苦参素治疗慢性乙型肝炎312例
张学武,安徽医科大学附属医院感染病科 安徽省合肥市 230022
张学武,胡国启, 李春玉, 周敏, 界首市人民医院感染病科 安徽省界首市 236500
张学武,男, 1963-09-10生, 安徽省临泉县人,2002年安徽医科大学硕士生,副主任医师, 主要从事病毒性肝炎的临床研究,发表论文25篇.
项目负责人:张学武, 236500, 安徽省界首市, 界首市人民医院感染病科. jsxyxk@sina.com
电话:0558-3170445 传真: 0558-4823808
, 百拇医药
收稿日期:2004-10-18 接受日期: 2004-11-22
Effect of Oxymatrine on chronic hepatitis B: ananalysis of 312 cases
Xue-Wu Zhang, Guo-Qi Hu, Chun-Yu Li, Min Zhou
Xue-Wu Zhang,Department of Infectious Diseases, Affiliated Hospital of Anhui MedicalUniversity, Hefei 236000, Anhui Province, China
Xue-Wu Zhang, Guo-Qi Hu, Chun-Yu Li, Min Zhou, Department ofInfectious Diseases, Jieshou People'sHospital, Jieshou 236500, Anhui Province, China
, http://www.100md.com
Correspondence to: Xue-Wu Zhang, Department of Infectious Diseases,Jieshou People'sHospital, Jieshou 236500, Anhui Province, China. jsxyxk@sina.com
Received: 2004-10-18 Accepted:2004-11-22
Abstract
AIM: To evaluate the efficacy and safety of Oxymatrine in thetreatment of chronic hepatitis B.
METHODS: Patients treated with Oxymatrine (n = 203) or withthe combination of Oxymatrine and Lamivudine (n = 109) wereretrospectively studied. The therapeutic response and the affectingfactors were analyzed.
, http://www.100md.com
RESULTS: Of the 312 patients, complete response (CR) rate,sustained response (SR) rate and exacerbation (EB) rate were 36.5%, 32.4%and 8.0%, respectively. The CRand SR rates of the patients with baseline ALT<1 334 nkat/L (uppernormal limit), 1 334 nkat/L≤ALT<3335 nkat/L, 3 335 nkat/L≤ALT<6670 nkat/L and ALT≥6670nkat/L were 21.4%, 33.8%, 39.7% and 59.5%, 14.3%, 31.6%, 38.5% and 47.6%,respectively (P = 0.0 012 and 0.0 027 for CR and SR, respectively);The CR and SR rates of the patients with HBV DNA<108copies/L, 108copies/L≤HBVDNA≤1011copies /L, and HBV DNA >1011copies /L were 57.9%, 37.4% and 26.5%, 50.0%, 28.9% and 8.2%, respectively(P = 0.0 262 and 0.0070 for CR and SR, respectively). The highestresponse occurred 6 months after treated with Oxymatrine, and furthertreatment did not yield higher response rate. The treatment with thecombination of Oxymatrine and lamivudine led to higher CR, SR rates andlower EB rate than with Oxymatrine alone (46.8%, 41.3%, 1.8% vs 31.0%, 27.6%, 11.3%, P = 0.0 048, 0.0 020, 0.0 009, respectively).
, 百拇医药
CONCLUSION: Oxymatrine is safe and effective in the treatment ofchronic hepatitis B. The response rates are positively correlated withbase-line ALT level, but negatively correlated with HBV DNA level beforetreatment. Combination with lamivudine can increase the response rate andreduce the exacerbation rate.
Key Words: Oxymatrine; Lamivudine; Chronic hepatitis B; Response
Zhang XW, Hu GQ, Li CY, Zhou M. Effect of Oxymatrine on chronic hepatitisB: an analysis of 312 cases. Shijie Huaren Xiaohua Zazhi 2005;13(3):317-320
, 百拇医药
摘要目的:探讨苦参素治疗慢性乙型肝炎的疗效、安全性及影响应答反应的相关因素.
方法:采取回顾性分析方法，对203例单独接受苦参素治疗与109例接受苦参素联合拉米夫定治疗的慢性乙型肝炎患者的临床资料进行回顾性分析，观察应答反应情况及影响应答反应的相关因素.
