In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data, Chinese medicine injection safety monitoring quality control indicators, including the monitoring center, monitoring personnel, hardware conditions, monitoring progress and the number of patients into the group, original documents and archives management, electronic data, adverse events, quality management were constructed. Its application in the creation of major new drugs technology major projects, 10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work, found the missing case surveillance, not reported adverse events, only reported adverse reactions, electronic data reporting lag, lack of level of efforts to control the problem, and corrected, the traditional Chinese medicine injection safety monitoring of quality control and quality assurance, and subsequent Chinese medicine safety monitoring quality control to provide the reference.
Humans ; Injections ; Medicine, Chinese Traditional ; adverse effects ; standards ; Quality Control

Adipocytes ; cytology ; Animals ; Cell Proliferation ; Cells, Cultured ; Flow Cytometry ; Hematopoietic Stem Cells ; cytology ; Rats ; Rats, Sprague-Dawley ; Stem Cells ; cytology

Acquired Immunodeficiency Syndrome ; prevention & control ; China ; Health Plan Implementation ; History, 20th Century ; History, 21st Century ; Humans ; Internationality ; Public Policy ; history ; Quality Control

Objective To observe the influences of 1,25-(OH)2D3 and salvia miltiorrhiza on hematopoiesis reconstruction and T cell subsets after allogeneic bone marrow transplantation in rats.Methods Donor rats were divided randomly into four groups,namely,Group A: aGVHD group;Group B: 1,25-(OH)2D3 group;Group C: salvia miltiorrhiza group;and Group D: two-drug combination group.We observed the survival time,peripheral blood cells,clinical manifestations of aGVHD and the changes of rat T cell subsets.Results Compared with those in aGVHD group,in every drug intervention group,the time for illness attack of aGVHD was delayed,aGVHD scoring was reduced and the average survival time was obviously prolonged(P

Objective To investigate the effect of 1,25-(OH)2D3 and salvia miltiorrhiza on T cell subsets and cytokines in rats after allogeneic bone marrow transplantation.Methods Female Wistar rats were used as recipients and male SD rats were used as donors.All Wistar rats were divided into aGVHD group and intervention groups at random,and the intervention groups were further divided into 1,25-(OH)2D3 group,salvia miltiorrhiza group and combination group.The changes of T cell subsets (CD4+ and CD8+) and cytokine (IL-2,IFN-?,IL-4 and IL-10) in every group were detected and measured.Results When the presentation of aGVHD was relatively conspicuous,CD4+ and CD8+ were increased,and the increase of CD4+ was predominant.Compared with the difference prior to transplantation,the difference was statistically significant (P

Objective To investigate the prevalence of subclinical hypothyroidism and its relation to serum total cholesterol (TC),triglyceride (TG) levels and non-alcoholic fatty liver.Methods Serum levels of TC,TG, TSH,TT_3 and TT_4 were determined in 1 602 subjects which were divided into groups by sex and age (20-39,40- 59 and≥60 years).Fatty liver was diagnosed by type B ultrasonography.Restults ( 1 ) Prevalence of subclinical hypothyroidism was 6.6% in this population.(2) The mean levels of serum TC and TG in subclinical hypothyroidism group and normal group showed no significant difference ( both P＞0.05 ).(3) On the whole,the prevalences of subclinical hypothyroidism in hypercholesterolemia group and normal cholesterolemia group showed significant difference (P＜0.01 ).(4) In the three age groups of male and few.ale examinees,the prevalences of subclinical hypothyroidism in hypercholesterulemla group and normal cholesterolemia group showed no significant difference ( all P＞0.05 ).In the multiple regression analysis,TSH level was not related with raised TC level.(5) In the three age groups of male,there was no significant difference between the prevalences of subclinical hypothyroidism in hypertriglyceridemla group and normal triglyceridemia group ( all P＞0.05 ).In female,expect for the elderly group (＞60 years old ),the prevalence of subclinical hypothyroidism was higher in hypertriglyceridemia group than that in normal triglyceridemia.However,in the multiple regression analysis, increased TSH level was positively associated with increased serum TG level ( OR = 1.072,P=0.013 and OR = 1.102,P = 0.03 ).(6) The prevalence of subclinical hypothyroidism in non-alcobolic fatty liver group and normal group showed no significant difference ( P＞0.05 ).In the multiple regression analysis,TSH level was not the independent risk factor of non-alcoholic fatty liver (P＞0.05 ).Conclusion Subclinical hypothyroidism is not asseciated with serum TC level but positively associated with serum TG level.Subclinical hypothyroidism does not apparently increase the prevalence of non-alcoholic fatty liver.

