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Objective:To investigate the influencing factors of anastomotic leakage after laparoscopic intersphincter resection (ISR) for extremely low rectal cancer and construction of nomogram prediction model.Methods:The retrospective case-control study was conducted. The clinicopathological data of 812 patients who underwent laparoscopic ISR for extremely low rectal cancer in the Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital) from February 2012 to February 2022 were collected. There were 459 males and 353 females, aged (51±11)years. Observation indicators: (1) surgical situations; (2) follow-up; (3) influencing factors of postoperative anastomotic leakage; (4) construction and evaluation of nomogram prediction model for postoperative anastomotic leakage. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M(range). Count data were described as absolute numbers. The COX proportional hazard model was used for univariate and multivariate analyses. The R software(3.5.1 version) was used to construct nomogram prediction model. The receiver operating characteristic (ROC) curve was drawn and the area under curve (AUC) was used to evaluate the efficacy of the nomogram prediction model. The Bootstrap method was used for internal verification and to calculate the average consistency index (C-index). Results:(1) Surgical situations. All 812 patients underwent laparoscopic ISR for extremely low rectal cancer, including 388 cases undergoing partial ISR, 218 cases undergoing subtotal ISR and 206 cases undergoing complete ISR. All 812 patients underwent ileal protective ostomy, and there were 306 cases with double anastomosis and 203 cases with left colic artery preserved, respectively. The operation time and volume of intraoperative blood loss of 812 patients was (179±33)minutes and (33±13)mL, respectively. (2) Follow-up. All 812 patients were followed up for (13.5±0.9)months. Of the 812 patients, there were 62 cases with postoperative anastomotic leakage and the healing time of these cases was (33±6)days. (3) Influencing factors of postoperative anastomotic leakage. Results of multivariate analysis showed that male, neoadjuvant chemoradiotherapy, failure of reser-ving left colic artery were independent risk factors of anastomotic leakage after laparoscopic ISR for extremely low rectal cancer ( hazard ratio=5.98, 4.00, 16.26, 95% confidence interval as 1.66-24.12, 1.30-12.42, 3.00-90.89, P<0.05). (4) Construction and evaluation of nomogram prediction model for postoperative anastomotic leakage. According to the results of multivariate analysis, male, neoadju-vant chemoradiotherapy and failure of reserving left colic artery were used to construct the nomogram prediction model for anastomotic leakage after laparoscopic ISR for extremely low rectal cancer, and the score of these indexes in the nomogram prediction model was 50, 49, 93, respectively. The total score of these index corresponded to the incidence rate of anastomotic leakage. Results of ROC curve showed that the AUC of nomogram prediction model of anastomotic leakage after laparoscopic ISR for extremely low rectal cancer was 0.87 (95% confidence interval as 0.80-0.93, P<0.05), with sensi-tivity and specificity 0.96 and 0.60, respectively. Results of internal verification showed that the C-index of nomogram prediction model was 0.87. Conclusion:Male, neoadjuvant chemoradiotherapy, failure of reserving left colic artery are independent risk factors of anastomotic leakage after laparo-scopic ISR for extremely low rectal cancer, and the nomogram prediction model based on these indexes can predict the incidence rate of postoperative anastomotic leakage.
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Purpose@#Loss-of-function mutations in the adenomatous polyposis coli (APC) gene are common in metastatic colorectal cancer (mCRC). However, the characteristic of APC specific mutations in mCRC is poorly understood. Here, we explored the clinical and molecular characteristics of N-terminal and C-terminal side APC mutations in Chinese patients with mCRC. @*Materials and Methods@#Hybrid capture-based next-generation sequencing was performed on tumor tissues from 275 mCRC pati-ents to detect mutations in 639 tumor-associated genes. The prognostic value and gene-pathway difference between APC specific mutations in mCRC patients were analyzed. @*Results@#APC mutations were highly clustered, accounting for 73% of all mCRC patients, and most of them were truncating mutations. The tumor mutation burden of the N-terminal side APC mutations group (n=76) was significantly lower than that of the C-terminal side group (n=123) (p < 0.001), further confirmed by the public database. Survival analysis showed that mCRC patients with N-terminus side APC mutations had longer overall survival than C-terminus side. Tumor gene pathway analysis showed that gene mutations in the RTK/RAS, Wnt and transforming growth factor β signaling pathways of the C-terminal group were significantly higher than those of the N-terminal group (p < 0.05). Additionally, KRAS, AMER1, TGFBR2, and ARID1A driver mutations were more common in patients with C-terminal side APC mutations. @*Conclusion@#APC specific mutations have potential function as mCRC prognostic biomarkers. There are obvious differences in the gene mutation patterns between the C-terminus and N-terminus APC mutations group, which may have certain guiding significance for the subsequent precise treatment of mCRC.
