AIM: To evaluate the bioequivalence of cinacalcet hydrochloride tablets in healthy Chinese volunteers. METHODS: A randomized, open, double-period and crossover trial was conducted, 48 healthy volunteers were administered a single dose of cinacalcet test tablets or reference tablets orally under each fasting and fed condition. The concentration of cinacalcet was determined by validated LC-MS/MS method. Pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.0 to study its bioequivalence. RESULTS: The main pharmacokinetic parameters of test tablets and reference tablets under fasting condition were as follows: C

Objective:To explore the risk factors of early delayed recovery after right ventricular-extrapulmonary arterial(RV-PA)conduit reconstruction.Methods:From 2017 to 2021, the children with RV-PA conduit reconstruction, who were treated in our hospital were retrospectively analyzed.The demographic data and peri-operative clinical data of the patients were collected for statistical analysis.Results:Fifty-five patients were included in the study.The patients were sequenced by the length of ICU stay.The time at the 75th percentile was defined as the critical value for grouping.According to the ICU stay time of the children, they were divided into normal recovery group(ICU stay ≤7 days, n=40)and delayed recovery group(ICU stay>7 days, n=15).The mechanical ventilator time in the whole group was 24(0, 1 408)h, and the ICU stay time was 4(1, 67)d.Six cases required extracorporeal membrane oxygenation (ECMO) support, and two cases died.In the multivariate Logistic regression analysis of two groups, long cardiopulmonary bypass(CPB) time( OR=1.034, 95% CI 1.009-1.061, P=0.009)and poor right ventricular function( OR=9.536, 95% CI 1.010-90.037, P=0.049)were independent risk factors for early delayed recovery. Conclusion:The risk of RV-PA conduit reconstruction is high.The proportion of ECMO support is increased.The mortality rate is higher.Right heart dysfunction and prolonged CPB time are risk factors for delayed postoperative recovery.

Objective: To describe eraly and midterm outcome of the Rastelli repair in Fuwai hospital Patients. Methods: From May 2010 to March 2017, 71 patients with transposition of the great arteries(TGA)with ventricular septal defect(VSD)and right ventricular outflow tract obstruction(RVOTO) or double outlet right ventricle(DORV)with VSD and RVOTO underwent Rastelli repair. 48 cases male , 23 cases female . Age at operation is(4.7±2.7) years. There are 10 TGA cases, 27 DORV cases, 34 CTGA cases in this group. 30 patients(42.3% , 30/71)received palliative operation prior to the Rastelli procedure, including 13 BT shunt and 17 bi-Glenn operation. 31 patients(43.7%, 31/71 )underwent the Rastelli procedure with VSD enlargement. Right ventricle-to-pulmonary artery connection were created with the use of 9 homografts, 56 valved bovine jugular vein, 6 man-made valved Gore-Tex conduit. The overall mean right ventricle-to-pulmonary artery conduit size was(17.9±3.3)mm. Results: CPB time was(209.0±83.4)minutes, aortic crossclamping time was(132.0±71.1)minutes, mechanical ventilation time was(102.6±81.7)h. Early mortality was 1.4%(1/71). morbidity in hospital was 16.9%, 4 patients with Ⅲ AVB implanted permanent pacemaker, Subxiphoid pericardial window drainage in 3 cases, delayed sternal closure in 3 and re-thoratomy for hemaostsis in 2.Follow up is from 4 months to 6.8 years. Overall survival was 97.2% and 97.2% at 1 and 5 years, respectively. Freedom from RVOTO was 98.6% and 84.1% at 1 and 5 years, respectively. Freedom from reintervention was 98.6% and 90.0% at 1 and 5years, respectively. 1 patients performed a conduit replacement. Seven patients performed 10 times balloon dilatation . Time-related freedom from recurrent LVOTO on echocardiogram in all patients, and the pressure gradient of the LV to the aorta was(10.5±8.8 )mmHg at the most recent follow-up. Conclusion The Rastelli operation remains the preferred procedure for part of the DORV , CTGA , TGA with VSD and severe fixed valvular or subvalvular PS. The Rastelli procedure can be performed with low early mortality. There is frequent need for late reoperation, especially for conduit replacement.

