柴胡舒肝散治疗常见病毒性肝炎的疗效及安全性
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摘要
为了系统评价柴胡疏肝散治疗常见病毒性肝炎的有效性和安全性,本研究机检索PubMed、EMbase、The Cochrane Library、Web of Science、中国生物医学文献数据库、知网、万方、维普等中、英文数据库,检索时限均从建库至2017年11月。文献筛选、资料提取和偏倚风险由2位评价员独立完成,之后采用RevMan 5.2软件进行Meta分析。共纳入19个研究,病毒性肝炎患者1 502例(均为乙型病毒性肝炎患者),其中柴胡疏肝散结合西药治疗763例为治疗组,单独用西药治疗739例为对照组,病人年龄为17～71岁。Meta分析结果表明:柴胡疏肝散结合西药治疗病毒性肝炎的总有效率(RD=0.14, 95%CI (0.09, 0.18), p<0.000 01),优于单独常规西药治疗组,差异均有统计学意义;病毒学指标HBV-DNA、肝功能指标ALT、AST、TBIL等治疗后均显著改善;治疗后不良反应发生率(RR=0.42, 95%CI (-0.29, 0.60), p<0.000 01)明显低于单独常规西药治疗组。本研究表明柴胡疏肝散配合西药可提高病毒性肝炎治疗的疗效,降低不良反应,具有一定的临床推广价值。
To evaluate the efficacy and safety of Chaihu Shugan Powder in the treatment of common viral hepatitis, thus providing evidence for the treatment of viral hepatitis. By searching PubMed, EMbase, The Cochrane Library, Web of Science, CBM, CNKI, Wanfang, CQVIP, RCT(randomized controlled trial) documents about Chaihu Shugan Powder or the similar decoctions combined with western medicine in the treatment of common viral hepatitis were found out. The literatures were evaluated using the Cochrane collaboration's risk of bias for quality evaluation table and RevMan5.2 software was adopted for Meta analysis. A total of 19 literatures, 1502 cases were included in the analysis. There was 763 cases treated with Chaihu Shugan Powder combined with western medicine as treatment group, and 739 cases treated solely with western medicine, as control. The patients reported were from 17 to 71 years old. The Meta analysis results showed that the differences of the clinical curative effects in the treatment of common viral hepatitis(total efficiency)(RD=0.14, 95% CI(0.09, 0.18), p<0.000 01),Negative seroconversion of HBV-DNA, ALT, AST and TBIL after treatment and the rates of adverse medification reactions(RR=0.42, 95% CI(-0.29, 0.60), p<0.000 01) between treatment group and control were all statistically significance. Chaihu Shugan Powder combined with chemical medicine should be better than that of conventional chemical medicine with better or similar effects and higher safety in the treatment of common viral hepatitis thus can be recommended to widely use in clinic treatment.
To evaluate the efficacy and safety of Chaihu Shugan Powder in the treatment of common viral hepatitis, thus providing evidence for the treatment of viral hepatitis. By searching PubMed, EMbase, The Cochrane Library, Web of Science, CBM, CNKI, Wanfang, CQVIP, RCT(randomized controlled trial) documents about Chaihu Shugan Powder or the similar decoctions combined with western medicine in the treatment of common viral hepatitis were found out. The literatures were evaluated using the Cochrane collaboration's risk of bias for quality evaluation table and RevMan5.2 software was adopted for Meta analysis. A total of 19 literatures, 1502 cases were included in the analysis. There was 763 cases treated with Chaihu Shugan Powder combined with western medicine as treatment group, and 739 cases treated solely with western medicine, as control. The patients reported were from 17 to 71 years old. The Meta analysis results showed that the differences of the clinical curative effects in the treatment of common viral hepatitis(total efficiency)(RD=0.14, 95% CI(0.09, 0.18), p<0.000 01),Negative seroconversion of HBV-DNA, ALT, AST and TBIL after treatment and the rates of adverse medification reactions(RR=0.42, 95% CI(-0.29, 0.60), p<0.000 01) between treatment group and control were all statistically significance. Chaihu Shugan Powder combined with chemical medicine should be better than that of conventional chemical medicine with better or similar effects and higher safety in the treatment of common viral hepatitis thus can be recommended to widely use in clinic treatment.
