Microbial contamination status of swimming places for infants and young children in Shijia-zhuang City and comparison with other public places, 2021–2022 / 环境与职业医学

Background At present, China's Public places health management regulations list 7 categories and 28 sub-categories of public places, but infant and young child swimming places are not in the list yet. Objective To understand the microbial pollution status in commercial infant and young child swimming places in Shijiazhuang City, compare with the microbial pollution in other five types of public places, and find the potential safety hazards in infant and young child swimming places. Methods A total of 3438 microbial samples were collected from the environment of infant and young child swimming places and 5 types of public places (hotels, barber stores, waiting rooms, shopping malls and supermarkets, and conventional swimming places) in Shijiazhuang City from 2021 to 2022. Sampling and monitoring were carried out according to the requirements of Examination methods for public places—Part 6: Technical specifications of health monitoring (GB/T 18204.6-2013). Chi-square test was used to compare hygiene qualification by microbial indicators, and Kruskal-Wallis H test was used to compare overall distributions of total bacterial counts on the surface of public articles. Results From 2021 to 2022, the highest qualified rate of microbial indicators on the surface of public articles was Staphylococcus aureus (100%) for all tested public places in Shijiazhuang City, followed by coliforms (99.44%), and that of total bacterial count was relative low (92.83%). The qualified rate of total bacterial count on the surface of public articles in the swimming places for infants and young children was 87.76%, and the qualified rates in hotels, barber stores, waiting rooms, shopping malls and supermarkets were all above 92%, and the difference among the 5 types of places was statistically significant (P<0.001). The highest value of total bacterial count on the surface of public articles in the swimming places for infants and young children was 80000 CFU·(25 cm2)−1 [100 CFU·(25 cm2)−1=4 CFU·cm−2]; that in 4 types of public places such as hotels (except mouthwash cups), barber stores, waiting rooms, and shopping malls or supermarkets was 2500 CFU·(25 cm2)−1. The difference of total bacteria count on the surface of public articles was statistically significant in comparing infant and young child swimming places with hotels (except mouthwash cups) or barber stores (H=5.432, H=2.997, both Ps<0.05); but the difference was not significant in comparing with waiting rooms and shopping malls or supermarkets (P>0.05). The qualified rates of total bacteria count and coliforms in pool water of infant and young child swimming places were 45.99% and 74.69% respectively, and the two indicators in pool water of conventional swimming places were 94.57% and 98.91% respectively; both showed significant differences between the two types of public places (χ2=162.532, χ2=71.910, both Ps<0.001). Conclusion Compared to conventional swimming places, hotels, barber stores, waiting rooms, and shopping malls or supermarkets, the infant and young child swimming places are not optimistic in hygiene condition; therefore, there is an urgent need to formulate national health standards for infants and young child swimming places, and include them in standard management to further improve their hygiene condition.

Optimization of Decoction Technology and Establishment of Quality Standard for Moringa oleifera Leaf Standard Decoction / 中国实验方剂学杂志

