Analysis on the results of external quality assessment for quality indicators of clinical laboratory in China / 中华医院管理杂志

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.

Expression and Clinical Significance of Serum sFas/sFasL in Patients with Secondary Hemophagocytic Lymphohistiocytosis / 中国实验血液学杂志

OBJECTIVE@#To investigate the expression and clinical significance of soluble Fas (sFas) and sFasL in patients with secondary hemophagocytic lymphohistiocytosis (sHLH).@*METHODS@#From September 2015 to December 2020, 86 sHLH patients who met the HLH2004 diagnostic criteria were collected. They were divided into 55 cases in the MAHLH group and 31 cases in the NonMAHLH group according to the etiology. Thirty healthy persons were chosen as the normal control group, and 20 patients with systemic lupus erythematosus (SLE) were chosen as the disease control group. The expression levels of sFas and sFasL in the serum of patients with each group were detected by ELISA, and the clinical data were collected for statistical analysis. The significance of sFas and sFasL in sHLH was analyzed by ROC curve.@*RESULTS@#Serum levels of sFas and sFasL in patients with newly diagnosed sHLH were significantly higher than those in disease control group and normal control group (P<0.01). The levels of sFas and sFasL in MAHLH group were significantly higher than those in nonMAHLH (infection related HLH and autoimmune disease related HLH) group (P<0.01). The serum levels of sFas and sFasL in 17 newly treated patients with sHLH (17/86) after treatment were significantly lower than those before treatment (P<0.01). The serum sFas level in newly diagnosed sHLH patients was positively correlated with SF(r=0.35), sCD25(r=0.79) and sFasL(r=0.73). The serum sFasL level was positively correlated with SF(r=0.39), sCD25(r=0.64) and sFas(r=0.73). Compared with the NonMAHLH group, the area under the ROC curve was 0.707 (95% CI: 0.593-0.821) (P=0.0015). The optimal critical value for diagnosing MAHLH by sFas level was 12 743 pg/ml, and the sensitivity and specificity were 70.9% and 71% respectively. Compared with the NonMAHLH group, the area under the ROC curve was 0.765(95% CI: 0.659-0.87)(P<0.01). The median OS time of sFas high expression group (≥16798.5 pg/ml) and sFasL high expression group (≥4 785 pg/ml) was significantly shorter than that of the low expression group (P<0.001).@*CONCLUSION@#Serum levels of sFas and sFasL can be used for the early diagnosis and differential diagnosis of sHLH disease, and are the factor related to the poor prognosis of sHLH.

Internal carotid artery pseudoaneurysm caused by parapharyngeal abscess: A case report / 北京大学学报(医学版)

Pseudoaneurysms of the neck are seldom, and those caused by neck infections especially parapharyngeal abscess are even rarer. However, it is life-threatening and may bring sudden death due to the obstruction of airway and the pseudoaneurysms rupture. We analyzed the clinical features, diagnosis and treatment of the disease through a case summary and literature review in order to guide clinical diagnosis and treatment of pseudoaneurysms. The patient, whom we presented was an 87-year-old male and admitted in emergency of our hospital with the chief complaint of neck swelling for 7 days and shortness of breath for 2 days. Cervical ultrasound examination showed that there was an liquid dark area next to the left common carotid artery which was approximately 8.0 cm × 5.0 cm, consideration of formation of left carotid artery pseudoaneurysm, and the liquid dark area which was visible on the right considered of pseudoaneurysm or infection. Angiography of neck showed a clustered high-density shadow around the bifurcation of the left carotid artery, with an overall range of approximately 65 mm × 52 mm × 72 mm, the pseudoaneurysms for sure, while on the right side of the lesion, mixed low density shadows with air could be seen, the parapharyngeal abscess for sure.Then he was diagnosed as the pseudoaneurysm of left internal carotid artery which was caused by parapharyngeal abscess. After tracheal intubation and anti-infection treatment, the patient died due to hemorrhagic shock of the ruptured of the pseudoaneurysm. Morever we performed literature search on PubMed, Wanfang database and CNKI with keywords of "neck pseudoaneurysm, neck infection, parapharyngeal abscess" and enrolled 10 cases. Then we summarized the clinical characteristics and treatment. We analyzed and summarized the 10 case reports, in which the number of male was 7. Among them, there were 4 pediatric, and 6 adults were enrolled overall. Most of the symptoms were neck swelling, and the diseased blood vessel was mainly the right internal carotid artery which accounted for half overall. All the patients underwent surgical intervention, and recovered well. So we draw the conclusion that the clinical incidence of cervical pseudoaneurysms is low and can be caused by a variety of factors, especially caused by infectious factors. When a patient has a progressive pulsating mass in the neck, the preliminary diagnosis should be made by ultrasound as soon as possible, and the aortic enhancement CT should be used to further confirm.For a patient with cervical pseudo-aneurysms caused by parapharyngeal infections, he should take operation timely combined with antibiotic treatment in time.

