目的 　系統(tǒng)評(píng)價(jià)前列腺素 E1 脂微球載體注射液治療病毒性肝炎的有效性和安全性。
方法 　采用 Cochrane 系統(tǒng)評(píng)價(jià)方法，計(jì)算機(jī)檢索 MEDLINE、 EMbase、Cochrane 圖書館臨床對(duì)照試驗(yàn)數(shù)據(jù)庫（CENTRAL）和 CNKI 等數(shù)據(jù)庫，檢索時(shí)間從 1978 年到 2007 年。納入在治療病毒性肝炎中，以前列腺素 E1脂微球載體注射液為試驗(yàn)組，其他藥物或空白治療為對(duì)照組的隨機(jī)對(duì)照試驗(yàn)。由 2 名研究者獨(dú)立評(píng)價(jià)納入研究的方法學(xué)質(zhì)量，并采用 RevMan 4.2.7 軟件對(duì)相關(guān)數(shù)據(jù)進(jìn)行 Meta 分析。
結(jié)果 　共納入包括 1218 例患者的 14 個(gè)研究，研究質(zhì)量均為 C級(jí)。其中 1 個(gè)研究為前列腺素 E1脂微球載體注射液與脈安定注射液對(duì)比，1 個(gè)研究為前列腺素 E1脂微球載體注射液與門冬氨酸鉀鎂對(duì)比，其余 12 個(gè)研究為前列腺素 E1脂微球載體注射液與空白對(duì)照比較。Meta 分析結(jié)果顯示：前列腺素 E1 脂微球載體注射液在總有效率上明顯優(yōu)于空白對(duì)照組［RR1.45，95%CI（1.29， 1.63）］，但在用藥后注射部位靜脈血管潮紅疼痛發(fā)生率也高于空白對(duì)照組[RR7.70，95%CI(2.57, 23.07)]，其余副反應(yīng)發(fā)生率前列腺素 E1脂微球載體注射液雖高于空白對(duì)照，但差異無統(tǒng)計(jì)學(xué)意義；前列腺素 E1脂微球載體注射液在死亡率上低于空白對(duì)照組［RR0.66，95%CI（0.53， 0.83）］。因各文獻(xiàn)數(shù)據(jù)存在臨床異質(zhì)性，故無法判斷前列腺素 E1脂微球載體注射液在肝功能恢復(fù)上是否優(yōu)于空白對(duì)照組。前列腺素 E1 脂微球載體注射液與脈安定注射液治療后總有效率的差異無統(tǒng)計(jì)學(xué)意義（P ＞ 0.05）；但前列腺素 E1脂微球載體注射液在總有效率上優(yōu)于門冬氨酸鉀鎂［RR1.54，95%CI（1.14，2.08）］。
結(jié)論 　現(xiàn)有研究結(jié)果顯示，與空白對(duì)照組相比，前列腺素 E1脂微球載體注射液可明顯提高病毒性肝炎治療后總有效率，并降低死亡率，但其副反應(yīng)發(fā)生率高于空白對(duì)照組；對(duì)前列腺素 E1脂微球載體注射液是否有助于肝功能恢復(fù)，尚無肯定結(jié)論。前列腺素 E1脂微球載體注射液治療病毒性肝炎的療效與安全性和脈安定注射液無明顯差別，而優(yōu)于門冬氨酸鉀鎂，但其證據(jù)強(qiáng)度很弱。

引用本文： 何清,王松,張琴,段鋼,邱谷香,許誠,李知玉,唐奇遠(yuǎn). 前列腺素E1脂微球載體注射液治療病毒性肝炎的有效性和安全性評(píng)價(jià). 中國循證醫(yī)學(xué)雜志, 2007, 07(10): 728-736. doi: 復(fù)制

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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.
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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.
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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.
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32. 周華堅(jiān), 李韶光, 楊小云, 等. 前列腺素E1脂微球載體制劑治療病毒性肝炎高膽紅素血癥的療效和安全性. 中國新藥雜志, 2005; 14 (7): 909-11.
