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

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

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

Recently traditional Chinese medicine (TCM)-induced liver injury has been an unresolved critical issue which impacts TCM clinical safety. The premise and key step to reduce or avoid drug-induced liver injury (DILI) is to identify the drug source of liver injury in early stage. Then the timely withdrawal of drug and treatment can be done. However, the current diagnosis of DILI is primarily governed by exclusive method relying on administering history supplied by patients and experience judgment from doctors, which lacks objective and reliable diagnostic indices. It is obvious that diagnosis of TCM-induced liver injury is especially difficult due to the complicated composition of TCM medication, as well the frequent combination of Chinese and Western drugs in clinic. In this paper, we proposed construction of research pattern and method for objective identification of TCM-related DILI based on translational toxicology, which utilizes clinical specimen to find specific biomarkers and characteristic blood-entering constituents, as well the clinical biochemistry and liver biopsy. With integration of diagnosis marker database, bibliographic database, medical record database and clinical specimen database, an integrative diagnosis database for TCM-related DILI can be established, which would make a transformation of clinical identification pattern for TCM-induced liver injury from subjective and exclusive to objective and index-supporting mode. This would be helpful to improve rational uses of TCM and promote sustainable development of TCM industry.
Animals ; Biomarkers, Pharmacological ; metabolism ; Biopsy ; methods ; Chemical and Drug Induced Liver Injury ; diagnosis ; metabolism ; pathology ; Early Diagnosis ; Humans ; Liver ; drug effects ; pathology ; Medicine, Chinese Traditional ; adverse effects ; Rats

Objective To determine the therapeutic effect of recombined rat insulin-like growth factory 1 gene and transforming growth factor beta-1(TGF-?_1)gene on anterior cruciate ligament transection(ACLT)- induced osteoarthritis-like changes in NZW rabbit knee joints.Methods Eighteen NZW rabbits were divided into 3 groups randomly after osteoanhritis was established by ACLT and another six rabbits were used as normal control group(group 1).Chondrocytes which had been transfected with IGF-1 gene,co-transfected with TGF-?_1 and IGF-1 gene(group 3,4)were injected into the rabbits knee joints.Experimental control group(group 2)only had ACLT bul was not transfected.After 4,8 weeks,rabbits were sacrificed and their joints were evaluated by morphological grades,histological examination,in situ hybridization examination,immunohistochemistry exami- nation,and transmission electron microscopy examination(TEM).Results The morphological grades showed that the normal control group had a very significant difference with the experimental control group(P

The newly revised Regulations for the Administration of Adverse Drug Reaction Reporting and monitoringhas been implemented since July 1, 2011. It is the most important regulation on adverse drug reaction (ADR) monitoring. This article will intensively read the regulation and analysis its significance on the traditional Chinese medicine adverse reaction monitoring, so as to make the revised content more clear and guide the ADR monitoring working better.
Adverse Drug Reaction Reporting Systems ; standards ; China ; Drug Monitoring ; standards ; Drug Therapy ; standards ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; standards

Objective SCAP are seen as seed cells of peri-apical tissue regeneration and used in periapical tissue regeneration project based on stem cells .In this study, we aim to explore the ef-fectdifferent mechanical stretch stress on the proliferation and differen-tiation potential of human stem cells from the apical papilla ( SCAP ) ,and to clarify the mechanism of how mechanical stretch stress regulate human SCAP ,which will provide theoretical guidance for ortho-dontic treatment . Methods Human SCAP was isolated , cultured and identified by combined explants method and enzymatic separa-tion method and limited dilution .MTT assay was used to detect the effect different static mechanical stretch stress stimulation have on the proliferation of SCAP .Western blot was used to detect the expression changes of SCAP osteogenesis /odontoblast differentiation-re-lated protein (ALP, OSX,DSP) under mechanical stretch stressand to detect the expression of SCAP endoplasmic reticulum stress mo -lecular chaperone GRP 78 under different static mechanical stretch stress . Results SCAP were successfully isolated and cultured , and we induced SCAP to differentiate into osteoblasts and adipocytes successfully by osteogenic medium and adipogenic medium .Flow cytometry was performed in accordance with SCAP immunophenotype .Compared with the control group , 150g mechanical stretch stress stimulation promoted SCAP proliferation first and then inhibited SCAP proliferation [(0.481±0.226),(1.375±0.104),(1.425± 0.136),(1.556±0.268),(0.589±0.29),P<0.05].It was same in the 200g group.250g mechanical stretch stress stimulation signifi-cantly inhibited SCAP proliferation [(0.373±0.146),(0.545±0.069),(0.745±0.273),(0.967±0.278),(1.060±0.362),P<0.05]. The expression levels of ALP , OSX and DSP protein in each group were higher than those in the control group (P<0.05).Compared with the control group, the expression of GRP78 protein was up-regulated (P<0.05). Conclusion Mechanical stretch stress could regulate the SCAP proliferation and osteogenesis/odontoblast differentiation .What′s more,endoplasmic reticulum stress played a role in osteogenesis/odontoblast differentiation under mechanical stretch stress and promoted SCAP osteogenesis /odontoblast differentiation .

