Effectiveness and Safety of Lipo-prostaglandin E1 Injectionfor Viral Hepatitis: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

HE Qing ,  WANG Song , ZHANG Qin , DUAN Gang , QIU Guxiang , XU Cheng , LI Zhiyu , TANG Qiyuang

Donghu hospital of Shenzhen, Shenzhen 518020;

Corresponding author：

WANG Song, Email: heqingjoe@163.com

Keywords：

Lipo-prostagladin E1 injection; Viral hepatitis; Systematic review; Randomized controlled trials

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Objective 　To evaluate the effectiveness and safety of Lipo-prostaglandin E1 injection in treating viral hepatitis.
Methods 　We searched MEDLINE, EMBASE, The Cochrane Library and CNKI from 1978 to June 2007. We identified randomized control led trials of Kai Shi injection versus other medicines or blank controlin treating viral hepatitis. The quality of included trials was evaluated independently by two reviewers. Meta-analyses were performed with The Cochrane Collaboration’s RevMan 4.2.7 software.
Results 　Fourteen studies involving 1 218 patients were included, one of these compared lipo-prostaglandin E1 injection versus Mai Anding injection, one compared lipo-prostaglandin E1 injection versus potassium-magnesium aspartate injection, and the other 12 compared Lipo-prostaglandin E1 injection versus blank control. Allincluded studies were assessed in terms of randomization, allocation concealment and blinding; and all were graded C(poor quality). Meta-analyses showed that, the total effective rate was significantly higher in the lipo-prostaglandin E1 injection group[RR 1.45, 95%CI (1.29, 1.63)] and the mortality was lower[RR 0.66, 95%CI (0.53, 0.83)] compared with the blank control group, but the incidence of phlebitis was significantlyhigher [RR 7.70, 95%CI (2.57, 23.07)]. There was no significant di f ference between Mai Anding inject ion and lipo-prostaglandin E1 injection in the total effective rate, but Lipo-prostaglandin E1 injection was more effective in improving patients’ liver functions. Compared with potassium-magnesium aspartate injection, the total effective rate was significantly higher in the lipo-prostaglandin E1 injection group[RR1.54, 95%CI (1.14, 2.08)].
Conclusion　 The evidence currently available shows that the effectiveness and safety of lipo-prostaglandin E1 injection are not significantly different from those of Mai Anding injection for patients with viral hepatitis. Compared with potassium-magnesium aspartate injection, Lipo-prostaglandin E1 injection could significantly improve the total effective rate, but since we only include 1 relevant randomized trials, the strength of this evidence is weak. When compared with the blank control, Lipo-prostaglandin E1 injection significantly improved the total effective rate, decreased mortality but increased the incidence of side effects and the existing evidence is insufficiant to show whether Lipo-prostaglandin E1 injection improves patients’ liver functions.

Citation： HE Qing,WANG Song,ZHANG Qin,DUAN Gang,QIU Guxiang,XU Cheng,LI Zhiyu,TANG Qiyuang. Effectiveness and Safety of Lipo-prostaglandin E1 Injectionfor Viral Hepatitis: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2007, 07(10): 728-736. doi: Copy

