OBJECTIVE To investigate and analyze the current management of drug clinical trial institutions in Jiangxi Province and the situation of undertaking drug clinical trials after the implementation of the filing system. METHODS A survey was conducted on 38 new institutions （obtained qualifications during the implementation of the filing system） and old institutions （obtained qualifications during the implementation of the recognition system） that had completed drug clinical trial institution qualification filing for more than one year in Jiangxi Province. The survey focused on the basic information of the institutions， the number of registered principal investigator （PI）， institutional hardware and information construction， personnel allocation and training， and drug registration clinical trials undertaken by the institutions. RESULTS Of 38 institutions surveyed， there were 22 general hospitals and 16 specialized hospitals； there were 24 old institutions and 14 new institutions. Whether in general hospitals or specialized hospitals， the old institutions were better than the new institutions in the number of approved beds， the number of outpatients， the number of inpatients， the number of specialties， and the number of PI； both old and new institutions had separate offices； all new institutions were set up with GCP pharmacy. The adoption of clinical trial management system in new institutions is significantly less than in old institutions. In the general hospital， both the number of full-time managers and the number of quality controllers in old institutions were significantly more than in the new institutions， while the opposite was true at the level of specialized hospitals. In terms of centralized training on GCP， new institutions were all better than the old ones. Whether in general hospitals or specialized hospitals， the number of drug registration clinical trial projects undertaken by new institutions was significantly less than that of old ones. CONCLUSIONS The new institutions are worse than the old institutions in comprehensive strength and information construction of hospitals， and the number of clinical trials undertaken by new institutions is also less than old institutions.

Hepatitis E is a globally distributed infection that varies in seroprevalence between developed and developing regions.In the less developed regions of Asia and Africa,a high seropositivity rate has been reported for hepatitis E virus(HEV)antibodies.Although acute hepatitis E is often self-limited and has a favorable prognosis,some populations experience severe manifestations,which may progress to liver failure.Moreover,some immunocompromised patients are at risk of developing chronic HEV infection and cirrhosis.Proactive screening,reducing misdiagnosis,improving patient management,timely anti-viral therapy for severe and chronic cases,and vaccination of high-risk groups are important measures to reduce the morbidity of hepatitis E.This review focused on the clinical presentation,management,and prevention of hepatitis E.

Background and aim:Few studies have reported hepatitis B surface antigen(HBsAg)kinetics after nucleos(t)ide analog(NA)discontinuation in patients with noncirrhotic chronic hepatitis B(CHB).The study specifically investigated long-term HBsAg kinetics after NA discontinuation. Methods:Between January 2014 to January 2024,this study prospectively enrolled 106 outpatients with noncirrhotic CHB who met the discontinuation criteria after NA consolidation treatment.Demographic,clinical,and laboratory data were collected and analyzed after NA discontinuation. Results:Ninety-six patients who finished 5 years of follow-up were included.HBsAg remained unde-tectable in 29 patients with end of treatment(EOT)HBsAg negativity.Among 67 patients with EOT HBsAg positivity,HBsAg seroclearance occurred in 12(17.9％)patients with an estimated annual inci-dence of HBsAg seroclearance of 3.6％.Patients with EOT HBsAg levels of ≤1000 IU/mL had a higher HBsAg seroclearance rate than those with EOT HBsAg levels of＞1000 IU/mL(33.3％vs.5.4％).The pro-portion of patients with HBsAg ≤1000 IU/mL increased during follow-up.Logistic regression analysis indicated that the EOT HBsAg level was an independent factor for HBsAg seroclearance and an HBsAg level decline exceeding 1 log10 IU/mL.The optimal EOT HBsAg cutoff for both HBsAg seroclearance and an HBsAg level decline exceeding 1 log10 IU/mL was 359 IU/mL. Conclusions:Patients with EOT HBsAg negativity experienced no relapse and maintained HBsAg sero-clearance during 5 years of follow-up after NA discontinuation.A higher HBsAg seroclearance rate can be obtained in patients with EOT HBsAg levels of ≤1000 IU/mL during 5 years of follow-up after NA discontinuation.Close monitoring and proper NA retreatment are recommended to guarantee the safety of NA discontinuation.

