A large-scale randomized prospective intervention study (Mega Study) was initiated by Ministry of Health and Welfare (MHW) Japan in 1993, and is on going with support from Sankyo Co., Ltd. This study is designed to test the hypothesis that reduction of serum cholesterol with pravastatin (a HMG-CoA reductase inhibitor) over an average of 5 years will reduce the incidence of fatal and nonfatal CHD (Coronary Heart Disease).
As a CRO (Contract Research Organization), we have set up a data center that is responsible for the conduction of this study. The main functions of the data center are to do patient registration, treatment randomization, clinical monitoring, data management, and statistical analysis.
This report outlines our some experiences with conduction of the data center, particularly relating to clinical monitoring, clinical data management, QA (Quality Assurance), and computer systems for such a data center.

Objective To explore the clinical features of tubal pregnancy and summarize the diagnosis and treatment.Methods The clinical data of 287 cases were reviewed including routine test,ultrasound examination,and laparoscopic surgery.The clinical features and indicators of surgery were evaluated,193 cases treated by laparoscopic surgery and 94 cases treated by traditional surgery.Results ( 1 ) The major clinical manifestations of tubal pregnancy were abdominal pain ( 100％ ),menopause ( 80.8％ ) and irregular vaginal bleeding (62.4％).(2) By ultrasound examination mass was found in 257 cases (89.5％ ),and pelvic cavity accumulates liquid in 167 cases (58.2％ ).In accessories division 32 cases ( 11.1％ ) had blastocyst and 19 cases (6.6％ ) had embryo or fetal heart.The positive rate of urine pregnancy test was 86.4％,and the average level of blood 3-HCG was (545.0 ± 231.6) U/L.( 3 ) The past medical history was as follows:Tirty-four cases ( 11.8％ ) with ligation or other method of contraception,43 cases ( 15.0％ ) with surgery,87 cases (30.3％ )with artiflcal abortion,and 33 cases ( 11.5％ ) with hepatitis,malaria or tuberculosis.(4)All the surgery succeed with an average surgery time of (44.5 ± 6.7 ) min.Ninety-seven cases were treated with blood transfusion and there were no complications.Operative wound of all patients were healed first term,and the time stay in hospital was (4.1 ± 2.7 ) d,and the levels of blood β-HCG all dropped ≥50％ by 24 h after surgery.Conclusion ( 1 ) Abdominal pain,menopause,and irregular vaginal bleeding are the major clinical manifestations of tubal pregnancy.(2)The best method of diagnosis in tubal pregnancy is blood β-HCG and ultrasound examination.(3) Laparoscopic gynaecological surgery has such merits as minimal invasion,and it is the best way for diagnosis and treatment of tubal pregnancy.

Objective: To detect the correlation of lymphatic vessel density (LVD) with a high mobility group box-1 Protein (HMGB1) and tumor-associated macrophages (TAMs) in cervical carcinoma and the effect on prognosis. Methods:Immunohistochem-istry was applied to detect HMGB1, CD68, and D2-40 expressions in cervical squamous cell carcinoma in 93 cases. t test,χ2 test, Spear-man rank correlation analysis, Kaplan-Meier method, and Cox regression were performed to analyze the expression levels, correlation, and prognosis. Results: HMGB1 protein, CD68, and D2-40 were highly expressed in CSCC. As HMGB1 and TAM expressions in-creased, lymphatic vessel density increased. As HMGB1 and TAM expressions decreased, lymphatic vessel density decreased. Positive correlations were also found between the HMGB1 protein, TAM content, and LVD. In the group with low HMGB1 and TAM expres-sions, the survival time of the group with a high LVD expression was significantly lower than that of the group with a low LVD expres-sion. A multivariate Cox regression model showed that HMGB1 and lymph node metastasis were independent prognostic factors. TAMs and LVD were not independent prognostic factors. Conclusion:HMGB1 proteins and TAMs were highly expressed in CSCC. Patients who exhibit increased HMGB1 expression or increased TAM count consequently show enhanced LVD expressions, increased lymph node metastasis, and poor prognosis.

Genetic diseases that have shown clinical symptoms in neonatal period are often characterized with atypical symptoms and serious condition, which contributes to difficulties in diagnosis and treatment.With the progress of sequencing technology, the next-generation sequencing technology is gradually applied to the clinical field with its advantages of high throughput, low cost and rapid detection.As one of next-generation sequencing technologies, the whole exome sequencing technology(WES)captures, enriches and sequences the genomic exon regions, and then the large amount of WES data is analyzed by bioinformatics methods and screened to find variant site in gene that causes genetic disease.WES technology has gradually become an important means of diagnosis in neonatal genetic diseases because of its advantages of comprehensive results and short reporting period.

