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

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

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

BACKGROUND:Keloid is a very chalenging problem in plastic surgery. Its pathogenesis is very complex, resulting from the combined action of many factors, such as various cytokines, signal transduction pathways, extracelular matrix,etc. At present, a critical role for mechanical force and mechanotransduction in the pathogenesis of keloids has been broadly concerned and becomes the focus of studying the pathogenesis of keloids.
OBJECTIVE:To summarize the progress of the mechanosignaling pathway involved in the pathogenesis of keloids in order to further understand the pathogenesis of keloids and provide new ideas for the prevention of keloids.
METHODS: The PubMed database and Elsevier database were retrieved for articles published from January 2000 to July 2014 by computer with key words of “keloid, molecular mechanism, mechanical stress, cutaneous scar, mechanobiology, mechanosignaling pathway” in English. A total of 23 articles were included which related to the molecular signal transduction mechanism and mechanosignaling pathway about keloids.
RESULTS AND CONCLUSION:The mechanosignaling transduction pathways, such as transforming growth factor-β/Smad, MAPK, integrin, Wnt/β-catenin, RhoA/ROCK and tumor necrosis factor-α/nuclear factor-κB signaling pathway, play an important role in the formation and development of keloids. A number of clinical trials have also shown the effectiveness of a part of mechanosignaling transduction pathway inhibitors in wound healing and reducing scar hyperplasia. The research about mechanosignaling transduction pathways involved in keloids has made some progress, but most stil remain in animal experimental stage. Secondly, various mechanosignaling transduction pathways about correlation and intersectionality stil need further studies to achieve a breakthrough in the prevention of keloids.

Objective To investigate whether mixed venous-arterial carbon dioxide difference (Pv-aCO2) combined with passive leg raising (PLR) could better guide volume management for patients post off-pump coronary artery bypass grafting (OPCABG).Methods Eighty patients experienced OPCABG, and admitted to Tianjin Chest Hospital from June 1st to October 1st in 2016 were enrolled. They were randomly divided into two groups: observation group given Pv-aCO2 combined with PLR directed therapy and control group given central venous pressure (CVP) directed therapy, 40 cases in each group. The difference in body temperature (T), heart rate (HR), mean arterial pressure (MAP), CVP, oxygenation index (PaO2/FiO2), mixed venous oxygen saturation (SvO2), Pv-aCO2, blood lactate (Lac), fluid intake, scores of the vasoactive agents at 6 hours post-operation, sequential organ failure assessment (SOFA) of 24 hours, mechanical ventilation time, the length of intensive care unit (ICU) stay, and hospitalization time were compared. The correlation between Pv-aCO2 and cardiac index (CI), Pv-aCO2 and Lac were analyzed by Spearman analysis in observation group.Results The T, HR, MAP, CVP, PaO2/FiO2, SvO2 and Lac at 6 hours post-operation were higher than those at admission in two groups, and Pv-aCO2 were significantly decreased. The SvO2 and fluid intake in observation group were higher than those in control group [SvO2: 0.671±0.068 vs. 0.634±0.052, fluid intake (mL): 454±151 vs. 304±106, bothP < 0.05], Pv-aCO2, Lac and scores of the vasoactive agents were lower than those in control group [Pv-aCO2 (mmHg, 1 mmHg = 0.133 kPa): 6.1±1.8 vs. 7.0±1.8, Lac (mmol/L): 1.7±0.5 vs. 2.8±0.6, scores of the vasoactive agents: 3.18±1.01 vs. 4.48±1.50, allP < 0.05], mechanical ventilation time and the length of ICU stay were less than those in the control group (hours: 16.52±6.41 vs. 21.96±9.00, 45.51±9.36 vs. 51.76±13.66, bothP< 0.05). There was no significant difference in SOFA, hospitalization time between the two groups. There was negative correlation with Pv-aCO2 and CI (r = -0.752,P < 0.01), and no correlation with Pv-aCO2 and Lac (r = -0.154,P = 0.171).Conclusion Pv-aCO2 combined with PLR can better guide volume management in the patients post OPCABG, reduce the usage of vasoactive agents and decrease the mechanical ventilation time and the length of ICU stay.