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Objective To evaluate the application and effect of signature verification technology in children's vaccination clinics (CVC) of Jiangsu Province in 2020. Methods The signature verification data were derived from the Jiangsu Provincial Vaccination Integrated Service Management Information System, and the inquiry and registration, informed consent, vaccine traceability code scanning and observation information of children's vaccination clinics in different regions were analyzed. 210 doses of vaccination information were randomly selected from CVCs in each county, and the length of vaccination services in different regions was compared. Results During 2020, all of CVCs in Jiangsu were equipped with signature verification technology, and the signature verification rate of each vaccination sector was more than 99.90%. The length of outpatient vaccination service and overall length of stay in southern Jiangsu were slightly shorter than those in other regions. Conclusion The introduction of electronic signature verification technology in CVCs can effectively standardize the vaccination. It is necessary to expand the functions of electronic signature verification equipment, strengthen data analysis and utilization, and guide vaccination scientifically.
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Objective:To analyze the implementation of the external quality assessment plan for quality indicators of clinical laboratories in China from 2016 to 2021, as well as that of the external quality assessment of 15 quality indicators in clinical laboratories, in order to provide reference for quality management of clinical laboratory specialties.Methods:The research data was collected from the external quality assessment plan for quality indicators, which was conducted by the National Center for Clinical Laboratories joining the clinical laboratory centers of 31 provinces (autonomous regions and municipalities directly). The essential information reported by each participating clinical laboratory from 2016 to 2021 and the external quality assessment data of 15 quality indicators in clinical laboratories were collected, followed by a descriptive analysis on the number of participating laboratories and the number of returns for each indicator. Median representation was used for the external quality assessment data of 15 quality indicators in clinical laboratories, and the TOPSIS method was applied to comprehensively evaluate the quality of the total testing process of participating clinical laboratories in each year.Results:From 2016 to 2021, the number of laboratories participating in the external quality assessment plan for quality indicators of clinical laboratory increased from 7 704 to 12 142. Quality indicators in pre-analytical phases: the incorrect sample type rate, incorrect sample container rater, and incorrect fill level rate had been decreasing year by year, reaching 0, 0, and 0.005 8% in 2021, respectively. The anticoagulant samples clotted rate had decreased from 0.068 6% in 2016 to 0.042 8% in 2021, and the blood culture contamination rate from 2017 to 2021 had been 0 without exception. The pre-examination turnaround time had been shortened from 28 minutes in 2016 to 2019 to 24 minutes in 2020 and 2021. Quality indicators in analytical phases: the intra-laboratory turnaround time had been extended from 45 minutes in 2016 to 2019 to 50 minutes in 2020 and 2021. Test covered by an IQC rate had been increasing year by year, reaching 60.61% in 2021. Test with inappropriate IQC performances rate was 0 in 2020 and 2021, the test covered by an EQA-PT control rate was 100%, and unacceptable performances in EQA-PT schemes rate from 2017 to 2021 was 0. The inter-laboratory comparison rate had increased from 1.56% in 2016 to 3.00% in 2021. Quality indicators in post-analytical phases: the incorrect laboratory reports rate, critical values notification rate and timely critical values notification rate had been 0, 100%, and 100%from 2016 to 2021 respectively. The comprehensive evaluation results of TOPSIS method showed that the overall quality level of clinical laboratory testing in 2020 was the highest, with Ci value of 0.850 5, while the lowest Ci value in 2016 was 0.143 6. Conclusions:The quality of clinical laboratory testing in China has been effectively improved. Clinical laboratories should continue to strengthen their monitoring of quality indicators, especially the intra-laboratory turnover time and the inter-laboratory comparison rate, for the purposes of identifying errors, analyzing causes and taking corrective measures to improve quality.