1.	Shi Tian, Wen Hong, Zuo Teng Jun Yi, Wu Teng Tai Min, etc. Observation on effects of Li pi-PGE1 in treating acute severe hepatitis. Comparison among different dosages in double blind trials in 53 hospitals in Japan. Pharmacology of communicable diseases, 1998; 8(4): 39-40.
2.	Yang HY, Zhang MG. Transport system for target drug. Journal of China-Japan Friendship Hospital, 2001; 15(5): 292-4.
3.	Chinese Society of Infectious Diseases and Parasitology and Chinese Society of Hepatology of Chinese Medical Association. The progamme of prevention and cure for viral hepatitis. Chinese Journal of Infectious Diseases, 2001; 19(1): 56-62.
4.	Chinese Society of Infectious Diseases and Parasitology and Chinese Society of Hepatology of Chinese Medical Association. The standard of diagnosis for viral hepatitis. Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases, 2001; 11(1): 56-60.
5.	Cui FQ, Chen HZ, Sha Q. Observation on effects of Kai Shi injection treating patients with severe icteric hepatitis. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2003; 12 (24): 2650.
6.	Zhou HJ, Li SG, Yang XY, et al. Effectiveness and safety of Lipi-PGE1 for treating viral hepatitis with hyperbilirubinemia. Chinese journal of new drugs, 2005; 14(7): 909-11.
7.	Huang TX, Song SL, Wu XZ, et al . Evaluation of ef fects of prostaglandin E1 in the treatment of acute viral cholestatic hepatitis E. Chinese journal of clinical hepatology, 2005; 21(6): 352-3.
8.	Meng L. Observation on effects of Kai Shi injection and Dan Shen compound treating viral cholestatic hepatitis B. Central plains medical journal, 2003; 30(24): 54-5.
9.	Chen L, Peng JJ, Yang LJ. Clin ical study on the effects of combin ing alplrosladil with in jectic hepatic growth factor therapy in patients with severe hepatitis. Journal of Huaihai medicine, 2005; 23(5): 346-7.
10.	Guan XH, Wen FY. Observation of therapeutic effect of combination therapy with liporostagladin E1 and diammonium glycyrrhizinate for intrahepatic cholestasis of chronic hepatitis B. Jouranl of current medicine and health, 2004; 20(13): 1202-3.
11.	Den X, Wang D, Lei G. Kai Shi injection for 30 cases in viral hepatitis with hyperbilirubinema. Chinese Journal of new drugs, 2002; 11(8): 647-8.
12.	Lu JZ. Observation on effects of Kai Shi for chronic severe hepatitis. Acta academiae medicinae Xuzhou, 2003; 23(4): 340-1.
13.	Chen L. Effects of lipid microspheres prostaglandin E1 injection on the treatment of chronic severe hepatitis. Chinese journal of clinical hepatology, 2004; 20(2): 89-90.
14.	Sha Q, Song Z. Application of proslaglandin E1 in serious cholestatic hepatitis. Chinese journal of gastrology and hepatology, 2004; 13(1): 78.
15.	Gu HH, Tian L, Xue LY. Clinical study of Li po PGE1 on chronic severe hepatitis. Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases, 2004; 21(1): 69-71.
16.	Lian YB, Ou WH, Wu CX, et al. Lipo-PGE1 for 40 cases in active hepatic cirrhosis. Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases, 2003; supply: 110-1.