Objective To study the current prevention and control status of iodine deficiency disorders (IDD) and learn the current situation of iodized salt consumption at household level in non-high iodine areas in 2015,this surveillance was conducted.Methods In 2015,according to National Surveillance Program on Iodine Deficiency Disorders,the surveillance was conducted at county level in 31 provinces,municipalities,autonomous regions (provinces) and Xinjiang Production and Construction corps (Xinjiang Corps).In each county city,district,banner (county),5 townships were randomly selected according to their sub-area positions of east,west,south,north and center;4 villages were randomly sampled in each chosen township;15 households were randomly selected in each chosen village.Edible salt sample was collected from each household.The iodine level in salt was determined by direct titration;the salt samples from Sichuan and other enhanced salt samples were detected by arbitration.Results There were totally 2 840 counties that reported the surveillance data.In total,849 193 salt samples were examined,including 845 906 salts determined by direct titration and 3 287 samples determined only by semi-quantitative detection.Weighted by population,the national coverage rate of iodized salt was 98.37％.At provincial level,the coverage rate of iodized salt was higher than 95％ except Tianjin,Shanghai and Shandong.At county level,2 669 counties had a coverage rate of iodized salt higher than or equal to 95％,171 counties were lower than 95％,and 31 counties were less than 80％.The national consumption rate of qualified iodized salt was 94.57％ (except 11 counties in Tibet).At provincial level,the consumption rate of qualified iodized salt was higher than 90％ except Shanghai (66.84％),Tianjin (79.14％),Tibet (82.09％) and Qinghai (89.22％).At county level,totally 2 633 counties had a rate of qualified iodized salt higher than 90％,and 196 counties were lower than 90％.The mean of iodine content in iodized salt was (25.37 ± 4.57) mg/kg.At provincial level,the means of iodine content in iodized salt were in the range of 23.51-28.95 mg/kg and the variable coefficient (CV) was in the range of 12.17％-27.37％,the CV was higher than 15％ in 24 provinces and Xinjiang Corps.Conclusions The coverage rate of iodized salt and the qualified iodized salt at national level are in a good condition.However,the problem of non-iodized salt is still serious in some provinces.

Objective To investigate the population nutritional status of iodine in areas at high risk of iodine deficiency disorders (IDD) in our country and provide scientific basis for development control strategy to IDD.Methods According to the national IDD surveillance protocol which was revised in 2012,township (town,street office) as a unit,seven provinces including Zhejiang,Fujian,Guangdong,Guangxi,Henan,Qinghai and Xinjiang,32 monitoring counties in high-risk areas were chosen into the survey by simple random sampling.New cretinism cases were searched,the thyroid volume was examined in children,the urinary iodine in children and pregnant woman,and the family salt iodine level was tested.Results The survey found no suspected cases and no confirmed endemic cretinism cases.The goiter rate was 1.8％ (141/7 968)and the median of urinary iodine was 163.0 μg/L in children in the 7 project provinces.In addition to the median urinary iodine of 305.1 μg/L in Henan children,the median urinary iodine in other provinces was in the 100-199 μ.g/L.The median of urinary iodine in pregnant women was 120.8 μg/L,in addition to the median urinary iodine of 234.9 μg/L in pregnant women in Henan,the median urinary iodine of pregnant women in other provinces was less than 150 μg/L.The coverage rate of iodized salt in the 7 project provinces was 80.3％ (1 577/1 963),the coverage rate of iodized salt was less than 80％ in Guangxi,Qinghai,Fujian and Zhejiang.The 176 villages in the 6 project provinces were surveyed iodized salt bought through network,except Qinghai.Sale of iodized salt from salt retail accounted for 96.3％ (737/765).Survey of the 7 provinces of 2 024 women,pregnant women found that purchased salt accounted for 87.3％(1 766/2 024).Purchased and replaced salts was accounted for 3.6％ (72/2 024) and 9.2％ (186/2 024),respectively.The survey did not found a children who had taken iodine oil,only 47.5％(487/1 026) of pregnant women in Xinjiang had taken iodine oil.Conclusions The iodine nutrition level is appropriate in children in the areas at high risk of IDD,but the iodine nutrition level in pregnant women is low.Some areas should improve the coverage rate of iodized salt and iodized salt concentration,take health education at the right moment,promote iodized salt for pregnant women,and prevent new cretinism cases.

