Subject recruitment is an important part of clinical researches. It should follow the ethical principles of fairness and representativeness. The recruitment process should pay attention to protecting the privacy of sub-jects. Various recruitment materials must be approved by the ethics committee before use. Whether could recruit el-igible subjects during Phase I clinical trials will have a significant impact on the results, which should attract the relevant persons′attention including the ethics committee, researchers, clinical research associate and the sponsor.

OBJECTIVE To analyze distribution and resistance of bacteria from lower respiratory tract infection in elderly patients,and provide reference for rationl use of agents in clinics.METHODS To collect phlegm specimens from lower respiratory tract infection in elderly patients from Jan 2003 to Jun 2005 in our hospital,to identify pathogens and drug sensitivity test,the results of examination were judged according to NCCLS standard.RESULTS Among 752 pathogens strains,Gram-negative bacteria and Gram-positive cocci were 70.9% and 17.6%,respectively;the most common pathogens of them were Klebsiella pneumoniae(ESBLs 27.7%)14.89%,Pseudomonas aeruginosa 14.36%,Escherichia coli(ESBLs 35.4%)12.77%,Staphylococcus aureus(MRSA 59.0%)11.70%,and fungi 11.57%.CONCLUSIONS The bacteria from lower respiratory tract infection in elderly patients are distributed extensively.In Gram-positive cocci,resistance to vancomycin is not found elsely.Gram-negative bacteria are especially sensitive to imipenem,but with some resistant strains.

Objective: To study the e ects of Heying Anxin Fang on cardiac function and intracellular Ca2+ concentration in cadiocyte of chronic congestive heart failure rats. Methods: Animal models of heart failure were induced by subcutaneous injection of a large dose of ISO, and were randomly divided into model group, Shenmai injection group, captopril group, high, middle and low dosages of Heyinganxin Fang group and normal group with 9 in each group. To determine the indexes of LVSP, LVEDP, +dp/dtmax ,-dp/dtmax and heart weight, and determine Ca2+ concentration in cardiomyocytes by ow cytometer. Results: Compared with normal group, the indexes of heart weight, Ca2+ concentration and LVEDP in model group increased, but indexes of LVSP, +dp/dtmax, -dp/dtmax decreased obviously(P

This paper introduces the international experiments of risk management in clinical trails, responsibility of sponsor, responsibility of investigator and responsibility of other participators and to help to improve our management level of clinical trails.

Objective This study was designed to assess whether Bushen Tongluo Fang(BSTLF),a Chinese materia medica formula,can ameliorate the hypercoagulable state in rats with membranous glomerulonephritis(MGN)induced by cationized bovine serum albumin(C-BSA)in order to gain an insight into the mechanisms responsible for its therapeutic effect.Methods Seventy-two male Sprague-Dawley rats were randomly separated into six groups:the normal control group,the MGN model group,the prednisone-plus-aspirin treatment group,and the low-,moderate-,and high-dose groups of BSTLF.The model of MGN was induced by sc(preimmunization)and iv injections of C-BSA in the latter five groups.After the development of MGN model,the decoctions of BSTLF and the prednisone-plus-aspirin solution were ig administered to the treatment groups respectively twice daily for four weeks.The rats in the model group received their drinking water as vehicle controls.Urinary albumin excretion for 24 h was measured using a rat albumin ELISA kit.The platelet aggregation was analyzed by turbidimetry.The plasma level of fibri-nogen(Fib)was determined by the von Clauss assay.Radioimmunoassay was used to examine thromboxane B2(TXB2)and 6-keto-prostaglandin F1?(6-keto-PGF1?)of the renal cortex.Results Urinary albumin excretion for 24 h,maximal platelet aggregation,plasma Fib level,and TXB2 production of renal cortex in the MGN model group were significantly higher than those in the normal control group,respectively.Compared with the MGN model group,these four measurements were decreased significantly in BSTLF-treated groups.The 6-keto-PGF1? production of renal cortex in the MGN model group was subnormal but no statistically significant differences were observed between the model group and BSTLF groups.Conclusion The results of this study suggest that the administration of BSTLF could attenuate platelet aggregability,lower plasma level of Fib and reduce thromboxane A2 production by renal cortex in the rats with MGN,so that their hypercoagulable state is corrected at least partly and glomerular microthroimbosis is prevented in several ways.These effects may contribute considerably to the mechanisms of BSTLF efficacy for chronic nephritis.

OBJECTIVE To investigate the status of hospital infection of elderly in internal medicine,in order to prevent and control hospital infection of them.METHODS A restrospective survey on 157 cases of hospital(infection) of elderly from Aug 2003 to Apr 2005 was conducted in internal medicine.(RESULTS)The results showed that the high risk wards were in geriatrics,neurology,endocrinology and(cardiovascular) departments.The high risk season was in winter.Respiratory tract was the most common(infective) site.Fungi were the main pathogens.CONCLUSIONS The hospital infection of elderly should be(controlled) better,geriatrics department is the key(control) unit.Winter is the key control season.The diagnostic level of clinician about the hospital(infection) of(edlerly) should be enhanced and the antibiotic must be used reasonably.

