Heluo Shugan Capsule for Liver Fibrosis of Chronic Hepatitis B: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

 WANGYuan ,  ZHONGSen , CHENJing

Department of Infectious Disease, the First Teaching Hospital, Chengdu University of Traditional Chinese Medicine; Chengdu 610072, China;

Corresponding?author：

ZHONGSen, Email: zhongsen6606@163.com

Keywords：

Heluo Shugan capsule; Chronic hepatitis; Liver fibrosis; Systematic review; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.20160148

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To systematically review the efficacy and safety of Heluo Shugan capsule in the treatment of hepatitis B fibrosis. Method We searched PubMed, The Cochrane Library (Issue 8, 2015), CBM, CNKI, VIP and WanFang Data from their inception to August 2015, to collect randomized controlled trials (RCTs) on Heluo Shugan capsule for hepatitis B fibrosis. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software. Results A total of 15 RCTs involving 1 840 patients were included. The results of meta-analysis showed that: (1) As for reduced level of serum hyaluronic acid (HA), Heluo Shugan capsule was superior to placebo (MD=82.31, 95%CI 37.44 to 127.19, P=0.000 3), but worse than Fuzheng Huayu capsule (MD=-137.45, 95% CI-196.29 to-78.62, P < 0.000 01), Fufang Biejia Ruangan tablet (MD=-51.19, 95% CI-67.58 to-34.81, P < 0.000 01) and Anti-fibrosis decoction (MD=-82.13, 95% CI-102.37 to-61.88, P < 0.000 01). (2) As for reduced level of serum laminin (LN), Heluo Shugan capsule was superior to placebo (MD=36.83, 95% CI 11.84 to 61.82, P=0.004), but worse than Fufang Biejia Ruangan tablet (MD=-36.00, 95% CI-64.29 to-7.71, P=0.01), Ganfujian capsule (MD=-22.14, 95% CI-37.28 to-7.00, P=0.004) and Anti-fibrosis decoction (MD=-38.64, 95% CI-75.00 to-2.29, P=0.04). (3) As for reduced level of serum procollagen type III peptide (PCIII), Heluo Shugan capsule was superior to placebo (MD=47.17, 95% CI 32.68 to 61.66, P < 0.000 01), but worse than Fuzheng Huayu capsule (MD=-4.80, 95% CI-9.08 to-0.51, P=0.03), Dahuang Zhechong pills (MD=-53.77, 95% CI-105.01 to-2.53, P=0.04), Ganfujian capsule (MD=-46.82, 95% CI-66.30 to-27.34, P < 0.000 01) and Anti-fibrosis decoction (MD=-28.68, 95% CI-55.59 to-1.77, P=0.04). (4) As for reduced level of serum type-IV-collagen (IV-C), Heluo Shugan capsule was superior to placebo (MD=72.77, 95% CI 47.65 to 97.89, P < 0.000 01), but worse than Fuzheng Huayu capsule (MD=-34.69, 95% CI-56.65 to-12.73, P=0.002), Dahuang Zhechong pills (MD=-21.26, 95%CI-38.79 to-3.73, P=0.02), Fufang Biejia Ruangan tablet (MD=-69.04, 95%CI-124.38 to-13.69, P=0.01), Ganfujian capsule (MD=-19.84, 95% CI-37.41 to-2.27, P=0.03) and Anti-fibrosis decoction (MD=-37.98, 95% CI-72.99 to-2.96, P=0.03). Conclusion Current evidence shows that, Heluo Shugan capsule was superior to placebo, but worse than Fufang Biejia Ruangan tablet, Fuzheng Huayu capsule, Dahuang Zhechong pills, Ganfujian capsule and Anti-fibrosis decoction in reducing the level of serum hepatic fibrosis. Due to the limited quantity and quality of included studies, more high-quality, large-scale RCTs are need to verify the above conclusion.

Citation： WANGYuan, ZHONGSen, CHENJing. Heluo Shugan Capsule for Liver Fibrosis of Chronic Hepatitis B: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2016, 16(8): 962-971. doi: 10.7507/1672-2531.20160148 Copy

