Objective To establish the analytical performance specifications(APS)for routine items of biochemical inspection based on the external quality assessment(EQA)and internal quality control(IQC)data.Methods The EQA data and IQC data of routine items of biochemistry inspection in clinical laboratory center of national health commission from 2021 to 2023 were collected from the Department Clinical Laboratory of Traditional Chinese Medicine Hospital of Chengdu Pidu District.Comparing the percentage difference of the EQA data and the IQC in control imprecision[expressed as the coefficient of variation(CV)]data with the 3-level evaluation criteria derived based on biological variation(BV),the percentage pass rate of EQA data and the pass rate of CV under control were calculated,so as to achieve the quality target of APS with 80％or more as the quality control product of this level as the routine biochemical test items of the laboratory.For the inspection items that did not reach BV standard APS or were not applicable to meet the standard,the APS would be set to the WS/T 403-2012 industry standard or based on current technical level.Results TEa/allowable CV of biochemical inspection items were as follows:Potassium(K)2.4％/1.9％,Sodium(Na)4.0％/0.9％,Chloride(Cl)4.0％/0.9％,Calcium(Ca)3.4％/1.8％,Phosphate(P)9.6％/1.9％,Magnesium(Mg)3.8％/2.0％,Glucose(Glu)6.1％/2.3％,Creatinine(Crea)3.9％/2.2％,Urea(Urea)8.6％/3.3％,Total protein(TP)4.9％/2.0％,Albumin(Alb)3.3％/1.9％,Total bilirubin(TBil)6.3％/2.4％,Alanine transaminase(ALT)9.3％/2.9％,Asparpartate transaminase(AST)6.2％/2.1％,γ-glutamyl transferase activity(GGT)9.2％/2.1％,Lactate dehydrogenase(LDH)6.8％/2.2％,Alkaline phosphatase(ALP)7.2％/3.3％,Total cholesterol(TC)of 8.3％/2.6％,Triglyceride(TG)12.9％/4.9％,Amylase(AMY)5.9％/1.6％,Creatine kinase(CK)4.3％/1.6％and Uric acid(UA)2.9％/1.0％.Conclusion The APS set based on BV or current technical level can be used as a quality target for routine laboratory clinical biochemistry testing programs,and the laboratory can select the suitable APS according to the actual situation.

Objective: To explore the causal relationship between the abundance of intestinal flora(IF) and the risk of developing acute myeloid leukemia(AML) using two-sample bidirectional Mendelian randomization(MR) methods. Methods: The MiBioGen Consortium and FinnGen databases were utilized for the IF abundance and AML genome-wide association datasets, respectively. The primary analysis method entailed variance inverse weighting, supplemented by weighted median test, while heterogeneity was assessed using Cochran′sQtest. Additionally, MR-PRESSO was employed to identify any outliers, while MR-Egger intercept was utilized to evaluate horizontal pleotropy. Results: Higher abundance of genetically determinedDialister(P=0.034,OR=4.373,95%CI:1.329-14.392),Veillonaceae(P=0.009,OR=2.029,95%CI:1.839-3.866), andLachnospiraceae UCG008(P=0.034,OR=3.827,95%CI:1.107-13.228) were found to be linked to an increased risk of AML. In contrast,Ruminococcaceae(P=0.042,OR=0.176, 95%CI:0.033-0.939) andPeptococcaceae(P=0.025,OR=0.168, 95%CI:0.035-0.803) were associated with a reduced risk of this disease. Conclusion Higher levels of theDialister, theVeillonellaceae, and theLachnospiraceae UCG008are risk factors for AML, while the familiesRuminococcaceaeandPeptococcaceaeare identified as protective factors against AML.

