This study was aimed to investigate potential biomarkers in different traditional Chinese medicine (TCM) syndromes of angina pectoris of coronary heart disease (CHD) by using metabolomic technology,and to explore the objective law of different TCM syndromes of CHD.Endogenous metabolites in serum and urine from the healthy group,and patients with DHD angina pectoris patients of the syndrome of Qi deficiency and blood stasis,as well as the syndrome of Qi deficiency,blood stasis and phlegm turbidity were detected by the liquid chromatography-mass spectrometry (LC-MS).Metabolic profiles were analyzed by the principal component analysis (PCA) and the orthogonal partial least squares discriminant analysis (OPLS-DA).The results showed that in PCA,the healthy group,Qi deficiency and blood stasis group,as well as the Qi deficiency,blood stasis and phlegm turbidity group can be obviously distinguished.Potential biomarkers in the Qi deficiency and blood stasis syndrome contained aspartyl methionine and cysteine sulfinic acid.Potential biomarkers in the Qi deficiency,blood stasis and phlegm turbidity syndrome contained hippuric acid,amino glucose,fructosamine and triglyceride.The objective performance of Qi deficiency syndrome was the absence of biotin,lysyl tyrosine,phosphatidylglycerol and glycocholic acid.It was concluded that through the new metabolomic technology,different endogenous metabolites in the syndrome of Qi deficiency and blood stasis,as well as the syndrome of Qi deficiency,blood stasis and phlegm turbidity of patients with DHD angina pectoris were detected.It provided ideas for the clinical practice of prevention,diagnosis and treatment of different TCM syndromes.

Objective To put forward reasonable and feasible recommendations aiming at enhancing the application safety of afterloading unit, through studying the human reliability in the emergency response against the source blockage of afterloading unit.Methods Based on the human cognition reliability model, ten operation errors during the emergency response against the source blockage of afterloading unit were analyzed and permissible time widow of emergency response operation were determined.The human error probability was calculated with the execution time of emergency response operation obtained through simulation, observation and recording.Results The operation action, relevant permissible time window and execution time were obtained with the corresponding human error probabilities in the range 0.04 - 0.27.Conclusions The human error model in emergency response against the source blockage of afterloading unit based on HCRmodel is feasible, and provides important reference basis to reduce the occurrence of potential exposure and mitigate the consequence of potential exposure.

Objective To investigate the dose distribution and radiation risk of Varian thoracic cone beam computed tomography (CBCT) with default parameters with reference to Monte Carlo simulation and International Commission on Radiological Protection (ICRP) report 110.Methods EGSnrc/BEAMnrc code was used to simulate the material, thickness, and geometry of the kV CBCT source (kVS) to establish the kVS model.A benchmarked MCSIM code was applied to calculate the dose distribution in the ICRP phantom after the scan with the standard thoracic parameters (110 kV, 20 mA, and 262 mAs), and the conversion coefficient of absolute dose was obtained in a spherical phantom following the TG-61 protocol.The results of Monte Carlo simulation were validated by PDD and Profile in a water phantom and the measurement of the absolute dose in the computed tomography dose index (CTDI) phantom and Alderson phantom.The models including BEIR VⅡ were used to evaluate the radiation risks.Results With reference to the criterion of 3%/1 mm, the uncertainties of PDD and Profile were less than 2%.The difference between the measured and calculated values was<2.9% in the CTDI phantom and ≤0.05 cGy in the Alderson phantom.In the ICRP110 phantom, the doses to the left lung, right lung, left breast, right breast, heart, thyroid, trachea, cancellous bone, and cortical bone were 1.28, 1.39, 1.74, 1.80, 1.46, 0.48, 0.88, 0.85, and 1.84 cGy, respectively.The relative risks of ischemic heart disease, breast cancer, lung cancer, thyroid cancer, and tracheal cancer in a standard scan were1.001 , 1.009, 1.019, 1.000, and 1.008, respectively. Conclusions The accumulated dose and long-term risks of CBCT during image-guided thoracic radiotherapy cannot be neglected and should be effectively controlled.