引文
Chen R.X.,2013,Effects of Chaihu Shugan Powder combined with diammnium glycyrrhizinate on chronic hepatitis B with liver-Qi stagnation,Neimenggu Zhongyiyao(Inner Mongolia Journal of Traditional Chinese Medicine),32(35):28-29(陈日霞,2013,柴胡疏肝散联合甘草酸二铵治疗慢性乙型肝炎证属肝郁气滞型疗效观察,内蒙古中医药,32(35):28-29)
Chen S.,Hong W.Y.,and Li Q.Q.,2011,Observation of 86 cases chronic hepatitis B treated with aderovir dipivoxil capsule plus Caihu Shugan Powder,Xiandai Yiyuan(Modern Hospital),11(5):42-43(陈穗,洪文扬,李秋泉,2011,阿德福韦酯胶囊加柴胡疏肝散治疗慢性乙型肝炎86例观察,现代医院,11(5):42-43)
Feng X.M.,2012,Effects of modified Chaihu Shugan Powder in treating chronic hepatitis B,Neimeng gu Zhongyiyao(Inner Mongolia Journal of Traditional Chinese Medicine),31(5):28-29(冯学明,2012,柴胡疏肝散化裁治疗慢乙肝疗效观察,内蒙古中医药,31(5):28-29)
Fu C.L.,and Zhu X.H.,2017,Mate analysis of effects of traditional Chinese and western medicine in treating liver cirrhosis from hepatitis B,Zhejiang Zhongxiyijiehe Zazhi(Zhejiang Journal of Integral Traditional and Western Medicine),27(5):442-446(付昌隆,朱肖鸿,2017,中西医治疗乙型肝炎肝硬化疗效Mate分析,浙江中西医结合杂志,27(5):442-446)
Gao X.G.,and Ruan L.G.,Clinical observation and evaluation of quality of life of Chaihu Shugan Powder combined with entecavir in treatment of chronic hepatitis B,Hubei Zhongyi Zazhi(Journal of Hubei Traditional Chinese Medicine),36(4):12-13(高雪岗,阮连国,2014,柴胡疏肝散加减联合恩替卡韦治疗慢性乙型肝炎患者的临床疗效及其生存质量评价,湖北中医杂志,36(4):12-13)
Gu X.F.,2008,Effects of self-designed Chinese medicine combined with antiviral drugs for the treatment of chronic hepatitis B,Neimenggu Zhongyiyao(Inner Mongolia Journal of Traditional Chinese Medicine),22(52):16-17(顾雪峰,2008,自拟中药方联合抗病毒药物治疗慢性乙型肝炎,内蒙古中医药,22(52):16-17)
Guo Z.F.,and Zhang Q.,Effects of adefovir dipivoxil combined with Chaihu Shugan Powder on early cirrhosis after hepatitis B:a clinical observation of 70 cases,Shizhen Guoyiguoyao(Lishizhen Medicine and Materia Medica Research),24(10):2441-2442(郭占芳,张乾,2013,阿德福韦酯联合柴胡疏肝散治疗乙型肝炎后早期肝硬化70例,时珍国医国药,24(10):2441-2442)
He N.Y.,Wang F.,Ma C.,Li C.Y.,Zeng X.,Deng Y.,Zhang L.M.,and Li Z.Y.,2013,Chemiluminescence analysis for HBV-DNA hybridization detection with magnetic nanoparticles based DNA extraction from positive whole blood samples,Journal of Biomedical Nanotechnology,9(2):267-273
Hu Y.H.,Hao X.K.,and Duan C.R.,2015,Clinical effects of Jianpi Shugan Decoction on chronic hepatitis B,Zhongyao Yaoli Yu Linchuang(Pharmacology and Clinics of Chinese Materia Medica),31(1):252-254(胡彦辉,郝先坤,段传荣,2015,健脾疏肝汤治疗慢性乙型病毒性肝炎的临床疗效分析,中药药理与临床,31(1):252-254)
