Objective To investigate the value of urine liver?type fatty acid?binding proteins(L?FABP) for early diagnosis and progress predicting of acute kidney injury(AKI)after lung transplantation. Methods Urine L?FABP and Scr blood samples in perioperative periods of 119 lung transplant recipients (hospitalized between 2013?2014)were involved in the research. Patients were divided into AKI group and non?AKI group according to KDIGO. Changes in urine L?FABP and Scr of two groups at various time points were recorded. Results Of 119 patients,57 developed AKI after surgery. Urine L?FABP from 0 h to 48 h in the two groups increased significantly, and the difference at 6 h to 48 h between the two groups is significant. In terms of diagnostic value,ROC area of urine L?FABP at 6h is 0.818. When 2254.52 ng/mg Cr was taken as diagnostic dividing line ,sensitivity and specificity was 0.782 and 0.814. In predicting AKI progression ,AUC below AUC of urine L?FABP 0.852. When 4313.17 ng/mgCr was taken as diagnostic dividing line ,sensitivity and specificity was 0.867 and 0.700. Conclusion Urinary L?FABP appears to be a sensitive and specific marker of AKI in lung transplant recipients ,could be a biological marker in the early diagnosis and progression tendency of AKI.

Objective To evaluate the efficacy of siege scheme of TCM for acute cerebral infarction bowel and visceral strike (block pattern). Methods Totally 110 patients were randomly divided into TCM siege scheme group (55 cases) and control group (55 cases) by randomized parallel controlled study with foresight and multicenter. The control group was treated with the standardized treatment, and TCM siege scheme group was treated with TCM siege scheme, including mild hypothermia TCM pillow therapy, TCM rectal enema, and other multiple treatments based on the standardized treatment. The Glasgow Coma Scale (GCS), the time of pulling out urine tube and nasal feeding tube, and the number of tracheotomy caused by illness changes of the two groups were compared. Results The baseline data of two groups have good comparability (P>0.05). On 10, 15 d of treatment, the number of lucid people in the TCM siege scheme group was significantly more than that in the control group (P<0.05). Compared with the control group, treatment group had less number of tracheotomy, and shorter time of success pulling out urine tube and nasogastric feeding tube (P<0.05). Conclusion TCM siege scheme can improve the consciousness of ischemic stroke in patients with acute cerebral infarction bowel and visceral strike, reduce complications, shows shorter successful pull urine tube and nasogastric feeding, and provides guarantee conditions for further rehabilitation treatment.

Objective To investigate the effect of high-flux hemodialysis on insulin resistance and microinflammatory state in elderly diabetic nephropathy (DN) patients with maintenance hemodialysis(MHD).Methods A total of 49 elderly DN patients with MHD and 10 healthy controls undergoing health examination survey were enrolled.Levels of homeostasis model assessment of insulin resistance index(HOMA-IR),interleukin-6(IL-6) and high sensitivity C-reactive protein(hs-CRP) were analyzed and compared between patients and the controls.Patients with MHD were randomly divided into two groups:high-flux hemodialysis(HFHD) group and low-flux hemodialysis (LFHD) group.Changes of the parameters including HOMA-IR,IL-6,hs CRP and urea excretion rate(kt/v) were observed before and after treatment for 12 months.Results Levels of IL-6,hs-CRP and HOMA-IR were significantly higher in DN patients with MHD than in the control group [(126.22±13.23)ng/L vs.(12.68±3.63)ng/L,(12.13±1.73)mg/L vs.(2.55±1.27) mg/L,(4.83 ±1.23) vs.(0.32 ± 0.15),respectively,all P＜ 0.01].The levels of IL-6 and Hs-CRP were positively correlated with HOMA-IR in elderly DN patients (R =0.656,0.729,R2 =0.43,0.532,both P＜0.01).Compared with before treatment,levels of fasting insulin(Fins),HOMA-IR and IL-6 were decreased in HFHD group after MHD for 12 months (all P＜ 0.05),while there were no differences in levels of Fins,HOMA-IR,IL-6 and hs-CRP in the LFHD group before and after MHD (all P＞0.05).The levels of Fins,HOMA-IR and IL-6 were significantly lower in the HFHD group than in the LFHD group after MHD for 12 months(all P＜0.05).Conclusions Insulin resistance and microinflammatory are common observed in elderly DN patients with MHD.High-flux hemodialysis may decrease the levels of IL-6 and hs-CRP,and ameliorate insulin resistance and microinflammatory state.

