Objective:To evaluate the therapeutic effect of sustained release bistratal drus film containing dexamethasoni acetate (DA) in treatment of oral ulcer. Methods:Totally 667(231 cases as control group) patients (June 1998 to September 2001) with recurrent aphthous ulcer, lichen planus, radio catarrh were studied randomly to evaluate the therapeatic effect in a single blind random way. Results:The effective rates of treated group and control group were 96.1% and 28.6%, respectively, and the difference between 2 groups was significant ( P

Objective:To evaluate the biological safety of the sustained release bistratal drug film of dexamethasoni acetate (DA). Methods:A series of tests, including acute toxicity test, cytotoxity test (agar overlay), oral mucous membrane irritation test and haemolysis test were conducted. Results:Cytotoxic effect was not observed, nor was toxic effect in mouse toxicity test. The haemolysis rate of this material was 0.46%. Local mucous membrane irritation reaction was not found. Conclusion:The drug film of DA shows excellent biocompatibility on the preliminary tests.

OBJECTIVE： To investigate the effects of total flavonoids of Jasminum nudiflorum （TFJN） on pancreatic islet function in type 2 diabetes mellitus （T2DM） model mice and its possible mechanism. METHODS： Totally 10 Kunming mice were included in blank group and given normal diet. Other 75 mice were included in model group and given high-lipid and high-glucose diet for 4 weeks combined with streptozotocin once via sublingual vein to induce T2DM model. After modeling， the mice were randomly divided into model group， metformin hydrochloride group （positive control， 350 mg/kg）， TFJN low-dose， medium-dose and high-dose groups （100， 200， 400 mg/kg， by crude drug）， with 10 mice in each group. Blank group and model group were given constant volume of normal saline intragastrically； administration groups were given relevant medicine intragastrically； once a day， for consecutive 6 weeks. The level of fasting dynamic blood glucose was measured after modeling （before medication） and 2， 4， 6 weeks after medication. The histomorphological characteristics of pancreatic tissue were observed by HE staining. The contents of serum insulin （INS）， insulin cell antibody （IAA）， TNF-α， IL-1β， IL-6， IL-18， CRP， leptin （LP） and adiponectin （ADPN） were measured by ELISA. RESULTS： Compared with blank group， islet atrophy， blurred boundary， insufficient cytoplasm and smaller volume of pancreatic tissue were observed in model group. The fasting dynamic blood glucose level （at different time points after medication）， the contents of IAA， TNF-α， IL-1β， IL-6， IL-18， CRP and LP were increased significantly， while the contents of INS and ADPN were decreased significantly （P＜0.01）. Compared with model group， above symptoms of pancreatic tissue in administration groups were relieved， and the fasting dynamic blood glucose level （2， 4， 6 weeks after administration in metform in hydrochloride group， 4， 6 weeks after administration in TFJN groups）， the contents of IAA， TNF-α， IL-1β， IL-6， IL-18， CRP and LP were decreased signifi- cantly， while the contents of INS and ADPN were increased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS： TFJN can repair the damaged pancreas of mice with T2DM， reduce the level of blood glucose， and improve the sensitivity of the body to insulin， the mechanism of which may be associated with reducing the secretion of inflammatory factors.

OBJECTIVETo compare the efficacy and safety of 5 mg perindopril arginine salt and 4 mg perindopril tert-butylamine salt for patients with mild to moderate essential hypertension.

METHODSThe study was designed as multicenter, randomized, double-blind, active controlled trial with two parallel groups enrolling 524 participants with mild to moderate essential hypertension. After 2-week run-in period, 186 patients were enrolled and randomly treated with 5 mg perindopril arginine salt and 183 patients were enrolled and randomly treated with 4 mg perindopril tert-butylamine salt. The random sequence was generated by the I.R.I.S., and a balance was made in each center. After double-blind treatment for 8 weeks, the dose could be doubled for patients with uncontrolled BP ((SBP) ≥ 140 mmHg (1 mmHg = 0.133 kPa) or diastolic blood pressure (DBP) ≥ 90 mmHg) and patients were treated for another 4 weeks.

RESULTSThe sitting SBP was similarly decreased by (19.9 ± 17.2) mmHg in perindopril arginine group and (18.5 ± 14.7) mmHg (P = 0.000 5) in perindopril tert-butylamine group post 8 weeks treatment. Dose was doubled in 109 patients (59.9%) in perindopril arginine group and 116 patients (63.7%) in perindopril tert-butylamine group. At 12 weeks post therapy, the sitting SBP decreased by (19.8 ± 16.2) and (19.6 ± 16.3) mmHg respectively in the 2 groups. The decrease of sitting DBP was also similar in both groups (-12.0 ± 10.0) mmHg and (-11.0 ± 8.9) mmHg (P < 0.000 1), respectively. The control rate or response rate was also similar between the two groups (control rate over 8 weeks was 38.5% vs. 31.3%, 95% CI (-2.6-16.9), control rate over 12 weeks was 36.3% vs. 35.7%, 95% CI (-9.3-10.4), response rate over 8 weeks was 64.3% vs. 63.2%, 95% CI (-8.8-11.0), response rate over 12 weeks was 65.9% vs. 64.8%, 95% CI (-8.7-10.9)). Incidence of adverse events was low and similar in both therapy groups.

CONCLUSIONSThe results show that perindopril arginine salt 5 mg is as efficient as perindopril tert-butylamine 4 mg on lowering BP for patients with mild to moderate essential hypertension. Both drugs have good safety profile and are well tolerated by patients in this cohort.

Antihypertensive Agents ; Arginine ; Blood Pressure ; Butylamines ; Double-Blind Method ; Essential Hypertension ; Humans ; Hypertension ; Perindopril ; Sodium Chloride