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1.
Journal of Pharmaceutical Practice ; (6): 86-90, 2023.
Article in Chinese | WPRIM | ID: wpr-964279

ABSTRACT

Objective To study the antifungal activity of a new series of triazole compounds with n-propyl side chain and disubstituted benzyl structure. Methods Eleven target compounds were designed and synthesized. The structures were confirmed by 1H NMR, and some compounds were confirmed by 13C NMR or HRMS. Three fungal strains were selected as experimental strains, and the antifungal activity was tested in vitro according to the standardized antifungal sensitivity test method recommended by National Committee for Clinical Laboratory Standards (NCCLS). Results Compound B11 showed better activity against candida albicans SC5314 than fluconazole and was comparable to posaconazole; Compounds B10, B11 and B4 showed better activity against cryptococcus neoformanis H99 than fluconazole, while compounds B2, B3, B5, B6 and B7 showed similar activity to fluconazole against cryptococcus neoformanis H99; while all compounds showed poor activity against aspergillus fumigatus. Conclusion Some of the target compounds with n-propyl side chain and disubstituted benzyl group structure had certain antifungal activity and could be identified as potential lead antifungal drugs.

2.
Journal of Pharmaceutical Practice ; (6): 625-628, 2023.
Article in Chinese | WPRIM | ID: wpr-996920

ABSTRACT

Objective To investigate the pathogenesis of superficial mycosis among naval trainees, and observe the efficacy of a novel antifungal drug. Methods A questionnaire survey was conducted on the onset, medication and recurrence of superficial fungal infection among the trainees from January, 2020 to July, 2020. At the same time, the new antifungal drug sulconazole nitrate spray was provided for treatment and the drug efficacy was observed. Results The participants generally lacked understanding and attention to superficial fungal infections. The incidence rate of superficial fungal infection was 52%, of which 76.2% of patients had recurrence of superficial fungal infection. The sulconazole nitrate spray showed great effect against these infections. Conclusion The trainees should understand the causes of superficial fungal infection through health education and seek medical treatment and medication in time. The cure rate of superficial fungal infections could only be improved through the collaborative management of the school, hospital, and trainees to reduce the impact of these infections on naval trainees’ work and life.

3.
Journal of Pharmaceutical Practice ; (6): 335-338, 2022.
Article in Chinese | WPRIM | ID: wpr-935032

ABSTRACT

Objective To investigate the medication adherence of military academy students with superficial mycoses. Methods A 8-item Morisky medication adherence scale (MMAS) was modified into 7-item scale to evaluate the compliance of antifungal drugs in the sick students. The reliability and validity of the scale were analyzed. Results A total of 243 questionnaires were collected, of which 242 were valid questionnaires. 90.08% of the students took topical medication and 8.68% were treated both with topical and systematic combination. High, medium and low medication adherence rates as assessed by the modified MMAS were 9.09%, 23.97% and 66.94%, respectively. The reliability analysis showed that the internal consistency coefficient (Cronbach’s α ) was 0.781,and the adjusted Cronbach’s α was 0.790, indicating the high reliability of the scale. The KMO value was 0.798, and the Bartlett’s spherical test value was 440.866, P=0.000. One factor was extracted by exploratory factor analysis. The factor loadings of the items were all above 0.5. Therefore, the high convergent validity was good. Conclusion The modified MMAS has good reliability and validity and is applicable for the evaluation of medication compliance for superficial mycoses. In this study, the military students have a low level of medication adherence for superficial mycoses. Effective measures should be taken to help students strengthen their daily medication management and improve compliance.

4.
Chinese Journal of Medical Education Research ; (12): 794-796, 2021.
Article in Chinese | WPRIM | ID: wpr-908885

ABSTRACT

Objective:To evaluate the application effect of online CBL teaching method under the background of emerging infectious diseases.Methods:With the help of network platforms, using CBL teaching method, through the students viewing online cases, making analysis and summary, and then sending online, in the form of interaction between teachers and students, the teaching work during the epidemic was successfully completed. Finally, the teaching effects of the two semesters before and after the epidemic were compared by means of total semester scores and questionnaires. And chi-square test and t test was adopted for statistical analysis. Results:The practice proved that online CBL teaching method could help students to achieve the same teaching effect as the traditional teaching method in the teaching of infectious diseases.Conclusion:Therefore, online CBL teaching method is worth popularizing in the background of emerging infectious diseases.

