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1.
Int Wound J ; 20(6): 2424-2439, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37102269

ABSTRACT

Excellent capability of exosome derived from human adipose-derived stem cell (ADSC) manifested in improving the quality of wound healing with SMD (STD Mean Difference). However, it is still in the preclinical stage and its efficacy remains uncertain. Emphasised the need for a systematic review of preclinical studies to the validity of it in ameliorate wound healing quality which accelerate the clinical application translation. We performed a systematic literature review to identify all published controlled and intervention studies comparing exosome derived from human ADSC with placebo in animal models of wound closure during wound healing. PubMed, Embase and Cochrane were employed. Risk of bias assessed by the SYRCLE tool aimed at preclinical animal studies. Administration of exosome derived from human ADSC extremely improved wound closure compared with controls, which is primary outcome (SMD 1.423, 95% confidence interval (CI) 1.137-1.709 P < .001), the same effect as ADSC. The therapeutic effect is further enhanced by modified ADSC-EV. Other outcomes: density and the number of blood vessels: (SMD 1.593 95% CI 1.007-2.179 P < .001);Fibrosis-related protein expression was highly expressed in the early term of wound healing, decreased in shaping period, which automatically regulates wound collagen deposition. Scar size, number of fibroblast and epithelial cell migration and proliferation expressed were ranked as follows: modified adipose stem cell exosomes > adipose stem cell exosomes > controls. Exosome derived from human ADSC, especially after enrichment for specific non-coding RNA, is a promising approach to improve healing efficiency.


Subject(s)
Diabetes Mellitus, Experimental , Exosomes , Animals , Humans , Adipose Tissue , Exosomes/metabolism , Wound Healing/physiology , Stem Cells
2.
Preprint in English | bioRxiv | ID: ppbiorxiv-503534

ABSTRACT

The high transmissibility of SARS-CoV-2 is a primary driver of the COVID-19 pandemic. While existing interventions prevent severe disease, they exhibit mixed efficacy in preventing transmission, presumably due to their limited antiviral effects in the respiratory mucosa, whereas interventions targeting the sites of viral replication might more effectively limit respiratory virus transmission. Recently, intranasally administered RNA-based therapeutic interfering particles (TIPs) were reported to suppress SARS-CoV-2 replication, exhibit a high barrier to resistance, and prevent serious disease in hamsters. Since TIPs intrinsically target the tissues with the highest viral replication burden (i.e., respiratory tissues for SARS-CoV-2), we tested the potential of TIP intervention to reduce SARS-CoV-2 shedding. Here, we report that a single, post-exposure TIP dose lowers SARS-CoV-2 nasal shedding and at 5 days post-infection infectious virus shed is below detection limits in 4 out of 5 infected animals. Furthermore, TIPs reduce shedding of Delta variant or WA-1 from infected to uninfected hamsters. Co-housed contact animals exposed to infected, TIP-treated, animals exhibited significantly lower viral loads, reduced inflammatory cytokines, no severe lung pathology, and shortened shedding duration compared to animals co-housed with untreated infected animals. TIPs may represent an effective countermeasure to limit SARS-CoV-2 transmission. SignificanceCOVID-19 vaccines are exceptionally effective in preventing severe disease and death, but they have mixed efficacy in preventing virus transmission, consistent with established literature that parenteral vaccines for other viruses fail to prevent mucosal virus shedding or transmission. Likewise, small-molecule antivirals, while effective in reducing viral-disease pathogenesis, also appear to have inconsistent efficacy in preventing respiratory virus transmission including for SARS-CoV-2. Recently, we reported the discovery of a single-administration antiviral Therapeutic Interfering Particle (TIP) against SARS-CoV-2 that prevents severe disease in hamsters and exhibits a high genetic barrier to the evolution of resistance. Here, we report that TIP intervention also reduces SARS-CoV-2 transmission between hamsters.

