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.
目的:观察α干扰素治疗HBeAg(+)慢性乙型肝炎患者过程中病毒学及血清学动态变化情况,通过早期疗效预测终末疗效。方法:观察144例HBeAg(+)慢性乙型肝炎患者经α干扰素治疗24WK及随访24WK 过程中HBV-DNA以及HBeAg变化情况.结果:经α干扰素治疗12、24、48WK时,HBV-DNA下降到可检测值以下病例数分别为32、32、31例;同期HBeAg发生血清转换病例数分别为16、17、21例。结论:干扰素治疗12WK时患者病毒学及血清学结果可早期预测终末疗效。
Objective To evaluate the effectiveness and safety of foscarnet sodium in the treatment of chronic hepatitis B. Methods We searched MEDLINE, EMbase, The Cochrane Library and CNKI from 1978 to June 2006. Randomized controlled trials of foscarnet sodium versus other drugs or no drugs in the treatment of chronic hepatitis B were identified. The quality of the included trials was evaluated by two reviewers independently. Meta-analysis was done using The Cochrane Collaboration’s RevMan 4.2.7. Results Seven studies (337 patients) were included; one compared foscarnet sodium versus interferon, and the other six compared foscarnet sodium versus no drugs. All the included studies were graded in terms of the quality of randomization, allocation concealment and blinding. All 7 studies were graded as level C. The meta-analysis showed that: ① foscarnet sodium was not significantly different from interferon in clinical efficacy, liver function, negative-conversion rate of virological markers and side effects. ② compared with the no drugs group, the negative-conversion rate of virological markers was significantly higher for the foscarnet sodium group, HBeAg (RR 6.20, 95%CI 1.76 to 21.79) and HBV-DNA (RR 4.13, 95%CI 1.32 to 12.86); but there were no significant differences in clinical efficacy, liver function and side effects. Conclusions Available evidence shows that: in the treatment of chronic hepatitis B the effectiveness and safety of foscarnet sodium are not significantly different from interferon, but only one trial is included in this review, so the evidence is weak. Compared with no drugs, foscarnet sodium significantly improves the negative-conversion rate of virological markers, but the evidence is insufficient to show whether foscarnet sodium could improve clinical efficacy and liver function, as well as reduce side effects.
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.
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.
目的 观察茵陈柴平汤治疗重度慢性乙型肝炎的疗效及不良反应。 方法 2009年3月－2010年3月，选择采用茵陈柴平汤联合常规保肝药物治疗50例重度慢性乙型肝炎患者（治疗组），并与50例仅用常规保肝药物治疗的重度慢性乙型肝炎患者（对照组）进行比较，观察治疗2、4周时的临床症状、肝功能及凝血酶原活动度等指标的变化。 结果 治疗2、4周时，治疗组在肝功能及凝血酶原活动度等指标均有显著改善，无严重不良反应；4周时，治疗组的症状缓解率（84%）明显高于对照组（66%）；其总有效率（96%）亦高于对照组（80%）。 结论 茵陈柴平汤治疗重度慢性乙型肝炎具有较好的临床疗效，且无严重不良反应。
Serum marker Golgi protein 73 (GP73) is a type Ⅱ integral membrane protein located in cellular Golgi apparatus. GP73 not only processes proteins, but also participates in cell differentiation, intercellular signaling, and apoptosis. With the development of proteomics technology, GP73 has been used as a novel serum marker for detecting liver diseases. This article reviews the research progress of GP73 in the clinical diagnosis value and prognosis prediction of chronic hepatitis B in recent years, in order to provide new ideas for the diagnosis and treatment of patients with chronic hepatitis B.
Objective To evaluate the efficacy and safety of genus Phyllanthus for chronic HBV infection. Design a systematic review of randomized clinical trials. Methods Randomized trials comparing genus Phyllanthus versus placebo, no intervention, general non-specific treatment, other herbal medicine, or interferon treatment for chronic HBV infection were identified by electronic and manual searches. Trials of Phyllanthus herb plus interferon versus interferon alone were also included. No blinding and language limitations were applied. The methodological quality of trials was assesses, by the Jadadscale plus allocation concealment. Results Twenty-two randomized trials (n=1 947) were identified. The methodological quality was high in five double blind trials and rest was low. The combined results showed that Phyllanthus species had positive effect on clearance of serum HBsAg (relative risk 5.64, 95%C1 1.85 to 17.21) compared with placebo or no intervention. There was no significant difference on clearance of serum HBsAg, HBeAg and HBV DNA between Phyllanthus and interferon. Phyllanthus species were better than non-specific treatment or other herbal medicines on clearance of serum HBeAg, HBeAg, HBV DNA, and liver enzyme normalization. Analyses showed a better effect of the Phyllanthus plus interferon combination on clearance of serum (1.56, 1.06 to 2.32) and HBV DNA (1.52, 1.05 to 2.21) than interferon alone. No serious adverse events were reported. Conclusions Based on the review Phyllanthus species may have positive effect on antiviral activity and liver biochemistry in chronic HBV infection. However, the evidence is not b due to the general low methodological quality and the variations of the herb. Further large trials are needed.