Huang Z.Q.,and Gao F.,2015,Observation of bupleurum Liver-Coursing Powder combined antiviral therapy applied in CBD correlation compensatory stage liver cirrhosis,Shijie Zhongyiyao(World Chinese Medicine),10(7):1009-1016(黄正桥,高锋,2015,柴胡疏肝散联合抗病毒药物治疗CBD相关性代偿期肝硬化的观察,世界中医药,10(7):1009-1016)
Liu L.Q.,and Wang J.H.,2006,Effects of modified Chaihu Shugan Powder combined with diammonium glycyrrhizinate on chronic hepatitis B with liver-Qi stagnation,Shizhen Guoyiguoyao(Lishizhen Medicine and Materia Medica Research),17(1):32(刘丽群,王嘉会,2006,柴胡疏肝散加减联合甘草酸二铵治疗证属肝郁气滞慢性乙型肝炎疗效观察,时珍国医国药,17(1):32)
Luo Q.,1991,A preliminary summary of the treatment of chronic hepatitis B with Chaihu Shugan Powder,Zhejiang Zhongxiyi Jiehe Zazhi(Zhejiang Journal of Integral Traditi onal and Western Medicine),(3):42(骆群,1991,柴胡疏肝散治疗慢性乙肝初步小结,浙江中西医结合杂志,(3):42)
Peng Z.P.,and Zhang T.,2013,Effects of modified Chaihu Shugan Powder on chronic hepatitis B:a clinical observation of 20 cases,Hunan Zhongyi Zazhi(Hunan Journal of Traditional Medicine),29(8):42-43(彭忠平,张涛,2013,柴胡疏肝散加减治疗慢性乙型肝炎20例疗效观察,湖南中医杂志,29(8):42-43)
Qin W.H.,Lu S.J.,and Liu H.H.,2014,Effects of Chaihu Shugan Powder combined with medical ozone therapy on chronic hepatitis B,Guangxi Zhongyiyao(Guangxi Journal of Traditional Chinese Medicine),37(2):44-45(覃武海,陆石俊,刘辉华,2014,柴胡疏肝散结合医用臭氧疗法治疗慢性乙型肝炎疗效观察,广西中医药,37(2):44-45)
Wang D.Y.,2015,Randomized controlled study on effects of Chaihu Shugan Powder combined with western medicine in treating chronic hepatitis B with liver-Qi stagnation,Shiyong Zhongyi Neike Zazhi(Journal of Practical Traditional Chinese Internal Medicine),29(8):121-123(王大勇,2015,柴胡疏肝散联合西药治疗肝气郁结型慢性乙型肝炎随机平行对照研究,实用中医内科杂志,29(8):121-123)
Wang Z.W.,Wu Q.,and Chen Y.H.,Clinical observation on treatment of hepatitis B with cirrhosis by adefovir dipivoxil combined with traditional Chinese medicines,Xinan Junyi(Journal of Military Surgeon in Southwest China),17(1):20-21(王兆伟,吴乔,陈永红,2015,中药联合阿德福韦酯治疗乙肝肝硬化临床观察,西南军医,17(1):20-21)
Wu C.M.,Ouyang Q.,Lin M.S.,Huang Q.,and Chen L.,2016,Clinical study on treatment of chronic hepatitis B with liver stagnation and spleen deficiency by Chaihu Shugan Powder and infrared irradiation,Zhejiang Zhongyi Zazhi(Zhejiang Journal of Traditional Chinese Medicine),51(8):561-562(吴春明,欧阳钦,林梅瑟,黄强,陈靓,2016,柴胡疏肝散联合红外线照射治疗肝郁脾虚型慢性乙型肝炎的临床研究,浙江中医杂志,51(8):561-562)
Xiao D.M.,2016,Randomized parallel-group research of Wenpi Shugan Decoction for treating cirrhosis after chronic hepatitis B,Shiyong Zhongyi Neike Zazhi(Journal of Practical Traditional Chinese Internal Medicine),30(3):52-54(肖德梅,2016,温脾疏肝汤联合西药治疗慢性乙型肝炎后肝硬化随机平行对照研究,实用中医内科杂志,30(3):52-54)
