多烯磷脂酰膽堿(易善復)治療慢性肝炎的系統評價_《中國循證醫學雜志》

作者：

胡國平 , 劉凱 , 王甦 , 唐紅 , 趙連三

四川大學華西醫院感染性疾病中心,生物治療國家重點實驗室,四川省感染性疾病分子生物學重點實驗室,成都,610041;

關鍵詞：

易善復多烯磷脂酰膽堿慢性肝炎隨機對照試驗系統評價 Meta分析

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目的　評價易善復治療慢性肝炎的有效性與安全性.
方法　計算機檢索EMBASE(1980～2003年5月)、MEDLINE(1966～2003年5月)、Cochrane圖書館(2003年第2期)、中國生物醫學文獻光盤數據庫(1979～2003年5月),并手工檢索8種主要的中文專業學術期刊(1989～2003年5月),納入比較易善復與安慰劑或空白治療慢性肝炎的隨機對照試驗.由兩名評價者獨立提取資料并進行方法學質量評估.試驗數據的統計分析采用Cochrane協作網提供的RevMan4.2軟件進行.
結果　最終納入6個RCT,共568例患者.對其中4個RCT(451例患者)的Meta 分析顯示,易善復治療慢性肝炎的有效率為52.5%,對照組的有效率為35.7%, 其差異具有統計學意義 [RR 1.81, 95%CI (1.41,2.33), Z=4.69, P＜0.000 01].對其中3個RCT(100例)的Meta 分析顯示,與對照組相比,易善復能夠改善慢性肝炎患者的病理組織學,其差異有統計學意義 [RR 2.58, 95%CI (1.61,4.15), Z=3.91, P＜0.000 1].此外,沒有報道與易善復治療慢性肝炎相關的嚴重不良反應.
結論　現有臨床證據表明,與安慰劑和空白對照組相比,易善復治療慢性肝炎有效,可改善患者的臨床癥狀,改善患者的病理組織學,同時有利于改善患者的肝功能,且無明顯藥物不良反應.但本系統評價納入的RCT和患者數量有限,其臨床療效須進一步開展大規模的高質量臨床試驗進行驗證.

引用本文： 胡國平,劉凱,王甦,唐紅,趙連三. 多烯磷脂酰膽堿(易善復)治療慢性肝炎的系統評價. 中國循證醫學雜志, 2005, 05(7): 543-548. doi: 復制

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14.	Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J]. JAMA, 1995; 273(5): 408-412.
15.	Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M. Does quality of reports of randomized trials affect estimates of intervention efficacy reported in Meta-analyses[J]? Lancet,1998; 352(9128): 609-613.
16.	Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses[J]. Annals of Internal Medicine, 2001; 135(11) : 982-989.
17.	Perter J, Jenkins BP, Portmann A.L, Eddleston W.F, Roger Williams. Use of polyunsaturated phosphatidyl choline in HBsAg negative chronic active hepatitis: results of prospective double blind controlled trial[J]. Liver, 1982; 2(3): 77-81.
18.	Kordac V, Brodanova M, Marecek Z, Jirasek AP. Essentiale forte in the treatment of chronic active hepatitis[J]. Prakt Lek (Praha), 1985; 65(43): 834-837.
19.	Niederau C, Strohmeyer G, Heintges T, Peter K, Gopfert E (Leich Study Group). Polyunsaturated phosphatidyl-choline and interferon alpha for treatment of chronic hepatitis B and C: a multi-center, randomized, double blind, placebo controlled trial[J]. Hepato-Gastroenterology, 1998; 45(21): 797-804.
20.	Llic V, Begic-Janev. The efficacy of "essential" phospholipids in the therapy of HBsAg+ chronic active hepatitis[J]. Med Welt, 1991; 41(47): 523-525.
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22.	Chalmers TC, Celano P, Sacks HS, Smith H Jr. Bias in treatment assignment in controlled clinical trials[J]. N Engl J Med, 1983; 309(354): 1358-1361.