Research on Rapid Detection Technology for Quality Control of Emergency Ventilator / 中国医疗器械杂志

OBJECTIVE@#In order to grasp the quality status of the first-aid ventilator in pre-hospital and field environment in time, the quality control and detection items of invasive ventilator were optimized to form a rapid detection operation process of first-aid ventilator and ensure the safety of patient treatment.@*METHODS@#Based on the quality control detection data of invasive ventilator in hospital in recent years, methods such as narrowing the range of qualified criteria and analyzing confidence interval were adopted to extract indicators prone to deviation and verify their correlation with similar indicators, so as to form an optimized rapid detection portfolio.@*RESULTS@#Compared with the original quality control detection procedures, the detection indicators of the rapid detection procedures were reduced from 5 categories of 24 indicators to 3 categories of 7 indicators. The detection time was shortened by 56.1% and the coincidence rate of the detection results was 100% after the actual measurement and verification.@*CONCLUSIONS@#Under the premise of ensuring the testing quality, the operating procedure for rapid detection of emergency ventilator can greatly reduce the detection time, and realize the rapid and high frequency quality control detection, so as to ensure the quality and safety of the equipment.

FGFC1 Inhibits Proliferation and Migration of Non-Small Cell Lung Cancer Cells via the PI3K/Akt/mTOR Signaling Pathway / 中国生物化学与分子生物学报

FGFC1 (Fungi fibrinolytic compound1) is a bisindole compound with good biological activity, which was first derived from the Stachybotrys longispora FG216. However, the anti-tumor effects of FGFC1 have not been reported. This study investigated the effect and mechanism of FGFC1 on the proliferation, apoptosis, migration and invasion of non-small cell lung cancer (NSCLC) cells.Firstly, PC9, H1975, HCT116, HeLa and 293T cells were treated with different concentrations of FGFC1, and the cell counting kit-8 assay was used to determine relative cell viability; flow cytometry was used to evaluate apoptosis; real-time PCR and Western blotting analysis were performed to measure the expression of apoptosis-related genes in PC9 cells; wound healing and Transwell invasion assays were used to measure the ability of migration and invasion; Western blotting was performed to measure the expression of kinase proteins involved in the PI3K/Akt/mTOR signaling pathway, exploring the influence of FGFC1 on this signaling pathway. We found that FGFC1 selectively inhibited the proliferation of PC9 cells. It also up-regulated the expression of apoptosis-promoting protein cleaved-caspase-3 and cleaved-PARP, and induced apoptosis in a dose-dependent manner (P < 0. 05). FGFC1 also significantly inhibited the migratory and invasive capacity of PC9 cells in a dose-dependent manner (P < 0. 05). Further studies confirmed that FGFC1 could inhibit the activation of the PI3K/Akt/mTOR signaling pathway with the down-regulation of the protein expression levels of p-PI3K, p-Akt and p-mTOR. Thus, we conclude that FGFC1 inhibited the proliferation of PC9 and H1975 cells, induced the apoptosis and inhibited the migration and invasion of PC9 cells, which may take place through down-regulating the PI3K/Akt/mTOR signaling pathway. These findings suggest that FGFC1 might be a new therapeutic target in NSCLC treatment in the future.