ObjectiveBased on response surface methodology combined with principal component analysis（PCA）， the optimal decocting process of Moringa oleifera leaf standard decoction was optimized， and its multi-index quality evaluation system was established， in order to provide scientific basis for the quality control of this standard decoction. MethodResponse surface methodology and PCA were used to optimize the decoction process by taking the relative peak areas of 8 characteristic peaks and dry extract yield as indexes. Based on this， the quality of 15 batches of the standard decoction was evaluated by high performance liquid chromatography（HPLC） characteristic chromatogram， determination of major components（neochlorogenic acid， L-tryptophan， cryptochlorogenic acid， vicenin-2， isoquercetin， astragalin）， determination of active parts（total flavonoids， total organic acids， total polysaccharides， total α-amino acids， total sinapine）， dry extract yield， specific gravity and pH. ResultThe optimal decocting process was to soak M. oleifera leaves（100.00 g） for 30 min and decoct twice with the first decoction of 12 times the amount of water for 30 min and the second decoction of 10 times the amount of water for 20 min. Standard decoction containing 0.2 g·mL-1 of crude drug was defined by x¯±30%， the specific gravity was 0.722-1.340， pH was 3.86-7.16， dry extract yield was 23.1%-42.9%， and the alcohol-soluble extract content was 8.26%-15.34%. Calculated according to the dried products of the standard decoction， the contents of neochlorogenic acid， L-tryptophan， cryptochlorogenic acid， vicenin-2， isoquercetin and astragalin were 1.99-3.69， 1.20-2.22， 1.44-2.67， 0.53-0.99， 2.45-4.55， 1.22-2.26 mg·g-1， the relative transfer rates relative to the herbs were 34.37%-63.83%， 62.43%-115.94%， 64.65%-120.06%， 56.98%-105.82%， 37.46%-69.57%， 41.81%-77.64%， respectively. The contents of total flavonoids， total organic acids， total polysaccharides， total α-amino acids， total sinapine were 10.19-18.92， 11.82-21.96， 94.07-174.71， 42.69-79.27， 9.55-17.73 mg·g-1， the relative transfer rates for herbs were 25.72%-47.77%， 41.78%-77.59%， 64.90%-120.54%， 42.30%-78.57%， 34.99%-64.99%， respectively. ConclusionThe optimized decocting technology of M. oleifera leaf standard decoction is stable and feasible， and the established multi-indicator quality evaluation system can lay the foundation for the quality control of this standard decoction.

Retrospective analysis and comparison of total internal disability preservation technique and standardized reconstruction technique / 中国骨伤

OBJECTIVE@#To investigate the efficacy and clinical results of total internal protection technique in anterior cruciate ligament reconstruction.@*METHODS@#A total of 56 patients undergoing anterior cruciate ligament reconstruction treated from January 2018 to December 2019 were selected. According to the different surgical methods, they were divided into total internal reconstruction group and standard bone tunnel group. There were 21 patients in the total internal reconstruction group, including 15 males and 6 females, aged from 20 to 48 with an average of (35.6±6.7) years old, and 35 patients in the standard tibial tunnel group, including 26 males and 9 females, aged 22 to 51 years old with an average of (33.7±9.6) years old. Preoperative examination of Lachman test was positive, magnetic resonance indicated anterior cruciate ligament rupture. There were no significant differences between the two groups in age, sex, body mass index, time from injury to ACL reconstruction, combined meniscus injury and operation method, operation time, ligament diameter, ligament length and other general information. Postoperative evaluation included operation duration, length and diameter of transplanted tendon after braid. International Knee Documentation Committee (IKDC) score, Lysholm score, Tegner score and perioperative complications 2 years after surgery.@*RESULTS@#Both groups were followed up, ranging from 24 to 30 months with an average of (26.9±3.4) months. Postoperative incision healing was good, and no failure or joint infection occurred at the last follow-up. There was no statistically significant difference between the two groups in IKDC score, Lysholm score and Tegner score before, 1 year and 2 years after surgery. However, IKDC score, Lysholm score and Tegner score at 1 year and 2 years after surgery.@*CONCLUSION@#The same postoperative function and stability of knee joint can be obtained by both the residual whole technique and the standardized reconstruction technique. In the residual whole group, only the semitendinosus muscle is taken, and the femoral thin muscle is retained, with greater tibial bone mass preserved, which is safe and effective in clinical practice.

Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials / 中国实验方剂学杂志

ObjectiveTo draft the Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials for standardizing thedata collection， storage， transmission， exchange， analysis， and evaluation of traditional Chinese medicine （TCM） studies. In addition to the application of conventional systematic review and meta-analysis， this draft will provide strong support for the development of automated systematic review， facilitate the efficient utilization of TCM clinical evidence， and underpin the evidence-based rapid decision-making in TCM. MethodThis study was structured into three stages. During the first stage （pre-research）， suggestions for formulating new standards were proposed based on comprehensive research and demonstration of views obtained from literature investigation and expert interviews. The second stage concentrated on drafting the standard by assembling a working group and crafting a draft solicitation document for metadata standards. At the third stage， feedback was sought from relevant institutions， organizations， and experts and scholars outside the research group via mail or other means to finalize the draft standard. ResultDuring the pre-research stage， a preliminary examination was conducted to assess the characteristics and current status of clinical research metadata standards， and the information was identified regarding the significance of formulating the standard， principles guiding metadata formulation， reference materials， and suggestions for metadata subset establishment. After establishing a working group and drafting the initial version of the standard， opinions from external experts were sought via email. Based on the comments， a third round of revisions was conducted， resulting in the finalization of a draft for the standard. The finalized version of the standard draft comprised 12 sections： preface， introduction， scope， normative reference documents， terms and abbreviations， principles and composition， metadata description method， metadata summary representation， metadata dictionary description， Extensible Markup Language （XML） markup example， JavaScript Object Notation （JSON） markup example， and references. Of these， the section of metadata summary representation/metadata dictionary description contained 6 metadata subsets， involving 20 metadata entities and 141 metadata elements. ConclusionThrough literature research， expert interviews， questionnaire surveys， standard drafting， and opinion solicitation， this study drafts the Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials. This draft plays a crucial role in standardizing TCM clinical research and advancing objective scientific evaluation and effective utilization of TCM.

The noise level in metro platforms and halls in a city / 上海预防医学

ObjectiveTo investigate the noise level and influencing factors in metro platforms and station halls， thereby providing the scientific basis for the establishment of hygienic standards. MethodsDuring the morning peak（7：00‒9：30）and off-peak （9：30‒17：00） on weekdays， the noise levels were measured with noise meters at 39 monitoring points of 13 station platforms and 31 monitoring points of 6 station halls. The monitoring points arrangement and detection methods referred to the Examination methods for public places—Part 1： physical parameters（GB/T 18204.1‒2013）. ResultsThe measured noise level in the station ranged from 69.25 to 86.17 dB（A）， accounting for 44.74% below 75 dB（A）， 89.47% below 80 dB（A） and 97.37% below 85 dB（A）.The noise level of the platform ［（76.38±4.19） dB（A）］ was higher than that of the station hall ［（74.24±4.50） dB（A）］（P<0.01）. The noise level of the elevated platforms ［（80.01±2.25） dB（A）］ was higher than that of the underground platforms ［（75.73±4.13） dB（A）］（P<0.01）， and the noise level of the platforms without platform screen doors（PSD） ［（80.21±5.08） dB（A）］ was higher than that of platforms with PSD［（74.73±3.16） dB（A）］ （P<0.01）. No statistical significant differences were observed among the different areas of the platforms， monitoring periods， platform depth， exit mode and operation years （P>0.05）. ConclusionThe noise level in metro stations in the city does not fully meet the requirements of current relevant standards. It is suggested to take noise reduction measures to reduce the noise of metro stations.

Interpretation of Gamma-ray spectrometry method for the determination of radionuclides in environmental and biological samples / 中国辐射卫生

Abstract@#As a rapid analytical method for both the types and activities of γ radionuclides, the γ-ray spectrometry method is widely used in the measurement of γ radionuclides in environmental and biological samples. The Gamma-ray Spectrometry Method for the Determination of Radionuclides in Environmental and Biological Samples (GB/T 16145—2022）was implemented  on  July  1,  2023,  replacing  the Determination of Radionuclides in Soil by Gamma Spectrometry (GB/T 11743—2013), Determination of Radionuclides in Water by Gamma Spectrometry (GB/T 16140—2018), Gamma Spectrometry Method of Analyzing Radionuclides in Biological Samples (GB/T 16145—2020), and Determination of Radionuclides in Air by Gamma Spectrometry (WS/T 184—2017). The background of the revised standard, the content and basis of the main revisions, and some issues that need to be discussed are briefly explained in this paper, in order to provide a useful reference for the detection of radioactivity in soil, water, biological, and air samples, as well as samples of similar matrices.