1.	?莊輝.乙型肝炎流行病學研究進展.中國醫學前沿雜志(電子版), 2009, 1(2):18-20.
2.	李幼平.循證醫學.第1版.北京:高等教育出版社. 2003:2-3, 183-186.
3.	中華醫學會傳染病和寄生蟲病學分會, 肝病學分會病毒性肝炎防治方案.中華內科雜志, 2001, 40(1):62.
4.	劉關鍵, 吳泰相. Meta分析的森林圖及臨床意義.中國循證醫學雜志, 2004, 4(3):198-200.
5.	張敏, 李長春.和絡舒肝膠囊治療慢性乙型肝炎肝纖維化56例.中西結合肝病雜志, 2006, 16(3):176-177.
6.	朱越, 索艾生.和絡舒肝膠囊治療慢性肝炎臨床研究.中西結合肝病雜志, 2002, 12(4):207-208.
7.	崔建軍, 許誠, 王松, 等.和絡舒肝膠囊抗肝纖維化的療效觀察.實用肝臟病雜志, 2003, 6(3):161-162.
8.	王融冰, 孫鳳霞, 王曉靜, 等.和絡舒肝膠囊治療慢性乙型肝炎縮脾療效觀察.世界中醫藥, 2006, 1(1):20-22.
9.	劉平, 胡義揚, 劉成, 等.扶正化瘀膠囊干預慢性乙型肝炎肝纖維化作用的多中心臨床研究.中西結合學報, 2003, 1(2):89-98.
10.	溫偉波, 王華寧, 李莉.肝平膠囊(復方319膠囊)治療慢性乙型肝炎肝纖維化臨床療效觀察.中國名族民間醫藥雜志, 2002, 57:210-212.
11.	葉軍, 張潔, 夏敏.肝平膠囊治療慢性乙型肝炎的臨床療效觀察.中華醫學全科雜志, 2003, 2(1):25-26.
12.	陳菊梅, 楊永平, 陳德永, 等.復方鱉甲軟肝片治療慢性乙型肝炎肝纖維化的臨床研究.中華實驗和臨床病毒學雜志. 2007, 12, 21(4):358-360.
13.	寧小燕, 唐蒙軒, 陳星浩, 等.華北煤炭醫學院學報. 2006, 8(3): 341-342.
14.	黃加權, 王軍, 郭威, 等.和絡舒肝膠囊治療慢性乙型肝炎臨床研究.中西醫結音肝病雜志, 2001, 11(2):69-70.
15.	陸海英, 曾爭, 吳赤紅, 等.復方鱉甲軟肝片治療慢性乙型肝炎早起肝硬化的臨床研究.胃腸病和肝病學雜志, 2007, 12(6):605.
16.	常紅, 李佃貴, 張绔, 等.肝復健膠囊治療慢性乙型肝炎肝纖維化患者92例臨床觀察.中成藥, 2009, 12(31):1812-1813.
17.	王融冰, 王曉靜, 李秀惠, 等.和絡舒肝膠囊治療慢性乙型肝炎臨床療效再評價試驗總結.中華中醫藥學會內科分會學術年會, 2007.
18.	王玨.治肝靈合劑逆轉慢乙肝肝纖維化的臨床研究.河北醫科大學, 2005.
19.	肖建珍, 龍湘珍, 易炎啟, 等.抗纖湯治療肝纖維化60例臨床觀察.湖南中醫雜志, 2002, 18(3):16, 21.
20.	Tong QX, Wu YY, Xu B, et al. Study on the effect of heluoshugan capsule on liver fibrosis induced by Schistosoma japonicum infection in mice. Zhongguo Ji Sheng Chong Xue Yu Ji Sheng Chong Bing Za Zhi, 2006, 24(2):129-132.
21.	Hu YY, Liu P, Liu C. et al. The value of serum markers in evaluating liver fibrotic changes. Zhonghua Gan Zang Bing Za Zhi, 2006, 14(3): 174-177.
22.	Liu P, Hu YY, Liu C. et al. Multicenter clinical study on Fuzhenghuayu capsule against liver fibrosis due to chronic hepatitis B. World J Gastroenterol, 2005, 11(19):2892-2899.
23.	Zhang G, Zhang FC, Wang TC, et al. The effects of Chinese national medicine of Huoxueruanjian compound on SMAD signal in hepatic stellate cell and its significance. Zhonghua Gan Zang Bing Za Zhi, 2004, 12(4):213-215.
24.	郭燕.高嘯.晏維, 等.和絡舒肝膠囊對肝纖維化肝組織中乙酰膽堿受體的影響.中國組織化學與細胞化學雜志. 2007, 16(2):154-158.
25.	Oben JA, Yang S, Lin H, et al. Acetylcholine pro2 motes the proliferation and collagen gene expression of myofibroblastic hepatic stellate cells. Biochem Biophys Res Commun, 2003, 300(1): 172-177.
26.	Oben JA, Roskams T, Yang S, et al. Hepatic fibro2 genesis requires sympathetic neurot ransmitters. Gut, 2004, 53(3):438-445.
27.	Oben JA, Yang S, Lin H, et al. Norepinephrine and neuropeptide Ypromote proliferation and collagen gene expression of hepatic myofibroblastic stellate cells. Biochem Biophys Res Commun, 2003, 302(4):685-690.
28.	Castilla-Cortazar I, Aliaga-Montilla MA, Salvador J, et al. Insulinlike growth factor-I restores the reduced somatostatinergic tone cont rolling growth hormone secretion in cirrhotic rats. Liver, 2001, 21(6):405-409.
29.	張雅, 劉關鍵.慢性肝病肝纖維化的診斷.中國循證醫學雜志, 2007, 7(4):316-319.
30.	李麗, 何清, 楊大國, 等.扶正化瘀膠囊治療慢性乙型肝炎肝纖維化有效性和安全性的系統評價.中國循證醫學雜志, 2008, 8(10): 892-897.
31.	郭西萍, 王婉, 張繼紅, 等.恩替卡韋聯合和絡舒肝膠囊治療活動性乙型肝炎肝硬化的療效評價.實用肝病雜志, 2009, 12(2):124-126.
32.	任澤久, 龔鈺清, 湯守斌, 等.益氣健脾化瘀消積法治療早期肝硬化32例總結.湖南中醫雜志, 2004, 20(4):17-18.
33.	病毒性肝炎防治方案.中華內科雜志, 2001, 40(1):62-68.
34.	任澤久, 柯昌征, 龔鈺清, 等.疏肝健脾軟堅合劑抗肝纖維化的臨床療效探討.中西醫結合肝病雜志, 2004, 14(5):270-271.
35.	馬建忠, 丁明霞.拉米夫定聯合和絡舒肝膠囊對慢性乙型肝炎肝纖維化指標的影響.中華現代中西醫雜志, 2005, 3(12):1087.
36.	許方瀝.慢性乙型肝炎中醫證候分型的文獻評價.實用肝臟病雜志, 2008, 11(2):109-112.
37.	曹家麟, 黃臘平, 祝梅君.肝炎肝硬化中醫證型與肝纖維化指標及病理改變相關性分析.中西醫結合肝病雜志, 2002, 12(4):234-235.
38.	朱方石, 金實, 汪悅.肝硬化中醫證型與肝纖維化指標相關性的研究.遼寧中醫雜志, 2000, 11(27):481-482.