3.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-934488

ABSTRACT

Objective:To improve the multiple-link operation efficiency, effect and satisfaction of transaxillary dual-plane breast augmentation by optimizing and upgrading the configuration of auxiliary tools.Methods:From January 2019 to May 2021, breast augmentation was performed in 130 female patients (aged 32±8 years) in the Cosmetic and Plastic Center of the First Affiliated Hospital of Harbin Medical University. The study was conducted among 63 patients who were eligible for the criteria of high configuration surgery. 67 patients underwent standard configuration surgery. The average operation time, intraoperative blood loss, drainage volume (24 hours after operation), postoperative visual analog scale (VAS) pain score and satisfaction were statistically analyzed.Results:The data of high configuration method and standard configuration method were compared as follows: average operation time was (78.6±12.2) min / (93.1±12.1) min ( t=15.73, P<0.05); the average intraoperative blood loss was (3.1±1.0) ml / (14.4±3.5) ml ( t=13.83, P<0.05); the drainage volume (24 hours after operation) was (37.2±8.2) ml / (61.4±10.9) ml ( t=20.82, P<0.05); the pain score on the first day after surgery was (6.1±1.7) points / (7.5±1.6) points ( t=8.57, P<0.05). The overall satisfaction rate was 97.1±1.6 / 95.6±2.0 ( t=5.58, P>0.001), at 6 months after operation. No severe complications were found during the follow-up period, such as capsular contracture, hematoma, infection and double bubble deformity. Conclusions:The use of ultrasonic knife with delivery bag is an effective optimization and upgrade of the endoscopic assisted transaxillary dual plane breast augmentation. The advantages of this method are obvious, highly efficient, safe, effective and satisfactory. It is worthy of clinical application and promotion.

4.
Journal of Clinical Hepatology ; (12): 1387-1392, 2022.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-924719

ABSTRACT

At present, antiviral therapy for chronic hepatitis B (CHB) has a low clinical cure rate and hardly remove cccDNA. With the progress of medical science, more and more new drugs are in the stage of research and development. This article focuses on the research and development of representative drugs with relatively detailed clinical trial data. Rapid progress has been made in the new drugs such as small-interfering RNA and core protein allosteric modulators in recent years. The results of clinical trials show that it still takes some time for new drugs to enter clinical use, and multi-drug combination therapy may become the trend of treatment in the future.

5.
Gut and Liver ; : 887-894, 2021.
Article in English | WPRIM (Western Pacific) | ID: wpr-914356

ABSTRACT

Background/Aims@#To investigate postpartum hepatic flares and associated factors in highly viremic pregnant patients in the immune tolerance phase who adopted telbivudine (LdT) treatment in the last trimester to reduce vertical transmission of hepatitis B virus. @*Methods@#Hepatitis B e antigen (HBeAg)-positive, highly viremic pregnant women were recruited for this prospective study. Treatment with LdT was started from 28 weeks of gestation. Virological and biochemical markers were examined before LdT treatment, antepartum and postpartum. Serial blood samples at the same time were collected to detect cytokines and cortisol (COR). @*Results@#Fifty-six of 153 patients (36.6%) had postpartum hepatic flares, defined as a 2-fold increase in alanine aminotransferase 6 weeks after delivery. Age and the antepartum alanine aminotransferase and postpartum HBeAg levels were independent influencing factors of postpartum hepatic flares. Cytokines showed no regularity during or after pregnancy. Compared with the patients with no postpartum flares, the patients with flares had lower baseline interferon γ and COR levels (p=0.022 and p=0.028) and higher postpartum interferon γ levels (p=0.026). @*Conclusions@#A high proportion of highly viremic and immune-tolerant pregnant patients treated with LdT in the last trimester had postpartum hepatic flares, which implied that these patients entered the immune clearance phase after delivery. Thus, this may create an appropriate opportunity for re-antiviral therapy.