Meta-analysis and systematic review of efficacy and safety of Lianhua Qingwen in adjuvant treatment of adult pneumonia / 中国中药杂志

To systematically evaluate the clinical efficacy and safety of Lianhua Qingwen in the treatment of adult pneumonia. The randomized controlled trial of Lianhua Qingwen combined with conventional Western medicine in the treatment of pneumonia were retrieved from PubMed, EMbase, Wanfang database, VIP database, and CNKI from the establishment of database to March 2020. Two researchers independently conducted literature screening and data extraction, and the third researcher was in charge of arbitration in case of any disagreement. Outcome indicators included total clinical effective rate, symptom improvement time, and incidence of adverse events. R 3.6.1 was used for Meta-analysis, and RevMan 5.3 was used for quality evaluation. Twenty-two studies were included, with a total of 2 007 patients, including 1 017 patients in the experimental group and 990 patients in the control group. The results showed that the total clinical effective rate of the experimental group was higher than that of the control group(RR=1.11, 95%CI[1.08, 1.15], P<0.001), and the antifebrile time(MD=-1.81, 95%CI[-2.42,-1.21], P<0.001), cough duration(MD=-2.32, 95%CI[-2.89,-1.76], P<0.001), rale duration(MD=-2.19, 95%CI[-2.74,-1.63], P<0.001), imaging recovery time(MD=-2.17, 95%CI[-2.76,-1.58], P<0.001) and post-treatment CRP(MD=-4.07, 95%CI[-6.39,-1.75], P<0.001] were all significantly lower than those of the control group. However, it did not proved that the experimental group was safer than the control group(RR=0.84, 95%CI[0.57, 1.24], P=0.382). The results confirmed that Lianhua Qingwen combined with conventional Western medicine in the treatment of pneumonia could improve the clinical treatment efficiency, shorten the time of fever, cough, rale disappearance and imaging recovery, improve CRP index and accelerate the recovery of pneumonia patients. However, the literatures included in this study had a low quality, and the conclusions still need to be further confirmed by more high-quality, multi-center, rigorously designed randomized controlled trial.

Expression and Clinical Significance of Soluble B7-H3 in Patient with Secondary Hemophagocytic Lymphohistiocytosis / 中国实验血液学杂志

OBJECTIVE@#To investigate the expression and clinical significance of soluble B7-H3 (sB7-H3) in patients with secondary hemophagocytic lymphohistiocytosis (sHLH).@*METHODS@#The plasma samples of 85 newly diagnosed sHLH patients from December 2012 to April 2018 were collected. The patients were divided into lymphoma-related HLH（LHLH）group and infection-related HLH（IHLH）group. The expression of sB7-H3 in plasma was detected by ELISA, and the clinical data were collected for analysis. Fifteen healthy people were chosen as control group.@*RESULTS@#The expression level of sB7-H3 in lymphoma-related HLH and infection-related HLH group significant increased as compared with the control group, (P＜0.05), and the expression level of sB7-H3 in lymphoma-related HLH group was significant higher than that in infection-related HLH group [(35.75± 9.90) vs (28.70±8.95) ng/ml)] (P＜0.001). There were no significant statistical difference in the expression of some clinical factors (including age, fever, splenomegaly, ANC, Plt, FIB, calcium ion, serum albumin, LDH, serum ferritin, sCD25) in lymphoma-related HLH and infection-related HLH group (P＞0.05). The evaluation of expression and significance of sB7-H3 in sHLH by using ROC curve, showed that the area under ROC curve comparison of patients in lymphoma-related HLH group and infection-related HLH group was 0.718 (95% CI 0.610-0.810) (P=0.0002), and predicting the sensitivity and specificity of the lymphoma-related HLH patients were 77.36% and 59.38%, respectively. The best cut-off value of patients in sB7-H3 was 29.81 ng/ml, the overall survival time of sB7-H3 high-expression group (≥29.81 ng/ml) was significant shorter than that in low-expression group (＜29.81 ng/ml) (24 vs 440 d) (P＜0.001). The clinical factors affecting the survival status of sHLH patients were neutrophils, albumin, serum ferritin, serum calcium ions and sB7-H3 levels.@*CONCLUSION@#sB7-H3 associates with poor prognosis of sHLH patients, and may be involved in disease progression.

