OBJECTIVE To evaluate the effectiveness， safety， economy， innovation， suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein （EC）， and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin （TB-PPD） were analyzed by the method of systematic review. Cost minimization analysis， cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD， and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation， suitability and accessibility were determined by systematic review and improved Delphi expert consultation， and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness， safety， economy， innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent， while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight， the scores of effectiveness， safety， economy， innovation， suitability， accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD， EC performs better in all dimensions of effectiveness， safety， economy， innovation， suitability and accessibility. However， it is worth noting that EC should further improve its availability in the dimension of accessibility.

Polymyxin B, which is a last-line antibiotic for extensively drug-resistant Gram-negative bacterial infections, became available in China in Dec. 2017. As dose adjustments are based solely on clinical experience of risk toxicity, treatment failure, and emergence of resistance, there is an urgent clinical need to perform therapeutic drug monitoring (TDM) to optimize the use of polymyxin B. It is thus necessary to standardize operating procedures to ensure the accuracy of TDM and provide evidence for their rational use. We report a consensus on TDM guidelines for polymyxin B, as endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. The consensus panel was composed of clinicians, pharmacists, and microbiologists from different provinces in China and Australia who made recommendations regarding target concentrations, sample collection, reporting, and explanation of TDM results. The guidelines provide the first-ever consensus on conducting TDM of polymyxin B, and are intended to guide optimal clinical use.
Humans ; Anti-Bacterial Agents/therapeutic use* ; China ; Drug Monitoring/methods* ; Polymyxin B ; Practice Guidelines as Topic

Objective:To investigate the predictive value of mucosal vascular pattern (MVP) under narrow-band imaging (NBI) enteroscopy in patients with ulcerative colitis (UC) in clinical remission for histological healing and clinical recurrence.Methods:A total of 142 patients with UC in clinical remission who visited the First Affiliated Hospital of Weifang Medical University from January 2018 to January 2021 were included in the study and underwent colonoscopy. The white light and NBI endoscopic images were collected and biopsies were obtained. The Mayo endoscopic score (MES) was calculated based on white light images, and MVP staging was evaluated based on mucosal vascular patterns under NBI. Nancy index (NI) was used to evaluate histological healing and patients were followed up for 1 year. The Spearman correlation coefficients of MES and MVP with histological healing and recurrence were calculated. The receiver operator characteristic (ROC) curve was plotted and the area under curve (AUC) was applied to evaluate the accuracy of white light and NBI endoscopy for predicting histological healing of UC in clinical remission.Results:According to the MVP criteria, 47 were defined as clear, 63 blurred, and 32 invisible. Spearman correlation analysis showed a significant correlation between MVP under NBI and histological healing ( r=0.549, P<0.001) and a moderate correlation between MES under white light and histological healing ( r=0.462, P<0.001). Spearman correlation analysis showed a moderate correlation between MVP under NBI and clinical recurrence ( r=0.451, P<0.001) and a moderate correlation between MES under white light and clinical recurrence ( r=0.352, P<0.001). AUC of NBI for diagnosing histological healing of UC in clinical remission was 0.809 (95% CI: 0.738-0.879), with a sensitivity of 84.6% (77/91) and specificity of 64.7% (33/51), superior to the white light endoscopy, of which AUC, sensitivity and specificity were 0.763 (95% CI: 0.678-0.848), 81.3% (74/91) and 66.7% (34/51). Conclusion:MVP staging under NBI could predict histological healing of UC patients in clinical remission and is superior to white light endoscopy.

Objective:To investigate the clinical effect of the transverse rectus abdominismuscle (TRAM) on reconstruction of the breast.Methods:The clinical data of 23 patients receiving TRAM breast reconstruction in our department from Jan. 2018 to Dec. 2019 were retrospectively analyzed.Results:The operation time of 23 patients ranged from 240 to 360 mins, andthe average time was about 300 mins. Intraoperative bleeding was about 120 to 200 ml, with an average of 170 ml. All the flaps survived successfully, but 2 cases were complicated with local fat necrosis. The postoperative period was between 6 and 12 months. No local tumor recurrence or metastasis was found inall patients during postoperative follow-up, and the breast shape was maintained in good condition.Conclusion:TRAM can make up for the regret of breast loss caused by breast cancer in female patients. It can bring confidence in life and work to female patients, and the technology is safe and reliable, which is worthy of promotion.

