Ten-year changes in clinical characteristics and antiviral treatment patterns of chronic hepatitis B in China: a CR-HepB-based real-world study / 中华肝脏病杂志

Objective: To understand ten-year changes in clinical characteristics and antiviral treatment patterns of chronic hepatitis B in China. Methods: Patients with chronic HBV infection:demographic, virologic, hematologic, blood biochemistry, and antiviral treatment data were extracted from the China Registry of Hepatitis B (CR-HepB) database between 2012 and 2022 for descriptive statistics and change trend analysis. Multiple group comparisons were conducted using the Kruskal Wallis H test, while counting data was compared between groups using χ (2) test. Results: A total of 180 012 patients with chronic HBV infection were included, with a median age of 40 years old, and a male proportion accounting for 60.2%. The HBeAg positive rate was 43.3%. Over time, the median age of new patients each year increased from 39 to 47 years, while the HBeAg positive rate decreased from 51.3% to 32.8%. The initial diagnosis of patients was mainly CHB (71.4%), followed by hepatitis B cirrhosis (11.8%), inactive HBsAg carrier status (10.6%), and chronic HBV carrier status (6.2%). Among the newly registered patients every year from 2012 to 2022, the proportion of hepatitis B cirrhosis remained stable, but after 2019, the proportion of CHB increased and the proportion of other diagnoses decreased. The proportion of patients with cirrhosis increased with age in different age groups, with 3.5%, 19.3%, and 30.4% in the < 40, 40-69, and≥70 age groups, respectively. The proportion of women in patients with cirrhosis also increased with age, from 16.1% in those < 30 years old to 44.3% in those≥80 years old. From 2012 to 2022, the proportion of patients receiving first-line nucleos(t)ide analog antiviral treatment increased year by year, from 51.0% in 2012-2013 to 99.8% in 2022. Conclusion: The CR-HepB registration data reflect the changes in clinical characteristics and antiviral treatment patterns in patients with chronic HBV infection in China over the past ten years and can thus provide a reference to promote hepatitis B diagnosis and treatment practice, as well as scientific research.

Recompensation of complications in patients with hepatitis B virus-related decompensated cirrhosis treated with entecavir antiviral therapy / 中华肝脏病杂志

Objective: To analyze the occurrence of recompensation conditions in patients with chronic hepatitis B virus-related decompensated cirrhosis after entecavir antiviral therapy. Methods: Patients with hepatitis B virus-related decompensated cirrhosis with ascites as the initial manifestation were prospectively enrolled. Patients who received entecavir treatment for 120 weeks and were followed up every 24 weeks (including clinical endpoint events, hematological and imaging indicators, and others) were calculated for recompensation rates according to the Baveno VII criteria. Measurement data were compared using the Student t-test or Mann-Whitney U test between groups. Categorical data were compared by the χ (2) test or Fisher's exact probability method between groups. Results: 283 of the 320 enrolled cases completed the 120-week follow-up, and 92.2% (261/283) achieved a virological response (HBV DNA 20 IU/ml). Child-Pugh and MELD scores were significantly improved after treatment (8.33 ± 1.90 vs. 5.77 ± 1.37, t = 12.70, P < 0.001; 13.37 ± 4.44 vs. 10.45 ± 4.58, t = 5.963, P < 0.001). During the 120-week follow-up period, 14 cases died, two received liver transplants, 19 developed hepatocellular cancer, 11 developed gastroesophageal variceal bleeding, and four developed hepatic encephalopathy. 60.4% (171/283) (no decompensation events occurred for 12 months) and 56.2% (159/283) (no decompensation events occurred for 12 months and improved liver function) of the patients had achieved clinical recompensation within 120 weeks. Patients with baseline MELD scores > 15 after active antiviral therapy achieved higher recompensation than patients with baseline MELD scores ≤15 [50/74 (67.6%) vs. 109/209 (52.2%), χ (2) = 5.275, P = 0.029]. Conclusion: Antiviral therapy can significantly improve the prognosis of patients with hepatitis B virus-related decompensated cirrhosis. The majority of patients (56.2%) had achieved recompensation. Patients with severe disease did not have a lower probability of recompensation at baseline than other patients.

