Objective To assess the efficacy between Peginterferon α-2a and common Interferon in HBeAg positive chronic hepatitis B. Methods MEDLINE, EBSCO, PubMed, CNKI, WangFang were searched from the beginning to May 2009, and the references of eligible studies were manually screened. Randomized controlled trials comparing Peginterferon-alpha2a with common interferon in HBeAg positive chronic hepatitis B were eligible for inclusion. Jadad score method was adopted to evaluate the methodological quality of included studies. Meta analysis was conducted by RevMan 5.0 software supplied by the Cochrane Collaboration. Subgroup analyses were used in treatment and observation course. Results Six randomized controlled trials were included (n=688). The treatment duration of 48 weeks and 24 weeks were reported in four and two studies, respectively. We carried out subgroup analysis according to treatment. Meta-analysis showed that Peginterferon-alpha2a (180 ug/d, 48 W) could significantly clear HBeAg, clear HBVDNA, normalize ALT and HBeAg seroconversion compared with common Interferon (Plt;0.05). Peginterferon-alpha2a (180 ug/d, 24 W) could effectively clear HBV DNA [P=0.04, RR=1.44, 95%CI (1.01, 2.05)], but was not effective in loss of HBeAg, HBeAg seroconversion and ALT normalization (Pgt;0.05). Conclusion The efficacy of 48 weeks treatment with Peginterferon α-2a is better than common Interferon. The efficacy of 24 weeks treatment with Peginterferon α-2a is only better in HBV-DNA negative rate than common Interferon. However, because the methodological quality of included studies is not high, this conclusion should be carefully considered in clinical use.
ObjectiveTo systematically evaluate the association between human leukocyte antigen DQ (HLA-DQ) gene rs2856718A>G, rs9275572A>G polymorphisms and the risk of chronic hepatitis B.
MethodsPubMed, EMbase, CBM, WanFang Data, CNKI and VIP databases were systematically searched from inception to April 2015 to collect case-control studies about HLA-DQ gene polymorphisms and the risk of chronic hepatitis B. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software, and Stata 12.0 software was used for sensitivity and publication bias analysis.
ResultsA total of 6 papers involving 8 case-control studies were included, which involved 3 690 cases and 6 267 controls. The results of meta-analysis showed that:the rs2856718A>G polymorphism was associated with the decreased risk of chronic hepatitis B (AG+GG vs. AA:OR=0.63, 95%CI 0.51 to 0.78, P=0.000; GG vs. AG+AA:OR=0.69, 95%CI 0.61 to 0.79, P=0.000; GG vs. AA:OR=0.56, 95%CI 0.48 to 0.64, P=0.000; GA vs. AA:OR=0.64, 95%CI 0.47 to 0.88, P=0.006; G vs. A:OR=0.74, 95%CI 0.68 to 0.79, P=0.000). The rs9275572A>G polymorphism was not associated with the risk of chronic hepatitis B (AG+GG vs. AA:OR=1.11, 95%CI 0.55 to 2.23, P=0.770; GG vs. AG+AA:OR=1.10, 95%CI 0.84 to 1.45, P=0.500; GG vs. AA:OR=1.14, 95%CI 0.54 to 2.41, P=0.730; AG vs. AA:OR=1.06, 95%CI 0.56 to 2.02, P=0.860; G vs. A:OR=1.11, 95%CI 0.83 to 1.48, P=0.490).
ConclusionHLA-DQ gene rs2856718 A>G polymorphism is significantly associated with decreased risk of chronic hepatitis B, but the rs9271319 A>G polymorphism is not associated with the risk of chronic hepatitis B.
ObjectiveTo evaluate the clinical efficacy and safety of telbivudine (TEV) combined with adefovir dipivoxil (ADV) for chronic hepatitis B (CHB), so as to provide references for clinical practice and research.
MethodsWe electronically searched databases including The Cochrane Library (Issue 7, 2013), PubMed, EMbase, Web of Science, CBM, CNKI, VIP, and WanFang Data from inception to August 21st, 2013, for the relevant randomized controlled trials (RCTs). Other sources were also retrieved. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the quality of included studies. Then, meta-analysis was performed using RevMan 5.1 software.
ResultsA Total of 11 RCTs involving 1 010 patients were included. The trial group were given TEV combined with ADV, while the control group were given TEV alone or ADV alone. The results of metaanalysis showed that, the combined use was superior to TEV alone or ADV alone in improving HBV-DNA negative rates at 12-, 24-, 48-weeks, HBeAg negative rates at 12-, 24-, 48-weeks, and ALT recovery rates at 12-, 24-weeks (P < 0.05). The results of qualitative analysis showed that, the trial group had a lower drug resistance rate, and both were alike in the incidence of adverse reaction.