1. ?莊輝.乙型肝炎流行病學研究進展.中國醫學前沿雜志(電子版), 2009, 1(2):18-20.
2. 李幼平.循證醫學.第1版.北京:高等教育出版社. 2003:2-3, 183-186.
3. 中華醫學會傳染病和寄生蟲病學分會, 肝病學分會病毒性肝炎防治方案.中華內科雜志, 2001, 40(1):62.
4. 劉關鍵, 吳泰相. Meta分析的森林圖及臨床意義.中國循證醫學雜志, 2004, 4(3):198-200.
5. 張敏, 李長春.和絡舒肝膠囊治療慢性乙型肝炎肝纖維化56例.中西結合肝病雜志, 2006, 16(3):176-177.
6. 朱越, 索艾生.和絡舒肝膠囊治療慢性肝炎臨床研究.中西結合肝病雜志, 2002, 12(4):207-208.
7. 崔建軍, 許誠, 王松, 等.和絡舒肝膠囊抗肝纖維化的療效觀察.實用肝臟病雜志, 2003, 6(3):161-162.
8. 王融冰, 孫鳳霞, 王曉靜, 等.和絡舒肝膠囊治療慢性乙型肝炎縮脾療效觀察.世界中醫藥, 2006, 1(1):20-22.
9. 劉平, 胡義揚, 劉成, 等.扶正化瘀膠囊干預慢性乙型肝炎肝纖維化作用的多中心臨床研究.中西結合學報, 2003, 1(2):89-98.
10. 溫偉波, 王華寧, 李莉.肝平膠囊(復方319膠囊)治療慢性乙型肝炎肝纖維化臨床療效觀察.中國名族民間醫藥雜志, 2002, 57:210-212.
11. 葉軍, 張潔, 夏敏.肝平膠囊治療慢性乙型肝炎的臨床療效觀察.中華醫學全科雜志, 2003, 2(1):25-26.
12. 陳菊梅, 楊永平, 陳德永, 等.復方鱉甲軟肝片治療慢性乙型肝炎肝纖維化的臨床研究.中華實驗和臨床病毒學雜志. 2007, 12, 21(4):358-360.
13. 寧小燕, 唐蒙軒, 陳星浩, 等.華北煤炭醫學院學報. 2006, 8(3): 341-342.
14. 黃加權, 王軍, 郭威, 等.和絡舒肝膠囊治療慢性乙型肝炎臨床研究.中西醫結音肝病雜志, 2001, 11(2):69-70.
15. 陸海英, 曾爭, 吳赤紅, 等.復方鱉甲軟肝片治療慢性乙型肝炎早起肝硬化的臨床研究.胃腸病和肝病學雜志, 2007, 12(6):605.
16. 常紅, 李佃貴, 張绔, 等.肝復健膠囊治療慢性乙型肝炎肝纖維化患者92例臨床觀察.中成藥, 2009, 12(31):1812-1813.
17. 王融冰, 王曉靜, 李秀惠, 等.和絡舒肝膠囊治療慢性乙型肝炎臨床療效再評價試驗總結.中華中醫藥學會內科分會學術年會, 2007.
18. 王玨.治肝靈合劑逆轉慢乙肝肝纖維化的臨床研究.河北醫科大學, 2005.
19. 肖建珍, 龍湘珍, 易炎啟, 等.抗纖湯治療肝纖維化60例臨床觀察.湖南中醫雜志, 2002, 18(3):16, 21.
20. Tong QX, Wu YY, Xu B, et al. Study on the effect of heluoshugan capsule on liver fibrosis induced by Schistosoma japonicum infection in mice. Zhongguo Ji Sheng Chong Xue Yu Ji Sheng Chong Bing Za Zhi, 2006, 24(2):129-132.
21. Hu YY, Liu P, Liu C. et al. The value of serum markers in evaluating liver fibrotic changes. Zhonghua Gan Zang Bing Za Zhi, 2006, 14(3): 174-177.
22. Liu P, Hu YY, Liu C. et al. Multicenter clinical study on Fuzhenghuayu capsule against liver fibrosis due to chronic hepatitis B. World J Gastroenterol, 2005, 11(19):2892-2899.