Forty cases of hyperlipidemia were treated by herbal moxa stick moxibustion and compared with 22 cases treated by Oenothera Oil Capsules. The results showed that LipidDecreasing Herbal Moxibustion could decrease the serum cholesterol and triglyceride and elevate high-density lipoprotein and change the ratio of TC-HDL-C/HDL-C in the patients, and its therapeutic effect was better than that of the control group treated by Oenothera Oil Capsules (P ＜ 0.01). Lipid-Decreasing Herbal Moxibustion can also improve the clinical symptoms and reduce the body weight.

Objective To investigate the features and correlation analysis of clinico-pathological and expression of phospholipase A2 receptor(PLA2R)in idiopathic membranous nephropathy. Methods A number of 244 patients of IMN proved by renal biopsy were recruited in Wuxi People's Hospital from July 2008 to February 2015. Data were restrospectively collected. Results In the 244 IMN patients(mean age 54.07 ± 15.22 years,130 males and 114 females),44.3% had hypertension and 62.7% had nephrotic syndrome. Compared with female patients ,male patients had more severe proteinuria and lower eGFR(P < 0.05). Compared with the group of proteinuria < 4 g/24 h,the groups of proteinuria 4~8 g/24 h and > 8 g/24 h had higher level of cholesterol and blood pressure ,lower eGFR and more severe tubulointerstitial lesions(P < 0.05). Pathological stage Ⅰ and Ⅱaccounted for 98%,and there were more severe tubulointerstitial lesions and lower eGFR in the patients of stage Ⅱthan that in the patients of stageⅠandⅠ~Ⅱ(P<0.05). The positive rate of PLA2R accounted for 84.3%. Lower eGFR and more severe tubulointerstitial lesions were found in PLA2R-positive patients than those in PLA2R-neg-ative patients(P < 0.05). Multiple regression analysis showed that tubulointerstitial lesions(B =-7.253),hyper-tension ratio(B=-10.726)and the level of cholesterol(B=-2.077)had negative correlations with eGFR(P<0.01, R2=0.470). Conclusions IMN patients of male gender,grave proteinuria,high pathological stage and positive PLA2R should be treated more actively , since severe tubulointerstitial lesions and kidney injury were more common in those patients.