5.
Chinese Journal of Hepatology ; (12): 436-439, 2019.
Article in Chinese | WPRIM | ID: wpr-805524

ABSTRACT

Objective@#To evaluate the changes in natural killer cell subsets marked with CD27 and CD11b for HBV carrier mice.@*Methods@#The pAAV-HBVl.2 plasmid was injected into the tail vein of C57BL/6 mice by hydrodynamic injection method to construct HBV-carrier model group and empty vector as the control group. Liver function and virological examination at different time points were used to judge the construction of HBV- plasmid carrier animal model. Flow cytometry was used to detect the frequency of NK cells and CD11b combined with CD27 NK cell subsets in spleen and liver. GraphPad Prism software was used for statistical analysis.@*Results@#HBV-carrier mouse model was successfully constructed. There were no statistically significant difference in NK cell frequencies between spleen and liver of HBV carrier mice (P> 0.05), compared to control group. NK cells were divided into four subsets with in combination to CD27 and CD11b: CD11b+CD27-(CD11b+SP), CD11b+CD27+(DP), CD11b-CD27+(CD27+SP) and CD11b-CD27-(DN). Furthermore, the spleen of HBV-carrier mice had no statistically significant difference (P> 0.05) with the frequency of the four NK-cell subsets. The frequency of DN NK cell subsets was significantly increased in the liver of HBV carrier mice than control group (P< 0.001); however, the frequency of CD11b+SP cell subsets was significantly decreased (P < 0.05).There were no statistical significance in the frequency comparison between NK subgroups of DP and CD27+SP NK cell subsets (P> 0.05).@*Conclusion@#HBV-carrier mice with abnormal distribution of hepatic NK cell subsets significantly increased and decreased the frequency of DN NK cell subsets and CD11b+SP cell subsets.

6.
Chinese Journal of Hepatology ; (12): 92-96, 2019.
Article in Chinese | WPRIM | ID: wpr-804765

ABSTRACT

Hepatitis B virus (HBV) carrier woman of childbearing age with high viral load is an important source of vertical transmission of hepatitis b virus from mother-to-child in China. Routine blockade with immunoglobulin combined with hepatitis B vaccine is used for neonates born to pregnant women with high viral load of hepatitis B virus, but in some cases, immunoprophylaxis fails. The main application of antiviral drugs in pregnancy is to reduce the serum viral load, thereby significantly improve the blocking rate of vertical transmission between mother and infant. Current evidence suggested that if the maternal age is less than 30 years old, with no obvious liver fibrosis or cirrhosis and there is no increase in ALT level >2ULN( upper limit of normal) during the treatment, the treatment with antiviral drugs can be stopped after delivery immediately. Additionally, ALT level should be examined at 4, 12 and 24 weeks after stopping the drug. Antiviral therapy for the occurrence of hepatitis attack should be given if criteria for HBV treatment are met.

