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

Objective To understand the demands of African students on the China?Africa malaria prevention training pro?grams as well as explore further suggestions on the student selection and course content design. Methods A self?administered questionnaire survey was conducted,and all the students who attended in the malaria prevention training courses in 2014 and 2015 were included. The Chi?square test was conducted to analyse the correlations between professional backgrounds ,work stat?ues and training needs. Results A total of 161 individuals were sampled eventually. These participants were trained in either English(58.4%)or French(41.6%). Most of the participants were male(69.3%),the major of them were mainly clinical tech?nology specialty(40.0%),and most of them worked in malaria area within 10 years(56.4%). Moreover,48.2%of the partici?pants used more than 76%of total work time on malaria control,and more than 80%worked in national or provincial/municipal level. The working areas of these participants were focused on clinical field(41.4%)and official field(29.9%),and only a few of them were from research positions(11.9%). The most needed course content in malaria training was strategy and epidemiolo?gy knowledge for malaria prevention and control(65.5%),while clinical workers were most needed to be trained(39.2%). The participants who came from French speaking countries preferred strategy training(χ2=12.528,P<0.01),and those worked in the national level were aslo more likely to choose strategies training course(χ2=10.508,P<0.05). Conclusions Currently, the China?Africa malaria prevention training programs could basically satisfy African students’needs. However,more aimed courses should be designed according to their professional backgrounds,national situation,work experiences on malaria con?trol,and institutional levels.

OBJECTIVETo assess the effectiveness and safety on post-stroke dysphagia in chronic stage treated with magnetic-ball sticking therapy at the auricular points.

METHODSNinety cases of post-apoplexy dysphagia in chronic stage were randomized into an auricular points group and an acupuncture group. In the auricular points group, the magnetic-ball sticking therapy was applied to subcortex (pizhixia, AT4), brainstem (naogan, AT(3,4i)), mouth (kou, CO1), cheek (mianjia, LO(5,6i)), tongue (she, LO2) and throat (yanhou, TG3) on one ear each time, and were changed on the other ear once every 3 days. In the acupucnture group, acupuncture was applied to Feng-chi (GB 20), Yifeng (TE 17), Shanglianquan (Extra), Jinjin (EX-HN 12), Yuye (EX-HN 13), Shuigou (GV 26) and Tongli (TH 5), etc. The needles were retained for 30 min in each treatment. The treatment was gi-yen once a day in the two groups and the treatment of 6 days made one session. There was 1 day at an interval among the sessions. Totally, 3 sessions of treatment were required. The video fluoroscopic swallowing study (VFSS) was performed for 4 kinds of food with different properties and shapes in each patient. The main indices were Rosenbek penetration-aspiration score, oral-retaining score and throat-retaining score. The efficacy, and the incidences of aspiration pneumonia and malnutrition were compared between the two groups. The nutrition indices were compared before and after treatment between the two groups, such as the skinfold thickness of triceps brachii muscle, serum albumin and peralbumin.

RESULTSIn 21 days of treatment, in the auricular points group, the 1 mL liquid loversol Rosenbek penetration-aspiration score (1.51 +/- 0.69), oral-retaining score (1.17 +/- 0.38) and throat-retaining score (1.30 +/- 0.66) were all lower than those (2.51 +/- 0.67, 1.63 +/- 0.72, 1.67 +/- 0.7) in the acupuncture group separately. The 10 mL liquid loversol Rosenbek penetration-aspiration score (2.27 +/- 0.65), oral-retaining score (1.60 +/- 0.50) and throat-retaining score (1.49 +/- 0.51) were all lower than those (4.19 +/- 0.73, 2.30 +/- 0.51, 2.41 +/- 0.50) in the acupuncture group separately. The 10 mL paste loversol Rosenbek penetration-aspiration score (1.68 +/- 0.81), oral-retaining score (1.11 +/- 0.31) and throat-retaining score (1.10 +/- 0.31) were all lower than those (3.91 +/- 0.68, 1.63 +/- 0.76, 1.60 +/- 0.76) in the acupuncture group separately. The 1/4 cake-form loversol Rosenbek penetration-aspiration score (2.60 +/- 0.65), oral-retaining score (1.40 +/- 0.50) and throat-retaining score (1.74 +/- 0.49) were all lower than those (4.14 +/- 1.10, 2.40 +/- 0.73, 2.30 +/- 0.83) in the acupuncture group separately. The incidence of aspiration pneumonia was 14.9% (7/47) in the auricular points group, which was lower than 55.0% (22/40) in the acupuncture group (P < 0.01). The incidence of malnutrition was 8. 5% (4/47) in the auricular points group, which was lower than 50.0% (20/40) in the acupuncture group (P < 0.01). In 21 days of treatment, the results of the skinfold thickness of triceps brachii muscle and serum albumin in the auricular points group were better than those in the acupuncture group (both P < 0.05).