ConclusionCompared with TEV alone or ADV alone, TEV combined with ADV could improve the clinical efficacy of treating CHB which is also fairly safe. Due to the limited quantity and quality of the included studies, the aforementioned conclusion still needs to be further verified by conducting more large-scale and high quality RCTs.
Objective To review the efficacy and safety of Kushenin combined with Adefovir Dipivoxil for Chronic Hepatitis B (CHB). Method Randomized controlled trails of Kushenin combined with Adefovir Dipivoxil for CHB were gathered from PubMed, CBMdisc (1978 to 2009), and CSJD (1989 to 2009), while other relative researches were searched manually; every research was evaluated, and then analyzed with RevMan 5.0.0 software. Result Ten randomized controlled trials were included; among total 855 patients, 436 were in trial group and the other 419 were in control group. As the Meta-analysis showed, the therapeutic effect of kushenin combined with Adefovir Dipivoxil was better than that of Adefovir Dipivoxil in aspects of improving the negative rate of serum ALT (RR=1.28, 95%CI 1.17 to 1.40), the negative rate of serum HBV-DNA (RR=1.27, 95%CI 1.13 to 1.42), the negative rate of serum HBeAg (RR=1.80, 95%CI 1.32 to 2.44), and the conversion rate of HBeAg and anti-HBe (RR2.06, 95%CI 1.43 to 2.95). Conclusion Kushenin combined with Adefovir Dipivoxil in treating CHB can improve the conversion rate of HBeAg and anti-HBe and further take better therapeutic effect.
Objective To evaluate the efficacy of adefovir monotherapy (ADF) versus adefovir-Matrine combination therapy (ADF+M) for chronic hepatitis B. Methods Such databases as The Cochrane Library, MEDLINE, PubMed, CBM, CNKI, WanFang and VIP Database were searched from the date of their establishment to July 2010, and the references of all included studies were also traced so as to identify randomized controlled trials (RCTs) of ADF versus ADF+M. Quality assessment and data extraction were conducted in accordance with the Cochrane Handbook 5.0.2 by two reviewers independently. Meta-analyses were conducted by using RevMan 5.0 software. Results A total of 24 RCTs involving 2 092 patients were included. The results of meta-analyses showed that at the end of the treatment for both six months and 12 months, respectively, the ADF+M group was superior to ADF group with a significant difference in both the HBeAg seroconversion rate as the primary outcome (six months: RR=2.05, 95%CI 1.53 to 2.74; 12 months: RR=2.13 95%CI 1.74 to 2.60) and the secondary outcome such as HBV-DNA negative conversion, HBeAg negative conversion, ALT normalization, HBV-DNA variation, complete response and HBsAg negative conversion, etc. Conclusion As the current evidence shows, ADF+M therapy is superior to ADF therapy for chronic hepatitis B. The significant difference can even be observed at the end of the treatment for six months. However, the results should be interpreted with caution because of the low quality of the included studies. High-quality, large-scale RCTs are needed to further prove the results.
Objective To evaluate the effectiveness and safety of kushenin for chronic hepatitis B. Methods We searched The Cochrane Hepato-Bil iary Group Controlled Trials Register (March, 2006), The Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 1, 2006), MEDLINE (1966 to present), EMBASE (1966 to present), OVID (1965 to present), the Chinese Biomedical Database (CBM) (1978 to 2006) and CNKI. Qual ity assessment and data extraction were conducted by two reviewers independently, and disagreement, if any, was resolved by discussion. Meta-analyses were performed for homogeneous studies. Results A total of 56 studies involving 5156 patients met the inclusion criteria. These included 3 randomized controlled trials (RCTs), 7 quasi-RCTs, and 46 other studies that did not report randomization methods. None of the trials enforced allocation concealment and only one trial performed blinding.We conducted subgroup analyses based on the outcome measures and interventions. Compared with interferon,the HBeAg seroconversion rate at 12 months after treatment was lower in patients treated with kushenin (RR=0.72, 95%CI 0.58 to 0.90); compared with lamivudine, a lower HBV DNA seroconversion rate after 12 and 24 weeks of treatment was associated with kushenin (RR=0.48, 95%CI 0.33 to 0.70; RR=0.40, 95%CI 0.26 to 0.63). No significant differences were noted between the kushenin group and the control group for all the other outcome measures. Conclusion Kushenin might be effective in normal izing ALT levels, clearing HBV DNA, achieving virus seroconversion and improving hepatic fibrosis, without any serious adverse effects. However, because the overall effects cannot be pooled for analysis, more evidence is needed to support this finding.