结果:312例患者完全应答率(CR)为36.5%，持续应答(SR)率32.4%;恶化率8.0%;基线ALT<1334nkat/L、1 334 nkat/L≤ALT<3335 nkat/L、3335 nkat/L≤ALT<6670 nkat/L及ALT≥6670 nkat/L的患者CR和SR分别为21.4%，33.8%，39.7%及59.5%和14.3%，31.6%，38.5%及47.6%(P = 0.0012和0.0 027);HBVDNA<108copies/L、108copies/L≤HBVDNA≤1011copies /L 及HBVDNA>1011copies /L的患者完全应答和持续应答率分别为57.9%，37.4%及26.5%和50.0%，28.9%及8.2%(P = 0.0262和0.0 070);苦参素治疗乙肝疗程以6mo时应答反应率最高，延长疗程应答率进一步提高有限;联合拉米夫定治疗的患者完全应答和持续应答率分别为46.8%和41.3%高于单用苦参素的31.0%和27.6%(P= 0.0 048和0.0020)，而恶化病例发生率明显低于单用苦参素组
, http://www.100md.com
(11.3% vs 1.8%，P =0.0 009).
结论:苦参素治疗慢性乙型肝炎有肯定的疗效，应答反应随基线ALT水平的升高而升高，而与治疗前HBVDNA水平呈负相关;苦参素单用治疗乙肝部分病例可发生病情恶化，联合拉米夫定治疗可提高应答反应率并降低恶化病例的发生率.
关键词:苦参素;拉米夫定; 慢性乙型肝炎;应答
张学武,胡国启, 李春玉,周敏.苦参素治疗慢性乙型肝炎312例. 世界华人消化杂志 2005;13(3):317-320
蔡雄,王国俊, 翟瑶, 樊成辉,张瑞祺, 徐文胜. 苦参素注射液治疗慢性乙型肝炎的临床疗效分析.
第二军医大学学报 1997;18:4749
, 百拇医药
2 李继强, 陈萦晅, 曾民德, 陆伦根, 邱德凯,茅益民, 范竹萍,华静.氧化苦参碱抗乙肝病毒的体外实验研究.
中华消化杂志 2001;21:550552
3 Dong Y, Xi H, Yu Y, Wang Q, Jiang K, Li L. Effects of oxymatrine onthe serum levels of T helper cell 1 and 2 cytokines
and the expression of the S gene inhepatitis B virus S gene transgenic mice:a study on the anti-hepatitis Bvirus
mechanism of oxymatrine. J GastroenterolHepatol 2002;17:1299-306
, 百拇医药
4 Chen XS, Wang GJ, Cai X. Inhibition of hepatitis B virus byoxymatrine in vivo. World J Gastroenterol 2001;7:49-52
5 Lu LG, Zeng MD, Mao YM, Li JQ, Wan MB, Li CZ, Chen CW, Fu QC, WangJY, She WM, Cai X, Ye J, Zhou XQ, Wang H,Wu SM, Tang MF, Zhu JS, Chen WX, Zhang HQ.Oxymatrine therapy for chronic hepatitis B: A randomized
double-blind and placebo-controlledmulti- center trial. World J Gastroenterol 2003;9:2480-2483
, 百拇医药
6 于岩岩, 斯崇文, 曾争. 苦参素制剂治疗慢性乙型肝炎的临床试验. 中华内科杂志 2001;40:843846
7 Yu YY, Wang QH, Zhu LM. A clinical research on oxymatrine for thetreatment of chronic hepatitis B.
Zhonghua Ganzangbing Zazhi 2002;10:280-281
8 张学武, 周敏, 胡国启.拉米夫定联合博尔泰力治疗慢性乙型肝炎临床研究. 临床肝胆病杂志 2001;17:165166
9 张学武, 周敏, 胡国启.博尔泰力治疗乙型肝炎活动性肝硬化的临床研究. 中西医结合肝病杂志 2002;12:141143
, 百拇医药
10 张学武, 周敏, 胡国启.博尔泰力治疗拉米夫定耐药性乙型肝炎的临床研究. 临床肝胆病杂志 2003;19:106107
11 高作文, 张瑞琪, 缪晓辉.苦参素注射液致慢性乙肝患者肝功能损害加重2例.