7.
Chinese Journal of Hepatology ; (12): 521-526, 2019.
Article in Chinese | WPRIM | ID: wpr-810759

ABSTRACT

Objective@#To explore the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection who received entecavir alone or in combination with anluohuaxianwan for 78 weeks.@*Methods@#Patients with chronic HBV infection were randomly treated with entecavir alone or in combination with anluohuaxian for 78 weeks. Ishak fibrosis score was used for blind interpretation of liver biopsy specimens. The improvement in liver fibrosis condition before and after the treatment was compared. Student's t test and non-parametric test (Mann-Whitney U-Test and Kruskal-Wallis test) were used to analyze the measurement data. The categorical variables were analyzed by Chi-square test method and Spearman’s rank correlation coefficient was used to test bivariate associations.@*Results@#Liver fibrosis improvement rate after 78 weeks of treatment was 36.53% (80/219) and the progression rate was 23.29% (51/219). The improvement of liver fibrosis was associated to the degree of baseline fibrosis and treatment methods (P < 0.05). The improvement rate of hepatic fibrosis in patients treated with anluohuaxianwan combined with entecavir at baseline F < 3 (54.74%, 52/95) was significantly higher than that in patients treated only with entecavir (33.33%, 16/48), P = 0.016 and the progression rate of hepatic fibrosis (13.68%, 13/95) was lower than that in patients treated alone (18.75%, 9/48), P = 0.466. In patients with baseline F < 3, the proportion of patients with improved and stable liver fibrosis in the combined treatment group (68.1%, 32/47) was higher than that in the treatment group alone (51.7%, 15/29).@*Conclusion@#Combined anluohuaxianwan and entecavir treatment can significantly improve the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection. Furthermore, it has the tendency to improve the stability rate and reduce the rate of progression of liver fibrosis.

8.
Chinese Journal of Hepatology ; (12): 481-482, 2019.
Article in Chinese | WPRIM | ID: wpr-810751

ABSTRACT

Liver cancer (HCC) holds third position for cause of cancer-related death worldwide. Therefore, it is urgent to explore new strategies for the diagnosis and treatment of liver cancer. Illustrating the successful experience of other tumors on precancerous lesions, this paper puts forward the idea of advance strategy for the diagnosis and treatment through dysplastic nodules, especially high-grade dysplastic nodules, which can reduce or delay the carcinogenesis of some patients with cirrhosis. It is hoped that this measure might improve the present situation of diagnosis and treatment of liver cancer in coming days in China.

9.
Chinese Journal of Hepatology ; (12): 457-459, 2018.
Article in Chinese | WPRIM | ID: wpr-806719

ABSTRACT

Objective@#To dynamically analyze the discipline status, influence factors and key issues of Chinese Journal of Hepatology from 2010 to 2016 and explore the development rules of citation indexes.@*Methods@#We collected information published by the China Institute of Scientific and Technological Information [China Science and Technology Journal Citation Report (Core Edition)] and Wanfang Database Periodicals statistical analysis platform from 2010 to 2016. A bibliometric analyses on article volume, citation frequency, citation rate, h-index, ratio of fund-aided papers, periodical influence, key number published period, number of relevant articles, and so on were analyzed for annual’s impact factor.@*Results@#According to the data released by the China Institute of Science and Technology Information, from 2010 to 2011, the impact factor of Chinese Journal of Hepatology was at leading level in the field of internal medicine and ranked sixth in the Journal of Internal Medicine. From 2012 to 2016, the overall comprehensive assessment score and citation frequency score of Chinese Journal of Hepatology were ranked first in the Journal of Gastroenterology. Core impact factors kept the discipline ahead. Indexes such as immediacy index, h- index, cited half-life and all other indicators were increased. Citation rate was >90% and cited issue number had greatly increased.@*Conclusion@#Chinese Journal of Hepatology has a leading position in the Journal of Gastroenterology and credited by inland readers and authors of digestive and infectious fields. It has played a positive role in promoting the development of the discipline.