Objective To evaluate the analytical performance of four lipoprotein associated phospholipase A2(Lp-PLA2)activity reagents on Beckman AU5800 automatic biochemical analyzer. Methods The remaining serum samples of 214 patients and 140 apparently healthy individuals were collected from March to July 2017 in Peking Union Medical College Hospital.These samples were used for method comparison and reference interval evaluation.According to the guidelines of EP15-A,EP6-A,EP-17 and EP7-P from Clinical and Laboratory Standards Institute(CLSI)standards,the precision, linearity, sensitivity and common interferences(e.g free bilirubin, conjunct bilirubin, hemoglobin and chyle)were assessed.According to EP9-A2,method comparisons of differents regents(Evermed,DiaSys,Hengxiao and Zhongyuan were labeled as A,B,C and D,respectively)were conducted and the differences were estimated at medical decision levels(328U/L,391U/L and 485U/L).Results The precision of four reagents were acceptable.The repeatability(CV%)of A to D were 0.5%-1.7%, 0.7%-3.0%, 0.9%-2.0% and 0.5%-3.3%,respectively.The reproducibility(CV%)were 0.7%-2.9%, 1.4%-3.2%, 1.3%-1.9%and 0.8%-4.1%,respectively.Both of those achievedlaboratory defined quality objective(<5%).The linearity of A to D were 44 -1 992 U/L,39 -1 798 U/L,13 -540 U/L and 75-1 717U/L,respectively.The regression coefficient R2 was between 0.997 and 1.000, and the correlation coefficient(r)was between 0.998 and 1.000.The interference of chyle were acceptable among these four reagents andmet the manufacturer′s requirementsor clinical needs.In a low level of Lp-PLA2,bilirubin had an obvious interferenceonreagent C;B and C were negatively affected when the hemoglobin was 4.5 g/L; and D was positively affected when the hemoglobin was 2.45 g/L.The regression coefficients R2 of A,C,D compared with B were between 0.978 and 0.995,and the correlation coefficients(r)were between 0.989 and 0.998. The expected differences at medical decision levels ranged from -240 U/L to 113 U/L.For A to D,the Lp-PLA2 activity results of 131(93.6%), 140(100%), 82(58.6%), and 128(91.4%)cases were analysed within the manufacturer′s claimed reference intervals.Conclusion The precision and linearity of the four Lp-PLA2 activity detection reagents used in automatic biochemical analyzer are good, but the anti-interference ability needs to be improved.

Objective To establish methods for the determination of spinosin and total saponins in compound Zaoshen tablet .Methods The separation of spinosin was performed on Agilent Zorbax SB C18 column (250 mm × 4 .6 mm ,5 μm) at 30℃ with water and acetonitrile as mobile phase for gradient elution at the flow rate of 1 .0 ml/min .The detection wavelength was 335 nm .Determination of total saponins was fulfilled by column chromatography followed by UV spectrometer with vanil-lin glacial acetic acid colorimetry .The detection wavelength was 560 nm .Results Linear range of spinosin was 20-100 μg/ml (r=0 .9990) and total saponins was 40-200 μg/ml (r=1 .0000) .The average recoveries for accuracy tests were 99 .55% and 99 .85% respectively .Conclusion Those methods are accurate and reliable .They can be used for the quality control of com-pound Zaoshen tablet .

Background and purpose: The literature on dose-volume parameters and pneumonitis is extensive. The results are inconsistent, both for the best predictive metrics and significant comorbid factors. This study aimed to investigate a prospective functional equivalent uniform dose (fEUD) with perfusion single photon emission computed tomography (SPECT) images as predictors of radiation pneumonitis (RP) in patients undergoing curative radiotherapy (RT). Methods: Functional lung imaging was performed using SPECT for perfusion imaging. Perfusion factors were defined as the mean percentile perfusion levels of the 4 areas, top to 75%, 75% to 50%, 50% to 25%, 25% to 0%, re-spectively. fEUD was calculated from perfusion factors and standard dose-volume parameters extracted from treatment planning computed tomography (CT) scans. Total lung (TL), ipsilateral (IL) and contralateral lung (CL) volumes minus gross tumor volume (GTV), whole-lung V5, V20, whole lung fEUD, IL and CL fEUD, and general equivalent uniform dose (gEUD) were analyzed to evaluate correlations between RP using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Statistical significance was defined as P<0.05. Results: A total of 15 patients treated with intensity modulated RT or 3D conformal RT were analyzed, grades≥3 RP were observed in 6 patients. There was only a trend toward significance for unilateral (UL) fEUD of higher dose side (P=0.007). Whole-lung V5, V20 were almost identical between patients who developed pneumonitis and patients who did not, as the values were below the recommended thresholds from published papers. Unilateral fEUDs were linear with unilateral gEUDs (t=0.815, P=0.000). Conclusion: SPECT-based equivalent uniform dose appears to be a better predictor of RP compared to stan-dard dose-volume parameters. Planning constraints should aim to keep unilateral fEUD below 21 Gy.