药物不良反应杂志 2002;2:120121
12 李忠, 杨丽, 张平, 姜波,许红萍.拉米夫定与苦参素联合序贯治疗慢性乙型肝炎的疗效观察.
遵义医学院学报 2003;26:371-372
13 方广强, 甄中锋. 氧化苦参碱联合胸腺肽治疗拉米夫定所致YMDD变异后的慢性乙型肝炎疗效观察.
传染病信息 2002;15:139140
, 百拇医药
14 周和龙, 杨小铭, 何生松, 朱华斌,黄华芳.拉米夫定单用或联合苦参素治疗慢性乙型肝炎.
医药导报 2003;22:845847
15 郭西萍, 杜亚平, 钟基大, 李国军. 干扰素联合苦参素治疗慢性乙型肝炎疗效观察.
中国抗感染化疗杂志 2001;1:8997
16 邹桂舟, 李旭, 叶珺, 叶英, 李鸿宾.苦参素联合干扰素对慢性乙肝病毒定量的影响.安徽医药 2003;7:1314
17 季瑜, 唐家槐. 苦参素缓解拉米夫定停药反跳效果观察. 现代中西医结合杂志 2004;13:776777
18 Lu LG, Zeng MD, Mao YM, Fang JY, Song YL, Shen ZH, Cao AP.Inhibitory effect of oxymatrine on serum hepatitis B
, 百拇医药
virus DNA in HBV transgenic mice. WorldJ Gastroenterol 2004;10:1176-1179
19 孙永年, 龚守军, 黄祝青.苦参素对慢性乙型肝炎血清肿瘤坏死因子-a、白介素-6、白介素-8的影响.
中国综合临床 2003;19:908909
20 甘建和, 朱翔, 赵卫峰, 罗二平. 苦参素治疗慢性乙型肝炎疗效观察. 苏州医学院学报 2001;21:698699
21 Chen YX, Mao BY, Jiang JH. Relationship between serum load of HBV-DNAand therapeutic effect of oxymatrine in
patients with chronic hepatitis B. ZhongguoZhongxiyi Jiehe Zazhi 2002;22:335-336
编辑 潘伯荣 审读 张海宁, http://www.100md.com( 张学武, 胡国启, 李春玉, 周 敏)
张学武,胡国启, 李春玉, 周敏, 界首市人民医院感染病科 安徽省界首市 236500
张学武,男, 1963-09-10生, 安徽省临泉县人,2002年安徽医科大学硕士生,副主任医师, 主要从事病毒性肝炎的临床研究,发表论文25篇.
项目负责人:张学武, 236500, 安徽省界首市, 界首市人民医院感染病科. jsxyxk@sina.com
电话:0558-3170445 传真: 0558-4823808
, 百拇医药
收稿日期:2004-10-18 接受日期: 2004-11-22
Effect of Oxymatrine on chronic hepatitis B: ananalysis of 312 cases
Xue-Wu Zhang, Guo-Qi Hu, Chun-Yu Li, Min Zhou
Xue-Wu Zhang,Department of Infectious Diseases, Affiliated Hospital of Anhui MedicalUniversity, Hefei 236000, Anhui Province, China
Xue-Wu Zhang, Guo-Qi Hu, Chun-Yu Li, Min Zhou, Department ofInfectious Diseases, Jieshou People'sHospital, Jieshou 236500, Anhui Province, China
, http://www.100md.com
Correspondence to: Xue-Wu Zhang, Department of Infectious Diseases,Jieshou People'sHospital, Jieshou 236500, Anhui Province, China. jsxyxk@sina.com
Received: 2004-10-18 Accepted:2004-11-22
Abstract
AIM: To evaluate the efficacy and safety of Oxymatrine in thetreatment of chronic hepatitis B.
METHODS: Patients treated with Oxymatrine (n = 203) or withthe combination of Oxymatrine and Lamivudine (n = 109) wereretrospectively studied. The therapeutic response and the affectingfactors were analyzed.