Yang L.,Wang X.F.,Liu C.,and Jiang H.,2012,Research progress on chemical constituents and pharmacological actions of Bupleurum Chinese,Zhongyiyao Xinxi(Information of Traditional Chinese Medicine),29(3):143-145(杨柳,王雪莹,刘畅,姜海,2012,北柴胡化学成分与药理作用的研究进展,中医药信息,29(3):143-145)
Yang L.P.,2014,Effects of adefovir dipivoxil combined with Chaihu Shugan Powder on chronic hepatitis B,Dangdai Yiyao Luncong(Contemporary Medicine Forum),12(17):171(杨丽萍,2014,用阿德福韦酯胶囊联合柴胡疏肝散治疗慢性乙肝的效果观察,当代医药论丛,12(17):171)
Zhang H.B.,2010,Treatment of chronic hepatitis B with Pegasys combined Chaihu Shugan Powder:a clinical observation of56 cases,Jiangxi Zhongyiyao(Jiangxi Journal of Traditional Medicine),41(332):37-38(张红兵,2010,派罗欣联合柴胡疏肝散治疗慢乙肝56例,江西中医药,41(332):37-38)
Zhang L.K.,2016,Clinical study on Chaihu Shugan Powder combined with western medicines in treating 72 cases of chronic hepatitis,Yiyao Qianyan(Medicine Frontiers),6(6):341-342(张隆科,2016,柴胡疏肝散联合西药治疗慢性肝炎72例的临床研究,医药前沿,6(6):341-342)
Zhong R.G.,Zhang J.Z.,Li J.,and Fu Z.X.,2009,Treatment of chronic hepatitis B with modified Chaihu Shugan Powder and western medicine:a clinical observation of 32 cases,Xin Zhongyi(Journal of New Chinese Medicine),41(4):22-23(钟荣光,张洁贞,李俊,傅志雄,2009,加味柴胡疏肝散联合西药治疗慢性乙型肝炎32例疗效观察,新中医,41(4):22-23)
Chen S.,Hong W.Y.,and Li Q.Q.,2011,Observation of 86 cases chronic hepatitis B treated with aderovir dipivoxil capsule plus Caihu Shugan Powder,Xiandai Yiyuan(Modern Hospital),11(5):42-43(陈穗,洪文扬,李秋泉,2011,阿德福韦酯胶囊加柴胡疏肝散治疗慢性乙型肝炎86例观察,现代医院,11(5):42-43)
Feng X.M.,2012,Effects of modified Chaihu Shugan Powder in treating chronic hepatitis B,Neimeng gu Zhongyiyao(Inner Mongolia Journal of Traditional Chinese Medicine),31(5):28-29(冯学明,2012,柴胡疏肝散化裁治疗慢乙肝疗效观察,内蒙古中医药,31(5):28-29)
Fu C.L.,and Zhu X.H.,2017,Mate analysis of effects of traditional Chinese and western medicine in treating liver cirrhosis from hepatitis B,Zhejiang Zhongxiyijiehe Zazhi(Zhejiang Journal of Integral Traditional and Western Medicine),27(5):442-446(付昌隆,朱肖鸿,2017,中西医治疗乙型肝炎肝硬化疗效Mate分析,浙江中西医结合杂志,27(5):442-446)
Gao X.G.,and Ruan L.G.,Clinical observation and evaluation of quality of life of Chaihu Shugan Powder combined with entecavir in treatment of chronic hepatitis B,Hubei Zhongyi Zazhi(Journal of Hubei Traditional Chinese Medicine),36(4):12-13(高雪岗,阮连国,2014,柴胡疏肝散加减联合恩替卡韦治疗慢性乙型肝炎患者的临床疗效及其生存质量评价,湖北中医杂志,36(4):12-13)