BackgroundObstruction of aqueous humor out flow pathway or abnormality of the extracellular matrix( ECM ) of trabecular meshwork cells causes high intraocular pressure. The balance of matrix metalloproteinases (MMPs) and tissue inhibitors of matrix metalloproteinases(TIMPs) is critical for the metabolism of ECM. Interleukin1α(IL-1α) can influence outflow of aqueous humor by regulating MMPs level. Objective This study was to investigate the effect of interleukin-1α on the expression of MMP-2,MMP-3 and TIMP-I in cultured swine trabecular meshwork cells.Methods Swine sclera with trabecular meshwork tissue was isolated from 20 swine eyes and cultured with explant cultured method. Cultured cells were passaged and third generation cells were identified by fibronectin ( FN ) and laminin ( LN ) staining. After 24 hours of serum starvation, trabecular meshwork cells treated with IL-1α at the concentration of 10 mg/L were regarded as the IL group,and serum-free culture medium used to treat trabecular meshwork cells was regarded as the control group. The expression of MMP-2, MMP-3 and TIMP-1 proteins in trabecular meshwork cells were detected by immunohistochemistry,and the expression of MMP-2 mRNA, MMP-3 mRNA and TIMP-1 mRNA were detected by RT-PCR. The examination results were compared between the two groups. ResultsThe third generation of cells were positive for FN and LM. Compared with the control group, the expression levels of MMP-3 and TIMP-1 proteins(A value) in trabecular meshwork cells were significantly higher in the IL group than the control group(t=-7. 694,t =-5. 199,P＜0. 05) ,but no obvious difference was found in the expression of MMP-2 between the two groups( t=-2. 365, P＞0.05 ). The higher expression levels in MMP-3 mRNA and TIMP-1 mRNA (A value) in trabecular meshwork cells were seen in comparison with the control group (t =-3. 025,t=-1. 921 ,P＜0. 05). However,similar results were found in the expression of MMP-2 mRNA between the two groups(t =- 1. 173, P＞0.05 ). ConclusionsThe overexpression of MMP-3 and TIMP-1 proteins and their mRNA leads to the imbalance of MMP-3/TIMP-1 and promotes the decomposition of ECM in the trabecular meshwork, and therefore increases aqueous outflow.

BACKGROUND: Pancreatic damage in critically ill patients is associated with the progressive failure of multiple organs, but little is known about its clinical characteristics. At present, no guidelines are available for the diagnosis and management of pancreatic damage. This study was undertaken to analyze the clinical and pathologic characteristics of pancreatic necrosis in critically ill children, and to find some biological markers of pancreatic damage or pancreatic necrosis. METHODS: We retrospectively reviewed the clinical data, laboratory results, and autopsy findings of 25 children, who were admitted to Hunan Children's Hospital, China from 2003 to 2009, and died of multiple organ failure. The autopsy revealed pancreatic necrosis in 5 children, in whom sectional or gross autopsy was performed. RESULTS: The 5 children had acute onset and a fever. Two children had abdominal pain and 2 had abdominal bulging, flatulence and gastrointestinal bleeding. Four children had abnormal liver function, characterized by decreased albumin and 3 children had elevated level of C-reactive protein (CRP). B-ultrasonography revealed abnormal acoustic image of the pancreas in all children, and autopsy confirmed pancreatic necrosis, which may be associated with the damage of the adrenal gland, liver, lung, heart, spleen, kidney, intestine, thymus, mediastinal and mesenteric lymph nodes and other organs. Children 1 and 2 died of acute hemorrhagic necrotizing pancreatitis (AHNP);children 3-5 died of multiple organ dysfunction syndrome (MODS) due to pancreatic necrosis. CONCLUSION: Pancreatic damage or pancreatic necrosis in critically ill children is characterized by acute onset, severity, short course, multiple organ damage or failure. It may be asymptomatic in early stage, and easy to be ignored.