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
5.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
6.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.Promotion of students'independent study by library of college and university of traditional Chinese medicine
Hong LIU ; Lijuan BAO ; Yunfeng PU ; Li ZHANG
Chinese Journal of Medical Library and Information Science 2015;(7):75-77
How to expand and deepen the educational function of library of college and university of traditional Chinese medicine by giving play to its strong points was analyzed in the new model of students'independent study , and measures to improve the information literacy and comprehensive literacy of students were elaborated, such as developing teaching reference books database, performing guidance for different readers, carrying out different activities that make entertainment a medium of education , in order to help students to acquire special knowledge outside of classroom .
9.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.
10.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