10.
Chinese Journal of Hepatology ; (12): 420-425, 2018.
Article in Chinese | WPRIM | ID: wpr-806712

ABSTRACT

Objective@#To explore the relationship between sialic-acid-binding immunoglobulin-like lectin 7 (Siglec-7) expressed on NK cells and hepatitis B virus-related cirrhosis.@*Methods@#Peripheral venous blood samples were collected from 23 healthy controls and 31 patients with hepatitis B virus-related cirrhosis (Child-Pugh A, n = 7; Child-Pugh B, n = 12; Child-Pugh C, n = 12). Peripheral blood mononuclear cells (PBMCs) were obtained by using Ficoll-Hypaque density gradient centrifugation and the expression of Siglec-7 and NK cells phenotype and their subpopulations were detected by flow cytometry. Comparisons between various groups were performed using t -test, one-way analysis of variance (ANOVA), and correlations between variables were analyzed using Pearson’s-correlation coefficient.@*Results@#(1) There was no significant difference in the percentage of NK cells and in their subpopulations with HBV-related cirrhosis and healthy controls. (2) Siglec-7 expression on NK cells in patients with HBV-related cirrhosis(62.44±13.45%)was significantly down-regulated than that to healthy controls(75.39±12.19%)while the frequency of Siglec-7+ NK cells were negatively correlated with Child-Pugh score. (3) Subpopulation analysis showed that Siglec-7 expression on CD56brightCD16-NK cells(66.99±15.93%)was significantly lower than CD56dimCD16+NK cells(76.54±13.9%) in HBV-related cirrhosis. However, the expression of Siglec-7 in healthy controls showed no difference in these two NK cell subsets. (4) Phenotypic analysis showed that Siglec-7+ NK cells express higher levels of activating receptor CD16, CD38, NKp46 and lower levels of inhibitory receptor CD158b. Indeed, the frequency of CD16 and CD38 on Siglec-7+ NK cells in HBV-related cirrhosis was lower than that in healthy controls.@*Conclusion@#The disease progression in patients with hepatitis B virus-related cirrhosis is associated to decreased frequencies of Siglec-7+NK cells.

11.
Chinese Journal of Hepatology ; (12): 10-12, 2018.
Article in Chinese | WPRIM | ID: wpr-805964

ABSTRACT

Patients with end-stage liver disease have an increased risk of developing bacterial infections, resulting in an increase in the number of hospitalizations and medical expenses, a decline in the quality of life of patients, and an increased fatality rate. Bacterial infections in patients with end-stage liver disease is mainly due to the falling off the body's immune response causing respiratory infections, spontaneous bacterial peritonitis, urinary tract infections and gastrointestinal infections. The diagnosis of bacterial infection is more challenging because the occurrence of infection shows no typical symptoms and signs. The examination of some biological markers has important clinical significance for early diagnosis. The clinical prognosis is entirely marked on the patient conditions, the effective control of infection, appropriate broad-spectrum antibiotics, and empiric therapy. Antibiotics are the choice, but also need to be alert against drug-induced liver damage.

12.
Chinese Journal of Hepatology ; (12): 756-764, 2018.
Article in Chinese | WPRIM | ID: wpr-810222

ABSTRACT

Objective@#Hepatitis B surface antigen (HBsAg) loss is seldom achieved with nucleos(t)ide analog (NA) therapy in chronic hepatitis B patients but may be enhanced by switching to finite pegylated-interferon (Peg-IFN) alfa-2a. We assessed HBsAg loss with 48- and 96-week Peg-IFN alfa-2a in chronic hepatitis B patients with partial response to a previous NA.@*Methods@#Hepatitis B e antigen (HBeAg)-positive patients who achieved HBeAg loss and hepatitis B virus DNA < 200 IU/mL with previous adefovir, lamivudine or entecavir treatment were randomized 1:1 to receive Peg-IFN alfa-2a for 48 (n = 153) or 96 weeks (n = 150). The primary endpoint of this study was HBsAg loss at end of treatment. The ClinicalTrials.gov identifier is NCT01464281.@*Results@#At the end of 48 and 96 weeks' treatment, 14.4% (22/153) and 20.7% (31/150) of patients, respectively, who switched from NA to Peg-IFN alfa-2a cleared HBsAg. Rates were similar irrespective of prior NA or baseline HBeAg seroconversion. Among those who cleared HBsAg by the end of 48 and 96 weeks' treatment, 77.8% (14/18) and 71.4% (20/28), respectively, sustained HBsAg loss for a further 48 weeks. Baseline HBsAg < 1 500 IU/mL and week 24 HBsAg < 200 IU/mL were associated with the highest rates of HBsAg loss at the end of both 48- and 96-week treatment (51.4% and 58.7%, respectively). Importantly, extending treatment from 48 to 96 weeks enabled 48.3% (14/29) more patients to achieve HBsAg loss.@*Conclusion@#Patients on long-term NA who are unlikely to meet therapeutic goals can achieve high rates of HBsAg loss by switching to Peg-IFN alfa-2a. HBsAg loss rates may be improved for some patients by extending treatment from 48 to 96 weeks, although the differences in our study cohort were not statistically significant. Baseline and on-treatment HBsAg may predict HBsAg loss with Peg-IFN alfa-2a.