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.

Glioblastoma is a malignant tumor in central nervous system, which has strong invasion, poor prognosis and short survival time. At present, the main treatment strategy of glioblastoma is surgical excision, supplemented by radiotherapy and chemotherapy. However, due to incomplete resection and high recurrence rate, it is urgent to find novel therapeutic method for glioblastoma. Photodynamic therapy, as a promising non-surgical treatment, provides a new strategy for postoperative adjuvant therapy of glioblastoma. This review summarizes the mechanism and clinical application of photodynamic therapy mediated by various photosensitizers in glioblastoma, in order to provide help for the treatment of glioblastoma.

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.
Benchmarking ; Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards ; Quality Control

Objective To explore the effects of transplantated bone marrow mesenchymal stem cells (MSCs) on myocardial fibrosis with the aid of ultrasound-mediated microbubbles (MB) and bispecific antibody(BiAb) combination.Methods With the aid of MB,isolated MSCs from male mice and the BiAb were transfused into female mice with isoproterenol-induced myocardial fibrosis via tail vein (MSCs + BiAb + MB group).BiAb was producted with anti-CD29 which can recognize MSCs and anti-myosin light chain antibody (AMLCA) which can specifically bind to injured myocardium.There were six groups investigated:MSC + BiAb + MB,MSC,BiAb,MB,MSC + BiAb,untreated,and control groups.Five weeks after treatment administration,the expressions of sex-determining region of Y-chromosome (SRY) in myocardium were detected by fluorescent quantitative PCR.The distribution of collagen was observed by sirius red staining.Heat shock protein-70 (HSP-70) in myocardium was detected by immunohistochemistry.Results The highest homing number of MSCs was in the MSCs + BiAb + MB group,MSCs + BiAb group ranked the second,and lowest in MSCs group.Compared to the untreated group,the MSCs + BiAb + MB,MSCs + BiAb and MSCs groups had less collagen deposition (P ＜0.05),and decreased level of HSP-70.Compared to those of the MSCs group,the collagen deposition were decreased in MSCs + BiAb + MB group (P ＜0.05).Conclusions MB and BiAb can promote the homing number of MSCs in mice.MB can further the homing rate and the repairing efficacy of MSCs.The homing MSCs can prevent the process of myocardial fibrosis.And HSP-70 was involved in the internal mechanism.

Objective: To compare the effect of galectin-3 (Gal-3), NT-proBNP and echocardiography paramerters on assessing cardiac function in patients with chronic heart failure (HF). Methods: A total of 144 patients treated in our hospital from 2016-03 to 2016-11 were enrolled. According to the NYHA classification, the patients were divided into 2 groups: HF group and Normal cardiac function group. n=72 in each group. Basic clinical information was collected, blood levels of Gal-3 and NT-proBNP were examined, echocardiography was conducted to measure left ventricular ejection fraction (LVEF) and left ventricular end diastolic diameter (LVEDD). Correlations between Gal-3, NT-proBNP and echocardiography parameters were studied, the abilities of Gal-3, NT-proBNP and echocardiography for estimating HF were compared. Results: Compared with Normal cardiac function group, HF group had increased blood levels of NT-proBNP [3499.5 (1431.3-9088.0) ng/L] vs [384.1 (122.1-1540.5) ng/L] and Gal-3 [3.0 (1.71-5.8) pg/ml] vs [1.9 (1.4-2.6) pg/ml], decreased LVEF [49.5% (42%-58%)] vs [62.5% (59%-67%)], enlarged LVEDD [52.0 (46.3-57.8) mm] vs [46.0 (42.0-49.0) mm] and elevated serum creatinine [113.6 (90.5-152.7) umol/L] vs 82.4 (69.1-97.4) umol/L], all P<0.05. Correlation analysis showed that NT-proBNP and Galectin-3 were positively related to LVEF and LVEDD; Gal-3 and NT-ProBNP had the strongest correlation (r=0.57, P<0.01). The AUC of ROC for Gal-3 was 0.674 (0.584-0.763), for NT-proBNP was 0.837 (0.771-0.902) and for LVEF was 0.806, (0.735-0.878) which implied that NT-proBNP was the most powerful parameter for estimating HF. Conclusion: Gal-3 had the ability to estimate HF and could be used as a biomarker, while its ability was lower than NT-proBNP in clinical practice.