Objective To investigate the clinico-pathological features of idiopathic membranous nephropathy (IMN ) and the expression of phospholipase A2 receptor (PLA2R ) in elderly patients. Methods A total of 109 elderly patients with IMN confirmed by renal biopsy at Wuxi People's Hospital from July 2008 to February 2015 were included.Data were retrospectively collected. Results (1)Participating patients with IMN had a mean age of (67.3 ± 5.4)years ,and 67.9% of them had hypertension and 65.1% had nephrotic syndrome.Compared with non-elderly patients ,elderly patients had a higher proportion with hypertension (67.9% vs.25.2%)(P＝0.000) ,higher systolic pressure[(143.1 ± 15.2)mmHg vs. (127.3 ± 13.3)mmHg](P＝ 0.000) ,higher diastolic pressure [(88.4 ± 10.0)mmHg vs. (80.2 ± 8.4)mmHg](P＝ 0.000) ,more severe tubulointerstitial lesions [(3.1±1.9)points vs.(2.0±1.9)points](P＝0.000),and lower eGFR[(70.9±22.9)ml·min－1· 1.73 m －2vs. (90.6 ± 27.1 ) ml·min－1·1.73 m －2] ( P ＝ 0.000 ). (2 ) There were more severe tubulointerstitial lesions[(4.7 ± 1.8)points vs. (2.4 ± 1.7)points ,2.9 ± 1.6 points](P ＝ 0.000 , 0.000)and lower eGFR[(50.4 ± 17.4)ml·min－1·1.73 m －2vs. (80.3 ± 19.7)ml·min－1·1.73 m －2, (72.3 ± 21.4)ml·min－1·1.73 m －2](P＝0.000 ,0.000)in elderly patients of pathological stage Ⅱ, compared with patients of pathological stages Ⅰ and Ⅰ-Ⅱ. (3)The rate of positive PLA2R was 82.4%.Patients with positive PLA2R had higher proteinuria[(4.5 ± 2.3)g vs. (2.9 ± 1.1)g](P＝0.042) ,lower eGFR[(66.8 ± 21.8)ml·min－1·1.73 m －2vs. (97.7 ± 16.0)ml·min－1·1.73 m －2](P＝0.000) ,and more severe tubulointerstitial lesions [(3.1 ± 2.0)points vs. (1.7 ± 1.1)points](P＝0.037)than patients with negative PLA2R. (4)Multiple regression analysis showed that PLA2R positive rate(P＝0.008) ,tubulointerstitial lesion(P＝0.000) ,and level of cholesterol(P＝0.025)were negatively correlated with eGFR (R2＝0.572). Conclusions Compared with non-elderly patients , elderly patients with IMN have poorer prognosis as a result of higher blood pressure and more severe tubulointerstitial lesions.Elderly patients with IMN of advanced pathological stages and positive PLA2R have more severe kidney injury and tubulointerstitial lesions ,resulting in poor prognosis.

Objective To investigate the efficacy of leflunomide combined with prednisone in the induction therapy of proliferative lupus nephritis (LN).Methods A prospective,multicenter,randomized controlled clinical trial was conducted in patients with biopsy-proved proliferative lupus nephritis recruited from 15 renal centers from 2013 to 2015.Patients were randomized to two groups.Oral leflunomide or intravenous cyclophosphamide was given to patients in each group.Both groups received a tapering course of oral prednisone therapy.All patients were followed up for 24 weeks.The blood biochemistry,urine index,clinical curative effect and adverse reaction were recorded and analyzed statistically.Results A total of 100 patients were enrolled in this clinical trial,including 48 patients in leflunomide group and 52 patients in cyclophosphamide group.After 24 weeks,the overall response rate was 79％ (95％ CI 67％-90％) in the leflunomide group and 69％ (95％ CI 56％-82％) in the cyclophosphamide group.23％ (95％CI 11％-35％) of patients in leflunomide group showed complete remission compared with 27％ (95％CI 24％-30％) in cyclophosphamide group (P=0.35).The levels of 24-hr urine protein excretion,SLEDAI and anti-dsDNA antibody titers were decreased in patients treated with leflunomide group after 24-weeks treatment.And the levels of serum albumin and complement 3 after treatment were significantly higher compared with these before treatment.There was also no significant difference in changes of 24-hr urine protein excretion,SLEDAI score,anti-dsDNA antibody titers,serum albumin and complement C3 levels after treatment between two groups.Incidence of adverse events did not differ between the leflunomide and cyclophosphamide group.Conclusions Leflunomide combined with prednisone showed same efficacy compared with cyclophosphamide as induction therapy for lupus nephritis.Leflunomide might be an useful medicine in the induction therapy of lupus nephritis.