Purpose: This study was aimed to investigate long-term survivals and toxicities of early-stage nasopharyngeal carcinoma (NPC) in endemic area, evaluating the role of chemotherapy in stage II patients. Materials and Methods: Totally 187 patients with newly diagnosed NPC and restaged American Joint Committee on Cancer/ International Union Against Cancer 8th T1-2N0-1M0 were retrospectively recruited. All received intensity-modulated radiotherapy (IMRT)±chemotherapy (CT) from 2001 to 2010. Results: With 15.7-year median follow-up, 10-year locoregional recurrence-free survival, distant metastasis-free survival (DMFS), disease-specific survival (DSS), and overall survival (OS) were 93.3%, 93.5%, 92.9% and 88.2%, respectively. Multivariable analyses showed cervical lymph nodes positive and pre-treatment prognostic nutritional index ≥ 52.0 could independently predict DMFS (p=0.036 and p=0.011), DSS (p=0.014 and p=0.026), and OS (p=0.002 and p < 0.001); Charlson comorbidity index < 3 points could predict DSS (p=0.011); age > 45 years (p=0.002) and pre-treatment lactate dehydrogenase ≥ 240 U/L (p < 0.001) predicted OS. No grade 4 late toxicity happened; grade 3 late toxicities included subcutaneous fibrosis (4.3%), deafness or otitis (4.8%), skin dystrophy (2.1%), and xerostomia (1.1%). No differences on survivals were shown between IMRT+CT vs. IMRT alone in stage II patients, even in T2N1M0 (p > 0.05). Unsurprising, patients in IMRT+CT had more acute gastrointestinal reaction, myelosuppression, mucositis, late ear toxicity, and cranial nerve injury (all p < 0.05) than IMRT alone group. Conclusion Superior tumor control and satisfying long-term outcomes could be achieved with IMRT in early-stage NPC with mild late toxicities. As CT would bring more toxicities, it should be carefully performed to stage II patients.

Background::The preferred therapeutic regimen for Toxoplasma encephalitis (TE) is a combination of pyrimethamine and sulfadiazine, and trimethoprim-sulfamethoxazole (TMP-SMX) plus azithromycin is the widespread alternative therapeutic regimen. The synergistic sulfonamides tablet contains TMP, sulfadiazine, and SMX and hypothetically could be used for TE treatment. This study aimed to compare the efficacy and safety of synergistic sulfonamides plus clindamycin (regimen B) with TMP-SMX plus azithromycin (regimen A) for the treatment of human immunodeficiency virus (HIV) associated TE.Methods::This was an open-labeled, multi-center randomized controlled trial recruited from 11 centers. Each recruited patient was randomly assigned to receive regimen A or regimen B for at least 6 weeks. The overall response was evaluated by assessment of the clinical response of TE-associated clinical features and the radiological response of TE-associated radiological findings. The overall response rate, clinical response rate, radiological response rate, and adverse events were assessed at 2, 6, and 12 weeks. Death events were compared between the two regimens at 6, 12, and 24 weeks.Results::A total of 91 acquired immunodeficiency syndrome (AIDS)/TE patients were included in the final analysis (44 in regimen A vs. 47 in regimen B). The overall response rate, which refers to the combined clinical and radiological response, was 18.2% (8/44) for regimen A and 21.3 % (10/47) for regimen B at week 6. The results of clinical response showed that, in comparison with regimen A, regimen B may perform better with regards to its effect on the relief of clinical manifestations (50.0% [22/44] vs. 70.2% [33/47], P = 0.049). However, no significant differences in radiological response, mortality events, and adverse events were found between the two regimens at week 6. Conclusions::Synergistic sulfonamides plus clindamycin, as a novel treatment regimen, showed no significantly different efficacy and comparable safety in comparison with the TMP-SMX plus azithromycin regimen. In addition, the regimen containing synergistic sulfonamides may exhibit advantages in terms of clinical symptom alleviation.Trial Registration::ChiCTR.org.cn, ChiCTR1900021195.