17.	Song SL, Zhu Y, Liu ZZ, et al. Evaluation of Effects of Prostagland in E1 in the Treatment of Chronic Fulminant Hepatitis. Chinese journal of medicine official, 2006; 34(4): 412-3.
18.	Zhao WF, Luo EQ, Jiag MH, et al. A Clinical Observation of Treatment of Li pid Microspheres Prostaglandin E1 Injection in Severe Hepatitis. Suzhou university joutnal of medical science, 2002; 22(4): 419-21.
19.	Recommendations of the Immunization Practices Advisory Committee (ACIP). Recommendations for protection against viral hepatitis. MMWR, 1985; 34: 313–335.
20.	Update on hepatitis B prevention. MMWR, 1987; 36: 353–366.
21.	Spiro HM: Clinical gastroenterology. New York: MacMillan, 1983:1354–1375.
22.	Ganem D, Prince AM. Hepatitis B virus infection-natural history and clinical consequences. N Engl J Med, 2004; 350: 1118-1129.
23.	WHO Global surveillance and control of hepatitis C. Report of a WHO Consultationorganized in collaboration with the Viral Hepatitis Prevention Board, Antwerp, Belgium. J Viral Hepat, 1999; 6: 35–47.
24.	Sugawara Y, Kubota K, Ogura T, et al . Protective ef fect of prostaglandin E1 against ischemia/Reperfusion-induced liver injury: Reults of aprospective, randomized study in cirrhotic patients undergoing subsegmentectomy. Hepatology, 1998; 29 (06): 969-976.
25.	Takahashi H, Imamura M, Mikami Y, et al. Exacerbation of acute pancreatitis in the preence of chronic liver injury in rats, with special reference to therapeutic effecacyof prostag-tandin E1 Pancreas, 1999; 19 (2):199-204.
26.	Hanazakik, Kajikawa S, Fujimori Y, et al. Effects of prostaglandin E1 and instration during hepatectom ofr cirrhotic hepatocellular carcinoma. Hepatogastroenterology, 2000; 47 (32): 461-464.
27.	市田文弘, 佐藤俊一, 武藤泰敏, 等. 前列腺素E_1脂微球载体制剂治疗急性重症肝炎的临床观察—日本53家医院不同剂量双盲试验的比较.传染病药学, 1998; 8(4): 39-40.
28.	杨华元, 张明刚. 靶向药物转运系统. 中日友好医院学报, 2001; 15(5): 292-4.
29.	中华医学会传染病与寄生虫病学分会、肝病学分会联合修订.病毒性肝炎防治方案.中华传染病杂志, 2001; 19(1): 56-62.
30.	中华医学会传染病与寄生虫病学分会肝病学分会联合修订. 病毒性肝炎的诊断标准. 中西医结合肝病杂志, 2001; 11(1): 56-60.
31.	崔凤芹, 程慧桢, 沙琪. 前列腺素E1脂微球载体治疗重度黄疸肝炎36 例疗效观察. 现代中西医结合杂志, 2003; 12(24): 2650.
32.	周华坚, 李韶光, 杨小云, 等. 前列腺素E1脂微球载体制剂治疗病毒性肝炎高胆红素血症的疗效和安全性. 中国新药杂志, 2005; 14 (7): 909-11.
33.	黄团新, 宋仕玲, 伍秀珍, 等. 脂微球载体前列腺素治疗急性戊型淤胆型肝炎临床评价.临床肝病杂志, 2005; 21(6): 3.
34.	孟丽. 前列腺素E1脂微球载体注射液联合复方丹参治疗慢性乙型肝炎高胆红素血症疗效观察. 中原医刊, 2003; 30(24): 54-5.
35.	陈丽, 彭俊娟, 杨丽君. 前列腺素E1脂微球载体合并促肝细胞生长素治疗重症肝炎临床研究. 淮海医药, 2005: 23(5): 346-7.
36.	观晓辉, 温帆渊. 前列腺素E1脂微球载体联合甘草酸二铵治疗慢性乙型肝炎肝内淤胆的疗效观察. 现代医药卫生, 2004; 20(13): 1202-3.
37.	邓欣, 王东, 聂广. 前列腺素E1脂微球载体治疗病毒性肝炎高胆红素血症30 例. 中国新药杂志, 2002: 11(8): 647-8.
38.	陆建中. 前列腺素E1脂微球载体治疗慢性重型肝炎52例临床观察.徐州医学院学报, 2003; 23(4): 340-1.
39.	陈林. 前列腺素E1注射液治疗慢性重型肝炎疗效观察.临床肝胆病杂志, 2004; 20(2): 89-90.
40.	沙琪, 宋政. 脂微球载体前列腺素E1 在重度黄疸肝炎中的应用(附50 例分析). 胃肠病学和肝病学杂志, 2004; 13(1): 78.
41.	顾慧华, 田力, 薛来英. 前列腺素E1脂微球载体制剂治疗慢性重型肝炎的临床研究. 中国现代应用药学杂志, 2004; 21(1): 69-71.
42.	连豫苞, 欧文湖, 吴春晓, 等. 前列腺素E1脂微球载体制剂治疗活动性肝硬化40例.中西医结合肝病杂志, 2003; supply: 110-1.
43.	宋仕玲, 朱艳, 刘章红, 等. 脂微球载体前列腺素对慢性重型肝炎患者有关血清学指标及预后的影响. 临床军医杂志, 2006; 34(4); 412-3.
44.	赵卫峰, 罗二平, 江敏华, 等. 前列腺素E1 脂微球注射液治疗重型肝炎的临床观察.苏州大学学报, 2002; 22(4): 419-421.