Clinical analysis of secondary hemophagocytic lymphohistiocytosis complicated with capillary leak syndrome / 中华血液学杂志

Objective: To investigate the clinical characteristics of secondary hemophagocytic lymphohistiocytosis (sHLH) complicated with capillary leak syndrome (CLS) . Methods: The clinical and laboratory data of 87 sHLH patients, who were treated in our hospital between January 2015 and December 2017, were retrospectively analyzed. Depending on whether they were complicated with CLS, 21 sHLH patients were classified as the CLS-sHLH group, while 66 were classified as the non-CLS-sHLH group. The differences of clinical manifestations, laboratory tests, treatment and prognosis between the two groups were compared. Results: There was no significant difference in the etiology of sHLH between the CLS-sHLH group and the non-CLS-sHLH group (P>0.05) . The neutrophil, fibrinogen and albumin levels in the CLS-sHLH group were lower than those in the non-CLS-sHLH group, while the triacylglycerol levels were higher than those in the non-CLS-sHLH group (P<0.05) . Varying degrees of edema, weight gain, hypotension, hypoproteinemia, oliguria and multiple serous effusions were observed in the CLS-sHLH group. Among them, there were 15 patients that CLS get improved, and the medial time of improvement was 7 (5-14) days. The other 6 patients did not get remission, while they died within 6-30 days. The median overall survival of the CLS-sHLH group was lower than that of the non-CLS-sHLH group (75 days vs not reached, P=0.031) . Conclusions: There may be no correlation between the cause of sHLH and the occurrence of CLS. Severity of neutropenia, fibrinogen and albumin levels, and triglyceride levels may be accompanied for sHLH patients complicated with CLS. Patients with sHLH who complicated with CLS have a poor prognosis. Active treatment of HLH and its primary disease, reasonable fluid replacement and oxygen supply are crucial, which can effectively control disease progression.

Scientific research reagents and consumables management mode based on network / 医疗卫生装备

Objective To explore a research reagents and consumables management method based on network to improve hospital reagents procurement management. Methods The current situation and existing problems of scientific research reagents and consumables management were introduced, and the necessity, significance and process of a network-based management mode were put forward. Results The newly-proposed management mode contributed to optimizing resources layout and controlling purchase process. Conclusion The network-based management mode enhances the efficiency of hospital consumables management,decreases the cost and improves hospital management. [Chinese Medical Equipment Journal,2018,39(5):81-83,96]

Discussions about Extra-Analytical Quality Indicators and Laboratory Performances by IFCC / 现代检验医学杂志

In the last few years much progress has been made in raising the awareness of laboratory medicine professionals a bout the effectiveness of quality indicators (QIs) in monitoring,and improving upon,performances in the extra-analytical phases of the total testing process (TTP).An effective system for management of QIs includes the implementation of an internal assessment system and participation in inter-laboratory comparison.A well-designed internal assessment system allows the identification of critical activities and their systematic monitoring.Active participation in inter-laboratory comparison provides information on the performance level of one laboratory with respect to that of other participating laboratories.In order to guarantee the use of appropriate QIs and facilitate their implementation,many laboratories have adopted the Model of Quality Indicators (MQI) proposed by Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of IFCC,since 2008,which is the result of international consensus and continuous experimentation,and updating to meet new,con stantly emerging needs.Data from participating laboratories are collected monthly and reports describing the statistical results and evaluating laboratory data,utilizing the Six Sigma metric,issued regularly.Although the results demonstrate that the processes need to be improved upon,overall the comparison with data collected in 2014 shows a general stability of quality levels and that an improvement has been achieved over time for some activities.The continuous monitoring of QI dataallows identification all possible improvements,thus highlighting the value of participation in the inter-laboratory program proposed by WGLEPS.The active participation of numerous laboratories will guarantee an ever more significant State-of-the-Art,promote the reduction of errors and improve quality of the TTP,especially the extra-analytical quality,thus guaranteeing patient safety.