Objective:To analyze the relationship between antithrombin Ⅲ(AT-Ⅲ) activity and survival, bleeding and thrombosis complications in patients with acute-on-chronic liver failure (ACLF), and to explore the prediction value of AT-Ⅲ activity in the prognosis of ACLF patients.Methods:The clinical data of 130 hospitalized patients with ACLF were retrospectively collected in Wuxi No.5 People′s Hospital from January 1, 2013 to April 1, 2019. The liver function, international normalized ratio (INR), and 90-day survival rate were detected. The AT-Ⅲ activity values at admission, week two, week four, and week eight of hospitalization were recorded, and the occurrences of fecal occult blood and femoral vein thrombosis were also recorded. The measurement data were compared by t test, analysis of variance, or rank sum test, and the categorical data were compared by chi-square test. The risk factors affecting the survival of ACLF patients were analyzed by Cox regression. The survival analysis was performed using the Kaplan-Meier method. Results:At the end of 90-day follow-up of 130 patients, 56 patients died, 20 patients (15.38%) were fecal occult blood positive and 15 (11.54%) had femoral vein thrombosis. The baseline AT-Ⅲ activity in the death group was lower than that in the survival group ((17.89±13.68)% vs (36.03±11.96)%), and the difference was statistically significant ( t=-8.045, P<0.01). The baseline AT-Ⅲ activities in fecal occult blood positive and negative patients were (18.26±11.52)% and (25.06±10.97)%, respectively, and in femoral vein thrombosis and non-thrombotic patients were (17.55±10.33)% and (32.48±11.88)%, respectively. The differences were both statistically significant ( t=8.746 and 8.090, respectively, both P<0.01). Through dynamic monitoring of AT-Ⅲ, the AT-Ⅲ activity showed a downward trend in the death group, while that showed an upward trend in the survival group, but the differences were not statistically significant ( F=0.282 and 0.401, respectively, both P>0.05). The Cox regression analysis suggested INR (odds ratio ( OR)=1.364, 95% confidence interval ( CI) 1.078-1.726, P=0.010) and AT-Ⅲ activity ( OR=0.930, 95% CI 0.906-0.954, P<0.01) were the independent factors affecting the survival of patients with ACLF. The area under the receiver operator characteristic curve of the AT-Ⅲ activity for predicting 90-day survival outcome of the patient was 0.706 (95% CI 0.773-0.952, P<0.01), and the cut-off value was 25%. Patients with AT-Ⅲ activity ≥ 25% had a higher survival rate than those with AT-Ⅲ activity <25% ( χ2=58.20, P<0.01). Conclusions:AT-Ⅲ activity is associated with fecal occult blood positive and femoral vein thrombosis in ACLF patients. The AT-Ⅲ activity is an independent influencing factor for predicting the prognosis of ACLF patients. Patients with AT-Ⅲ activity less than 25% have the higher mortality rate.

A male patient, with diagnose of Madelung disease, was admitted in September 2009. He has been a heavy drinker for decades before onset of the disease. This patient was characterized by the large amount of symmetrical deposits of adipose tissue in the subcutaneous layer around neck, and without obesity on other sites. The excessive adipose tissue was surgically removed by three steps. Appearance almost returned to normal. No recurrence happened after 8 years of follow-up.

Objective: To investigate the incidence and clinical features to probe the risk factors of hemorrhagic cystitis (HC) in children and adolescents with hematological diseases post haplo-hematopoietic stem cell transplantation (haplo-HSCT) . Methods: Medical records of 62 children and 27 adolescents with hematological diseases treated with haplo-HSCT between 2015 and 2016 were analyzed. Results: Of 89 cases (56 boys and 33 girls) , 44 patients were diagnosed with ALL, 33 AML, 3 AHL and 9 MDS. HC occurred in 32 of the 89 patients with an incidence of 36%, including 6 with grade Ⅰ, 16 with grade Ⅱ, 8 with grade Ⅲ, 2 with grade Ⅳ HC, respectively. The median time of HC onset was 25 days (range 2-55 days) after haplo-HSCT with the median duration as 19 days (range 3-95 days) , all of them were cured. The incidence of HC was lower in the group of children than that in the group of adolescents (27.4% vs 55.6%, χ²=6.466, P<0.05) , and the incidence of HC was higher in the group of patients who were ≥5 years old than that in the group of patients who were <5 years old (0 vs 34%, χ²=4.043, P<0.05) . Conclusion HC is one of common complications in children and adolescents with hematological diseases post haplo-HSCT, older age was associated with increased mortality.

