In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data, Chinese medicine injection safety monitoring quality control indicators, including the monitoring center, monitoring personnel, hardware conditions, monitoring progress and the number of patients into the group, original documents and archives management, electronic data, adverse events, quality management were constructed. Its application in the creation of major new drugs technology major projects, 10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work, found the missing case surveillance, not reported adverse events, only reported adverse reactions, electronic data reporting lag, lack of level of efforts to control the problem, and corrected, the traditional Chinese medicine injection safety monitoring of quality control and quality assurance, and subsequent Chinese medicine safety monitoring quality control to provide the reference.
Humans ; Injections ; Medicine, Chinese Traditional ; adverse effects ; standards ; Quality Control

Action Potentials ; drug effects ; physiology ; Animals ; Guinea Pigs ; Heart Ventricles ; drug effects ; Lysophospholipids ; pharmacology ; Myocardial Contraction ; drug effects ; physiology ; Myocardium ; Sphingosine ; analogs & derivatives ; pharmacology

Evidence body is defined as an evidence complex incorporating the evidence obtained from various research methods and various resources. As one of common parenterally administered Chinese medicines, Shuxuetong's safety drew high concern from doctors. However, we only have grasped several but less systematic evidence on the safety of Shuxuetong. To build a safety evidence body of Shuxuetong injection. Review and evaluate the evidence related to the safety of Shuxuetong injection after accumulating, searching and classfying related literature. Accoeding to levels of evidence from high to low, the evidence related to the safety of Shuxuetong injection was classified as following: the evidence from a long-term, prospective, large-sample-size and intensive hospital monitoring study was the strongest; the evidence of hospital information system (HIS) data analysis; the evidence of spontaneous reporting system (SRS) data analysis; the evidence of adverse drugreactions (ADRs)/adverse drug events (ADEs) reported in systematic evaluation, ADRs case report, toxicological tests, pharmacological tests were weakest. Based on the evidence body, Shuxuetong Injection was proved to be safe, and its ADRs were mainly allergic reactions, and more often happened among the old patients.
Adverse Drug Reaction Reporting Systems ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Prospective Studies

The accurate medical treatment is based on the information of the genome, which is the best treatment for the patients. Population pharmacokinetic study can be formulated according to the individual differences of patients to the dose, in the accurate medical model which has a unique advantage. At present, there are many problems such as adverse drug reaction in Chinese traditional medicine, and it is necessary to introduce a group of medicine on the basis of precise medical treatment. However, due to the different characteristics of traditional Chinese medicine and chemical medicine, it is necessary to combine the population pharmacokinetics, genetics and statistical methods to establish a research method which is in line with the characteristics of Chinese medicine. The key scientific problem is to make clear the active components of Chinese medicine metabolism of the drug metabolic enzyme gene, and pay attention to the analysis of the polymorphism of the overall role of drug metabolism enzymes in the human body. Clear key scientific issues and break through the bottleneck, so as to achieve the precise medical treatment, to international.
Humans ; Medicine, Chinese Traditional ; Pharmacokinetics

objective To determine the existence of virulence-associated invA gene in different genospeeies of Leptospira interrogans reference strains in China.and to understand the alterations of invA gene transcription and expression of L.interrogans strain Lai before or after infecting cells.Methods PCR was applied to detect the invA gene of four L.interrogans strains belonging to four different genospecies and L.biflexa strain Patoc Ⅰ.The entire invA genes from the L.interrogans strains were cloned and then sequenced.The prokaryotic expression system of invA gene of L.interrogans serogroup Icterohaemorrhagiae serovar Lai strain Lai was constructed.Using Ni-NTA affinity chromatography,the target recombinant protein rInvA was extracted and purified.Rabbits were immunized with rInvA to obtain antiserum and the titer of antiserum was determined by immunodiffusion test.A model of L interrogans strain Lai infecting human embryo kidney cell line HEK293 was established to detect the alterations of invA gene transcription and expression of the leptospiral strain before or after infecting the host cells by real-time fluorescent quantitative RTPCR and western blot assay.Results All the four tested L.interrogans strains had invA gene whereas L.biflexa strain Patoc Ⅰ not.The similarity of nucleotide and putative amino acid sequences of invA genes from the four L.interrogans strains belonging four different genospecies were 99.33%-100%and 98.66%-100%,respectively.The constructed prokaryotic expression system could efficiently express rInvA and the immunodiffusion titer of rabbit anti-rInvA serum was 1:16.After L.interrogans strain Lai infecting HEK293 cells for 30 min or above,the microbe could adhere the surface of the cells.On the 30 min after the infection,the mRNA level of invA gene of L.interrogans strain Lai was remarkably upregulated,and on the 45 min after infection the mRNA level presented a peak value and then graduated decreased.On the 45 min or 60 min after L.interrogans strain Lai infecting HEK293 cells,InvA protein could be detectable but before infection or after infection for over 90 min the InvA protein expression was negative.Conclusion The invA gene is a unique gene for pathogenic L.interrogans.The invA gene of L interrogans has characteristics of cell-touched expression and transient expression,which may have a close correlation with adhering and invading host cells.

