黃信彰 台北榮民總醫院
慢性Ｃ型肝炎的病人約有百分之十至三十在十至二十年之追蹤會發展成肝硬化，甚至導致成肝癌發生。因此，慢性Ｃ型肝炎雖然時常沒有症狀，但是，積極而有效的治療確是必須的。西藥干擾素加上抗病毒藥物雷巴威靈（ribavirin）治療成功率約50%~79%，但其副作用仍使部份病人無法忍受。而傳統的中藥治療慢性Ｃ肝炎已為民間廣為使用，但因尚未有一明確的科學研究及嚴謹的血清生化及病毒核酸指數作為治療效果的評估。
本研究為榮陽治肝湯對慢性Ｃ型肝炎病人之療效評估;一隨機雙盲對照及交叉研究之第二年連續計畫，目的即在探討榮陽治肝湯 (龍膽瀉肝湯、加味逍遙散、丹參和厚?的組合，是中醫界常用來治療肝炎且在細胞及動物研究模式中具抗病毒、抗發炎、抗氧化及免疫調節功能) 在慢性Ｃ型肝炎病人的治療療效，尤其瞭解其對血清肝轉氨?及Ｃ型肝炎病毒核酸的影響。研究對象為曾經接受干擾素為主的標準治療，且治療失敗(含不反應及復發)，或不適合接受干擾素治療的慢性C型肝炎患者，第一期我們預計收集36位(目前收集18位)符合收案條件之慢性Ｃ型肝炎病人且經中醫師辯證屬於肝鬱血瘀合併肝經濕熱的證型者同時願意接受榮陽治肝湯治療者，研究對象隨機分成二組，一組給予榮陽治肝湯每天十五公克，分三次服用，為期十二週，另一組給予外形及味道相似但內容為澱粉之安慰劑，每天服用三次，為期十二週，於十二週結束後，停藥二週，再將二組互換，原來接受榮陽治肝湯者換成接受安慰劑，原來接受安慰劑組換成接受榮陽治肝湯為期十二週。研究治療期間定期評估其臨床症狀、副作用以及中醫證型變化，同時抽血偵測血清肝轉氨?以及血中Ｃ型肝炎病毒核酸濃度之變化。更利用疲倦量表及生活品質問卷來了解對病人生活品質之影響。預期將可知道榮陽治肝湯是否對慢性Ｃ型肝炎病人是否有降血中肝轉氨?以及血中Ｃ型肝炎病毒核酸濃度之能力。研究第二年我們將針對將繼續收集第一期之病人至36位同時將第一期有療效之慢性Ｃ型肝炎病人進行二十四週之治療及評估其停藥後二十四週之長期持續療效 (sustained response)，期望能以嚴謹及科學的研究方法來評估榮陽治肝湯治療慢性Ｃ型肝炎的療效及安全性。本研究將以嚴謹及科學的研究方法來評估榮陽治肝湯治療慢性Ｃ型肝炎的療效及安全性，本研究結果將提供中西醫界在治療慢性Ｃ型肝炎之重要參考。
關鍵字：榮陽治肝湯；慢性Ｃ型肝炎；血清肝轉氨?；Ｃ型肝炎病毒核酸；中醫證型；疲倦量表生活品質問卷
Clinical efficacy of Rong-Yang-Jyh-Gan-Tang on patients with chronic hepatitis C: a double-blinded randomized placebo-controlled cross-over study (second year project)(2-2)
HSIN-CHANG HUANG Taipei Veterans General Hospital
10 to 30% of patients with chronic hepatitis C virus (HCV) infection will progressive insidiously to cirrhosis after 10 to 20 years’ follow-up, and some will develop hepatocellular carcinoma. Combination of interferon with ribavirin has 50%~79% sustained response rate in treating chronic hepatitis C patients, but the side effects often lead to intolerance of patients. Traditional Chinese medicine has been widely used by the publics in Taiwan However, the efficacy of traditional Chinese medicine has not been confirmed because there were no evidence-based results or scientific parameters such as serum liver transaminase or viral load available in the evaluation of treatment response. This study evaluates the clinical efficacy of Rong-Yang-Jyh-Gan-Tang (a combination of long-dan-xie-gan-tang, jia-wei-xia-yao-san, dan-shen and hou-po) on patients with chronic hepatitis C. Rong-Yang-Jyh-Gan-Tang and its ingredients have been proven to have in vitro or in vivo anti-viral, anti-inflammatory, immune modulation effect, and been commonly used in clinical practice of Chinese Medicine in Taiwan. The purpose of this study is to evaluate the clinical efficacy of Rong-Yang-Jyh-Gan-Tang in treating patients with chronic hepatitis C, particularly emphasize on the effect on serum liver transaminase and HCV RNA. In the first part, we will enroll 36 patients (currently 18 patients) with chronic hepatitis C who were not response or not suitable for standard interferon-based therapy into this study. Patients will be diagnosed first by Chinese herbal doctor to identified as “dampness heat stasis” and “liver Qi stagnation” by Bian-Zheng-lun-zhi and then randomized and allocated to receive Rong-Yang-Jyh-Gan-Tang/placebo 15gm per day and three time a day or placebo for 12weeks. After 2 weeks’ washout period, patients will be crossed over to receive placebo/ Rong-Yang-Jyh-Gan-Tang for another 12 weeks. In the second year project, we will continue enroll patients in the first part study and those patients who had response will receive a 24 weeks course of Rong-Yang-Jyh-Gan-Tang to evaluate the sustained response 24 weeks after stopping treatment. Patients will return to clinics as schedule and blood tests for complete blood count, liver biochemistries and HCV RNA will be performed. Clinical symptoms and side effects of Rong-Yang-Jyh-Gan-Tang will also be recorded in detail during and after treatment. We also apply Chinese Medicine symptoms score, fatigue severity score and quality of life questionnaire to evaluate the change of quality of life in these patients. This study will in a rigid and scientific way to evaluate the clinical efficacy of Rong-Yang-Jyh-Gan-Tang on patients with chronic hepatitis C.
