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

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

As a common protease with high similarity among coronavirus species, the main protease (M^pro) of SARS-CoV-2 is responsible for the catalytic hydrolysis of viral precursor proteins into functional proteins, which is essential for coronavirus replication and is one of the ideal targets for the development of broad-spectrum antiviral drugs. This paper reviews the main protease inhibitors of SARS-CoV-2, including their molecular structures, potencies and drug-like profiles, binding modes and structure-activity relationships, etc.

COVID-19 epidemic continues to spread around the world till these days, and it is urgent to develop more safe and effective new drugs. Due to the limited P3 biosafety laboratories for directly screening inhibitors of virulent viruses with high infectivity, it is necessary to develop rapid and efficient screening methods for viral proteases and other related targets. The main protease (M^pro), which plays a key role in the replication cycle of SARS-CoV-2, is highly conserved and has no homologous proteases in humans, making it an ideal target for drug development. From two different levels, namely, molecular level and cellular level, this paper summarizes the reported screening methods of SARS-CoV-2 M^pro inhibitors through a variety of representative examples, expecting to provide references for further development of SARS-CoV-2 M^pro inhibitors.

OBJECTIVETo study the histological change of microscrew-bone interface, detect the relative cytokine of gingival crevicular fluid, and explore the impossible mechanism of peri-implantitis.

METHODSFour male Beagles were collected. Randomly select one side of animals jaw as the experimental group to induce the peri-implantitis, and another side as the control group. Four microscrews were implanted on each side. In the 1st, 2nd, 3rd, 4th weeks after implantation, collect peri-implant sulcular fluid (PISF) and detect tumor necrosis factor-alpha (TNF-alpha) levels before sacrificed, and the harvest tissue were observed in histological ways.

RESULTSAccording to the extension of time after implantation, the experimental group showed visible progress of interface destruction: 1st week after implantation showed large numbers inflammatory cells collected at the neck but did not undermine the cortical bone; 2nd week after implantation, cortical bone were observed angular absorption; Bone resorption continued to develop and at the 4th week, bone resorption were enlarged to the second thread of microscrew and the interface was filled with a large number of collagen fibers.

CONCLUSIONThe destruction of interface began at the neck of microscrew, and the further development was along the interface in depth. Both microscrews with peri-implantitis and the healthy controls showed the presence of TNF-alpha. Inflammation accumulation might trigger the up-regulation of TNF-alpha level, and the onset of inflammation would enhance the up-trend.

Animals ; Bone and Bones ; Dental Implants ; Dogs ; Gingival Crevicular Fluid ; Male ; Peri-Implantitis ; Tumor Necrosis Factor-alpha

The basic theory of Higher Order Spectral Analysis and the most generally used Bispectrum are introduced in the paper. By certain experiments of EEG signal acquisition and bispectrum analysis, it is showed that the Higher Order Spectrum has an advantage over power spectrum, which is based on Second Order Statistics, in processing non-linear signal and restraining Gauss noise signal.
Electroencephalography ; methods ; Signal Processing, Computer-Assisted

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Child ; China ; Disasters ; statistics & numerical data ; Earthquakes ; Female ; Fractures, Open ; psychology ; surgery ; Humans ; Leg Injuries ; psychology ; surgery ; Male ; Middle Aged

OBJECTIVETo explore the quality of life among people living with HIV/AIDS (PLWHA) and analyze the influencing factors in Kunming.

METHODSA cross-sectional survey was conducted from March to April in year 2011, and 247 PLWHA were selected by convenience sampling from Yunnan CDC, Yunnan and Kunming infectious disease hospitals. General questionnaires, the simplified Chinese edition of medical outcomes study-HIV health survey (MOS-HIV, including 11 dimensions) and Social Support Scale were used. t test and multivariable linear regression model were used to analyze the results.

RESULTSFor the subjects investigated, the age was (39.8 +/- 11.9) years old, the median (quartile) value of symptoms related to HIV infection was 1(2). As to the scores of quality of life measured by MOS-HIV, physical summary score was 47.4 +/- 11.2, mental summary score was 43.6 +/- 9.7; for the scores of 11 dimensions of the MOS-HIV,that were general health (42.9 +/- 19.9), physical function (79.4 +/- 24.9), role function (59.8 +/- 48.2), social function (67.0 +/- 33.6), cognitive function (71.0 +/- 25.4), pain (81.3 +/- 26.2), mental health (62.0 +/- 22.3), vitality (49.3 +/- 23.8), health distress (74.4 +/- 21.0), quality of life (51.8 +/- 21.1), health transition (49.0 +/- 29.8). The total score of social support was 28.6 +/- 7.6, of which the score of subjective social support was 17.2 +/- 6.3, the score of the objective social support was 5.9 +/- 2.2; the score of the utilization of social support was 5.5 +/- 1.9. Multivariable linear regression analysis showed that the more the symptoms related to HIV infection, the lower the physical summary scores (standardized coefficients b' = -0.22), the general health (b' = - 0.31), the physical function (b' = -0.16), the role function (b' = -0.23), the pain (b' = -0.21), the mental health (b' = -0.22), the vitality (b' = -0.22) and the health distress scores (b' = - 0.24) (all P values < 0.05); the older the age, the lower the physical summary scores (b' = - 0.16), the mental summary scores (b' = - 0.16), the physical function (b' = -0.26), the vitality (b' = -0.26) and the quality of life scores (b' = -0.17) (all P values < 0.05); the higher the score of the subjective social support,the higher the physical summary scores (b' = 0.26), the mental summary scores (b' = 0.22), the general health (b' = 0.27), the social function (b' = 0.26), the mental health (b' = 0.15) and the quality of life scores (b' = 0.22) (all P values < 0.05); the higher the score of the utilization of social support, the higher the physical function (b' = 0.16) and the health transition scores (b' = 0.31) (all P values < 0.05).

CONCLUSIONPLWHA in Kunming have relatively lower scores of quality of life. A large number of symptoms during infection, older age and lower score of subjective social support were the hazard factors of quality of life in PLWHA.

Acquired Immunodeficiency Syndrome ; epidemiology ; Adult ; China ; epidemiology ; Cross-Sectional Studies ; Factor Analysis, Statistical ; Female ; HIV Infections ; epidemiology ; Humans ; Male ; Middle Aged ; Quality of Life ; Social Support ; Surveys and Questionnaires