Gu X.F.,2008,Effects of self-designed Chinese medicine combined with antiviral drugs for the treatment of chronic hepatitis B,Neimenggu Zhongyiyao(Inner Mongolia Journal of Traditional Chinese Medicine),22(52):16-17(顾雪峰,2008,自拟中药方联合抗病毒药物治疗慢性乙型肝炎,内蒙古中医药,22(52):16-17)
Guo Z.F.,and Zhang Q.,Effects of adefovir dipivoxil combined with Chaihu Shugan Powder on early cirrhosis after hepatitis B:a clinical observation of 70 cases,Shizhen Guoyiguoyao(Lishizhen Medicine and Materia Medica Research),24(10):2441-2442(郭占芳,张乾,2013,阿德福韦酯联合柴胡疏肝散治疗乙型肝炎后早期肝硬化70例,时珍国医国药,24(10):2441-2442)
He N.Y.,Wang F.,Ma C.,Li C.Y.,Zeng X.,Deng Y.,Zhang L.M.,and Li Z.Y.,2013,Chemiluminescence analysis for HBV-DNA hybridization detection with magnetic nanoparticles based DNA extraction from positive whole blood samples,Journal of Biomedical Nanotechnology,9(2):267-273
Hu Y.H.,Hao X.K.,and Duan C.R.,2015,Clinical effects of Jianpi Shugan Decoction on chronic hepatitis B,Zhongyao Yaoli Yu Linchuang(Pharmacology and Clinics of Chinese Materia Medica),31(1):252-254(胡彦辉,郝先坤,段传荣,2015,健脾疏肝汤治疗慢性乙型病毒性肝炎的临床疗效分析,中药药理与临床,31(1):252-254)
Huang Z.Q.,and Gao F.,2015,Observation of bupleurum Liver-Coursing Powder combined antiviral therapy applied in CBD correlation compensatory stage liver cirrhosis,Shijie Zhongyiyao(World Chinese Medicine),10(7):1009-1016(黄正桥,高锋,2015,柴胡疏肝散联合抗病毒药物治疗CBD相关性代偿期肝硬化的观察,世界中医药,10(7):1009-1016)
Liu L.Q.,and Wang J.H.,2006,Effects of modified Chaihu Shugan Powder combined with diammonium glycyrrhizinate on chronic hepatitis B with liver-Qi stagnation,Shizhen Guoyiguoyao(Lishizhen Medicine and Materia Medica Research),17(1):32(刘丽群,王嘉会,2006,柴胡疏肝散加减联合甘草酸二铵治疗证属肝郁气滞慢性乙型肝炎疗效观察,时珍国医国药,17(1):32)
Luo Q.,1991,A preliminary summary of the treatment of chronic hepatitis B with Chaihu Shugan Powder,Zhejiang Zhongxiyi Jiehe Zazhi(Zhejiang Journal of Integral Traditi onal and Western Medicine),(3):42(骆群,1991,柴胡疏肝散治疗慢性乙肝初步小结,浙江中西医结合杂志,(3):42)
Peng Z.P.,and Zhang T.,2013,Effects of modified Chaihu Shugan Powder on chronic hepatitis B:a clinical observation of 20 cases,Hunan Zhongyi Zazhi(Hunan Journal of Traditional Medicine),29(8):42-43(彭忠平,张涛,2013,柴胡疏肝散加减治疗慢性乙型肝炎20例疗效观察,湖南中医杂志,29(8):42-43)
Qin W.H.,Lu S.J.,and Liu H.H.,2014,Effects of Chaihu Shugan Powder combined with medical ozone therapy on chronic hepatitis B,Guangxi Zhongyiyao(Guangxi Journal of Traditional Chinese Medicine),37(2):44-45(覃武海,陆石俊,刘辉华,2014,柴胡疏肝散结合医用臭氧疗法治疗慢性乙型肝炎疗效观察,广西中医药,37(2):44-45)