, http://www.100md.com
RESULTS: Of the 312 patients, complete response (CR) rate,sustained response (SR) rate and exacerbation (EB) rate were 36.5%, 32.4%and 8.0%, respectively. The CRand SR rates of the patients with baseline ALT<1 334 nkat/L (uppernormal limit), 1 334 nkat/L≤ALT<3335 nkat/L, 3 335 nkat/L≤ALT<6670 nkat/L and ALT≥6670nkat/L were 21.4%, 33.8%, 39.7% and 59.5%, 14.3%, 31.6%, 38.5% and 47.6%,respectively (P = 0.0 012 and 0.0 027 for CR and SR, respectively);The CR and SR rates of the patients with HBV DNA<108copies/L, 108copies/L≤HBVDNA≤1011copies /L, and HBV DNA >1011copies /L were 57.9%, 37.4% and 26.5%, 50.0%, 28.9% and 8.2%, respectively(P = 0.0 262 and 0.0070 for CR and SR, respectively). The highestresponse occurred 6 months after treated with Oxymatrine, and furthertreatment did not yield higher response rate. The treatment with thecombination of Oxymatrine and lamivudine led to higher CR, SR rates andlower EB rate than with Oxymatrine alone (46.8%, 41.3%, 1.8% vs 31.0%, 27.6%, 11.3%, P = 0.0 048, 0.0 020, 0.0 009, respectively).
, 百拇医药
CONCLUSION: Oxymatrine is safe and effective in the treatment ofchronic hepatitis B. The response rates are positively correlated withbase-line ALT level, but negatively correlated with HBV DNA level beforetreatment. Combination with lamivudine can increase the response rate andreduce the exacerbation rate.
Key Words: Oxymatrine; Lamivudine; Chronic hepatitis B; Response
Zhang XW, Hu GQ, Li CY, Zhou M. Effect of Oxymatrine on chronic hepatitisB: an analysis of 312 cases. Shijie Huaren Xiaohua Zazhi 2005;13(3):317-320
, 百拇医药
摘要目的:探讨苦参素治疗慢性乙型肝炎的疗效、安全性及影响应答反应的相关因素.
方法:采取回顾性分析方法，对203例单独接受苦参素治疗与109例接受苦参素联合拉米夫定治疗的慢性乙型肝炎患者的临床资料进行回顾性分析，观察应答反应情况及影响应答反应的相关因素.
结果:312例患者完全应答率(CR)为36.5%，持续应答(SR)率32.4%;恶化率8.0%;基线ALT<1334nkat/L、1 334 nkat/L≤ALT<3335 nkat/L、3335 nkat/L≤ALT<6670 nkat/L及ALT≥6670 nkat/L的患者CR和SR分别为21.4%，33.8%，39.7%及59.5%和14.3%，31.6%，38.5%及47.6%(P = 0.0012和0.0 027);HBVDNA<108copies/L、108copies/L≤HBVDNA≤1011copies /L 及HBVDNA>1011copies /L的患者完全应答和持续应答率分别为57.9%，37.4%及26.5%和50.0%，28.9%及8.2%(P = 0.0262和0.0 070);苦参素治疗乙肝疗程以6mo时应答反应率最高，延长疗程应答率进一步提高有限;联合拉米夫定治疗的患者完全应答和持续应答率分别为46.8%和41.3%高于单用苦参素的31.0%和27.6%(P= 0.0 048和0.0020)，而恶化病例发生率明显低于单用苦参素组
, http://www.100md.com
(11.3% vs 1.8%，P =0.0 009).
结论:苦参素治疗慢性乙型肝炎有肯定的疗效，应答反应随基线ALT水平的升高而升高，而与治疗前HBVDNA水平呈负相关;苦参素单用治疗乙肝部分病例可发生病情恶化，联合拉米夫定治疗可提高应答反应率并降低恶化病例的发生率.
关键词:苦参素;拉米夫定; 慢性乙型肝炎;应答
张学武,胡国启, 李春玉,周敏.苦参素治疗慢性乙型肝炎312例. 世界华人消化杂志 2005;13(3):317-320
蔡雄,王国俊, 翟瑶, 樊成辉,张瑞祺, 徐文胜. 苦参素注射液治疗慢性乙型肝炎的临床疗效分析.
第二军医大学学报 1997;18:4749
, 百拇医药
2 李继强, 陈萦晅, 曾民德, 陆伦根, 邱德凯,茅益民, 范竹萍,华静.氧化苦参碱抗乙肝病毒的体外实验研究.