6.
Journal of Clinical Hepatology ; (12): 1268-1274, 2021.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-877314

ABSTRACT

Nucleos(t)ide analogues (NAs), which are widely used as the first-line anti-hepatitis B virus (HBV) drugs in clinical practice, can effectively inhibit the replication of HBV DNA, significantly slow down disease progression in chronic hepatitis B (CHB) patients, and reduce the development of end-stage liver diseases such as liver failure and liver cancer. However, for some CHB patients receiving first-line NAs for 48 weeks or longer, serum HBV DNA is still persistently or intermittently higher than the lower detection of limit of sensitive nucleic acid detection reagents. After discussion by the authors, low-level viremia (LLV) is defined as follows: persistent LLV refers to the condition in which CHB patients, who receive entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide fumarate for ≥48 weeks, test positive for HBV DNA by two consecutive detections with sensitive quantitative PCR, with an interval of 3-6 months, but have an HBV DNA level of <2000 IU/ml; intermittent LLV refers to the condition in which patients test positive for HBV DNA intermittently by at least three consecutive detections with sensitive quantitative PCR, with an interval of 3-6 months, but have an HBV DNA level of <2000 IU/ml. For the diagnosis of LLV, the issues of poor compliance and drug-resistant mutations should be excluded. LLV might be associated with the increased risk of progression to liver fibrosis or hepatocellular carcinoma in patients with liver cirrhosis under NA treatment, but there are still controversies over whether the original treatment regimen with NAs should be changed after the onset of LLV. This article summarizes the incidence rate of LLV under NA treatment and the influence of LLV on prognosis and analyzes the possible mechanisms of the osnet of LLV, so as to provide a reference for the management of LLV in patients treated with NAs.

7.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-877087

ABSTRACT

Objective To employ Logistic regression modeling to analyze the related factors influencing the accuracy of the high performance liquid chromatography (HPLC) determination of preservatives in beverages. Methods The HPLC separation was performed on a Zorbax Eclipse Plus C18 column with methanol-ammonium acetate solution as mobile phase. The external standard method was used to determine 5 beverage preservatives. The influencing factors on the measurement accuracy were statistically evaluated with univariate and multivariate analysis. Results Univariate analysis showed that the recovery rate of the added standard in the determination of coffee beverage preservatives by HPLC was affected by the pretreatment method, and the difference was statistically significant (P<0.05). Multivariate analysis showed that the main influencing factors on the accuracy of determination of sorbic acid was the pretreatment method (OR=5.406, P<0.05), while the sample type was a protective factor (OR=0.134, P<0.05). For the determination of benzoic acid, the main factor influencing the accuracy was the sample type (OR=1.112, P<0.05), while the pretreatment method was a protective factor (OR=0.447, P<0.05). Conclusion Logistic regression analysis can identify risk factors for the accuracy of the determination, and provide statistical modeling support for the experimental optimization.

8.
Medicine (Baltimore) ; 98(29): e16222, 2019 Jul.
Article in English | MEDLINE | ID: mdl-31335672

ABSTRACT

RATIONALE: HIV-related lymphoma, especially non-Hodgkin lymphoma, is one of the most common malignant tumors in HIV/acquired immune deficiency syndrome (AIDS) patients. Autologous hematopoietic stem cell transplantation (AHSCT) for the patients with Burkitt lymphoma (BL) is needed to be further explored. PATIENT CONCERNS: A 57-year-old man was hospitalized with intermittent pain on upper abdomen and melena for >1 month. DIAGNOSIS: HIV antibody testing was positive. The upper gastrointestinal endoscopy was performed and histopathology and immunohistochemistry revealed BL. INTERVENTIONS: Highly effective antiretroviral therapy and sixth cycles of chemotherapy were administered, followed by autologous hematopoietic stem cell transplantation. OUTCOMES: The patient has had tumor-free survival for >6 years with normal CD4+ T cell counts and HIV viral load below the lowest detection LESSONS:: The patient was treated with AHSCT followed complete remission after chemotherapy and achieved long-term disease-free survival. AHSCT may be a promising way for clinical cure of HIV-related BL.


Subject(s)
Antiretroviral Therapy, Highly Active/methods , Burkitt Lymphoma , HIV Infections , Hematopoietic Stem Cell Transplantation/methods , Transplantation Conditioning/methods , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Burkitt Lymphoma/complications , Burkitt Lymphoma/pathology , Burkitt Lymphoma/surgery , Disease-Free Survival , Endoscopy, Gastrointestinal/methods , HIV Infections/complications , HIV Infections/diagnosis , HIV Infections/drug therapy , Humans , Immunohistochemistry , Male , Middle Aged , Transplantation, Autologous/methods , Treatment Outcome , Viral Load/methods
9.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-792198