1. Shi Tian, Wen Hong, Zuo Teng Jun Yi, Wu Teng Tai Min, etc. Observation on effects of Li pi-PGE1 in treating acute severe hepatitis. Comparison among different dosages in double blind trials in 53 hospitals in Japan. Pharmacology of communicable diseases, 1998; 8(4): 39-40.
2. Yang HY, Zhang MG. Transport system for target drug. Journal of China-Japan Friendship Hospital, 2001; 15(5): 292-4.
3. Chinese Society of Infectious Diseases and Parasitology and Chinese Society of Hepatology of Chinese Medical Association. The progamme of prevention and cure for viral hepatitis. Chinese Journal of Infectious Diseases, 2001; 19(1): 56-62.
4. Chinese Society of Infectious Diseases and Parasitology and Chinese Society of Hepatology of Chinese Medical Association. The standard of diagnosis for viral hepatitis. Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases, 2001; 11(1): 56-60.
5. Cui FQ, Chen HZ, Sha Q. Observation on effects of Kai Shi injection treating patients with severe icteric hepatitis. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2003; 12 (24): 2650.
6. Zhou HJ, Li SG, Yang XY, et al. Effectiveness and safety of Lipi-PGE1 for treating viral hepatitis with hyperbilirubinemia. Chinese journal of new drugs, 2005; 14(7): 909-11.
7. Huang TX, Song SL, Wu XZ, et al . Evaluation of ef fects of prostaglandin E1 in the treatment of acute viral cholestatic hepatitis E. Chinese journal of clinical hepatology, 2005; 21(6): 352-3.
8. Meng L. Observation on effects of Kai Shi injection and Dan Shen compound treating viral cholestatic hepatitis B. Central plains medical journal, 2003; 30(24): 54-5.
9. Chen L, Peng JJ, Yang LJ. Clin ical study on the effects of combin ing alplrosladil with in jectic hepatic growth factor therapy in patients with severe hepatitis. Journal of Huaihai medicine, 2005; 23(5): 346-7.
10. Guan XH, Wen FY. Observation of therapeutic effect of combination therapy with liporostagladin E1 and diammonium glycyrrhizinate for intrahepatic cholestasis of chronic hepatitis B. Jouranl of current medicine and health, 2004; 20(13): 1202-3.
11. Den X, Wang D, Lei G. Kai Shi injection for 30 cases in viral hepatitis with hyperbilirubinema. Chinese Journal of new drugs, 2002; 11(8): 647-8.
12. Lu JZ. Observation on effects of Kai Shi for chronic severe hepatitis. Acta academiae medicinae Xuzhou, 2003; 23(4): 340-1.
13. Chen L. Effects of lipid microspheres prostaglandin E1 injection on the treatment of chronic severe hepatitis. Chinese journal of clinical hepatology, 2004; 20(2): 89-90.
14. Sha Q, Song Z. Application of proslaglandin E1 in serious cholestatic hepatitis. Chinese journal of gastrology and hepatology, 2004; 13(1): 78.
15. Gu HH, Tian L, Xue LY. Clinical study of Li po PGE1 on chronic severe hepatitis. Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases, 2004; 21(1): 69-71.
16. Lian YB, Ou WH, Wu CX, et al. Lipo-PGE1 for 40 cases in active hepatic cirrhosis. Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases, 2003; supply: 110-1.
17. Song SL, Zhu Y, Liu ZZ, et al. Evaluation of Effects of Prostagland in E1 in the Treatment of Chronic Fulminant Hepatitis. Chinese journal of medicine official, 2006; 34(4): 412-3.
