There is a new research model named 'registry study/patient registry' in Western medicine, which could be referred to by Chinese medicine researchers, such as active safety surveillance. This article will introduce registry study from different aspects as the developing history, features, and application in order to inform Chinese medicine researchers of future studies.
Marketing ; Medicine, Chinese Traditional ; adverse effects ; economics ; Phytotherapy ; adverse effects ; economics ; Registries ; Safety Management ; methods

The paper is focused on the clinical applications of Tanreqing injection after listing, detecting and analyzing the related blood indicators of patients with allergic reactions based on prospective, multi-center, large sample, registration-type clinical safety monitoring nested case-control study (NCCS) to explore the possible mechanisms of allergic reaction of Tanreqing injection, 3 006 patients cases used with Tanreqing injection were monitored, including 3 cases of adverse reactions and 2 cases of allergic reactions. Each patient of allergic reactions, according to the ratio of 1:4 matches four cases of not adverse reactions as a control group of patients, while 5 healthy and 5 cases of volunteers into the healthy group. We examined the correlation detection of cases of allergic reactions among groups such as T-IgE, IgA, IgG, C3, C4, IFN-g, IL-2, IL-4, IL-6, IL-10. Allergic reactions of Tanreqing injection may be mediated by IgE as type I based on existing research data. This results and conclusions will promote the justifiability and safety of clinical applications.
Adolescent ; Adult ; Case-Control Studies ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Hypersensitivity ; diagnosis ; metabolism ; Interleukin-10 ; metabolism ; Interleukin-2 ; metabolism ; Interleukin-4 ; metabolism ; Interleukin-6 ; metabolism ; Male ; Prospective Studies ; Young Adult

Objective: To observe the effect of moxibustion on acupoints Zusanli (ST 36) and Liangmen (ST 31) on cell proliferation and cell apoptosis of gastric mucosa in rats with stress ulcer, investigatethe mechanism of moxibustion in promoting the repair of gastric mucosal injury at cellular and molecular levels. Methods: Sixty healthy Sprague-Dawley rats were randomly divided into four groups: the restraint control group, model group, moxibustion on acupoints group and moxibustion on non-acupoints group. Water immersion and restraint stress (WRS) was used to copy the stress ulcer model of rats, radio-immunoassay was used to detect the content of transforming growth factor (TGF-α), and S-P immunohistochemical assay was adopted to determine the HSP70 expression, the proliferating cell nuclear antigen (PCNA) and cell apoptosis index in gastric mucosa. Results: For the WRS-induced gastric ulcer model of rat,the gastric mucosal injury (gastric ulcer index, UI) was increased, the content of TGF-α was decreased, PCNA was also decreased, HSP70 expression and cell apoptosis index were all increased (P＜0.01). Moxibustion on acupoints Zusanli (ST 36) and Liangrnen (ST 31) could decrease UI, increase the content of TGF-α, promote the expression of PCNA and HSP70,decrease cell apoptosis index in gastric mucosa, with significant differences when compared with the model group and control group (P＜0.01). Conclusions: Moxibustion on acupoints Zusanli (ST 36) and Liangmen (ST 31) had protective effect on the gastric mucosa of stress ulcer, its mechanism may be promoting the TGF-α synthesis, stimulating cell proliferation in gastric mucosa and inhibiting cell apoptosis in gastric mucosa, and this process is related to the moxibustion-induced HSP70 expression.

