Levothyroxine anaphylaxis is a rare yet severe adverse reaction to exogenous levothyroxine. While levothyroxine desensitization is commonly employed, its direct application in patients with severe shock poses considerable risks. Omalizumab may offer a potential adjunctive approach to induce tolerance to levothyroxine. We reported a case of a 30-year-old female with a history of thyroid papillary carcinoma who developed anaphylactic shock following oral administration of 50 μg levothyroxine daily after surgery. High serum level of immunoglobulin E (IgE 99.2 kU/L) and positive intradermal tests to all brands of levothyroxine available in China confirm a type Ⅰ hypersensitivity reaction. Several reports have proven the role of omalizumab in desensitization protocol in IgE-mediated diseases; therefore, she was pretreated with three courses of omalizumab (150 mg intradermal injection every four weeks). She then successfully completed oral levothyroxine desensitization and tolerated treatment dose of levothyroxine without experiencing allergic symptoms along with normalization of thyroid function. Further research is warranted to assess its potential as a standard treatment in difficult-to-treat levothyroxine hypersensitivity.

Objective To analyze the mortality risk and evaluate the curative effects of surgery and non-surgery on NSCLC with diameter > 7.0 cm. Methods We collected the data of NSCLC patients with diameter > 7.0 cm from 2010 to 2015 from the SEER database. The 1, 2, 3-year survival rates were analyzed by life table method. Overall survival curve was estimated by Kaplan-Meier method. Univariate and multivariate Cox regression models were used to analyze the independent prognostic factors. Results The 1, 2, 3-year survival rates were 51.8%, 33.0% and 25.0%, respectively. In univariate and multivariate analyses, tumor size, N stage and treatment were the independent prognostic factors (P < 0.001). Conclusion Surgery is benefited for the prognosis of stage N0-N1 NSCLC patients with diameter > 7.0 cm. And for stage N2 NSCLC patients with diameter 7.0-9.0 cm, surgical treatment has advantages in improving the prognosis. Surgical and non-surgical patients with tumor diameter ≥9.0 cm or lymph node N3 stage have no statistically significant differences in prognosis. In addition, palliative treatment does not improve the prognosis of patients.

Objective:To study the real-world outcome of China FDA-approved Sofosbuvir (SOF)/Velpatasvir (VEL) in Northwest China.Methods:In this multicenter, prospective, real-world cohort study, we recruited patients from 10 sites from Northwest China, who were chronically infected with HCV GTs 1-6 from 06/2018 to 09/2019. Patients received SOF (400mg)/VEL (100mg) for 12 weeks, and with ribavirin 900-1200 mg for GT3 cirrhosis and for any genotype decompensated cirrhosis. The primary endpoint was sustained virological response at 12-weeks post-treatment (SVR12) and safety. The secondary endpoint was the change of liver function after the achievement of SVR12.Results:Totally, 143 patients were enrolled in the study, four patients were lost to follow-up and one died during the follow-up, 138 patients were included in per-protocol analysis. Of the 138 patients, the mean age 53 years, 53.6% male, 94.2% Han nationality, 53.6% liver cirrhosis, 10.1% HBsAg +, 6.5% renal dysfunction, 5.1% treatment-experienced, and 16.7% patients received ribavirin treatment. The genotype distribution was as follows: 35.5% GT1, 42.8% GT2, 15.9% GT3, and 5.8% un-typed. The SVR12 rate was 96.5% (138/143, 95% CI: 93.5%-99.6%) for intention-to-treat analysis, and in per-protocol analysis, all 138 patients obtained SVR12 (100%). Compared with baseline, the serum total bilirubin, ALT and AFP levels decreased (all P < 0.05), as well as increased ALB and platelet count (all P < 0.001) at post-treatment 12-weeks. Overall adverse events (AEs) rate is 29.0%, and the most common AEs were anemia (14.5%) and fatigue (8.0%). Severe side effects (edema and fatigue) occurred in 2 patients, one of whom needed a short-term interruption of treatment due to fatigue. Conclusion:In this real-world cohort study, 12-week SOF/VEL regimen with or without ribavirin achieved high SVR12 rates (96.5%-100% overall) with excellent safety profile among patients with HCV GT1/2/3 infection including patients with GT3 and cirrhosis, and led to improvement of liver function.

Objective To investigate the effect of enteral nutrition support via naso-jejunal tube in esopha-geal carcinoma patients treated with radiotheraphy.Methods 36 esophageal carcinoma patients were randomly assigned into enteral nutrition(EN)group,while 38 patients assigned to control group.All patients underwent defini-tion IMRT combined with weekly concurrent chemotherapy of paclitaxel-nedaplatin.The naso -jejunal tubes were bedside inserted by hand in EN group.Enteral nutrition support began the day after the tube insertion.The control group took food orally.Nutrition was assessed through body weight,BMI,lymphocyte,albumin,pre -albumin and hemoglobin.Treatment induced complications were recorded.Results The degree of nutritional reduction was lower in EN group and significantly different with the control group.The EN group underwent (4.5 ±1 .1 )cycles concurrent chemotherapy,the control group underwent (3.1 ±2.3)cycles concurrent chemotherapy(t=6.21,P=0.027).The hematotoxicity induced by chemoradiotherapy(CRT)was statistically severe in the control group(χ2 =24.64,P<0.01),while radiation esophagitis was similar between the two groups.Conclusion EN support via naso -jejunal tube in esophageal carcinoma patients treated with radiotheraphy may improve the nutritional status,alleviate CRT induced hematotoxicity,increase tolerance of CRT.

