【摘要】：背景:肝纖維化是各種慢性肝病的重要病理特征,也是發(fā)展至肝硬化的必經階段,因此,尋找有效藥物,阻斷、延緩及逆轉肝纖維化已成為治療慢性肝病中的一個關鍵性問題。正如國際現代肝病學的奠基人Hans Popper教授所說“誰能預防和治療肝纖維化,誰就能治愈大多數慢性肝病”[1]。目前對肝纖維化的治療尚無理想藥物,而中藥抗纖維化治療的有效的報道日漸增多[2]。但是中藥療效并沒有得到國際的廣泛認同,中藥抗纖維化的療效也存在爭議和質疑,為此本研究擬通過詢證醫(yī)學方法,分析當前中藥抗纖維化療效的客觀現狀,對中藥抗纖維化的臨床應用提供依據。目的:通過文獻綜合分析,判斷中藥治療肝纖維化療效的確切性。方法:計算機檢索中國生物醫(yī)學文獻數據庫(CBM)、中國知網(CNKI)、維普資訊網(VIP)、萬方數據資源系統(tǒng)、百鏈數據庫(Medalink)、Pub Med及Google學術搜索引擎中系統(tǒng)全面地進行文獻搜索,檢索的具體日期為從建庫至2016年1月。納入所有有關中藥或中成藥治療肝纖維化的研究試驗,同時查閱所有檢出文獻的參考文獻作為補充,必要時與文獻作者聯(lián)系,進一步取得全文或相關試驗數據。通過閱讀文獻題名、摘要或全文,排除不符合納入標準的研究試驗。選擇肝纖維化評價的“金標準”肝組織病理學作為主要指標,輔以血清肝纖維化指標、肝生化及不良反應等指標,對納入研究的文獻進行質量評價和數據提取后,應用Rev Man5.3統(tǒng)計軟件進行統(tǒng)計學分析。結果:最終有26篇符合納入標準的文獻,共2913例患者納入臨床評價,其中中藥組2424例,對照組489例。所有研究對象均為肝纖維化病理分級S1-S4的患者,中藥組以“中藥或中成藥或聯(lián)合一般護肝藥物”為主要治療;對照組使用“一般護肝藥物或安慰劑”為主要治療。統(tǒng)計分析結果顯示:治療療程為6個月時,與對照組相比,中藥組在改善肝組織纖維化程度{WMD=1.97,95%CI[-3.60,-0.33],P=0.02}、肝組織炎癥活動度{WMD=1.62,95%CI[-3.19,-0.05],P=0.04}、透明質酸(HA){SMD=1.48,95%CI[-2.26,-0.70],P=0.0002}、層粘連蛋白(LN){SMD=0.94,95%CI[-1.52,-0.35],P=0.002}、Ⅲ型前膠原(PC-Ⅲ){SMD=1.44,95%CI[-2.45,-0.42],P=0.005}、Ⅳ型膠原(Ⅳ-C){SMD=0.62,95%CI[-1.11,-0.12],P=0.01}、谷丙轉氨酶(ALT){WMD=13.90,95%CI[-25.55,-2.25],P=0.02}、白蛋白(ALB){WMD=3.06,95%CI[0.65,5.47],P=0.01}方面均具有統(tǒng)計學意義。而中藥組在降低總膽紅素(TB){WMD=3.13,95%CI[-7.17,0.91],P=0.13}方面較對照組無統(tǒng)計學意義。結論:目前研究提示:1.中藥可以改善肝組織學纖維化程度及炎癥活動度;2.中藥可以顯著降低血清肝纖維化指標;3.中藥對膽汁代謝影響不大。綜上所述,中藥對肝纖維化治療是確切有效的。
[Abstract]:Background: hepatic fibrosis is an important pathological feature of various chronic liver diseases, and it is also a necessary stage for the development of liver cirrhosis. Therefore, finding effective drugs, blocking, delaying and reversing liver fibrosis has become a key problem in the treatment of chronic liver diseases. As Professor Hans Popper, founder of International Modern Hepatology, said, "whoever can prevent and treat liver fibrosis can cure most chronic liver diseases." [1] At present, there are no ideal drugs for the treatment of liver fibrosis, and the effective reports of antifibrosis therapy of traditional Chinese medicine are increasing day by day [2]. However, the curative effect of traditional Chinese medicine has not been widely accepted by the world, and the effect of anti-fibrosis of traditional Chinese medicine has also been disputed and questioned. Therefore, this study intends to analyze the current objective status of anti-fibrosis effect of traditional Chinese medicine by means of inquiry and evidence medicine. To provide the basis for the clinical application of traditional Chinese medicine in anti-fibrosis. Objective: to evaluate the efficacy of traditional Chinese medicine in the treatment of hepatic fibrosis by comprehensive literature analysis. Methods: the Chinese Biomedical Literature Database (CBM),) was searched by computer, and the (VIP), Wanfang data Resource system (VIP),) was used in the (CNKI), WIP Web of China knowledge Network (CNKI),). The literature search was carried out systematically and comprehensively in the 100-chain database (Medalink) / Pub Med and Google academic search engine. The specific date of retrieval is from the construction of the database to January 2016. To include all relevant Chinese medicine or traditional Chinese medicine in the treatment of liver fibrosis research trials, at the same time consult all the reference literature as a supplement, if necessary contact the author of the literature, further obtain the full text or related experimental data. Exclude research experiments that do not meet the inclusion criteria by reading the title, abstract, or full text of the literature. The "golden standard" liver histopathology of liver fibrosis evaluation was selected as the main index, supplemented by serum hepatic fibrosis index, liver biochemistry and adverse reactions, and the quality evaluation and data extraction of the literature involved in the study were carried out. Rev Man5.3 statistical software was used for statistical analysis. Results: there were 26 articles in accordance with the inclusion criteria. A total of 2913 patients were included in the clinical evaluation. There were 2424 cases in the traditional Chinese medicine group and 489 cases in the control group. All the subjects were patients with pathological grade S1-S4 of hepatic fibrosis. The traditional Chinese medicine group was treated mainly with "Chinese medicine or traditional Chinese medicine or combined general liver protection drug", while the control group with "general liver protection drug or placebo" as the main treatment. The results of statistical analysis showed that when the course of treatment was 6 months, compared with the control group, 涓嵂緇勫湪鏀瑰杽鑲濈粍緇囩氦緇村寲紼嬪害{WMD=1.97,95%CI[-3.60,-0.33],P=0.02},鑲濈粍緇囩値鐥囨椿鍔ㄥ害{WMD=1.62,95%CI[-3.19,-0.05],P=0.04},閫忔槑璐ㄩ吀(HA){SMD=1.48,95%CI[-2.26,-0.70],P=0.0002},灞傜矘榪炶泲鐧，

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