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.

AIM:To assess the efficacy and safety of in vivo electroporation (EP)-mediated dual-plasmid hepatitis B virus (HBV) DNA vaccine vs placebo for sequential combination therapy with lamivudine (LAM) in patients with chronic hepatitis B.METHODS:Two hundred and twenty-five patients were randomized to receive either LAM + vaccine (vaccine group, n = 109) or LAM + placebo (control group, n = 116). LAM treatment lasted 72 wk. Patients received the DNA vaccine or placebo by intramuscular injection mediated by EP at weeks 12 (start of treatment with vaccine or placebo, SOT), 16, 24, and 36 (end of treatment with vaccine or placebo, EOT).RESULTS:In the modified intent-to-treat population, more patients had a decrease in HBV DNA > 2 log10 IU/mL in the vaccine group at week 12 after EOT compared with the control group. A trend toward a difference in the number of patients with undetectable HBV DNA at week 28 after EOT was obtained. Adverse events were similar. In the dynamic per-protocol set, which excluded adefovir (ADV) add-on cases at each time point instantly after ADV administration due to LAM antiviral failure, more patients had a decrease in HBV DNA > 2 log10 IU/mL in the vaccine group at week 12 and 28 after EOT compared with the control group. More patients with undetectable HBV DNA at week 28 after EOT in the vaccine group were also observed. Among patients with a viral load < 1000 copies/mL at week 12, more patients achieved HBeAg seroconversion in the vaccine group than among controls at week 36 after EOT, as well as less virological breakthrough and YMDD mutations.CONCLUSION:The primary endpoint was not achieved using the HBV DNA vaccine. The HBV DNA vaccine could only be beneficial in subjects that have achieved initial virological response under LAM chemotherapy.

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.

Background and Aim: Daclatasvir plus asunaprevir has demonstrated efficacy and safety in patients with chronic hepatitis C virus genotype 1b infection. This study focused on evaluating daclatasvir plus asunaprevir in interferon (+/- ribavirin)-ineligible or -intolerant Asian patients with genotype 1b infection from mainland China, Korea, and Taiwan.Methods: Interferon (+/- ribavirin)-ineligible and -intolerant patients with genotype 1b infection received daclatasvir 60 mg tablets once daily plus asunaprevir 100 mg soft capsules twice daily for 24 weeks. The primary endpoint was sustained virologic response at post-treatment week 24 (SVR24).Results: Of the 159 patients treated, 89.3% were Chinese, 65.4% were female, and 73.6% were interferon-intolerant. Cirrhosis was present in 32.7% of patients, and 40.3% had IL28B non-CC genotypes. SVR24 was achieved by 145/159 (91.2%) patients (100% concordance with SVR12) and was similarly high in cirrhotic patients (47/52, 90.4%). SVR24 was higher in patients without baseline NS5A (L31M or Y93H) resistance-associated variants (RAVs) (137/139, 98.6%), including those with cirrhosis (43/44, 97.7%). Prevalence of baseline NS5A RAVs was low (19/159, 11.9%), particularly in mainland China (10/127, 7.9%). One death (0.6%), five serious adverse events (3.1%), and three grade 4 laboratory abnormalities (1.9%) occurred on treatment; none were considered related to study drugs. Two patients (1.3%) discontinued because of adverse events. Treatment was generally well tolerated regardless of cirrhosis status.Conclusions: Daclatasvir plus asunaprevir achieved a SVR24 rate of 91.2%, rising to 98.6% in patients without baseline NS5A RAVs, and was generally well tolerated in interferon (+/- ribavirin)-ineligible or -intolerant patients with genotype 1b infection from mainland China, Korea, and Taiwan.

Objective:The trial is to evaluate the efficacy and safety of PEG-Tα1 combined adefovir dipivoxil therapy in patients with HBeAg-positive chronic hepatitis B comparing with adefovir dipivoxil alone, and investigate the pharmacodynamic mechanisms of PEG-Tα1.Methods:This study was a multi-centre, randomized, double-blind and placebo with basic therapy controlled clinical trial.116 CHB patients were randomized and assigned in group A ( PEG-Tα1 1.6 mg/mL, q.w., 24 weeks+adefovir dipivoxil capsule 10 mg,&nbsp;q.d., 48 weeks) or ( PEG-Tα1 placebo 1 mL, q.w., 24 weeks+adefovir dipivoxil capsule 10 mg, q.d., 48 weeks).Statistical analy-sis was performed at the end of the 48th week.The primary efficacy endpoint was the loss of HBeAg at 48 weeks, and the secondary end-points included laboratory indexesabout serology, virology and biochemisty.Pharmocodynamic parameters were also analyzed.Results:The loss of HBeAg at 48 weeks in group A was 14.29%(8/56), and in group B was 8.93%(5/56).The difference was not statistical-ly significant ( P=0.5567) despite of a growing trend in group A.The differences in the secondary efficacy endpoints between the two groups were not statistically significant (P>0.05).The pharmacodynamic parsameters such as the number of CD3 +, CD4 +and CD8 +T cells at week 4 and 24 of group A were demonstrated a growing trend and reached the peak at week 4, but no significant differences (P>0.05) were found comparing with group B.Conclusion:The combination treatment of PEG-Tα1 and adefovir dipivoxil showed satisfac-tory safety, and promoted cellular immune responses.The efficacy would warrant further investigation in phaseⅢclinical trial in the near future.

