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Objective To observe the serum betatrophin levels in patients with type 2 diabetes mellitus (T2DM) and to explore the role of betatrophin in the pathogenesis of diabetic retinopathy (DR).Methods A total of 59 patients with T2DM (DM group) and 14 healthy controls (NC group) were enrolled in the study.Vision,slit lamp microscope,indirect ophthalmoscope,fluorescein fundus angiography were performed on all the subjects.According to the results of the examination combined with the international DR clinical staging criteria,the patients were divided into no DR (Non-DR) group,non-proliferative DR (NPDR) group,and proliferative DR (PDR) group,with 30,20 and 9 patients in each,respectively.The fasting blood glucose (FPG),insulin (FIN),C-peptide,glycated hemoglobin (HbA1c),total cholesterol (TC),triglyceride (TG),high-density lipoprotein (HDL-C),low-density lipid Protein (LDL-C) levels were detected.The level of betatrophin in serum was determined by enzyme-linked immunosorbent assay.The correlation between betatrophin and other indicators was analyzed by Spearman correlation.The influencing factors of PDR were analyzed by logistic regression.Results Compared with subjects in the NC group,the level of FPG (F=-4.316,P＜0.001),FIN (F=2.142,P=0.001),HbA1c (F=-5.726,P＜0.001),TC (t=3.609,P=-0.010),LDL-C (t=0.000,P=0.003),and betatrophin (F=-2.263,P=0.024) were significantly increased and HDL-C level (F=-3.924,P＜0.001) was decreases in the DM group.The difference of TG level between two groups was not statistically significant (F=-1.422,P=0.155).Compared with the Non-DR group and the NPDR group,the serum C-peptide (F=7.818,P=0.020) and betatrophin levels (F=1 2.141,P=0.002) were significantly increased in the PDR group.Spearman correlation analysis showed that the levels of betatrophin in the DM group was positively correlated to TC (r=0.304,P=0.019).The serum levels of betatrophin was positively correlated to body mass index in the Non-DR group (r=0.513,P=0.004).Furthermore,in the PDR group,a significant positive correlation was observed between the serum betatrophin levels and diastolic blood pressure (r=0.685,P=0.042).Logistic regression analysis showed that the duration of diabetes,serum C-peptide and betatrophin levels were risk factors for PDR.After controlling for the duration and serum C-peptide,the PDR risk for betatrophin levels great than or equal to 1.0 ng/ml was 12 times as much as betatrophin levels less than 1.0 ng/ml in T2DM patients.Conclusions The serum betatrophin content of patients with T2DM is abnormal.Betatrophin may be involved in the occurrence and development of PDR.
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Compound Traditional Chinese Medicine (CTCM) applying for FDA approval as botanical drug is a systemic and innovative work.Compound Danshen Dripping Pill (T89) is the first CTCM completed FDA global multi-center Phase Ⅲ clinical trial,which has become a benchmark for TCM globalization.Extensive experiences have been accumulated through the 20 years' research and development.Tasly fully considered the characteristics of CTCM while complying with FDA regulations during the entire application process.In which,product indication was clearly defined and agreed,clinical trial protocol was scientifically and innovatively designed with gold standard,phase Ⅱ study was well completed,SPA for phase Ⅲ study was obtained,and eventually the global multi-center phase Ⅲ study was successfully completed.In order to better support T89's application,Tasly conducted series of additional studies and introduced many innovations,such as drug-drug interaction study for TCM,finger printing study for CTCM,quality consistency study,biological assay study and etc.Globalization of T89 is not only a product creating history,but also a process for Tasly and the US FDA working together to continuously innovate and create history in innovating modern TCM standards,improving industrial chain GMP system for botanical drugs,making technical breakthroughs,exploring regulatory pathways and increasing product value.It represents the national power and historical progress in medicine.
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Because of the unique nature and treatment concept of traditional Chinese medicines (TCMs), TCMs have been respected again since 70s of last century. The regulatory agencies of some developed countries (the FDA, EMA and Health Canada etc) have published new guidance/guidelines/directives in recent years, such as the botanical drug product guidance of the FDA, the evidence for quality of finished natural health products guidance of the Health Canada and the guideline on quality of herbal medicinal products/ traditional herbal medicinal products of the EMA etc. All of the regulatory agencies are willing to scientifically evaluate the herbal medicines and accept it as therapeutic product. This paper analyzed the history of herbal medicine regulation and the similarities and differences of the regulatory requirements of the European Union, the United States and Canada, proposed possible future direction of the international development of Chinese medicine from the perspective of global regulatory affairs.
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Humans , Canada , Drug and Narcotic Control , History , European Union , Herbal Medicine , History , History, 20th Century , History, 21st Century , Phytotherapy , Reference Standards , Plants, Medicinal , Chemistry , United StatesABSTRACT
It has been 4 years since Natural Health Products Regulations(NHPRs)was enforced by Health Canada in January of 2004.In the past time,how will it affect the marketed Traditional Chinese Medicines(TCM) in Canadian market? Recently,The two TCM products Carditionic Pill (Fufang Danshen Diwan)and Chaihu Pill from Tasly have been newly certificated by Health Canada recently.Taking them as examples,this article introduces the current status.opportunities and challenges for the regulation of TCM in Canada.and suggests that the domestic TCM corporations push the product registration as soon as possible.
