With the deployment of electronic medical records systems, more and more routine clinical data are recorded electronically, which become a potential data source for new drug clinical trials. In this paper, we summarized the opportunities, challenges, obstacles and the latest development in this field.
Clinical Trials as Topic ; Data Collection ; methods ; Drug Evaluation ; Electronic Health Records

Objective To evaluate the diagnostic performance of a point-of-care testing for sensitive cardiac troponin Ⅰ (POCT-cTnI) in early diagnosis of chest pain patients who had a high pretest probability of acute myocardial infarction (AMI).Methods Total of 127 patients with new-onset chest pain at the emergency department were enrolled.Blood samples were drawn for the routine blood test,and determined POCT-cTnI and central laboratory testing for high sensitive cardiac troponin T (CLT-hscTnT) at admission,three and then at six hours after admission.All patients were divided into AMI group and non-AMI group according to the final diagnosis,which was adjudicated independently by two physicians who reviewed all available medical records for the 90-day follow-up period,and they were unaware of the results of the investigational assays of cardiac troponins.The receiver operating characteristic (ROC) curves were constructed to assess and compare the diagnostic performance of AMI of two cardiac troponin assays.The comparison of areas under the ROC curves (AUC) was performed by DeLong test,and the sensitivity,specificity,negative predictive values (NPV) and positive predictive values (PPV) for the target markers were calculated by applying a maker-specific cutoff value.Results The final diagnosis of AMI was made in 40 of 127 patients (31.5 ％).The diagnostic accuracy of the two assays oBtained at presentation,as quantified by AUC,was no statistically differences (AUC for POCT-cTnⅠ,0.901,95％ CI,0.901 to 0.947;and for CLT-hscTnT,0.907,95％ CI,0.842 to 0.951;Z =0.235,P =0.745).The AUC for POCT-cTnI at 3 hours after admission was significantly higher than that on admission (0.931 vs.0.858;Z =-2.038,P =0.042),while there was on further improvement at 6 hours after admission (0.931 vs.0.949;Z =-1.435,P =0.151).With use of POCT-cTnI (cutoff value 0.023 ng/mL,which was the 99th percentile upper reference limit) on adimission,the clinical sensitivity was 77.5％,and the specificity was 94.2％.A single sample of POCT-cTnI at 3 hours after admission improved the diagnostic accuracy,with a sensitivity of 96.4％,a specificity of 92.0％,and a NPV of 98.6％,a PPV of 81.8％.While,with use of CLT-hscTnT (cutoff value 0.014 ng/mL,was the 99th percentile upper reference limit) at 3 hours after admission,the NPV reached to 100％.Conclusions The use of a POCT-cTnI assay in chest pain patients can identify and exclude the AMI rapidly and exactly at three hours after admission,and the diagnostic performance is equivalent to CLT-hscTnT.

Objective To explore the HEART risk score in predicting 30-day major adverse cardiovascu-lar events (MACE)for the patients presenting to Emergency Department (ED) with acute chest pain. Methods Patients presented in our ED with acute chest pain were enrolled from January,2016 to April,2016. All cause MACE of each patient were followed up at 30 days by Health insurance information management System and call . Results Total 209 patients were enrolled(mean age 65.28 ± 16.85 years;52.63%male). The age,hypertension, ratio of ACS,SpO2,in-patient number HEART score in MACE subject were significantly higher than that in non MACE patients(P<0.05). The blood pressure at admission of MACE patients was significantly decrease than that in non MACE patients(P<0.05). The MACE within 30 days was 5.74%. The respective areas under the curve (AUC)for 30-day MACE(95% CI)was 0.908(0.846 ~ 0.974). The percent of patients with 30-day MACE with HEART scores between 0% and 3,4 ~ 6,and 7 ~ 10 was 0%,2.5%,and 27%,respectively. Conclusion HEART score can be simple,rapid and accurate prediction of emergency department of patients with acute chest pain within 30 days of MACE,effective elimination of low-risk patients with MACE,it plays a very important role for disease assessment and diagnosis and treatment process in emergency department.