原发性胆汁性肝硬化（ primary biliary cirrhosis ， PBC ）是一种以肝脏为首要靶器官的慢性进展性自身免疫性疾病，患者的抗线粒体抗体（ antimitochondrial antibodies ， AMA）阳性率＞95％，AMA攻击聚集于PBC患者胆管上皮内的丙酮酸脱氢酶E2成分，其病变主要为肝内细小胆管的进行性非化脓性破坏性炎症，有长期持续性肝内胆汁淤积，最终演变为再生结节不明显性肝硬化［1，2］。国内外大量文献报道了PBC与干燥综合征、系统性硬化病、系统性红斑狼疮、甲状腺功能障碍等自身免疫性疾病重叠的病例［3～5］，但关于PBC合并多发性肌炎（ polymyositis ， PM）的报道较少。本文报道了1例PBC合并PM的临床特点。

Objective: To observe the clinical effect of Liuweiwuling tablets combined with telbivudine in treatment of hepa-titis B liver fibrosis.Methods: One hundred and twenty cases of chronic hepatitis B ( CHB) patients with fibrosis were randomly divided into two groups:the observation group and the control group.The observation group of 64 cases received Liuweiwuling tablets and oral telbivudine;the control group of 56 cases received simple oral telbivudine.The changes of clinical symptoms, liver function and index hepatic fibrosis of the two groups were observed before and after treatment.Results: After 24 weeks′treatment, the value of ALT, AST and TBil of the observation group [respectively, (25.4 ±16.3) U/L, (28.4 ±15.9) U/L, (22.8 ±10.7) μmol/L] were all lower than the control group [respectively, (44.7 ±19.6) U/L, (40.1 ±17.1) U/L, (35.2 ±11.5) μmol/L, P<0.05] and the difference was statistically significant (P<0.05) .And the index hepatic fibrosis of both groups was all reduced after treatment, while the reduction of the observation group was significantly higher than the con-trol group.Conclusion: The therapy of Liuweiwuling tablets combined with telbivudine in treatment of CHB fibrosis can improve liver function and promote negative conversion of HBV DNA, meanwhile, it can also decrease the serum liver fibrosis indexes and increase the treatment effect.

OBJECTIVE:To investigate the efficacy profile of entecavir capsule (ETV) as a chronic hepatitis B therapy, as compared to lamivudine (LAM).METHODS:In this multicenter, randomized, double-blind, parallel group evaluation of ETV, 232 subjects were administered a 96-week course of 0.5 mg/day ETV or 100 mg/day LAM. PCR measurement of hepatitis B virus (HBV) was conducted throughout the treatment course to determine achievement of complete virologic response (CVR; defined as less than 500 copies/ml of HBV DNA) or experience of virology rebound ( more than 500 copies/ml of HBV DNA after achievement of CVR).RESULTS:After week-48 of treatment, the ETV group showed a higher CVR rate (90.3% vs. LAM: 59.4%) and lower virology rebound rate (1.9% vs. LAM: 13.9%). After week-96 of treatment, the ETV group continued to have a higher CVR rate (86.0% vs. LAM: 71.4%), and virology rebound was experienced by significantly less subjects in the ETV group (1.2% vs. LAM: 11.9%, P = 0.005).CONCLUSION:ETV therapy can quickly and continuously suppress HBV replication in chronic hepatitis B patients, and has a lower resistance rate than LAM. Compared to LAM, ETV may be a superior long-term treatment choice for chronic hepatitis B.