Objective To study the incidence and risk factors of new foot ulcer among diabetic patients on peritoneal dialysis.Methods This is a single-center prospective cohort study.Clinically-stable diabetic patients on peritoneal dialysis in our renal division were recruited from January 2014 to June 2014.Baseline data including general information,biochemistry data,dialysis adequacy,the dorsalis pedis artery pulse,clinical symptoms of diabetic foot and ankle brachial index were recorded.All patients were followed till to Dec 31,2015.The outcomes consisted of new foot ulcer,amputation due to foot ulcer or gangrene,and lower limb vascular blood supply revascularization.Results Totally 108 patients were recruited and followed up the average time (17.7±5.6) months.Among 108 patients,16 cases had a history of diabetic foot ulcer,and 1 case had amputation.During the follow-up,11 cases (10.2％) had new foot ulcer,3 cases (2.8％) had amputation due to foot ulcers or gangrene,and 8 cases (7.4％) had lower limb vascular blood supply revascularization.A total of 13 cases (12％) had composite end points with 81.3 times/1000 patients of incidence.Univariate and multivariate Cox regression models showed that the history of foot ulcer was the only independent risk factors for new foot ulcers-related composite end points.Conclusion The incidence of new foot ulcer-related composite end points was 12％,which could be independently predicted by the history of diabetic foot ulcer.

Objective To investigate the effects of initiating oral-medication and insulin-treatment to residual islet function in adult patients with latent autoimmune diabetes in adults (LADA).Methods Fifty nice inpatients and 11 outpatients of LADA were enrolled from the Peking Union Medical College Hospital from January 1981 to October 2014,including 34 cases with initiating insulin therapy and 36 cases with initiating oral medication.Patients were followed up at least twice and with a 6-month interval.The age,body mass index (BMI),diagnosis time,fasting C peptide (FCP),2-hour postprandial C peptide (2 hCP),glycosylated hemoglobin (HbA1c) were compared between two groups.Results The age of disease onset in insulin-treatment group was significantly lower than that in oral-medication group (t =2.049,P =0.045).The proportion of patients complicated with other autoimmune diseases in oralmedication group were higher than that in insulin-treatment group [24％ (8/34) vs.47％ (17/36),x2=4.275,P=0.039].The FCP and 2 hCP in insulin-treatment group were significantly higher than those in oral-medication group [FCP:0.25 (0.00-0.80) vs.0.00 (0.00-0.60) μg/L,Z =3.498,P =0.030,2 hCP:0.42(0.02-1.20) vs.0.14(0.02-0.19) μg/L,Z =3.235,P=0.001] on 6 month after treatment;however,there were no significant differences on 6-12 months,13-36 months or 37-60 months after treatment between two groups.No antibody negative conversion was detected in 10 inpatients,who were reexamined with glutamic acid decarboxylase antibody (GADA) more than twice.The detection rate of diabetes retinopathy was 4％ (1/26) in insulin-treatment group and 28％ (8/29) in oralmedication group (x2 =6.179,P =0.013).Conclusion Initiating insulin therapy at first diagnosis of LADA can protect the residual islet function,and may reduce the rate of diabetic retinopathy.