Objective To investigate the intelligence standard for diagnose the sub-cretin children and children with mental retardation of socio-cultural type.Methods The full intelligence quotient(IQ),verbal intelligence quotient(VIQ)and performance intelligence quotient(PIQ)was tested by Wechsler scale(C-WISC)for mild iodine deficiency disordem children,children living in abnormal socio-cultural condition and normal children aged 7～14 years old in Qinba mountain area.The test results had been compared between the groups.Results There were no significant difference between psychomotor functioning well children and children living normal sociocuhural condition in VIQ,PIQ and full IQ(89.24±18.44 vs 90.75±17.58,87.58±15.78 vs 88.95±15.56,87.42±17.84 vs 89.02±17.18,t=1.14,1.19 and 1.24,respectively,all P＞O.05).PIQ and full IQ were significantly lower in mild iodine deficiency disorders children than in children with abnormal socio-cultural background (65.81±10.22 vs 72.33±13.23,62.42±12.31 vs 68.13±14.54,t=3.26,2.55,P＜0.01 or＜0.05,respectively).But the VIQ was not significantly different between these two groups.The average difference of VIQ and PIQ among mild iodine deficiency disorders children wag-0.32 without significant difierence(t=0.28,P＞0.05),however it was-2.91 among children under abnormal socio-cultural condition with significant difierenee(t=-3.59,P＜0.01).Conclusions IQ for iodine deficiency disorders children is characterized by that VIQ is damaged in parallel with PIQ,while that in children under abnormal soeio-cuhural condition is marked by that VIQ is retarded more severely than PIQ,which ean be used as an intelligence standard for differentiating the sub-cretin children from children wjth socio-cuhural mental retardation.

Objective To establish a rapid assay with high sensitivity and specificity based on the sequences for group specific gene (GS) and pathogenicity island pag A gene.Methods The PCR primers and probes were designed after the whole sequence was systemically analyzed with bio-informafion tools and blasted with Genebank database.The amplicons were inserted into plasmids so that they could be used as the standard templates to evaluate the sensitivity of the diagnostic system.This assay was based on TaqMan probes and portable Smartcycle PCR machine.Results The detection level was approximately 100 copies per reaction.There was no cross-reaction with other species of Bacillus.This assay could be completed in one hour in laboratory.Conclusion The duplex TaqMan PCR assay could be used to detect Bacillus anthracis rapidly with high sensitivity and specificity.

OBJECTIVETo detect the blood perfusion of the necrotic area and the femoral head and neck junction in the patients diagnosed as osteonecrosis of femoral head (ONFH) with laser doppler flowmetry (LDF).

METHODSFrom 2007 to 2008, 50 patients with ONFH 82 hips were performed core decompression and autologous stem cells transplantation. Group A was for ARCO stage II 46 hips (IIA 6 hips, IIB 22 hips, IIC 18 hips), and Group B was for stage III 36 hips (IIIA 20 hips, IIIB 10 hips, IIIC 6 hips). Blood perfusion of necrotic area and femoral head and neck junction with LDP were detected during the operation. Statistical analysis was made.

RESULTSIn Group A, the perfusion volume of necrotic area was (30.2 +/- 3.0) PU, and the perfusion volume of femoral head and neck junction was (103.4 +/- 4.4) PU. In Group B, the perfusion volume of necrotic area was (30.6 +/- 2.8) PU, and the perfusion volume of femoral head and neck junction was (103.4 +/- 3.9) PU. In Group A and Group B, the perfusion volume of necrotic area was lower than that of femoral head and neck junction, and the difference was significant (P < 0.01).

CONCLUSIONSLDF can effectively detect that the perfusion volume of ONFH decreased, which provides a theoretical basis in order to further study the pathogenesis of ONFH. Meanwhile, there is application value of LDF on the study of ONFH.

Adult ; Female ; Femur Head ; blood supply ; Femur Head Necrosis ; pathology ; Hemodynamics ; Humans ; Laser-Doppler Flowmetry ; Male ; Microcirculation ; Middle Aged

Hepatitis B ; diagnosis ; etiology ; Humans ; Male ; Middle Aged ; Neurosyphilis ; complications ; diagnosis ; Optic Neuritis ; complications ; diagnosis

OBJECTIVETo study on basic Volt-ampere (V-A) characteristics of human acupoints and the changes with physiologic and pathologic changes, and probe their biophysical basis.

METHODSThe research works of this research group about V-A characteristics of acupoints in recent 10 years were systematized and analyzed.

