Effectiveness and Safety of Xiao Chai Hu Tang plus Interferon for Chronic Hepatitis B: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

HU Xiaoyu ,  ZHONG Sen , CHEN Jing , LI Hui

Department of Infectious Disease, The First Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, China;

Corresponding author：

ZHONG Sen, Email: zhongsen6606@163.com

Keywords：

Xiao Chai Hu Tang; Chronic hepatitis B; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.20110051

Video：

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Objective 　To compare the combination of Xiao Chai Hu Tang and interferon versus the simple interferon for the management of chronic hepatitis B (CHB) in terms of clinical therapeutic effect and safety.
Methods 　Such databases as PubMed, CBM disc, CNKI, VIP, Japana Centra Revuo Medicina were searched to include the randomized control trials (RCTs) of treating chronic hepatitis B by using Xiao Chai Hu Tang plus interferon as the treatment group and the interferon as the control group. The quality of the inclusive methodology was evaluated by two reviewers independently. RevMan5.0.24 software was employed for meta-analyses.
Results 　Seven RCTs involving 668 patients were included and all of them were classified as Grade C methodologically. The results of meta-analyses demonstrated: compared with the simple interferon treatment, adding Xiao Chai Hu Tang to interferon was able to significantly increase the HBV-DNA negative conversion ratio (RR=1.44, 95%CI 1.18 to 1.76, P=0.000 4) and the HBeAg negative conversion ratio (RR=1.54, 95%CI 1.21 to 1.94, P=0.000 4); when the intervention duration was more than 12 weeks, the ALT normalization rate was improved significantly (24 weeks: RR=1.39, 95%CI 1.17 to 1.66, P=0.000 2; 12 weeks: RR=1.79, 95%CI 1.23 to 2.61, P=0.002) and the incidence of flu-like symptoms induced by interferon was significantly reduced (liver-protection treatment: RR=0.54, 95%CI 0.40 to 0.73, P lt;0.000 1; Non-liver-protection treatment: RR=0.75, 95%CI 0.59 to 0.95, P=0.02). The funnel plot was asymmetric, indicating publication bias.
Conclusion 　Although Xiao Chai Hu Tang maybe has certain potential supplementary benefits to interferon for the management of CHB. The results of the above meta-analyses should be interpreted prudently because there exit disparities in domestic and international trails with the shortage of double blind or multi-centered clinical trials with high quality. The current evidence provides no way to compare the combination of Xiao Chai Hu Tang plus interferon with the simple interferon for the treatment of CHB and no accurate conclusion in terms of clinical therapeutic effects and safety.

Citation： HU Xiaoyu,ZHONG Sen,CHEN Jing,LI Hui. Effectiveness and Safety of Xiao Chai Hu Tang plus Interferon for Chronic Hepatitis B: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2011, 11(3): 308-313. doi: 10.7507/1672-2531.20110051 Copy

1.	12 Nakagawa A, Yamaguchi T, Takao T, et al . Five cases of drug-induced pneumonitis due to Sho-saiko-to or interferon-alpha or both. Nihon Kyobu Shikkan Gakkai Zasshi , 1995, 33(12):.
2.	杨绍基. 传染病学. 第1版. 北京: 人民卫生出版社, 2005: 25.
3.	甲战生. 肝病细胞治疗基础与临床. 第1版. 北京: 人民卫生出版社, 2005: 1.
4.	中华医学会肝病学分会, 中华医学会感染病学分会. 慢性乙型肝炎防治指南. 中华流行病学杂志. 2006, 27(1): 79-88.
5.	张卓然, 倪语星, 尚红. 病毒性疾病诊断与治疗. 第1版. 北京: 科学出版社, 2009: 213.
6.	薄其兰, 杜雯雯. 干扰素联合小柴胡汤治疗慢性乙型肝炎50例疗效观察. 山东医药, 2006, 46(8): 82-83.
7.	张迎春, 刘中景. 加味小柴胡汤联合干扰素治疗HBeAg阳性慢性乙型肝炎疗效初步临床观察. 中国实用医药, 2008, 3(33): 50-51.
8.	单秀民, 于征. 小柴胡汤对干扰素流感样反应的影响. 山东中医杂志, 2006, 25(8): 528-529.
9.	黄和冲. 干扰素联合小柴胡冲剂治疗慢性乙肝40例疗效分析. 苏州医学院学报, 2001, 21(5): 561-562.
10.	李旭红, 王崇国. α-1b干扰素联合小柴胡汤治疗慢性乙型肝炎—附56例疗效分析. 临床肝胆病杂志, 2001, 17(3): 187-187.
11.	何炳福, 周建康, 沈华江. 小柴胡片联合干扰素治疗慢性乙型肝炎肝纤维化的临床研究. 中国中西医结合消化杂志, 2008, (6): 384-387.
12.	史文英, 张军勤. 干扰素联合小柴胡汤治疗慢性乙型病毒性肝炎. 湖北中医杂志, 2006, 28(12): 35.
13.	闻集普, 姚昌绶, 王伯祥. 日本对小柴胡汤治疗慢性肝病的研究: 疗效、机制与禁忌. 中西医结合肝病杂志, 2004, 14(6): 378-381.
14.	温志坚, 曹毓, 彭龙玲. 小柴胡汤提取物体外抗HBV活性研究. 中西医结合肝病杂志, 2000, 10(4): 29-30.
15.	孙兰, 朱晓洪, 李庆勇. 中药配方颗粒制备小柴胡汤的药效研究. 中药药理与临床, 2004, 20(2): 4-5.
16.	倪勤, 翟琦, 余敏, 等. 小柴胡片抗乙型肝炎病毒的初步实验研究. 新疆医科大学学报, 2001, 24(2): 156.
17.	刘中景, 熊曼琪. 小柴胡汤抗鸭乙肝病毒的实验研究. 中国中西医结合杂志, 2000, 20(11): 853-855.
18.	杨书兰, 黄正昌, 朱辨弦, 等. 柴胡和小柴胡汤对鸭乙型肝炎治疗作用的研究. 广州中医药大学学报, 2003, 20(4): 289-293.
19.	陈压西, 郭树华, 齐珍元, 等. 小柴胡汤胶囊抗鸭乙型肝炎病毒的实验研究. 中西医结告肝痛杂志, 2000, 10(2): 17.
20.	王明如. 小柴胡汤治疗肝病的原理研究. 中成药, 1998, 20(2): 37-38.
21.	满川博美. ラットにおけるハロセン肝障害に対する小柴胡湯の効果. 国外医学?中医中药分册, 1991, 13(5): 40.
22.	-1366.