Objective To explore the efficacy of craniotomy and aneurysm clipping in elderly patients with ruptured intracranial aneurysms.Methods Totally 75 elderly patients with ruptured intracranial aneurysms in our hospital who underwent craniotomy and intracranial aneurysm clipping:approaching into head by wing point based on CT image,selecting the appropriate position and angle for clipping the aneurysm.Surgical efficacy and postoperative complications were observed.Prognosis was assessed by Glasgow Outcome Scale (GOS).Results 77 aneurysms presented in 75 patients and 76 aneurysms were clipped.The main postoperative complications were intracranial hematoma (5 cases),pulmonary infection (4 cases),electrolyte imbalance (10 cases),intracranial infection (2 cases),arrhythmia (3 cases),gastrointestinal bleeding (5 cases),cerebral infarction (3 cases).GOS assessment demonstrated that prognosis in 48 cases was good (64.0％),16 cases was moderate disability (21.3％),6 cases was severe disability (8.0％),2 cases was vegetative survival (2.7％),3cases was in death (4.0％).The cure rate was 64.0％ and the overall good-prognosis rate was 85.3％.Conclusions Craniotomy and aneurysm clipping has a better surgical efficacy and a high cure rate in elderly patients with ruptured intracranial aneurysm.

Objective To investigate whether functional Wnt-?-catenin signaling is present in activated hepatic stellate cells (HSC),and the effect of blocking this signaling on activation of HSC. Methods?-catenin expression in HSC was examined by immunocytochemistry.Wnt signalings in HSC-T6 were assessed using a T cell factor (TCF)-dependent luciferase reporter gene (pTOP- FLASH) assay.Wnt signalings in HSC-T6 were blocked by transfecting with a dominant negative TCF (dnTCF) expression plasmid,then the expression of alpha smooth muscle actin (?-SMA) and collagen typeⅠwere examined by Western blot.Results?-catenin staining was positive in the nuclei of HSC-T6.Luciferase activity in the cells transfected with pTOPFLASH was significantly higher than that in the cells transfected with pFOPFLASH (P

Tanreqing injection is suitable for early pneumonia, acute bronchitis, acute exacerbations of chronic, and upper respiratory tract infection which are classified with phlegm-heat obstructing lung syndrome of traditional Chinese medicine. To understand the clinical adaptation syndromes and medication characteristics of the post-market Tanreqing injection, the research team of the paper monitored the patients who are used with Tanreqing injection from September 2012 to October 2013 in four leader hospitals based on the method--prospective, multi-center, large sample, registration-type hospital centralized monitoring,and analyzes the general information, diagnostic information and medication characteristics of patients, in order to produce evidence for clinical practice and medication decisions and to establish the foundation of rational drug use.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Child ; Child, Preschool ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; therapeutic use ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Prospective Studies ; Respiratory Tract Infections ; Young Adult

This study aims to assess if adverse drug reactions (ADRs) to parenterally administered salvianolate are allergic in origin. Hospital information system (HIS) data from 20 hospitals in China were used to carry out a retrospective nested case control design study. Included were patients who received dexamethasone for suspected allergic reactions after receiving parenterally administered salvianolate. These were compared with non-allergic reaction people. Single factor logistic regression and multiple factor logistic regression were used to analyze data. Condition on admission, allergic history, dosage, disease status and drug combinations were taken into account in cases of suspected allergic reactions. After analysis in two subgroups we found that the condition on admission had a significant effect, P values was < 0.000 1 on suspected cases of allergic reactions in the first subgroup analysis. For the second subgroup analysis, we found condition on solvents had a significant effects, P values was 0.005 1 on suspected cases of allergic reactions. We also found that using other four injections at the same time as parenterally administered salvianolate could be risky factors in suspected cases of allergic reactions. For the second subgroup analysis combining using three injections could increase risks. However, further research for verification is required. This study can provide guidance for safe clinical practice in using parenterally administered salvianolate.
Adult ; Aged ; Aged, 80 and over ; Case-Control Studies ; Drug-Related Side Effects and Adverse Reactions ; diagnosis ; Female ; Hospital Information Systems ; Humans ; Male ; Middle Aged ; Plant Extracts ; adverse effects ; therapeutic use ; Retrospective Studies