Clinical value of plasma scaffold protein SEC16A in evaluating hepatitis B-related liver cirrhosis and hepatocellular carcinoma / 中华肝脏病杂志

Objective: To investigate the clinical value of plasma scaffold protein SEC16A level and related models in the diagnosis of hepatitis B virus-related liver cirrhosis (HBV-LC) and hepatocellular carcinoma (HBV-HCC). Methods: Patients with HBV-LC and HBV-HCC and a healthy control group diagnosed by clinical, laboratory examination, imaging, and liver histopathology at the Third Hospital of Hebei Medical University between June 2017 and October 2021 were selected. Plasma SEC16A level was detected using an enzyme-linked immunosorbent assay (ELISA). Serum alpha-fetoprotein (AFP) was detected using an electrochemiluminescence instrument. SPSS 26.0 and MedCalc 15.0 statistical software were used to analyze the relationship between plasma SEC16A levels and the occurrence and development of liver cirrhosis and liver cancer. A sequential logistic regression model was used to analyze relevant factors. SEC16A was established through a joint diagnostic model. Receiver operating characteristic curve was used to evaluate the clinical efficacy of the model for liver cirrhosis and hepatocellular carcinoma diagnosis. Pearson correlation analysis was used to identify the influencing factors of novel diagnostic biomarkers. Results: A total of 60 cases of healthy controls, 60 cases of HBV-LC, and 52 cases of HBV-HCC were included. The average levels of plasma SEC16A were (7.41 ± 1.66) ng/ml, (10.26 ± 1.86) ng/ml, (12.79 ± 1.49) ng /ml, respectively, with P < 0.001. The sensitivity and specificity of SEC16A in the diagnosis of liver cirrhosis and hepatocellular carcinoma were 69.44% and 71.05%, and 89.36% and 88.89%, respectively. SEC16A, age, and AFP were independent risk factors for the occurrence of HBV-LC and HCC. SAA diagnostic cut-off values, sensitivity, and specificity were 26.21 and 31.46, 77.78% and 81.58%, and 87.23% and 97.22%, respectively. The sensitivity and specificity for HBV-HCC early diagnosis were 80.95% and 97.22%, respectively. Pearson correlation analysis showed that AFP level was positively correlated with alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil), and γ-glutamyltransferase (GGT) with P < 0.01, while the serum SEC16A level was only slightly positively correlated with ALT and AST in the liver cirrhosis group (r = 0.268 and 0.260, respectively, P < 0.05). Conclusion: Plasma SEC16A can be used as a diagnostic marker for hepatitis B-related liver cirrhosis and hepatocellular carcinoma. SEC16A, combined with age and the AFP diagnostic model with SAA, can significantly improve the rate of HBV-LC and HBV-HCC early diagnosis. Additionally, its application is helpful for the diagnosis and differential diagnosis of the progression of HBV-related diseases.

Clinical study of serum human-βeta-defensin-1 level for evaluating short-term prognosis in patients with acute-on-chronic liver failure / 中华肝脏病杂志

Objective: To evaluate the diagnostic value of serum human-βeta-defensin-1 level (HBD-1) for short-term (28-day) prognosis in patients with acute-on-chronic liver failure (ACLF). Methods: Fifty cases diagnosed with ACLF were selected. 20 cases with decompensated cirrhosis and 20 cases with compensated cirrhosis who were admitted at the same time were included. Age, gender, serum HBD-1 level, C-reactive protein (CRP), procalcitonin (PCT), neutrophil count/lymphocyte ratio (NLR), blood routine, coagulation function, liver function, kidney function, and other indicators from the three groups of patients were collected. Patients with ACLF were screened for indicators related to the short-term (28-day) prognosis. Patients were divided into an improvement group and a worsening group according to the 28-day disease outcome. The serum HBD-1 level and other above-mentioned indicators were compared between the two patient groups. The receiver operating characteristic (ROC) curve was used to analyze the diagnostic efficacy of serum HBD-1 levels for short-term prognosis in patients with ACLF. PCT, NLR, and prothrombin activity (PTA) application as a mono indicator and HBD-1 in combination with NLR, PCT, and PTA were compared to evaluate diagnostic efficacy for short-term prognosis in patients with ACLF. The intergroup mean of measurement data was determined using a t-test or analysis of variance. χ (2) test was used for comparison of count data. Spearman's rank correlation analysis was used for correlation analysis. Results: There was no statistically significant difference in age and gender among the three groups: ACLF, decompensated cirrhosis, and compensated cirrhosis (P > 0.05). The expression levels of serum HBD-1 in the ACLF group, decompensated cirrhosis group, and compensated cirrhosis group were (319.1 ± 44.4) ng/ml, (264.5 ± 46.5) ng/ml and (240.1 ± 35.4) ng/ml, respectively, while the ACLF group expression levels were significantly increased, with statistical significance (P < 0.01).The serum HBD-1 level was significantly higher in the ACLF worsening group (346.2 ± 43.6) ng/ml than that in the improvement group (308.5 ± 40.6) ng/ml, and the difference was statistically significant (P < 0.05). Correlation analysis showed that HBD-1, NLR, PCT, prothrombin time (PT), and international standardized ratio (INR) were negatively correlated with the 28-day disease outcome (improvement) of patients (P < 0.05). PTA was positively correlated with 28-day disease outcome (improvement) (P < 0.05). The area under the receiver operating characteristic curve (AUC) for evaluating HBD-1's diagnostic efficacy for short-term prognosis in patients with ACLF was 0.774, with a sensitivity of 0.750, a specificity of 0.786, and a cut-off point of 337.96 ng/ml. PCT, NLR, and PTA had greater diagnostic efficacy. HBD-1 combined with PTA had the highest diagnostic efficacy, with an AUC of 0.802, a sensitivity of 0.778, and a specificity of 0.786. The diagnostic efficacy of HBD-1+PCT, HBD-1+NLR and HBD-1, PCT, and NCR was superior to PTA mono. Conclusion: The serum HBD-1 level gradually increases with the aggravation of liver function injury and is negatively correlated with the short-term prognosis in patients with ACLF. Serum HBD-1 level has high sensitivity and specificity in predicting short-term prognosis in patients with ACLF, and its diagnostic efficacy is superior to that of PCT, NLR, and PTA. The combined application of HBD-1 and PTA has higher diagnostic efficacy; however, when the serum HBD-1 level is greater than 337.96ng/ml, it indicates poor prognosis in patients.

