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價_《中國循證醫學雜志》

作者：

何清 ,  王松 , 張琴 , 段鋼 , 邱谷香 , 許誠 , 李知玉 , 唐奇遠

深圳市東湖醫院 ( 深圳 518020);

關鍵詞：

前列腺素 E1 脂微球載體注射液病毒性肝炎系統評價隨機對照試驗

視頻：

導出 下載 收藏 掃碼 引用

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

目的　系統評價前列腺素 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 系統評價方法，計算機檢索 MEDLINE、 EMbase、Cochrane 圖書館臨床對照試驗數據庫（CENTRAL）和 CNKI 等數據庫，檢索時間從 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組，其他藥物或空白治療為對照組的隨機對照試驗。由 2 名研究者獨立評價納入研究的方法學質量，并采用 RevMan 4.2.7 軟件對相關數據進行 Meta 分析。
結果　共納入包括 1218 例患者的 14 個研究，研究質量均為 C級。其中 1 個研究為前列腺素 E1脂微球載體注射液與脈安定注射液對比，1 個研究為前列腺素 E1脂微球載體注射液與門冬氨酸鉀鎂對比，其余 12 個研究為前列腺素 E1脂微球載體注射液與空白對照比較。Meta 分析結果顯示：前列腺素 E1 脂微球載體注射液在總有效率上明顯優于空白對照組［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生率也高于空白對照組[RR7.70，95%CI(2.57, 23.07)]，其余副反應發生率前列腺素 E1脂微球載體注射液雖高于空白對照，但差異無統計學意義；前列腺素 E1脂微球載體注射液在死亡率上低于空白對照組［RR0.66，95%CI（0.53， 0.83）］。因各文獻數據存在臨床異質性，故無法判斷前列腺素 E1脂微球載體注射液在肝功能恢復上是否優于空白對照組。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計學意義（P ＞ 0.05）；但前列腺素 E1脂微球載體注射液在總有效率上優于門冬氨酸鉀鎂［RR1.54，95%CI（1.14，2.08）］。
結論　現有研究結果顯示，與空白對照組相比，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，但其副反應發生率高于空白對照組；對前列腺素 E1脂微球載體注射液是否有助于肝功能恢復，尚無肯定結論。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，而優于門冬氨酸鉀鎂，但其證據強度很弱。

引用本文： 何清,王松,張琴,段鋼,邱谷香,許誠,李知玉,唐奇遠. 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價. 中國循證醫學雜志, 2007, 07(10): 728-736. doi: 復制

