目的 探讨原发性胆汁性胆管炎(PBC)与原发性胆汁性肝硬化患者临床指标的差异.方法 2015年5月～2021年9月我院诊治的PBC患者164例,其中胆管炎组70例,肝硬化组94例.收集临床指标,应用Logistic回归分析影响PBC患者疾病进展的相关危险因素.结果 本组肝硬化患者年龄为(58.6±13.0)岁,显著大于胆管炎组[(53.4±11.1)岁,P<0.05];血清谷丙转氨酶、谷草转氨酶、碱性磷酸酶、总胆红素分别为49.7(27.5,80.2)U/L、62.6(44.9,114.7)U/L、156.8(126.5,230.5)U/L和31.5(17.6,88.4)μmol/L,显著高于胆管炎组[分别为39.3(23.9,66.0)U/L、36.4(26.8,63.4)U/L、126.5(94.8,187.3)U/L和14.6(10.0,24.3)μmol/L,P<0.05];肝硬化组血清抗核抗体和抗gp210抗体阳性率分别为91.5％和43.6％,显著高于胆管炎组的80.0％和25.7％(P<0.05);肝硬化组血清IgG、IgA和IgM水平分别为17.0(13.2,20.9)g/L、3.5(2.5,4.8)g/L和2.9(2.0,4.8)g/L,显著高于胆管炎组[分别为14.2(12.7,15.8)g/L、2.6(2.0,3.4)g/L和1.8(1.2,3.3)g/L,P<0.05],而补体C3和C4水平分别为0.7(0.5,0.9)g/L和0.1(0.1,0.2)g/L,显著低于胆管炎组[分别为1.2(1.1,1.4)g/L和0.2(0.2,0.3)g/L,P<0.05];多因素Logistic回归分析发现IgM增高和补体C4降低是PBC进展至肝硬化的独立危险因素(P<0.05).结论 原发性胆汁性胆管炎患者进展至肝硬化阶段有一些显著的临床指标变化,血清IgM水平升高和补体C4水平降低有一定的提示作用.

海蓝组织细胞增多症(sea-blue histiocytosis,SBH)是一种家族性常染色体隐性遗传的脂质代谢性疾病,病理上表现为组织细胞内蜡样脂或神经鞘磷脂和脑苷脂的过度贮积.临床上,该病主要表现为肝脾肿大、血小板减少,骨髓中出现大量的海蓝组织细胞.现对本科收治的4例SBH患者临床资料进行总结并结合文献分析报道如下.

Objective:To investigate the clinical features of chronic hepatitis B patients after stopping nucleos (t) ide analogues and related factors for hepatitis B relapse. Methods:We investigated 73 chronic hepatitis B patients who withdrew nucleos (t) ide analogues and analyzed the reasons for withdrawal and related factors for hepatitis B relapse. Results:Those who stopped lamivudine had longer relapse time compared with combination therapy (P=0. 031). Among patients with total treatment duration more than 24 months, those who stopped entecavir had longer relapse time compared with combination therapy (P=0. 048), and lower HBV DNA level while relapsed compared with lamivudine (P=0. 039). The COX proportional hazards model analysis showed that total treatment duration was the risk factor for hepatitis B relapse after stopping nucleos (t) ide analogues with patients who did not achieve cessation criteria. Conclusion:Most patients stopped nucleos (t) ide analogues without achieving cessation criteria. There was a still high relapse rate among patients in spite of they had achieved cessation criteria. The longer antiviral treatment duration was associated with a short time recurrence with those who did not achieve cessation criteria.

Objective: To analyze the changing trends in etiologies of hospitalized patients with liver disease and provide clinical basis for the formulation of medical policy. Methods: Patients who were hospitalized in the Department of Infectious Diseases from 2006 to 2014 were selected as the research subjects. Data of patients with liver diseases were retrospectively analyzed to determine the proportion of main causes of infection, the proportion of different viral infections in viral hepatitis, and the changing trends in proportion of hepatitis B in different age groups. Kruskal-Wallis test was used for statistical analysis. Results: During 9 consecutive years, the overall proportion of inpatients with liver disease decreased continuously, but the number of patients increased. The top five etiologies of liver diseases were viral hepatitis, drug-induced liver disease, autoimmune liver disease, alcoholic and non-alcoholic fatty liver disease. The proportion of viral hepatitis decreased gradually, and the proportion of drug-induced liver disease and autoimmune liver disease increased markedly. Among viral hepatitis patients, hepatitis B, hepatitis C and hepatitis E were in the top three, with hepatitis B stabilized at around 70%, and the proportion of hepatitis C showed an upward trend. The hospitalization time of hepatitis B patients was gradually shortened, the difference was statistically significant (χ (2) = 205.31, P < 0.001), and the hepatitis B patients were mainly distributed in age groups 31-40, 41-50, and 51-60, the total proportion was above 60%. The difference between the different years of the same age group was not evident, but the proportion of hepatitis B patients decreased gradually in the 14-23 -year- old age group, the difference was statistically significant (χ (2) = 19.51, P = 0.01). Conclusion: Liver disease still holds a principal position in the distribution of infectious diseases, and especially the cause of non-infectious liver disease require sufficient attention and concern. The use of hepatitis B vaccine has effectively diminished the infection rate, but the prevention and control of chronic hepatitis B infection is still facing challenges.