目的 觀察阿德福韋酯聯合胸腺五肽治療乙型肝炎病毒e抗原（HBeAg）陽性慢性乙型肝炎2年的療效。 方法 2007年1月－2009年1月間178例慢性乙型肝炎患者隨機分為試驗組91例和對照組87例。試驗組給予胸腺五肽1 mg，隔日皮下注射，療程52周；同時阿德福韋酯10 mg/d口服104周。對照組給予阿德福韋酯10 mg/d，口服104周。治療26、52、104周及停藥52周時，分別檢測血清丙氨酸氨基轉移酶（ALT）、天冬氨酸氨基轉移酶（AST）、乙型肝炎病毒（HBV）DNA含量及HBV血清標志物。 結果 治療52周后，試驗組在ALT復常率、AST復常率、HBV DNA轉陰率、HBeAg轉陰率與HBeAg/HBeAb血清轉換率方面都比對照組高。停藥52周時，試驗組與對照組的ALT復常率、AST復常率、HBV DNA轉陰率、HBeAg轉陰率、HBeAg/HBeAb血清轉換率分別為74.73%與51.72%、75.82%與54.02%、25.27%與8.05%、26.37%與10.34%、18.68%與8.05%（χ2=10.652、9.313、9.421、7.574、4.313，P＜0.05）。 結論 阿德福韋酯聯合胸腺五肽治療HBeAg陽性慢性乙型肝炎比單獨使用阿德福韋酯抗病毒治療效果更好，有助于提高HBeAg/HBeAb血清轉換率，減少停藥后病毒學突破，并且使用安全。Objective To evaluate the efficacy of adefovir dipivoxil (ADV) combined with thymopentin on chronic hepatitis B patients with positive hepatitis B e antigen (HBeAg). Methods Between January 2007 and January 2009, 178 chronic hepatitis B patients with positive HBeAg were randomly divided into two groups: the treatment group (91 cases) and the control group (87 cases). All patients in two groups received 10 mg of ADV once a day for 104 weeks, while the patients in the treatment group received 1 mg of thymopentin for subcutaneous injection every other day for 52 weeks. The rates of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) normalization, serum hepatitis B virus (HBV) DNA clearance and HBeAg loss and anti- HBeAg seroconversion were evaluated at pretreatment, and 52, 104 and 156 weeks after treatment, respectively. Results After 52-week treatment, The rates of ALT and AST normalization, serum HBV DNA clearance and HBeAg loss and anti- HBeAg seroconversion in the treatment group were higher than those in the control group. In 52-week follow-up after 104 weeks treatment, the rates of ALT and AST normalization , serum HBV DNA clearance and HBeAg loss and anti- HBeAg seroconversion of two groups were 74.73% versus 51.72%, 75.82% versus 54.02%, 25.27% versus 8.05%, 26.37% versus 10.34%, 18.68% versus 8.05%, respectively (χ2 = 10.652, 9.313, 9.421, 7.574, 4.313; P＜0.05). Conclusions It is more effective for adefovir dipivoxil combined with thymopentin on HBeAg-positive patients with chronic hepatitis B than using adefovir alone. Combination treatment could improve the rates of HBeAg seroconversion and reduce the breakthrough of HBV after drug withdrawal. And it is safe.
Objective To investigate the current situation of randomized controlled trials or clinical controlled trial (RCT/CCT) on chronic hepatitis B and whether to offer reliable evidence for clinical practice in China. Methods RCT/CCT identified from six Chinese clinical journals were searched manually and assessed according to international standard of evidence-based medicine. Results 308 issues containing 212 therapeutic articles and 88 RCT/CCT on chronic hepatitis B were identified and analyzed. Conclusion the quantity and quality of RCT/CCT of chronic hepatitis B did not meet the need of clinical practice.