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  1. 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. 2. Yang HY, Zhang MG. Transport system for target drug. Journal of China-Japan Friendship Hospital, 2001; 15(5): 292-4.
  3. 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. 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. 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. 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. 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. 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. 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. 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. 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. 12. Lu JZ. Observation on effects of Kai Shi for chronic severe hepatitis. Acta academiae medicinae Xuzhou, 2003; 23(4): 340-1.
  13. 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. 14. Sha Q, Song Z. Application of proslaglandin E1 in serious cholestatic hepatitis. Chinese journal of gastrology and hepatology, 2004; 13(1): 78.
  15. 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. 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. 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. 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. 19. Recommendations of the Immunization Practices Advisory Committee (ACIP). Recommendations for protection against viral hepatitis. MMWR, 1985; 34: 313–335.
  20. 20. Update on hepatitis B prevention. MMWR, 1987; 36: 353–366.
  21. 21. Spiro HM: Clinical gastroenterology. New York: MacMillan, 1983:1354–1375.
  22. 22. Ganem D, Prince AM. Hepatitis B virus infection-natural history and clinical consequences. N Engl J Med, 2004; 350: 1118-1129.
  23. 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. 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. 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. 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. 27. 市田文弘, 佐藤俊一, 武藤泰敏, 等. 前列腺素E_1脂微球載體制劑治療急性重癥肝炎的臨床觀察—日本53家醫(yī)院不同劑量雙盲試驗(yàn)的比較.傳染病藥學(xué), 1998; 8(4): 39-40.
  28. 28. 楊華元, 張明剛. 靶向藥物轉(zhuǎn)運(yùn)系統(tǒng). 中日友好醫(yī)院學(xué)報(bào), 2001; 15(5): 292-4.
  29. 29. 中華醫(yī)學(xué)會(huì)傳染病與寄生蟲病學(xué)分會(huì)、肝病學(xué)分會(huì)聯(lián)合修訂.病毒性肝炎防治方案.中華傳染病雜志, 2001; 19(1): 56-62.
  30. 30. 中華醫(yī)學(xué)會(huì)傳染病與寄生蟲病學(xué)分會(huì)肝病學(xué)分會(huì)聯(lián)合修訂. 病毒性肝炎的診斷標(biāo)準(zhǔn). 中西醫(yī)結(jié)合肝病雜志, 2001; 11(1): 56-60.
  31. 31. 崔鳳芹, 程慧楨, 沙琪. 前列腺素E1脂微球載體治療重度黃疸肝炎36 例療效觀察. 現(xiàn)代中西醫(yī)結(jié)合雜志, 2003; 12(24): 2650.
  32. 32. 周華堅(jiān), 李韶光, 楊小云, 等. 前列腺素E1脂微球載體制劑治療病毒性肝炎高膽紅素血癥的療效和安全性. 中國新藥雜志, 2005; 14 (7): 909-11.
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  35. 35. 陳麗, 彭俊娟, 楊麗君. 前列腺素E1脂微球載體合并促肝細(xì)胞生長素治療重癥肝炎臨床研究. 淮海醫(yī)藥, 2005: 23(5): 346-7.
  36. 36. 觀曉輝, 溫帆淵. 前列腺素E1脂微球載體聯(lián)合甘草酸二銨治療慢性乙型肝炎肝內(nèi)淤膽的療效觀察. 現(xiàn)代醫(yī)藥衛(wèi)生, 2004; 20(13): 1202-3.
  37. 37. 鄧欣, 王東, 聶廣. 前列腺素E1脂微球載體治療病毒性肝炎高膽紅素血癥30 例. 中國新藥雜志, 2002: 11(8): 647-8.
  38. 38. 陸建中. 前列腺素E1脂微球載體治療慢性重型肝炎52例臨床觀察.徐州醫(yī)學(xué)院學(xué)報(bào), 2003; 23(4): 340-1.
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