Objective To study the clinical efficacy and safety of microwave ablation (MWA) in the treatment of autonomous functional thyroid nodules(AFTN) . Methods Sixty-seven nodules of 53 AFTN patients who refused or were not suitable for surgical resection and 131I therapy were enrolled in the study . All the nodules were evaluated by ultrasound ,color Doppler flow imaging ( CDFI) and contrast enhanced ultrasound(CEUS) ,and all of them were benign and confirmed by pathology . And then ,percutaneous MWA was performed . Fluid isolation and mobile ablation were used to completely inactivate the nodules ,and CEUS was used to evaluate the efficacy of the treatment . The following items included thyroid hormone level ,nodule volume ,nodular blood supply ,thyroid radionuclide imaging ,conscious symptom ,beauty score and complication . Finally ,the factors influencing the curative effect were analyzed . Results The follow-up period was at least 12 months . Compared with before treatment ,the differences of thyroid hormone level , the volume of nodules ,the nodule blood supply were statistically significant ( P ＜ 0 .01) . The 61 hot nodules" changed to cold or warm nodules" . The differences between the improvement ratio of conscious symptoms and beauty scores were statistically significant( P ＜ 0 .05) . The cure ratio in this study was 81 .13% ,and the incidence of complications was 11 .32% ,and the recurrence ratio was 4 .48% . The nodule volume≥14 .04 ml or in a dangerous position were the main factors affecting the curative effect . Conclusions MWA can inactivate the AFTN in situ ,make it lose the secretory function and reduce the volume of nodules . Therefore ,percutaneous MWA guided by ultrasound and CEUS treatment of AFTN can be regarded as another safe and effective treatment besides surgical resection or 131I therapy .

Objective To retrospectively study the incidence and risk factors of thyroid disease induced by peginterferon plus ribavirin (Peg IFN/RBV) antiviral treatment in patients with chronic hepatitis C (CHC).Methods From January 2012 to December 2014,a total of 362 CHC patients were treated with Peg IFN/RBV antiviral therapy at Wuxi Fifth People's Hospital,among whom 315 patients were included in this study.Thyroid function,autoantibodies and thyroid ultrasound were measured at baseline,weeks 12,24 and 48.Comparisons between groups were performed using chi-square test for qualitative data and the unpaired t test for continuous variables.Results After treatment,thyroid dysfunction developed in 12.1％ of patients.Positive anti-thyroid peroxidase and anti-thyrobolulin antibodies were detected in 21％ of patients.The thyroid ultrasound changes developed in 14.9％ of the patients,among whom normal thyroid function and thyroid autoantibodies negative were detected in 8.7 ％ of patients.The titer of thyroid autoantibodies increased steadily from baseline to the end of treatment.Logistic regression analysis showed that positive thyroid autoantibody (OR =5.423,95％ CI:3.441 8.716),sustained virological response (OR=7.201,95％CI:6.231-10.206),female(OR=1.22,95％ CI:0.951-2.212) were the risk factors of thyroid dysfunction.Conclusions Peg IFN/RBV antiviral treatment increases the incidence of thyroid disease in CHC patients.Positive thyroid autoantibody,sustained virological response and the female gender are the risk factors of thyroid dysfunction.

AIM:To investigate the changes of connexin 43 (Cx43) via establishing a model of sympathomi-metic atrial fibrillation ( AF) .METHODS:The mongrels ( n=15) were randomly divided into control group , rapid atrial pacing (RAP) group and isoprenaline (ISO) perfusion+RAP group (ISO+RAP group).All mongrels’ hearts were taken out rapidly by median sternotomy to establish the cardiac model with Langendorff perfusion in vitro.The atrial effective re-fractory period ( AERP) and AF inducability were tested .The expression and distribution of tyrosine hydroxylase ( TH) were analyzed by immunohistochemistry .Total protein level of Cx 43 and phosphorylation of Cx 43 were determined by West-ern blot.The distribution of Cx43 were also observed by immunofluorescence staining .The cell apoptosis was analyzed by TUNEL staining.The generation of reactive oxygen species ( ROS) in the mitochondria was measured by fluorescence spec-trophotometry .RESULTS:No significant change of AERP was found between control group and RAP group , while that in ISO+RAP group was significantly decreased (P<0.05) and induced AF.Compared with control group, the expression of TH, apoptotic index and the generation of ROS increased gradually (P<0.05), while the content of Cx43 decreased grad-ually both in the total protein and the phosphorylation levels in RAP group and ISO +RAP group (P<0.05).The fluores-cence intensity of Cx43 was also attenuated and Cx43 were lateralized apparently in RAP group , while Cx43 were character-ized as punctate distribution in ISO +RAP group.CONCLUSION:Sympathetic nerves may activate autophagosome at in-tercalated discs and trigger cell apoptosis , resulting in remodeling and downregulation of Cx 43 via oxidative stress , thus having effects on mediating and maintaining AF .