Chen Zhe, Ma Xiao, Zhao Yanling, Wang Jiabo, Zhang Yaming, Zhu Yun, Wang Lifu, Chen Chang, Wei Shizhang, Yang Zhirui, Gong Man, Shen Honghui, Bai Zhaofang, Guo Yuming, Niu Ming, Xiao Xiaohe
China Military Institute of Chinese Medicine, 302 Hospital of People's Liberation Army, Beijing 100039, China ; Pharmacy College, Chengdu University of Traditional Chinese Medicine, Chengdu 611137, China.
China Military Institute of Chinese Medicine, 302 Hospital of People's Liberation Army, Beijing 100039, China.
Evid Based Complement Alternat Med. 2015;2015:529636. doi: 10.1155/2015/529636. Epub 2015 Aug 11.
Objective. To evaluate the efficacy and safety of Kushenin (KS) combined with nucleoside analogues (NAs) for chronic hepatitis B (CHB). Methods. Randomized controlled trials (RCTs) of KS combined with NAs for CHB were identified through 7 databases. Frequencies of loss of serum HBeAg, HBeAg seroconversion, undetectable serum HBV-DNA, ALT normalization, and adverse events at 48 weeks were abstracted by two reviewers. The Cochrane software was performed to assess the risk of bias in the included trials. Data were analyzed with Review Manager 5.3 software. Results. 18 RCTs involving 1684 subjects with CHB were included in the analysis. KS combined with NAs including lamivudine (LAM), entecavir (ETV), adefovir dipivoxil (ADV), and telbivudine (TLV) showed different degree of improvement in CHB indices. KS combined with NAs increased the frequency of loss of serum HBeAg, HBeAg seroconversion, undetectable HBV-DNA levels, and ALT normalization compared with single agents. It also decreased serum ALT and AST level after one-year treatment. However, KS combined with TLV did not show a significant difference in CHB indices. The side-effects of KS combined with NAs were light and of low frequency. Conclusion. KS combined with NAs improves the efficacy of NAs in CHB.
目的。评估苦参素(KS)联合核苷类似物(NAs)治疗慢性乙型肝炎(CHB)的疗效和安全性。方法。通过7个数据库检索KS联合NAs治疗CHB的随机对照试验(RCTs)。由两名研究者提取48周时血清HBeAg消失、HBeAg血清学转换、血清HBV-DNA检测不到、ALT正常化的频率以及不良事件。使用Cochrane软件评估纳入试验的偏倚风险。采用Review Manager 5.3软件进行数据分析。结果。分析纳入了18项涉及1684例CHB患者的RCTs。KS联合包括拉米夫定(LAM)、恩替卡韦(ETV)、阿德福韦酯(ADV)和替比夫定(TLV)在内的NAs在CHB指标上显示出不同程度的改善。与单一药物相比,KS联合NAs增加了血清HBeAg消失、HBeAg血清学转换、HBV-DNA水平检测不到以及ALT正常化的频率。治疗一年后还降低了血清ALT和AST水平。然而,KS联合TLV在CHB指标上未显示出显著差异。KS联合NAs的副作用较轻且发生率较低。结论。KS联合NAs提高了NAs治疗CHB的疗效。