3.Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines.
Hong-jiao LI ; Li-yun HE ; Bao-yan LIU
China Journal of Chinese Materia Medica 2015;40(12):2461-2463
The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.
Drugs, Chinese Herbal
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adverse effects
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economics
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therapeutic use
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Humans
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Medicine, Chinese Traditional
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Product Surveillance, Postmarketing
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methods
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Quality Control
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Randomized Controlled Trials as Topic
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Respiratory Tract Infections
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drug therapy
4.Isolation and cultivation of goat temporomandibular joint disc cells
Weina SHU ; Hong KANG ; Weiping ZHANG ; Xin LI ; Guangjie BAO
Journal of Practical Stomatology 2010;26(2):165-168
Objective:To study the isolation, culture and identification of the TMJ cells and to observe the biological characteristics of cultured fibrochondrocytes. Methods:The TMJ discs were dissected from two 1 month goats under sterile conditions and were digested with collagenase. The cells were collected. Morphological changes and attachment efficiency were constantly observed under phase-contrast microscope. Immunohistochemical staining for type I collagen as well as toluidine blue staining were performed. Ultrastructures of the TMJ cells were observed under transmission electron microscope. Results: Most of the primary fibrochondrocytes presented a short spindle-shape while the rest showed polygon-shape. On the 7th day, the perliferating fibrochondrocytes started to contact each other to form a monolayer covering the bottom of the incubation disc. Immunohistochemical staining of type I and toluidine blue staining exhibited positive results. The fibrochondrocytes cytoplasms were rich in mictochondria and endoplasm reticulum. Conclusion: The fibrochondrcytes isolated from one-month-old goat TMJ disc have good proliferation ability in vitro and cells from passage 1 to 3 might be used as seed cells for TMJ disc tissue engineering.
5.Type and distribution of cells in goat temporomandibular joint discs and its significance in tissue engineering design
Weina SHU ; Hong KANG ; Weiping ZHANG ; Xin LI ; Guangjie BAO
Chinese Journal of Tissue Engineering Research 2009;13(46):9022-9026
BACKGROUND:There is no common cognition in the cell type in the temporomandibular joint(TMJ)discs,and names describing TMJ disc cells also vary a lot.OBJECTIVE:To characterize the type and the distribution of cells in the TMJ disc of goats DESIGN,TIME AND SETTING:A single sample observation was completed in Cettutar and Motecutar Biologicat Center and Electron Microscope Center of Lanzhou University from March to May in 2007.MATERlALS:TMJ discs were obtained from two one-month-old healthy goats that were slaughtered freshly.METHODS:Bilateral TMJ discs of goats were cut off completely and were divided into 6 parts by 3 cuts in the major axis direction (mediolaterally)and 2 cuts in the minor axis direction(anteroposteriorly).Then the marked samples were fixed in 10%neutral formalin Iiquid for 24 hours and embedded by paraffin.MAIN OUTCOME MEASURES:Hematoxylin and eosin staining were used to identify regional variation of cell type and cellnumbers.Toluidine blue staining and collagen type Ⅰimmunohistochemical assay were performed to test the distribution of collagens.Transmission etectren microscopy was used to observe the ultrastructure of cells of goat TMJ discs.RESULTS:TMJ discs were comprised of cells and collagen fibers distributing unevenly.Collagens were mostly type Ⅰ.Collagen fibers were wave or crimping and approximately parallel to each other.with cells scattered in their matrix.Fibroblast-like cells and chondrocyte-like cells were the main two types of cells existing,with the former predominating over the later in a ratio of 2.05:1 approximately.There were no significant regional differences in cell type and distribution statistically.Transmission electron microscopy denoted that fibroblast-iike cells have fairly larger fusiform or irregular nuclei with very few organelles,while the chondrocyte-like cells exhibited round or elliptical nuclei,well defined pericellular electron lucent zones,unconspicuous cytocysta and non-distinctive pseudopodia CONCLUSION:There are no significant differences in type,number and arrangement of cells in TMJ discs of one-month-old goats statistically,with Fibroblast-like cells predominating slightly over chondrocyte-like cells.
