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

Background The reduced glutathione(GSH) is a water soluble antioxidant in retina and it is an important component of thiol.Diabetes induce the oxidative response of retina.It is very important to detect the content of thiol in retina for the evaluation of its antioxidant role.Objective This study was to investigate the effect of carnosine,aspirin and a combination of carnosine and aspirin eye drops on the change of the thiol contents in the retina of the diabetic rats. Methods Diabetic models were induced in 76 clean male Sprague-Dawley(SD) rats by intraperitoneal injection of streptozotocin(65 mg/kg).The 0.02 mi sodium citrate buffer was injected in 12 control rats.1%camosine eye drops or 0.05%aspirin eye drops were topically administered respectively in carnosine group (19 rats)or aspirin group(19 rats)two times per day for a period of 8 weeks,and the combination of 1%carnosine eye drops and 0.05%aspirin eye drops was used in the combination group at the same way(19 rats).At the end of 8 weeks.The animMs were sacrificed and the eyeballs were enucleated for the detect of thiols in the retina by colorimetry.Results The body weight of SD rats was significantly reduced and the blood glucose level was evidently arose in model group,camosine group and aspirin group in comparison with control group(P＜0.05),but those of combination group compared with control group was insignificantly changed(P＞0.05).The level of thiol in retina was(1 90.35+46.62)ms/gprot in model group,showing a considerable decrease in comparison with control (202.77+53.49 ms/gprot)(P＜0.05).However,the thiol level rose to(378.40±165.06)mg/gprot in camosine group and(351.88±211.62)mg/gprot in aspirin group,showing a statistically significant difference in comparison with control group(P＜0.05).The content of thiol in combination group compared with control group Was insignificant changed(166.972±50.287 mg/gprot us 202.77±53.49 mg/gprot).Curiously the levels in the combination group were not different from the normal control group. Conclusion The carnosine and aspirin eye drops may protect the retina against the oxidative damage caused by diabetes.

Objective To study the expression of BMI-l gene in children with acute leukemia and its clinical significance.Methods The clinical specimens of 46 children with acute leukemia who were diagnosed lately in the Third Affiliated Hospital of Zhengzhou University and other hospitals in Zhengzhou from Jul.1,2008 to Apr.30,2009 were collected,while peripheral blood specimens of 30 healthy children were collected as control group.With the guardians′ informed consent,the experiment was approved through the hospital ethics committee.The level of BMI-1 mRNA′s expression was tested using reverse transcription-polymerase chain reaction(RT-PCR),while data were analyzed through the application of SPSS 12.0 statistical software.Results 1.The level of BMI-l gene′s expression in children with acute leukemia was significantly higher than that in control group(P0.05),after complete remission,BMI-1 mRNA was not detected in the 2 groups;4.Compared with the complete remission group,expression of BMI-1 mRNA in the untreated group and the recurrence group was significantly higher(P0.05).Conclusions BMI-1 gene was highly expressed in children with acute leukemia,and the level of the gene expression in patients of complete remission normalized,which suggests that the gene may be involved in the occurrence and the development process of leukemia;therefore,it is possible to regard the gene as a molecular marker to evaluate the development,relapse and prognosis of the patients with acute leukemia.

AIM: To compare the clinical results of suture method and partial eyelash resection treating for pediatric eyelid trichiasis, and screen an effective method for the treatment of pediatric lower eyelid trichiasis.
METHODS: Fifty-six cases of pediatric patients with lower eyelid trichiasis were randomly divided into a control group and an observation group in accordance with the method of drawing lots, and each group was 28 cases. The control group was treated with suture method, and the observation group was treated with partial eyelash resection. The clinical efficacy, patient satisfaction before and after treatment, and the incidence of complications were compared.
RESULTS:(1) The clinically total effective rate was 74%of the control group, which was 89% of the observation group, and there were statistical differences of the clinical efficacy between the two groups ( P<0. 05 ); ( 2 ) the satisfaction scores were (3. 89±1. 22) points and (6. 27±1-86) points of the the control group before and after treatment, which were ( 4. 00±1. 34 ) points and ( 8-95±2-34) points of the observation group, and there were statistical differences of the two groups before and after treatment (P<0. 05), and the scores of the observation group were higher than that of the control group ( P<0-05);(3) complications such as swelling and stitches off appeared in both groups, and the rate was 21% in the control group, which was 11% in the observation group, and there were statistical differences between the two groups (P<0. 05).
CONCLUSION: The treatment of children with lower eyelid trichiasis, suture method is simple and can be performed under local anesthesia in collaboration with children, but with a higher relapse rate, some patients required reoperation;partial resection of eyelashes can be more thoroughly solve the problem of pediatric eyelid trichiasis with low recurrence rate, but children need to be under general anesthesia with some of big risk. So partial resection of eyelashes is unsuitable for using in clinical practice widely and can be used in special cases.

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 observe the therapeutic effect of herbal decoction Kugan Yin for cystic hyperplasia of breast.Methods The 131 cases of cystic hyperplasia of breast in phlegm combining qi stagnation syndrome were randomized into treatment group(68 cases)which was treated by Kugan Yin and control group(63 cases)which was treated by Rupixiao Tablets(Tablets for dissolving breast nodules).The changes of symptoms and signs,level of serum sexual hormone and molybdenum target mammography analysis of two groups were observed for comparison.Results The total effective rate of treatment group was obviously better than that of con- trol group(P

Objective To study the changes of serum protein spectrum in patients with systematic lupus erythematosus (SLE) in order to screen specific protein markers. Methods Serum samples from 72 patients with SLE and 85 age- and sex-matched controls were assessed using surface-enhanced laser desorp-tion/ionization time-of-flight mass spectrometry (SELDI-TOF-MS) with weak cation exchange (CM10) pro-rein chip. Forty samples from the patients and 50 control samples were randomly selected to serve as a pre-liminary training set; significantly different protein peaks were automatically chosen for the system training and development of a decision classification tree model. The validity of the model was then challenged with a blind test set (including another 32 samples from patients and 35 from human controls). Results A total of 73 effective protein peaks were detected within the mass/charge ratio (m/z) interval 2000 - 50000, among which, 15 protein peaks significantly differed between patients with SLE and controls (P < 0.01). Three pro-tein peaks with an m/z value of 4001, 6305 and 7356 were automatically chosen as a biomarker pattern in the training set that discriminated patients with SLE from controls with a sensitivity of 90.0% (36/40), speci-ficity of 92.0% (46/50) and accuracy rate of 91.1% (82/90). When the SELDI marker pattern was tested with the blinded test set, it yielded a sensitivity of 87.5% (28/32), specificity of 91.4% (32/35) and accuracy rate of 89.6% (60/67). Conclusions SELDI-TOF-MS protein chip could be used to screen serum protein for SLE, and the decision classification tree model with these biomarkers may favor the diagnosis of SLE.

Animals ; Antineoplastic Agents ; therapeutic use ; Bone Density Conservation Agents ; therapeutic use ; Bone Neoplasms ; drug therapy ; secondary ; Breast Neoplasms ; drug therapy ; pathology ; Chemotherapy, Adjuvant ; Diphosphonates ; therapeutic use ; Female ; Humans ; Imidazoles ; therapeutic use ; Neoadjuvant Therapy ; Osteoporosis ; prevention & control

Adult ; Anti-Inflammatory Agents ; therapeutic use ; Churg-Strauss Syndrome ; drug therapy ; pathology ; Follow-Up Studies ; Humans ; Male ; Methylprednisolone ; therapeutic use