In recent years,corneal refractive surgery continues to develop with becoming to be one of the most prevalent utilizations of correction of many patients and brings about better visual quality for ametropic patients.Meanwhile,some patients are subjected to optical complications,and poor night vision is one of the most serious problems which are complained by sufferers after refractive surgery,such as glare,halo and reduce of contrast sensitivity,and the affective factors include age,pupil diameter,high order aberation,scattering,pre-estimated diopter,corneal healing,individual sensitivity to surgery,which are supposed to attract the attention of the majority of clinicians and researchers,at the same time.Ophthalmic clinical doctors and researchers only fully understand the mechanism of the above factors and explore the corresponding measures in order to purposefully treat these complications.In addition,ophthalmologists should be aware of the interaction of these factors and their relationship with individual sensitivity and explore the impact of postoperative visual impairment and the way to avoid them in clinical practice inorder to improve the visual quality by controlling the postoperative optical complications.

Objective:To investigate the correlation between the secreted frizzled related protein 5 (SFRP5), 25-hydroxy vitamin D [25(OH)D], retinol binding protein 4 (RBP4) and the degree of illness in elderly patients with type 2 diabetes mellitus (T2DM) and the evaluation value of curative effect.Methods:One hundred and thirteen elderly patients with T2DM who treatment in Taihu Hospital of Wuxi City from January 2018 to October 2019 were selected as the study group, and 113 healthy patients during the same period were selected as the control group. The serum levels of RBP4, SFRP5, and 25(OH)D were compared between the two groups, patients with different disease levels, and patients with or without vascular complications. Spearman was used to analyze the correlation between each index and the degree of illness, and Pearson was used to analyze the correlation between each index and the insulin resistance index (HOMA-IR). The receiver operating characteristic (ROC) curve and area under ROC (AUC) were used to analyze the value of SFRP5, 25(OH)D, RBP4 and the combination of the three to predict vascular disease in T2DM patients.Results:The levels of RBP4 , HOMA-IR in study group were higher than those in control group: (22.96 ± 2.26) μg/L vs.(11.28 ± 1.69) μg/L, 3.83 ± 0.70 vs.1.65 ± 0.59, the levels of SFRP5, 25(OH)D in study group were lower than those in control group: (9.28 ± 3.14) μg/L vs. (14.65 ± 3.38) μg/L, (32.65 ± 5.12) nmol/L vs. (51.29 ± 6.33) nmol/L, and the differences were statistically significant ( P<0.05). The level of RBP4 in severe group was higher than that in mild group:(26.91 ± 2.51) μg/L vs. (19.35 ± 2.23) μg/L, the levels of SFRP5, 25(OH)D in severe group were lower than those in mild group: (7.13 ± 2.98) μg/L vs. (11.25 ± 3.30) μg/L, (27.97 ± 4.56) nmol/L vs. (36.93 ± 5.50) nmol/L, and the differences were statistically significant ( P<0.05). The levels of SFRP5, 25(OH)D in patients with macrovascular disease were the lowest, followed by those with microvascular and those without vascular disease; the level of RBP4 in patients with macrovascular disease was the lowest, followed by those with microvascular and those without vascular disease, and the differences were statistically significant ( P<0.05). There was a positive correlation between RBP4 and the degree of illness and HOMA-IR ( P<0.05), and there was a negative correlation between 25(OH)D and SFRP5 and the degree of illness and HOMA-IR ( P<0.05). The AUC of SFRP5 for predicting vascular disease was 0.721, and the cut-off value was ≤11.14 μg/L , with a sensitivity of 78.21%, and a specificity of 60.00%.The AUC of 25(OH)D for predicting vascular disease was 0.786, and the cut-off value was ≤ 36.56 nmol/L, with a sensitivity of 87.18%, and a specificity of 65.71%. The AUC of RBP4 for predicting vascular disease was 0.816, and the cut-off value was greater than 21.45 μg/L , with a sensitivity of 57.69% and a specificity of 94.29%. The AUC of SFRP5 + 25(OH)D + RBP4 for predicting vascular disease was 0.847, with a sensitivity of 70.51% and a specificity of 85.71% ( P<0.05). Conclusions:In severe T2DM elderly patients with vascular complications, the levels of blood SFRP5, 25(OH)D and RBP4 are increased and significantly related to the patient′s condition and insulin resistance, and they can predict the occurrence of vascular disease.

