Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.
Drug Evaluation ; methods ; Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional

The adverse reaction monitoring is important in warning the risks of traditional Chinese medicines at an early stage, finding potential quality problems and ensuring the safe clinical medication. In the study, efforts were made to investigate the risk signal mining techniques in line with the characteristics of traditional Chinese medicines, particularly the complexity in component, processing, compatibility, preparation and clinical medication, find early risk signals of traditional Chinese medicines and establish a traditional Chinese medicine safety evaluation system based on adverse reaction risk signals, in order to improve the target studies on traditional Chinese medicine safety, effective and timely control risks and solve the existing frequent safety issue in traditional Chinese medicines.
China ; epidemiology ; Drug Evaluation ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Product Surveillance, Postmarketing

Objective To investigate the relationship between apoptosis of bone marrow cells and tumor necrosis factor-?(TNF-?),Fas/FasL expression in children with aplastic anemia.Methods The concentration of TNF-? in supernatant of cultured bone marrow mononuclear cell(BMMC) was measured by enzyme linked immunosorbent assay.The expression of Fas/FasL,apoptosis ratio of bone marrow CD34+ cell were evaluated by flow cytometry.Results The concentration of TNF-? in supernatant of cultured BMMC in AA group[SAA (27.9?8.20) ng/L;CAA (23.6?6.78) ng/L] increased significantly compared with control group(t=3.432 P0.05).Apoptosis ratio of CD34+ cell in SAA group[(24.6?9.56)%] and CAA group[(20.9?7.32)%] significantly increased compared with control group(t=3.492,3.458 Pa0.05).The concentration of TNF-? was positively correlated with the expression of CD34+ Fas+ in all types AA children(r=0.542 P0.05).Conclusions TNF-? and Fas/FasL system can be involved in inducing CD34+ cell apoptosis.This may contribute to understanding the decreased number of stem cells and bone marrow failure.

Traditional Chinese medicine Polygoni Multiflori Radix is dried roots of Polygonaceae Polygortum multiflorum Thunb. Its clinical application records were first discovered in literatures of the Tang dynasty. The origins, efficacy, toxicity, processing and taboos of Polygoni Multiflori Radix have been discussed in many ancient herb literatures. In recent years, with the increase in the public awareness in health, Polygoni Multiflori Radix admits preparations have been more widely applied in the treatment and prevention of diseases. However, there have been more and more reports about Polygoni Multiflori Radix induced liver injury, the safety of Polygoni Multiflori Radix has increasingly attracted attention of the society. In this paper, the authors summarized and analyzed the toxicity and medication risk factors of Polygoni Multiflori Radix recorded in ancient herb literatures, and proposed that more attention shall be given to the effect of the planting and processing methods on the components and toxicity of Polygoni Multiflori Radix in safety studies, which provides clues for the further studies.
China ; Drugs, Chinese Herbal ; adverse effects ; history ; History, Ancient ; Humans ; Medicine in Literature ; Medicine, Chinese Traditional ; history ; Polygonum ; adverse effects ; Risk Assessment

The renal toxicity and mutagenicity of aristolochic acid (AA) as well as its carcinogenicity on upper urinary tract transitional epithelial cells have been widely known. Since 2003, drug regulatory departments have successively cancelled the quality standards for AA-containing medicines such as Aristolochiae Radix, Aristolochiae Manshuriensis Caulis and Aristolchiae Fangchi Radix, and adopted measures for strengthening regulation and revising package insert or quality standards for other AA-containing medicines, including Aristolochia Cinnabarina Radix, Aristolochiae Fructus, Aristolochiae Mollissimae Herba, in order to control its safety risk. In recent years, domestic and foreign studies on AA have mainly involved action mechanism and clinical performance of AA toxicity, early-stage diagnosis and treatment method. In this paper, authors gave a brief summary and evaluation on risk factors for using AA-containing medicines, and offered measures and suggestions for preventing and controlling AA toxicity.
Animals ; Aristolochia ; adverse effects ; chemistry ; Aristolochic Acids ; analysis ; therapeutic use ; toxicity ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; analysis ; therapeutic use ; toxicity ; Humans

In this study, OVA-induced asthma mice was taken as the model, and orally administered with different concentration of ethanol extracts of crude and processed Stemona tuberosa, in order to determine the cytokine level released from Th1 and Th2 in splenocytes. RT-PCR was carried out to determine the genetic expression of T-bet/GATA-3 in lung, and compare the differentiation between ethanol extracts of crude and processed S. tuberosa in therapeutic effect on asthma in mice. According to the results, compared with the crude samples, processed samples significantly increased the levels of inflammatory factor INF-gamma (P < 0.05) and decreased IL-5 (P < 0.05) in splenocytes. According to the RT-PCR results, the administration of processed samples could increase the ratio of T-bet/GATA-3 (P < 0.05). The experiment showed that ethanol extracts of both crude and processed S. tuberosa could treat asthma by regulating Th1/Th2 ratio, but processed samples showed more notable effect. This indicated that crude and processed S. tuberosa had significant pharmacological difference. Therefore, it was more rational to apply processed S. tuberosa in clinical treatment of asthma and chronic cough, which layed a foundation for further revealing the processing mechanism of S. tuberosa.
Administration, Oral ; Animals ; Asthma ; drug therapy ; immunology ; metabolism ; Disease Models, Animal ; Drugs, Chinese Herbal ; administration & dosage ; pharmacology ; therapeutic use ; GATA3 Transcription Factor ; metabolism ; Gene Expression Regulation ; drug effects ; Mice ; Mice, Inbred BALB C ; Stemonaceae ; chemistry ; T-Box Domain Proteins ; metabolism ; Th1 Cells ; drug effects ; secretion ; Th2 Cells ; drug effects ; secretion