目的:通过研究囊尾蚴病的流行病学和临床特征,加强临床工作者对囊尾蚴病的认识,提高临床诊治水平.方法:回顾性分析2009年1月-2015年12月于南京医科大学第一附属医院住院治疗的8例以头痛为主要症状并确诊为囊尾蚴病患者的流行病学资料、临床表现、辅助检查结果、诊断、治疗与转归等.结果:8例囊虫病患者中,男5例、女3例,年龄23～54岁,平均年龄40岁;汉族7例,侗族1例;3例有喜食生肉、涮火锅等爱好,其余5例无明确流行病学史.临床表现方面,7例为脑囊尾蚴病,1例为混合型囊尾蚴病(脑型合并皮下及肌肉型);5例以头痛伴或不伴恶心、呕吐为首发症状,2例以头痛伴癫痫为首发症状,1例以头痛伴上肢不利为首发症状.3例患者白细胞轻度升高,2例轻度贫血,嗜酸性粒细胞计数均在正常范围内.5例患者行脑脊液检查,3例蛋白含量升高,2例细胞数轻至中度升高,且以淋巴细胞增多为主.7例患者行血清囊尾蚴特异性抗体检测,有4例阳性.5例患者行头颅CT,仅1例影像学初步诊断时考虑脑囊虫病可能;8例患者均行头颅MRI,有4例影像学初步诊断时考虑寄生虫或囊虫病可能.3例患者予以吡喹酮,1例予以口服吡喹酮及槟榔南瓜子,2例予以阿苯达唑抗虫治疗,2例行脑室-腹腔分流术并予以吡喹酮抗虫治疗.结论:非流行区医务工作者对于无法用常见病解释的头痛、癫痫患者应警惕囊尾蚴病可能.

Objective:To investigate whether the MSC-conditioned medium (MSC-CM) can protect injured liver and reduce liver fibrosis and its potential mechanisms.Methods:Six-week-old SD rats were allocated into three groups(each group n=8) as follows:model group;treatment group;normal group.The liver fibrosis model was established by intraperitoneal injection of low dose of CCL4 (1.5 mL/kg)twice a week for eight weeks.MSCs were grown for 3～5 generation for the preparation of MSC-CM,which was concentrated 25-fold using ultrafiltration.From weeks 5 to 8,MSC-CM was injected every day with a dose of 2 mg/kg by tail vein in the treatment group;at the same time,the other two groups were injected with the same dose of L-DMEM.At the end of the experiment,hepatic stellate cells (HSCs) were isolated by in situ perfusion and density gradient centrifugation,and liver tissue was collected for pathologic analysis.The collagenous fiber was detected by Masson staining,while the expression of alpha-smooth muscle actin (α-SMA) in liver tissues was measured by immunohistochemical staining.To evaluate liver fibrosis,the gene and protein expression of α-SMA,transforming growth factor beta 1 (TGF-β1),collagen Ⅰ,matrix metalloproteinases-2 (MMP-2),tissue inhibitor of metalloproteinases-2 (TIMP-2) in HSCs were evaluated by quantitative real-time PCR and Western blot.Results:In liver tissues,histological improvement was observed in hepatic fibrosis after MSC-CM treatment(P＜0.01);the expression of α-SMA and collagenous fiber was significantly lower in the treatment group compared to the model group(P＜0.05),but not equal to the normal group.In HSC study,the mRNA expressions of TGF-β1,α-SMA,collagen Ⅰ in the treatment group were significantly decreased than those in the model group (P＜0.05);and their protein expressions were also lower in the treatment group(P＜0.05),and the mRNA expression of MMP-2 increased compared to the model group.Conclusion:Our results showed that MSC-CM has a therapeutic effect on CCL4-induced liver fibrosis.And this process may be related to down-regulaing expression of TGF-β1,inhibiting HSCs activation and promoting collagen degradation.