Objective To investigate the prevalence of hyperuricemia in health check-up population of Beijing suburb.Methods Total 1 336 rural residents in Nankou Township of Beijing received health check-up from July to Aug 2014,including 686 subjects aged 20-59 years (young/middle-aged group) and 650 subjects aged 60-96 years (elderly group).The blood pressure and body mass index (BMI) were measured;serum uric acid (SUA),fasting blood glucose (FBG) and blood lipids (TG,TC,HDL-C,LDL-C) were determined.The SUA levels ＞ 420 μmol/L for male and ＞ 360 μmol/L for female were defined as hyperuricemia.Results The four quartiles of SUA levels were 27.00-254.59 μmol/L (Q1),254.60-302.35 μmol/L (Q2),302.36-359.78 μmol/L(Q3) and 359.79-702.0 μmol/L (Q4).The prevalence of hyperuricemia was significantly higher in young/middle-aged group than that in elderly group [20.41％ (140/686) vs.13.85％ (90/650),x2 =10.08,P =0.001 5],the systolic blood pressure [SBP,(126.8±15.7) vs.(116.7±12.0)mmHg(1 mmHg=0.133 kPa),t=2.76,P=0.008],FBG [(7.40±4.10) vs.(6.11 ±2.03)mmol/L,t=2.12,P=0.036],TC [(5.52±1.10) vs.(5.23±1.00)mmol/L,t =2.04,P =0.045],LDL-C [(3.5 ±0.7) vs.(2.4 ±0.9)mmol/L,t =2.21,P =0.029]in young/middle-aged group were significantly higher than those in elderly group.BMI,FBG were significantly higher in Q4 than those in other quartiles [BMI:(26.44 ± 3.88) vs.(24.19 ± 3.37),(25.49±3.42) and (25.61 ±3.49)kg/m2,t =2.78,P=0.008;FBG:(8.19 ±1.52) vs.(6.34±1.34),(6.09 ± 1.51) and (6.40 ± 1.98) mmol/L,t =2.80,P =0.007].The triglyceride (TG) levels in group Q3 and Q4 [(1.85 ± 0.90) and (1.92 ± 0.44) mmol/L] were higher than those in Q1 and Q2 [(1.37 ±0.76) and (1.70 ±0.84) mmol/L,t =2.1,P =0.035].Only 9.57％ subjects (22/230)with hyperuricemia was not combined with metabolic disorder;subjects combined with one and two metabolic disorders accounted for 20.87％ (48/230) and 69.57％ (160/230),respectively.Conclusion Screening for hyperuricemia is important for comprehensiye treatment and management of hyperuricemia in rural residents,especially in the young and middle-aged population.

Objective:To compare the dosimetric differences between volumetric modulated arc radiotherapy with RapidArc and fixed-field intensity modulation radiation therapy (IMRT) for nasopharyngeal carcinoma (NPC), and identify the techniques from which patients of different T stages can gain the maximum benefit. Methods:Sixty non-metastatic patients with NPC were randomly selected. According to the T staging of 2008 Chinese Classification, T1-T2 stage cases were observed in 20 of the 60 patients, whereas T3 and T4 stage cases were seen with 20 patients each. RapidArc and IMRT treatment plans were managed by the Eclipse treatment planning sys-tem of Varian Co., US. The dosimetry of the target volume coverage, organs at risk (OARs), monitor unit (MU) per second, and deliv-ery time were evaluated. Results:Both techniques reached the requirement of clinical treatment. The coverages of planning target vol-ume, conformity index, and homogeneity index were similar. However, the stratified analysis of T staging indicated that RapidArc plans led to an increased dose to the tumor target (P<0.05) and an improved homogeneity index (P=0.059) in the T4 stage cases. RapidArc al-lowed a statistical dose reduction to the OARs, including optic nerves, lens, temporal lobe, V20 of the parotids, larynx, and temporo-mandibular joint (P<0.05). In the T-stage stratified analysis, the D1%and Dmax of brain stem in T1-T3 stages were similar but statistical-ly low in T4 stage in the RapidArc group (P<0.05). Compared with those in IMRT group, the MUs and the delivery time in RapidArc group were reduced by 65%and 63%, respectively. Conclusion:Both RapidArc and IMRT attained the clinical requirement for NPC. RapidArc technique showed improvements in the OARs and reduction in MUs and delivery time. The target volume coverages were similar for T1-T3 stage. However, RapidArc delivered an increased dose to the tumor target in T4 stage cases, and the dose to OARs was reduced.

Objective To realize the status in the implementation of three industry standards of central sterile sup-ply department (CSSD),and provide a scientific basis for carrying out of the standards. Methods According to three standards,investigation forms were designed by specialists,written survey on 365 hospitals in 9 provinces and field investigation on 1 5 hospitals in 3 provinces were performed,the implementation of three standards were investi-gated.Results Of 365 hospitals,the number of provincial and ministerial level,municipal level,and county level hospitals were 90,87 and 188 respectively. More than 94% of hospitals established CSSD management system and regulations,>90% of hospitals met the requirements of CSSD layout;All hospitals were equipped with pressure steam sterilizer,all levels of hospitals basically equipped with the necessary equipments and facilities;CSSD respon-sible officers of 94.52% (345/365)of hospitals participated in training on standards;69.61% (252/362)of hospi-tals were using or developing CSSD information systems;>92% of the CSSD responsible officers considered that three standards played an important role in facilitating centralized management,and improving the quality of clean-ing,disinfection and sterilization.Conclusion Hospitals need to strengthen the management and training on stand-ards of CSSD,management of loaner instruments and development of information system need to be standardized.

OBJECTIVETo introduce some methods of safety assessment in randomized controlled clinical trials.

METHODSRecent advances and current parctice in normalized safety assessment were reviewed and relevant data analyzed. RESTULTS: The statistical issues including analysis and presentation of adverse events data and laboratory data were involved and summed up.

CONCLUSIONWith the progressive development of randomized controlled clinical trials in China, the methods introduced in this paper are sure to prove of consultative value for the safety assessment.