Effects of titanium dioxide nanoparticles and lipopolysaccharide on antioxidant function of liver tissues in mice / 北京大学学报(医学版)

OBJECTIVE@#To compare the effects of different sized titanium dioxide (titanium dioxide, TiO2) on the antioxidant function of liver tissues in mice, and study the effect of TiO2 nanoparticles on the susceptibility of lipopolysaccharide (LPS) on liver tissues.@*METHODS@#Ninety 4-week-old clean-grade male ICR mice were divided into 18 groups, in which the mice were fed for different feed involving ordinary feed, nanometer TiO2 feed which meant the feed including 1% (mass fraction) TiO2 nanoparticles, and submicron TiO2 feed which meant the feed including 1% (mass fraction) TiO2 submicron particles. Respectively, they were fed for 1 month, 3 months and 6 months. On the second day after the feeding, respectively, 0 and 10 mg/kg LPS were given by gavage. The mice were harvested after 4 h and the body weight and liver weight for calculating the liver coefficient were recorded. Then the liver tissue homogenates were prepared for determining the antioxidant indexes including the total antioxidant capacity (T-AOC), total superoxide dismutase (T-SOD), glutathione peroxidase (GSH-PX), and malondialdehyde (MDA).@*RESULTS@#The change of body weight in mice was only discovered in group fed for 1 month, which showed significant decrease of body weight in treatment groups compared with control group. And there was no significant change of the liver coefficient in each group. Compared with control groups, nanometer TiO2 groups and submicron TiO2 group, the activity of T-AOC, T-SOD and MDA of nanometer TiO2+LPS group and submicron TiO2+LPS group in which the mice were fed for 1 month and 6 months increased in different degree. And another result was also existing. The MDA activity of liver in different sized treatment groups fed for 3 months decreased. Neither significant difference between the results of different sized TiO2 treatment groups, nor significant difference among different sized TiO2 groups and the control groups were observed.@*CONCLUSION@#Longterm peroral TiO2 nanoparticles and TiO2 submicron particles are more likely to cause damage to the liver in the growing mice, and the damage may be either reductive or oxidative. In addition, small sized TiO2 can increase the susceptibility of mice liver to LPS and the susceptibility will increase with the increase of exposure time.

Imaging findings of bone infarction in children with systemic lupus erythematosus / 中国骨伤

<p><b>OBJECTIVE</b>To investigate diagnostic value of MRI, X ray and CT for bone infarction in children with systemic lupus erythematosus.</p><p><b>METHODS</b>Eleven systemic lupus erythematosus children with bone infarction were retrospectively analyzed from January 2015 to January 2017 , and tested by MRI, X-ray and CT. Among them, including 1 male and 10 females aged from 6 to 16 years old with an average of 13 years old. All patients were detected by MRI, 9 patients were detected by X-ray and 3 patients were detected by CT, imaging findings were analyzed.</p><p><b>RESULTS</b>The location of bone infarction involved 60 sits, 30 sites located on metaphyseal-diaphyseal region, 8 located on patella, 21 located on epiphysis, and 1 located on talus. Focus of 11 patients were detected by MRI, the main manifestation showed geographic change, long T1 and T2 signal could seen around focus, and showed double ring sign and three ring sign; 5 of 9 patients by X-ray examination detected focus;2 of 3 patients by CT examination detected focus. No abnormity seen at early stage by X-ray and CT examination, and low density focus around harden edge at chronic stage.</p><p><b>CONCLUSIONS</b>MRI could display bone fracture at early stage, X-ray and CT could only display lesion at chronic stage, MRI is the most effective method in diagnosing bone infarction.</p>

UPLC/ESI-QTOF-MS-based metabolomics survey on the toxicity of triptolide and detoxication of licorice / 中国天然药物

Triptolide (TP) from Tripterygium wilfordii has been demonstrated to possess anti-inflammatory, immunosuppressive, and anticancer activities. TP is specially used for the treatment of awkward rheumatoid arthritis, but its clinical application is confined by intense side effects. It is reported that licorice can obviously reduce the toxicity of TP, but the detailed mechanisms involved have not been comprehensively investigated. The current study aimed to explore metabolomics characteristics of the toxic reaction induced by TP and the intervention effect of licorice water extraction (LWE) against such toxicity. Obtained urine samples from control, TP and TP + LWE treated rats were analyzed by UPLC/ESI-QTOF-MS. The metabolic profiles of the control and the TP group were well differentiated by the principal component analysis and orthogonal partial least squares-discriminant analysis. The toxicity of TP was demonstrated to be evolving along with the exposure time of TP. Eight potential biomarkers related to TP toxicity were successfully identified in urine samples. Furthermore, LWE treatment could attenuate the change in six of the eight identified biomarkers. Functional pathway analysis revealed that the alterations in these metabolites were associated with tryptophan, pantothenic acid, and porphyrin metabolism. Therefore, it was concluded that LWE demonstrated interventional effects on TP toxicity through regulation of tryptophan, pantothenic acid, and porphyrin metabolism pathways, which provided novel insights into the possible mechanisms of TP toxicity as well as the potential therapeutic effects of LWE against such toxicity.

