The time-to-event index is a kind of common evaluation index. It measures the speed of intervention effect. It is different from other index in research design, source material filling, data checking and statistical analysis. To obtain the time-to-event index, investigators can fill in the table directly and statistical analyst can compute after clinical observation. When filling in the source material or data checking, it is should be noticed that the logical relation between the time-to-event index and the visiting point and between the time-to-event index and the correlative other indicator. When statistical analyzing, it is an important issue how to deal with the cases whose time-to-event index does not appear till the observation period ends. Understanding the difference clearly can make the time-to-event index evaluate the effect of the intervention truly and make the clinical observation results reliable.
Clinical Trials as Topic ; Female ; Humans ; Male ; Observational Studies as Topic ; Research ; Research Design

Acupuncture Therapy ; instrumentation ; methods ; standards ; China ; Humans ; Moxibustion ; instrumentation ; methods ; standards ; Needles ; standards ; Reference Standards

Firstly, the essay introduces the definition of bio-burden, the significance of determination of bio-burden and the specific performance requirements. Then, the essay introduces the method selection and validation on the bio-burden determination of surgical drapes, gowns and clean air suits.
Equipment Contamination ; Surgical Attire ; microbiology ; standards ; Surgical Drapes ; microbiology ; standards

Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.
China ; Clinical Trials as Topic ; standards ; Drug Evaluation ; Drug Therapy ; standards ; trends ; Drugs, Chinese Herbal ; standards ; therapeutic use ; Humans ; Quality Control ; Research

Objective To investigate the development and metastasis of malignant choroidal melanoma cell strain OCM-1-gfp modified with green fluorescent protein(GFP) and the factors which affected the tumor biological behaviors. Methods GFP was transfected into malignant melanoma cell strain OCM-1.Melanoma cells with high and stable expression of GFP were injected into subretinal space and the subcutaneous space of hind leg of Balb/c nude mouse respectively in order to establish orthotopic and heterotopic transplanted tumor models.The development and metastasis process of orthotopic tumor models was observed directly by fluorescence microscope,and the size of the hypodermal tumor was measured by vernier.The expressions of 13 genes in melanoma were detected by means of immunohistochemistry staining. Results Malignant choroidal melanoma cell strain OCM-1 stably expressed GFP and preserved the characteristics of parental generation,OCM-1-gfp may develop melanoma and continue to metastasize in nude mouse.Positive expression of most of the antibodies,including Rb,p53,p21,E_2F,NF?B,cyclin D1,proliferation cellular nuclear antigen(PCNA),bcl-2、bcl-XL/S,bax,and epithelial growth factor(EGF)and its receptor(EGFR),was found.While the staining of inhibition gene p16 was negative. Conclusions GFP is the marker for observing the development and metastasis of malignant choroidal melanoma in vivo.The rate of tumor formation and development process in orthotopic models does not differs much from which in heterotopic models of malignant choroidal melanoma.The expressions of lots of genes in malignant choroidal melanoma developed from OCM-1-gfp including p16、p53、NF?B,cyclin D,PCNA,EGF,and EGFR are abnormal.

Objective The aim of this study was to establish a new method for genotyping ATP7B Arg778Leu gene mutation that does not require RFLP PCR or sequencing.Method 4-primer amplification refractory mutation system (ARMS)-PCR was performed to screen the Arg778Leu mutation in 47 unrelated Wilson's disease (WD) patients and 30 unrelated healthy controls.Direct sequencing was used to confirm the specific amplification products.Results PCR products were visualized on agarose gel electrophoresis.Among the 47 WD patients,4 were homozygous and 14 were heterozygous for this mutation.The total mutation rate was 38.3% (18/47).The results of direct sequencing completely consisted with the results of 4-primer ARMS-PCR.Conclusions The ATP7B Arg778Leu gene mutation is a hot spot for the research of Chinese WD patients.4-primer ARMS-PCR is a fast convenient and accurate method for typing mutation in high throughput population screening.This approach can be used to detect other point mutations.

Objective To evaluate the effectiveness and safety of total pelvic floor reconstruction treating female pelvic organ prolapse with prolift system .Methods The effectiveness and complications 24 cases genital pro-lapse according to POP Q stages who underwent total pelvic floor reconstruction surgery with prolift system were retro -spectively reviewed.Results The mean operative time was (97.5 ±23.3) min.The average blood loss (68.5 ± 28.1)mL.The mean postoperative hospital′s day was (8.9 ±2.3)days.The symptoms of all patients with peivic floor prolapse disappeared .2 cases sufferd pain and mesh erosion ,1 case had buttock abscess during follow-up.All recov-ered after treatment .Conclusion The short-term curative of total pelvic floor reconstruction surgery with prolift sys-tem is good.These cases have some postoperative complication .Such operation mode should be selected comprehen-sively.

Objective To investigate the CT characteristics of primary pulmonary sarcoma (PPS).Methods The CT findings,clinical and pathologic data of 5 patients with PPS were analyzed retrospectively and summarized by reviewing the relevant literatures.Results Mass were bigger, the largest diameter was about 9.8 cm, with an average of 6.3 cm.The tumors displayed staghorn shape in 1 case,quasi-circular mass in 1 case and irregular agglomerate in 3 cases.Spicule sign was not found in all cases.No hilar lymph nodes swelling were seen and mediastinal lymph nodes swelling were seen in 2 cases.Calcification was not found in all cases.1 case with ipsilateral pulmonary artery aneurysms caused by pulmonary artery infringed.1 case with pulmonary embolism under the same side.The lesions of all cases were mild enhancement.2 cases were accompanied by ipsilateral hydrothorax.Bone destruction was not found in all cases.Conclusion CT features of PPS are of certain relative specificity.A definite diagnosis is depended on pathology.

Objective To investiGate the value of procalcitonin( PCT ),C reactive protein( CRP ), white blood cell( WBC)and platelet in the diaGnosis of neonatal infection. Methods The clinical data of 57 cases with neonatal infection in the First Hospital of Hefei were retrospectively analyzed. Select 65 healthy neonates in the same period as control Group. Compared two Groups of serum PCT,CRP,WBC and platelet levels, and diaGnosed of sensitivity,specificity of neonatal infection. Results There were statistical siGnificant differences between infection Group and control Group interms of CRP,WBC and PCT in newborn health neonates ( P<0. 05),but except the platelet( P>0. 05). The sensitivity and specificity of PCT were 54. 4% and 92. 3%, of CRP were 43. 9% and 84. 6%,of WBC was 29. 8% and 90. 8%,and of PLT were 38. 6% and 69. 2%. Conclusion PCT,CRP,WBC are of diaGnostic siGnificance for early diaGnosis of neonatal infection,and PCT has hiGh sensitivity and specificity of diaGnosis of neonatal infectious diseases.

With the advancement of society and development of medicine,how to improve the humanistic quality of medical graduate students becomes an important subject for medical graduate student education.Graduate school of Capital Medical University takes a series of effective measure to improve humanistic quality of medical graduate student in these years,and try hard to make students become persons with humanistic ability in the graduate education.