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Objective:To establish preliminary quality specifications for emergency examination turnaround time (TAT).Methods:The National Center for Clinical Laboratories organized 31 provinces (autonomous regions and municipalities directly) and Xinjiang production and Construction Corps centers to launch a synchronous Quality Indicators (QIs)-External Quality Assessment (EQA) program and the collected data were reported via developed online EQA system. The essential information of the clinical laboratories, the data of pre-examination and intra-laboratory TAT quality indicators of emergency departments at each specialty (biochemistry, automatic immunity, three routines tests and coagulation) and four specific tests (blood potassium, troponin I/T, white blood cell count and international normalized ratio (INR)) were collected from 2019 to 2021. TAT returned the median and 90th percentile ( P90) of the specified month were calculated. The median (lower quartile, upper quartile) of the TAT returned laboratories were calculated and second result grading statistics for 2021 (2 422 tertiary hospital and 5 088 secondary hospital) were performed to understand the difference of pre-examination and the laboratory TAT between different tertiary hospitals. Results:From 2019 to 2021, there were 9 540 laboratories, 9 709 laboratories and 10 653 returned laboratories. The pre-examination TAT of each specialty was similar, and the results were relatively stable. The median distribution was about 15 (10, 30) min, and the monthly P90 distribution was about 20 (10, 30) min. The distribution results of the median intra-laboratory TAT in each specialty were as follows: automatic immunity≥biochemistry>coagulation>three routine tests. The distribution of the latest (second result in 2021) survey results of each specialty were as follows: automatic immunity 53 (30, 60) min, biochemistry 45 (30, 60) min, coagulation 30 (23, 40) min, and three routine tests 20 (11, 30) min. The median results of monthly P90 of intra-laboratory TAT were as follows: 60 min for automatic immunity and biochemistry specialty, about 38 min for coagulation specialty, and about 27 min for three routines tests. The hierarchical statistical results showed that the monthly P90 distribution of laboratory TAT of the pre-examination and intra-laboratory TAT from the tertiary hospital was higher than that of the secondary hospital. The pre-examination TAT of each specialty of the tertiary hospital/secondary hospital was as follows: biochemistry 35 (22, 60)/20 (11, 30) min, automatic immunity 33 (20, 60)/20 (10, 30) min, three routine tests 30 (20, 49)/20 (10, 30) min and coagulation 31 (20, 58)/20 (10, 30) min, the intra-laboratory TAT of each specialty of the tertiary hospital/secondary hospital was as follows: biochemistry 65 (50, 91)/60 (40, 70) min, automatic immunity 75 (55, 113)/60 (40, 90) min, three routine tests 30 (23, 38)/28 (19, 30) min and coagulation 53 (36, 72)/35 (30, 57) min. In terms of the distribution results of the median of intra-laboratory TAT of the four specific tests, 96.76% (9 484/9 801) of the blood potassium and 95.96% (8 733/9 101) of the troponin I/T medical institutions were TAT within 69 min in the laboratories, 95.34% (9 679/10 152) of the white blood cell count medical institutions were TAT within 31 min in the laboratories, and 98.85% (9 462/9 572) of the INR medical institutions were TAT within 66 min in the laboratories. Conclusions:This survey provides a preliminary quality specification for the emergency department turnaround time at each specialty. Lower quartile, median and upper quartile of the monthly P90 at the tertiary and secondary hospitals can be used to define the best, appropriate and minimum performance levels, respectively.