Background Hepatitis B virus infection is a serious health problem worldwide. Traditional Chinese medicinal herbs have been widely used to treat chronic liver diseases, and many controlled trials have been done to investigate their efficacy. Objectives To assess the efficacy and safety of traditional Chinese medicinal herbs for chronic hepatitis B infection. Search strategy Searches were applied to the following electronic databases: the CHBG Trials Register, the Cochrane Complementary Medicine Field Trials-Register, the Cochrane Library, MEDLINE, EMBASE and BIOSIS. Five Chinese journals and conference proceedings were handsearched. No language restriction was used. Selection criteria Randomized or quasi-randomized trials with at least three months follow-up. Thais of Chinese medicinal herbs (single or compound) compared with placebo, no intervention, general non-specific treatment or interferon treatment were included. Trials of Chinese medicinal herbs plus interferon versus interferon alone were also included. Trials could be double-blind, single-blind or not blinded. Data collection and analysis Data were extracted independently by two reviewers. The methodological quality of trials was evaluated using the Jadad-scale plus allocation concealment. Intention-to-treat analyses were performed. Main Resuits Nine randomized trials, including 936 patients, met the inclusion criteria. Methodological quality was considered adequate in only one trial. There was a significant funnel plot asymmetry (regression coefficient= 3.37, standard error 1.40, P=0.047). Ten different medicinal herbs were tested in the nine trials. Compared to non-specific treatment or placebo, Fuzheng Jiedu Tang (compound of herbs) showed significantly positive effects on clearance of serum HBsAg, HBeAg, and HBV DNA; Polyporus umbellatus, polysaccharide on serum HBeAg and HBV DNA; Phyllanthus amarus on serum HBeAg. Phyllanthus compound and kurorinone showed no significant effect on clearance of serum HBeAg and HBV DNA and on alanine aminotransferase normalization compared to interferon treatment. There were no significant effects of the other examined herbs. Reviewer’s conclusions Some Chinese medicinal herbs may work in chronic hepatitis B. However, the evidence too weak to recommend any single herb. Rigorously designed, randomized, double-blind, placebo-controlled trials are required.
ObjectiveTo systematically review the efficacy and safety of Heluo Shugan capsule in the treatment of hepatitis B fibrosis.
MethodWe searched PubMed, The Cochrane Library (Issue 8, 2015), CBM, CNKI, VIP and WanFang Data from their inception to August 2015, to collect randomized controlled trials (RCTs) on Heluo Shugan capsule for hepatitis B fibrosis. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software.
ResultsA total of 15 RCTs involving 1 840 patients were included. The results of meta-analysis showed that: (1) As for reduced level of serum hyaluronic acid (HA), Heluo Shugan capsule was superior to placebo (MD=82.31, 95%CI 37.44 to 127.19, P=0.000 3), but worse than Fuzheng Huayu capsule (MD=-137.45, 95% CI-196.29 to-78.62, P < 0.000 01), Fufang Biejia Ruangan tablet (MD=-51.19, 95% CI-67.58 to-34.81, P < 0.000 01) and Anti-fibrosis decoction (MD=-82.13, 95% CI-102.37 to-61.88, P < 0.000 01). (2) As for reduced level of serum laminin (LN), Heluo Shugan capsule was superior to placebo (MD=36.83, 95% CI 11.84 to 61.82, P=0.004), but worse than Fufang Biejia Ruangan tablet (MD=-36.00, 95% CI-64.29 to-7.71, P=0.01), Ganfujian capsule (MD=-22.14, 95% CI-37.28 to-7.00, P=0.004) and Anti-fibrosis decoction (MD=-38.64, 95% CI-75.00 to-2.29, P=0.04). (3) As for reduced level of serum procollagen type III peptide (PCIII), Heluo Shugan capsule was superior to placebo (MD=47.17, 95% CI 32.68 to 61.66, P < 0.000 01), but worse than Fuzheng Huayu capsule (MD=-4.80, 95% CI-9.08 to-0.51, P=0.03), Dahuang Zhechong pills (MD=-53.77, 95% CI-105.01 to-2.53, P=0.04), Ganfujian capsule (MD=-46.82, 95% CI-66.30 to-27.34, P < 0.000 01) and Anti-fibrosis decoction (MD=-28.68, 95% CI-55.59 to-1.77, P=0.04). (4) As for reduced level of serum type-IV-collagen (IV-C), Heluo Shugan capsule was superior to placebo (MD=72.77, 95% CI 47.65 to 97.89, P < 0.000 01), but worse than Fuzheng Huayu capsule (MD=-34.69, 95% CI-56.65 to-12.73, P=0.002), Dahuang Zhechong pills (MD=-21.26, 95%CI-38.79 to-3.73, P=0.02), Fufang Biejia Ruangan tablet (MD=-69.04, 95%CI-124.38 to-13.69, P=0.01), Ganfujian capsule (MD=-19.84, 95% CI-37.41 to-2.27, P=0.03) and Anti-fibrosis decoction (MD=-37.98, 95% CI-72.99 to-2.96, P=0.03).
ConclusionCurrent evidence shows that, Heluo Shugan capsule was superior to placebo, but worse than Fufang Biejia Ruangan tablet, Fuzheng Huayu capsule, Dahuang Zhechong pills, Ganfujian capsule and Anti-fibrosis decoction in reducing the level of serum hepatic fibrosis. Due to the limited quantity and quality of included studies, more high-quality, large-scale RCTs are need to verify the above conclusion.
