Objective To explore the key points of forensics appraisal of medical disputes in mental hospitals,strengthen the management of mental hospitals,prevent medical disputes and improve medical quality.Methods Using the written judgment of China Judgments Online as materials,the order multi-class Logistic regression analysis was conducted on the common faults and level of responsibility in cases of death resulting from mental hospital treatment.Results Improper nursing,improper management,insufficient knowledge of the disease,unclear information,inadequate rescue,improper medication,unclear diagnosis were the risk factors of the degree of responsibility of medical disputes,and other diseases were protective factors.Conclusion Analyzing the common faults and identification points of death disputes in mental hospitals and rectifying them from two aspects can effectively prevent the occurrence of medical disputes,improve the quality of medical treatment,and achieve a win-win situation for doctors and patients.

Objective: To understand the situation of blood pressure control and its influencing factors in elderly patients with hypertension in Hangzhou, and to provide basis for the management of elderly patients with hypertension in community. Methods: The subjects of this study were hypertension patients aged 60 years and over in Hangzhou community health management of basic public health services. Demographic data and life behaviors were collected by a questionnaire survey, physical examination and laboratory tests were carried out. The multivariate logistic regression model was used to analyze the influencing factors for blood pressure control in elderly patients with hypertension. Results: A total of 109 583 people were investigated, with 50 500（46.08%） males and 59 083（53.92%） females. The control rate was 47.70% ( 52 273/109 583 ). After adjusted for age and gender, regular medication ( OR=0.874, 95%CI: 0.838-0.912 ) was the protective factor, obesity ( OR=1.291, 95%CI: 1.260-1.324 ), abnormal fasting plasma glucose ( OR=1.218-1.344, 95%CI: 1.178-1.410 ), the number of unhealthy lifestyles ( OR=1.271-1.292, 95%CI: 1.231-1.344 ), the items of dyslipidemia ( OR=1.047-1.253, 95%CI: 1.017-1.311 ), and the number of cardiovascular risk factors above ( OR=1.254-2.109, 95%CI：1.175-2.281 ) were the risk factors for blood pressure control in elderly patients with hypertension. Conclusions The control rate of elderly patients with hypertension in Hangzhou is 47.70%, which is associated with irregular medication, unhealthy lifestyle, obesity, dyslipidemia, abnormal fasting plasma glucose and clustering of these factors.

OBJECTIVE： To provide a theoretical basis for the development of the following products of Coptis chinensis- Zingiber ojjicinale couplet medicine （“Coptis chinensis-Zingiber ojjicinale” for short） prescription. METHODS： The prescriptions containing Coptis chinensis-Zingiber ojjicinale were collected from the Dictionary of TCM Prescription and input into TCM inheritance support platform software （V2.5） to establish the database. The frequency of major diseases and compatibility medicinal materials were analyzed statistically. The core combination of medicinal materials in the prescriptions containing Coptis chinensis-Zingiber ojjicinale were analyzed statistically with association rule Apriori algorithm （support degrees were 15％， 20％， 25％， confidence was 0.90）. Top 2 main diseases in the list of frequency， compatibility medicinal materials for dispelling internal cold and medicine for clearing heat with highest compatibility frequency were selected and analyzed in respect of prescription rules. RESULTS： A total of 492 prescriptions containing Coptis chinensis-Zingiber ojjicinale were screened， 9 kinds of major diseases （frequency≥15）， such as dysentery， diarrhea， accumulation， fullness. There were 21 commonly used compatibility medicinal materials （frequency≥55）， including Angelica sinensis-Panax ginseng， Magnolia officinalis， Aconitum carmichaelii， Scutellaria baicalensis， etc. There were 19 commonly used medicinal materials combinations， including Coptis chinensis-Zingiber ojjicinale-Panax ginseng， Coptis chinensis-Zingiber ojjicinale- Magnolia officinalis， Coptis chinensis-Zingiber ojjicinale-Angelica sinensis. There are 5 kinds of core medicinal materials commonly used in treating dysentery with Coptis chinensis-Zingiber ojjicinale，and 9 kinds of core medicinal materials for treating dysentery. There are 8 kinds of core medicinal materials in Coptis chinensis-Zingiber ojjicinale compatible with medicine for dispelling internal cold Aconitum carmichaelii prescription.and 7 core medicinal materials in compatible with medicine for clearing heat Scutellaria baicalensis prescription. CONCLUSIONS： The major diseases treated with prescriptions containing Coptis chinensis-Zingiber ojjicinale are mainly digestive tract diseases. It can treat different diseases being compatible with different medicinal materials， this study aslo can provide theoretical basis for the development of subsequent products.