Objective To observe the effect of high dose of methylprednisolone on Balb /c mice with acute paraquat( PQ)poisoning. Methods Balb / c mice were randomly divided into poisoning group( 30 mice),treatment group( 30 mice),and medrol control group( 5 mice). The poisoning group and treatment group were randomly divided into 6 sub-groups according to different PQ doses( 50,70,100,150,200,and 300 mg /( kg·d),respectively) by i. p. injection; after recieving the PQ injection,the mice in treatment group were immediately received 200 mg / kg of methylprednisolone i. p. injection. The control mice were only received 200 mg / kg of methylprednisolone by i. p. injection. The LD50values between poisoning group and treatment group were compared each other. Results( 1) At 24,48 and 72 h after exposure to paraquat,the LD50values were216. 67 mg / kg,216. 67 mg / kg and 188. 24 mg / kg,respectively,in poisoning group,and 70. 42 mg / kg,70. 42 mg / kg and87. 66 mg / kg in treatment group,respectively.( 2) The LD50values in treatment group were smaller than that in poisoning group at either 24,48 or 72 h after exposure to paraquat. Conclusion A single intraperitoneal injection of high-dose methylprednisolone could accelerate the death of Balb / c mice with paraquat poisoning.

目前,已将马埃立克体和人粒细胞埃立克体合并为无形体属,同时将人粒细胞埃立克体病更名为人粒细胞无形体病[1].无形体病( Anaplasmosis)是一类新发人兽共患自然疫源性疾病,由嗜粒细胞无形体(Anaplasma phagocytophilum)引起,经蜱传播,主要表现为虫咬焦痂、发热、头痛、肌痛、皮疹以及WBC、PLT减少,被认为是病死率很高的蜱源立克次体病之一[2-3].

Results There were no significant differences in mortality (28.26% versus 24.49%) between the two groups on day 28 after poisoning. The mean time between poisoning and death in HP-CVVH group was (5.2±2.1) days, which was significantly longer than that (3.8±1.7) days in HP group (P<0.05). The ratio of residual normal lung in 3D-CT image on 6th day after poisoning in HP-CVVH group was (31.80±12.71)%,which was significantly higher than that (25.60±14.06)% in HP group (P < 0.05). Conclusion The combined therapy of HP and CVVH could prevent advances in lung injury induced by acute paraquat poisoning and prolong survival time, but failed to reduce mortality of paraquat-poisoned patients.

Script electrical messagecase record（S-EMR） puts clinical data into clinic trial databases completely,it can be used as the records of medical action.The evidence of quality of health care,medical tangle and monitoring of the process of health care service can be recorded.The assess of quality of health care,management of medical performance and analysis of medical care can be consistently operated.The S-EMR is exactly the key to the collection,reservation,management and statistics of case history.

<正>据国家卫生部《2009中国卫生统计年鉴》统计,门急诊病历目前占医院总病历数量的95%以上,且逐年呈递增趋势,但门急诊病历管理一直处于相对薄弱的地位。在当前条件下,医院急需解决的问题是怎样建设医院门急诊手写病历质量管理系统,如何通过信息化的手段,加强内部对医疗质

Objective To evaluate the efficacy and safety of entecavir dispersible tablet for the treatment of chronic hepatitis B(CHB).Methods A randomized,double-blind,double-dummy and active drug-controlled trial was performed.Totally 120 CHB patients were randomly divided into a test group(n=80) and a control group(n=40).During the first 24 weeks,the patients in the test group were administered with 0.5 mg of entecavir dispersible tablet and one tablet of dummy entecavir(Baraclude) once daily and those in the control group with 0.5 mg of entecavir and one tablet of dummy entecavir dispersible tablet once daily.Then all the patients received open-labeled entecavir dispersible tablet(0.5 mg/d) for another 24 weeks.Results Serum HBV DNA levels of the test group and the control group decreased by 4.98 and 4.73 log10 at week 12,by 5.45 and 5.00 log10 at week 24,and by 5.19 and 5.01 log10 at week 48,respectively,and the differences were not significant between the two groups.The rates of serum HBV DNA suppression(less than 1×102 U/ml) of the test group and the control group were 41.33% and 51.43% at week 12,83.10% and 74.19% at week 24 and 76.47% and 67.74% at week 48,respectively,and the differences were not significant between the two groups.Compared with the baseline levels,all the patients in both groups had a decrease(≥2 1og10) in serum HBV DNA levels at week 12 and 24,and 95.59% of the patients in the test group and all the patients in the control group had that decrease at week 48.The differences were not significant between the two groups.The rates of ALT normalization in the test group and the control group were 92.00% and 82.86% at week 12,97.18% and 93.55% at week 24,and 83.82% and 90.32% at week 48,respectively,and the differences were not significant between the two groups.No patients in the two groups had any severe adverse events.Conclusions Entecavir dispersible tablet has antiviral efficacy on CHB patients,with the same therapeutic efficacy as entecavir.It is an effective and safe agent for the treatment of CHB patients.