中华消化杂志 2001;21:550552
3 Dong Y, Xi H, Yu Y, Wang Q, Jiang K, Li L. Effects of oxymatrine onthe serum levels of T helper cell 1 and 2 cytokines
and the expression of the S gene inhepatitis B virus S gene transgenic mice:a study on the anti-hepatitis Bvirus
mechanism of oxymatrine. J GastroenterolHepatol 2002;17:1299-306
, 百拇医药
4 Chen XS, Wang GJ, Cai X. Inhibition of hepatitis B virus byoxymatrine in vivo. World J Gastroenterol 2001;7:49-52
5 Lu LG, Zeng MD, Mao YM, Li JQ, Wan MB, Li CZ, Chen CW, Fu QC, WangJY, She WM, Cai X, Ye J, Zhou XQ, Wang H,Wu SM, Tang MF, Zhu JS, Chen WX, Zhang HQ.Oxymatrine therapy for chronic hepatitis B: A randomized
double-blind and placebo-controlledmulti- center trial. World J Gastroenterol 2003;9:2480-2483
, 百拇医药
6 于岩岩, 斯崇文, 曾争. 苦参素制剂治疗慢性乙型肝炎的临床试验. 中华内科杂志 2001;40:843846
7 Yu YY, Wang QH, Zhu LM. A clinical research on oxymatrine for thetreatment of chronic hepatitis B.
Zhonghua Ganzangbing Zazhi 2002;10:280-281
8 张学武, 周敏, 胡国启.拉米夫定联合博尔泰力治疗慢性乙型肝炎临床研究. 临床肝胆病杂志 2001;17:165166
9 张学武, 周敏, 胡国启.博尔泰力治疗乙型肝炎活动性肝硬化的临床研究. 中西医结合肝病杂志 2002;12:141143
, 百拇医药
10 张学武, 周敏, 胡国启.博尔泰力治疗拉米夫定耐药性乙型肝炎的临床研究. 临床肝胆病杂志 2003;19:106107
11 高作文, 张瑞琪, 缪晓辉.苦参素注射液致慢性乙肝患者肝功能损害加重2例.
药物不良反应杂志 2002;2:120121
12 李忠, 杨丽, 张平, 姜波,许红萍.拉米夫定与苦参素联合序贯治疗慢性乙型肝炎的疗效观察.
遵义医学院学报 2003;26:371-372
13 方广强, 甄中锋. 氧化苦参碱联合胸腺肽治疗拉米夫定所致YMDD变异后的慢性乙型肝炎疗效观察.
传染病信息 2002;15:139140
, 百拇医药
14 周和龙, 杨小铭, 何生松, 朱华斌,黄华芳.拉米夫定单用或联合苦参素治疗慢性乙型肝炎.
医药导报 2003;22:845847
15 郭西萍, 杜亚平, 钟基大, 李国军. 干扰素联合苦参素治疗慢性乙型肝炎疗效观察.
中国抗感染化疗杂志 2001;1:8997
16 邹桂舟, 李旭, 叶珺, 叶英, 李鸿宾.苦参素联合干扰素对慢性乙肝病毒定量的影响.安徽医药 2003;7:1314
17 季瑜, 唐家槐. 苦参素缓解拉米夫定停药反跳效果观察. 现代中西医结合杂志 2004;13:776777
18 Lu LG, Zeng MD, Mao YM, Fang JY, Song YL, Shen ZH, Cao AP.Inhibitory effect of oxymatrine on serum hepatitis B
, 百拇医药
virus DNA in HBV transgenic mice. WorldJ Gastroenterol 2004;10:1176-1179
19 孙永年, 龚守军, 黄祝青.苦参素对慢性乙型肝炎血清肿瘤坏死因子-a、白介素-6、白介素-8的影响.
中国综合临床 2003;19:908909
20 甘建和, 朱翔, 赵卫峰, 罗二平. 苦参素治疗慢性乙型肝炎疗效观察. 苏州医学院学报 2001;21:698699
21 Chen YX, Mao BY, Jiang JH. Relationship between serum load of HBV-DNAand therapeutic effect of oxymatrine in
patients with chronic hepatitis B. ZhongguoZhongxiyi Jiehe Zazhi 2002;22:335-336
编辑 潘伯荣 审读 张海宁, http://www.100md.com( 张学武, 胡国启, 李春玉, 周 敏)