Objective To investigate the clinical significance of serum omentin-1 levels in obesity and essential hypertension patients and its related influencing factors. Methods One hundred and thirty patients with obesity admitted to the Cadre Health Care Department of Navy General Hospital from Jun. 2011 to Dec. 2013 were enrolled in this study. According to the blood pressure,130 obesity patients were divided into simple obesity group( n=64 )and obesity hypertension group( n=66 ). Sixty non obesity patients with normal blood pressure were enrolled as control group. Serum omentin-1 levels were assessed by enzyme linked immunosorbent assay ( ELISA). Association between omentin-1 and biochemical parameters( including systolic blood pressure( SBP), diastolic blood pressure(DBP),body mass index(BMI),waist hip ratio(WHR),fasting blood glucose(FBG), triglyceride(TG),total cholesterol(TC),low density lipoprotein cholesterol(LDL-C),high density lipoprotein cholesterol( HDL-C),fasting insulin( FINS),insulin resistance index( HOMA-IR)and high sensitive C reactive protein(hs-CRP))were analyzed. Results Serum omentin-1 levels in control group was(26. 7 ± 5. 1)μg/L, significantly higher than that in simple obesity group and obesity hypertension group((22. 1 ± 3. 2)μg/L,(18. 3 ± 3. 4)μg/L;F=33. 7,P﹤0. 01),and serum omentin-1 levels in obesity hypertension group was significantly lower than that in simple obesity group( t =21. 5,P ﹤0. 05). Pearson correlation analysis showed that serum omentin-1 negatively correlated with BMI,WHR,SBP and HOMA-IR( r = - 0. 447,- 0. 340,- 0. 350,-0. 397;P﹤0. 01). There were no significant relations between omentin-1 and age,DBP,FBG,FBG,TG,TC, LDL-C,HDL-C,FINS and hs-CRP( P ﹥0. 05 ). Multiple stepwise regression analysis showed that HOMA-IR, BMI and SBP were independent influencing factors of serum Omentin-1. Conclusion The serum omentin-1 level decreases in the obesity hypertension patients. Omentin-1 is negatively correlated with BMI,SBP,and HOMA-IR, which may contribute to the underlying pathophysiology of obesity and essential hypertension.

Objective To analyze, treatment of ipsilateral Pilon and calcaneal fractures (IPCF). Methods Injury causes included fallings in seven patients, traffic injury in two and impact injury in one, with ISS score of 5-22 points. There were seven patients with open injuries and 3 with close ones. Nine pa-tients had Ⅱ-Ⅲ degree of Pilon fractures according to the AO/OTA classification and six comminuted com-pression calcaneal fractures according to the Essex-Loprest classification. The Pilon fractures were fixed by cannulated nail, screw or Kirschner wire through open reduction in six patients including four fixed with ex-ternal fixators (the calcaneal fractures were fixed with percutaneous eannulated nail or Kirschner wire by poking reduction). The calcaneal fractures were fixed with only Kirschner wire through poking reduction in two patients and double fractures treated conservatively in two. Results The reduction of Pilon and cal-caneal fractures treated by operation were markedly improved in six patients, while there occurred angular deformity and joint surface introeession in the patients treated conservatively. The wound healing of soft tis-sue was sound in seven patients but unsatisfactory in the other three. The ankle-hind foot score was 82-94 points in four patients who were followed up. Conclusions IPCF is caused by the high energy force and characterized by severe injures of the soft tissues and the bone tissues at the distal tibia and calcaneua, for which limited internal fixation plus external fixation are suitable treatment choice.

Objective To investigate the clinical results and related key points of surgical treatment for Hawkins Ⅲ talus neck fractures.Methods From March 2005 to March 2010,26 patients with Hawkins Ⅲ talus neck fracture were treated and 21 of them were followed,including 13 males and 8 females,with an average age of 37.6 years.The fractures occurred on the left side in 11 patients and on the right side in 10patients.The mechanism of injury included high falling injury in 13 patients,traffic accident injury in 7 patients and rolling down injury in 1 patient.Five cases were closed fractures and 6 cases were open fractures.A bilateral approach,the medial and lateral approaches,was used to perform the operation with cannulated screw fixation in emergency.After external fixation in functional position for 6 weeks without loading,ankle joints were allowed to take exercise with hinge brace and to bear partially basing on plain radiograph 12-16weeks later.The weight-bearing should be adjusted with follow-up.Functional results were assessed according to AOFAS (American Orthupaedic Foot and Ankle Society,AOFAS)score.Results The average duration of follow-up was 36.6 months (range,6-60 months).All fractures gained union and the average union time was 4.5 months.The average AOFAS score was 78.6.There were 4 cases in excellent results,10 in good,5 in fair and 2 in poor.The overall excellent and good rate was 67.8％.Traumatic arthritis occurred in 13 cases and avascular necrosis in 5 cases.Conclusion The effect of surgical treatment for Hawkins Ⅲtalus neck fracture via a bilateral approach is satisfactory.

The safety of TCM injection triggered attentions and hotspots in recent years in China.The centralized monitoring of TCM injection provided important evidence for analyzing the safety risk of TCM injections,recognizing adverse reactions and contraindications and perfecting the instructions.This study aimed at exploring the ethical problems on centralized monitoring.In this paper,we retrieved and screened the ethical issues of TCM injections over hospital centralized monitoring in China National Knowledge Infrastructure (CNKI,1979-Ju1.,2016).Issues over it were put forward and addressed.It is found that the current ethical issues related to hospital centralized monitoring lacks sufficient attentions,corresponding norms and requirements.Based on the ethical issues reflected from the literatures,suggestions should be pressed ahead with the ethical review of centralized surveillance,signing of informed consents,registration of research programs,data statistics and reporting stages,for the better protection of the rights and interests of subjects and improvement of research quality.