“慢性丙型病毒性肝炎证候规律及中西医结合治疗方案的研究”研究方案

doi:10.3736/jcim20110404

Abstract

Background: Chronic hepatitis C is one of the major causes of end-stage liver disease with a high incidence rate, amounting to a grave and serious problem of public health. Currently, interferon-based (with or without ribavirin) antiviral therapy has limited use due to its stringent indications, possible contraindications and side effects. Traditional Chinese medicine (TCM) may have advantages in the prevention and treatment of chronic hepatitis C and it is of significant value to discover the advantages. Through this research, a safe and effective treatment protocol of TCM or integrated TCM and Western medicine for chronic hepatitis C can be formed. To this end, during China’s Eleventh Five-Year Plan, special research projects on acquired immune deficiency syndrome (AIDS), viral hepatitis and the other major infectious diseases were established. Our studies on chronic hepatitis C constitute one of the major special research topics.
Methods and design: Clinical information of patients with chronic hepatitis C will be first collected in a large, multicenter epidemiological survey. Positive symptoms will be analyzed by rapid cluster analysis, principal constituent analysis and factor analysis, and syndrome types will be diagnosed based on expert advice. Concurrently, a large, multicenter, randomized, parallel-group prospective study will be launched based on evidence-based medical principles to evaluate the effects and safety of the treatment protocol for chronic hepatitis C. The evaluated indexes will include the normalization rate of liver function, virological improvement and quality of life improvement for the short-term efficacy and the incidence of liver cirrhosis and (or) primary liver cancer and mortality for the long-term efficacy.
Discussion: This study will investigate the TCM syndrome differentiation norms and the syndrome distribution rules of chronic hepatitis C and evaluate the efficacy and safety of a treatment protocol for chronic hepatitis C based on TCM theory or combined treatment of TCM and Western medicine. The study results will be helpful to developing a TCM treatment program for chronic hepatitis C.

Key words: hepatitis C,chronic, clinical protocol, interferon, ribavirin, traditional Chinese medicine, multicenter study, prospective study, randomized controlled trial

Hong-ming Nie, Yue-qiu Gao, Jian-jie Chen. Syndrome distribution among patients with chronic hepatitis C and interventions of integrated traditional Chinese and Western medicine: Study protocol. Journal of Chinese Integrative Medicine, 2011, 9(4): 365-373.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20110404

http://www.jcimjournal.com/EN/Y2011/V9/I4/365

[1]	Strader DB, Wright T, Thomas DL, Seeff LB . American Association For the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C[J]. Hepatology, 2004,39(4):1147-1171 doi: 10.1002/hep.20119
[2]	Epidemiology and natural history. In: Schinazi RF, Sommadossi JP, Thomas HC. Therapies for viral hepatitis[M]. London: International Medical Press, 1998
[3]	Chinese Society of Hepatology and Chinese Society of Infectious Diseases and Parasitology of Chinese Medical Association. Prevention and treatment program for hepatitis C in China[J]. Zhonghua Gang Zang Bing Za Zhi, 2004,12(4):194-198
	中华医学会肝病学分会,中华医学会传染病与寄生虫病学分会. 丙型肝炎防治指南[J]. 中华肝脏病杂志, 2004,12(4):194-198
[4]	Lindsay KL . Introduction to therapy of hepatitis C[J]. Hepatology, 2002,36(5 Suppl 1):S114-S120 doi: 10.1002/hep.1840360715 pmid: 1240758412
[5]	Seeff LB, Hoofnagle JH . National Institutes of Health Consensus Development Conference: management of hepatitis C: 2002[J]. Hepatology, 2002,36(5 Suppl 1):S3-S20 doi: 10.1310/hct.2003.4.1.008 pmid: 12407571
[6]	McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, Nyberg LM, Lee WM, Ghalib RH, Schiff ER, Galati JS, Bacon BR, Davis MN, Mukhopadhyay P, Koury K, Noviello S, Pedicone LD, Brass CA, Albrecht JK, Sulkowski MS; IDEAL Study Team . Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection[J]. N Engl J Med, 2009,361(6):580-593 doi: 10.1056/NEJMoa0808010 pmid: 19625712
[7]	Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J . Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection[J]. N Engl J Med, 2002,347(13):975-982 doi: 10.1056/NEJMoa020047 pmid: 12324553
[8]	Chen JJ, Wang LT, Ren JJ, Gao YQ, Le M, Zhuo YH . Clinical study on chronic hepatits C treated with Qinggan Granules[J]. Zhong Xi Yi Jie He Gan Bing Za Zhi, 2001,11(4):195-197
	陈建杰, 王灵台, 任进余, 高月求, 乐敏, 卓蕴慧 . 清肝冲剂对慢性丙型肝炎的作用研究[J]. 中西医结合肝病杂志, 2001,11(4):195-197
[9]	Chen JJ, Wang LT, Ren JJ, Gao YQ, Zhuo YH, Le M . Clinical study on chronic hepatitis C treated with Kidney-Tonifying Granule[J]. Zhongguo Zhong Xi Yi Jie He Xiao Hua Za Zhi, 2001,9(6):334-336
	陈建杰, 王灵台, 任进余, 高月求, 卓蕴慧, 乐敏 . 补肾冲剂治疗慢性丙型肝炎的临床研究[J]. 中国中西医结合消化杂志, 2001,9(6):334-336
[10]	Li Y, Chen JJ . Study of HCV genetype distribution to 71 patients with chronic hepatitis C in Shanghai district[J]. Zhong Xi Yi Jie He Gan Bing Za Zhi, 2006,16(6):360-362
	李莹, 陈建杰 . 上海地区71例慢性丙型病毒性肝炎患者基因型分布研究[J]. 中西医结合肝病杂志, 2006,16(6):360-362
[11]	Li YP, Huang ZJ, Zhang H, Chen C . Feasibility of the MOS 36-item Short Form Health Survey in the assessment of the quality of life in hepatitis B patients[J]. Zhongguo Yu Fang Yi Xue Za Zhi, 2007,8(4):352-355 doi: 10.3969/j.issn.1009-6639.2007.04.007
	李跃平, 黄子杰, 张宏, 陈聪 . SF-36量表在乙型肝炎患者生存质量测量中的可行性评价[J]. 中国预防医学杂志, 2007,8(4):352-355 doi: 10.3969/j.issn.1009-6639.2007.04.007
[12]	Wu CH, Deng QW, Ji XS, Yan LM . Preliminary use of the CLDQ in chronic hepatitis B patients[J]. Zhongguo Lin Chuang Xin Li Xue Za Zhi, 2003,11(1):60-62 doi: 10.3969/j.issn.1005-3611.2003.01.020
	吴创鸿, 邓启文, 纪晓抒, 阎郎明 . 慢性肝病问卷在慢性乙型肝炎患者中的试用[J]. 中国临床心理学杂志, 2003,11(1):60-62 doi: 10.3969/j.issn.1005-3611.2003.01.020

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Syndrome distribution among patients with chronic hepatitis C and interventions of integrated traditional Chinese and Western medicine: Study protocol

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