ABSTRACT

Objective To establish comprehensive understanding of the self-rated health of the Chinese doctors and nurses and probe into their influencing factors. Methods Data were drawn from a hospital performance survey, which was conducted by the Peking Union School of Public Health from March 18th to April 9th, 2019, among the 144 tertiary public hospitals in 31 provinces, autonomous regions, and municipalities. The survey included a cell-phone based questionnaire filled out by the sampled doctors and nurses, in which they were asked to rate their health using a 5-level Likert scale(from " very poor" to " very good" ). Mann-Whitney U test was used to analyze the differences in self-rated health between doctors and nurses. Chi-square test and two-class multivariate logistic regression were performed to analyze factors affecting self-rated health of the providers. Results Among the 144 sample hospitals, the proportion of doctors, who rated their health as " healthy" , was 20.30% (4 979/24 529), that of nurses was 28.92% (8 361/28 910). It was worse than that in some developed countries and lower than the general population in China. Multi-variate analysis showed that adequate sleeping time, satisfaction with the work and with the doctor-patient relationship, were positively associated with the level of self-rated health of the sampled doctors and nurses(P<0.05). It was also found that the longer the average weekly working time, the higher the recognition of " the work load is too heavy" , the lower the proportion of doctors and nurses who rated their health as " healthy" (P <0.05). Conclusions Sleep time, job satisfaction, workload and doctor-patient relationship are important factors affecting self-rated health of the Chinese doctors and nurses.

10.
Chinese Journal of Hepatology ; (12): 261-266, 2019.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-805048

ABSTRACT

Objective@#To observe the changes of liver function, virology and serology and the safety of drug withdrawal in pregnant women who are chronic hepatitis B virus (HBV) carriers.@*Methods@#A prospective clinical cohort was established to enroll pregnant women who are chronic HBV carriers and they were divided into the nucleoside/nucleotide analogs (NAs) intervention group and the non-NAs intervention group according to patients' wishes. Liver function, HBV DNA and HBV serological markers were detected at gestation, postpartum 6 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks.@*Results@#351 patients were enrolled, 320 in the NAs intervention group and 31 in the non-NAs intervention group. The proportion of postpartum hepatitis flares in both groups was higher than that in pregnancy (39.4% vs 12.5%, P < 0.001; 38.7% vs 3.2%, P = 0.001). Six weeks postpartum was the peak period of hepatitis flares, and 96.0% (121/126) of the hepatitis flares occurred within 24 weeks postpartum. At 6 weeks postpartum, there were 6 cases of alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN) in the NAs intervention group. The rate of the hepatitis flare after drug withdrawal was 16.7% (34/203).@*Conclusion@#Regardless of the presence or absence of NAs intervention, pregnant women who are chronic HBV carriers have a certain proportion of hepatitis flares during pregnancy and postpartum, and the hepatitis flare even have a tendency to be severe. Therefore, drug withdrawal after delivery is not always safe, which requires close observation and classification. At 6 weeks postpartum, the incidence of hepatitis flares was high, and those who meet the treatment indications can get better therapeutic effects if given appropriate treatment. The vast majority (96%) of postpartum hepatitis flares occur within 24 weeks, so it is recommended to follow up to at least 24 weeks postpartum after discontinuation.

11.
Chinese Journal of Hepatology ; (12): 88-91, 2019.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-804764

ABSTRACT

The reports of liver dysfunction during pregnancy or postpartum have gradually increased in pregnant women who are chronic carriers of hepatitis B virus (HBV), but there is no consensus on when to intervene and how to deal with it. This article reviewed recent literature reports and found that pregnant women who are chronic carriers of HBV, regardless of intervention of nucleos(t)ide analogs (NAs), have a certain proportion of hepatitis flares or severe disease during pregnancy and postpartum, suggesting that postpartum drug withdrawal is not always safe, and close follow-up is required. Furthermore, it recommends that treatment should be in accordance to the gestational weeks and ALT levels. NAs are the main treatment choice in the onset of hepatitis flares during pregnancy, however, postpartum hepatitis flares requires NAs or interferon therapy, and it have been reported that combination of NAs and interferon might achieve higher therapeutic response.