Interpretation of the essential updates in guidelines for the prevention and treatment of chronic hepatitis B (Version 2022) / 中华肝脏病杂志

Chinese Society of Hepatology and Chinese Society of Infectious Diseases, Chinese Medical Association update the guidelines for the prevention and treatment of chronic hepatitis B (version 2022) in 2022. The latest guidelines recommend more extensive screening and more active antiviral treating for hepatitis B virus infection. This article interprets the essential updates in the guidelines to help deepen understanding and better guide the clinical practice.

Study on HBV-related acute-on-chronic liver failure risk factors and novel predictive survival model / 中华肝脏病杂志

Objective: To identify the predisposing factors, clinical characteristics, and risk factors of disease progression to establish a novel predictive survival model and evaluate its application value for hepatitis B virus-related acute-on-chronic liver failure. Methods: 153 cases of HBV-ACLF were selected according to the guidelines for the diagnosis and treatment of liver failure (2018 edition) of the Chinese Medical Association Hepatology Branch. Predisposing factors, the basic liver disease stage, therapeutic drugs, clinical characteristics, and factors affecting survival status were analyzed. Cox proportional hazards regression analysis was used to screen prognostic factors and establish a novel predictive survival model. The receiver operating characteristic curve (ROC) was used to evaluate predictive value with the Model for End-Stage Liver Disease (MELD) and the Chronic Liver Failure Consortium Acute-on-Chronic Liver Failure score (CLIF-C ACLF). Results: 80.39% (123/153) based on hepatitis B cirrhosis had developed ACLF. HBV-ACLF's main inducing factors were the discontinuation of nucleos(t)ide analogues (NAs) and the application of hepatotoxic drugs, including Chinese patent medicine/Chinese herbal medicine, non-steroidal anti-inflammatory drugs, anti-tuberculosis drugs, central nervous system drugs, anti-tumor drugs, etc. 34.64% of cases had an unknown inducement. The most common clinical symptoms at onset were progressive jaundice, poor appetite, and fatigue. The short-term mortality rate was significantly higher in patients complicated with hepatic encephalopathy, upper gastrointestinal hemorrhage, hepatorenal syndrome, and infection (P < 0.05). Lactate dehydrogenase, albumin, the international normalized ratio, the neutrophil-to-lymphocyte ratio, hepatic encephalopathy, and upper gastrointestinal bleeding were the independent predictors for the survival status of patients. The LAINeu model was established. The area under the curve for evaluating the survival of HBV-ACLF was 0.886, which was significantly higher than the MELD and CLIF-C ACLF scores (P < 0.05), and the prognosis was worse when the LAINeu score ≥ -3.75. Conclusion: Discontinuation of NAs and the application of hepatotoxic drugs are common predisposing factors for HBV-ACLF. Hepatic decompensation-related complications and infection accelerate the disease's progression. The LAINeu model can predict patient survival conditions more accurately.