13.
Chinese Journal of Hepatology ; (12): 744-749, 2018.
Article in Chinese | WPRIM | ID: wpr-810220

ABSTRACT

Objective@#To compare the efficacy and safety of plasma exchange (PE) combined with double plasma absorption and simple PE in the treatment of acute-on-chronic liver failure.@*Methods@#We retrospectively analyzed 251 cases of acute-on-chronic liver failure treated with artificial liver treatment since January 2015. Changes in clinical manifestations, laboratory tests, and complications of the patients before and after different modes of treatment were compared and short-term efficacy was tracked. In accordance with different data, t-test, Pearson's chi-squared test and Fisher's exact test were used for statistical analysis.@*Results@#The effectiveness of low-volume PE combined with double plasma molecular adsorption system (DPMAS) and equal amount of PE combined with DPMAS was significantly better than simple PE (83.7%, 84.05% and 82.15 vs 55.6%, P < 0.05) in early stage of liver failure. In late-stage of liver failure, there was no significant difference in the treatment efficiency of each group (P > 0.05). Bilirubin and bile acid levels were significantly decreased in combined treatment groups than that to simple PE group (P < 0.05). PTA and albumin improvement rate of DPMAS PE groups were significantly lower than that of simple PE group (P < 0.05). There was no statistical difference in adverse reactions between each group.@*Conclusion@#PE combined with DPMAS improves the treatment efficiency of early hepatic failure and decrease dosage of plasma when compared with simple PE. A beforehand DPMAS treatment after PE treatment can improve the adverse effects of DPMAS on blood coagulation function and albumin levels.

14.
Chinese Journal of Hepatology ; (12): 585-589, 2018.
Article in Chinese | WPRIM | ID: wpr-810119

ABSTRACT

Objective@#To study the functional effects of killer cell lectin-like receptor subfamily G member 1 (KLRG1) expression on natural killer cells (NK cell) in chronic hepatitis B virus infection (HBV).@*Methods@#Peripheral blood mononuclear cells (PBMC) were extracted from 120 patients with chronic hepatitis B virus infection and 19 healthy persons. The frequency of NK cells and KLRG1+ NK cells in peripheral blood was detected by flow cytometry. Interferon-γ levels secreted by NK cells were detected in peripheral blood. Statistical analysis of experimental data was performed using GraphPad Prism 6.03 software.@*Results@#The frequency of NK cells in HBV-infected group (16.92% ± 7.9%) was not significantly different from that in healthy controls (10.57% ± 6.5%). The frequency of KLRG1+NK cells in HBV-infected group was significantly higher (49.43% ± 21.2%) than that to healthy control group (31.60% ± 17.9%), (t = 7.347 6, P < 0.001). IFN-γ secretion of KLRG1 + NK cells in HBV-infected patients (2.59% ± 1.0%) were significantly lower than healthy controls (5.96% ± 2.4%), (P = 0.009).@*Conclusion@#HBV infection can increase the expression of KLRG1 in NK cells and further reduce the secretion of IFN-γ in NK cells, which may be an important cause for chronic HBV infection.

15.
Journal of Clinical Hepatology ; (12): 438-443, 2018.
Article in Chinese | WPRIM | ID: wpr-694731

ABSTRACT

Acute liver failure (ALF) is a rare life-threatening disease with rapid progression and a low survival rate and affects the function of multiple organ systems.Early identification of cause and protection of vital organs are critical for patients'survival.With the development in artificial liver,stem cell transplantation,and liver transplantation in recent years,the outcome of ALF has been greatly improved.This article elaborates on the treatment of ALF from the aspects of the etiology of ALF and major organ systems involved and introduces the latest advances in artificial liver and stem cell transplantation.