OBJECTIVE:To provide reference for rational drug use and strengthen the management of adjuvant medication man-agement in the hospital. METHODS:1 080 and 860 discharged medical records of 12 Vitamins for injection were selected from our hospital during Jun.-Nov. 2014 (pre-special comment group,i.e. group A) and Jun.-Nov. 2015 (post-special comment group,i.e. group B),respectively. The application of 12 Vitamins for injection,hospitalization stay,drug cost and the incidence of ADR were compared before and after adjuvant medication special comment. RESULTS:After adjuvant medication special comments,the propor-tion of drug use of no indication,unsuitable solvent selection,irrational drug dosage,drug use of drug interaction and contraindica-tion,drug cost and the incidence of ADR in group B were all lower than in group A,with statistical significance(P<0.05). There was no statistical significance in hospitalization stay between 2 groups(P>0.05). CONCLUSIONS:Clinical pharmacists adopt adju-vant medication special comments to effectively standardize clinical application of 12 Vitamins for injection in our hospital.

Objective Using evidence-based nursing method to formulate an nursing program for one heat stroke ( HS) with rhabdomyolysis ( RM) and multiple organ dysfunction syndrome ( MODS) patient, who were treated by continuous renal replacement therapy( CRRT) . Methods Based on fully assessing the patients′conditions, the clinical problems were put forward according to PICO principles. The Cochrane library, MEDLINE, PubMed, EBMR inquiry evidence-based medicine databases, National Guideline Clearinghouse, RNAO, CBM, WanFang database, CNKI and Critical Care Medicine Branch of Chinese Medical Association clinical guidelines were retrieved to collect high quality clinical evidence, and then the optimum nursing program was designed in line with patients′conditions and relatives′willingness. Results Ten trials and one application guideline were included. The available clinical evidence displayed that:(1)HS patient with RM should be given CRRT as soon as possible, it could not only reduce core body temperature, but also effectively removed myoglobin and significantly improved renal function; ( 2 ) Femoral vein catheter was the first choice for establishing vascular access;(3)The systemic anticoagulation with un-fractionated heparin should be scheduled for coagulation laboratory examination and closely observed the hemorrhage; ( 4 ) Routine use of intermittent saline flush pipes was not recommended. So finally a nursing plan was made in combination with literature evidence, patients′ condition and relatives′ willingness: we used CRRT early; choose femoral vein catheter;closely observed of hemorrhage and adjusted the dose of heparin according to activated partial thromboplastin time ( APTT) when using systemic anticoagulation with un-fractionated heparin, not used intermittent saline flush pipes. After CRRT and other comprehensive treatment, the patient regained consciousness after seven days. Myoglobin was down to 200 ng/ ml from 1 455 ng/ ml admission, with astable vital signs. Conclusions HS patients with RM should be given CRRT as soon as possible. Femoral vein catheter is the first choice for establishing vascular access. The systemic anticoagulation with un-fractionated heparin should be scheduled for coagulation laboratory examination and closely observed of hemorrhage. Routine use of intermittent saline flush pipes is not recommended.

Objective To investigate the effects of transient receptor potential vanilloid 1 activation by capsaicin on the oxidative stress in lipopolysaccharide-induced lung injury in mice in order to elucidate the potential mechanisms.Methods A total of 108 specific pathogen free (SPF) ICR male mice were randomly divided into six groups:normal control group (n =18),capsaicin control group (CAP control group,n =18),capsazepine control group (CAPZ control group,n =18),acute lung injury group (n =18),capsaicin treatment group (CAP treatment group,n =18) and capsazepine treatment group (CAPZ treatment group,n =18).After modeling,superoxide dismutase (SOD),catalase (CAT) and malondiachehyche (MDA) levels in lung were measured with the method of chromatometry,and the expression of heme oxygenase 1 (HO-1) in lung tissue was assessed with enzyme linked immunosorbent assay (ELISA),while the level of NF-E2-related factor-2 (Nrf2) was determined by western blotting and the expression of Nrf2 mRNA was measured by RTPCR.Pathological changes of lung tissue were observed under light microscope.Results The activities of SOD and CAT in lung tissue at 3,8,16 h were dramatically lower in acute lung injury group than those in normal control group (P ＜ 0.05),while the level of MDA was higher.Compared with acute lung injury group,the lung levels of SOD and CAT at 8 h and 16 h were higher in CAP treatment group (P ＜0.05),while the lung level of MDA was lower (P ＜ 0.05).The levels of SOD and CAT in CAPZ treatment group were decreased at 8 h and 16 h,while the levels of MDA in this group were increased at 3,8,16 h (P ＜0.05).The pulmonary levels of HO-1,Nrf2 and expression of Nrf2 mRNA were significantly higher in acute lung injury group than those in normal control group (P ＜ 0.05).Compared with acute lung injury group,the levels of HO-1,NRF2 and expression of NRF2 mRNA were increased markedly in CAP treatment group (P ＜ 0.05)and were obviously decreased in CAPZ treatment group (P ＜0.05).At 8 h,16 h after modeling,the degree of lung damage was ameliorated in CAP treatment group compared with acute lung injury group under light microscope,while the lung damage was aggravated in CAPZ treatment group.Conclusions The activation of TRPV1 could apparently up-regulate the levels of CAT,SOD,Nrf2,HO-1,and reduce the MDA level in lung tissue of mice with acute lung injury,ultimately protecting the endotoxemia mice from oxidative stress.