To explore the effects of KIAA0196 gene on cardiac development and the establishment of zebrafish strain.
 Methods: Peripheral blood and gDNA from patients were extracted. Copy number variation analysis and target sequencing were conducted to screen candidate genes. The KIAA0196 knockout zebrafish was generated by CRISPR/Cas9 to detect whether KIAA0196 deficiency could affect cardiac development. Finally, the wild-type and mutant zebrafish were anatomized and histologically stained to observe the phenotype of heart defects.
 Results: The KIAA0196 knockout zebrafish strain was successfully constructed using CRISPR/Cas9 technology. After 60 hours fertilization, microscopic examination of KIAA0196 knockout zebrafish (heterozygote + homozygote) showed pericardial effusion, cardiac compression and severely curly tail. Compared with wild-type zebrafish, the hearts of mutant KIAA0196 zebrafish had cardiac defects including smaller atrium and larger ventricle, and the myocardial cells were looser.
 Conclusion: KIAA0196 gene plays an important regulatory role in the development of heart. It might be a candidate gene for congenital heart disease.
Animals ; DNA Copy Number Variations ; Heart ; Heart Defects, Congenital ; genetics ; Humans ; Myocytes, Cardiac ; Phenotype ; Proteins ; Zebrafish ; genetics ; Zebrafish Proteins ; genetics

Objective To compare the clinical curative effects of PTA and simple pharmacotherapy for intrapopliteal artery ischemic disease.Methods Seventy-three patients with intrapopliteal artery ischemic disease were divided into PTA group (n=37) and pharmacotherapy group (n=36).Their ABI,claudication distance,vascular patency,rest pain and amputation rate were recorded and analyzed with SPSS 22.0 at months 1,3,6,12,18 and 24 respectively before and after treat ment.The vascular patency and amputation rate were analyzed according to the Kaplan-Meier curve.Results The ABI was higher in PTA group than in pharmacotherapy group during the 1-24 months following up period after treatment,and was still higher in PTA group than in pharmacotherapy group at month 24 after treatment (0.640±0.238 vs 0.500±0.152,P=0.038).The claudication distance was shorter and the rest pain was milder in PTA group than in pharmacotherapy group at months 1 and 3,and at months 1-18 respectively (P＜0.05,P＜0.01).No significant difference was found in amputation-free survival curves between the two groups (Plogrank =0.618).Conclusion The symptom improvement of PTA is better than that of pharmacotherapy for patients with severe rest pain or severe intermittent claudication.

Objective: To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control. Methods: A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), and a non-inferiority test was also performed. Results: A total of 561 patients with genotype 1/6 CHC were enrolled, among whom 529 received treatment; 90.9% of these patients had genotype 1 CHC. The data of the full analysis set showed that SVR rate was 69.80% (95% CI 65.00%-74.60%) in the trial group and 74.16% (95% CI 67.73%-80.59%) in the control group (P = 0.297 0). The data of the per protocol set (PPS) showed that SVR rate was 80.63% (95% CI 76.04%-85.23%) in the trial group and 81.33% (95% CI 75.10%-87.57%) in the control group (P = 0.849 8), and the 95% CI of rate difference conformed to the non-inferiority standard. The analysis of the PPS population showed that of all subjects, 47.9% achieved rapid virologic response, with a positive predictive value of 93.8%. The incidence rate of adverse events was 96.30% in the trial group and 94.94% in the control group, and the incidence rate of serious adverse events was 5.13% in the trail group and 5.06% in the control group. Conclusion In the regimen of Peg-IFN-α combined with ribavirin for the treatment of genotype 1/6 CHC, the new investigational drug Peg-IFN-α-2b(Y shape, 40 kD) has comparable clinical effect and safety to the control drug Peg-IFN-α-2a.