12.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-797502

ABSTRACT

Objective@#To establish comprehensive understanding of the self-rated health of the Chinese doctors and nurses and probe into their influencing factors.@*Methods@#Data were drawn from a hospital performance survey, which was conducted by the Peking Union School of Public Health from March 18th to April 9th, 2019, among the 144 tertiary public hospitals in 31 provinces, autonomous regions, and municipalities. The survey included a cell-phone based questionnaire filled out by the sampled doctors and nurses, in which they were asked to rate their health using a 5-level Likert scale(from " very poor" to " very good" ). Mann-Whitney U test was used to analyze the differences in self-rated health between doctors and nurses. Chi-square test and two-class multivariate logistic regression were performed to analyze factors affecting self-rated health of the providers.@*Results@#Among the 144 sample hospitals, the proportion of doctors, who rated their health as " healthy" , was 20.30%(4 979/24 529), that of nurses was 28.92%(8 361/28 910). It was worse than that in some developed countries and lower than the general population in China. Multi-variate analysis showed that adequate sleeping time, satisfaction with the work and with the doctor-patient relationship, were positively associated with the level of self-rated health of the sampled doctors and nurses(P<0.05). It was also found that the longer the average weekly working time, the higher the recognition of " the work load is too heavy" , the lower the proportion of doctors and nurses who rated their health as " healthy" (P<0.05).@*Conclusions@#Sleep time, job satisfaction, workload and doctor-patient relationship are important factors affecting self-rated health of the Chinese doctors and nurses.

13.
Chinese Journal of Hepatology ; (12): 813-818, 2018.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-810254

ABSTRACT

Objective@#To analyze the therapeutic effect on HBeAg-negative chronic hepatitis B patients treated with Peg-IFNα-2a combined with NAs to obtain the influencing factors for predicting HBsAg clearance.@*Methods@#A retrospective study was conducted to investigate the effect of pegylated interferon alpha-2a combined with nucleoside analogues (lamivudine/adefovir dipivoxil) on HBeAg-negative chronic hepatitis B. The treatment course was 96 weeks. Patients were followed up 120 weeks after the treatment. HBsAg clearance at 120 weeks was taken as the objective of the study. Logistic regression and receiver operating characteristic curve analysis screened the related factors affecting HBsAg clearance. χ 2 test was used to compare count data.@*Results@#111 patients were treated with pegylated interferon alpha-2a combined with nucleoside analogues, and 107 patients completed the scheduled course of treatment and follow-up. HBsAg clearance rate at120 week was 29.0% (31/107). The influencing factors for analysis were: (1) gender had no effect on HBsAg clearance rate; age and baseline levels of HBV DNA and alanine aminotransferase had no significant effect on HBsAg clearance; low baseline level of HBsAg (< 3.023 lgIU/ml) was beneficial to HBsAg clearance. The area under the working characteristic curve of the subjects was 0.746, the positive predictive value was 44.4%, and the negative predictive value was 86.8%. (2) HBsAg quantification or decline in 24 weeks and 48 weeks of treatment had a good predictive effect on HBsAg clearance, and the 48 weeks predicted value was higher than 24 weeks. When the HBsAg quantification was≤2.070 lgIU/ml at 48 weeks, the area under the receiver operating characteristic curve was 0.931, the positive predictive value was 52.8%, and the negative predictive value was 94.4%. When HBsAg decreased from baseline to≥0.991 lgIU/ml, the area under the receiver operating characteristic curve was 0.888, the positive predictive value was 50.8%, and the negative predictive value was 97.9%. (3) The analysis of HBsAg subgroup levels at 48 weeks suggested that the "interval analysis" can forecast HBsAg clearance more exactly than "nodal analysis" .The final HBsAg clearance rate of 100 IU/ml < HBsAg≤1 000 IU/ml, 10 IU/ml < HBsAg≤100 IU/ml and HBsAg≤10 IU/ml groups reached 6.7%, 31.8% and 67.7%, respectively. (4) The ALT abnormal group in the course of treatment obtained a higher HBsAg clearance rate (48.0%, 12/25).@*Conclusion@#96-weeks long-term treatment with pegylated interferon-alpha -alpha-2a combined with nucleoside analogues for HBeAg-negative chronic hepatitis B has a good predictive value for HBsAg clearance at baseline and during treatment. The "interval level" of HBsAg at 48-weeks is more accurate in predicting HBsAg clearance, suggesting that HBeAg-negative chronic hepatitis B patients with low HBsAg levels at 48-weeks are the advantageous populations with HBsAg clearance. These patients are worthy of prolonged treatment to pursue "clinical cure".

