2.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.Treatment of Sepsis-associated Encephalopathy by Xingnaojing Injection: a Clinical Observation.
Su LV ; Jia LI ; Bao-ping CAO ; Ji-hong ZHU
Chinese Journal of Integrated Traditional and Western Medicine 2015;35(7):792-795
OBJECTIVETo observe the efficacy of Xingnaojing Injection (XI) in treatment of sepsis-associated encephalopathy (SAE).
METHODSTotally 65 SAE patients were retrospectively analyzed at EICU from September 2010 to September 2013. They were assigned to the control group (32 cases) and the treatment group (33 cases) according to whether they received XI. Patients in the control group received anti-infection and symptomatic support, while those in the treatment group were intravenously injected with XI at 20 mL per day for additional 7-10 days. The fever clearance time, Glasgow coma scale (GCS), C-reactive protein (CRP), neuron-specific enolase (NSE), and improvement of electroen-cephalogram (EEG) were observed in the two groups.
RESULTSCompared with the control group, the fever clearance time was shortened, CRP levels decreased, GCS score and efficacy of EEG was alleviated in the treatment group after treatment with statistical difference (P < 0.05). No adverse reaction occurred during medication.
CONCLUSIONX1 was safe and effective in treatment of SAE.
C-Reactive Protein ; metabolism ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Humans ; Injections ; Phosphopyruvate Hydratase ; metabolism ; Sepsis-Associated Encephalopathy ; drug therapy ; Treatment Outcome
7.High IgE syndrome and its oral manifestatiom.
Li-mei GAO ; Hong-yan LIU ; Bao-hua XU
Chinese Journal of Stomatology 2011;46(12):771-773
8.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.
9.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.
10.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.