Preparation of the first national reference standard for determination of HEK293 cell DNA content / 中国生物制品学杂志

@#Objective To prepare a national reference standard for the quantification of HEK293 cell DNA content,so as to provide a support for the determination of residual DNA in HEK293 cells in the industry.Methods HEK293 cell DNA prepared using Genomic-tip 500/G and genomic DNA purification reagents was used as source materials,and the purity and content were assessed using ultraviolet spectrophotometry and agarose gel electrophoresis.After dilution to approximately 100 ng/μL,the DNA was aliquoted at 160 μL/tube.Five different laboratories were organized for collaborative calibration by using ultraviolet spectrophotometry, and the stability and applicability were evaluated.Results The HEK293 cell DNA national reference standard exhibited A_(260)/A_(280) ratios between 1.8 and 2.0 and displayed a single band on electrophoresis,meeting the specified criteria.Collaborative calibration across five laboratories yielded 78 valid data points with an average content of 104.8 ng/μL,a relative standard deviation(RSD) of 4.2%.The 95% confidence interval for the mean was 103.8—105.8 ng/μL,and the 95% reference range for single measurements was 96.0—113.6 ng/μL.The average confidence limit rate was 1.0%,and the recommended storage condition was-80 ℃.Applicability studies were conducted using two different models of fluorescence quantitative PCR instruments.The reference standard exhibited good applicability within the range of 0.3—3 000 pg/reaction,with amplification efficiencies of 101% and 95%,and R~2 values of 0.999 2 and 0.999 5 for the standard curves,respectively.Conclusion This batch of HEK293 cell DNA national reference standard meets all required specifications and can be utilized as a national reference standard for fluorescence quantitative PCR detection,with a certified content of 104.8 ng/μL,assigned batch number 270039-202301.

Influence of geometric factor on detection efficiency in low-background α/β radioactivity measurement / 中国辐射卫生

Objective To study the influence of the radius of the active zone of the plane source and the horizontal distance between the source center and the center of the detection window on the detection efficiency of low-background α/β measuring instruments. Methods The geometric factor was calculated under different conditions in MATLAB, and a traceable plane source was used to test and analyze two commonly used measuring instruments. Results With the other parameters unchanged, when the radius of the active zone R1 = 9 mm, the G value was greatest; and when the horizontal distance a = 0 mm, the G value was greatest. According to the calculation formula of the verification regulation, for the 90Sr-90Y planar source, at the maximum value of a, the detection efficiency of FYFS-400X was 1.2% lower, and that of MPC-9604 was 3.2% lower; for the 241Am planar source, the detection efficiency of MPC-9604 was 1.9% lower at the maximum value of a. Conclusion The geometric factor decreases with the increase in the radius of the active zone and the horizontal distance between the source center and the center of the detection window. At the central position, the geometric factor has less influence on the relative standard uncertainty of detection efficiency. When using a standard plane source for counting, measures should be taken to ensure that the plane source is always centrally located in the sample tray.

Evaluation value of RDW-SD,RPR and RLR on decompensation stage of cirrhosis in primary biliary cholangitis / 重庆医学

Objective To analyze the evaluation value of the standard deviation of erythrocyte volume distribution width(RDW-SD),erythrocyte volume distribution width standard deviation and platelet ratio(RPR)and erythrocyte volume distribution width standard deviation and lymphocyte ratio(RLR)in the de-compensation stage of cirrhosis in primary biliary cholangitis(PBC).Methods The blood routine indexes of 68 patients with PBC admitted and treated in this hospital from January 2019 to June 2021 were retrospective-ly analyzed and divided into the compensation stage(n=36)and decompensation stage(n=32)according to the diagnostic standard.2 mL venous blood was extracted from the patient on an empty stomach in the early morning.The red blood cell(RBC),mean corpuscular volume(MCV),hemoglobin(Hb),hematocrit(HCT),mean erythrocyte hemoglobin content(MCHC),RDW-SD,white blood cell(WBC),neutrophil absolute value(N#),lymphocyte absolute value(L#),platelet count(PLT),mean platelet volume(MPV),platelet volume distribution width(PDW),etc.were detected.The platelet to lymphocyte ratio(PLR),RPR and RLR were calculated.The influencing factors of decompensation stage of PBC cirrhosis were analyzed by binary logistic regression,and the receiver operating characteristic(ROC)curve was used to analyze the diagnostic values of different indicators in the decompensation stage of PBC cirrhosis.Results There were statistically significant differences in age,RBC,Hb,HCT,RDW-SD,L #,PLT,RPR and RLR between the compensation group and decompensation group in PBC cirrhosis(P＜0.05).The binary logistic regression analysis showed that the age[odds ratios(OR)=1.087,95％confidence intervals(CI):1.015-1.165,P＜0.05],RDW-SD(OR=1.144,95％CI:1.030-1.270,P＜0.05)and RLR(OR=1.041,95％CI:1.007-1.075,P＜0.05)were the independent risk factors for progressing to the decompensation stage in the patients with PBC cirrhosis com-pensation stage.The ROC curve analysis showed that the areas under ROC curve(AUC)of RDW-SD,RPR and RLR for the diagnosis alone of decompensation stage of PBC cirrhosis were 0.726,0.778 and 0.798,re-spectively,and the differences were not statistically significant(P＞0.05).Conclusion Combined with the age factor,regular monitoring of RDW-SD,RPR and RLR levels has a high predictive value for the develop-ment of PBC cirrhosis compensation stage to decompensation stage.