Wang D.Y.,2015,Randomized controlled study on effects of Chaihu Shugan Powder combined with western medicine in treating chronic hepatitis B with liver-Qi stagnation,Shiyong Zhongyi Neike Zazhi(Journal of Practical Traditional Chinese Internal Medicine),29(8):121-123(王大勇,2015,柴胡疏肝散联合西药治疗肝气郁结型慢性乙型肝炎随机平行对照研究,实用中医内科杂志,29(8):121-123)
Wang Z.W.,Wu Q.,and Chen Y.H.,Clinical observation on treatment of hepatitis B with cirrhosis by adefovir dipivoxil combined with traditional Chinese medicines,Xinan Junyi(Journal of Military Surgeon in Southwest China),17(1):20-21(王兆伟,吴乔,陈永红,2015,中药联合阿德福韦酯治疗乙肝肝硬化临床观察,西南军医,17(1):20-21)
Wu C.M.,Ouyang Q.,Lin M.S.,Huang Q.,and Chen L.,2016,Clinical study on treatment of chronic hepatitis B with liver stagnation and spleen deficiency by Chaihu Shugan Powder and infrared irradiation,Zhejiang Zhongyi Zazhi(Zhejiang Journal of Traditional Chinese Medicine),51(8):561-562(吴春明,欧阳钦,林梅瑟,黄强,陈靓,2016,柴胡疏肝散联合红外线照射治疗肝郁脾虚型慢性乙型肝炎的临床研究,浙江中医杂志,51(8):561-562)
Xiao D.M.,2016,Randomized parallel-group research of Wenpi Shugan Decoction for treating cirrhosis after chronic hepatitis B,Shiyong Zhongyi Neike Zazhi(Journal of Practical Traditional Chinese Internal Medicine),30(3):52-54(肖德梅,2016,温脾疏肝汤联合西药治疗慢性乙型肝炎后肝硬化随机平行对照研究,实用中医内科杂志,30(3):52-54)
Yang L.,Wang X.F.,Liu C.,and Jiang H.,2012,Research progress on chemical constituents and pharmacological actions of Bupleurum Chinese,Zhongyiyao Xinxi(Information of Traditional Chinese Medicine),29(3):143-145(杨柳,王雪莹,刘畅,姜海,2012,北柴胡化学成分与药理作用的研究进展,中医药信息,29(3):143-145)
Yang L.P.,2014,Effects of adefovir dipivoxil combined with Chaihu Shugan Powder on chronic hepatitis B,Dangdai Yiyao Luncong(Contemporary Medicine Forum),12(17):171(杨丽萍,2014,用阿德福韦酯胶囊联合柴胡疏肝散治疗慢性乙肝的效果观察,当代医药论丛,12(17):171)
Zhang H.B.,2010,Treatment of chronic hepatitis B with Pegasys combined Chaihu Shugan Powder:a clinical observation of56 cases,Jiangxi Zhongyiyao(Jiangxi Journal of Traditional Medicine),41(332):37-38(张红兵,2010,派罗欣联合柴胡疏肝散治疗慢乙肝56例,江西中医药,41(332):37-38)
Zhang L.K.,2016,Clinical study on Chaihu Shugan Powder combined with western medicines in treating 72 cases of chronic hepatitis,Yiyao Qianyan(Medicine Frontiers),6(6):341-342(张隆科,2016,柴胡疏肝散联合西药治疗慢性肝炎72例的临床研究,医药前沿,6(6):341-342)
Zhong R.G.,Zhang J.Z.,Li J.,and Fu Z.X.,2009,Treatment of chronic hepatitis B with modified Chaihu Shugan Powder and western medicine:a clinical observation of 32 cases,Xin Zhongyi(Journal of New Chinese Medicine),41(4):22-23(钟荣光,张洁贞,李俊,傅志雄,2009,加味柴胡疏肝散联合西药治疗慢性乙型肝炎32例疗效观察,新中医,41(4):22-23)