Clinical trials of drugs for rare diseases face special challenges such as a limited number of patients, difficult recruitment, long trial period, and frequent video interviews during the trial. Therefore, in the clinical operation of rare diseases, a decentralized clinical trials (DCT) model based on the " patient-centred" research and development concept is implemented. With the help of decentralized elements and digital health technology, the barriers of geographical restrictions can be overcome and subjects do not have to be limited to traditional clinical trial sites (hospitals/research centers), which can significantly reduce the burden on subjects, increase their representation, and obtain a wider range of scientific research data. To guide the industry′s scientific and standardized application of DCT in the research and development of drugs for rare diseases, the Center for Drug Evaluation of the National Medical Products Administration (NMPA) organized the stake holders to draft the Technical Guideline for the Application of Decentralized Clinical Trials in the Research and Development of Drugs for Rare Diseases. This guideline provides scientific recommendations for the development and implementation of DCT for rare disease drugs. It aims to solve the difficult and key problems during rare disease drug research and development, improve the efficiency and optimize patient experience. This article, combining the research and development concepts in the guideline, explains the current research and development thinking on the application of DCT in the research and development of rare disease drugs, with a view of providing reference for the industry.

Objective:To investigate the epidemiology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in patients with maintenance hemodialysis (MHD) in Jiangsu province during SARS-CoV-2 pandemic in China from December 7, 2022 to January 27, 2023, and to analyze the influencing factors of all-cause death.Methods:It was a multi-center cross-sectional investigation. Structured questionnaire was used to collect patient information by medical staff of each hemodialysis center (room) as investigators. Part of the demography data and laboratory examination data came from the Jiangsu Province Hemodialysis Data Information System. MHD patients from hemodialysis centers (rooms) at all levels of medical institutions and independent hemodialysis institutions in Jiangsu province during the outbreak of SARS-CoV-2 infection were included, and the clinical characteristics and all-cause mortality of confirmed and suspected cases of SARS-CoV-2 infection were analyzed.Results:Questionnaire surveys and data analysis on 57 278 patients in 407 hemodialysis centers (rooms) were completed, accounting for 90.41% of the total number of MHD patients (63 357 cases) in Jiangsu province during the same period. There were 24 038 cases (41.97%) of SARS-CoV-2 infection and 14 805 cases (25.85%) of suspected infection, which were widely distributed in all dialysis centers in Jiangsu province. After clinical classification of 38 843 confirmed and suspected SARS-CoV-2 infection cases, 3 662 cases were severe and critical cases, accounting for 9.43% of the infected and suspected cases. Among the patients who had completed the questionnaires, there were 1 812 all-cause deaths, with an all-cause mortality rate of 3.16%. Multivariate logistic regression analysis showed that elderly (taking ≤50 years as a reference, 51-59 years: OR=1.583, 95% CI 1.279-1.933, P=0.001; 60-69 years: OR=3.972, 95% CI 3.271-4.858, P<0.001; 70-79 years: OR=7.236, 95% CI 5.917-8.698, P<0.001; ≥80 years: OR=11.738, 95% CI 9.459-14.663, P<0.001), male ( OR=1.371, 95% CI 1.229-1.529, P<0.001), and co-infection with hepatitis B virus (HBV) (positive serum HBV surface antigen, OR=0.629, 95% CI 0.484-0.817, P<0.001) were independent influencing factors for all cause mortality. Receiver-operating characteristic curve analysis showed that the area under the curve for male, age and current HBV infection prediction of all-cause death was 0.529 ( P<0.001), 0.724 ( P<0.001) and 0.514 ( P=0.042), respectively, and the cut-off value for age prediction of all-cause death was 65.5 years old. Compared with patients without HBV infection, MHD patients with HBV infection significantly reduced the proportion of severe and critically ill patients, all-cause hospitalizations and all cause deaths when infected with SARS-CoV-2 (4.99% vs. 6.41%, χ2=6.136, P=0.013; 8.90% vs. 11.44%, χ2=11.662, P<0.001; 2.01% vs. 3.37%, χ2=10.713, P=0.001, respectively). Conclusion:The MHD patients in Jiangsu province are susceptible to SARS-CoV-2. Elderly age and male gender are independent risk factors for death in MHD patients during the epidemic, while the HBV infection may be a protective factor for death of MHD patients infected with SARS-CoV-2.