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Objective:The allowable total error ( TEa),allowable imprecision ( CV)and allowable bias( Bias)were recommended for 34 routine chemistry analytes in China. Methods:According to the performance specification setting mode newly determined at the Milan conference in Italy,the performance specification was derived based on components biological variation (BV)and current state of the art mode. The data(including EQA data and IQC data)of laboratories participating in the routine chemistry and lipids and lipoproteins EQA activities of the national center for clinical laboratories from 2019 to 2021 was collected through clinet-EQA. For the analytes with biological variation(BV)data,compared the'percentage difference′ of EQA data and the'in-control coefficient of variation of the month′ of IQC data of each research analyte with the three levels evaluation criteria derived based on BV,and calculated the percentage difference passing rate and CV passing rate of all batches in each year. When the passing rate reaches 80%,the performance specifications of this level met the requirements of the recommended performance specifications of the analyte. For the analytes without BV data or analytes whose performance specifications at three levels derived based on BV could not be used as recommended standards,the recommended performance specifications are derived based on the current state of the art. After obtaining the recommended TEa and allowable CV for each analyte,used the formula | Bias|≤ TEa-z? CV to derive the recommended allowable bias. Results:The results of TEa ( CV)% recommended by 34 analytes are as follows:K4.7(2),Na4(1.5),Cl4(1.4),Ca5(2),P9.6(3.9),Glu6.4(2.5),Urea8(3),UA12(4.1),Cre11(3.3),TP5(2),Alb5.2(2.4),TC8.6(2.7),TG13.5(5),HDL-C16.5(4.3),LDL-C20.5(6.2),ApoAⅠ16(5.3),ApoB 17.1(5.5),Lp(a) 24.1(10.4),TBil 12.4(5),DBil 20(7.3),ALT16(5),AST13.5(4.8),ALP17.5(4.8),AMY13.1(3.3),CK11.3(3.8),LDH11(3.9),CHE13.4(5.3),LIP20(6.9),Fe13.3(5.2),Mg14(4.5),Cu17.9(6.8),Zn15.1(6.4),γ-GGT10(3.3),α-HBDH18(5.8).The formula | Bias|≤ TEa-z? CV is used to derive the allowable bias of 34 analytes. Conclusions:For 34 clinical routine chemistry quantitative analytes,the allowable total error,allowable imprecision and allowable bias that meet the current state of the art of Chinese laboratories are recommended.
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Objective:An on-line calculator for calculating the frequency of internal quality control is recommended to select quality control procedures and appropriate run lengths for general chemistry in Beijing Tongren Hospital.Methods:The cumulative controlled coefficient of variations of 10 general chemical tests in the laboratory department of Beijing Tongren Hospital for 19 consecutive months were used as the imprecision. The mean value of absolute percentage difference between the quality control results and the target value of 15 batches of 10 tests in the external quality assessment (EQA) general chemistry in 2018 was used to estimate the Bias of each test. Use the allowable range of EQA target value of the National Center for Clinical Laboratories in 2018 to estimate the total allowable error (TEa) of each test. The data were input into the Westgard internal quality control frequency calculator, and 10 different candidate statistical quality control (SQC) procedures and corresponding run lengths were calculated online, including single rule and multiple rule, number of quality control concentration levels (or test projects) ranging from 1 to 4. The SQC program with relatively simple quality control rules and long run length was selected according to the actual situation of the laboratory.Results:The 1 3s, N=3 or 1 3s, N=2 rule could be adopted for ALP and CR, and the corresponding run length was 1000. TBIL and ALT projects can adopt 1 3s, N=3 or 1 3s, N=2 rule and its corresponding run length; UA can use multiple rules 1 3S/2 2S/R 4s/4 1s, N=4 (run length 395) or 1 3S/(2of3) 2S/R 4s/3 1s N=3 (run length 259); CHO, AST and AMY can adopt two multiple rules 1 3S/2 2S/R 4s/4 1s, N=4 or 1 3S/(2of3) 2S/R 4s/3 1s, N=3 and their corresponding run length. GGT project can adopt 1 3S/2 2S/R 4s/4 1S, N=4 rule (run length 50); The run length of 10 candidate quality control rules calculated by LDH was too short, the detection performance should be improved preferentially, and the quality control rules and corresponding run length were not recommended for the time being. Conclusion:The Westgard internal quality control frequency online calculator is easy to operate. Clinical laboratories can use this calculator to select SQC program and appropriate run length. It is recommended that laboratories adjust SQC program according to the current actual situation.