Objective: To investigate the clinical effect and safety of long-acting pegylated interferon-α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 μg/week) in the treatment of HBeAg-positive chronic hepatitis B (CHB) patients, with standard-dose Peg-IFN-α-2a as positive control. Methods: This study was a multicenter, randomized, open-label, and positive-controlled phase III clinical trial. Eligible HBeAg-positive CHB patients were screened out and randomized to Peg-IFN-α-2b (Y shape, 40 kD) trial group and Peg-IFN-α-2a control group at a ratio of 2:1. The course of treatment was 48 weeks and the patients were followed up for 24 weeks after drug withdrawal. Plasma samples were collected at screening, baseline, and 12, 24, 36, 48, 60, and 72 weeks for centralized detection. COBAS® Ampliprep/COBAS® TaqMan® HBV Test was used to measure HBV DNA level by quantitative real-time PCR. Electrochemiluminescence immunoassay with Elecsys kit was used to measure HBV markers (HBsAg, anti-HBs, HBeAg, anti-HBe). Adverse events were recorded in detail. The primary outcome measure was HBeAg seroconversion rate after the 24-week follow-up, and non-inferiority was also tested. The difference in HBeAg seroconversion rate after treatment between the trial group and the control group and two-sided confidence interval (CI) were calculated, and non-inferiority was demonstrated if the lower limit of 95% CI was > -10%. The t-test, chi-square test, or rank sum test was used according to the types and features of data. Results: A total of 855 HBeAg-positive CHB patients were enrolled and 820 of them received treatment (538 in the trial group and 282 in the control group). The data of the full analysis set showed that HBeAg seroconversion rate at week 72 was 27.32% in the trial group and 22.70% in the control group with a rate difference of 4.63% (95% CI -1.54% to 10.80%, P = 0.1493). The data of the per-protocol set showed that HBeAg seroconversion rate at week 72 was 30.75% in the trial group and 27.14% in the control group with a rate difference of 3.61% (95% CI -3.87% to 11.09%, P = 0.3436). 95% CI met the non-inferiority criteria, and the trial group was non-inferior to the control group. The two groups had similar incidence rates of adverse events, serious adverse events, and common adverse events. Conclusion In Peg-IFN-α regimen for HBeAg-positive CHB patients, the new drug Peg-IFN-α-2b (Y shape, 40 kD) has comparable effect and safety to the control drug Peg-IFN-α-2a.

BACKGROUND:Some studies have focused on bone marrow mesenchymalstem cells (BMSCs) combined with allograft bone or artificial bone substitute materials for bonedefect repair. But there is no report on BMSCs combined with Bio-oss for repair of rabbit skull defects as yet.OBJECTIVE:To observe the effect ofBMSCs combined with Bio-oss in repairing skull defects in rabbits.METHODS:BMSCs from male rabbits were isolated, cultured, and used as seed cells. In the skull of the female rabbits,three full-thickness bone defects with the same external diameter of 6 mm were made by a ring bone drill. Ninety-six female rabbits were randomly divided into four groups, and given Bio-oss/BMSCs in combination group, Bio-oss alone in Bio-oss group, BMSCs implantation in BMSCs group, and no intervention in blank group. All the implant surfaces were covered with guided tissue regeneration membrane.RESULTS AND CONCLUSION:The osteogenic effect in the combination group was better than that in the other three groups, and the Bio-oss group showed better osteogenesis in comparison with BMSCs and blank groups. But there was no significant difference between the BMSCs and blank groups. These findings indicate that the combined use of BMSCs as seed cells and Bio-oss as a scaffold material exerts overt osteogenic effects in rabbit skull defect area, which provides a new idea for the clinical treatment of bone defects.