Objective:To observe the effects of moxibustion pretreatment on Glutathione Peroxidase(GSH-Px),Superoxide Dismutase(SOD),and Malondialchehyche(MDA)in gastric mucosa of rats with stress ulcer,and to investigate the mechanism of moxibustion pretreatment preventing the oxidized injury of gastric mucosa.Methods:Forty-eight healthy SD rats were randomly allocated into 4 groups,namely control group,model group,acupoint moxibustion group,and non-acupoint moxibustion group.The ulcer model was developed by restraint and water immersion stress,Ulcer index(UI)was calculated with Guth method,and the contents of GSH-Px,and MDA and SOD activity in the gastric tissues were measured with chromatometry method.Results:Compared those in the model group and nonacupoint moxibustion group,moxibustion at Zusanli(ST 36)could decrease the UI(P<0.01)and MDA(P<0.05)contents,and increase the activity of GSH-Px(P<0.01)and SOD(P<0.05).Conclusion:Pretreatment of moxibustion at Zusanli(ST 36)could promote the recovery of gastric injury in rats induced by restraint and water immersion stress by enhancing the activity of GSH-Px and SOD,and lower MDA content.

There are few articles or reports collecting evidence about parenterally administered salvianolate from premarketing and postmarketing research or studies systematically. This article is an exact miniature of a systematical report about parenterally administered salvianolate. We analyzed information from four aspects, such as quality control reports, non-clinical premarketing safety experiments, postmarketing research (efficacy studies, hospital information system data and national spontaneous reporting system data) and literature analysis. All the four aspects build an evidence body for Kudiezi Solution in order to inform its safety use in clinical practice and further study.
Hospital Information Systems ; Humans ; Plant Extracts ; administration & dosage ; adverse effects

Objective To study the clinical features and follow-up of newborns with severe hypoxic-ischemic encephalopathy ( HIE) , and to provide the basis for rational diagnosis, treatment and follow-up.Methods Clinical data of cases of HIE from the Neonatal Department of our Hospital from January 2011 to October 2014 were studied retrospectively. The data of general information, laboratory examination, treatment, outcome, follow-up and prognosis of the patients were collected. Multivariate logistic regression analysis was used to study the influential factors of the prognosis of HIE.Results A total of 123 infants with sever HIE were enrolled in our study. In addition to general therapy, 6 cases were treated with mild hypothermia, and 21 cases were treated with high pressure oxygen. 60 cases improved our treatment, 55 cases had withdrawal treatment with parental consent, and 8 cases died. Single factor analysis showed that 5 minutes Apgar score, convulsions, coma, pH, BE, organ injury, and mild hypothermia treatment were the risk factors that affect the prognosis of severe HIE. Multiple factors analysis showed that 5 min Apgar score <3 points ( OR=4. 071 ,95℅CI 1. 309-15. 613 ) and BE≤-10 mmol/L ( OR=36. 810, 95℅CI 5. 913-41. 119) were independent risk factors of prognosis of severe HIE ( P<0. 05). Hospitalization within the first 72 hours of life ( OR=0. 096, 95℅CI 0. 096-0. 353) was a protective factor of severe HIE. Multiorgan injury ( mainly the injury of brain, lung and heart) and electrolyte imbalance ( mainly hypocalcemia and hyponatremia ) were common complications of serve HIE. In the follow-up of these patients, 33 cases were loss in follow up, and 49 cases died (8 cases died during hospitalization, 41 cases died after withdrawal of treatment). The top five causes of death were abandonment of treatment due to financial reasons and the fear of adverse outcome (n=20), multiple organ dysfunction ( n =16 ) , and pneumothorax ( n =4 ) , diffuse intravascular coagulation (n=6), and shock (n=3). 41 cases survived were followed up for 9~54 months. The critical clinical conditions observed among these infants included cerebral palsy ( n = 5 ) , epilepsy ( n = 3 ) and developmental retardation(n=26).Conclusions There are many complications of severe HIE.The mortality of severe HIE is high, and the incidence of poor outcome of survivors is also high. Timely detection of risk factors is the key to the prevention of severe HIE. Long-term prognosis of severe HIE requires proper organization of neonatal follow up.