Meta AnalysisID 3748
口服氧化苦参碱治疗乙型肝炎肝硬化：随机临床试验的系统评价
CRD42018095275
To determine the efficacy and safety of oral oxymatrine for hepatitis B cirrhosis.
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Record Fields
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- Meta Analysis Id
- 3748
- Evidence Id
- 12306
- Core Evidence Id
- 12306
- Source Meta Analysis Id
- 3708
- Herb2 Meta Analysis Id
- HBMA003708
- Crd Id
- CRD42018095275
- Title
- Oral oxymatrine for hepatitis B cirrhosis: a systematic review of randomized clinical trials
- Review Question
- To determine the efficacy and safety of oral oxymatrine for hepatitis B cirrhosis.
- Study Type Included
- Regardless of the length of treatment, we will include all randomised controlled trials that compare therapeutic effects, liver function indexes, liver fibrosis indexes, HBV DNA seroconversion rates, the rates of HBeAg changes to negative, as well as adverse incidence rates between oxymatrine taking orally and conventional therapy for hepatitis B cirrhosis.
- Condition Being Studied
- The latest clinical practice guidelines published by European Association for the study of liver (EASL) point out that about one third of the world's population has been or is infected with hepatitis B virus (HBV), and over 0.5-1 million people die of HBV-related end stage liver diseases or hepatocellular carcinoma(HCC) per year [1]. For CHB patients without treatment, the 5-year cumulative incidence of developing cirrhosis ranges from 8% to 20%. For those untreated patients with compensated cirrhosis, the 5-year cumulative incidence of hepatic decompensation is approximately 20%. The 5-year survival rate of decompensated cirrhosis patients without treatment is 14 to 35% [1]. Therefore, effective and safe management of the cirrhosis stage is necessary. Effective antiviral therapy is essential for improving the prognosis of the disease, and is also an important part of the overall treatment strategy of HBV-related cirrhosis [1]. At present, Interferon-alfa, nucleos(t)ide analogue polymerase inhibitors including lamivudine (LAM), adefovir (ADV), entecavir (ETV), telbivudine, and tenofovir (TLV) are the available treatments [2]. However, long-term application of these medicine often lead to resistance and give rise to serious clinical problems [3]. As a single-therapy treatment may result in the emergence of both viral drug-resistance and dose-dependent side-effects [4], some physicians attempt to combine conventional medicine with Traditional Chinese medicine to enhance curative effect. Oxymatrine extracted from the root of Sophora flavescens Alt, is a mixture of the alkaloids oxymatrine (the main content > 98%) and oxysophocarpine. A large number of studies have shown that oxymatrine with anti-HBV effects has functions of treating hepatocyte injury, chronic hepatitis B, liver fibrosis, and tissue inflammation [5-6]. A increasing number of clinical controlled studies have found that oxymatrine combined with conventional therapy could improve the curative effect of hepatitis B cirrhosis, but there is no systematic review of it. We will therefore conduct a meta-analysis to assess the clinical value including liver function indexes, liver fibrosis indexes, Child-Pugh grade and other relevant outcomes of oxymatrine combined with conventional therapy for the treatment of hepatitis B cirrhosis, which provides a possible complementary and alternative therapy for global application. References: [1]. European Association For The Study Of The Liver. EASL Clinical Practice Guidellines: Management of chronic hepatitis B[J]. Journal of Hepatology, 2012, 57(1):167-185. [2]. Woo G, Tomlinson G, Nishikawa Y, et al. Tenofovir and entecavir are the most effective antiviral agents for chronic hepatitis B: a systematic review and Bayesian meta-analyses[J]. Gastroenterology, 2010, 139(4):1218-1229. [3]. Toy M, Veldhuijzen I K, de Man R A, et al. Potential impact of long-term nucleoside therapy on the mortality and morbidity of active chronic hepatitis B[J]. Hepatology, 2009, 50(3):743-751. [4]. Clinical Observation of Treating Patient with Chronic Hepatitis B by Lamivudine Combined with Marine Injection[J]. Journal of Medical Forum, 2004. [5]. Ma Z J, Li Q, Wang J B, et al. Combining Oxymatrine or Matrine with Lamivudine Increased Its Antireplication Effect against the Hepatitis B Virus In Vitro[J]. Evidence-Based Complementray and Alternative Medicine,2013,(2013-01-21), 2013, 2013(1):186573. [6]. Kang W Z, Xie Y M, Nie Q H, et al. Effect of Oxymatrine on experimental liver fibrosis[J]. World Chinese Journal of Digestology, 2003, 11(2):195-198.
- Participant
- Patients who have been diagnosed with HBV-related cirrhosis based on the Viral Hepatitis Prevention and Treatment Programs revised in Xi'an Conference or 2010 Chinese guidelines for the management of chronic hepatitis B will be included, regardless of compensatory or decompensation stage, age and sex. Patients with definite diagnosis of cirrhosis should be based on liver biopsy or laboratory, imaging examination compatible with the diagnosis of cirrhosis. Chronic HBV patients but not developing cirrhosis, patients with liver cirrhosis unrelated to HBV, patients with liver cirrhosis with combined HBV and HCV, and patients with hepatocellular carcinoma will be excluded.
- Animal
- Human Disease Modelled
- Intervention
- Oral oxymatrine, regardless of dosage, used alone or combined with conventional treatments such as lamivudine, entecavir, adefovir, interferon, etc.
- Comparator Control
- Control group: placebo, conventional treatment and routine care such as lamivudine, entecavir, adefovir, interferon, etc.
- Main Outcome
- (1) Liver function indexes: ALT, TBIL, AST, ALB; (2) Liver fibrosis indexes: LN, HA, PCⅢ,ⅣC; (3) Child-Pugh grade.
- Outcome Measure
- Additional Outcome
- (1) HBV DNA seroconversion rates; (2) Rates of HBeAg changes to negative; (3) Adverse incidence rates.
- Study Method
- Intervention, Meta-analysis, Systematic review
- Keyword
- Alkaloids; Administration, Oral; Drugs, Chinese Herbal; Drug Therapy; Hepatitis B; Humans; Liver Cirrhosis; Medicine, Chinese Traditional; Quinolizines; Treatment Outcome
- Contact
- Xiaotao Jiang [email protected]
- Organisational Affiliation
- Guangzhou University of Chinese Medicine http://www.gzucm.edu.cn/
- Funding Source
- Funding provided by Fengbin Liu
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- China
- Review Stage
- Review Ongoing
- First Submission Date
- 2018-05-19
- Registration Date
- 2018-06-11
- Anticipated Start Date
- 2018-07-15
- Anticipated Completion Date
- 2018-09-15
- Title Cn
- 口服氧化苦参碱治疗乙型肝炎肝硬化：随机临床试验的系统评价
- Title En
- Oral oxymatrine for hepatitis B cirrhosis: a systematic review of randomized clinical trials
- Bilingual Status
- complete