中醫藥治療慢性B型肝炎回顧性資料統計及臨床治療數據分析研究

Retrospective Analysis of Traditional Chinese Medicine Treating Chronic Hepatitis B and Clinical Statistics

楊賢鴻(Sien-Hung Yang) ； 陸庭譯(Ting-Yee Lok)

《中醫藥雜誌》 28卷2期 (2017/12) Pp. 83-98

https://doi.org/10.3966/241139642017122802008

摘要

慢性B型肝炎感染的形成與宿主感染HBV時的年齡與途徑密切相關。許多研究證實，嬰幼兒的天然免疫系統對HBV缺乏反應，而獲得性免疫系統則會被HBV抑制，因而形成慢性感染，全世界達2億5千7百萬人，75％分佈在亞洲，其中以華人居最多數。B型肝炎疫苗能有效防範HBV的傳播，而干擾素與核苷（酸）類似物充實了西醫治療慢性B型肝炎的彈藥庫。但是，仍有二個盲點：1.缺乏治療慢性B型肝炎帶原的有效藥物；2. HBsAg轉陰，產生Anti-HBs的終極治癒目標仍遙不可及，尤其是對華人，確切原因不明。由於中醫藥治療慢性B型肝炎帶原的臨床試驗，能符合多中心、隨機、雙盲、安慰劑控制條件且能被國際期刊接受後刊登者非常稀少，為能一窺究竟，本研究特將過去14年（2001.1.1至2014.12.31）治療慢性B型肝炎與帶原病例作一回顧性分析，結論是肯定的：慢性B型肝炎帶原不但可以中醫藥治癒，且可達致終極治癒目標：16.5％（21/127）HBsAg血清轉陰，年轉陰率（每100人年）5.26％；在產生Anti-HBs的血清轉換方面，比率為11.81％（15/127），年轉換率3.76％，均具統計學意義。另外，在慢性B型肝炎的中醫藥治療方面，HBsAg血清轉陰率為5.90％（6/102），年轉陰率1.97％；產生Anti-HBs的血清轉換率為2.94％（3/102），均具統計學意義，且高於自然轉陰率。中醫藥治療慢性B型肝炎帶原與慢性B型肝炎有效的機轉可能是活化了對HBV特異之免疫系統中某些環節，進而降解了HBV，甚至包括cccDNA在內。但這方面仍需進行一系列的臨床實驗予以證實。

關鍵字

慢性B型肝炎 ； 中醫藥

並列摘要

The age at which a person is infected by HBV and the route of transmission are closely related to the chronic evolution of the infection. A great number of studies conclude that the lack of response to HBV by the innate immunity of the neonate and viral suppression of the acquired immunity lead to chronicity. There are estimated 257 million chronically infected people worldwide with 75% among them in Asia making up mostly by Chinese. A prophylactic HBV vaccine is effective in preventing the spread of the infection. Interferon and nucleos(t)ide analogues bolster up the arsenal of the physician in treating chronic hepatitis B. However, there are still 2 bottlenecks: 1. the lack of an effective regiment in treating chronic hepatitis HBV carriers; 2. achieving treatment end points of HBsAg seroclearance/ conversion is almost unattainable, especially to the Chinese, for unknown reasons. As clinical trials of Traditional Chinese Medicine(TCM) treatment of chronic hepatitis B carriers meeting the criteria of multicenter, randomized, double-blind and placebo-controlled being accepted for publication in international journal are very rare, we decide to analyze retrospectively our treatment of chronic hepatitis B carriers using TCM over the past 14 years (Jan. 1, 2001 thru Dec. 31, 2014) in order to shed some light on this important issue. The results are affirmative. TCM could not only be used to treat chronic hepatitis B carriers but also achieving treatment end points: 16.5%(21/127) of HBsAg seroclearance with an annual rate of 5.26%; 11.81%(15/127) of HBsAg seroconversion rate with an annual rate of 3.76%, all with statistical significance. With regard to treating chronic hepatitis B with TCM, the rate of HBsAg seroclearance is 5.90%(6/102) with an annual rate of 1.97%. The rate of HBsAg seroconversion is 2.94%(3/102). All rates are statistically significant. The mechanism of the effectiveness of TCM in treating chronic hepatitis B carriers and chronic hepatitis B patients could be activation of certain parts of the immune system specific to HBV. However, it needs to be ascertained by a series of clinical tests.

並列關鍵字

Chronic Hepatitis B ； Traditional Chinese Medicine

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