Study on the quality of Bolbostemmatis Rhizoma standard decoction by HPLC fingerprint combined with quantitative analysis of multi-components by single marker / 国际中医中药杂志

Objective:To establish the HPLC fingerprint of Bolbostemmatis Rhizoma standard decoction; To determine the three effective components with similar structure by quantitative analysis of multi-components by single marker (QAMS); To evaluate the quality of Bolbostemmatis Rhizoma standard decoction.Methods:HPLC was adopted to establish the fingerprints of 15 batches of Bolbostemmatis Rhizoma standard decoction. The Chromatographic column was Waters XBridge Phenyl (4.6 mm×250 mm, 5 μm). The mobile phase was acetonitrile-0.1% phosphoric acid solution with gradient elution. Cluster analysis (HCA) and principal component analysis (PCA) were conducted based on the relative peak area of common peaks. The same method as the fingerprint was used to establish QAMS of tubeimoside A, B, C on Bolbostemmatis Rhizoma standard decoction.Results:There were 14 common peaks in the fingerprint of Bolbostemmatis Rhizoma standard decoction. It was confirmed that the peak 3 was L-tryptophan, the peak 11 was tubeimoside B, the peak 12 was tubeimoside C, and the peak 13 was tubeimoside A. 15 batches of Bolbostemmatis Rhizoma standard decoction from different origins were divided into 3 categories by HCA and PCA. There was no significant difference between QAMS and the external standard method (ESM) through the system suitability inspection. Conclusion:This method is accurate, reliable and has good specificity, which can effectively evaluate the quality of Bolbostemmatis Rhizoma standard decoction.

Clinical application status and research progress in fetal growth standards / 复旦学报（医学版）

Ultrasound measurement of fetal biological parameters is an important indicator for evaluating fetal intrauterine growth and development,and its corresponding fetal growth standards are important criteria for determining whether the measurement parameters are normal or have fetal growth restriction.There are classic regional standards of prenatal ultrasonic measurement that have been used for many years,as well as international standards that have received widespread attention in recent years.However,there is no unified global standard.This paper reviewed the development process and clinical application status of fetal growth standards,explore future research trends,with a view to providing reference value for clinical practice.

A retrospective study on multi-targeted small molecule tyrosine kinase inhibitors combined with immune checkpoint inhibitors for 21 patients with advanced solid tumors after standard treatment failure / 实用医学杂志

Objective To investigate the clinical efficacy and safety of the combination therapy of multi-targeted small molecule tyrosine kinase inhibitors(MTKIs)with immune checkpoint inhibitors(ICIs)for late-stage solid tumor in the patients with failed standard treatment regimens.Methods The patients with advanced solid tumors who had been hospitalized in our hospital from January 2021 to January 2023 after failure of≥2 standard treatment regimens were selected and treated with MTKIs combined with ICIs.The efficacy and safety of this regimen were retrospectively studied.Results A total of 21 patients were included.As of March 1,2022,the overall popula-tion had an ORR of 38%,a DCR of 67%,a median progression free survival(mPFS)of 10 months,and a median survival(mOS)of 15 months.Common adverse reactions were pneumonia and oral ulcers.Conclusion For the patients with advanced solid tumors who have failed standard treatment,MTKIs combined with ICIs may be a treat-ment option,but prospective studies with a larger sample size are needed to confirm the efficacy and safety of this combination therapy and to explore the population most likely to benefit from this treatment method.