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Objective To study the effect of pioglitazone on the differentiation and function of rat osteoclast-like cells (OLC), and to probe the relationship between activated PPARγ2 and osteoclasts. Methods On day 1 of OLC formation from nonadherent bone marrow ceils (BMC) obtained from rats induced by M-CSF and receptor activator of NF-кB ligand (RANKL), 1, 5 and 10μmol/L pioglitazone hydrochloride was added. RT- PCR was performed to determine the mRNA expressions of PPARγ2 and receptor activator of NF-кB (RANK) on day 3, 5 and 7 during incubation, the number of tartrate-resistant acid phosphatase (TRAP)-positive cells,the number of bone resorption pits and the ratio of its area on dentin slice were counted, the activity of TRAP and the mean fluorescence intensity of integrin β3 (CD61) of OLC were also measured. Results (1) The effect on the differentiation of OLC: The addition of pioglitazone at the start of the culture period induced a dose-dependent decrease in TRAP-positive OLC and the activity of TRAP (P < 0.01 or P < 0.05) ; the mRNA expression of PPARγ2 was up-regulated by 5 and 10 μmol/L pioglitazone in the early stage of incubation and attenuated with thematuration of OLC on the contrary, however, the expression of RANK was down-regulated by 5 and 10 μmol/L piolitazone in every stage of incubation (P < 0.05 or P < 0.01), combined with decrease in TRAP-positive OLC from day 3 by 10 μmol/L pioglitazone. (2) The effect on the function of OLC: the number of bone resorption pits and the ratio of its area on dentin slice were decreased in groups of 5 and 10 μmol/L pioglitazone (P < 0.01 orP < 0.05), no obvious change was noted in the group with 1 μmol/L pioglitazone compared with the control group; the mean fluorescence intensity of CD61 were down-regulated in groups of 5 and 10 μmol/L pioglitazone (P < 0.05 or P <0.01). Conclusion Activation of PPARγ2 pathway by pioglitazone could partially inhibit differentiation and function of OLC derived from rat BMC.
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ObjectiveTo investigate the kidney protective e ffects of losartan in diabetic rat and its kidney protective mechanism. MethodsThe rats were randomly divided into the following groups:norm al control (group C), streptozotocin diabetic (group DM) and diabetic rats t reated with losartan (group DL). After eight weeks study, the mRNA expressions of transforming growth factor ? 1(TGF ? 1), TGF ?type Ⅱ receptor (T? RⅡ)and fibronectin in renal cortices of all three groups were measured by quan titative reverse transcription and polymerase chain reaction(RT PCR). The prote in expressions of transforming growth factor ? 1(TGF ? 1), T?RⅡ and fib ronectin in renal cortices of all three groups were measured by histoimmunochemi stry.The levels of blood glucose,urea and creatinine were measured by biochemic al assy.The concentrations of blood insulin and angiotensin Ⅱ were measured by radioimmunoassay. The rates of urinary albumin excretion were measured by sulfos alicylic acid assay.ResultsAfter eight weeks, mean glomerula r volume, kidney weight / body weight ratio, urinary albumin excretion ratio, bl ood urea and creatinine were significantly higher in diabetic group than in norm al control group(P
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Chinese materia medica (CMM) plays an important role both in the disease prevention and therapy system and also in natural drug screening. Biotechnology exhibits applicable prospects in modern research of CMM with progress of natural science and technologies. Amplification fragment length polymorphism (AFLP), restriction fragment length polymorphism (RFLP), random amplification polymorphism of DNA (RAPD), and microsatellite DNA have been used to discriminate and breed herbal varieties. Genetic transformation and techniques of tissue and cell culture are explored to protect herbal resouces and to produce active components or parts on a commercial scale. High throughput technologies of proteome and biochip are expected to probe molecular targets and routes of CMM with the changes of proteome and gene expression. The results can be helpful to novel drug development and secondary exploitation, so as to promote the modernization process of CMM.
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AIM: To develop and perfect the similarity algorithm on chromatographic fingerprints of traditional Chinese medicine(TCM). METHODS: The experimental and simulated data were used to investigate and verify the characteristics on the new and former methods on similarity evaluation for chromatographic fingerprints method. RESULTS: There are many strong points for new similarity algorithm in practice. CONCLUSION: The new method provides more rationality and practicability in TCM quality control and analysis compare to existing methods.
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Objective To investigate the effects of N-acetylcysteine (NAC) on the expression of cardiac adiponectin and its receptors in streptozotocin-induced diabetic rats. Methods Thirty-two male Wistar rats were randomly divided into four groups, with 8 in each: untreated control group (C group), NAC-treatment group (CT group), diabetic untreated group (D group) and diabetic NAC-treatment group (DT group). After 8 weeks, plasma glucose and insulin, and cardiomyocyte cross sectional area were measured. Cardiac protein expression of adiponectin receptor 1 and 2 (adipoR1 and adipoR2), AMP-activated protein kinase ? (AMPK?), phosphorylation of AMP-activated protein kinase ?-subunits and glucose transporter 4 (GluT4) were determined by Western blotting. Plasma and myocardial adiponectin levels were measured by radioimmunoassay. Plasma and myocardial free 15-F2t-isoprostane levels were assayed by enzyme immunoassay. Results Compared with C group, the ratio of ventricular weight to body weight and cardiomyocyte cross-sectional area, plasma and levels of free 15-F2t-isoprostane in myocardium and the protein expression of myocardial adipoR1 increased significantly in diabetic rats (D group) (P