Objective To evaluate the efficacy and safety of Entecavir dispersible tablets for the 24-week treatment of chronic hepatitis B in China.Methods Randomized,double-blinded and controled trial was preformed.Over the 24 weeks,120 chronic hepatitis B patients were randomly divided into the test group(n=80)and control group(n=40).Those in the test group were administered with 0.5 mg of Entecavir dispersible tablets and one tablet of dummy Baraclude once daily and those in the control group with 0.5 mg of Baraclude and one tablet of dummy Entecavir dispersible tablet once daily.Results At week 12 and 24,as to median serum HBV-DNA levels and alanine aminotransferase levels,there was no difference between two groups.No patients in the two groups had any severe adverse event.Conclusion Entecavir dispersible tablets are an effective and safe drug for the treatment of chronic hepatitis B patients.

Objective: To evaluate the efficacy and safety of the domestic adefovir dipivoxil capsule of 10 mg·d~(-1) in the 48-weeks treatment of chronic hepatitis B patients with HBeAg positive in China. Methods: Study design was a multi-center,randomdy, double blind,placebo controlled study. 240 Chinese patients were randomly assigned in a 2:1 ratio to receive either adefovir dipivoxil or placebo for the first 12 weeks, then patients received open-labelled adefovir dipivoxil for the week 12～48. The primary efficacy endpoint in this study was the log10 reduction of serum HBV DNA from baseline. Secondary endpoints were the rate of patients ALT normalization and the rate of patients with HBeAg loss and HBeAg seroconversion at week 48. Results: At week 12, the logarithmic value of hepatitis B virus(HBV) DNA level in group B was reduced by(3. 01 ± 1. 34) , higher than that of group A (P < 0. 05). At week 48, the logarithmic values of HBV DNA level in group A and B were reduced by (2. 73 ± 1. 56) and (3. 02 ± 1. 55) .respectively. The rates of HBV DNA undetectable were 27. 5% and 31. 6% , respectively. The rates of HBeAg loss were 27. 5% and 41. 2% , respectively. The rate of HBeAg seroconversions were 8.7% and 8. 8% , respectively, and the rates of ALT normalization were 81. 2% and 82. 4%, respectively. There were no severe adverse events. Comparing with baseline levels,the serum creatinine was not changed. Conclusion: Adefovir dipivoxil 10 mg once daily was safe and effective in patients with HBeAg-positive chronic hepatitis B.

AIM: To analyse the level of Th1 cytokine secreted by PBMC and its correlated factors in patients with chronic HCV infection. METHODS: Th1 cytokine (IL-2, IFN-γ, TNF-α) in supernatant and HCV RNA in serum were assayed by ELISA and fluorescent quantitative PCR respectively after PBMCs in patients with chronic HCV infection were cultured in vitro for 72 h. HCV RNA genotype was detected by RT-PCR. RESULTS: Compared with normal persons [(33.6±14.2) pg/mL], IFN-γ was increased in HCV RNA negative persons [(55.5±32.7) pg/mL], but not in HCV RNA positive persons. TNF-α was increased in all patients with chronic HCV infection. ALT and AST in HCV RNA positive persons were higher than those in negative persons. IFN-γ and TNF-α had no difference among the patients infected with different HCV genotypes. CONCLUSION: IFN-γ is important for viral clearance. TNF-α is one of the important factors in the mechanism of liver injury.

Objective:To analyse the relationship of HCV RNA titre,ALT,AST and cytokines secreted by PBMCs in vitro in patients with chronic HCV infection.METHOD:after cultured 72 hour in vitro,cytokines (IL-2、IL-4、IL-10、IFN-γ、TNF-α) in supernatant secreted by PBMCs were detected by ELISA.HCV RNA in serum were assayed by fluorescent quantitation PCR.RESULT:the level of ALT and AST is higher in HCV RNA positive patients than in negative patients.However,the level of ALT and AST had no significant differnece in positive patients.No matter HCV RNA titre was high or low,the level of cytokine secreted by PBMCs had no significant difference.The analysis showed IFN-γlevel screted by PBMCs was correlated with the level of ALT and AST (r=0.8178,P=0.02,r=0.7517,P=0.04).CONCLUSION:Liver injury may relate with serum HCV RNA titre.IFN-γmay impaired liver when anti-HCV immune response was induced by it.