Objective To explore ways and means to improve the investigator compliance through the evaluation and analysis of the investigator compliance of TCM clinical research projects of chronic diseases. Methods Totally 28 studies from the project Chinese medicine clinical study on prevention and treatment of chronic disease started in 2010 or 2011 and ended in 2015 were collected. The investigator compliance was analyzed by the evaluation form, which were drafted by quality control core team of TCM projects of chronic diseases, as research method performance, compliance of subjects inclusion and exclusion, integrity, accuracy and normalization of case report form in final quality evaluation for TCM clinical research on chronic diseases. Results There were 19 excellent studies according to investigator compliance, accounting for 67.9%, including 3 studies with ten score, accounting for 10.7%. There were 8 good studies according to investigator compliance, accounting for 28.6%. There was 1 study up to standard, accounting for 3.6%. 11 studies included unreasonable changes in the record during the process of implementation. 12 studies included missing in the filling of research records during the process of implementation. Conclusion In general, 28 studies of TCM linical research projects for chronic diseases show high investigator compliance. The existing problems are mainly found in the integrity and normalization of research records.

Objective To study the expression of skin aspartic protease (SASPase) in lesions of cutaneous lupus erythematosus (CLE) and its role in the pathogenesis of CLE.Methods Skin samples were resected from the lesions and normal skin of 9 patients with CLE,including 3 cases of subacute cutaneous lupus erythematosus (SCLE),4 cases of discoid lupus erythematosus (DLE) and 2 cases of acute cutaneous lupus erythematosus (ACLE).Keratinocytes were isolated from the tissue samples and cultured in serum-free medium.Total proteins were extracted from the keratinocytes and separated by two-dimensional gel electrophoresis.ImageMaster 2D analysis software was used to assess differentially expressed proteins in keratinocytes between the lesional and normal skin,which were identified by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF-MS).The expression levels of SASPase were further determined by Western blot.The data were analyzed statistically by Student's t test.Results Keratinocytes were isolated from the tissue samples and successfully cultured in vitro.Two-dimensional electrophoresis profiles of proteins from the keratinocytes were obtained with high resolution and reproducibility,and the average matching protein spots were about 1200 with the matching rate higher than 80％.As Western blot showed,the relative expression level of SASPase was 0.463 ± 0.018 in keratinocytes from the lesional skin,and 0.145 ± 0.011 in those from the normal skin (P ＜ 0.05).The Western blot results were consistent with those of two-dimensional electrophoresis.Conclusion The initiation and progression of CLE seem to be associated with the abnormal activation and overexpression of SASPase.

Objective To observe the clinical efficacy and safety of calcipotriol betamethasone ointment for the treatment of pso‐riasis vulgaris in the stable stage of patient .Methods This was a randomized ,parallel controlled clinical trials ,in which 90 patients with psoriasis vulgaris were randomly divided into experimental group and controlled group .All of them received 4 weeks of thera‐py .We compared the efficacy and safety 1 ,2 ,4 week after treatment by calcipotriol betamethasone ointment .Results About the clinical efficacy ,according to the decrease in percentage of psoriasis area and severity index (PASI) were:23 patients in the experi‐mental group were effective(efficacy rate is 76 .67% ) ,14 patients in control group Ⅰ was effective(efficacy rate is 46 .67% ) ,15 pa‐tients in control group Ⅱ was effective(efficacy rate is 50% ) .The differention between experimental group and the two control groups was significant(P< 0 .05 ,P< 0 .01) .After 1 ,2 ,4 weeks of therapy ,the decrease in percentage of PASI of experimental group is higher than that in the control groups .The scores of the observed erythema ,infiltration ,scale were decreased ,and the total scores of PASI are also decreased 4 weeks after therapy .The decrease score of experimental group is higher than that of control group Ⅰ(P<0 .01) and control group Ⅱ(P<0 .01) .The side effects of the experimental group are mild such as itching ,folliculi‐tis ,erythema ,and the laboratory examinations had no abnormal changes .Conclusion Calcipotriol betamethasone ointment was more effective to treat the stable stage psoriasis vulgaris patients compared with single use of halometasone or calcipotriol .It takes effect quickly ,and could be more feasible and safe .