14.
Chinese Journal of Hepatology ; (12): 756-764, 2018.
Article in Chinese | WPRIM (Western Pacific) | 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.

15.
Chinese Journal of Hepatology ; (12): 187-194, 2017.
Article in Chinese | WPRIM (Western Pacific) | 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.

16.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-615272

ABSTRACT

Objective To evaluate the feasibility and safety profile of pegylated-interferonα-2a (Peg IFNα-2a) combined with adefovir dipivoxil (ADV) in inactive hepatitis B surface antigen (HBsAg) carriers (IHC).Methods This was a single center, prospective and open-label study.IHC were divided into therapeutic group (T, 112 subjects) and control group (C, 72 subjects) according to personal willingness.Patients with hepatitis B virus (HBV) DNA<20 IU/mL were treated with Peg IFNα-2a monotherapy, and those with HBV DNA ≥20-<2 000 IU/mL were treated with Peg IFNα-2a combined with ADV.Total therapy duration was 96 weeks.For patients who achieved HBsAg seroconversion and continued consolidation treatment for 24 weeks, the treatment duration could be less than 96 weeks.t test was used for continuous variable comparison between the two groups, while chi-square test or Fisher′s exact probability method was used for counting data analysis.The related factors affecting HBsAg clearance was analyzed by univariate or multivariate logistic regression analysis.Results A total of 194 patients were enrolled with 112 in therapeutic group and 72 in control group.The HBsAg clearance rate and seroconversion rate at week 48 in therapeutic group were 30.8% (32/104) and 26.0% (27/104), respectively.The rates at week 96 increased to 45.2% (47/104) and 38.5% (40/104), respectively.The HBsAg clearance rates at weeks 48 and 96 in control group were both 1.5% (1/68).HBsAg seroconversion was not achieved in control group.The HBsAg clearance rate in treatment group was significantly higher than that in control group (χ2=39.066, P<0.01).The quantitative HBsAg levels at baseline (OR=2.313, 95%CI: 1.258-4.251, P=0.007), week 12 (OR=3.159, 95%CI: 1.826-5.466, P<0.01) and week 24 (OR=3.347, 95%CI: 2.050-5.465, P<0.01), the decline of HBsAg at week 12 (OR=5.343, 95%CI: 2.085-13.689, P<0.01), and week 24 (OR=4.855, 95%CI: 2.380-9.902, P<0.01), and alanine transaminase (ALT) elevation at week 12 (OR=3.520, 95%CI: 1.369-9.052, P=0.009) were independent predictors for HBsAg clearance.Conclusions Peg IFNα-2a-based treatment for IHC could achieve higher HBsAg clearance rate and seroconversion rate, and has a safety profile.Decline of HBsAg at week 12 and week 24 with ALT elevation at week 12 could predict a higher HBsAg clearance rate.

17.
Journal of Clinical Hepatology ; (12): 1063-1066, 2017.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-613375

ABSTRACT

Pegylated interferon (PEG-IFN) combined with ribavirin (PR regimen) has been used in China for more than 10 years.With the development of direct-acting antiviral agents (DAAs),the therapeutic regimens for hepatitis C has become more and more diverse.In the regimen of DAAs combined with PR regimen,IFN helps to benefit the long-term prognosis of patients with chronic hepatitis C (CHC),and the addition of DAAs may improve therapeutic effect,shorten the course of treatment,and further improve the current status of treatment of CHC.This article introduces the advantages and disadvantages of PR regimen,DAAs combined with PR regimen,and oral regimen with DAAs,in order to investigate the therapeutic regimens suitable for different CHC patients and provide a reference for clinical practice.