Objective To observe the high iodine induced thyroid goiter condition,iodine nutritional status and coverage rate of non-iodized salt in high water iodine areas.Methods The household non-iodized salt was monitored in counties (cities,regions) of high water iodine areas and high iodine diseased areas in Tianjin,Hebei,Shanxi,Jiangsu,Anhui,Shandong,Henan and Shaanxi provinces.Among the monitoring sites,where the water iodine were 150-300 μg/L or higher than 300 μg/L,50％ of the them were selected to investigate the water iodine,children urinary iodine and thyroid volume of children in high iodine counties.Results Household edible salt was monitored in 110 counties of 8 provinces,with a total of 25 597 salt samples.The number of non-iodized salt was 24 640,and the coverage rate of non-iodized salt was 96.3％.After being weighted based on the population of counties,the coverage rate of non-iodized salt was 96.9％.In all,73 survey areas include 183 663 people,64 monitoring sites (87.7％) where the water iodine level were higher or equal to 150 μg/L and the median of water iodine was 250.8 μg/L.Totally 5 991 children aged 6-12 were measured thyroid volume,the total goiter rate was 6.2％,the children thyroid goiter rate was higher than 5％ in Hebei,Shanxi,Henan,Tianjin and Shandong provinces.Totally 4 618 children were detected urinary iodine,the median urinary iodine concentration was 373.0 μg/L,and the children median urinary iodine concentration was exceeded 300 μg/L in Tianjin,Hebei,Shanxi,Jiangsu and Shandong provinces.The children urinary iodine concentration and goiter rate increased gradually with increasing of water iodine content.Conclusions The non-iodized salt coverage rate is high in high water iodine areas,most monitored areas have changed drinking water sources,but the median water iodine concentration is still higher than 150 μg/L.Children median urinary iodine concentration is higher than 300 μg/L,iodine is in a excessive status.The children total goiter rate is higher than 5％.Some countermeasures are proposed to search low iodine water,change water sources,do health education,and add other surveillance measures,such as thyroid function detection on target groups,and so on.

Objective:To monitor iodized salt consumption and evaluate iodine deficiency status in 2014 in China.Materials and Methods:In 2014,a nationwide cross-sectional survey was conducted in 31 provinces (in this study,provinces,autonomous regions and municipalities in Mainland China were named as provinces).Probability proportional to size sampling method was adopted to recruit children ages 8-10 and pregnant women.47,467 children's and 18,994 pregnant women's urine samples were collected and 47,706 children's thyroid volumes were examined.Iodine content in salt was determined with 46,900 edible salt samples from children's households;urinary iodine concentration (UIC) was tested from children and pregnant women's urine samples;thyroid volume of children was assessed by ultrasound.Results:The national coverage rate of iodized salt and consumption rate of qualified iodized salt were 96.3％ and 91.5％,respectively.Median iodine content in iodized salt was 25.2 mg/kg.In 22 of 31 provinces,the provincial coverage rates of iodized salt were over 95％.And consumption rates of qualified iodized salt were more than 90％ in 21 provinces.In this study,the national median urinary iodine concentration (MUIC) of children in China was 197.9 μg/L.At the provincial level,MUIC of children in 19 provinces was 100-199 μg/L,which in 12 provinces was 200-299 μg/L.The national MUIC of pregnant women in 2014 was 154.6 μg/L,slightly higher than the lower limit of the WHO criteria for adequate (150-249 μg/L).At the provincial level,MUIC of pregnant women in 18 provinces was 100-149 μg/L,which in 13 provinces was 150-249 μg/L.The national prevalence of goiter among children in 2014 was 2.6％,of which only Shandong province (5.6％) exceeded the national standard (5％).Conclusions:In China,iodine deficiency disorders (IDD) has been eliminated since 2005.And in 2014,the IDD-free status still remained.