The changes of interstitial cells of Cajal(ICC)distribution and connexin 43(Cx43)expression in gastric muscle layers were assayed in gastroparesis models of streptozotocin-induced diabetic rats.The results showed that gastric emptying was significantly delayed,the contraction frequency and amplitude of gastric muscle segments were greatly decreased,Cx43 gray values were significantly increased and Cx43 distributed homogeneously with ICC immunopositivity in the model rats.These changes appear to be related to the pathogenesis of diabetic gastroparesis.

Objective To identify histopathologic correlates for the various MRI appearances of breast fibroadenomas.Methods Thirty-eight fibroadenomas in 33 patients(aged 24—57 years)examined with gadolonium-enhanced MR imaging were observed for signal intensity on T_2-weighted images,contrast enhancement,shape,and internal septation,and these findings were correlated with histopathologic findings.All cases underwent surgery and were proved by pathology.Results(1)The lesion shape was lobular,or round in 34 of 38 fibroadenomas(89.5%).(2)The signal intensity on T_1-weighted images was less than or equal to that of fibroglandular tissue in all cases.The signal intensity on T_2-weighted images was highly varible:high T_2 signal intensity was associated with more myxomatous stromal(mean myxoid-sclerotic index value of 1.9),higher stromal cellularity(mean stromal cellularity index value of 2.2); Fibroadenomas with low T_2 signal intensity had stromal that was nearly uniformly sclerotic(mean myxoid- sclerotic index values of 2.8)and low stromal cellularity(mean stromal-cellularity index value of 1.2). Significant differences were found between these two groups,x~2=11.267 and x~2=10.415(P0.05).The degree of contrast enhancement was proved to be related to ages of patients.The enhancement was more intensely in younger patients.(5)Internal septations were identified within nine of 33 enhancing fibroadenomas (27.3%)and appeared to correlated with collagenous bands at histopatholigic analysis.Conclusions Fibroadenomas demonstrate marked histopathologic variability.The resultant variability in the MR appearance correlated with the degree of myxomatous or sclerotic and stromal cellularity.Lobulation and internal septation,which appear to reflect intrinsic growth patterns of fibroadenomas,may provide more reliable information for distinction.Familiarity with the diagnostic features would facilitate to make the differential diagnosis correctly.

The capsule-style micro-system is a hot spot of minimally-invasive medical instruments. Progresses of some typical capsule-style micro-systems, such as the wireless endoscope, site specific delivery capsule (SSDC), alimentary tract sampling capsule, PH capsule, etc. are introduced here in detail. The research activities in China and the developing trend of capsule-style micro-systems are discussed too.
Drug Delivery Systems ; instrumentation ; methods ; Endoscopes, Gastrointestinal ; classification ; Endoscopy, Gastrointestinal ; methods ; Humans ; Hydrogen-Ion Concentration ; Minimally Invasive Surgical Procedures ; instrumentation ; methods

OBJECTIVESince the dermatology life quality index (DLQI), a self-administered general dermatology quality of life instrument, was originally developed and published in a dermatology clinic at University hospital of Wales, our goal was to popularize the disease-specific scale used in measuring the quality of life of patients with skin diseases and to assess the reliability and validity of its Chinese version.

METHODSWe administered the DLQI to 236 out-patients attending our dermatology clinic and results that had been found by those who originated the DLQI, were examined. The reliability and validity of DLQI were assessed by means of reliability analysis and factor analysis.

RESULTSOverall, the DLQI seemed easy to administer and could be completed within 3 minutes. The internal consistency coefficient rates of this unidimensional measure were 0.87 (Cronbach's alpha) and 0.85 (Spearman-brown, s) with high inter-correlations found between the dimensions with a correlation coefficient ranging from 0.4024 - 0.6569. Factor analysis resulted in a unidimensional pattern, which supported the use of a total DLQI-C score.

CONCLUSIONDLQI was an easy and efficient instrument for assessing the quality of life in patients with dermatological problems and with better reliability and validity. Thus, it could be used in both research and clinical settings in China.

Eczema ; psychology ; Female ; Humans ; Male ; Psoriasis ; psychology ; Quality of Life ; Reproducibility of Results ; Sickness Impact Profile ; Skin Diseases ; psychology ; Surveys and Questionnaires