1. 12 Nakagawa A, Yamaguchi T, Takao T, et al . Five cases of drug-induced pneumonitis due to Sho-saiko-to or interferon-alpha or both. Nihon Kyobu Shikkan Gakkai Zasshi , 1995, 33(12):.
2. 杨绍基. 传染病学. 第1版. 北京: 人民卫生出版社, 2005: 25.
3. 甲战生. 肝病细胞治疗基础与临床. 第1版. 北京: 人民卫生出版社, 2005: 1.
4. 中华医学会肝病学分会, 中华医学会感染病学分会. 慢性乙型肝炎防治指南. 中华流行病学杂志. 2006, 27(1): 79-88.
5. 张卓然, 倪语星, 尚红. 病毒性疾病诊断与治疗. 第1版. 北京: 科学出版社, 2009: 213.
6. 薄其兰, 杜雯雯. 干扰素联合小柴胡汤治疗慢性乙型肝炎50例疗效观察. 山东医药, 2006, 46(8): 82-83.
7. 张迎春, 刘中景. 加味小柴胡汤联合干扰素治疗HBeAg阳性慢性乙型肝炎疗效初步临床观察. 中国实用医药, 2008, 3(33): 50-51.
8. 单秀民, 于征. 小柴胡汤对干扰素流感样反应的影响. 山东中医杂志, 2006, 25(8): 528-529.
9. 黄和冲. 干扰素联合小柴胡冲剂治疗慢性乙肝40例疗效分析. 苏州医学院学报, 2001, 21(5): 561-562.
10. 李旭红, 王崇国. α-1b干扰素联合小柴胡汤治疗慢性乙型肝炎—附56例疗效分析. 临床肝胆病杂志, 2001, 17(3): 187-187.
11. 何炳福, 周建康, 沈华江. 小柴胡片联合干扰素治疗慢性乙型肝炎肝纤维化的临床研究. 中国中西医结合消化杂志, 2008, (6): 384-387.
12. 史文英, 张军勤. 干扰素联合小柴胡汤治疗慢性乙型病毒性肝炎. 湖北中医杂志, 2006, 28(12): 35.
13. 闻集普, 姚昌绶, 王伯祥. 日本对小柴胡汤治疗慢性肝病的研究: 疗效、机制与禁忌. 中西医结合肝病杂志, 2004, 14(6): 378-381.
14. 温志坚, 曹毓, 彭龙玲. 小柴胡汤提取物体外抗HBV活性研究. 中西医结合肝病杂志, 2000, 10(4): 29-30.
15. 孙兰, 朱晓洪, 李庆勇. 中药配方颗粒制备小柴胡汤的药效研究. 中药药理与临床, 2004, 20(2): 4-5.
16. 倪勤, 翟琦, 余敏, 等. 小柴胡片抗乙型肝炎病毒的初步实验研究. 新疆医科大学学报, 2001, 24(2): 156.
17. 刘中景, 熊曼琪. 小柴胡汤抗鸭乙肝病毒的实验研究. 中国中西医结合杂志, 2000, 20(11): 853-855.
18. 杨书兰, 黄正昌, 朱辨弦, 等. 柴胡和小柴胡汤对鸭乙型肝炎治疗作用的研究. 广州中医药大学学报, 2003, 20(4): 289-293.
19. 陈压西, 郭树华, 齐珍元, 等. 小柴胡汤胶囊抗鸭乙型肝炎病毒的实验研究. 中西医结告肝痛杂志, 2000, 10(2): 17.
20. 王明如. 小柴胡汤治疗肝病的原理研究. 中成药, 1998, 20(2): 37-38.
21. 满川博美. ラットにおけるハロセン肝障害に対する小柴胡湯の効果. 国外医学?中医中药分册, 1991, 13(5): 40.
22. -1366.

Chinese Journal of Evidence-Based Medicine

Effectiveness and Safety of Xiao Chai Hu Tang plus Interferon for Chronic Hepatitis B: A Systematic Review

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