Biomechanical characteristics of "All-on-4" concept analyzed by three-dimensional finite element method / 中国组织工程研究

BACKGROUND:With the increasing demand for edentulous jaw restoration,"All-on-4"concept is widely used.The load transfer mode of implant is different from that of natural tooth.The three-dimensional finite element analysis can study the stress distribution of implants and surrounding bone tissues under functional loading.On this basis,it provides research methods for finding suitable implant materials,optimizing implant geometry,and designing clinical surgical protocols. OBJECTIVE:To review researches related to three-dimensional finite element analysis in"All-on-4"concept. METHODS:Relevant literature published from 2003 to 2023 was searched in CNKI and PubMed databases with the search terms of"finite element method;All-on-4;edentulous;biomechanics"in Chinese and English.Finally,65 articles were included for review. RESULTS AND CONCLUSION:(1)In the case of insufficient horizontal bone mass,we can choose to apply narrow diameter implants,but we need to pay attention to the effect of the presence of the cantilever on the stress distribution and reduce the risk of failure.(2)The"All-on-4"concept reduces the stress distribution of bone by tilting the distal middle implant,but the ideal angle of the distal implant tilt in different jaw types requires further study.(3)The presence of cantilevers increases the risk of implant failure,and keeping the cantilever length/AP distance ratio at 0.9 helps to minimize mechanical complications.(4)When a framework is made of a material with a lower elastic modulus,the stress on the framework itself will be smaller,but it will increase the stress on the implant,prosthetic screw,abutment and peri-implant bone.On the contrary,when a material with a higher elastic modulus is used,it can reduce the stress on the prosthetic components,implants and peri-implant bone in the restoration,but the stress on the framework itself is higher.(5)The"All-on-4"concept allows for a better mechanistic balance,but requires the development of a long-term,effective treatment program that is tailored to the patient's specific situation.(6)Proper occlusal scheme is the key to the success of implant treatment,and there is no difference between canine-guide occlusion and group function occlusion in terms of the longevity of the restoration.However,there are many factors that influence occlusal design,and further in vitro experiments as well as a number of clinical studies are needed to explore the ideal occlusal design of the"All-on-4".

Establishment and application of drug use evaluation criteria of fibrinogenase for injection / 药物流行病学杂志

Objective To establish the drug use evaluation(DUE)standard of fibrinogenase for injection and provide a reference for the rational clinical application of fibrinogenase for injection.Methods Based on the specification of fibrinogenase for injection,the DUE standard was established from three aspects:drug indication,drug process and drug results,with reference to relevant guidelines and literature,and through discussion with clinical experts.A retrospective survey was conducted to evaluate the inpatients using fibrinogenase for injection from January 2021 to December 2021 in Ningde Hospital of Traditional Chinese Medicine,Fujian Province.Results A total of 256 patients were included,with a medication reasonable rate of 61.72％.The irrational use of drugs was mainly including the inappropriate usage and dosage(3.91％),off-label medication(1.95％),no skin test(8.98％),too long or inadequate course of medication(25.00％).Conclusion The DUE standard established of fibrinogenase for injection is scientific,practical and feasible.The use of fibrinogenase for injection in contraindications and high blood coagulation state,and off-label medication can be further optimized.