Objective To investigate the changing trend of platelet count (PLT) and related influencing factors in patients with hepatitis B virus-related chronic-on-acute liver failure (HBV-ACLF) after artificial liver support system (ALSS) therapy. Methods A total of 152 patients with HBV-ACLF who were hospitalized and treated in The Third Affiliated Hospital of Sun Yat-Sen University from January 2018 to November 2021 were included in the study, among whom 102 patients received plasma exchange (PE) and 50 patients received double plasma molecular absorption system combined with low-dose PE, and their clinical data and laboratory marker were measured. The independent samples t -test or the Mann-Whitney U test was used for the comparison of continuous data between two groups, and the chi-square test was used for the comparison of categorical data between two groups; a multivariate logistic regression analysis was used to investigate the risk factors for PLT > 50×10 9 /L after ALSS therapy; the receiver operating characteristic (ROC) curve was used to investigate the value of baseline PLT in predicting PLT > 50×10 9 /L after ALSS therapy. Results The patients were mostly middle-aged male adults; among the 152 patients, 70 (46.1%) had liver cirrhosis on admission, 114 (75.0%) received three sessions of ALSS therapy, and 88% had a baseline PLT count of > 50×10 9 /L. There was a significant reduction in PLT from baseline to after ALSS therapy (79.5±47.7 vs 112.5±64.1, t =4.965, P < 0.001), and at 1 week after treatment, PLT increased to the baseline level (97.2±50.7 vs 112.5±64.1, t =1.787, P =0.075). As for the change in PLT from baseline to 1 week after ALSS therapy, the liver cirrhosis group had a significantly greater reduction in PLT than the non-liver cirrhosis group ( U =1986.5, P =0.026), while there was no significant difference between different procedures of ALSS therapy and different sessions of treatment (3-5 sessions) (all P > 0.05). The multivariate logistic regression analysis showed that cirrhosis (odds ratio [ OR ]=3.097, 95% confidence interval [ CI ]: 1.255-7.645, P =0.014) and PLT > 50×10 9 /L at baseline ( OR =0.019, 95% CI : 0.002-0.154, P < 0.001) were independent risk factors for PLT > 50×10 9 /L after ALSS therapy. The ROC curve analysis of baseline PLT showed that PLT > 80.5×10 9 /L at baseline was the optimal cut-off value affecting PLT > 50×10 9 /L after treatment, with an area under the ROC curve of 0.818. Conclusion The influence of ALSS therapy on PLT is temporary, but cirrhotic patients have a weaker PLT generation ability than non-cirrhotic patients. PLT > 80.5×10 9 /L at baseline is the optimal cut-off value to reduce the risk of bleeding after ALSS therapy.

Objective:To report the clinical and genetic characteristics of a family of creatine transporter deficiency (CRTR-D) caused by SLC6A8 gene mutation.Methods:A patient, who came from Department of Neurology, Shanxi Children′s Hospital in September 2018, with epilepsy and unexplained general developmental retardation, was clinically examined. The medical history of his family was also collected. Genetic detection was performed to analyze their genetic causes.Results:The proband, a three years and three months old boy, was walking unsteadily, unable to speak and having frequent seizures, with increased urine creatine/creatinine ratio and decreased peak of cerebral creatine indicated by magnetic resonance spectrum. The proband′s uncle had the similar symptoms with him. The mother of the proband only showed some learning difficulties, while the father, sister and grandparents of the proband had no symptoms. The proband was found to have TTC deletion mutation of SLC6A8 gene (NM_005629), c. 1222_1224del (p.Phe408del), suggestting the diagnosis of X-linked CRTR-D. The proband′s mother and grandmother had heterozygous mutations. The proband′s uncle carried the same hemizygous mutation, which was not detected in the proband′s father, sister or grandfather.Conclusion:In this family of CRTR-D caused by SLC6A8 gene mutation, two female carriers with the same mutation presented different clinical features, suggesting phenotypic variation, which has a great significance in studying the correlation between genotype and phenotype.