Acupuncture Therapy ; Adolescent ; Adult ; Female ; Humans ; Male ; Middle Aged ; Respiration Disorders ; physiopathology ; therapy ; Yawning ; Young Adult

This study aims to explore and analyze the condition of concurrent diseases and medicine use of traditional Chinese medicine (TCM) and western medicine among the patients with insomnia. One thousand and sxity seven cases of data from 20 national hospitals' hospital information system (HIS) databases were collected. The frequent concurrent diseases included hypertension (26.9%), brain blood supply insufficiency (24.93%), cerebral infarction (19.49%), blood lipoprotein disturbance (15.28%), coronary heart disease (14.15%), headache (10.68%), chronic gastritis (8.81%), type 2 diabetes mellitus (7.87%), depressive disorder (7.4%) and anxiety disorder (6.65%). The 10 most frequently-used western drugs included alprazolam (35.99%), aspirin (25.4%), olanzapine (24.18%), cinepazide (23.06%), flupentixol & melitracen (18.74%), zolpidem (18.37%), oxiracetam (15.65%), estazolam (15%), aniracetam (13.4%) and piracetam (13.31%). The 10 most frequently-used TCM included Shuxuening injection (16.4%), Shuxuetong injection (15.18%), extract of ginkgo biloba leaf (14.71%), gastrodin (12.46%), Dengzanxixin injection (11.34%), Xueshuantong (8.53%), Danhong injection (6.37%), compound liquorice tablet (5.81%), Sanqi Tongshu capsule (5.72%) and sowthistle-leaf ixeridium injection (5.34%). Among all combined uses, the most frequent western drug use was alprazolam and olanzapine, while combined use of hypnotic drug and Huoxuehuayu formula is the most frequent. This study concludes that the concurrent diseases mainly include cardio-cerebrovascular diseases, metabolic disorders and anxiety-depression disorders, with increasing tendency of diseases types by ages, especially for cardio-cerebrovascular diseases. The most frequently-used hypnotic is alprazolam in the insomnia patients, and it is worth being concerned about the off-label use of olanzapine as an antipsychotic for the treatment of insomnia However, due to the fact that all cases data are from the inpatients, these findings have some limitations.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Alprazolam ; therapeutic use ; Anti-Anxiety Agents ; therapeutic use ; Antipsychotic Agents ; therapeutic use ; Benzodiazepines ; therapeutic use ; Cerebral Infarction ; drug therapy ; epidemiology ; etiology ; Coronary Disease ; drug therapy ; epidemiology ; etiology ; Diabetes Mellitus, Type 2 ; drug therapy ; epidemiology ; etiology ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Headache ; drug therapy ; epidemiology ; etiology ; Humans ; Hypertension ; drug therapy ; epidemiology ; etiology ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Sleep Initiation and Maintenance Disorders ; complications ; drug therapy ; epidemiology ; Young Adult

Adult ; Carcinogens ; Epoxy Compounds ; poisoning ; Female ; Humans ; Lymphocytes ; drug effects ; metabolism ; Male ; Multivariate Analysis ; Mutation ; drug effects ; Occupational Exposure ; analysis ; Regression Analysis ; Sister Chromatid Exchange ; drug effects

Objective To explore the relationship of Helicobacter pylori (Hp) infection and carotid plaques in patients with coronary heart disease and analyze the related factors of carotid plaques.Methods This study enrolled 209 patients.13C-urea breath test (13C-UBT) was used to assess Hp infection.Based on the results of 13C-UBT,patients were divided into infection-positive group (101 patients) and infection-negative group (108 patients).The incidence of carotid plaques was detected by color Doppler,and plasma homocysteine (Hcy),total cholesterol (TC),low density lipoprotein cholesterol (LDL-C),fibrinogen (Fbg),high sensitivity C reactive protein (hs-CRP) were measured and compared.Results The incidence of carotid plaques in infection-positive group(69.31％,70/101) was higher than that in infection-negative group (55.56％,60/108),and there was significant difference (P =0.040).There was significant difference in hs-CRP between infection-positive group and infection-negative group [(3.91 ± 1.91) mg/L vs.(2.65 ± 1.15)mg/L] (P =0.041).There were no significant difference in Hcy,TC,LDL-C,Fbg between infection-positive group and infection-negative group (P ＞ 0.05).Logistic regression analysis showed that Hp infection was correlated with carotid plaques in patients with coronary heart disease.The severity of Hp infection had no significant effect on the incidence of carotid plaques.Conclusions Hp infection-positive patients with coronary heart disease may have a higher incidence of carotid plaque,regardless of Hcy,LDL-C,Fbg and TC level.This study shows that Hp is correlated with carotid plaque.The severity of Hp infection has no significant effect on the incidence of carotid plaque.

OBJECTIVETo understand the real world, the use of ultra- treatment Shuxuetong injection on liver and kidney functions are affected.

METHODThe 18 hospitals of the country's HIS data sources from which to choose to use Shuxuetong injection, between the ages of 18 to 80 years, using Shuxuetong and the first seven days after discontinuation of at least 7 days has once aspartate aminotransferase or alanine aminotransferase, or creatinine or blood urea nitrogen were measured value as a research object, the number of days of medication is based on more than 14 days, divided into treatment group and the normal course of super-group to reach the normal range of physical and chemical indicators 200% of the upper limit is defined as abnormal. Using the propensity score method, balance the known confounding factors, differences in the occurrence of abnormal renal function and compared between the two groups.

RESULTThe treatment group and the normal course of super-group, resulting in alanine aminotransferase, aspartate aminotransferase, creatinine, urea nitrogen equally likely targets abnormal changes, no statistically significant difference.

CONCLUSIONBased on the available data did not find "super treatment using Shuxuetong damage the liver and kidney function" the situation, but the clinical disease lasts insist on the principle can not be arbitrarily extended treatment to prevent long-term medication.

Adult ; Aged ; Aged, 80 and over ; Alanine Transaminase ; metabolism ; Aspartate Aminotransferases ; metabolism ; Blood Urea Nitrogen ; Creatinine ; blood ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Humans ; Kidney ; drug effects ; metabolism ; Liver ; drug effects ; metabolism ; Liver Function Tests ; Male ; Middle Aged ; Young Adult