Abstract
Kushenin (KS) has become a traditional Chinese medicine preparation that plays an important role in treating chronic hepatitis B (CHB). Many clinical studies have discussed its curative effect and safety in combination with adefovir dipivoxil (ADV) or entecavir (ETV) for treating CHB, but there is still a lack of a systematic analysis. Therefore, this study evaluated the efficacy and safety of KS through a meta-analysis to better guide clinical treatment. Seven databases were searched to identify randomized controlled trials (RCTs) concerning KS combined with ADV or ETV for treating CHB. The primary outcomes included serum viral indices and adverse events, and the secondary outcomes were liver function indices. The risk of bias of the included RCTs was appraised by Cochrane software. STATA 15.1 and Review Manager 5.3 software were used for the meta-analysis. Thirty-two RCTs recruiting 3343 patients with CHB were collected for this meta-analysis. KS combined with ETV or ADV led to an amelioration of the CHB index to various degrees. In short, the meta-analysis indicated that the combination group, compared to the single group, showed great improvement in HBeAg seroconversion, frequency of undetectable HBV-DNA levels, loss of serum HBeAg, and loss of serum HBsAg. The combination treatment also decreased serum HBV-DNA levels when compared to the levels after the single treatment. However, KS combined with ADV or ETV displayed no remarkable difference in the incidence of adverse events or in serum ALT levels. Current evidence showed that, compared with the use of either drug alone, KS combined with ADV or ETV can improve the clinical efficacy of CHB treatment.
Highlights
Chronic hepatitis B (CHB), which is one of the most significant global health issues, seriously endangers the lives of humans worldwide. e number of people in the world who are chronically infected with hepatitis B virus exceeds 350 million, accounting for approximately 5% of the world’s population [1]
To provide possibly better alternative therapies for global application, this study presented a meta-analysis of KS combined with adefovir dipivoxil (ADV) or ETV for patients with CHB and evaluated its efficacy through indicators such as serum liver fibrosis, serum viral indices, liver function index, and adverse events
It is a mixed alkali of oxymatrine and a very small amount of oxysophocarpine, of which oxymatrine accounts for more than 98% and is the main component of KS [40]. e mechanism of action of KS is to inhibit the damage to hepatocytes caused by the hepatitis virus by promoting the expression of microRNA122 and interferon-α in hepatocytes
Summary
Chronic hepatitis B (CHB), which is one of the most significant global health issues, seriously endangers the lives of humans worldwide. e number of people in the world who are chronically infected with hepatitis B virus exceeds 350 million, accounting for approximately 5% of the world’s population [1]. Antiviral therapy, which is the use of antiviral drugs such as nucleoside/nucleotide analogues to treat patients with CHB, has a high relapse rate after drug withdrawal and promotes the development of drug resistance in the virus, accelerating the deterioration caused by the disease. Immunomodulators such as conventional or polyethylene glycol interferon have very limited curative effects, and some side effects, such as flu-like symptoms, may occur during the treatment process [2, 4]. To provide possibly better alternative therapies for global application, this study presented a meta-analysis of KS combined with ADV or ETV for patients with CHB and evaluated its efficacy through indicators such as serum liver fibrosis, serum viral indices, liver function index, and adverse events
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