Quality Requirements for Reference Intervals and Decision Limits in Clinical Laboratory / 现代检验医学杂志

Reference intervals and decision limits are critical parts of the clinical laboratory report.The evaluation ot their correct use represents a tool to verify the post analytical quality.Four elements are identified as indicators:① The use of decision limits for lipids and glycated hemoglobin.② The use of common reference values.③The presence of gender-related reference intervals for at least the following common serum measurands (besides obviously the fertility relate hormones):alkaline phosphatase (ALP),alanine aminotransferase (ALT),creatine kinase (CK),creatinine,gamma-glutamyl transferase (GGT),IgM,ferritin,iron,transferrin,urate,red blood cells (RBC),hemoglobin (Hb) and hematocrit (HCT).④) The presence of age-related reference intervals.The problem of specific reference intervals for elderly people is discussed,but their use is not recommended.On the contrary it is necessary the presence of pediatric age-related reference intervals at least for the following common serum measurands:ALP,amylase,creatinine,inorganic phosphate,lactate dehydrogenase,aspartate aminotransferase,urate,insulin like growth factor 1,white blood cells,RBC,Hb,HCT,alfafetoprotein and fertility related hormones.The lack of such reference intervals may imply significant risks for the patients.

Investigations on the determination methods of alert thresholds for critical values in clinical laboratories / 临床检验杂志

Objective To retrospectively analyze the literature of alert thresholds for the critical values of clinical biochemistry and hematology tests in adults,and collect the evidence source of these alert thresholds.Methods The literatures during 2006 and 2016 were retrieved,and the evidence sources were evaluated and ranked using the 1999 Stockholm hierarchy for analytical performance specifications in laboratory medicine.Results Thirty most frequently reported laboratory tests with alert thresholds were presented with evidence rankings.Four determination methods of alert thresholds were reported in 92 articles with alert thresholds for critical values.Among them,70％ of alert thresholds were set by individual institutions,18％ by the surveys of clinical laboratories or clinicians,2％ by the recommendation of professional institutions,and 10％ by the evaluation of clinical findings.The sources of these alert thresholds were ranked into level 4,level 3,level 2 and leve 1,respectively.In addition,the alert thresholds of 7 clinical laboratory tests were presented as critical δ values.Conclusion The alert thresholds are set mainly by individual institutions in current clinical laboratoties,followed by the surveys of clinical laboratories or clinicians.Moreover,the general level of evidence source is lower.

An empirical study on concentration ratio of Chinese patent medicine industry in China and its influencing factors / 中草药

This review is used to improve the concentration ratio and competitiveness of Chinese patent medicine industry, and to provide reference for policy-making. The concentration ratio of Chinese patent medicine industry was calculated by CRn. The multiple regression model was conducted to analyze the Chinese patent medicine industry’s concentration factors influencing. Product differentiation, scale economy, and foreign capital economy proportion have a great impact on the concentration of Chinese patent medicine industry. The enhancement of product differentiation and scale economy can improve the concentration of Chinese patent medicine industry. The entry of foreign capital can also increase the concentration of Chinese patent medicine industry. However, related research shows that the entry of foreign capital will bring some security problems. Therefore, it is necessary to take some measures to prevent the potential risks brought by foreign corporations when improve the competitiveness of Chinese patent medicine industry and enhance Chinese enterprises’ strength by utilizing foreign capital.