Treatment of Chronic Aplastic Anemia with Chinese Patent Medicine Pai-Neng-Da Capsule () for Replacing Androgen Partially: A Clinical Multi-Center Study / 中国结合医学杂志

OBJECTIVE@#To evaluate the efficacy and safety of Pai-Neng-Da Capsule (, panaxadiol saponins component, PNDC) in combination with the cyclosporine and androgen for patients with chronic aplastic anemia (CAA).@*METHODS@#A total of 79 CAA patients was randomly divided into 2 groups by a random number table, including PCA group [43 cases, orally PNDC 320 mg/d plus cyclosporine 5 mg/(kg·d) plus andriol 80 mg/d] and CA group [36 cases, orally cyclosporine 5 mg/(kg·d) plus andriol 160 mg/d]. All patients were treated and followed-up for 6 treatment courses over 24 weeks. The complete blood counts, score of Chinese medical (CM) symptoms were assessed and urine routine, electrocardiogram, hepatic and renal function were observed for safety evaluation. Female masculinization rating scale was established according to the actual clinical manifestations to evaluate the accurate degree of masculinization in female CAA patients treated by andriol.@*RESULTS@#The effective rates were 88.1% (37/42) in the PCA group and 77.8% (28/36) in the CA group based on the standard for the therapeutic efficacy evaluation of hematopathy. There was no significant difference in the white blood cell (WBC) counts, platelet counts and hemoglobin concentration of peripheral blood between two groups after 6 months treatment. The masculinization score of female patient in the PCA group was significantly lower than the CA group (P<0.05). The mild abdominal distention was observed in 1 cases in the PCA group. In CA group, the abnormalities in the hepatic function developed in 2 cases and the renal disfunction was found in 1 case.@*CONCLUSION@#The PNDC possesses certain curative effects in the treatment of CAA without obvious side-effects and can partially replace andriol thereby to reduce the degree of masculinization [Registried at Chinese Clinical Trial Registry (ChicTR1900028153)].

Applied research of ultrasound attenuation parameter in the diagnosis of metabolic dysfunction-associated fatty liver disease / 中华肝脏病杂志

Objective: To evaluate the efficacy, establish a diagnostic model, and value of ultrasound attenuation parameters (UAP) to diagnose hepatic steatosis in metabolic dysfunction-associated fatty liver disease (MAFLD) and its relevant disorders. Methods: 3770 cases were selected from the Health Examination Center of the Third Hospital of Hebei Medical University between October to December 2020. MAFLD diagnosis was based on the Asia-Pacific region MAFLD clinical diagnosis and treatment guidelines. The degree of hepatic steatosis was divided into mild, moderate and severe according to ultrasound imaging. UAP, clinical characteristic indexes, serum biochemical indexes, characteristics of hepatic steatosis and related factors were compared and analyzed in MAFLD patients and healthy controls. Logistic regression method was used to analyze the independent risk factors affecting the progression of hepatic steatosis in MAFLD to establish the diagnostic model. The clinical efficacy of UAP and the new model in diagnosing MAFLD was evaluated by the receiver operating characteristic curve (ROC). One-way ANOVA was used to compare means among multiple groups. Mann-Whitney U test was used to compare non-normally distributed measurement data between the two groups, and rank-sum test was used to compare multiple groups. χ2 test was used to compare count data between groups. Results: Among the 3 770 cases, 650 were MAFLD, with a prevalence rate of 17.24%, and the highest prevalence was 37.23% in the age group of 60-69. The prevalence rate was significantly higher in male than female (30.34% vs. 9.17%). Age-sex analysis showed that the prevalence rate in males aged 30-69 years was 38.26%, and that in females aged over 60 years was 31.94%. UAP was significantly higher in patients with MAFLD than healthy controls (278.55 dB/m vs. 220.90 dB/m, Z=-12.592, P＜0.001), and an increasing trend with increased degree of hepatic steatosis (mild:257.20 dB/m, moderate:286.20 dB/m, and severe: 315.00 dB/m) were observed. The cut-off values of UAP for the diagnosis of mild, moderate and severe hepatic steatosis were 243≤UAP＜258 dB/m, 258≤UAP＜293 dB/m, ≥293 dB/m in MAFLD. The sensitivity and specificity were 67.20%, 93.60%, 95.90%, and 82.10%, 72.00%, and 84.80%, respectively. UAP, alanine aminotransferase and fasting blood glucose were independent risk factors for the progression of hepatic steatosis in MAFLD. The combined MAFLD classification model (UAG model) was established. The AUC of mild, moderate and severe hepatic steatosis in MAFLD were 0.906, 0.907, and 0.946, respectively, and the sensitivity and specificity were 76.50%, 82.10%, 98.00%, and 90.80%, 83.30% and 76.10%, respectively. Conclusion: MAFLD is a common disease in the general population, with a higher incidence in male and elderly female over 30 years of age. UAP can be used as a new noninvasive diagnostic technique to evaluate hepatic steatosis in MAFLD. The UAG model has a good diagnostic efficacy on MAFLD and its relevant disorders, and thus can be used as a guide for evaluating clinical diagnosis and prognosis.