Objective:To observe the curative effect of Ruangan Huaxian decoction combined with Entecavir in treating hepatic fibrosis of chronic hepatitis B patients with syndromes of liver depression,spleen deficiency and blood stasis obstruction and its effect on their quality of life.Method:A total of 100 patients with chronic hepatitis B were randomly divided into treatment group and control group according to parallel experimental design and randomized controlled single blind test.The treatment group (50 cases) was given Entecavir and Ruangan Huaxian decoction,and control group (50 cases) was given Entecavir and traditional Chinese medicine placebo.The course of treatment was 6 months.The changes in liver function,fibrosis index and hepatitis B virus etiology and quality of life were observed and compared before and after treatment.Before and after treatment,Medical Outcome Study 36-itenl Short Form Health Survey (SF-36) and Chronic Liver Disease Questionnaire (CLDQ) scale were used to measure patient's quality of life in both groups.Result:After treatment,alanine transaminase (ALT) normalization rate in observation group was significantly higher than that of control group (P ＜ 0.05).There were significant differences in hyaluronan (HA),laminin (LN),Ⅳ-C and PC Ⅲ between two groups after treatment (P ＜ 0.05,P ＜ 0.01).After treatment,the liver fibrosis indexes in treatment group were significantly lower than those in control group (P ＜ 0.05,P ＜ 0.01).After treatment,there was no significant difference in HBV-DNA negative rate,HBsAg negative rate,HBeAg negative rate and HBeAg conversion rate between two groups.Compared with before treatment,the oblique diameter and the diameter of portal vein of liver,and the diameter of splenic vein and the thickness of spleen in treatment group were significantly lower after treatment (P ＜ 0.05).After treatment,the treatment group was significantly lower than control group,but with no statistical significance.The total effective rate was 92％ in treatment group and 74％ in control group.There was a significant difference between the treatment group and the control group (P ＜ 0.05).After treatment,two groups showed higher CLDQ scale abdominal symptoms (AS),fatigue (FA),systemic symptoms (SS) and activity (AC) scores than those before treatment,and the treatment group was significantly higher than control group (P ＜ 0.05).After treatment,two groups showed higher SF-36 scale physical functioning (PF),role physical (RP),vitality (VT),body pain (BP) and general health (GH) than before treatment,and the treatment group was significantly higher than the control group (P ＜ 0.05).Conclusion:Ruangan Huaxian decoction combined with Entecavir for chronic hepatitis B liver fibrosis with syndromes of liver depression,spleen deficiency and blood stasis obstruction is safe,reliable and effective.It can significantly improve the quality of life of CHB patients.

Objective To investigate the efficacy and safety of type Y pegylated interferon α -2b (YPegIFNα-2b,40kD) in the treatment of patients with chronic hepatitis C virus genotypes 2/3 infection in arandomized,PegIFNα-2a-controlled phase III clinical trial. Methods A multi-center,randomized,open-label and positive controlled phase III clinical trial was conducted in this study. Chronic hepatitis C (CHC) patients who met inclusion criteria were randomly allocated in a ratio of 2:1 to 2 cohorts and treated with YPegIFNα-2b or PegIFNα-2a (180 μg),respectively,and ribavirin for 24 weeks,and they were all followed-up for 24 weeks after discontinuation of the regimen. The primary efficacy was assessed by sustained virological response (SVR). Results Two hundred fifty-five participants with genotypes 2 or 3 HCV infection were enrolled. Intention-to-treat analysis showed that SVR were 85.4%(95% CI 79.94%-90.94%) and 79.5% (95% CI 70.84%-88.20%) in patients treated with YPegIFNα-2b and PegIFNα-2a,respectively (P=0.2402);95% confidence intervals of rate difference conformed to standard of non-inferiority. Positive predictive value of rapid virological response for SVR was 90.1%;Additionally,there were no significant differences in adverse effects (95.6% vs. 95.2%) and severe adverse effects (3.8% vs. 3.6%) between the YPegIFNα-2b- and control agent-treated patients with CHC. Conclusions YPegIFNα-2b provides an alternative efficacious treatment option in patients with chronic HCV genotypes 2/3 infection as its similar efficacy and safety to PegIFNα-2a in this pilot clinical trial.