Objective To investigate the therapeutic effect of trimetazidine(TMZ) and atorvastatin on coronary no-flow/slow-flow phenomenon (CNFP/CSFP) emergency pereutaneous coronary intervention (PCI)Methods Thirty-two patients with acute myocardial infarction were selected as our subjects,who hospitalized from April 2007 to May 2012 after PCI with CNFP/CSFP.Patients were administrated with the TMZ (60 mg/d)and atorvastatin (20 mg/d) for 6 months besides the routine therapy.The changes of the clinical symptoms including ECG exercise test,coronary flow of coronary angiography(CAG) were recorded and the level of serum high sensitivity C-reactive protein (hs-CRP),matrix metalloproteinase-9 (MMP-9),tumor necrosis factor-α (TNF-α) and interleukin-6(IL-6) were measured before and after the treatment.Results (1)The symptoms of the patients were improved remarkably;the effective rate was 87.5％ (28/32).The improving rate of ECG was 90.6％.The CTFC of patients after treatment was (20.17 ± 4.36),significantly lower than that of before treatment (35.34 ± 7.43,t =2.409,P ＜ 0.05).(2) The levels of hs-CRP,MMP-9,TNF-a and IL-6 at after treatment were (3.34 ±0.47) mg/L,(173.09 ±42.19) μg/L,(8.47 ±2.09) μg/L,(89.37 ± 18.72) ng/L,lower than that of before treatment ((12.34 ± 2.43) mg/L,(972.68 ± 131.91) μg/L,(23.54 ± 7.48) μg/L,(154.39 ± 42.07) ng/L),and difference were significant (t =2.537,2.789,2.691,2.430,P ＜ 0.01 or P ＜0.05).Conclusion The therapy approach of TMZ and atorvastatin plus routine treatment of nitrate and aspirin showed a better therapeutic effect on CNFP/CSFP.The causes of CNFP/CSFP may relate to inflammation.

Objective To investigate the effect and safety of rotational power-driven thrombectomy therapy through intrapulmonary for acute massive pulmonary thromboembolism.Methods Sixteen patients of acute massive pulmonary thromboembolism diagnosed by CT and pulmonary angiography were treated with Straub Rotarex system.The successful rate,release of clinical manifestations and the blood hemodynamic changes were observed and analyzed.Results The clinical manifestations were improved remarkably in all the 16 patients,arterial partial pressure of oxygen,saturation of arterial blood oxygen,shock index,Miller score and mPAP were (56.7± 13.4) mm Hg,84.1 ± 10.4)％,(1.27 ±-0.39),(22.7±11.4) and (36.3 ±9.4) mm Hg respectively before treatment,and (92.2 ± 8.6) mm Hg,(96.6 ± 12.7) ％,(0.57 ± 0.42),(12.1 ± 7.8)points and (21.9 ± 7.3) mm Hg respectively after treatment,which were all improved significantly (t =-2.794,2.601,-2.592,-2.638,-2.617,P ＜ 0.01).Conclusion Rotational power-driven thrombectomy therapy through intrapulmonary is an effective and safe technique for the treatment of acute massive pulmonary embolism.

Objective To compare the egicacy and security of intracoronary administration of tirofiban combined high-dose adenosine during percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (STEMI).Methods Eighty-eight cases with STEMI were randomly divided into observation group(44 cases) who were accepted 2 times intracoronary adenosine(2 mg,10 ml 0.9％ NaCl),and control group(44 cases) who were afforded only 10 ml 0.9％ NaCl by prospective,double-blind,and random study.The two groups were received10 g/kg tirofiban after aspiration catheter in the culprit lesion distal bolus injection of 3 rain,at the same time,continuous infusion of 0.15 g/(kg · min) for 24 h.The postoperative coronary arteriography and electrocardiogram were evaluated.Meanwhile,the postoperative myocardial blush grade(MBG),thrombolysis in myocardial infarction (TIMI),corrected TIMI frame counts (CTFC),ST-segment elevation resolution (STR) major adverse cardiac events (MACE),and adverse reactions of adenosine were recorded.Results There was no significant difference in terms of postoperative TIMI and STR between two groups (P ＞ 0.05).The CTFC of observation group was (24.4 ± 4.9) frames,significant better than that of control group((21.9 ±3.7) frames;t =2.701,P ＜0.01).The ratio of MBG in observation group was 24/44,higher than that of control group(14/44 ; x2 =4.632,P ＜ 0.05).There were no significant difference regarding of the ratio of death,MACE,target vessel revascularization,grade of NYHA between observation and control group at followed up for 1 and 12 month (P ＞ 0.05).The ratio of patients with blood pressure decrease ≥ 10 mm Hg,new second degree atrioventricular block in observation group were 15.9％ and 20.5％,higher than that in control group (2.3％ and 15.9％ ; x2 =4.950,7.221 ; P =0.026,0.007).The adverse reaction was transient.Conclusion The intracoronary administration of tirofiban combined high-dose adenosine during PCI in patients with STEMI plays an effective role on improvement of myocardial perfusion.