CONCLUSIONThe magnetic-ball sticking therapy at auricular points achieves the definite efficacy on post-stoke dysphagia in chronic stage and decreases the incidences of aspiration pneumonia and malnutrition. The efficacy of this therapy is better than acupuncture.

Acupuncture, Ear ; instrumentation ; Aged ; Deglutition Disorders ; etiology ; therapy ; Female ; Humans ; Magnetics ; instrumentation ; Male ; Middle Aged ; Stroke ; complications ; Treatment Outcome

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

BACKGROUND: There are currently many cryopreservation methods for the aminotic membrane, which have varying effects on the ultrastructure and biological activity of amniotic membrane, but on no one is effective.
OBJECTIVE: To compare the effects of different cryopreservation methods on the ultrastructure and viability of aminotic membrane and to seek the ideal cryopreservation method.
METHODS: Aminotic membrane separated from the fresh placenta was preserved respectively with deep-frozen cryopreservation and vitrification, and everyway was run for 3 and 6 months. Fresh aminotic membrane was used as control. The ultrastructure of aminotic membrane was observed by transmission electron microscopy, and the viability of aminotic membrane was assessed by microcomputer analysis system for biological oxygen consumption, and immunohistochemical staining combined with image analysis system was used for lactate dehydrogenase activity.
RESULTS AND CONCLUSION:After 3 and 6 months of crypreservation, the damage to the ultrastructure of aminotic membrane by vitreous cryopreservation was slighter than that of amniotic membrane cryopreserved at-80℃. Compared with the fresh aminotic membrane, the gray value of lactate dehydrogenase and partial pressure of oxygen were significantly decreased in the cryopreserved aminotic membrane by deep-frozen cryopreservation at 3 and 6 months (P < 0.05) and by vitreous cryopreservation at 6 months (P < 0.05), but there was no statisticaly significant difference in the change rate of oxygen partial pressure and the gray value of lactate dehydrogenase between the fresh aminotic membrane and the cryopreserved aminotic membrane by vitreous cryopreservation at 3 months. The present study led to the conclusion that vitreous cryopreservation protocol alows to not only maintain the integrity of AM, but also to preserve the viability of the cels. So the vitreous cryopreservation is superior to the deep-frozen cryopreservation for cryopreservation of aminotic membrane.

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.

Pectin, a polysaccharide extracted from the cell wall of plants, was used as the drug carrier to synthesize the pectin-adriamycin conjugates (P(A)n). The structure of the conjugates was confirmed by UV and IR. The degree of esterification (DE) of the pectin was assessed, and it was found that DE significantly influenced the carboxy group contents, inherent viscosity and galacturonic acid contents of the pectin. The results of drug release test in vitro showed that the conjugate was stable in normal saline, but was gradually enzymolyzed to release the adriamycin in blood plasma and in lymph nodes. The results of lymphatic targeting study of P(A), demonstrated that the modification of DE or drug coupling capacity of pectin significantly influenced the lymphatic targeting characteristics of P (A)n. The adriamycin concentration of lymph nodes was 208 times higher than that of plasma after local injection of the P(A)n, of which the adriamycin content was 27.9% and the pectin was deesterificated 120 minutes by the use of hypothermy alkaline deesterification method.
Animals ; Antibiotics, Antineoplastic ; administration & dosage ; pharmacokinetics ; Doxorubicin ; administration & dosage ; pharmacokinetics ; Drug Carriers ; chemistry ; Esterification ; Lymph Nodes ; metabolism ; Pectins ; administration & dosage ; pharmacokinetics ; Rabbits