Current status of blood pressure control in elderly hypertensive patients under the antihypertensive standard recommended by Chinese experts / 中华老年心脑血管病杂志

Objective To analyze the antihypertensive compliance rate,drug use and complication distribution among very old hypertensive inpatients under the antihypertensive standard of 150/90 mm Hg in our country(1 mm Hg=0.133 kPa).Methods A total of 409 hospitalized patients aged ≥80 years and diagnosed with hypertension in all departments of Air Force Medical Center of PLA were enrolled,and according to their clinical outcomes,they were divided into intensive antihypertensive group(106 cases,SBP＜130 mm Hg),standard antihypertensive group(155 ca-ses,SBP 130-149 mm Hg)and non-standard blood pressure group(148 cases,SBP ≥150 mm Hg).The status of blood pressure control was analyze in each group.Results When 150/90 mm Hg was used as the blood pressure standard,25.9％were in the intensive blood pressure group,37.9％were in the standard blood pressure group,36.2％were in the non-standard blood pressure group.The proportion of patients aged＞90 years was significantly lower in the non-standard blood pressure group than the intensive antihypertensive group and the standard anti-hypertensive group(4.1％vs 7.5％and 12.3％,P＜0.05).The ratio of single-drug therapy was significantly higher in the standard antihypertensive group than the intensive antihypertensive group(46.5％vs 32.1％,P＜0.05),and that of dual combination therapy was obviously higher in the intensive antihypertensive group than the standard antihypertensive group(35.8％vs 22.6％,P＜0.05).The proportions of heart damage and cerebrovascular damage were significantly higher(43.4％vs 21.9％,26.4％vs 14.8％),and the proportion of complicated retinopathy was notably lower(11.3％vs 23.9％)in the intensive antihypertensive group than the standard antihypertens-ive group(P＜0.05).Conclusion For very old hypertensive patients in our country,it is more sci-entific and practical to use 150/90 mm Hg as the starting standard for blood pressure reduction.Intensified blood pressure reduction increases cardiovascular and cerebrovascular damages in them instead.

Quality evaluation for Beidougen Formula Granules / 中成药

AIM To evaluate the quality of Beidougen Formula Granules.METHODS Fifteen batches of standard decoctions and three batches of formula granules were prepared,after which paste rate and contents,transfer rates of magnoflorine,daurisoline,dauricine were determined.HPLC specific chromatograms were established,and cluster analysis was adopted in chemical pattern recognition.RESULTS For three batches of formula granules,the paste rates were 15.1%-16.6%,the contents of magnoflorine,daurisoline,dauricine were 18.93-19.39,9.42-9.60,6.79-6.85 mg/g with the transfer rates of 34.42%-35.25%,43.81%-44.65%,27.27%-27.51%from decoction pieces to formula granules,respectively,and there were seven characteristic peaks in the specific chromatograms with the similarities of more than 0.95,which demonstrated good consistence with those of standard decoctions and accorded with related limit requirements.Fifteen batches of standard decoctions were clustered into two types,and the medicinal materials produced from Jilin,Hebei,Shangdong could be used for the preparation of formula granules.CONCLUSION This reasonable and reliable method can provide references for the quality control and clinical application of Beidougen Formula Granules.

Application progress on export vaccine traceability labeling system based on Global Standard 1 / 中国生物制品学杂志

@#COVID-19 is a respiratory disease caused by SARS-CoV-2 infection,which has strong infectivity and seriously threatens human health all over the world. Vaccination is the most effective means to prevent SARS-CoV-2 infection. World Health Organization(WHO)has required the use of Global Standard 1(GS1)for the tracking and traceability of COVID-19vaccines and therapeutics. Traceability identification system is the basis and core of traceability system,as well as the premise of implementation of traceability,throughout the whole product traceability process. By carrying out unique global coding for all levels of packaging and logistics units of export vaccine products,and establishing vaccine traceability codes and logistics unit traceability codes,we can help export vaccine manufacturers establish traceability systems,realize the traceability of product information in production,circulation,use and other links,strengthen the quality and safety supervision of export vaccine products,strengthen the risk monitoring,early warning and effective disposal,as well as strengthen the recall of defective products and analysis of causes,so as to enhance the international market's trust and recognition of Chinese vaccine safety. This paper summarizes the importance of establishing traceability system for export vaccine products,the application of GS1 system in medical field at home and abroad,the traceability identification coding,barcode representation and quality requirements of export vaccine products,in order to provide a reference for establishing traceability identification system for export vaccine products in China and meeting the requirements of international standards and regulations.

