Objective To investigate the significance of serum krebs Yon den lungen-6(KL-6), surfactant protein A(SP-A), surfactant protein D(SP-D )and matrix metalloprotease 7(MMP-7) in the diagnosis of idiopathic pul-monary fibrosis (IPF) and its relationship with pulmonary function .Methods Serum levels of KL-6, SP-D, SP-A and MMP-7 were detected by ELISA in 38 patients with IPF and serum from 38 patients with pneumonia and 38 normal controls.Serum levels of markers were further analyzed by operating characteristic curve receiver (ROC), from which the ideal level of each serum marker was obtained , and the follow-up of 6 months in patients with IPF . Explore the significance of the diagnosis of IPF and its correlation with pulmonary function .Results The expres-sion of MMP-7, SP-A, SP-D and KL-6 in serum of IPF patients was higher than that in the control group and healthy control group ( P<0.05) .The optimal cutoff value of KL-6 was 723.0 U/ml, SP-A was 67.2 ng/ml, SP-D was 98.1 ng/ml, and MMP-7 was 10.1 ng/ml.The sensitivity of KL-6 was 71.1% and 98.7%, SP-A was 81.6%and 97.4%, SP-D was 81.6%and 97.4%, MMP-7 was 68.4%and 98.7%.The sensitivity of combined KL-6, SP-A, SP-D and MMP-7 four serum markers was 100%, compared with a single serum index , the P value was less than 0.05, with statistical significance .IPF patients serum SP-A, MMP-7 and forced vital capacity within 6 months were significantly correlated(r1 =-0.574,P1 <0.001;r2 =-0.465,P2 =0.003).Conclusion KL-6, SP-A, SP-D and MMP-7 were highly expressed in serum of patients with IPF , and in the diagnosis of IPF , com-bined detection of 4 serum markers can improve the early diagnosis of IPF patients .Combined serum SP-A and MMP-7 levels can improve the accuracy of the IPF patients with pulmonary function changes , the prediction of dis-ease progression has a certain significance .

Animals ; Cells, Cultured ; Female ; Granulosa Cells ; metabolism ; Pituitary Adenylate Cyclase-Activating Polypeptide ; genetics ; metabolism ; Platelet Activating Factor ; pharmacology ; RNA, Messenger ; genetics ; Rats ; Rats, Sprague-Dawley

ICH GCP requires that all information of clinical trial should be recorded, processed, and stored in a way that allows the accurate reporting, interpretation and verification. A trial master file (TMF) contains all paper or electronic records/documentations related to a clinical trial. As a tool of the retrospective analysis, the TMF profile should be able to reproduce the full procedure of the trial completely. As a part of TMF profiles, both the accuracy and completeness of clinical data management documentation are important in data integrity. It is helpful to learn the workflow of clinical data management in different stage of a clinical trial, to understand which documents are essential, and why the documentation of clinical data management is important for data integrity. This paper elaborates how to perform the good documentation practice of clinical data management, and suggests that both the precise and efficient document management and regular quality control may ensure the high quality of clinical data documentation management on the basis of an intensive awareness of the overall process of clinical data management.
Clinical Trials as Topic ; Data Curation ; standards ; Information Storage and Retrieval ; methods ; standards

Chromatography, Gas ; methods ; Dimethoate ; blood ; Humans ; Insecticides ; blood ; Methyl Parathion ; blood

Objective To construct the luciferase reporter gene vector of cell division cycle 2 (Cdc2) gene promoter and determine its transcriptional activity. Methods Primers were designed based on human Cdc2 promoter sequence from UCSC software. Then Cdc2 promoter from human genome DNA was replicated. After pGL3-Basic vector and Cdc2 promoter were digested with restriction enzymes SacⅠand XhoⅠseparately, Cdc2 promoter was inserted into pGL3-Basic vector. The recombinant plasmid named pGL3-Cdc2-promoter was transiently co-transfected into U2OS cells with control vector pRL-SV40, and then the activity of dual luciferase was detected. Results pGL3-Cdc2-promoter was constructed successfully. The restriction analysis and sequencing proved the entirely correct sequencing results. The luciferase activity was higher in pGL3-Cdc2-promoter/pRL-SV40 group than that of pGL3-Basic/pRL-SV40 group (1.591 5±0.199 8 vs 0.049 9±0.010 4). Conclusion pGL3-Cdc2-promoter can be transcribed and activated in U2OS cells. This study provided an important basis for screening and evaluation of anticancer drugs.

Objective To evaluate the value of MRI in diagnosing the premature closure and other deformities of the growth plate followed physeal injury. Methods Twenty-one children with suspected or known premature closure of the growth plate followed injury were examined with X-ray and MRI. In addition to conventional T 1WI and T 2WI for all cases, 8 were also examined with spectral pre-saturation inversion recovery sequence. The value of MRI in diagnosing and imaging the premature closure of the growth plate (PCGP) was analyzed. Results PCGP was seen in all 21 cases, 6 in the distal femur, 6 in the proximal tibia, and 9 in the distal tibia. 19 patients with angular deformities and 2 cases with both angular and shorten deformities. MRI can much more clearly visualize the cartilage of the growth plate than conventional X-ray. A stripe of low signal intensity through the cartilage of the growth plate indicated premature closure of the growth plate. 8 cases with spectral pre-saturation inversion recovery sequence can visualize the PCGP more clearly than with Spin Echo and Fast Field Echo. Conclusion MRI has an important role in diagnosing and visualizing the PCGP. The configuraton of the PCGP can be accurately mapped with MR imaging and treatment planning is facilitated.

Objective To study the clinical features of follicular occlusion triad, and whether it is a hereditary disease. Methods Based on the clinical examination of a case who developed squamous cell carcinoma secondary to follicular occlusion triad, the pedigree of the patient was surveyed and analyzed. Results There were a total of thirteen patients in this pedigree, the age of onset was about 20 years old. The clinical features and laboratory examination of the proband was consistent with follicular occlusion triad. Conclusions Hereditary factor is important in the pathogenesis in follicular occlusion triad,and the disease maybe an autosomal dominant inherited disease.

Objective To study the meaning of breast cancer staging system by AJCC eighth edition to invasive lobular carcinoma and analysis the clinical pathological characteristics.Methods According to the eighth edition of the AJCC staging to evaluate the TNM stage and prognosis evaluation of invasive lobular carcinoma cancer patient in Peking University Shenzhen Hospital from 2011 to 2016,and compared with others in clinical pathological data.Results There were 21 cases of invasive lobular carcinoma,accounting for 2.7％ of all invasive breast cancer.We found that invasive lobular carcinoma shows no significant difference (P ＞ 0.05) in ages,menstrual status,molecular features and anatomic staging and prognosis staging with others;histological grade were significantly different (P ＜ 0.05).There were significant differences in the prognosis and staging of invasive lobular carcinoma.Conclusions Eighth AJCC staging systemn provides a new reference for the clinical treatment of breast cancer,should be evaluated with anatomic stage.Histological grade is relatively good in invasive lobular carcinoma and the prognosis is good,needs more research to the individualized treatment of invasive lobular carcinoma.

ObjectiveTo explore the influence factors of prognosis of spinal cord injury patients. MethodsFollow-up data of 121 cases with spinal cord injury was analysed with retrospective cohort study.ResultsThe highest recover rate was in the patients who accepted the special rehabilitation therapy,while that of recovering two class was in the patients who accepted the magnetic stimulation.Conclusions Special recovering cure and magnetic stimulation can surely promote recovery of spinal cord injury patients.