Objective To study the changes in serum adiponectin level in children with severe sepsis,and to explore its clinical significance.Methods A prospective study was conducted,and 39 cases of critically ill children with severe sepsis and 47 cases of sepsis were enrolled into the Pediatric Intensive Care Unit(PICU),Children's Hospital of Nanjing Medical University from July 2012 to July 2014.Thirty cases of critically ill children without sepsis were enrolled as a control group.The plasma adiponectin,procalcitonin(PCT),and C-reactive protein(CRP)were determined with enzyme linked immunosorbent assay(ELISA)within 24 hours after PICU admission.The pediatric critical illness score(PCIS)was recorded.Results Among severe sepsis group,sepsis group and control group,there was no statistical significance in body temperature,heart rate,body mass index,PCIS,white blood cell count,platelet count,bilirubin,creatinine,pH value and activated partial thromboplastin time(APTT)(all P>0.05).Plasma adiponectin in the severe sepsis group[(0.102±0.041)mg/L] significantly decreased compared with that in the sepsis group[(0.125±0.046)mg/L] and the control group[(0.147±0.047)mg/L](F=8.456,P=0.000).The level of CRP in the severe sepsis group[(60.68±59.43)mg/L] significantly increased compared with that in the sepsis group[(52.76±26.67)mg/L] and the control group[(33.89±6.87)mg/L](F=17.416,P=0.000).There was a statistical significance in PCT level in the severe sepsis group,the sepsis group and the control group(x2=27.269,P=0.000).Further comparison showed that there was a significant difference in PCT level between the severe sepsis group and the sepsis group(Z=-4.679,P=0.000),which was also statistically significant between the severe sepsis group and the control group(Z=-4.244,P=0.000);there was no significant difference between the sepsis group and the control group(Z=-0.340,P=0.733).Negative correlation was found between plasma adiponectin and CRP(r=-0.219,P=0.042),PCT(r=-0.303,P=0.005).The correlation between plasma adiponectin and PCIS was positively correlated(r=0.332,P=0.002).Conclusions Plasma adiponectin decreased in severe sepsis children and was significantly associated with the severity of the disease.Detection of plasma adiponectin levels in children with sepsis has an important clinical significance in evaluating the severity of sepsis.Plasma adiponectin is negatively correlated with CRP and PCT,and plays a role in diagnosis of infection.

Objective To explore the reliability of serum people end limb homologous protein 2 (Pygo2) levels in diagnosis of liver fibrosis in patients with chronic hepatitis C (CHC). Methods 90 patients with CHC were enrolled in this study, and they were divided into F0,F1,F2,F3 and F4 hepatic fibrosis according to liver fibrosis scores. Serum Pygo2 levels were tested by enzyme-linked immunosorbent assay,and the correlation between serum Pygo2 levels and liver fibrosis staging was performed. With liver biopsy as the gold standard of diagnosis,the ROC curves were delineated and the area under the curves(AUC) was calculated to evaluate the diagnostic efficacy for liver fibrosis. Results Out of 90 patients with CHC,the histopathological examination found F0 in 6 cases (6.7%),F1 in 13 (14.4%),F2 in 26(28.9%),F3 in 35 (38.9%) and F4 in 10(11.1%);Serum Pygo2 levels in F2 group was higher than that in F1 [(70.1±19.8) ng/ml vs. (55.9±20.4) ng/ml,P<0.05],serum Pygo2 levels [(100.1±24.6) ng/ml] in F3 was significantly higher than that in F2 (P<0.001),and serum Pygo2 levels in F4 [(145.6 ±45.7) ng/ml] was much higher than in F3 (P<0.01);There were a statistically positive correlation between serum Pygo2 levels and hepatic fibrosis staging (r=0.704,P<0.01);assuming serum Pygo2 levels ≥69.1 ng/mL,≥83.9 ng/mL and ≥109.60ng/mL as the cut-off-value for diagnosis of obvious (F≥2) and severe liver fibrosis (F≥3) or liver cirrosis (F=4),the AUC of ROC curves were 0.8824 (95% CI:0.806~0.959),0.9004 (95% CI:0.836~0.964) and 0.8834 (95% CI:0.768~0.999),respectively. Conclusion Serum Pygo2 level could be used to diagnose liver fibrosis in patients with CHC,which warrants further study.