Comparison of the chemical components in Artemisiae Scopariae Herba standard decoction and its decoction pieces / 中国药房

OBJECTIVE To compare the chemical components contained in Artemisiae Scopariae Herba （ASH） standard decoction and its decoction pieces， and provide foundation of their pharmacological substances. METHODS ASH standard decoction and its decoction pieces were prepared； UFLC-Q-TOF-MS/MS method was used for the detection in the negative ion mode， and the total ion chromatogram was extracted by the PeakView 1.6 software. By comparing with reference substances， literature data， and online search of compound database such as PubChem， the chemical components contained in ASH standard decoction and its decoction pieces were identified and analyzed for the differences. RESULTS A total of 125 chemical components were identified in ASH standard decoction and its decoction pieces， including 50 organic acids， 39 flavonoids， 3 coumarins， 2 amino acids， 5 lignans， and 26 others. 3-methoxy-caffeic acid-4-O- β -D-glucoside， p-hydroxybenzoic acid， caffeic acid 4-O- glucoside， spiraeoside， and phenyl β-D-glucoside in ASH standard decoction were not detected in its decoction pieces， while 6′-6′ chlorogenic acid dimer， quercetin-5-glucoside， apigenin 7-methyl ether 5-（6″-malonylglucoside）， quercetin-3-O-arabinoside， 6″-caffeoylhyperin and 6-O-caffeoyl-D-glucoside in decoction pieces were not detected in the standard decoction. CONCLUSIONS Most components in ASH decoction pieces are transferred to its standard decoction， but a few components undergo chemical reactions in whole or in part during the boiling process， transforming into other or new components in the standard decoction.

Investigation and analysis of the current situation of case reporting ethical review and patient informed consent reports in comprehensive journals of clinical medicine in China / 中国医学伦理学

ObjectiveTo investigate and analyze case reporting ethical review and patient informed consent reports published in the comprehensive journals of clinical medicine in China in 2022. MethodsAccording to the data from the 2022 Edition of the Chinese Science and Technology Journal of the Citation Reports （Extended Version），the case reports published in comprehensive journals of clinical medicine in 2022 were selected as the research objects.The information on ethics and patient informed consent was extracted from the case reports that met the selection criteria，and Microsoft Excel 2021 and SPSS 21.0 were used to sort out and analyze the data. ResultsA total of 587 case reporting articles were published in the 42 included journals in 2022，of which 36 （6.13%） reported on science and technology ethics and/or informed consent.Case reports reporting on science and technology ethics and/or informed consent mostly came from the key magazine of China technology （88.89% Vs.65.88%），and the proportion of manuscripts involving science and technology ethics on the official website of the journal was relatively high （86.11% Vs.63.88%），and the difference was statistically significant （P<0.01）. ConclusionThe proportion of case reports of science and technology ethics and/or informed consent in journals of comprehensive discipline classification of clinical medicine was relatively low.Currently，most international journals are required to obtain the informed consent of patients or legal guardians before publishing case reports.Compared with this，there are still certain gaps in China，which need to be paid great attention to.

Discussion on the legal attributes of provincial Chinese herbal pieces processing norms / 中国药房

OBJECTIVE To provide a reference for the definition of the legal attributes of the provincial Chinese herbal pieces processing norms and the improvement of legal expression for the drug standards in Drug Administration Law. METHODS Based on the legal evolution of local drug standards in China， the composition of national drug standards for Chinese herbal pieces and the composition of current provincial Chinese herbal pieces processing norms were analyzed； at the same time， based on the method of legal interpretation， the legal connotation of the provincial Chinese herbal medicine processing norms in Drug Administration Law was investigated. RESULTS & CONCLUSIONS In the practice of drug supervision， the provincial Chinese herbal pieces processing norms are essentially local drug standards. The newly revised Drug Administration Law defines the drug standards specifically， but does not stipulate the legal attribute of drug standards for the provincial Chinese herbal pieces processing norms， and there are certain legislative technical defects. It is suggested that when amending the Drug Administration Law， the legal attributes of the drug standards of the provincial Chinese herbal medicine processing norms should be clarified.