Objective:To observe the clinical efficacy of Jianpiqinghua Particles and Wentong Powder on early stage of diabetic feet adding to basal treatment,and to establish a standardized clinical diabetic foot prevention program of integrated traditional Chinese medicine.Methods:Take a randomized blind placebo-controlled add-on trial:The treatment group of 20 was given with Jianpiqinghua Particle(oral),Wentong Powder(foot washing),the control group of 20 was given placebo by same methods.The course in both groups was16 weeks.The change of total effect body and foot feeling(VAS scale),electro-neurophysiological examination and ankle/brachial ratio were evaluated.Results:The TCM group was superior to the control group in improving the body and feet clinical symptoms,nerve conduction velocity,evoked potential amplitude and the ABI index(P

Aninductivelycoupledplasmamassspectrometric(ICP-MS)methodbasedonquadrupole reaction/collision ( DRC) was developed for the determination of K,Na,Ca,Mg,Al,Cu,Zn,Pb,As and Mn in food. Samples were digested with HNO3 and H2 O2 followed by dilution with ultrapure water and then analyzed directly by ICP-MS. The signal sensitivity of high concentration element ( K, Na, Ca, Mg and Al ) was suppressed easily by adjusting the voltage parameters of DRC quadrupole ( Rpa) , and the food samples could be online diluted any multiples ( i. e. from one time to million times) according to the actual need. In order to eliminate mass spectral interferences of 40 Ar35 Cl+, the operational conditions of the DRC, working with CH4 as reaction gas, were optimized for 75 As. The limits of detection for the K, Na, Ca, Mg, Al varied from 0. 013-0. 027 mg/L, and Cu, Pb, Zn, As, Mnvaried from 0. 12-0. 61 μg/L. The accurate and reliable results were obtained for validation of the ICP-MS method with food reference material according to the national standard GBW10023 , GBW10015 , GBW10018 , GBW10017 , GBW10019 and GBW10024 . As the routine method in our laboratory, the satisfactory results indicate that it has great potential for the determination of low and high concentration level elements by one single analysis in various samples.

Objective To evaluate the feasibility of active breathing control (ABC) in conformal radiotherapy (CRT) for patients with non-small cell lung cancer (NSCLC). Methods From Feb 2005 to Mar 2008, 29 patients with inoperable NSCLC (stage Ⅱ-Ⅳ) were evaluated. For each patient, two series of CT scans were obtained with free breathing (FB) and ABC system during simulation, respectively. Then two confonnal radiotherapy (CRT) plans were finished based on the two sets of reconstructed images. The pattern of post-inspiratory breath-hold was triggered at 80% of the peak of inspiration curve. The margin of clinical target volume (CTV) to planning target volume (PTV) was 0. 6 cm for lesions of the superior lobe, and 1.0 cm for the lesions of middle and inferior lobes. Three to five coplanar fields were performed in conformal radiotherapy. The gross tumor volume (GTV), CTV, PTV, volume of the bilateral lungs (Volume_(lung)), V_(20) and mean lung dose (MLD) of two plans were evaluated by dose-volume histogram (DVH). The World Health Organization criteria and National Cancer Institute Common Toxicity Criteria 3.0 (NCI-CTC3.0) scale were used to assess the immediate response and acute side-effect, respectively. Results Significant differences of GTV, CTV, FIN, Volum_(lung), V_(20) and MDL were observed between the two plans (36. 35 cm~3 vs. 31.40 cm~3, t = 9. 70, P <0. 001 ;82. 33 cm~3 vs. 70. 83 cm~3, t = 8. 19, P < 0. 001 ; 230. 73 cm~3 vs. 197.59 cm~3 ,t=5.72,P <0. 001 ;21.66% vs. 18. 76% ,t = 11.16,P <0. 001 ;1329. 07 Gy vs. 1143. 14 Gy, t = 13. 24, P < 0. 001). With ABC, all patients completed their treatment successfully except one patient for financial problems. The median radiation dose to the GTV was 64 Gy (60 -64 Gy). The overall immediate response rate was 64% (18/28). According to the NCI-CTC 3.0, grade 1 and 2 acute radiation-related toxicities occurred in 68% (19/28) and 18% (5/28) of patients for esophagitis, 82% (23/28) and 7% (2/28) for pneumonitis, respectively. Grade 1, 2 and 3 bone marrow suppression occurred in 57% (16/28), 25% (7/28) and 14% (4/28) of patients, respectively. Grade 1 and 2 acute cardiac injuries occurred in 86% (24/28) and 14% (4/28) of patients. Conclusions During CRT for patients with NSCLC, the use of ABC can decrease the radiation dose and acute complications of normal tissues.