Objective To construct human SREBP-1c-promoter reporter gene vector and to detect its function.Methods Human blood genome DNA was extracted and pGL3-Basic-SREBP-1c-promoter reporter gene vector was constructed.Furthermore,the function of SREBP-1c-promoter was confirmed by dual-luciferase reporter assay.ResultspGL3-Basic-SREBP-1c-promoter reporter gene vector was successfully constructed and the promoter activity was obviously repressed by co-transfection FoxO1.Overexpression FoxO1 inhibited the SREBP-1c protein expression.Conclusion FoxO1 repressed the SREBP-1c protein expression through inhibition the SREBP-1c transcription.

This paper was aimed to analyze the correlation between quality evaluation and whole complete quality assessment in traditional Chinese medicine (TCM) clinical research progress,in order to discuss key steps and strategies in the clinical research progress.In accordance with the quality control indexes,all projects of Prevention and Treatment of Chronic Disease of TCM were given a research progress evaluation and complete condition.The scores were described with radar map method.The influence of research progress to whole complete quality was analyzed with correlation methods.The results showed that there was a significant correlation between research progress (including included cases and completed cases) and the total score of quality control (P ＜ 0.05).It was concluded that research progress was a key step to influence the entire clinical research level.It is necessary to strengthen the supervision on research progress to guarantee the whole research level.

Objective:To analyze the influencing factors of perioperative nosocomial infection in elderly patients with hip fracture under the background of enhance recovery after surgery so as to provide guidance for prevention and control of the nosocomial infection.Methods:The clinical data were collected from 1 628 elderly patients with hip fracture who were hospitalized from January 2018 to August 2019,during the implementation of enhance recovery after surgery in Tianjin hospital. Medical records of the patients were reviewed and statistically analyzed through hospital medical record system, the incidence of perioperative nosocomial infection and the influencing factors for the infection were observed.Results:Of the 1 628 hospitalized patients with hip fracture, 102 had nosocomial infection, 125 case-times, with the infection rate 6.27%(102/1 628) and the case-times infection rate 7.68%(125/1 628). Lower respiratory tract, urinary tract and surgical site were the dominant infection sites, accounting for 72.80% (91/125), 11.20% (14/125) and 10.40% (13/125) respectively. Univariate analysis and multivariate logistic regression analysis indicated that bone traction( OR value was 2.152, 95% CI 1.130-4.097), surgery ( OR value was 0.268, 95% CI 0.133-0.537), hospitalization days≥15 d( OR value was 12.123, 95% CI 6.017-24.426), indwelling urinary catheter ( OR value was 7.566, 95% CI 4.093-13.986), cardiac insufficiency( OR value was 2.112, 95% CI 1.192-3.740), electrolyte disturbance( OR value was 2.383, 95% CI 1.396-4.067), lower extremity arteriosclerosis obliterans( OR value was 2.540, 95% CI 1.279-5.045) and senile dementia( OR value was 3.673, 95% CI 1.670-8.082) were the influencing factors for the perioperative nosocomial infection. Conclusions:The main influencing factors of nosocomial infection in elderly patients with hip fracture during the perioperative period were bone traction, operation, length of stay, indwelling urinary catheter and coexisting diseases. The risk of nosocomial infection can be reduced by applying the concept of enhance recovery after surgery in clinical orthopedics, comprehensively optimizing perioperative management and implementing effective prevention and control measures of nosocomial infection.

Objective:To explore the effect of the traditional Chinese medicine (TCM) admission management system in the practice of promoting TCM characteristic nursing in Western medicine hospitals.Methods:Using the cluster sampling method, 839 officially staffed nurses from 42 nursing units in the Cancer Hospital of the University of Chinese Academy of Sciences were selected as the research object. In April 2018, it began to implement TCM admission management. We compared the patients' satisfaction with TCM nursing and quality control inspection scores of departments before and after implementation.Results:After the implementation of TCM nursing admission management, the satisfaction of patients with TCM nursing were all higher than those before implementation ( P<0.05) . From April 2018 to March 2020, the number of departments carrying out more than 3 TCM nursing techniques increased from 8 wards in 2018 to 33 wards in 2020. The average score of special quality control inspections for TCM specialists was increasing year by year. The quality control inspection scores in 2018, 2019 and 2020 were (92.80±2.02) , (96.17±3.04) , and (98.27±3.11) respectively. Conclusions:The implementation of the TCM admission management system, the implementation of TCM characteristic nursing in the whole hospital, and effective supervision and quality control can continuously improve the quality of TCM nursing, and also enable the long-term development of TCM characteristic nursing in Western medicine hospitals.