Objective To investigate the clinical characteristics and risk factors of bacterial liver abscess (BLA) complicated with septicemia.Methods Fifty two BLA patients complicated with septicemia admitted in our hospital from January 2011 to December 2015 were retrospectively reviewed;and 52 cases of BLA without septicemia admitted at the same period were randomly selected as control group.The clinical manifestations, laboratory and radiographic findings, clinical outcome of these patients were analyzed.Logistic regression analysis was used to study the clinical features and risk factors of BLA complicated with septicemia.Results Compared to the control group, the BLA with septicemia group had higher prevalence rates in diabetes mellitus, malignant tumors, jaundice, albumin <35 g/L, BUN≥8.2 mmol/L, hyperglycemia, multiple abscesses and abscesses size ≥10 cm(P<0.05 or <0.01).The blood culture showed that K.pneumoniae(63.3%) was the most commonly isolated pathogen, followed by E.coli(16.7%).Univariate analysis revealed that diabetes mellitus(OR=2.200,95%CI 1.042-4.646), malignant tumors (OR=3.667,95%CI 1.023-13.143), albumin <35 g/ L(OR=2.800,95%CI 1.009-7.774), BUN≥8.2 mmol/L(OR=3.167,95%CI 1.265-7.929), hyperglycemia(OR=3.400,95%CI 1.254-9.216), multiple abscesses(OR=2.667,95%CI 1.043-6.815), abscesses size≥10 cm (OR=5.000,95%CI 1.096-22.820) were positively associated with bacterial liver abscess complicated with septicemia.Multivariate Logistic regression showed that abscesses size≥10 cm (OR=14.016,95%CI 1.354-145.070) was an independent risk factor for complication of with septicemia.Conclusion septicemia is a common complication for bacterial liver abscess, clinically effective measures shauld be taken to prevent and control risk factors associated with septicemia.

[Abstract ] Objective The role of serum Pygo2 expression in children with non-alcoholic fatty liver disease(NAFLD) in the disease process and whether it can be used to evaluate the degree of liver fibrosis still remain unknown .The article aimed to detect Pygo 2 expression in the peripheral blood of children with NAFLD and ana-lyze its relationship with traditional serum hepatic fibrosis index in or-der to evaluate the clinical significance of Pygo 2 measurement in chil-dren with NAFLD . Methods We enrolled 120 cases of childhood obesity and 18 healthy controls in Anhui Provincial Hospital and the First Affiliated Hospital of Nanjing Medical University from September 2014 to February 2016.The cases of childhood obesity were di-vided into simple obesity group ( n=44, no diffuse fatty liver under liver ultrasound detection ) , NAFL group ( n=35, diffuse fatty liver with normal liver function under liver ultrasound detection ) and NASH group ( n=41, diffuse fatty liver with abnormal liver function under liver ultrasound detection ) .The peripheral serum was collected from all patients and healthy controls .ELISA was used to detect serum Pygo2 expression and radioimmunoassay was used to detect the serum hyaluronia acid (HA), procollagen type Ⅲ(PCⅢ), pro-collagen type Ⅳ(CⅣ) and laminin(LN) levels.Finally the serum ALT and γ-GT levels were measured with totally automatic enzymat-ic method. Results Pygo2 expression in NAFL group [52.1(12.3)μg/L] and NASH group[78.3(50.0)μg/L] increased signifi-cantly compared with simple obesity group [43.2(18.7)μg/L](P<0.05).Pygo2 expression in NASH group increased significantly compared with control group [41.7(16.8)μg/L] and NAFL group (P<0.001).The serum hepatic fribrosis and inflammation markers ( HA, PC, ALT, C III and IV gamma-GT) levels gradually increased in the obese children .There were statistically positive correla-tions between serum Pygo2 and HA, PCⅢ, CⅣ, ALT or γ-GT (P<0.001).In particular, more significant positive correlations were found between serum Pygo2 and HA, CⅣor γ-GT (r=0.708, P<0.001;r=0.589, P<0.001;r=0.674, P<0.05). Conclusion The degree of liver fibrosis worsens with the increase of Pygo 2 expression and Pygo 2 is in remarkable correlation with conventional he-patic fibrosis serum makers ( HA, C IV) orγ-GT, which shows Pygo 2 expression can be taken as the clinical evaluation index of liver fibrosis in children with NAFLD .