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Objective:By reviewing and analyzing the results of external quality assessment of pre-test quality indicators related to the acceptability of microbiology laboratory sample from 2016-2021, we aimed to understand the acceptability of microbiology laboratory sample and therefore to provide a reference for establishing preliminary quality specifications.Methods:The National Center for Clinical Laboratories organized 31 provinces (including autonomous regions and municipalities directly under the Central Government) and the Xinjiang production and Construction Corps centers to launch a synchronous Quality Indicators (QIs)-External Quality Assessment (EQA) program and the collected data were reported via an online EQA system. The essential information of the clinical laboratories and the data of quality indicators from 2016 to 2021 were collected and the data from overall, continuous return laboratories were analyzed. Sigma values were calculated to assess the quality level of laboratory.Results:The median of the 13 quality indicators of national laboratories for all years was 0 (except for the first microbiological contaminated sample rate in 2018). Ten of the quality indicators (incorrect fill level rate, sample loss rate, misidentified sample rate, unsuitable sample for storage rate before analysis, sample damaged rate during transportation, sample transported at inappropriate temperature rate, sample with excessive transportation time rate, inappropriate time in sample collection rate, sample recollection rate for error due to laboratory staff, sample recollection rate for error not due to laboratory staff) had quartiles of 0 for all years, reaching six sigma level. The results of the median (upper quartile) of each year of the three quality indicators of continuous return laboratories for tertiary hospitals show that the incorrect sample container rate was the lowest, followed by the incorrect sample type rate, and the microbiological contaminated sample rate was the highest. The highest values of corresponding median (upper quartile) results were 0.047% (0.191%), 0.059% (0.252%), 0.251% (0.6%) respectively. The median incorrect sample type rate and median incorrect sample container rate in 2016/1 and 2021/1 tertiary hospitals were ranked by province respectively. The median for the incorrect sample type rate of Liaoning, Hebei, Jiangxi, Tianjin, Beijing, Guizhou, Gansu, Qinghai and Ningxia tertiary hospitals in 2021/1 was significantly lower than the respective values in 2016/1, and the median for incorrect sample container rate of Liaoning, Sichuan, Zhejiang, Hubei, Shanxi, Tianjin, Chongqing, Guizhou, Ningxia and Hunan tertiary hospitals in 2021/1 was significantly lower than those respective values in 2016/1.Conclusions:The results of the sample acceptability of microbial laboratory are generally acceptable. The laboratories should explore and establish their own quality indicators system, strengthen the long-term monitoring of key quality indicators and improve their service quality.
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Objective:Patient risk-based statistical quality control (SQC) program was designed for 9 specific protein projects using Westgard sigma rules with run length.Methods:The cumulative coefficient of variation of immunoglobulin (Ig)G, IgA, IgM, C3, C4, rheumatoid factor (RF), antistreptolysin O (ASO), transferrin (TRF) and prealbumin (PA) from the laboratory department of Beijing Tongren Hospital between December 2018 to May 2019 were used as the estimated value of imprecision. The mean of the absolute value of the percentage difference of 10 batches in the laboratory, which was derived from the results of participating the external quality assessment (EQA), was used as the estimated value of bias. The National Center for Clinical Laboratories EQA evaluation criteria was used as an allowable total error (TEa), and the sigma value of each project (σ) was calculated. Westgard Sigma rule with run length was used to design appropriate SQC program for each project, including quality control rules, number of control measurements (N) and frequency of quality control.Results:The sigma value was larger than 6 for SQC procedure of IgG, IgA, IgM, C4 and TRF. SQC could be established with the use of 1 3s rule, number of control measurements (N)=2, number of runs (R)=1, and a run length of 1 000 patient samples. Combined with the average daily workload, internal quality control could be conducted once every 10 days for IgG, IgA, IgM and C4, every 50 days for TRF. The σ was 5.86 for C3, SQC program could be established with run length of 450 using 1 3S/2 2S/R 4s rule (N=2, R=1), combined with average daily workload, internal quality control could be conducted every 4.5 days. σ was between 3 and 4 for RF, ASO and PA. With the use of 1 3S/2 2S/R 4s/4 1s/6 X rule (N=6, R=1), SQC program with a run length of 45 and higher frequency internal quality control activities. Conclusion:It is feasible to use Westgard sigma rules with run length for the laboratories design of personalized risk-based SQC procedures, the method is very simple and intuitive. This tool is valued to be recommended to be actively applied by all clinical laboratories.
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This article reviews the emerging artificial intelligence (AI) technology and its application in the field of aneuploidy prenatal screening from the aspects of the research methods of AI, the status of prenatal screening, and the role of AI in the integration of the screening markers, improvement of the screening performance, and optimization of screening strategy, etc. There is no doubt that AI has great potential in improving the ability of disease prediction through, integrating various screening data, discovering additional value of the data, and reducing social medical expenses. However, AI technology should be viewed and used in a scientific, rational, and comprehensive way to achieve the ideal effect in the field of prenatal screening.