【摘要】 目的 通过检测临床确诊为慢性乙型肝炎患者血清谷丙转氨酶（ALT）、谷草转氨酶（AST）、甲状腺激素T3、T4及促甲状腺素（TSH）含量，进一步探讨慢性乙型肝炎患者肝损情况与甲状腺分泌功能的关系。 方法 收集2009年1-4月79例确诊为慢性乙型肝炎患者（病例组）血清标本，分别检测其ALT、AST、甲状腺激素T3、T4及TSH含量。以同期健康体检者30例作为对照组。比较两组的差异及各指标间的相关性。 结果 病例组AST为（87±113） U/L、ALT为（135±241） U/L、AST/ALT为0.97±0.57、TSH为（1.63±1.29） mU/L、T3为（1.61±0.52）ng/mL、T4为（10.7±2.9） μg/dL，对照组分别为（23±5） U/L、 （18±5） U/L、1.31±0.26、（2.13±0.90） mU/L、（1.19±0.16） ng/mL和（8.6±0.9） μg/dL，两组各指标比较均有统计学差异（Plt;0.01）。所有指标均正常的共有6例（7.6%），有73例（92.4%）存在不同程度的指标异常；在68例AST/ALT比值降低的慢性乙型肝炎患者（93.2%）中，伴有单纯T4升高的有11例（16.2%），单纯T3升高的有4例（5.9%），T3、T4同时升高的有11例（16.2%），T3、T4同时升高且TSH降低的有2例（2.9%），1例T4升高且TSH降低（1.5%），1例仅TSH升高（1.5%）；在4例AST/ALT比值正常的慢性乙型肝炎患者（5.5%）中，有1例T3、T4同时升高且TSH降低，1例T3和T4同时升高，1例单纯T4升高，1例单纯TSH降低；有1例仅AST/ALT比值升高而其他项正常。 结论 慢性乙型肝炎患者除AST/ALT比值异常外，还同时伴有不同程度的甲状腺激素指标异常，其原因可能与慢性乙型肝炎应用干扰素治疗时甲状腺功能受损有关。【Abstract】 Objective To explore the relationship between liver damage and the secretion function of thyroid by detecting the serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), T3, T4, and thyroid stimulating hormone (TSH) in patients with chronic hepatitis B. Methods The serum samples of 79 patients with chronic hepatitis B from January to April 2009 were collected, and the ALT, AST, T3, T4, and TSH concentrations were detected. Another 30 healthy subjects were selected as the control. The detected indexes were compared between the two groups. Results In the case group, the concentration of AST was (87±113)U/L, ALT was (135±241)U/L,AST/ALT was 0.97±0.57, TSH was (1.63±1.29) mU/L, T3 was (1.61±0.52) ng/mL, and T4 was (10.7±2.9) μg/dL; while in the control group, the concentrations of the items were (23±5) U/L, (18±5)U/L, 1.31±0.26, (2.13±0.90) mU/L, (1.19±0.16) ng/mL, and (8.6±0.9) μg/d L, respectively. The differences between the two groups were significant (Plt;0.01). Among the 79 case, 6 (7.6%) had a totally normal result, and 73(92.4%) had an abnormal result. There were 68 patients who had a low ratio of AST/ALT, among whom 11 (16.2%) had a simple T4 elevation, 4(5.9%) had a simple T3 elevation,11(16.2%) had an elevation of both T3 and T4, 2 (2.9%) had an elevation of both T3 and T4 and a depression of TSH, 1(1.5%) had an elevation of T4 and a depression of TSH, and 1 (1.5%) had a simple TSH elevation. There were 4 cases who had a normal ratio of AST/ALT, among whom 1 had an elevation of both T3 and T4 and a depression of TSH, 1 had an elevation of both T3 and T4, 1 had a simple T4 elevation, and 1 had a simple TSH depression. There was 1 case who had only an elevation of AST/ALT. Conclusion Most of the patients with chronic hepatitis B have an abnormal result of thyroid hormone together with the abnormal ratio of AST and ALT. The reason mainly lies in the damage of thyroid function by the usage of interferon for the therapy of chronic hepatitis B.
Objective To compare adefovir monotherapy with adefovir-thymosin alpha-1 combination therapy for chronic hepatitis B. Methods We searched The Cochrane Library, MEDLINE, PubMed, the Chinese Biomedical Database (CBM), CNKI, Wanfang, and VIP databases up to February 2010 to identify randomized controlled trials (RCTs) comparing adefovir plus thymosin alpha-1 versus adefovir alone for chronic hepatitis B. We also scanned references of all included studies and pertinent reviews. The methodological quality assessment and data extraction were conducted by two reviewers independently according to the Cochrane Reviewer’s Handbook 5.0.2 . Meta-analyses were performed using RevMan 5.0 software. Results Eleven trials involving 895 patients were included. The results of meta-analyses shoued: the HBeAg seroconversion rate of the combination therapy group was higher than that of the monotherapy group, both at the sixth month and the twelfth month (RR=1.77, 95%CI 1.38 to 2.27; RR=1.74, 95%CI 1.44 to 2.10); and there were also significant differences between the two groups for secondary outcomes including HBV-DNA negative, ALT normalization, etc.Conclusion Adefovir-thymosin alpha-1 combination therapy might be more effective than adefovir monotherapy for chronic hepatitis B. Significant differences are even observed at the sixth month. 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.