Objective: To investigate the clinical effect and safety of long-acting pegylated interferon-α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 μg/week) in the treatment of HBeAg-positive chronic hepatitis B (CHB) patients, with standard-dose Peg-IFN-α-2a as positive control. Methods: This study was a multicenter, randomized, open-label, and positive-controlled phase III clinical trial. Eligible HBeAg-positive CHB patients were screened out and randomized to Peg-IFN-α-2b (Y shape, 40 kD) trial group and Peg-IFN-α-2a control group at a ratio of 2:1. The course of treatment was 48 weeks and the patients were followed up for 24 weeks after drug withdrawal. Plasma samples were collected at screening, baseline, and 12, 24, 36, 48, 60, and 72 weeks for centralized detection. COBAS® Ampliprep/COBAS® TaqMan® HBV Test was used to measure HBV DNA level by quantitative real-time PCR. Electrochemiluminescence immunoassay with Elecsys kit was used to measure HBV markers (HBsAg, anti-HBs, HBeAg, anti-HBe). Adverse events were recorded in detail. The primary outcome measure was HBeAg seroconversion rate after the 24-week follow-up, and non-inferiority was also tested. The difference in HBeAg seroconversion rate after treatment between the trial group and the control group and two-sided confidence interval (CI) were calculated, and non-inferiority was demonstrated if the lower limit of 95% CI was > -10%. The t-test, chi-square test, or rank sum test was used according to the types and features of data. Results: A total of 855 HBeAg-positive CHB patients were enrolled and 820 of them received treatment (538 in the trial group and 282 in the control group). The data of the full analysis set showed that HBeAg seroconversion rate at week 72 was 27.32% in the trial group and 22.70% in the control group with a rate difference of 4.63% (95% CI -1.54% to 10.80%, P = 0.1493). The data of the per-protocol set showed that HBeAg seroconversion rate at week 72 was 30.75% in the trial group and 27.14% in the control group with a rate difference of 3.61% (95% CI -3.87% to 11.09%, P = 0.3436). 95% CI met the non-inferiority criteria, and the trial group was non-inferior to the control group. The two groups had similar incidence rates of adverse events, serious adverse events, and common adverse events. Conclusion: In Peg-IFN-α regimen for HBeAg-positive CHB patients, the new drug Peg-IFN-α-2b (Y shape, 40 kD) has comparable effect and safety to the control drug Peg-IFN-α-2a.

Objective: To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control. Methods: A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), and a non-inferiority test was also performed. Results: A total of 561 patients with genotype 1/6 CHC were enrolled, among whom 529 received treatment; 90.9% of these patients had genotype 1 CHC. The data of the full analysis set showed that SVR rate was 69.80% (95% CI 65.00%-74.60%) in the trial group and 74.16% (95% CI 67.73%-80.59%) in the control group (P = 0.297 0). The data of the per protocol set (PPS) showed that SVR rate was 80.63% (95% CI 76.04%-85.23%) in the trial group and 81.33% (95% CI 75.10%-87.57%) in the control group (P = 0.849 8), and the 95% CI of rate difference conformed to the non-inferiority standard. The analysis of the PPS population showed that of all subjects, 47.9% achieved rapid virologic response, with a positive predictive value of 93.8%. The incidence rate of adverse events was 96.30% in the trial group and 94.94% in the control group, and the incidence rate of serious adverse events was 5.13% in the trail group and 5.06% in the control group. Conclusion: In the regimen of Peg-IFN-α combined with ribavirin for the treatment of genotype 1/6 CHC, the new investigational drug Peg-IFN-α-2b(Y shape, 40 kD) has comparable clinical effect and safety to the control drug Peg-IFN-α-2a.

Pyogenic liver abscess (PLA) is a rare infectious disease caused by bacteria with an incidence rate of 0.006％-2.2％ worldwide,which is more common in Asia.In recent years,it is found that diabetes is a potential and controllable risk factor of PLA.The risk in diabetic patients complicated with PLA increases 3.6 times higher than in those without diabetes,and cryptogenic infection was the most frequent pathogenesis.There are many differences in clinical features,laboratory tests,complication and treatment between PLA patients with and without diabetes.The advances in diagnosis and treatment of PLA patients with diabetes are reviewed in this article.