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Objective:To evaluate the efficacy and safety of 125I seeds implantation for lymph nodes metastasis (LNM) from radioactive iodine-refractory differentiated thyroid carcinoma (RAIR-DTC), and to verify the computer three-dimensional treatment planning system (TPS) from the dosimetry accuracy in assisting seeds implantation to treat LNM. Methods:Retrospective analysis was performed on 17 RAIR-DTC patients with LNM admitted to the General Hospital of Northern Theater Command from December 2016 to January 2019 (8 males, 9 females, median age 58 years). All patients underwent preoperative TPS planning design, CT-guided puncture and 125I seeds implantation (seed activity 14.8-25.9 MBq). The dosimetric results of postoperative validation were compared with those of preoperative planning, including the dosimetric parameters such as target volume before and after surgery and the dose received by 90% and 100% gross tumor volume (GTV) ( D90, D100), the percentage received by 100% and 150% of the prescription dose ( V100, V150), homogeneity index (HI). All patients underwent CT after 6 months to compare the LNM size, serum thyroglobulin (Tg) level, and the improvement of complications before and after treatment. Efficacies were divided into complete remission (CR), partial remission (PR), stable disease (SD), and progressive disease (PD). Paired t test or Wilcoxon signed rank test were used to analyze the data. Results:Among 17 patients, a total of 226 125I radioactive seeds were implanted. Among them, 1 achieved CR, 10 achieved PR, 4 were with SD, and 2 were with PD. The diameter of LNM was 1.40(0.65, 3.05) cm before treatment and was 0.40(0.21, 0.91) cm 6 months after treatment ( z=-3.95, P<0.05). The Tg before treatment was 23.50(20.94, 72.92) μg/L and was 8.90(3.20, 40.22) μg/L 6 months after treatment ( z=-5.009, P<0.001). Tg antibody were all negative. There were 90.90% (20/22) of patients had slightly lower D90 than the prescribed dose ((12 378.8±3 182.0) vs (12 497.8±1 686.4) cGy; t=0.251, P>0.05). The postoperative dose parameters D100 and V150 ((6 881.5±1 381.8) cGy, (58.5±18.4)%) were both lower than those of preoperative plan ((8 085.8±2 330.0) cGy, (66.5±17.7)%; t values: 8.913, 3.032, both P<0.05), and the remaining indicators were not significantly different from those of the preoperative plan ( t values: 0.251, 1.493, z values: from -1.604 to -0.593, all P>0.05). Conclusions:According to the TPS preoperative plan, 125I seeds implantation for treating RAIR-DTC LNM can achieve the expected dose distribution, and the short-term tumor local control is effective. It is a safe and effective treatment method.
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Objective:To investigate the use of the reference intervals for blood cell counting and the reference of industry standard in China.Methods:Information from all laboratories was collected using online questionnaire in 18 reference intervals survey in blood cell counting in 2019. The information includes the source of the reference intervals, the verification of the reference intervals, and the upper and lower limits of the reference intervals, the method used, the instrument, the reagent and the calibrator. Microsoft Excel 2007 software was used to analyze the results of all laboratories. The median and 95% confidence interval were calculated. The distribution of the reference intervals for blood cell counting and their conformance to industry standards were analyzed.Results:2, 869 labs reported the data. The main sources were industry standards and National Guide to Clinical Laboratory Procedures. The proportion was 33.30%-35.02% and 28.55%-30.90% respectively. 49.44%-55.13% of laboratories validated the reference interval when citing industry standards. The reference interval grouping of most laboratories (89.37%-91.69%) cited in RBC, Hgb and Hct were consistent with the industry standards. We compared the upper and lower limits of the reference intervals with that given by the industry standards, when the lower limit of the reference intervals of mean corpuscular hemoglobin concentration, absolute neutrophils count, absolute basophils count, absolute monocyte count, and lymphocyte percentage were compared. The upper limit of reference intervals of neutrophils percentage as well as upper and lower limits of reference intervals of mean corpuscular volume, mean corpuscular hemoglobin, absolute eosinophil count, basophils percentage, and monocyte percentage were also compared. The median and mode were equal and consistent with industry standards. For other labs, the upper and lower limits of the reference intervals were not consistent with the reference intervals given by the industry standards.Conclusion:The use of reference intervals for blood cell counting was not the same, and the implementation of industry standards was not optimistic. A considerable number of laboratories had not verified the reference intervals, so it was necessary to promote the industry standards for reference intervals.