Osteoporotic fracture is the most destructive ending of osteoporosis, many interacting risk factors play a role in its occurrence. With age, the bodies function decline gradually. Symptoms like soreness of the waist, back pain, cramp of the lower limb and weakness appears. These are related to TCM syndrome factors like kidney deficiency, liver deficiency, spleen deficiency and blood stagnation. Symptoms can act as a warning of the occurrence of osteoporotic fracture in the early stages. The risk assessment tool of osteoporotic fracture is mostly developed on the basis of modern risk factors and thus lacks syndrome differentiation, that may limit its utilization. If the relevant content of syndrome differentiation is integrated into the forecasting tool and a risk assessment tool of osteoporotic fracture which complies with the demographics of China is built up, population risk assessment for high of risk could be established and scientific evidence for the adoption of effective interventions could be applied.
Bone Density ; China ; epidemiology ; Humans ; Osteoporotic Fractures ; epidemiology ; genetics ; metabolism ; physiopathology ; Risk Assessment ; Risk Factors

Objective To study and evaluate the consistency and diagnostic value of electrogastrogram(EGG) and gastroscopy in children′s gastrosis diagnosis.Methods A total of 136 children were checked with gastroscopy and EGG during the same period,then compared the diagnostic accordance rate with 2 ways,and analyzed the characteristics of EGG.Results EGG showed certain characteristics in different gastrosis.Diagnosis of EGG in the group of functional illness was consistence with gastroscopy at 95.8%;others were less than 40%.Conclusion EGG can be used as a method of special value to diagnose children′s functional gastrosis and a screening means in general gastrosis.

OBJECTIVEMedicinal properties are the basic attribute of traditional Chinese medicines (TCM), while the medicinal property theory is the core theoretical foundation of TCM formula combination. In this particle, authors studied the characteristics of pharmacological effects of property combination of traditional Chinese medicines distributing along meridians, with the aim to introduce the medicinal property combination regularity into the design and optimization process of compound TCMs, and bring the medicinal property theory into full play in guiding the formula combination.

METHODIn this paper, TCMs distributing along "the lung meridian" was taken for example. The medicinal property combinations of TCMs distributing along "the lung meridian" recorded in Pharmacopeia (2010) was collected and processed. Besides, Chinese journal full-text database (CNKI) was used to collect all of pharmacological study literatures concerning the above TCMs that have been published since 1980. The pharmacological information was also supplemented by reference to Science of Chinese Materia Medica and Clinical Science of Chinese Materia Medica.

RESULTTCMs distributing along the lung meridian with different properties and tastes showed significant differences in pharmacological effects. For example, mild-sweet-lung medicines could lower blood sugar levels, decrease anoxia and enhance immunity; Mild-bitter-lung medicines showed anti-bacterial, anti-hypertension, anti-oxidation effects; Hot-sweet-lung medicines showed antibechic and anti-bacterial effects. And Hot-bitter-lung medicines showed phlegm eliminating and anti-inflammatory effects. Meanwhile, TCMs distributing along the lung meridian had similar pharmacological characteristics, such as anti-bacterial and anti-inflammatory effects, which is consistent with lung's feature in susceptibility to exogenous pathogenic factors.

CONCLUSIONIn this study, authors discovered pharmacological characteristics of different TCMs distributing along the lung meridian, which links TCM theory with modern study achievements and lays a foundation for establishing a TCM property formula combination system.

Databases, Factual ; Drugs, Chinese Herbal ; administration & dosage ; chemistry ; Humans ; Lung ; drug effects ; Lung Diseases ; drug therapy ; Meridians

Objective By virtual screening in MDL,to search for a novel γ-secretase inhibitor.Methods A series of compounds were designed,synthesized,and evaluated based on pharmacophore model of γ-secretase inhibitors by virtual screening in MDL.Results The drug-likeness analytic data synthesized indicated that target compounds had drug-likeness.Each svnthesized compound was checked by IR spectroscopy,~1H and ~(13)C-NMR spectroscopy.Conclusion The designed compounds had better activity by model prediction.And the optimal compound showed a significant estimated activity value of 0.025 nmol/L and can be used as a lead for further drug development.