23. Zhang G, Zhang FC, Wang TC, et al. The effects of Chinese national medicine of Huoxueruanjian compound on SMAD signal in hepatic stellate cell and its significance. Zhonghua Gan Zang Bing Za Zhi, 2004, 12(4):213-215.
24. 郭燕.高嘯.晏維, 等.和絡舒肝膠囊對肝纖維化肝組織中乙酰膽堿受體的影響.中國組織化學與細胞化學雜志. 2007, 16(2):154-158.
25. Oben JA, Yang S, Lin H, et al. Acetylcholine pro2 motes the proliferation and collagen gene expression of myofibroblastic hepatic stellate cells. Biochem Biophys Res Commun, 2003, 300(1): 172-177.
26. Oben JA, Roskams T, Yang S, et al. Hepatic fibro2 genesis requires sympathetic neurot ransmitters. Gut, 2004, 53(3):438-445.
27. Oben JA, Yang S, Lin H, et al. Norepinephrine and neuropeptide Ypromote proliferation and collagen gene expression of hepatic myofibroblastic stellate cells. Biochem Biophys Res Commun, 2003, 302(4):685-690.
28. Castilla-Cortazar I, Aliaga-Montilla MA, Salvador J, et al. Insulinlike growth factor-I restores the reduced somatostatinergic tone cont rolling growth hormone secretion in cirrhotic rats. Liver, 2001, 21(6):405-409.
29. 張雅, 劉關鍵.慢性肝病肝纖維化的診斷.中國循證醫學雜志, 2007, 7(4):316-319.
30. 李麗, 何清, 楊大國, 等.扶正化瘀膠囊治療慢性乙型肝炎肝纖維化有效性和安全性的系統評價.中國循證醫學雜志, 2008, 8(10): 892-897.
31. 郭西萍, 王婉, 張繼紅, 等.恩替卡韋聯合和絡舒肝膠囊治療活動性乙型肝炎肝硬化的療效評價.實用肝病雜志, 2009, 12(2):124-126.
32. 任澤久, 龔鈺清, 湯守斌, 等.益氣健脾化瘀消積法治療早期肝硬化32例總結.湖南中醫雜志, 2004, 20(4):17-18.
33. 病毒性肝炎防治方案.中華內科雜志, 2001, 40(1):62-68.
34. 任澤久, 柯昌征, 龔鈺清, 等.疏肝健脾軟堅合劑抗肝纖維化的臨床療效探討.中西醫結合肝病雜志, 2004, 14(5):270-271.
35. 馬建忠, 丁明霞.拉米夫定聯合和絡舒肝膠囊對慢性乙型肝炎肝纖維化指標的影響.中華現代中西醫雜志, 2005, 3(12):1087.
36. 許方瀝.慢性乙型肝炎中醫證候分型的文獻評價.實用肝臟病雜志, 2008, 11(2):109-112.
37. 曹家麟, 黃臘平, 祝梅君.肝炎肝硬化中醫證型與肝纖維化指標及病理改變相關性分析.中西醫結合肝病雜志, 2002, 12(4):234-235.
38. 朱方石, 金實, 汪悅.肝硬化中醫證型與肝纖維化指標相關性的研究.遼寧中醫雜志, 2000, 11(27):481-482.

Chinese Journal of Evidence-Based Medicine

Heluo Shugan Capsule for Liver Fibrosis of Chronic Hepatitis B: A Systematic Review

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