Objective To evaluate the factors associated with recurrence of chronic hepatitis B (CHB) after nucleoside analogs (NAs) withdrawal.Methods A literature search from PubMed,Wanfang data,CQVIP,CNKI,Duxiu and SinoMed was conducted to identify studies on the recurrence of CHB after NAs withdrawal.Meta-analysis was performed using RevMan 5.3.Random-effects or fixed-effects model was performed based on the heterogeneity.Weighted mean difference (WMD) was used to assess the continuous data,and odds ratio (OR) was used to assess the dichotomous data.Publication bias was evaluated with Egger' s regression test using Stata SE 11.0.Results A total of 20 case-control studies were included in this analysis.The recurrence rates were 21.0％,30.4％,33.2％ in HBeAg-positive CHB patients,and 26.5％,34.1％,50.1％ in HBeAg-negative patients after NAs withdrawal for 3 months,6 months and 1 year,respectively.For patients treated with lamivudine,the recurrence rates of CHB were 21.0％,28.0％,34.3％ at 3-,6-and 12-month after NAs withdrawal.Meta analysis demonstrated that among HBeAg-positive CHB patients,the average age (WMD =7.36,95％ CI:5.72-9.00,Z =8.81,P ＜0.01) and baseline HBV DNA level (WMD =0.26,95％ CI:0.05-0.46,Z =2.44,P =0.01) were higher in recurrence group,while antiviral treatment duration was shorter in recurrence group (WMD =-3.12,95％ CI:-4.56--1.68,Z =4.26,P ＜ 0.01),and the rate of recurrence was higher in patients with liver cirrhosis (OR =2.59,95％ CI:1.33-5.04,Z =2.79,P ＜ 0.01).Among HBeAg negative patients,the average age of patients in recurrence group was higher than that in non-recurrence group (WMD =5.90,95％ CI:1.57-10.23,Z =2.67,P ＜ 0.01),and no difference was observed in other factors between recurrence and non-recurrence patients.Among patients treated with lamivudine,the average age (WMD =7.68,95％ CI:5.02-10.34,Z =5.66,P ＜0.01) and baseline HBV DNA level (WMD =0.26,95％ CI:0.05-0.46,Z =2.44,P =0.01) were higher,while antiviral treatment duration was shorter in recurrence group (WMD=-2.11,95％CI:-3.85--0.38,Z=2.39,P＜0.01),and the rate of recurrence was higher in patients with liver cirrhosis (OR =2.59,95％ CI:1.33-5.04,Z =2.79,P ＜ 0.05).Conclusion Among HBeAg-positive and lamivudine-treated patients,age,baseline HBV DNA level,antiviral treatment duration and liver cirrhosis are associated with the recurrence of CHB after NAs withdrawal; while for HBeAg-negative patients,age is the only risk factor.

目的:研究间充质干细胞(mesenchymal stem cell,MSC)移植后对肝纤维化及肝星状细胞(hepatic stellate cells,HSC)活化的抑制作用.方法:Ficoll-Hypaque梯度密度离心法及细胞贴壁培养法分离纯化4周龄SD大鼠骨髓间充质干细胞(bone marrow mesenchymal stem cell,BM-MSC).取18只SD大鼠,通过腹腔小剂量注射四氯化碳(CCl4)8周,进行肝纤维化造模,在造模4周时,取其中9只作为治疗组,每周经尾静脉移植给予该组每只大鼠6×106个MSC;另外9只作为模型对照组,经尾静脉给予不含MSCs的等量生理盐水;另取9只大鼠,作为正常对照组,仅给予尾静脉等量生理盐水注射,持续4周.自实验开始,每周用全自动生化分析仪测定血清丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、总胆红素(TBIL)、白蛋白(ALB)水平,至结束共测定8次.实验终点时通过免疫组化对α平滑肌肌动蛋白(α-smooth muscle actin,α-SMA)、转化生长因子β1(transforming growth factor β1,TGF-β1)和Ⅰ型胶原蛋白(collagen Ⅰ,COL Ⅰ)在肝组织中的定位和表达进行研究;原位灌注和梯度密度离心法分离HSC,326 nm紫外光激发和α-SMA免疫荧光染色法鉴定HSC;qRT-PCR和Western blot检测HSC中α-SMA、TGF-β1基因和蛋白的表达水平.结果:与模型组相比,治疗组经MSC移植后,血清ALT、AST、TBIL水平,肝组织纤维化和炎症程度,肝组织α-SMA、TGF-β1和COLⅠ表达水平,HSC中α-SMA、TGF-p1基因和蛋白表达水平均明显降低.结论:肝纤维化SD大鼠经BM-MSC尾静脉移植治疗后肝功能显著改善、肝纤维化程度减轻,可能与抑制HSC活化有关.