Objective: To study the clinical efficacy of Qixie-Huoxue-Tongluo decoction combined with ozagrel sodium injection in treatment of cerebral thrombosis. Methods: According to the random number table method, 91 cerebral thrombosis patients who met the inclusion criteria were divided into the control group (45 cases) and the study group (46 cases). The control group was treated with ozagrel sodium injection on the basis of routine treatment, while the study group was treated with Qixie-Huoxue-Tongluo decoction on the basis of the control group. The two groups were treated for 7 days. The National Institute of Health Stroke Scale (NIHSS)was used to assess the degree of neurological impairment, the Activity of Daily Living (ADL) was used to assess the quality of life; and the levels of MDA, SOD, NO, neuron-specific enolase (NSE) and neuronal protein (S-100β)were detected by ELISA.The clinical efficacy was evaluated. Results: The total effective rate was 93.5% (43/46) in the study group and 71.1% (32/45) in the control group, there was significant difference between the two groups (χ²=7.853, P=0.005). After treatment, the NIHSS score in the study group was significantly lower than that in the control group (16.1 ± 5.0 vs. 20.3 ± 5.3; t=3.889, P<0.01), and the ADL score in the study group (51.9 ± 9.3 vs. 45.3 ± 8.6, t=3.461) was significantly higher than that in the control group (P<0.01); the serum level of MDA (3.10 ± 0.48 mmol/L vs. 4.25 ± 0.76 mmol/L, t=11.427) and NO (41.14 ± 6.74 U/L vs. 62.20 ± 8.43 U/L, t=10.028) in the study group were significantly lower than those in the control group (P<0.01), the SOD (204.36 ± 21.29 vs. 163.39 ± 17.45, t=13.177) level in the study group was significantly higher than that of the control group (P<0.01); the serum NSE (4.85 ± 1.03 μg/L vs. 7.93 ± 1.14 μg/L, t=13.529) and S-100β protein (0.18 ± 0.03 μg/L vs. 1.02 ± 0.15 μg/L, t=37.232) levels in the study group were significantly lower than those in the control group (P<0.01). Conclusions Qixie-Huoxue-Tongluo decoction combined with ozagrel sodium injection can improve the degree of neurological impairment in patients with cerebral thrombosis, improve the quality of life clinical efficacy. And the mechanism may be related to inhibition of lipid peroxidation, anti-free radicals and so on.

Objective To investigate the relationship between interventricular septum thickness(IVS) and renal function in patients with diabetes mellitus.Methods Two hundred and sixty-five patients of type 2 diabetes without dialysis were enrolled in a cross-sectional study.According to their IVS,the patients were divided into normal group (IVS≤ 11 mm) and higher IVS group (IVS ＞ 11 mm).All patients according to evaluated glomerular filtration rate (eGFR) level were divided into eGFR≥60 ml· min-1 · (1.73 m2) 1 group and eGFR ＜ 60 ml· min-1 · (1.73 m2)-1 group.The demographic characteristic,biochemical examination,eGFR,and proteinuria of different groups were compared.Pearson or spearman correlation was used to analyze the relationship between eGFR,IVS and other parameters.eGFR ＜ 60 ml · min-1 · (1.73 m2)-1 and IVS thickening were analyzed by binary logistic regression.Risk factors affect the prognosis of renal function in patients with diabetes mellitus were analyzed by Cox regression analysis.Results Compared with normal group,patients in the higher IVS group had higher systolic pressure (P=0.002),their level of Scr,BUN,24 h urinary protein were increased (all P ＜ 0.05),while the level of eGFR,albumin (ALB),hemoglobin (Hb) and fasting blood glucose were decreased (all P ＜ 0.05).The prevalence of hypertension was increased (81.16％ vs 58.67％,x2=11.273,P=0.001),and there was also a difference in the proportion of patients in each stage of CKD (x2=34.593,P ＜ 0.001).Correlation analysis showed that IVS was positively correlated with BMI,systolic BP,Scr,BUN,24 h urinary albumin,24 h urinary protein (all P ＜ 0.05),while negative correlation was observed between the thickened degree of IVS and Hb,albumin,eGFR and total calcium (all P ＜ 0.05).It's worth noting that IVS also correlated with history of hypertension and degree of renal injury (all P ＜ 0.01).Logistic regression analysis showed that longer duration of diabetes,higher systolic pressure and BUN were independent risk factors for eGFR ＜ 60 ml·min-1·(1.73 m2)-1 (all P ＜ 0.05),while higher Hb and Alb were independent protective factors for eGFR ＜ 60 ml· min-1· (1.73 m2)-1 (all P ＜ 0.05).Logistic regression analysis also showed that the baseline increased Scr was independent risk factor for interventricular thickening (P ＜ 0.05),while the increase of fasting blood-glucose was independent protective factor for interventricular thickening (P ＜ 0.05).Cox regression analysis showed that interventricular thickening was an independent risk factor in predicting the progression of type 2 diabetes (HR=1.396,95％ CI=1.098-1.774,P=0.006).Conclusion Interventricular septum thickness is closely related to the state of renal function,as well as is an independent risk factor to predict kidney function decline in patients with type 2 diabetes.