18. Zhao WF, Luo EQ, Jiag MH, et al. A Clinical Observation of Treatment of Li pid Microspheres Prostaglandin E1 Injection in Severe Hepatitis. Suzhou university joutnal of medical science, 2002; 22(4): 419-21.
19. Recommendations of the Immunization Practices Advisory Committee (ACIP). Recommendations for protection against viral hepatitis. MMWR, 1985; 34: 313–335.
20. Update on hepatitis B prevention. MMWR, 1987; 36: 353–366.
21. Spiro HM: Clinical gastroenterology. New York: MacMillan, 1983:1354–1375.
22. Ganem D, Prince AM. Hepatitis B virus infection-natural history and clinical consequences. N Engl J Med, 2004; 350: 1118-1129.
23. WHO Global surveillance and control of hepatitis C. Report of a WHO Consultationorganized in collaboration with the Viral Hepatitis Prevention Board, Antwerp, Belgium. J Viral Hepat, 1999; 6: 35–47.
24. Sugawara Y, Kubota K, Ogura T, et al . Protective ef fect of prostaglandin E1 against ischemia/Reperfusion-induced liver injury: Reults of aprospective, randomized study in cirrhotic patients undergoing subsegmentectomy. Hepatology, 1998; 29 (06): 969-976.
25. Takahashi H, Imamura M, Mikami Y, et al. Exacerbation of acute pancreatitis in the preence of chronic liver injury in rats, with special reference to therapeutic effecacyof prostag-tandin E1 Pancreas, 1999; 19 (2):199-204.
26. Hanazakik, Kajikawa S, Fujimori Y, et al. Effects of prostaglandin E1 and instration during hepatectom ofr cirrhotic hepatocellular carcinoma. Hepatogastroenterology, 2000; 47 (32): 461-464.
27. 市田文弘, 佐藤俊一, 武藤泰敏, 等. 前列腺素E_1脂微球载体制剂治疗急性重症肝炎的临床观察—日本53家医院不同剂量双盲试验的比较.传染病药学, 1998; 8(4): 39-40.
28. 杨华元, 张明刚. 靶向药物转运系统. 中日友好医院学报, 2001; 15(5): 292-4.
29. 中华医学会传染病与寄生虫病学分会、肝病学分会联合修订.病毒性肝炎防治方案.中华传染病杂志, 2001; 19(1): 56-62.
30. 中华医学会传染病与寄生虫病学分会肝病学分会联合修订. 病毒性肝炎的诊断标准. 中西医结合肝病杂志, 2001; 11(1): 56-60.
31. 崔凤芹, 程慧桢, 沙琪. 前列腺素E1脂微球载体治疗重度黄疸肝炎36 例疗效观察. 现代中西医结合杂志, 2003; 12(24): 2650.
32. 周华坚, 李韶光, 杨小云, 等. 前列腺素E1脂微球载体制剂治疗病毒性肝炎高胆红素血症的疗效和安全性. 中国新药杂志, 2005; 14 (7): 909-11.
33. 黄团新, 宋仕玲, 伍秀珍, 等. 脂微球载体前列腺素治疗急性戊型淤胆型肝炎临床评价.临床肝病杂志, 2005; 21(6): 3.
34. 孟丽. 前列腺素E1脂微球载体注射液联合复方丹参治疗慢性乙型肝炎高胆红素血症疗效观察. 中原医刊, 2003; 30(24): 54-5.
35. 陈丽, 彭俊娟, 杨丽君. 前列腺素E1脂微球载体合并促肝细胞生长素治疗重症肝炎临床研究. 淮海医药, 2005: 23(5): 346-7.
36. 观晓辉, 温帆渊. 前列腺素E1脂微球载体联合甘草酸二铵治疗慢性乙型肝炎肝内淤胆的疗效观察. 现代医药卫生, 2004; 20(13): 1202-3.
37. 邓欣, 王东, 聂广. 前列腺素E1脂微球载体治疗病毒性肝炎高胆红素血症30 例. 中国新药杂志, 2002: 11(8): 647-8.
38. 陆建中. 前列腺素E1脂微球载体治疗慢性重型肝炎52例临床观察.徐州医学院学报, 2003; 23(4): 340-1.
39. 陈林. 前列腺素E1注射液治疗慢性重型肝炎疗效观察.临床肝胆病杂志, 2004; 20(2): 89-90.
40. 沙琪, 宋政. 脂微球载体前列腺素E1 在重度黄疸肝炎中的应用(附50 例分析). 胃肠病学和肝病学杂志, 2004; 13(1): 78.
41. 顾慧华, 田力, 薛来英. 前列腺素E1脂微球载体制剂治疗慢性重型肝炎的临床研究. 中国现代应用药学杂志, 2004; 21(1): 69-71.
42. 连豫苞, 欧文湖, 吴春晓, 等. 前列腺素E1脂微球载体制剂治疗活动性肝硬化40例.中西医结合肝病杂志, 2003; supply: 110-1.
43. 宋仕玲, 朱艳, 刘章红, 等. 脂微球载体前列腺素对慢性重型肝炎患者有关血清学指标及预后的影响. 临床军医杂志, 2006; 34(4); 412-3.
44. 赵卫峰, 罗二平, 江敏华, 等. 前列腺素E1 脂微球注射液治疗重型肝炎的临床观察.苏州大学学报, 2002; 22(4): 419-421.

Chinese Journal of Evidence-Based Medicine

Effectiveness and Safety of Lipo-prostaglandin E1 Injectionfor Viral Hepatitis: A Systematic Review

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