Clinical application of serum Golgi protein 73 in patients with chronic liver diseases / 中华肝脏病杂志

Golgi protein 73 (GP73) is a transmembrane protein on the Golgi apparatus and can be cut and released into the blood. In recent years, an increasing number of clinical studies have shown that the elevated serum GP73 level is closely related to liver diseases. And thus GP73 is expected to be used as a new serum marker for assessing progress of chronic liver diseases. Herein, the clinical application of serum GP73 in chronic hepatitis, liver fibrosis, liver cirrhosis and hepatocellular carcinoma with different etiologies was reviewed based on available literatures; and a research outlook in this field is made.

Modified Tuoli Xiaodusan-assisted Treatment of Hp-positive Peptic Ulcer / 中国实验方剂学杂志

ObjectiveTo observe the clinical efficacy of modified Tuoli Xiaodusan （TLXDS） in adjuvant treatment of Helicobacter pylori （Hp）-positive peptic ulcer （PU） with cold-heat complex syndrome and explore its regulating effect on invasive/protective factors. MethodA total of 136 patients were randomly assigned into the control group （68 cases， including 4 cases missing， 3 cases eliminated， and 61 cases completed） and the TLXDS group （68 cases， including 4 cases missing， 1 case eliminated， and 63 cases completed）. Both groups adopted the quadruple therapy of acid suppression and Hp eradication. The patients in the control group received Weinai'an capsules orally at 4 capsules/time and 3 times/day， and those in the TLXDS group took modified TLXDS orally at 1 dose/day. The administration of both groups lasted for 8 consecutive weeks and the follow-up lasted for 12 months. Electronic gastroscopy was carried out before and after treatment for evaluating the healing of ulcer， the score of mucosal morphology， and the maturity of regenerated mucosa. The Hp infection and the score of cold-heat complex syndrome were evaluated before and after treatment. The serum levels of gastrin （GAS）， prostaglandin E2 （PGE2）， pepsinogen （PG）-Ⅰ， PG-Ⅱ， epidermal growth factor （EGF）， and trefoil factor 2 （TFF-2） were determined before and after therapy. The recurrence of Hp and PU was recorded， and the drug safety was evaluated. ResultAfter treatment， the mucosal morphology score and the traditional Chinese medicine （TCM） syndrome score in the TLXDS group were lower than those in the control group （P<0.01）. The levels of GAS， PG-Ⅰ， and PG-Ⅱ in the TLXDS group were lower than those in the control group （P<0.01）， whereas those of PGE2， EGF， and TFF-2 showed an opposite trend （P<0.01）. After treatment， the Hp eradication rate in the TLXDS group was 95.24% （60/63）， higher than that （83.61%， 51/61） in the control group （χ2=4.467， P<0.05）. The total effective rate of TCM syndromes in the TLXDS group was 98.41% （62/63）， higher than that （81.97%， 50/61） in the control group （χ2=9.589， P<0.01）. The total effective rate of the TLXDS group under gastroscopy was 98.41% （62/63）， higher than that （86.89%， 53/61） in the control group （χ2=4.525， P<0.05）. The excellent and good rate of regenerated mucosal maturity in the TLXDS group was 92.06% （58/63）， also higher than that （73.77%， 45/61） in the control group （χ2=7.372， P<0.01）. After 12 months of follow-up， the TLXDS group had lower PU recurrence rate ［19.05% （12/63） vs 37.70% （23/61）， χ2=5.325， P<0.05］ and lower Hp recurrence rate ［15.00% （9/60） vs 33.33% （17/51）， χ2=5.165， P<0.05） than the control group. No adverse reactions related to TLXDS were detected. ConclusionModified TLXDS-assisted quadruple therapy demonstrates significant short-term clinical efficacy and high Hp eradication rate for Hp-positive PU （cold-heat complex syndrome） patients. Moreover， it can adjust the levels of invasive/protective factors to facilitate ulcer healing and reduce the recurrence rates of Hp and PU in a long term， with good clinical safety.

Discussion on Technical Review Guidance for Registration of Personalized Additive Manufacturing Medical Devices of Passive Implantable Bone, Joint and Oral Hard Tissues / 中国医疗器械杂志

OBJECTIVE@#This paper introduces the key content and background of Technical Review Guidance for the Registration of Personalized Additive Manufacturing Medical Devices of Passive Implantable Bone, Joint and Oral Hard Tissues.@*METHODS@#The core contents and importance of the construction of personalized design validation and verification and additive manufacturing system are described respectively.@*RESULTS@#The personalized design needs to be carried out under the control of interactive cooperation between healthcare professional and engineer. And the performance of personalized device must be validated and verified completely. At the same time, in view of the particularity of the quality management system of additive manufacturing, the technical focus is expounded.@*CONCLUSIONS@#New ideas and methods shall be used in evaluate and administrate personalized additive manufacturing medical device.