Cost-Minimization Analysis of Baofukang Compared with Langyi in the Treatment of Pregnancy with Vulvovaginal Candidiasis / 中国药学杂志

OBJECTIVE: To conduct an economic evaluation of Baofukang versus Langyi in the treatment of pregnancy with vulvovaginal candidiasis by means of cost-minimization analysis. Furthermore, provide reference for reasonable clinical prescription and decision-making. METHODS: Meta-analysis was conducted to support the safety data and effectiveness data of pharmacoeconomic evaluation based on literature review; guidelines and clinical experts' suggestion were used to find out treatment routes to calculate total direct medical costs. Cost-minimization analysis was conducted from the societal perspective. RESULTS: The total direct medical costs of group Baofukang was lower than group Langyi's. Sensitivity analysis indicated the results were robust. CONCLUSION: In contrast with Langyi, Baofukang is a more economic therapy in the treatment of pregnancy with vulvovaginal candidiasis.

Pragmatic Approach of Verification of Examination Procedures in Clinical Laboratory for Imprecision,Trueness and Diagnostic Accuracy / 现代检验医学杂志

Objective To propose a practice model for implementing procedures employed for the verification of validated ex-amination procedures already used for at least 2 years in their laboratory,in agreement with the ISO 15189 requirement at the Section 5.5.1.2.Methods In order to identify the operative procedure to be used,approved documents were identified, together with the definition of performance characteristics to be evaluated for the different methods;the examination proce-dures used in laboratory were analyzed and checked for performance specifications reported by manufacturers.Then,opera-tive flow charts were identified to compare the laboratory performance characteristics with those declared by manufacturers. Results The choice of performance characteristics for verification was based on approved documents used as guidance,and the specific purpose tests undertaken,a consideration being made of:imprecision and trueness for quantitative methods;diag-nostic accuracy for qualitative methods;imprecision together with diagnostic accuracy for semi-quantitative methods.Conclu-sion The described approach,balancing technological possibilities,risks and costs and assuring the compliance of the funda-mental component of result accuracy,appears promising as an easily applicable and flexible procedure helping laboratories to comply with the ISO 15189 requirements.

Sulfur-containing derivatives as characteristic chemical markers in control of sulfur-fumigated Moutan Cortex / 药学学报

The amount of sulfur dioxide residue is currently employed by Chinese Pharmacopoeia (CP) as an index to screen sulfur-fumigated herbs, but it is unclear if this index can objectively reflect the quality of sulfur-fumigated herbs. In the present study, sulfur-containing derivatives were confirmed in sulfur-fumigated Moutan Cortex (MC) by UPLC-QTOF-MS/MS analysis, and the contents of sulfur-containing derivatives and sulfur dioxide residues were statistically analyzed both in self-made and commercially available sulfur-fumigated and non-fumigated MC as well as the samples thereof before and after eight-month storage. The amount of sulfur dioxide was significantly decreased, but that of the newly-generated sulfur-containing markers was not, after eight-month storage of the sulfur-fumigated MC samples, indicating that the amount of sulfur dioxide residue may not be positively correlated with the quality of sulfur-fumigated MC. Therefore, sulfur dioxide residue index alone may not objectively reflect the sulfur-fumigation extent (quality change extent) of MC, more specific method using characteristic sulfur-containing derivatives as chemical markers should be developed to supplement the sulfur dioxide residue determination in the quality control of sulfur-fumigated MC.

Hot air-microwave combination drying method for processing Angelicae Sinensis Radix / 中草药

Objective: In this study, the feasibility of hot air-microwave combination drying method for processing Angelicae Sinensis Radix (ASR) was investigated and evaluated. Methods: Hot air temperature, drying time, microwave electric current, and microwave time were taken into consideration. The combined drying method was optimized based on the standards of ASR documented in Chinese Pharmacopoeia (2015 version). After that, microorganisms, heavy metals, harmful elements, and active ingredients (ferulic acid, coniferyl ferulate, senkyunolide I, senkyunolide H, senkyunolide A, E-ligustilide, Z-ligustilide, n-butylidenephthalide, riligustilide, and levistilide A) were detected to evaluate the quality of processed samples. Results: The optimal method was that samples were dried in hot air (70℃) for 20 h, then heated in microwave (100 mA) for 6 min. The number of microorganisms in processed samples equaled to sulfur-fumigated samples; Heavy metals and harmful elements were qualified after this processing; The new drying method for processing ASR had no significant effect on the active ingredient. Conclusion: After this process, the physical and chemical indicators of ASR are in line with the criteria of Chinese Pharmacopoeia. This hot air-microwave combination drying method should be a fast drying method for post-harvest handling of ASR.