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Objective To optimize the synthesis method of 18F-T807 and study preliminary biodistribution. Methods 18F-T807 was synthesized using an optimized method in TRACERlab FXFN synthesizer with a t-BOC（t-Butyloxy carbonyl）-protected 18F-T807 precursor NPPI-9 as starting material, improving experimental conditions for synthesis, then QC and biodistribution study in Wistar rats conducted. Results The improved synthesis conditions increased the synthesis yield from 20.5%±6.1% to 25.7%±5.8%. QC met the standard. Wistar rats had higher intake in kidney, liver, blood and lowest intake in brain, heart, lung. Conclusion The optimized synthesis method to synthesize 18F-T807 is simple and easy, and high yield, which can meet the needs of scientific research and clinical practice.
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Follow-up is a crucial step for the screening of neonatal genetic and metabolic diseases, which can directly influence the detection, diagnosis, efficacy of treatment, as well as the quality of neonatal screening. In view of the lack of follow-up, full understanding, and inconsistent requirement between various agencies and personnel in China, there is an urgent need for standardization. The Committee for Proficiency Testing of the Neonatal Genetic Metabolic Disease Screening Center of the National Health Committee of China has organized the writing of expert consensus for follow-up of neonatal genetic and metabolic disease screening after thorough discussion, so as to guide the follow-up work and improve its quality.
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Humans , Infant, Newborn , China , Consensus , Follow-Up Studies , Genetic Diseases, Inborn , Diagnosis , Metabolic Diseases , Diagnosis , Genetics , Neonatal ScreeningABSTRACT
Objective To analyze the metabolic differences of 11C-flumazenil (11C-FMZ) with different specific radioactivity by detecting the percentage proportion of the main metabolites in vivo. Methods 5 male and 5 female volunteers with average age of (41.7±4.7) years and weight of (69.3±6.8) kg were selected from May to October 2019. 11C-FMZ with high and low specific radioactivity (268.3±57.2)×103 and (57.8±11.4)×103 Ci/mol was injected successively. The percentage of injected dose/liter of 11C-FMZ and its metabolites in the plasma at 1, 2, 3, 4, 5, 10, 15, 20, 30, 40 and 60 min after the injection was measured. Paired sample mean t test was used to calculate and compare the percentage of metabolites in the two groups. Results The percentage proportion of metabolites increased gradually with time, and reached the stable level after 15 min. The percentage proportion of low specific radioactivity group was higher than that of high specific radioactivity group with a significant statistical difference between 15 min and 60 min (P<0.05). Conclusion The metabolic rate of 11C-FMZ with different specific radioactivity was significantly different after injection and the specific radioactivity difference should be avoided if possible in clinical application.
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Objective@#To compare the lateralization accuracy and localization accuracy of MRI, interictal 18F-fluorodeoxyglucose(FDG) and 11C-flumazenil(FMZ) PET/CT imaging for refractory epilepsy(REP) in patients with hippocampal sclerosis(HS).@*Methods@#A total of 41 classical HS patients (25 males, 16 females; age: 15-61 years) with REP from General Hospital of Northern Theater Command of PLA between January 2017 and October 2018 were retrospectively analyzed. All patients underwent MRI, interictal 18F-FDG and 11C-FMZ PET/CT imaging, followed by the resection of epileptogenic foci. The pathological diagnosis was taken as the gold standard. Visual and semi-quantitative analyses were used to analyze the images. The lateralization accuracy and localization accuracy of the three imaging methods for epileptogenic foci were calculated and compared(χ2 test).@*Results@#The lateral accuracy and localization accuracy of MRI were 70.73%(29/41) and 60.98%(25/41), those of interictal 18F-FDG PET/CT imaging were 78.05%(32/41) and 70.73%(29/41), and those of interictal 11C-FMZ PET/CT imaging were 100%(41/41) and 100%(41/41), respectively. The interictal 11C-FMZ PET/CT imaging was the best among 3 imaging methods(χ2 values: 1.976-12.902, all P<0.01).@*Conclusions@#All 3 imaging methods have their advantages and limitations. The interictal 11C-FMZ PET/CT imaging has a high value in the localization of classical HSREP, which can significantly improve the diagnostic accuracy of classical HSREP and guide clinical operation.