Impact of “Elaphurus davidianus return home project” on the transmission of schistosomiasis in Poyang Lake areas / 中国血吸虫病防治杂志

Objective To investigate the prevalence of Schistosoma japonicum infections in Elaphurus davidianus released to Poyang Lake areas and evaluate the impact of the project of “E. davidianus released to wild environments for natural reproduction and growth” “(E. davidianus return home project”) on the transmission of schistosomiasis in Poyang Lake areas. Methods During the period from April 2018 to December 2019, the population distribution, inhabiting activity and natural reproduction of E. davidianus released to Poyang Lake areas were investigated by means of GPS and artificial observations. The S. japonicum infection was identified in animal feces in E. davidianus inhabitats using a hatching test, and snail distribution was surveyed in E. davidianus inhabiting grass islands using a systematic sampling method. Results A total of 51 E. davidianus were released to the Poyang Lake areas in 2018, which subsequently produced 5 E. davidianus habitats in Yinlong Lake, Longkou, Nanchi Lake, Lianzi Lake and Zhu Lake. E. davidianus was found to predominantly inhibit in grass islands, farmlands and forest lands in hilly regions around the Poyang Lake areas. The natural reproduction rate of E. davidianus was 25% in the habitats in 2019, and the mean density of snails was 0.009 to 0.039 snails/0.1 m2 in E. davidianus inhabitats; however, no S. japonicum infection was identified in snails. In addition, the mean densities of wild E. davidianus and bovine feces were 4.6 samples/hm2 and 2.1 samples/hm2, Conclusions The E. davidianus released to Poyang Lake areas may get infections with S. japonicum, and cause schistosomiasis transmission through fecal contamination in grass islands. The impact on and the prevalence of S. japonicum infection was 4.35% and 13.16% (P = 0.236), respectively; however, the intensities of S. japonicum infections were “+++” and “+”, respectively. Conclusions The E. davidianus released to Poyang Lake areas may get infections with S. japonicum, and cause schistosomiasis transmission through fecal contamination in grass islands. The impact on local schistosomiasis transmission and the response strategy requires to be investigated following the release of E. davidianus to lake regions, to ensure the achievement of the goal of schistosomiasis elimination and the successful implementation of the “E. davidianus return home project” in Poyang Lake areas.

Health-related quality of life of patients with inflammatory bowel disease in Singapore

BACKGROUND/AIMS: Inflammatory bowel disease (IBD) is associated with considerable impairment of patients’ health-related quality of life (HRQoL). Knowledge of factors that significantly affect IBD patients’ HRQoL can contribute to better patient care. However, the HRQoL of IBD patients in non-Western countries are limited. Hence, we assessed the HRQoL of Singaporean IBD patients and identified its determinants. METHODS: A prospective, cross-sectional study was conducted at Singapore General Hospital outpatient IBD Centre. The HRQoL of IBD patients was assessed using the short IBD questionnaire (SIBDQ), Short Form-36 physical and mental component summary (SF-36 PCS/MCS) and EuroQol 5-dimensions 3-levels (EQ-5D-3L) and visual analogue scale (VAS). Independent samples t-test was used to compare HRQoL between Crohn’s disease (CD) and ulcerative colitis (UC). Determinants of HRQoL were identified through multiple linear regression. RESULTS: A total of 195 IBD patients (103 UC, 92 CD) with a mean disease duration of 11.2 years were included. There was no significant difference in HRQoL between patients with UC and CD. Factors that significantly worsened HRQoL were presence of active disease (b=−6.293 [SIBDQ], −9.409 [PCS], −9.743 [MCS], −7.254 [VAS]), corticosteroids use (b=−7.392 [SIBDQ], −10.390 [PCS], −8.827 [MCS]), poor medication adherence (b=−4.049 [SIBDQ], −1.320 [MCS], −8.961 [VAS]), presence of extraintestinal manifestations (b=−13.381 [PCS]), comorbidities (b=−4.531 [PCS]), non-employment (b=−9.738 [MCS], −0.104 [EQ-5D-3L]) and public housing (b=−8.070 [PCS], −9.207 [VAS]). CONCLUSIONS: The HRQoL is impaired in this Asian cohort of IBD. The magnitude of HRQoL impairment was similar in UC and CD. Clinical characteristics were better determinants of patients’ HRQoL than socio-demographic factors. Recognizing the factors that impact patients’ HRQoL would improve the holistic management of IBD patients.