18.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-484427

ABSTRACT

Objective The purpose of this study was to explore the effect of FVIII(factor VIII,FVIII)and VWF (von Willebrand factor,VWF)elevation on the severity, prognosis and inpatient complications such as infections and neuroworsening in patients with acute ischemic stroke. Methods Ninety patients with acute ischemic stroke and 50 pa?tients without ischemic stroke were recruited from affiliated Shengjing hospital of China Medical University between De?cember 2014 and March 2015 . We tested FVIII and VWF levels of all the patients. Patients with acute ischemic stroke were divided into 4 groups:both FVIII and VWF within normal range(FVIII-/VWF-);elevated FVIII, but normal VWF (FVIII↑/VWF-); FVIII within normal range, but elevated VWF(FVIII-/VWF↑); and elevation of both FVIII and VWF(FVIII↑/VWF↑). Results The median of VWF was higher in the case group (1521.88 U/L) than in the control group (1281.77U/L)(P=0.023). Compared with patients with both FVIII and VWF within normal range, patients with ele? vation of both FVIII and VWF had more severe neurological dysfunction(NIHSS at admission>5)(OR=3.643,95%CI:1.258~10.549,P=0.017)and poorer prognosis(mRS>2 at the point of 3 months after stroke)(OR=7,95%CI:2.304~21.266,P=0.001), higher proportion of mRS>2 at discharge(OR=3.797,95%CI:1.346~10.713,P=0.012),and more in?patient complications such as infections(OR=3.913,95%CI:1.115~13.729,P=0.033)and neuroworsening(OR=5.538, 95%CI:1.099~27.908,P=0.038). After additional adjustment for various confounding factors, elevation of both FVIII and VWF was an independent predictor of poor prognosis in patients with acute ischemic stroke(OR=4.495,95%CI 1.012~19.957,P=0.048). Conclusions The elevation of FVIII and VWF is positively associated with the severity and prognosis in patients with acute ischemic stroke, which may serve as an independent predictor of poor prognosis.

19.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-467344

ABSTRACT

Objective To evaluate the efficacy of pegylated interferon ( PegIFN ) α-2a plus ribavirin ( RBV) therapy for chronic hepatitis C ( CHC) in non-responders, and to investigate the related influencing factors.Methods A prospective, open, multicenter and randomized study was conducted.A total of 81 CHC non-responders were recruited from 10 clinical centers during February 2009 to November 2011.Patients were randomly assigned into two groups:group A (n=37) was given PegIFNα-2a plus RBV treatment for 72 weeks and group B (n=44) was given PegIFNα-2a plus RBV treatment for 96 weeks.Both groups were followed up for 24 weeks after treatment.Virological responses in two groups were observed, and treatment efficacies among patients with different genotypes, and among those with different previous treatment were compared.SAS software was used for statistical analysis.Results Fifty-two patients ( 28 from group A and 24 from group B) completed the study in total.The rates of rapid virological response ( RVR) , complete early virological response ( cEVR ) , end of treatment viral response ( ETVR ) and sustained virological response (SVR) in group A were 25.0% (7/28), 60.7% (17/28), 67.9%(19/28) and 60.7%(17/28), respectively; while those in the group B were 41.7% (10/24), 70.8%(17/24), 70.8%(17/24) and 70.8% (17/24), respectively; and there were no significant differences between two groups (P>0.05).SVR was observed in 82.9%(29/35) of patients with CC genotype of IL-28B, which was higher than that in patients with other genotypes ( 3/13 ) , and the difference was of statistical significance (P0.05).The rates of RVR, cEVR, ETVR and SVR in patients who were previously treated with IFN were 36.4%(12/33), 81.8%(27/33), 81.8%(27/33) and 75.8%(25/33), and the rates of cEVR, ETVR and SVR were higher than those in patients who were previously treated with PegIFN (P0.05).Adverse events occurred in 38 patients (46.9%), but no severe ones were observed. Conclusion The efficacy of PegIFNα-2a plus RBV therapy for CHC in non-responders is satisfactory, which may influenced by IL-28B genotypes and previous treatment.

20.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-480081

ABSTRACT

von Willebrand factor (vWF) and factor Ⅷ (FⅧ) exist in a complex form in blood.After being activated,they mediated platelet adhesion and aggregation,and play an important role in the course of thrombosis.The levels in blood of both of them were affected by a variety of factors.vWF and FⅧ are closely associated with the risk,etiological type,severity and outcome of acute ischemic stroke.Studies on the corresponding antagonistic drugs have made a breakthrough,and these drugs may become more advantageous antithrombotic s.

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