1. 王莉. 慢性肝炎的分類--診斷、分級、分期[J]. 國外醫學: 消化系疾病分冊, 1995; 15(2): 100～102.
2. 張孝秩, 貢德曼, 巫善明, 陳慶年. 復方多稀磷脂酰膽堿治療慢性乙型活動性肝炎的隨機對照雙盲臨床試驗[J]. 藥物流行病學雜志, 1995; 4(1): 4～6.
3. 中華醫學會傳染病與寄生蟲病學分會肝病學分會. 聯合修訂病毒性肝炎防治方案[J]. 中華傳染病雜志, 2001; 19(1): 56～62.
4. 中華肝病協會肝纖維化研究組. 肝纖維化診斷及療效評估共識[J]. 中華肝臟病雜志, 2002; 10(5): 327.
5. 王家良, 劉鳴主編. 循證醫學[M]. 北京: 人民衛生出版社, 2001; 34.
6. 王寶恩, 李俊紅, 林三仁, 閔佳, 張玲霞, 李俊紅. 易善復硬膠囊治療慢性病毒性肝炎多中心、隨機雙盲、安慰劑對照臨床試驗[R].(總結報告,由安萬特公司提供)2000.
7. Wang L. The classification of chronic hepatitis-diagnosis ,grade and stage[J]. Foreign Medical Sciences:(section of digestive disease), 1995; 15(2): 100-102.
8. Zhang XZ, Gunderman KJ, Wu SM, Chen QN. Therapeutic effect of polyenephosphatidylcholine compound in chronic active hepatitis B in a double-blind randomized controlled trials[J]. Chin J of Pharmacoepidemiology, 1995; 4(1): 4-6.
9. Chinese Infectious and Parasitic Diseases Association and Chinese Liver Diseases Association. The protocol of prevent and treatment of viral hepatitis[J]. Chin J of Infectious Diseases, 2001; 19(1): 56-62.
10. Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, Kiernan TW, Wollman J. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis[J]. Hepatology, 1981; 1(3): 43.
11. Hepatic Fibrosis Study Group of Chinese Liver Diseases Association. Consensus on evaluation of the diagnosis and efficacy of hepatic fibrosis[J]. Chin J of hepatology, 2002; 10(5): 327.
12. Wang JL, Liu M, Chief Editor. Evidence-based medicine[M]. Peking: The people sanitary publishing company, 2001; 34.
13. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: Is blinding necessary[J]? Control Clin Trials, 1996; 17(34): 1-12.
14. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J]. JAMA, 1995; 273(5): 408-412.
15. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M. Does quality of reports of randomized trials affect estimates of intervention efficacy reported in Meta-analyses[J]? Lancet,1998; 352(9128): 609-613.
16. Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses[J]. Annals of Internal Medicine, 2001; 135(11) : 982-989.
17. Perter J, Jenkins BP, Portmann A.L, Eddleston W.F, Roger Williams. Use of polyunsaturated phosphatidyl choline in HBsAg negative chronic active hepatitis: results of prospective double blind controlled trial[J]. Liver, 1982; 2(3): 77-81.
18. Kordac V, Brodanova M, Marecek Z, Jirasek AP. Essentiale forte in the treatment of chronic active hepatitis[J]. Prakt Lek (Praha), 1985; 65(43): 834-837.
19. Niederau C, Strohmeyer G, Heintges T, Peter K, Gopfert E (Leich Study Group). Polyunsaturated phosphatidyl-choline and interferon alpha for treatment of chronic hepatitis B and C: a multi-center, randomized, double blind, placebo controlled trial[J]. Hepato-Gastroenterology, 1998; 45(21): 797-804.
20. Llic V, Begic-Janev. The efficacy of "essential" phospholipids in the therapy of HBsAg+ chronic active hepatitis[J]. Med Welt, 1991; 41(47): 523-525.
21. Wang BE, Li JH, Lin SR, Min J, Zhang LX, Li JH. The multi-central randomized double-blind controlled clinic trials of essentiale for chronic viral hepatitis[R]. (The end report ,supplied by avantis) 2000.
22. Chalmers TC, Celano P, Sacks HS, Smith H Jr. Bias in treatment assignment in controlled clinical trials[J]. N Engl J Med, 1983; 309(354): 1358-1361.

《中國循證醫學雜志》

多烯磷脂酰膽堿(易善復)治療慢性肝炎的系統評價

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《中國循證醫學雜志》

多烯磷脂酰膽堿(易善復)治療慢性肝炎的系統評價

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