Role of Vascular Niche of Bone Marrow in the Development of MLL-AF9 Induced Acute Myclaid Leukemia / 中国实验血液学杂志

OBJECTIVE@#To investigate the role of bone marrow vascular niche in the development of MLL-AF9 acute myeloid leukemia (AML).@*METHODS@#Transplantation experiments were performed to establish non-radiated MLL-AF9 AML model; the half-bone immunofluorescence staining and tile-scan imaging of two-photon confocal microscopy were used to obtain the data of 3 main bone marrow niche cells; flow cytometry analysis was performed to characterize leukemia cells in different anatomical sites.@*RESULTS@#In the early stage of MLL-AF9 AML, the proportion of leukemia cells in the metaphysis of the femur was significantly higher than that in the diaphysis. The detection of apoptosis and proliferation rate of leukemia cells showed that the percentage of leukemia cells in metaphysis significantly decreased, and the proliferation (S/G/M phase) was also significantly more active. These different features of leukemia cells may relate with different bone marrow microenvironment. The image data of 3 major components of bone marrow niche (endothelial cells, endosteum, megakaryocytes) showed different distribution of blood vessels in metaphysis and diaphysis. Furtherly comparing the spatial distance between leukemia cells and endothelial cells, endosteum, megakaryocytes indicated that leukemia cells are closer to the blood vessels, suggesting the important role of blood vessels in the development of leukemia. Glucose uptake assays and intracellular ROS detection showed that the supportive role of blood vessels for leukemia cells did not related with nutrient metabolism pathway.@*CONCLUSION@#The vascular niche plays an important role in the development of leukemia, and does not relate with the transport of nutrients and the elimination of metabolic waste, instead, which may relate with perivascular cytokines or other vascular functions.

Survey of Schistosoma japonicum infections in wild animals in hilly transmission-controlled areas of Jiangxi Province / 中国血吸虫病防治杂志

Objective To understand the situation of Schistosoma japonicum infections in wild animals in transmission-controlled schistosomiasis-endemic areas in Jiangxi Province, so as to provide scientific evidence for implementing precision control interventions and achieving the goal of transmission interruption and elimination of schistosomiasis. Methods Five endemic villages from Ruichang City and Pengze County that were heavily endemic for schistosomiasis in Jiangxi Province, were selected as the study villages. Wild animals like wild mice were captured, and the livers of wild animals were purchased from the snail habitats in the study villages for detection of S. japonicum infections. In the study villages, S. japonicum human infections were screened using indirect hemagglutination assay (IHA) followed by parasitological examinations with miracidial hatching test and Kato-Katz method, and the S. japonicum infection in livestock was tested using a miracidial hatching test with a plastic tube. In addition, snail survey was conducted in the study villages by means of systematic sampling combined with environmental sampling, and the S. japonicum infection in snails was detected using a loop-mediated isothermal amplification (LAMP) assay. Results A total of 240 liver specimens were sampled or purchased from 5 species of wild animals in the study villages, including wild mice, weasels, pigs, deer and rabbits. A total of 172 wild mice were captured, with a 2.91% rate of S. japonicum infection, and there was no S. japonicum infection detected in other wild animals. The prevalence of Capillaria hepatica infection was 12.21%, 1.96% and 12.50% in wild mice, deer and pigs, respectively. In addition, there was no S. japonicum infection found in either humans or livestock in the study villages, and the mean snail density varied from 0.13 to 0.80 snails/0.1 m2 in the study villages. LAMP assay detected S. japonicum infection in 2 tubes in a study village. Conclusions The role of wild animals in schistosomiasis transmission and their potential risks can not be neglected in hilly schistosomiasis-endemic areas of Jiangsu Province after transmission control. Intensified surveillance and targeted control measures should be implemented to consolidate schistosomiasis control achievements.

Survey of Schistosoma japonicum infections in wild animals in hilly transmission-controlled areas of Jiangxi Province / 中国血吸虫病防治杂志

Objective To understand the situation of Schistosoma japonicum infections in wild animals in transmission-controlled schistosomiasis-endemic areas in Jiangxi Province, so as to provide scientific evidence for implementing precision control interventions and achieving the goal of transmission interruption and elimination of schistosomiasis. Methods Five endemic villages from Ruichang City and Pengze County that were heavily endemic for schistosomiasis in Jiangxi Province, were selected as the study villages. Wild animals like wild mice were captured, and the livers of wild animals were purchased from the snail habitats in the study villages for detection of S. japonicum infections. In the study villages, S. japonicum human infections were screened using indirect hemagglutination assay (IHA) followed by parasitological examinations with miracidial hatching test and Kato-Katz method, and the S. japonicum infection in livestock was tested using a miracidial hatching test with a plastic tube. In addition, snail survey was conducted in the study villages by means of systematic sampling combined with environmental sampling, and the S. japonicum infection in snails was detected using a loop-mediated isothermal amplification (LAMP) assay. Results A total of 240 liver specimens were sampled or purchased from 5 species of wild animals in the study villages, including wild mice, weasels, pigs, deer and rabbits. A total of 172 wild mice were captured, with a 2.91% rate of S. japonicum infection, and there was no S. japonicum infection detected in other wild animals. The prevalence of Capillaria hepatica infection was 12.21%, 1.96% and 12.50% in wild mice, deer and pigs, respectively. In addition, there was no S. japonicum infection found in either humans or livestock in the study villages, and the mean snail density varied from 0.13 to 0.80 snails/0.1 m2 in the study villages. LAMP assay detected S. japonicum infection in 2 tubes in a study village. Conclusions The role of wild animals in schistosomiasis transmission and their potential risks can not be neglected in hilly schistosomiasis-endemic areas of Jiangsu Province after transmission control. Intensified surveillance and targeted control measures should be implemented to consolidate schistosomiasis control achievements.

