Résumé
Objective:To explore the long-term effect of Zhenzhu Tiaozhi capsule（FTZ） on hemoglobin A1c（HbA1c）in patients with type 2 diabetes mellitus （T2DM） based on real-world data. Method:T2DM patients who were provided with FTZ （FTZ group） and those receiving conventional hypoglycemic drugs （control group） were extracted from the hospital information system （HIS） of the First Affiliated Hospital of Guangdong Pharmaceutical University， followed by propensity score matching （PSM） for balancing the confounding factors between groups. With HbA1c as the efficacy evaluation index， the difference in efficacy between the two groups was compared using <italic>t</italic>-test and <italic>χ</italic><sup>2</sup> test. For repeated measurement data of the same patient， the difference in efficacy and the stability of FTZ against HbA1c were analyzed by generalized estimating equation （GEE）. The factors that might affect the efficacy of FTZ against HbA1c were subjected to multivariate linear regression analysis （MLRA）， and the subgroup analyses were then conducted after the stratification of relevant factors. Result:There were 46 patients included in the FTZ group and 1 208 patients in the control group. PSM yielded 42 pairs of samples with balanced covariates between groups. As revealed by one-year observation， ① HbA1c in the FTZ group after treatment was 6.51%±1.09%. No significant difference was observed either in pre- and post-treatment comparison in the FTZ group or in its comparison with the control group. At the same time， the HbA1c compliance rate in the FTZ group was 73.8% after treatment. No significant difference was observed either in pre- and post-treatment comparison in the FTZ group or in its comparison with the control group. ② The GEE results showed that the post-treatment HbA1c levels in the two groups were not significantly different from each other. Moreover， the HbA1c level remained stable over treatment time. ③ MLRA and subgroup analyses results demonstrated that FTZ was more effective in patients with high baseline HbA1c ［<italic>β</italic>=-0.530，95% confidence interval（CI） -0.850～-0.209，<italic>P</italic><0.01］ or those who were complicated with hypertension （<italic>β</italic>=-0.918，95%CI -1.614～-0.222，<italic>P</italic><0.05）. Conclusion:In the real world， FTZ is able to control the blood sugar， and its effect is similar to those of conventional hypoglycemic drugs. Besides， it is capable of stabilizing the blood sugar for a long time.
Résumé
AIM:To investigate the effect of Fufang Zhenzhu Tiaozhi capsule(FTZ)on serum lipids and in-flammatory factors in rabbits with abdorminal aortic restenosis after balloon angioplasty.METHODS: New Zealand white rabbits(n=30)were divided into 5 groups.Except blank control group,the rabbits in other groups were used to establish abdominal aortic endothelium exfoliative vascular stenosis model.After 4 weeks of high-fat diet feeding,the animals in rest-enosis model group and drug treatment groups underwent percutaneous balloon dilatation in the stenosis.The angiographic stenosis was analyzed by a two-dimensional quantitative coronary angiography workstation with a digital subtraction X -ray machine.Blood samples were taken during angiography and the profiles of serum lipids and cytokines were measured.The expression of nuclear factor-κB(NF-κB)in the blood vessels was determined by immunohistochemistry.RESULTS:An-giography confirmed that the rates of area stenosis and diameter stenosis were significantly decreased in treatment groups compared with restenosis model group(P<0.01).Compared with restenosis model group,the serum lipid profiles and cy-tokine concentrations in drug treatment groups were significantly decreased(P<0.05).Immunohistochemistry showed the expression of NF-κB in restenosis model group was significantly higher than that in blank control group and drug treatment groups(P<0.05).CONCLUSION: FTZ significantly reduces the blood lipids and inflammatory factors in abdominal aortic restenosis model,and the anti-inflammatory effect may be related to the regulation of NF-κB pathway to inhibit the production of various inflammatory factors.
Résumé
Objective To establish a reverse-phase liquid chromatography method for the determination of seven alkaloids (magnoflorine,columbamine,jatrorrhizine,epiberberine,coptisine,palmatine,and berberine) in Fufang Zhenzhu Tiaozhi Capsule.Methods Chromatography was performed on a Dionex Acclaim C18 column (250 mm × 4.6 mm,5.0 μm) at 30 ℃.The mobile phase was composed of acetonitrile-potassium dihydrogen phosphate solution (0.015 mol/L,40:60,including 1.7 g/L sodium dodecyl sulfate and phosphoric acid used to regulate pH value to 3.0),with a flow rate of 1.0 mL/min.The detection wavelength was 270 nm.Results The calibration curves of magnoflorine,columbamine,jatrorrhizine,epiberberine,coptisine,palmatine,and berberine were linear in the range of 1.07-10.65,0.78-7.55,0.75-7.50,1.60-15.95,2.69-26.85,2.31-23.10,and 6.04-60.40 mg/mL.The average recoveries of magnoflorine,columbamine,jatrorrhizine,epiberberine,coptisine,palmatine,and berberine were 101.0％,101.2％,100.1％,100.0％,100.1％,101.1％,and 99.7％,respectively.Conclusion The method could be used for the quantitative determination of the preparation.