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

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

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

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 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.

OBJECTIVETo investigate the effect of Xiaoyao Powder (XP) and its compatible prescriptions on the ethology, morphology, and activities of neurotransmitters, thus exploring their effects and mechanism in preventing and treating D-galactose induced Alzheimer's disease (AD) model mice, and clarifying the compatibility mechanism for soothing Gan, nourishing blood, and invigorating Pi.

METHODSSixty SPF mice were randomly divided into the blank control group, the model group, and the XP group, Shugan Jianpi group (SJ), Shugan Yangxue group (SY), and Jianpi Yangxue group (JY), 10 in each group.The AD mouse model was prepared by peritoneal injecting D-galactose. Meanwhile, mice in the blank control group and the model group were administered with physiological saline (at the daily dose of 24 mL/kg) by gastrogavage. Mice in the XP group (2.485 g/kg), the SY group (1.136 g/kg), the SJ group (1.775 g/kg), and the JY group (2.059 g/kg) were administered with corresponding medicated decoction by gastrogavage, with the gastric volume of 24 mL/kg. On the 41st day the training of capability for learning and memory was started. On the 42nd day capability for learning and memory was tested. The brain tissue was cut. One half was used to determine the contents of homogenate acetyl cholinesterase (AchE), choline acetyltransferase (ChAT), and monoamine oxidase (MAO).Another half was used to carry out morphological observations.

RESULTSThe capability for learning and memory could be improved and the latency time could be lowered in all the treatment groups. Besides, the homogenate AchE and MAO could also be elevated, ChAT could be lowered; the morphology, number, and distribution of neurons could be improved. But the improvement of ethology, morphology, and activities of neurotransmitters were most obviously seen in the XP group.

CONCLUSIONSXP could improve the ethology, morphology, and activities of neurotransmitters, and showed better effects on prevention and treatment of AD. The rationality of compatibility methods and combination thinking ways of soothing Gan, nourishing blood, and invigorating Pi were clarified.

Alzheimer Disease ; metabolism ; psychology ; Animals ; Behavior, Animal ; Disease Models, Animal ; Drugs, Chinese Herbal ; pharmacology ; Female ; Male ; Mice ; Mice, Inbred Strains ; Neurotransmitter Agents ; metabolism

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 To investigate the chemotherapy on coagulation function in patients with gastrointestinal cancer.Methods One hundred eight-one cases of gastrointestinal cancer patients who were taken chemotherapy in our hospital were collected from January 2009 to May 2012.According to tumor metastasis,they were divided into distant metastasis group ( n=68) and no distant metastasis group ( n=113 ),and then 270 cases of healthy persons were matched as control group.Plasma prothrombin time ( PT),activated partial thromboplastin enzyme time ( APTT),plasma fibrinogen ( FIB ),the total thrombin time ( TT),and D-dimer (DD) level were observed and compared between these groups.And the level of coagulation indicators in patients with gastrointestinal cancer was compared before and after chemotherapy.Results There were significant differences among three groups on levels of PT,APTT,FIB,TT and D-D (F=4.443,4.791,5.795,3.671,10.564,respectively,P＜0.05) before chemotherapy.The PT[(11.31 ±0.98) s and (11.20 ±0.95) s vs (11.99±0.89)s] and APTT[(29.01 ±4.52)s and (28.25 ±3.98)s vs (30.45 ±4.95)s] and TT [(19.35 ± 2.09) s and (18.68 ± 1.98 ) s vs (19.98 ± 1.89 ) s] in the tumor without distant metastasis and tumor distant metastasis groups were significantly lower than those in the healthy control group ( P＜0.05 ),however FIB[(3.05 ±0.68) g/L and (3.89 ± 1.01 ) g/L vs (2.29 ±0.38) g/L] and D-D[(98.88 ± 15.94) μg/L and (227.31 ± 35.12 ) μg/L vs (35.41 ± 3.43 ) μg/L] were significantly higher than those in the healthy control group (P＜0.05);FIB[(3.89 ± 1.01 ) g,/L vs (3.05±0.68) g/L],DD[(227.31 ± 35.12) μg/L vs (98.88 ± 15.94) μg/L] in distant metastasis group were also significantly higher than those in no distant metastasis group( P＜0.05 ).On comparison before and after chemotherapy,there was no significant difference on PT,APTT,D-D and TT between distant metastasis group and no distant metastasis group ( P ＞ 0.05 ),but FIB decreased significantly in two groups after chemotherapy [Distant metastasis group:( 3.25 ± 0.78 ) g/L vs (3.89 ± 1.01) g/L;No distant metastasis group:( 2.58 ± 0.75 ) g/L vs ( 3.05 ± 0.68 ) g/L;P＜0.05 )] Conclusion The patients with gastrointestinal cancer are on the hypercoagulable state.In addition,hypercoagulable state could be increased with the emergence of metastases.Chemotherapy may be a transient increasing in the risk of thrombosis.Clinicians need to recognize the hypercoagulable state in cancer patients before and after chemotherapy,that will provide help for clinical treatments.