Significance of high expression of PTP1B in the valuation of progenosis of ovarian cancer / 临床与实验病理学杂志

Purpose To investigate the expressions of PTP1B in epithelial ovarian cancer tissues and to analysis its correlation with clinical pathological and survival significance.Methods The expression of PTP1B in ovarian cancer tissues was detected by Oncomine database and immunohistochemistry.The relationships between PTP1B expression and clinicopathological features, including prognosis significance, were analyzed. Results Oncomine database showed that the mRNA expression of PTP1B in ovarian cancer was significantly higher than that in normal tissues (P<0.001). Immunohistochemical staining showed that PTP1B expression was significantly correlation with FIGO stage (P<0.001), omentum majus metastasis (P=0.002). Kaplan-Meier analyses revealed that ovarian cancer patients with high PTP1B expression tumors had a significantly worse overall survival rate than those with low PTP1B expression tumors (P<0.001). Multivariate analysis showed that FIGO stage, PTP1B expression were independent survival predictors.Conclusion PTP1B expression may be involved in the tumor progression and poor prognosis of patients with ovarian cancer, and it might be used as one of the valuable markers for poor prognosis in patients with ovarian cancer.

Discussion on Administrative Innovation of Medical Device in China and U.S / 中国医疗器械杂志

This article refreshes the innovative review approach of medical device in China at first. It proposes reference through presenting a series of existing review and approval of innovative medical device in U.S. as well as new tools and methods for supporting scientific review.

Discussion on Clinical Trial Design of Artificial Hip Prosthesis / 中国医疗器械杂志

Recently, the registration of artificial hip prosthesis products increased year by year. In the new version of the provisions for medical device registration, the domestic or import of such products in the registration declaration may need to complete a clinical trial in the country. How to carry out scientific clinical trials of the product design is the common concern of enterprises and clinical trial institutions. To review the guideline and literature concerning registration for artificial hip prosthesis, the focus on clinical trial design of artificial hip prosthesis include clinical inclusion, evaluation standard, sample size. Through the discussion, we hope to provide advice and guidance for clinical trials of this kind of products.

Cefoxitin plus levofloxacin for prevention of severe infection after transrectal prostate biopsy / 中华男科学杂志

<p><b>Objective</b>To evaluate the effect of cefoxitin prophylactic in reducing the incidence of severe infection after transrectal prostate biopsy (TRPB).</p><p><b>METHODS</b>This retrospective study included 155 cases of TRPB with a 5-day administration of oral levofloxacin at 200 mg bid (the control group) and another 167 cases with a 3-day administration of oral levofloxacin at the same dose plus intravenous cefoxitin at 2.0 g 2 hours before TRPB (the experimental group) according to the distribution characteristics of drug-resistance bacteria in our department. The patients of the control and experimental groups were aged (68.68 ± 8.12) and (68.72 ± 7.51) years, with PSA levels of (19.78 ± 21.57) and (21.15 ± 42.63) μg/L, involving (11.68 ± 1.44) and (11.77±1.02) biopsy cores, respectively. Comparisons were made between the two groups of patients in the incidence rate of severe infection, which was defined as lower urinary track symptoms plus the systemic inflammatory response syndrome (SIRS) within 7 days after TRPB.</p><p><b>RESULTS</b>The incidence rate of postoperative severe infection was significantly lower in the experimental group than in the control (0.6% ［1/167］ vs 5.8% ［9/155］, P < 0.05). Blood cultures revealed positive E-coli strains in 6 cases in the control group, including 5 ESBL-positive and 4 quinolone-resistant and amikacin-sensitive cases, all sensitive to cefoxitin, cefoperazone/sulbactam and imipenem. The only one case of severe infection was shown to be negative in blood culture.</p><p><b>CONCLUSIONS</b>Preoperative intravenous administration of cefoxitin according to the specific distribution characteristics of drug-resistance bacteria can significantly reduce the incidence of severe infection after TRPB.</p>