Metabolic characteristics of 39 human brain tumor tissues, including 15 astrocytomas, 13 fibroblastic meningiomas and 11 transitional meningiomas from 39 individual patients, have been studied using high resolution magic-angle spinning (HRMAS) 1H NMR spectroscopy in conjunction with principal component analysis (PCA). With rich metabolite information, 1H NMR spectra showed that the tumor-tissuc metabonome was dominated by lipids, lactate, myo-inositol, ereatine, choline metabolites such as choline, phosphocholine and glycerophosphocholine, amino acids such as alanine, glutamate, glutamine, taurine, N-acetyl-aspartate and glutathione. PCA of the tumor NMR spectra clearly showed metabonomic differences between low-grade astrocytomas and meningiomas whereas such differences were more moderate between fibroblastic and transitional meningiomas. Compared with meningiomas, the low-grade astrocytomas had higher levels of glycerophosphocholine, phosphocholine, myo-inositol and creatine but lower levels of alanine, glutamate, glutamine, glutathione and taurine. The N-acetyl-aspartate level was low but detectable in low-grade astrocytomas whereas it was not detectable in meningiomas. It is concluded that tissue metabonomics technology consisting of HRMAS 1H NMR spectroscopy and multivariate data analysis (MVDA) offers a useful tool (1) for distinguishing different types of brain tumors, (2) for providing the metabolic information for human brain tumors, which are potentially useful for understanding biochemistry of tumor progression.

Objective:To compare the clinical efficacy between puncture assisted by a "TINAVI" orthopaedic robot versus freehand puncture in vertebroplaty for osteoporotic vertebral compression fracture(OVCF) of the upper thoracic vertebra.Methods:A retrospective study was conducted of the 19 patients (20 vertebral bodies) with OVCF of the upper thoracic vertebra who had been treated at Department of Spine Surgery, Honghui Hospital from January 2018 to March 2019 by robotic vertebroplasty (robot group) and of another 21 counterpart patients (21 vertebral bodies) who had been treated by conventional vertebroplasty from January 2016 to December 2017 (freehand group). Puncture was conducted by a "TINAVI" orthopaedic robot in the robotic vertebroplasty but freehand in the conventional vertebroplasty. The robot group had 5 males and 14 females, aged from 62 to 88 years; the freehand group had 6 males and 15 females, aged from 64 to 83 years. The 2 groups were compared in terms of operation time, bone cement volume, postoperative complications (cement leakage, infection and embolism), visual analogue scale (VAS), Oswestry disability index (ODI), anterior height (AH) and kyphosis angulation (KA) of the injured vertebra at day 1 and last follow-up after surgery.Results:The 2 groups were comparable because there were no significant differences between them in the preoperative general data ( P>0.05). Vertebroplasty via unilateral puncture approach was completed uneventfully in the 19 patients (20 vertebral bodies) in the robot group and in the 21 patients (21 vertebral bodies) in the freehand group. The 40 patients were followed up for 6 to 12 months (mean, 8.3 month). The operation time [(37.9±8.2) min], bone cement volume [(2.3±0.9) mL] and rate of cement leakage (10.0%, 2/20) in the robot group were all significantly less or lower than those in the freehand group [(46.2±9.4) min, (4.2±1.3) mL and 42.9% (9/21)] ( P<0.05). No infection or embolism was observed in either group. There were no significant differences between the 2 groups in VAS, ODI, AH or KA of the injured vertebra at day 1 or last follow-up after surgery ( P>0.05). Conclusion:In vertebroplaty for OVCF of the upper thoracic vertebra, compared with conventional freehand puncture, puncture assisted by a "TINAVI" orthopaedic robot can lead to satisfactory clinical efficacy because it reduces operation time, volume of bone cement injection, and thus incidence of bone cement leakage.