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

BACKGROUND:Under mitomycin C treatment, feeder cells appear to have restricted proliferation, but they are stil able to secret different cytokines. Non-mesenchymal stem cells from the bone marrow and secreted factors in plasma maintain the micro-environment suitable for the growth of mesenchymal stem cells that can improve the yield of mesenchymal stem cells.
OBJECTIVE:To study the biological characteristics of C57 mouse bone marrow mesenchymal stem cells isolated using a whole bone marrow adherent culture technique.
METHODS:Using the whole bone marrow adherent culture technique, purified and amplified C57 mouse bone marrow mesenchymal stem cells were harvested. cellproliferation kinetics, immune cellsurface markers, multiple differentiation potential and cellcycle were detected.
RESULTS AND CONCLUSION:Using the whole bone marrow culture, mouse bone marrow mesenchymal stem cells were harvested and capable of adhering to the plastic culture vessel. The obtained cells expressed CD45, CD105 and Sca-1, but were negative for CD34, CD33 and C-kit. The doubling time was (57.11±1.5) hours. The cells could be induced to differentiate into osteoblasts, adipocytes and chondrocytes. The cellcycle analysis showed that 64%of cells were in G 0-G 1 phase. These indicates that C57 mouse bone marrow mesenchymal stem cells isolated using a whole bone marrow adherent culture technique have biological characteristics of mesenchymal stem cells.

In order to investigate the effect of malic enzyme on anaerobic mixed acid fermentation,the gene encoding NAD+-dependent malic enzyme was amplified from E.coli DH5? genome by using PCR and cloned into vector pTrc99a to give an expression vector pTrc99a-sfcA.Malic enzyme was overproduced by E.coli FMJ39(ldh,pfl)harboring pTrc99a-sfcA under the condition of IPTG induction.The results of anaerobic fermentation indicated overexpression of malic enzyme would have influence on the pathway of formate,acetate and succinate of FMJ39.The concentration of formate and acetate was 17.58% and 15.27% higher than FMJ39,the succinate concentration was reduced by 26.87%.There was no obvious citrate concentration change.The experimental results also indicated that high concentration of L-Thr and L-Ser would induce the Tdc operon to convert pyruvate into formate and acetate even when pfl gene encoding the pyruvate formate lyase was inactivated.

Objective To investigate the efficacy,safety and localization of multilayer amniotic membrane transplantation(AMT) for corneal perforation associated with ulceration.Design A retrospective clinical case series.Participants Nine patients(9 eyes)with corneal perforation secondary to ulceration were enrolled into this study.These were little response to medicine,including bacterial keratitis(4 eyes ),fungal keratitis(2 eyes),fungal and bacterial mixed keratitis( 1 eye),virus keratitis( 1 eye),and Mooren's ulcer ( 1 eye).Size of perforation was 0.5～3.0 mm in diameter.Methods The AMT was applied to tamp the perforation,fill the ulcer and cover the surface of ulcer.After surgery,the medicine was continued to be used to treat the original corneal ulcer.The follow-up ranged from 6～20 months.In the suffering eyes,reformation of anterior chamber,healing of ulcer,complications and recurrence of ulceration were observed.Main Outcome Measures Of the postoperative eyes,reformation of anterior chamber,healing of ulcer,complications and recurrence of ulceration.Results The anterior chamber reformed at the first postoperative day in 9 eyes,and kept in normal depth in the follow-up time.At postoperative 2 months,the ulcer healed with sear and a smooth surface.Corneal thickness of the ulcer area recovered almost to normal.During follow up,no recurrence of ulceration or severe complications was noted.Conclusions Multilayer AMT is a safe and effective method for the management of small corneal perforation associated with ulceration,but the ulcer healed with scar.(Ophthalmol CHN,2008,17:101-103)