RESULTSV-A characteristic curve of human acupoints is of the both characteristics of non-linear and inertia. Compared with controlled point, the lower electric resistance characteristic of acupoints is not popular and the lower inertia is popular. V-A area of acupoints has no obvious circadian rhythms and the inertia area of a large part of acupoints has obvious circadian rhythms, with the phase of peak value corresponding to the phase of valley value of body temperature rhythms. V-A characteristics of acupoints in the patients of heart disease or stomach diseases changes obviously, and these changes have a certain specificities of acupoints. After remission of the lesion, the V-A characteristics of acupoints restore normal. The V-A area and the inertia area of acupoints in the corpse are obviously smaller than the normal person, with disappearance of the characteristics of both the non-linear and inertia of the normal person.

CONCLUSIONHuman acupoints have characteristics of non-linear and inertia, and the non-linear characteristic reflects complexity of physiology and behavior, while the inertia characteristic is related with energy metabolism of acupoints. The inertia area can more sensitively reflect human physiologic and pathological changes as compared with the V-A area, so it is an important index for the studies on electric characteristics of acupoints in the future.

Acupuncture Points ; Biophysical Phenomena ; Biophysics ; Electric Conductivity ; Heart Diseases ; physiopathology ; Humans ; Stomach Diseases ; physiopathology

OBJECTIVETo study the clinical characteristics of the patients with dengue fever (DF) seen from 2002 to 2006 in Guangzhou in order to prevent and treat dengue fever better.

METHODSClinical data from 1342 inpatients with DF seen from 2002 to 2006 were retrospectively analyzed. The dengue virus was isolated by C6/36 cell culture and genotyped by reverse transcriptase-polymerase chain reaction and gene sequence analysis.

RESULTSThe average age of the patients was 34.4 years, without sex difference in distribution. Most of the patients had obvious toxemic symptoms including fever (100 percent), headache (85.9 percent), myalgia (64.5 percent), bone soreness (46.6 percent) and skin rash (65.9 percent). Leukopenia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase and hypokalemia were found in 66.0 percent, 61.3 percent, 69.0 percent , 85.7 percent and 28.4 percent of patients, respectively. DF-IgM could be detected in 90 percent of patients. The virus was identified as dengue virus type-I.

CONCLUSIONSThe epidemic of DF was caused by dengue virus- I from 2002 to 2006 in Guangzhou. Most of the patients had classic DF clinical manifestation with high percentage of hepatic injury. Few patients progressed to dengue hemorrhagic fever.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Viral ; blood ; Child ; Child, Preschool ; China ; epidemiology ; Dengue ; diagnosis ; epidemiology ; immunology ; physiopathology ; Dengue Virus ; genetics ; isolation & purification ; Female ; Humans ; Infant ; Male ; Middle Aged ; Retrospective Studies ; Young Adult

It has been reported that the frequency modulation (FM) or FM direction sensitivity and forward masking of central auditory neurons are related with the neural inhibition, but there are some arguments, because no direct evidence of inhibitory synaptic input was obtained in previous studies using extracellular recording. In the present study, we studied the relation between FM direction sensitivity and forward masking of the inferior collicular (IC) neurons using in vivo intracellular recordings in 20 Mus musculus Km mice. Thirty seven with complete data among 93 neurons were analyzed and discussed. There was an inhibitory area which consisted of inhibitory postsynaptic potentials (IPSP) at high frequency side of frequency tuning of up-sweep FM (FMU) sensitive neurons (n = 12) and at low frequency side of frequency tuning of down-sweep FM (FMD) selective neurons (n = 8), while there was no any inhibitory area at both sides of frequency tuning of non-FM sweep direction (FMN) sensitive neurons (n = 17). Therefore, these results show that the inhibitory area at low or high frequency side of frequency tuning is one of the mechanisms for forming FM sweep direction sensitivity of IC neurons. By comparison of forward masking produced by FMU and FMD sound stimuli in FMU, FMD and FMN neurons, the selective FM sounds could produce stronger forward masking than the non-selective in FMU and FMD neurons, while there was no forward masking difference between FMU and FMD stimuli in the FMN neurons. We suggest that the post-action potential IPSP is a potential mechanism for producing stronger forward masking in FMU and FMD neurons.
Acoustic Stimulation ; Action Potentials ; Animals ; Inferior Colliculi ; cytology ; Inhibitory Postsynaptic Potentials ; Mice ; Neurons ; cytology