The accurate medical treatment is based on the information of the genome, which is the best treatment for the patients. Population pharmacokinetic study can be formulated according to the individual differences of patients to the dose, in the accurate medical model which has a unique advantage. At present, there are many problems such as adverse drug reaction in Chinese traditional medicine, and it is necessary to introduce a group of medicine on the basis of precise medical treatment. However, due to the different characteristics of traditional Chinese medicine and chemical medicine, it is necessary to combine the population pharmacokinetics, genetics and statistical methods to establish a research method which is in line with the characteristics of Chinese medicine. The key scientific problem is to make clear the active components of Chinese medicine metabolism of the drug metabolic enzyme gene, and pay attention to the analysis of the polymorphism of the overall role of drug metabolism enzymes in the human body. Clear key scientific issues and break through the bottleneck, so as to achieve the precise medical treatment, to international.
Humans ; Medicine, Chinese Traditional ; Pharmacokinetics

Evidence body is defined as an evidence complex incorporating the evidence obtained from various research methods and various resources. As one of common parenterally administered Chinese medicines, Shuxuetong's safety drew high concern from doctors. However, we only have grasped several but less systematic evidence on the safety of Shuxuetong. To build a safety evidence body of Shuxuetong injection. Review and evaluate the evidence related to the safety of Shuxuetong injection after accumulating, searching and classfying related literature. Accoeding to levels of evidence from high to low, the evidence related to the safety of Shuxuetong injection was classified as following: the evidence from a long-term, prospective, large-sample-size and intensive hospital monitoring study was the strongest; the evidence of hospital information system (HIS) data analysis; the evidence of spontaneous reporting system (SRS) data analysis; the evidence of adverse drugreactions (ADRs)/adverse drug events (ADEs) reported in systematic evaluation, ADRs case report, toxicological tests, pharmacological tests were weakest. Based on the evidence body, Shuxuetong Injection was proved to be safe, and its ADRs were mainly allergic reactions, and more often happened among the old patients.
Adverse Drug Reaction Reporting Systems ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Prospective Studies

The supramolecular inclusion properties of beta-cyclodextrin (beta-CD) and resveratrol (Res) were investigated using drug-protein interaction spectroscopy method. The differences between the results of interaction spectroscopy method and the results of classical method were compared. The total energy of the stable inclusion of cyclodextrin-resveratrol was calculated by Gaussian theory calculation. The stable inclusions in the process of interaction between resveratrol/inclusion complex and bovine lactgoferrin (BLF) were studied by molecular modeling. The results showed that the interaction spectroscopy method could explain the property of the inclusion in a more sensitive manner, it also interpreted the conveying mechanism of BLF binding with inclusion complex. The molecular modeling result showed consistent results with Gaussian theory calculation; both of the two methods obtained the stable configuration of beta-CD-Res inclusion. The relevant result provided an experimental consequence for the pharmacology research of beta-cyclodextrin-resveratrol inclusion complex as well as offering a new reference to the future research of supramolecular inclusion compound.
Animals ; Cattle ; Lactoferrin ; chemistry ; Magnetic Resonance Spectroscopy ; Models, Molecular ; Stilbenes ; chemistry ; beta-Cyclodextrins ; chemistry

Objective:From a professional competency-based perspective,this study aimed to explore appro-priate ways for certifying counselors and psychotherapists in China,and focused on improving the evaluation pro-gram for clinical and counseling psychologist of the Clinical and Counseling Psychology Registration System (CCPRS)of Chinese Psychological Society.Method:The theories and methods for certifying counselors and psy-chotherapists in China and overseas were summarized by using the literature method,based on which the design principles for certification in China were determined.Using the expert method,the core competencies of Chinese counselor and psychotherapist were proposed to form the index system of evaluation.A survey was also conducted to obtain a preliminary validity of the improved evaluation program.Result:Design principles for certifying coun-selors and psychotherapists were multi-trait,multi-method,and multi-informant.The core competencies of Chinese counselor and therapist included six domains,which were professional attitudes and conduct,ethics and law,clinical knowledge and skills,science and research,relationship building,cultural diversity and Chinese culture,case man-agement,respectively.Results from the expert judgments indicated that the evaluation materials which formulated by the improved program could assess all six core competencies and had acceptable reliabilities(Cronbach's α=0.74-0.97).And the expert evaluation about the improved program was high.Conclusion:The core competencies of Chinese counselor and therapist,which formulated by the improved evaluation program,reflect the necessary attitudes,knowledge and skills that needed when engaged in the professional practice of counseling and psychothera-py,and also can be used as a reference for counselor and psychotherapist education,training,practice,and compe-tency evaluation in China.The improved evaluation program can be used as a transitional way for certifying coun-selors and psychotherapists in China.