BACKGROUND: The angiotensin-converting enzyme (ACE) is the important component of the renin-angiotensin-aldosterone system (RAS). The ACE gene has, in fact,insertion/deletion polymorphism in intron 16, consisting of a 287-base pair Alu repeat sequence. ACE gene heterozygotes insertion/deletion (I/D) polymorphism is correlated with cardiovascular disease and IgA nephropathy and other diseases. OBJECTIVE: To investigate the distribution of ACE gene I/D polymor-phism in Chinese Han population in comparison with other known ethnic populations. DESIGN: Observation study on healthy individuals of Han nationality. SETTING: Key Laboratory of Clinical Immunology of Jiangsu Province; Department of Laboratory Medicine, First Hospital Affiliated to Soochow University; Department of aboratory Medicine, College of Medical Technology of Jiangsu University PARTICIPANTS: Totally 241 healthy individuals who received the healthy examination in the First Hospital of Soochow University between December 2005 and January 2006 were recruited in the experiment. They were 152 male and 89 female , with mean age of (27±8)years. All the participants without blood relationship were Han nationality from Suzhou region in China, free from disorder of hepatic, renal, endocrine and cardio- cerebrovascular diseases which were confirmed by clinical and experimen- tal examination. METHODS: Genotype of ACE gene I/D polymorphism allele of 241 healthy individuals of Han nationality was detected with polymerase chain reaction (PCR). PCR purified products with genotype of deletion/deletion (DD) and insertion/insertion (Ⅱ) polymorphism were performed DNA sequencing with fluorescence-labeled end termination method. MAIN OUTCOME MEASURES: Genotype and allele frequency of ACE gene I/D, as well as the comparison between them and those of other ethnic population. RESULTS: All the 241 subjects participated in final result analysis. ① The genotypes of ACE were DD, Ⅱ and ID. Compared with allele Ⅰ, allele D lost 287-base pair Alu repeat sequence. ②The frequencies of genotype Ⅱ, ID and DD were 46.1％, 41.5％ and 12.4％ respectively, with an allelic frequency of 66.8％ for allele Ⅰ and 33.2％ for allele D. ③The distribution of ACE genotype was similar between Japanese and Han nationality crowd, both presenting that type Ⅱ was commonly seen and type DD was the least; ID was mostly found in European and American crowd, but Ⅱ was little found. There was racial diversify of frequency of the distribution of ACE genotype among individuals of Han nationality and Japanese as well as Europeans and Americans. Compared with other nationalities, allele Ⅰ of individuals of Han nationality was significantly higher than that of above nationalities (χ2=105.55,P ＜ 0.01), but allele D was obviously lower (χ2=87.54,P ＜ 0.01). CONCLUSION: ACE gene polymorphism has racial diversify. To know genetic features of ACE gene polymorphism of individuals of different na tionalities is the basis and prerequisite to study the correlation of ACE gene I/D polymorphism with diseases.

OBJECTIVE:To establish a method for the bacterial endotoxin test of nicardipine hydrochloride glucose injection.METHODS:The bacterial endotoxin test was carried out according to the bacterial endotoxin test in the addenda of China Pharmacopeia 2005 edition(second part).RESULTS:Nicardipine hydrochloride glucose injection showed interference on the bacterial endotoxin test when water was taken as solvent.The preliminary interference test and interference test revealed that using thinnerⅠas solvent,the sample injection in over 4-fold dilution had no interference on the bacterial endotoxin test.CONCLUSIONS:It is feasible for bacterial endotoxin test of nicardipine hydrochloride glucose injection be conducted in a limit value of 0.5 EU?mL-1.The bacterial endotoxin text can substitute pyrogen test in the detection of nicardipine hydrochloride glucose injection.

Objective To evaluate the combination of the mortality in emergency department sepsis (MEDS) score with blood lactate level in the risk stratification of patients with severe sepsis in the emergency department (ED).Methods 665 adult patients with severe sepsis admitted from May 2011 to December 2012 in ED were found to be eligible for the study.MEDS score,acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score,and arterial blood lactate was determined,and the outcomes in 28 days were recorded.Logistic regression analysis was used to evaluate the relationship between each predictive factor score and prognosis.Each predictive factor was compared with the areas under the receiver operating characteristics (ROC) curve (AUC).Results The mortality in 28 days was 34.6％ in 665 patients.The mortality in group of MEDS score 12-27 was significantly higher than that group of MEDS score＜12 [51.0％ (156/306) vs.20.6％ (74/155),x2=28.414,P=0.000].In the meantime,APACHE Ⅱ score and blood lactate level were also significantly higher in group of MEDS score 12-27 than those in group with MEDS score＜12 [APACHE Ⅱ score:26.4 ± 10.6 vs.21.7 ± 8.1,t=-3.555,P=0.002; lactate (mmol/L):4.9 (2.3,9.9)vs.3.9 (1.5,8.9),Z=-2.352,P=0.023].Kaplan-Meier survival analysis showed significantdifference in the two groups (the Log Rank test 36.71,P ＜0.01).The levels of 3 predictive factors were predominantly higher in non-survivors than survivors [MEDS score:14.1 ± 6.7 vs.8.2 ± 4.5,t=-6.929,P=0.000; APACHE Ⅱ score:28.1 ±7.1 vs.22.2± 11.3,t=-6.472,P=0.000; lactate (mmol/L):5.4 (2.9,11.0) vs.3.8 (1.2,9.1),t=-6.472,P=0.004].The AUCs were 0.813,0.706 and 0.727 for MEDS score,APACHE Ⅱ score and blood lactate respectively.The predictive ability for 28-day mortality of MEDS score was better than blood lactate (P=0.008) and APACHE Ⅱ score (P=0.005).The AUC of MEDS score combined with lactate was 0.865,and 28-day mortality prediction was better than MEDS score (AUC 0.865 vs.0.813,P＜0.001).The sensitivity (83.1％),specificity (93.2％),positive prediction value (PPV,62.4％),and negative prediction value (NPV,92.1％) for MEDS score combined with lactate were highest among all predictors.Conclusion MEDS score combined with lactate is a good risk stratification tool for emergency patients with severe sepsis,and its prognostic capability is better than either MEDS score,APACHE Ⅱ score or blood lactate.