Objective To compare the efficacy of lymph nodes(LNs) dissection between video-assisted thoracic surgery (VATS) and thoracotomy in the treatment of clinical stage Ⅰ lung cancer.Methods A comprehensive search of PubMed,Ovid Medline,EMBASE,Web of Science,ScienceDirect,the Cochrane Library,Scopus database and Google Scholar was performed to identify studies comparing VATS and thoracotomy in LNs dissection.The data was analyzed by RevMan 5.3 software and SPSS 18.0.Results After selection,23 articles met the inclusion criteria.2 316 patients were involved in VATS group and 3 346 patients were involved in Open group.Meta analysis showed that less total LNs(95％ CI:-1.64--0.60,P ＜ 0.0001),totalLNsstations(95％CI:-0.61--0.01,P=0.04) andN1 LNs(95％CI:-0.28--0.02,P=0.02)were dissected in VATS group.On the left side,more LNs were dissected in VATS group(95％ CI:0.51-3.22,P =0.007).The same number of mediastinal LNs (95％ CI:-0.74-0.15,P =0.20),mediastinal LNs stations (95％ CI:-0.20-0.14,P =0.76),right side LNs (95 ％ CI:-1.52-2.23,P =0.71) were harvested in both groups.Conclusion In the surgical treatment of clinical stage Ⅰ lung cancer,less total LNs,total LNs stations and N1 LNs were dissected in VATS group,while more left side LNs were harvested by VATS.The same number of mediastinal LNs,mediastinal LNs stations right side LNs were harvested in the two groups.This conclusion still needs to be further proved by more high-quality and large-scale RCTs.

Objective To investigate the clinical effects differences of two kinds of D2 lymphadenectomy in the treatment of patients with advanced gastric cancer including open operation and laparoscopy operation.Methods 90 patients with advanced gastric cancer were chosen in recent years in our hospital and were randomly divided into both group including group A (45 patients)with D2 lymphadenectomy by open operation and group B (45 patients) with D2 lymphadenectomy by laparoscopy operation;and the clinical indicators in peri-operation period,the dissec-tion number of lymph node,survival rate in 1 year with follow-up and postoperative complication incidence of both groups were compared.Results The clinical indicators in peri-operation period of group B was significantly better than that of group A (t=2.13,2.56,1.98,1.96,1.94,2.05,2.10,all P<0.05).The N2 dissection number of lymph node of group B was significantly fewer than that of group A (t=2.15,P<0.05).The survival rate in 1 year with follow-up of group A and group B were separately 88.89%and 91.11%,there was no significant difference in survival rate in 1 year with follow-up between the two groups(χ2 =1.67,P>0.05).The postoperative complication incidence of group A and group B were separately 20.00% and 8.89%,the postoperative complication incidence of group B was significantly lower than that of group A (χ2 =9.44,P<0.05).Conclusion Compared with D2 lymph-adenectomy by open operation,D2 lymphadenectomy by laparoscopy operation in treatment of patients with advanced gastric cancer can efficiently decrease the degree of surgical trauma,accelerate the process of recovering after opera-tion,and be helpful to reduce the risk of postoperative complications.