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脂微球載體制劑治療急性重癥肝炎的臨床觀察—日本53家醫院不同劑量雙盲試驗的比較.傳染病藥學, 1998; 8(4): 39-40.
28.	楊華元, 張明剛. 靶向藥物轉運系統. 中日友好醫院學報, 2001; 15(5): 292-4.
29.	中華醫學會傳染病與寄生蟲病學分會、肝病學分會聯合修訂.病毒性肝炎防治方案.中華傳染病雜志, 2001; 19(1): 56-62.
30.	中華醫學會傳染病與寄生蟲病學分會肝病學分會聯合修訂. 病毒性肝炎的診斷標準. 中西醫結合肝病雜志, 2001; 11(1): 56-60.
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. 現代中西醫結合雜志, 2003; 12(24): 2650.
32.	周華堅, 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.
33.	黃團新, 宋仕玲, 伍秀珍, 等. 脂微球載體前列腺素治療急性戊型淤膽型肝炎臨床評價.臨床肝病雜志, 2005; 21(6): 3.
34.	孟麗. 前列腺素E1脂微球載體注射液聯合復方丹參治療慢性乙型肝炎高膽紅素血癥療效觀察. 中原醫刊, 2003; 30(24): 54-5.
35.	陳麗, 彭俊娟, 楊麗君. 前列腺素E1脂微球載體合并促肝細胞生長素治療重癥肝炎臨床研究. 淮海醫藥, 2005: 23(5): 346-7.
36.	觀曉輝, 溫帆淵. 前列腺素E1脂微球載體聯合甘草酸二銨治療慢性乙型肝炎肝內淤膽的療效觀察. 現代醫藥衛生, 2004; 20(13): 1202-3.
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.	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.徐州醫學院學報, 2003; 23(4): 340-1.
39.	陳林. 前列腺素E1注射液治療慢性重型肝炎療效觀察.臨床肝膽病雜志, 2004; 20(2): 89-90.
40.	沙琪, 宋政. 脂微球載體前列腺素E1 在重度黃疸肝炎中的應用(附50 例分析). 胃腸病學和肝病學雜志, 2004; 13(1): 78.
41.	顧慧華, 田力, 薛來英. 前列腺素E1脂微球載體制劑治療慢性重型肝炎的臨床研究. 中國現代應用藥學雜志, 2004; 21(1): 69-71.
42.	連豫苞, 歐文湖, 吳春曉, 等. 前列腺素E1脂微球載體制劑治療活動性肝硬化40例.中西醫結合肝病雜志, 2003; supply: 110-1.
43.	宋仕玲, 朱艷, 劉章紅, 等. 脂微球載體前列腺素對慢性重型肝炎患者有關血清學指標及預后的影響. 臨床軍醫雜志, 2006; 34(4); 412-3.
44.	趙衛峰, 羅二平, 江敏華, 等. 前列腺素E1 脂微球注射液治療重型肝炎的臨床觀察.蘇州大學學報, 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脂微球載體制劑治療急性重癥肝炎的臨床觀察—日本53家醫院不同劑量雙盲試驗的比較.傳染病藥學, 1998; 8(4): 39-40.
28. 楊華元, 張明剛. 靶向藥物轉運系統. 中日友好醫院學報, 2001; 15(5): 292-4.
29. 中華醫學會傳染病與寄生蟲病學分會、肝病學分會聯合修訂.病毒性肝炎防治方案.中華傳染病雜志, 2001; 19(1): 56-62.
30. 中華醫學會傳染病與寄生蟲病學分會肝病學分會聯合修訂. 病毒性肝炎的診斷標準. 中西醫結合肝病雜志, 2001; 11(1): 56-60.
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. 現代中西醫結合雜志, 2003; 12(24): 2650.
32. 周華堅, 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.
33. 黃團新, 宋仕玲, 伍秀珍, 等. 脂微球載體前列腺素治療急性戊型淤膽型肝炎臨床評價.臨床肝病雜志, 2005; 21(6): 3.
34. 孟麗. 前列腺素E1脂微球載體注射液聯合復方丹參治療慢性乙型肝炎高膽紅素血癥療效觀察. 中原醫刊, 2003; 30(24): 54-5.
35. 陳麗, 彭俊娟, 楊麗君. 前列腺素E1脂微球載體合并促肝細胞生長素治療重癥肝炎臨床研究. 淮海醫藥, 2005: 23(5): 346-7.
36. 觀曉輝, 溫帆淵. 前列腺素E1脂微球載體聯合甘草酸二銨治療慢性乙型肝炎肝內淤膽的療效觀察. 現代醫藥衛生, 2004; 20(13): 1202-3.
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. 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.徐州醫學院學報, 2003; 23(4): 340-1.
39. 陳林. 前列腺素E1注射液治療慢性重型肝炎療效觀察.臨床肝膽病雜志, 2004; 20(2): 89-90.
40. 沙琪, 宋政. 脂微球載體前列腺素E1 在重度黃疸肝炎中的應用(附50 例分析). 胃腸病學和肝病學雜志, 2004; 13(1): 78.
41. 顧慧華, 田力, 薛來英. 前列腺素E1脂微球載體制劑治療慢性重型肝炎的臨床研究. 中國現代應用藥學雜志, 2004; 21(1): 69-71.
42. 連豫苞, 歐文湖, 吳春曉, 等. 前列腺素E1脂微球載體制劑治療活動性肝硬化40例.中西醫結合肝病雜志, 2003; supply: 110-1.
43. 宋仕玲, 朱艷, 劉章紅, 等. 脂微球載體前列腺素對慢性重型肝炎患者有關血清學指標及預后的影響. 臨床軍醫雜志, 2006; 34(4); 412-3.
44. 趙衛峰, 羅二平, 江敏華, 等. 前列腺素E1 脂微球注射液治療重型肝炎的臨床觀察.蘇州大學學報, 2002; 22(4): 419-421.

《中國循證醫學雜志》

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價

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

Format

Content

《中國循證醫學雜志》

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價

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

Format

Content

摘要全文圖表視頻參考文獻施引文獻補充材料