16.
Journal of Pharmaceutical Practice ; (6): 17-21,86, 2017.
Article in Chinese | WPRIM | ID: wpr-790689

ABSTRACT

Objective Based on the structure-activity relationships on the reported antifungal agents bearing quinoline or thiophene moieties ,novel compounds bearing both quinoline and thiophene were designed ,synthesized ,and evaluated for in vitro antifungal activity against Candida albicans .Methods With 5-cyanothiophene-2-carbaldehyde or 5-cyanothiophene-3-car-baldehyde as starting materials ,13 compounds were synthesized via reductive amination ,reduction of cyano group and amida-tion of quinoline-or isoquinoline-carboxylic acid .Their chemical structures were characterized by 1 H NMR and MS . In vitro antifungal screening against Candida albicans SC5314 was performed with the microbroth dilution method .Results All the compounds exhibited potent antifungal activities against Candida albicans .Among them ,compound 6k showed the highest an-tifungal activity with MIC80 value of 0 .5 μg/ml ,which is same potent as fluconazole .Conclusion The designed compounds bearing both quinoline and thiophene exhibited potent antifungal activities ,and deserve further research .

17.
Chinese Journal of Hepatology ; (12): 726-731, 2017.
Article in Chinese | WPRIM | ID: wpr-809425

ABSTRACT

Objective@#To investigate the value of neutrophil-lymphocyte ratio (NLR) in predicting hepatitis B-related liver failure.@*Methods@#A total of 349 subjects were enrolled, among whom 60 were healthy persons who underwent physical examination (group A), 111 had severe chronic hepatitis B (group B), 92 had decompensated hepatitis B cirrhosis (group C), and 86 had acute-on-chronic liver failure (ACLF) (group D). Routine blood test results, liver function parameters, and coagulation parameters were collected, and NLR was calculated. According to disease progression, group B was further divided into groups B1 (with progression to ACLF) and B2 (without progression to ACLF). NLR was compared between groups, and its prognostic value was evaluated.@*Results@#NLR was 2.22(1.76-3.05) in group A, 2.54(1.78-3.49) in group B, 3.07(1.95-5.04)in group C, and 3.41(2.01-5.15) in group D, and NLR gradually increased with the aggravation of disease condition. The univariate and multivariate regression analyses of groups B1 and B2 showed that NLR and prothrombin activity were prognostic factors for disease progression. There was a significant difference in baseline NLR between groups B1 and B2 (3.87 ± 1.54 vs 2.71 ± 1.54, P = 0.004). There was a significant increase in NLR when severe hepatitis B in 16 patients progressed to ACLF (P = 0.042). The receiver operating characteristic (ROC) curve analysis showed that the cut-off value of NLR for predicting the progression of severe hepatitis B to ACLF was 2.79, with an area under the ROC curve (AUC) of 0.739 (P = 0.002). NLR was also a reference index for judging end-stage liver disease with a cut-off value of 3.94 (AUC = 0.612, P = 0.001).@*Conclusion@#Peripheral NLR can reflect disease progression and predict the development of liver failure.

18.
Chinese Journal of Hepatology ; (12): 651-654,711, 2017.
Article in Chinese | WPRIM | ID: wpr-809286

ABSTRACT

Acute-on-chronic liver failure is a syndrome characterized by acute exacerbation of chronic hepatitis, organ failure, and high mortality. Clinical treatment of acute-on-chronic liver failure included comprehensive medical treatment, artificial liver support system, and liver transplantation, but such methods have their own shortcomings and patients tend to have a poor prognosis. Mesenchymal stem cells (MSCs), as a new type of cell therapy, have wide sources and are easy to extract and culture. Many studies have shown that MSC treatment not only helps to achieve a high survival rate, but also has good tolerability and safety; therefore, the clinical value of MSCs has become a hot research topic. This article reviews the clinical studies on acute-on-chronic liver failure, related mechanisms, and research advances, in order to provide a reference for future clinical trials and application.

19.
Chinese Journal of Hepatology ; (12): 589-596, 2017.
Article in Chinese | WPRIM | ID: wpr-809156

ABSTRACT

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.

20.
Chinese Journal of Hepatology ; (12): 187-194, 2017.
Article in Chinese | WPRIM | ID: wpr-808373

ABSTRACT

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.

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