that test preparation and reference preparation are bioequivalent under fed and single-dose administration, safe and well tolerated in healthy subjects.
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Issues caused by maxillofacial tumours involve not only dealing with tumours but also repairing jaw bone defects. In traditional tumour therapy, the systemic toxicity of chemotherapeutic drugs, invasive surgical resection, intractable tumour recurrence, and metastasis are major threats to the patients' lives in the clinic. Fortunately, biomaterial-based intervention can improve the efficiency of tumour treatment and decrease the possibility of recurrence and metastasis, suggesting new promising antitumour therapies. In addition, maxillofacial bone tissue defects caused by tumours and their treatment can negatively affect the physiological and psychological health of patients, and investment in treatment can result in a multitude of burdens to society. Biomaterials are promising options because they have good biocompatibility and bioactive properties for stimulation of bone regeneration. More interestingly, an integrated material regimen that combines tumour therapy with bone repair is a promising treatment option. Herein, we summarized traditional and biomaterial-mediated maxillofacial tumour treatments and analysed biomaterials for bone defect repair. Furthermore, we proposed a promising and superior design of dual-functional biomaterials for simultaneous tumour therapy and bone regeneration to provide a new strategy for managing maxillofacial tumours and improve the quality of life of patients in the future.
Subject(s)
Humans , Biocompatible Materials , Bone Regeneration , Bone and Bones , Quality of LifeABSTRACT
Objective To adopt Suitability Assessment of Materials for suitability assessment of domestic Kegel exercise online health education written materials. Methods After Searching Kegel exercise online health education written materials in search engines, four health education professionals assessed the suitability of the collecting materials.One professional evaluated all collecting materials,and all materials were divided into three parts. The other three professionals evaluated one part agian independently.Excel and SPSS 19.0 were used to analyze the results. Results 38 Kegel exercise online health education written materials were collected.2(5.3%)of the materials were assessed as"Superior",23 (60.5%) of the materials were "Adequate", and 13 (34.2%) of the materials were evaluated as "Not suitable". Average percentage score was 44.05% (24% ~74% ), and the overall assessment was"Adequate". Conclusion Most domestic Kegel exercise online health education written materials′quality should be certified and suitability were adequate,which need some improvement.
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A total of 128 patients with coronary heart disease/angina pectoris who underwent coronary arterial stent implantation were collected in this study between January and December 2002.① At 6-18 months of follow up,coronary artery angiography (CAG) showed that diameter stenosis rate ＞I 50% was considered the restenosis.While,36 out of 128 lesions had restenosis,and the rate was 28.1%.Serum lipoprotein (a) level in the restenosis group was significantly higher than non-restenosis group (P ＜ 0.01).②All patients were divided into high lipoprotein (a) group (the concentration ≥ 230 mg/L) and low lipoprotein (a) group (the concentration ＜ 230 rag/L).Restenosis rate in the high lipoprotein (a) group was significantly higher than low lipoprotein (a) group (P ＜ 0.05).Intravascular ultrasound showed that area and volume of newborn endomembrane in the high lipoprotein (a) group were significantly higher than slow lipoprotein (a) group after coronary arterial stent implantation (P ＜ 0.01).③ Correlation analysis suggested that.lipoprotein (a) was positively correlated with area and volume of newborn plaque (P ＜ 0.05).
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A total of 128 patients with coronary heart disease/angina pectoris who underwent coronary arterial stent implantation were collected in this study between January and December 2002.① At 6-18 months of follow up,coronary artery angiography(CAG) showed that diameter stenosis rate ≥ 50% was considered the restenosis.While,36 out of 128 lesions had restenosis,and the rate was 28.1%.Serum lipoprotein(a) level in the restenosis group was significantly higher than non-restenosis group(P