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

Objective:To explore the MRI features of cerebral amyloid angiopathy-related inflammation (CAA-ri).Methods:The clinical and imaging data of 12 patients with CAA-ri diagnosed in Affiliated Guizhou Aviation Industry Cor Ltd No 300 Hospital of Zunyi Medical University (9 cases), Xingyi People′s Hospital (2 cases) and Anshun people′s Hospital (1 case) from June 2013 to June 2020 were analyzed retrospectively. There were 3 females and 9 males, aged from 57 to 89 years old, with an average age of 71±10 years. The twelve patients included 5 cases with probable CAA-ri and 7 cases with possible CAA-ri. The duration of the disease ranged from 30 minutes to 2 years. One patient has ApoE ε4/ε4 gene overexpressed. All the 12 patients underwent MRI, including susceptibility weighted imaging in 12 cases, DWI in 10 cases, contrast enhanced MRI (CE-MRI) in 9 cases, MRS in 3 cases, MRA in 7 cases, and perfusion-weighted imaging in 1 case.Results:Imaging features of CAA-ri included encephalopathic, tumoral, classical cerebral amyloid angiopathy(CAA) manifestations. Twelve cases of encephalopathic manifestations showed patchy white matter hyperintensity (WMH) involving U-shaped fibers on T 2 weighted fluid-attenuated inversion recovery sequence (FLAIR), usually asymmetric,with various degree of mass effect, no diffusion restriction on DWI and no enhancement on CE-MRI. One case showed a single tumoral lesion with irregular enhancement on CE-MRI. The classic CAA findings included hemorrhagic lesions (microhemorrhage in 8 cases, lobar hemorrhage in 6 cases, subarachnoid hemorrhage in 3 cases, iron deposition on the brain surface in 7 cases) and ischemic lesions (microinfarction in 1 case, enlarged perivascular space and interlobar space in 4 cases). Follow-up showed lesions absorption and/or new lesion formation in 5 cases. Conclusions:The MRI features of CAA-ri are mainly patchy WMH involving U-shaped fibers on T 2 FLAIR, usually asymmetric, with wandering and alternating features, and inconsistency with clinical manifestations.

Objective To explore the effect of chitosan on vascular smooth muscle cells inhibited proliferation from rabbit arteriovenous fistula and its mechanisms.Methods Established rabbit fistula model on carotid arteryinternal jugular vein.After 1 month cultured VSMCs with primary culture by tissue-pieces inoculation.Cultured VSMCs were divided into three groups:①normal control group.②FBS-treated group:cell were treated with 5％,10％,20％ for 48 h,respectively; established the model of rabbit VSMCs proliferation.③chitosan-treated group:VSMCs cultured with 20％ FBS were exposed to different doses of chitosan(10,100,500,1000,2000μg/ml) for 48 h.And VSMCs were treated for different time (0,12,24,48 h) with Chitosan 1000 μg/ml.Expression levels of PCNA and TLR4/ NF-κB were detected by Western blotting.RT-PCR were applied to measure the mRNA expression of PCNA and TLR4.The protein levels of TLR4 and NF-κB were detected by immunofluorescence.Results Compared with low concentration serum group,FBS-treated VSMCs exhibited a increase in mRNA and protein expression of PCNA and TLR4.FBS-induced protein expression of PCNA and TLR4/NF-κB were reduced by chitosan.Also mRNA expression of PCNA and TLR4 were reduced.They were dependent on concentration and time.In rabbit VSMCs TLR4 was mainly expressed in the cytoplasm and NF-κB expressed mainly in the nucleus.Compared with normal control group,TLR4 and NF-κB protein expression were significantly decreased by chitosan.Conclusion High concentration serum induced VSMCs proliferation.Chitosan can inhibit the proliferation of rabbit VSMCs.It is speculated that the mechanism may be related to the expression of TLR4 receptor activation,reducing expression of downstream factor MyD88 and NF-κB.It is suggest that chitosan can become potential new drugs of arteriovenous fistula prevention of intimal hyperplasia.

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

OBJECTIVETo understand the real world Shuxuetong injection suspicious allergic factors.

METHODNational 18 hospitals of the hospital information system using Shuxuetong data, using design methods retrospective nested case-control, and contrast using Shuxuetong after the occurrence of allergic reactions in patients with non-allergic patients differences in age, gender, admission illness, allergies, etc.

RESULTBased on available data, indicate suspicious allergies affect Shuxuetong factors may be hospitalized illness, solvent, single dose, concomitant medications.

CONCLUSIONWhen using Shuxuetong for critically ill patients should use caution and pay attention to solvents, dose, combination therapy of choice clinically. Conclusions of this study need further study to be verified.

Case-Control Studies ; Drugs, Chinese Herbal ; adverse effects ; Female ; Humans ; Hypersensitivity ; Injections ; Male ; Retrospective Studies