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The laboratory medicine is aimed to support clinical decisions and patient health by providing accurate results. The internal statistical quality control (SQC) can help laboratories detecting the instability of the analytical system and preventing laboratories from reporting the patient results with medically important errors, so it is essential to ensure the quality of testing results and patient safety. The traditional methods of designing SQC strategy are based on the probability of error detection (Ped) and the probability of false rejection (Pfr). With the introduction of risk management concepts, the design of SQC strategy began to be based on the patient risk parameter [MaxE(Nuf)] proposed by Parvin, which means the maximum increase in the number of unacceptable patient results reported compared to the in-control condition during the existence of an undetected out-of control error condition. MaxE(Nuf) is related to the SQC frequency and patient risk, which is very essential for optimizing the SQC frequency and designing a risk-based SQC strategy.
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Objective@#To evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine (PPV23) and trivalent influenza vaccine (TIV) in preschoolers.@*Methods@#A total of 1 035 children aged 3-7 years were enrolled in this study and randomly divided into three groups, inoculated PPV23, TIV and both, respectively. A one-year follow-up study was conducted for immunogenicity and safety analysis.@*Results@#A total of 1 035 serological specimens were collected, including 327 in PPV23 group, 348 in TIV group and 360 in concomitant vaccination group. No significant differences in geometric mean concentrations (GMC) of seven pneumococcal serotypes were observed between the PPV23 group and the concomitant vaccination group. Compared with the TIV group, the concomitant vaccination group showed higher serological conversion rate of H3 type (88.75% vs 84.20%, P=0.01), but lower serological conversion rate of B type (92.84% vs 98.56%, P<0.001). There was no significant difference in the primary adverse reactions between the three groups (P=0.197). The rate of secondary adverse reactions occurred in the concomitant vaccination group was 3.61%, which was higher than that of the other two groups (both P<0.001). All adverse reactions were mild or moderate, and cured after treatment.@*Conclusions@#Concomitant immunization with PPV23 and TIV is safe and have good immunogenicity, thus a viable immune strategy for susceptible children.
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Objective@#To investigate the status of clinical laboratory construction in China and evaluate its completeness, adequacy and effectiveness.@*Methods@#An electronic investigation on laboratory construction was conducted in March 2019. The questionnaires were synchronously distributed to 14 055 laboratories covering 31 provincial administrative units in China. Excel 2010 and SPSS 20 were used for analysis of four main indicators: gross area, total equipment value, human resource, and testing items. Descriptive statistics were demonstrated and comparisons of the indicators among different types of laboratories were checked with the Kruskal-Wallis test.@*Results@#A total of 9 966 valid questionnaires were returned, with an effective recovery of 70.9%. The overall median of the four indicators were respectively: gross area(344.5 square meters), total equipment value(RMB 4.15 million), staff number(12) and testing item number(160). The difference of all four indicators among various types of laboratories was significant(P<0.05).@*Conclusions@#The construction of laboratories in primary hospitals and private hospitals is not satisfying, especially the equipment and human resource. More attention on the awareness to improve clinical laboratory construction for further quality improvement and patient safety is needed.
ABSTRACT
Objective To investigate the status of clinical laboratory construction in China and evaluate its completeness,adequacy and effectiveness.Methods An electronic investigation on laboratory construction was conducted in March 2019.The questionnaires were synchronously distributed to 14 055 laboratories covering 31 provincial administrative units in China.Excel 2010 and SPSS 20 were used for analysis of four main indicators:gross area,total equipment value,human resource,and testing items.Descriptive statistics were demonstrated and comparisons of the indicators among different types of laboratories were checked with the Kruskal-Wallis test.Results A total of 9 966 valid questionnaires were returned,with an effective recovery of 70.9％.The overall median of the four indicators were respectively:gross area(344.5 square meters),total equipment value (RMB 4.15 million),staff number(12) and testing item number(160).The difference of all four indicators among various types of laboratories was significant (P ＜ 0.05).Conclusions The construction of laboratories in primary hospitals and private hospitals is not satisfying,especially the equipment and human resource.More attention on the awareness to improve clinical laboratory construction for further quality improvement and patient safety is needed.