Objective To evaluate the efficiency and safety of lamivudine (LAM) and adefovir dipivoxil (ADV) combination therapy in patients with chronic hepatitis B (CHB) associated compensated liver cirrhosis.Methods From June 2007 to February 2009,patients vith CHB associated compensated liver cirrhosis of eight hospitals were enrolled.According to random code table,these patients were divided into initial LAM group and initial ADV group in 1:1 ratio.Patients of the two groups received ADV or LAM monotherapy initially.At week 24 or week 36 of treatment,if the serum hepatitis B virus (HBV) DNA level of patients exceeded 3.30 lglU/mL or virological breakthrough (VBT) occurred,the other medicine was added for combination therapy.At week 48,the treatment of all the patients was changed to two medicine combination therapy till week 96.During follow-up period,the occurrences of complications of liver cirrhosis or hepatocellular carcinoma,virological and biochemical responses,VBT,HBV drug resistance gene mutations and adverse reactions were observed.Fisher' s exact test was performed for statistical analyses.Results Among the 206 patients and in 96 weeks' follow-up,a total of 17 cases developed complications of liver cirrhosis or hepatocellular carcinoma and in which eight cases were hepatocellular carcinoma (3.88％).At week 96 of treatment,HBV DNA negative convertion rate of initial ADV group was 80.9％ (76/94) and that of initial LAM group was 70.5％ (67/95).The alanine aminotransferase (ALT) levd normalization rate of initial ADV group was 95.7 ％ (90/94) and that of initial LAM group was 87.4％ (83/95).Compared with the baseline,the serum albumin level increased 2.5 and 3.3 g/L,respectively,and the prothrombin time shortened 0.6 and 0.7 seconds,respectively.The accumulated VBT rate of initial ADV group was 7.84％ (8/102) and that of initial LAM group was 23.08％ (24/104),the difference was statistically significant (Fisher's exact test,P=0.003).Among 14cases without virus negative convertion at week 96 of treatment,11 cases developed VBT during treatment and in which seven cases were with gene mutations and the other four cases were wild strains.During treatment,adverse reactions included abdominal discomfort,elevated fasting blood glucose,high blood pressure and dizziness,which improved after symptomatic treatments.Conclusion Both ADV and LAM initiated combination therapy can prevent the occurrences of complications of liver cirrhosis or hepatocellular carcinoma in patients with CHB associated compensated liver cirrhosis,and furthermore,it obtains sustained virological response and biochemical function improvement,with slight adverse reaction.

Objective To evaluate the efficacy and safety of reduced glutathione enteric-coated capsule in the management of chronic hepatitis B.Methods A multi-center,randomized,double-blind and double-dummy,positive-and parallel-controlled trial was conducted in patients with mild or moderate chronic hepatitis B.Two hundred and four subjects were randomly divided into reduced glutathione enteric-coated capsule group (n =102) and control group (reduced glutathione tablet group,n=102).Patients in both groups were orally dosed 0.4 g three times daily for 12 weeks.There were 17 dropout cases,and finally 187 patients were available for the assessment.Difference of quantitative date was analyzed by rank sum test,and differene of measurement date was compared with analysis of variance.Results At the end of week 12,parameters of liver functions were significantly improved when compared with baseline in both reduced glutathione enteric-coated capsule group [alanine aminotransferase (ALT):64 U/L vs 134 U/L,T=-1050.5,P＜0.01; aspartate aminotransferase (AST):47 U/L vs 76 U/L,T=-1033.5,P＜ 0.01; total bilirubin (TBil):15 μmol/L vs 16 μmol/L,T=-681.0,P＜0.05; gamma-glutamyltransferase (γ-GT):38 U/L vs 47 U/L,T=-545.0,P＜0.05] and control group (ALT:72 U/L vs 122 U/L,T=-1205.5,P＜0.01; AST:51 U/L vs 72 U/L,T=-1187.5,P＜0.01; TBil:15 μmol/L vs 17 μmol/L,T=-624.5,P＜0.05; γ-GT:36 U/L vs 52 U/L,T=-776.0,P＜0.05).The rates of significant improvement and improvement in reduced glutathione enteric coated capsule group were 28.72％(27/94) and 12.77％ (12/94),respectively,and those in control group were 18.28％ (17/93) and 12.90％ (12/93),respectively.The differences between two groups were not statistically significant (x2=0.679,P＞ 0.05).The incidences of medication related adverse events were low [10.64 ％ (10/94) and 10.75 ％ (10/93) for reduced glutathione enteric-coated capsule group and control group,respectively,P＞0.05],with good safety.Conclusion Reduced glutathione enteric-coated capsule significantly decreases aminotransferase levels in chronic hepatitis B with good safety.

目的:探讨儿童噬血细胞综合征(HPS)的临床特点、诊断、治疗及预后。方法:回顾分析2006年1月至2009年3月我院收治的27例儿童HPS的临床资料。结果:临床表现为持续高热、肝脾肿大、全血细胞减少、甘油三酯增高、血清铁蛋白增高、肝功能异常、凝血功能障碍、低纤维蛋白原血症,骨髓涂片中找到噬血细胞。诊断15例与感染相关,其中9例为EB病毒感染,4例为非感染相关的噬血细胞综合征,8例原因不明。结论:儿童HPS的原发病最常见为EB病毒感染,早期积极治疗原发病的同时予以免疫抑制剂及对症支持治疗能取得较好疗效。