Objective To assess the variations in different thyroid stimulating hormone(TSH) and free thyroxine (FT4) detection kits for evaluating thyroid function during pregnancy and to establish the corresponding normal reference ranges.Methods This study was based at the International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiaotong University School of Medicine.A total of 200 pregnant women who visited the hospital between June,2011 and September,2012 were recruited in this study according to the National Academy of Clinical Biochemistry (NACB) criteria.Blood samples were sequentially collected from the women at the first (T1,9-12 weeks),second (T2,16-24 weeks) and third (T3,32-36 weeks) trimesters to determine the serum TSH and FT4 levels using four different detection kits (Siemens-C,Siemens-Ⅰ,Abott and Roche).A linear trend test was used to analyze serum TSH and FT4 levels with four different kits.A percentile range of P2.5 to P97.5 was used to establish the normal trimester-dependent reference ranges of TSH and FT4 levels for different detection kits.The Bootstrap method was used to compare the differences in the four reference ranges.Results Similar dynamic changes in TSH and FT4 levels during pregnancy were detected among the different kits (F=0.950,P=0.595; F=11.640,P=0.081,respectively).Among the four reference ranges of TSH,the Roche kit showed the most remarkable fluctuation during pregnancy,while Roche kit in the first trimester and Siemens C kit in the second and third trimesters showed larger fluctuations in reference ranges of FT4.More importantly,the reference ranges of TSH and FT4 showed significant variations among the four different kits in each trimester (TSH:T1:F=2 945.390,P ＜ 0.01; T2:F=2 826.260,P ＜ 0.01; T3:F=1 698.360,P ＜ 0.01.FT4:Tl:F=1 145.440,P ＜ 0.01; T2:F=2 260.240,P ＜ 0.01; T3:F=1 439.920,P ＜ 0.01).Conclusions TSH and FT4 measurement using four different commercial kits showed similar trimester-dependent dynamic changes.However,it is necessary to establish trimester-dependent and detection kit dependent normal reference ranges of TSH and FT4 for thyroid function evaluation for pregnant women.

Objective To establish a diabetic rat model of hindlimb ischemia, and provide a test method for dia-betic limb ischemia and diabetic foot study.Methods Twenty-five Wistar rats were divided into three groups:the model group and control group ( n=10) , and sham operated group ( n=5) .The rats of model group were induced by intraperito-neal injection of streptozotocin ( STZ, 60 mg/kg) , with the blood glucose level over 16.8 mmol/L, while the rats of control group were injected with normal saline.All the rats had the left femoral artery and its branches ligated, and then Doppler scan blood flow analysis was performed for the two hind limbs after operation at different time points.In the meantime, the changes of body weight and blood glucose were observed.The animals were sacrificed at 21days after operation.HE stai-ning was used to observe the pathological changes of gastrocnemius and femoral arteries.Capillary density and intima hyper-plasia were examined using immunostaining for CD31 and a-SMA.Results Blood glucose of the model group rats was sig-nificantly increased as well as the quantity of urine and feces,and associated with weight loss, which were maintained for more than 21 days.The blood flow of control rats was markedly decreased immediatly after operation, reached to the lowest point after surgery, and recovered from 7 -14 days after operation.In contrast to the control group, the model group showed a marked reduction in blood flow in the ischemic hind limb.Pathological examination revealed remarkable vascular atrophy and a significantly reduced number of vessels per high power field in the gastrocnemius muscle of model group rats with respect to the control group, and the femoral arteries of model rats were more narrowed than that of the control rats. Conclusions In this study, an effective, convenient diabetic rat model of hindlimb ischemia is successfully established which will facilitate the studies of drug intervention for diabetic limb ischemia and diabetic foot in the future.