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当代中国慢性乙型肝炎中药临床研究:分析综述。

Contemporary clinical research of traditional Chinese medicines for chronic hepatitis B in China: an analytical review.

机构信息

Liver-Biliary-Pancreatic Center and the Liver, Digestive Diseases, and Metabolism Laboratory, NC, USA.

出版信息

Hepatology. 2010 Feb;51(2):690-8. doi: 10.1002/hep.23384.

Abstract

UNLABELLED

Chronic hepatitis B (CHB) is major global health problem. In China, where about 120,000,000 persons are chronically infected, CHB has been treated for centuries with traditional Chinese medicines (TCMs). This review summarizes and meta-analyzes the results of randomized controlled trials (RCTs) of TCM formulations reported in China in 1998-2008 for treatment of CHB. RCTs comparing either TCM formulations alone or in combination with interferon (IFN) or lamivudine (LAM) versus IFN or LAM were included. Chinese electronic databases were searched. The methodological quality of RCTs was assessed using the Jadad scale. TCMs had a greater beneficial effect (P = 0.0003) than IFN and a slightly better effect (P = 0.01) than LAM on the normalization of serum alanine aminotransferase. TCMs had a similar beneficial effect when compared with IFN or LAM for CHB on antiviral activity as evidenced by the loss of serum hepatitis B e antigen and hepatitis B virus (HBV) DNA. TCMs enhanced IFN and LAM antiviral activities and improvements of liver function. The quality of many studies was poor; reports often lacked information regarding methods of randomization or blinding and adverse events.

CONCLUSION

Some TCMs seem effective as alternative remedies for patients with CHB, suggesting that further study of TCMs in the treatment of CHB is warranted, both in preclinical models of HBV infection and in higher quality RCTs worldwide.

摘要

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慢性乙型肝炎(CHB)是全球主要的健康问题。在中国,约有 1.2 亿人患有慢性乙型肝炎,这种疾病已经被用中药(TCM)治疗了几个世纪。这篇综述总结和荟萃分析了 1998 年至 2008 年在中国发表的关于中药制剂治疗 CHB 的随机对照试验(RCTs)的结果。纳入了比较中药制剂单独或与干扰素(IFN)或拉米夫定(LAM)联合与 IFN 或 LAM 治疗的 RCTs。检索了中国电子数据库。使用 Jadad 量表评估 RCTs 的方法学质量。与 IFN 相比,TCM 对血清丙氨酸氨基转移酶正常化的有益效果更大(P=0.0003),与 LAM 相比,效果略好(P=0.01)。与 IFN 或 LAM 相比,TCM 对乙型肝炎病毒(HBV)e 抗原和 HBV DNA 血清丢失的抗病毒活性具有相似的有益效果。TCM 增强了 IFN 和 LAM 的抗病毒活性和肝功能改善。许多研究的质量较差;报告往往缺乏关于随机化或盲法和不良事件的方法的信息。

结论

一些中药似乎对 CHB 患者作为替代疗法有效,这表明有必要进一步研究中药在治疗 CHB 中的作用,包括在乙型肝炎病毒感染的临床前模型和全球高质量 RCTs 中。

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