6.Correlation of asthma susceptibility gene polymorphisms with API positive infantile wheezing
Hong CHEN ; Haipei LIU ; Yixiao BAO ; Li HUA
Journal of Clinical Pediatrics 2013;(6):547-550
10.3969/j.issn.1000-3606.2013.06.014
7.Effect of Buzhong Yiqi Decoction on Gastrin Gene Expression in Spleen-qi Deficiency Rats
Xiaowei ZHENG ; Suzhen BAO ; Hong SONG ; Rongqun LI ; Ying WANG ;
China Journal of Traditional Chinese Medicine and Pharmacy 2005;0(12):-
Objective: To explore the effect of buzhong yiqi decoction(BZYQD) with various concentrations at different time points on gastrin(GAS) gene expression level in spleen-qi deficiency rats.Methods: The spleen-qi deficiency rats were randomly divided into the model control group and the low,medium and high dosage of BZYQD groups.Reverse transcriptase polymerase chain reaction was used to observe the effect of BZYQD on the GAS mRNA of gastric antrum in rats treated at different time points(7,14,21d).Results: As compared with that in model control group,the GAS gene expression level were significantly higher both in the medium and high dosage groups(P
8.Clinical study of the visual quality after implantation of an aspherical intraocular lens Acrysof IQ
Jio GUO ; Xu-Dong SONG ; Hong-Li BAO ;
Ophthalmology in China 1994;0(02):-
Objective To observe the clinical effects after implantation of an aspherical intraocular lens Acrysof IQ.Design Prospective,randomized concurrent-controlled study.Participants 64 patients(64 eyes)with bilateral senile cataracts.Methods Pa- tients were operated with phacoemulsification and IOL implantation.They were divided randomly into 2 groups according to the table of random number:one group with Aerysof IQ(aspherical IOL)implantation and the other with Acrysof SN60AT(spherical IOL).Thor- ough ophthalmic examinations,including visual acuity,slit lamp examinations,fundoseopy,wavefront aberrometry,contrast sensitivity, were performed 1 week,1 month and 3 months after surgery.Main Outcome Measures Visual acuity,the best corrected visual acuity, spherical aberration(C 12),the root mean square of the total higher-order aberration(RMSh),and contrast sensitivity at 4 kinds of light backgrounds.Results At 1 postoperative month,RMSh(0.30?0.68?m)and C12(0.07,?0.04?m)in aspherical IOL group were signifi- cantly lower than those of the spherical IOL group(0.49?0.14?m,0.36?0.06?m)(P=0.00)with a 6.0 mm aperture.At 3 postoperative months the RMSh(0.30?0.07?m)and C12(0.06?0.06?m)in aspherical IOL group were significantly lower than those of the spherical IOL group(0.47?0.14?m,0.34?0.06?m)(P=0.00)with a 6.0 mm aperture.The asphefieal IOL(Acrysof IQ)provided statistically sig- nificant better contrast sensitivity at all spatial frequencies under mesopic conditions(3 cd/m~2)with and without glare(P
9.Analysis of Clinical Symptoms and Blood Lipid Components in Simple Obesity Children
A-YI-GU-LI ; yong-hong, CHEN ; jun-bao, DU
Journal of Applied Clinical Pediatrics 2004;0(07):-
Objective To analyze blood lipid components in simple obesity children and to explore the effects of obesity in the lipid metabolism and its clinical significance.Methods A total of 90 children,including 50 simple obesity children(obesity group)and 40 normal children(control group),were enrolled in this study.The age ranged from 2.5 to 16.0 years.Their blood lipid profiles of all the children were analyzed.The blood lipid profiles were examined by biochemical analysis,including triglyeride(TG),total cholesterol(TC),low density lipoprotein(LDL) and high density lipoprotein(HDL),and the livers of all the children were analyzed.The blood lipid profiles were examined by ultrasonograph.Results 1.There were no significant differences in age and height in obesity group and control group,but there were significant differences in body mass index(BMI) and blood pressure(P0.05),which had no statistical meaning.3.Liver ultra sonogram showed that 18 cases had fatty liver(36%) in simple obesity children.Conclusions Metabolic disorder of blood lipid is present in simple obesity children,who have a tendency to get fatty liver.LDL is markedly elevated in obesity group.Arteriosclerotic cardiovascular disease should be prevented at earlier period of childhood.
10.MRI Diagnosis of Small Epidermoids in the Cerebellopontine Angle:Preliminary Study
Hong BAO ; Yongsheng DING ; Jun YUAN ; Ming LI
Journal of Practical Radiology 1996;0(04):-
Objective To investigate the best MR technique for detecting small epidermoids in the cerebellopontine angle.Methods 7 patients with pathologically-proved small epidermoids only located in the cerebellopontine angle were collected. The imaging techniques included:conventional T1WI and T2WI, fluid attenuated inversion recovery(FLAIR),diffusion weighted imaging(DWI) and balanced fast field echo(B-FFE) .The findings were retrospectively analyzed.Results 6 of 7 cases of epidermoid tumours localized at the cerebellopontine angle and exhibited the similar signal intensity as the cerebrospinal fluid(CSF) on T1WI and T2WI.The remaining case was slightly isointense on either T1WI or T2WI.On FLAIR images in 6 cases,3 cases showed slightly hyperintensity, 1 case showed doubtful heterogeneous signal intensity and 2 cases did not reveal any abnormal signal intensity.3 cases were hyperintense differenting from CSF on DW images. All of seven cases showed heterogeneous signal characteristics and were quite different from CFS on B-FFE.Meanwhile B-FFE also produced clearly the tissue contrast of trigeminus embedded in epidermoids of the cerebellopontine angle.Conclusion B-FFE is much more useful for the early diagnosis of epidermoids in the cerebellopontine angle and it also can provide precise preoperative information about the trigeminus encasement.