Objectives To understand current situation in national prevention and control of iodine deficiency disorders (IDD),and to evaluate the progress in eliminating IDD in 31 provinces and Xinjiang Production and Construction Corps (Corps) in China.Methods In 2011,30 units were sampled in each of 31 provinces and Corps in China based on the sampling method of Probability Proportional to Size.After excluding townships of water iodine level higher than 150 μg/L,1 primary school was chosen in each unit,by the randomized sampling method,40 students in cach school were sampled for examining their thyroid volume,among them,12 students were tested for their urinary iodine level and for their household salt iodine level and per capital daily salt intake.Near the location of these primary schools,3 townships were chosen,5 pregnant women and 5 lactating women in each township were sampled to test their urinary iodine level.Besides,1 water sample was sampled according to the location in each village (east,west,south,north,and middle) in non-central water supplying villages,and 2 tap water samples in central water supplying villages.The ultrasound was used to detect goiter size according to the diagnostic criteria for endemic goiter; As3+-Ce4+ catalytic spectrophotometry using ammonium per sulfate digestion (WS/T 107-2006) was used to test the urinary iodine level; the testing method recommended by the National Iodine Deficiency Disorders Reference Lab was applied to test the water iodine level,the direct titration method among the generic methods of iodide testing for salt production industry (GB/T 13025.7-1999) was used to determine the salt iodine level; and the arbitration method was adopted for quantitative determination in case of well salt or special salts and the salt intake was estimated based on three-day weighed food record.Evaluation standards are as follows:urinary iodine level of children:deficient is the median of urinary iodine (MUI) less than 100 μg/L,adequate is MUI at 100-199 μg/L,more than adequate is MUI at 200-299 μg/L,and excessive is MUI equal to or greater than 300 μg/L;salt iodine:definition of qualified iodized salt is (35-± 15) mg/kg; non-iodized salt (GB 5461-2000) is iodine less than 5 mg/kg; definition of unqualified iodized salt is iodine between 5-＜ 20 mg/kg or higher than 50 mg/kg.The total population of the sixth national census was used for statistical data correction.Results Among 31 provinces and Corps,children's goiter rate was 2.4％,which was obviously lower than the IDD elimination standard at the national level (＜ 5％); the national iodized salt coverage rate was 98.0％ and the consumption rate of qualified iodized salt was 95.3％,both figures had achieved the national standard (the iodized salt coverage should be greater than 95％ and the consumption rate of qualified iodized salt greater than 90％).The median of salt iodine was at 30.2 mg/kg; the MUI of children,pregnant women and lactating women was 238.6,184.4 and 174.4 μg/L,respectively.Urinary iodine of children was higher than adequate level,of both pregnant women and lactating women were at adequate level.The surveillance results of water iodine in 25 provinces revealed that the median was at 5.6 μg/L; the salt intake surveillance results among students' households in 24 provinces and the Corps revealed that the daily intake was 10.1 g per person a day.Conclusions National IDD prevention and control strategy integrated with universal salt iodization as a key measure has achieved remarkable impacts.IDD has been eliminated at the national level.

Objective To identify the suitable echocardiographic predictor,the standard 2-demensional echocardiography and speckle tracking imaging (STI) techniques were applied for the late referred children with transposition of great arteries with intact ventricular septum (TGA-IVS) after neonatal period.Methods 22 children with TGA-IVS after neonatal period were enrolled.According to the intraoperative left ventricular (LV)/right ventricular systolic pressure ratio,they received pulmonary artery banding (PAB group,n =10) or arterial switch operation (ASO group,n =12).15 body surface area matched healthy children were served as control group,Echocardiography was performed before the operation.The dynamic images in basal and apical short axis view were collected respectively.Meanwhile,using the STI technique,the rotation curves at apex and base was analyzed.Results All the patients discharged eventually.A right to left bulging of the ventricular septum was observed in all the patients by the 2D short-axis view.There were no differences in wall thickness and ejection fraction between control,PAB and ASO group.Compared with the control group,the end diastolic diameter,end diastolic volume and indexed LV mass in PAB and ASO group were significantly reduced,however,no difference in the end diastolic diameter and volume and LV mass was observed between the PAB and ASO group.The hypoplasia of LV in PAB and ASO group was associated with an extended time to peak basal rotation and reduced basal rotation and global torsion.Furthermore,the shorter time to peak apical rotation and reduced apical rotation and global torsion were only observed in PAB group.Conclusions The standard echocardiography could be useful for the initial evaluation for regressed LV of the children with TGA-IVS.However,STI allows a much more precious approach to the assessment of LV regressing after neonatal period.The apical rotation and global torsion might be the better predictor to identify the borderline or regressed LV for the surgical management for the children with TGA-IVS.

Objective To analyze the clinical features and the effect of therapy on cutaneous emphysema of chest wall and/or pneumomediastinum complicated in severe acute triphosgene poisoning patients.Methods Among 81 triphosgene poisoning patients,5 complicated with cutaneousemphysema of chest wall and/or pneumomediastinum were analyzed in respect of the clinical data including age,gender,arterial blood gas (ABG),modes of mechanical ventilation support and so on.Results Five patients consisting of 3 males and 2 females,aged (23.20 ± 5.17) years,were complicated with cutaneous emphysema of chest wall and/or pneumomediastium with a prevalence rate of 0.06％.Of them,4 were alleviated completely and 1 died of acute respiratory distress syndrome (ARDS).There was no significant difference in arterial blood gas analysis (ABG) between patients with cutaneousemphysema and/or pneumomediastinum and patients without ( P ＞ 0.05 ).Conclusions Triphosgene-induced acute lung injury treated with mechanical ventilation support with high PEEP is highly suggested as high risk factor for the formation of cutaneous emphysema of chest wall and/or pneumomediastinum in severe acute Triphosgene poisoning patients.It is very important to set the PEEP level of mechanical ventilation support as low as possible for avoidance of alveolar rupture.