Chlorzoxazone ; blood ; Chromatography, High Pressure Liquid ; methods ; Cytochrome P-450 CYP2E1 ; blood ; Humans

Child ; Diagnosis, Differential ; Humans ; Lung ; pathology ; Lung Diseases, Interstitial ; diagnosis ; therapy ; Male ; Treatment Outcome

Objective To review the experience of modified sternal elevation in management of pectus excavatum deformities. Methods A retrospective study was carried out on 268 children with pectus excavatum deformities from January 2002 to December 2005.Of these patients,213 were boys and 55 were girls.Their age ranged from 2 to 16 years and 2 months[mean,(4.48?2.74) years)].Among then,69 cases were aged from 2 to 3 years,130 cases from 3 to 6 years and 69 cases over 6 years.268 patients with PE underwent modified sternal elevation and fixation with the home made stainless steel strut.The lung cysts,esophageal hatal hernia and congenital heart diseases were surgical treated simultaneously.Results There was no death postoperative.Postoperative compli- cations included pneumonia in 1 case,subcutaneous fluid in 2.the foUow-up period was 1-5 years.One patient was found having light notch in sternum.All patients had satisfactory results.In 165 cases stainless steel strut have been taken off postoperatively and no recurrence occurred.Conclusion The modified sternal elevation procedure for pectus excavatum results in an excellent cosmetic outcome.

Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase III studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.
Clinical Trials, Phase III as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Medical Informatics

Due to a great amount of data in clinical trials, the data cleansing needs to adopt a variety of measures, including the latest developed visual check approach. According to the different types of clinical data and the different stages in the course of clinical data management, this study reviews 8 types of visual graphics that show the relevance and trend among the data. The series of graphics can rapidly detect abnormal data, monitor clinical research in real-time, make the data management process much easier and improve the clinical trial efficiency and data quality.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Information Storage and Retrieval ; methods

Photothermal therapy (PTT) is a highly effective anti-tumor method. However, when laser radiation was used to ablate tumors, it usually triggers a series of inflammatory reactions, promoting the further development of tumors and affecting the effect of anti-tumor therapy. Therefore, it is an effective method to improve the anti-tumor effect by suppressing the inflammatory response through the precise targeted delivery of anti-inflammatory drug while realizing the photothermal treatment of tumors. To this end, the redox-responsive linker 3,3'-dithiodipropionic acid was used to bond the classic hydrophobic anti-inflammatory drug 18β-glycyrrhetinic acid (18β-GA) and the hydrophilic fragment methoxy-polyethylene glycol (mPEG-NH₂) to obtain redox-responsive amphiphilic polymer PEG-DA-GA in this study. Then, photothermal agent IR-780 was encapsulated to prepare redox-responsive polymer micelle PDG/IR-780 NPs. The PDG/IR-780 NPs exhibited uniform particle size of 80.2 ± 5.3 nm and the polydispersity index (PDI) was 0.215 ± 0.079. All animal experiments followed the ethical requirements formulated by the Ethics Committee of Sichuan University. The results showed that PDG/IR-780 NPs could respond to the abundant glutathione (GSH) in tumor cells to promote the disintegration of nanoparticle and the release of 18β-GA, thus significantly improved the killing efficiency on 4T1 cells, when compared with the non-redox-responsive control PSG/IR-780 NPs. When the concentration of 18β-GA was 50 μg·mL^-1, the cell viability of 4T1 cells in the PDG/IR-780 NPs group was only (19.29 ± 1.80) %, which was significantly lower than the result of in PSG/IR-780 NPs group (29.30 ± 1.37) %. The results of frozen sections of tumor tissues showed that the designed PDG NPs can promote the tumor-targeted distribution of drugs compared with the free drug group. Eventually, PDG/IR-780 NPs achieved wonderful anti-tumor efficacy on 4T1 triple-negative breast cancer model, revealing the new possibility of the combined therapy strategy of photothermal and anti-inflammatory therapy.

ObjectiveTo explore the effect and limitation of α1 adrenergic recepter blockers used in bladder management of spinal cord injured patients.Methods70 patients were divided into two groups who received intermittent catheterization and intermittent catheterization combined with Alfuzosin respectively. After 4 months of treatment, the residual urine and the time to reduce the residual urine were compared.ResultsThere was no differences in deducing the residual urine and the time to reduce the residual urine between the two groups.ConclusionAlfuzosin has limited effect in reducing the residual urine in bladder management.