Objective: To analyze the clinical pathologic characteristics of cases with fluorescence in situ hybridization (FISH) positive of exfoliated urothelial cells, so as to evaluate the clinical utility of FISH in the diagnosis of urothelial carcinoma (UC).Methods: A total of 271 cases of FISH positive in Department of Urology of Peking University First Hospital from Apr.2012 to Sep.2015 were recruited in this study.Retrospective analysis was made on their clinical data.For FISH analysis, labeled probes specific for chromosomes 3, 7, 17, and the p16 (9p21) gene were used to assess chromosomal abnormalities indicative of malignancy.The positive predict values (PPV) of all the techniques were analyzed.Results: Of the 271 patients, 207 cases were UC, 7 cases were non-UC, and 57 cases were benign diseases.The PPV of FISH in detecting UC was 76.4%, while the 95% confidence interval (CI) 71.3% to 81.5%.In the cohort of FISH positive, this value was similar to that of urinary cytology (PPV 86.8%, 95% CI: 78.5%-95.0%).The PPV of FISH was lower than that of cystoscopy and ureteroscopy (PPV 96.1%, 95% CI: 91.7%-100.0%).There were significant differences between this study and the PPV of FISH reported abroad (PPV 53.9%, χ2=33.048, P<0.001).Of all the UC with FISH positive, bladder cancer showed an earlier pathological stage versus renal pelvic carcinoma and ureteral carcinoma, with significance (χ2=5.894, P=0.015, and χ2=13.601, P<0.001, respectively).However, no difference was found in the size, pathological stage and pathological grade of tumors between the urinary cytology positive group and the urinary cytology negative group.The rate of high-grade UC in ureteral carcinoma of FISH positive was 92.3%, much higher than that of ureteral carcinoma reported domestically.Conclusion: The PPV of FISH in detecting UC is higher relatively, with a better clinic value for Chinese patients.The ureteral carcinoma with FISH positive obtains a higher pathological grade, which is of great guiding significance for UC.

Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.
Equipment and Supplies ; Medical Audit

The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.
China ; Equipment and Supplies ; Medical Audit ; Quality Control

Objective To evaluate the efficacy and safety of epalrestat, an aldose reductase inhibitor, and epalrestat plus methylcobalamine on diabetic peripheral neuropathy, as compared with methylcobalamine. Methods A total of 444 subjects with diabetic neuropathy were enrolled in the study, and divided into methylcobalamine group ( n= 145 ) , epalrestat group ( n = 143 ) , and methylcobalamine combined with epalrestat group ( n = 156 ) . Therapeutic efficacay was assessed in terms of clinical symptoms and physical examinations by using Michigan Neuropathy Screening Instrument ( MNSI ) , and electrophysiological assessments. Results After 4 to 12-weeks′treatment, symptoms and signs of neuropathy ( using MNSI ) are significantly improved in the three groups ( P<0. 01). The mean changes of MNSI ( questionnaire) score from baseline were higher in epalrestat group and methylcobalamine combined with epalrestat group as compared with that of methylcobalamine group(P<0. 05), but no difference was detected in the change of MNSI ( physical examination ) score from baseline among three groups. After treatment for 12 weeks, motor nerve conduction velocity ( MNCV ) was significantly improved in epalrestat group and methylcobalamine combined with epalrestat group(P<0. 05), but no difference was detected in MNCV at 12 week among three groups(P>0. 05). Conclusion Epalrestat is effective and safe in the treatment of diabetic neuropathy. Furthermore, epalrestat is more efficacious in ameliorating symptoms and MNCV of neuropathy than methylcobalamine. However, while no improved efficacy is shown with the combined treatment.

Persistent Chlamydia trachomatis urogenital tract infection may lead to pelvic inflammatory disease, ectopic pregnancy and tubal infertility in women, and urethritis, epididymitis and other complications in men, which is a hotspot and chanllenge in disease control at home and abroad. In recent years, many researches have shown that Chlamydia trachomatis aberrant reticulate body may be one of the major causes of persistent infection. This review summarized the genomic and proteomic characteristics of Chlamydia trachomatis aberrant reticulate body induced under various conditions in vitro, aiming to elucidating its role in antimicrobial resistance. The identification of persistent infection-related factors, providing new diagnostic targets for the detection of subclinically refractory long-term infections, is a prerequisite for finding appropriate methods to diagnose and treat the complications of Chlamydia trachomatis infection and is crucial for identifying new targets in the post-genomic era.