• 四川大學華西醫(yī)院消化內科,成都,610041;

目的 　評價烏司他丁治療急性胰腺炎的有效性和安全性.
方法 　應用國際Cochrane協(xié)作網(wǎng)系統(tǒng)評價方法對烏司他丁治療急性胰腺炎的隨機對照試驗(RCT)進行系統(tǒng)評價.計算機檢索Cochrane臨床對照試驗資料庫(2004年第3期)、MEDLINE(1966～2004)、EMBASE(1984～2004)和中國生物醫(yī)學文獻數(shù)據(jù)庫(1978～2004),手工檢索發(fā)表與未發(fā)表的中文文獻,納入烏司他丁與其他治療措施相比較的隨機對照試驗,是否使用盲法語種均不受限制.統(tǒng)計學處理采用Cochrane協(xié)作網(wǎng)提供的RevMan 4.2軟件.
結果 　共納入17個RCT,1 199例患者,所有納入試驗在治療末均未進行隨訪.烏司他丁加常規(guī)治療與常規(guī)治療比較:6個試驗的Meta 分析結果顯示,烏司他丁組的治療有效率(176/189,93.12%)明顯高于對照組(143/195,73.33%),其差異具有統(tǒng)計學意義[Peto OR 4.29,95%CI(2.49,7.37), P lt;0.00001].烏司他丁組平均住院日低于對照組,其差異具有統(tǒng)計學意義[WMD -4.93,95%CI (-7.76,-2.09), P＝0.0007].烏司他丁加常規(guī)治療與其他藥物加常規(guī)治療比較:2個試驗的Meta分析結果顯示,烏司他丁組的治療有效率(131/151,86.75%)與對照組(99/123,80.49%)相比有增高趨勢,但差異無統(tǒng)計學意義[Peto OR1.46,95%CI(0.76,2.80), P=0.26].1個試驗顯示,烏司他丁組的平均住院日為23.5±7.5天,低于對照組34.0±6.4天,其差異有統(tǒng)計學意義(P lt;0.05).且不良反應發(fā)生率(7/488,1.43%)較低.
結論 　本研究所納入試驗的方法學質量均較低,雖顯示烏司他丁在改善急性胰腺炎近期臨床療效指標方面優(yōu)于常規(guī)治療,但因尚無評價遠期療效的試驗,尚不能對其療效得出可靠的結論.

引用本文： 楊錦林,郭 震,吳宗英,王一平,曾 超. 烏司他丁治療急性胰腺炎療效的系統(tǒng)評價. 中國循證醫(yī)學雜志, 2005, 05(4): 323-330. doi: 復制

1. 袁耀宗, 諸琦, 夏璐. 生長抑素及大黃素對犬急性壞死性胰腺炎Oddi括約肌的作用[J]. 中華消化雜志, 1999; 19(4): 252～255.
2. 關英, 米鍵, 許靜. 抑肽酶藥物不良反應與合理性用藥的前瞻性觀察[J]. 世界華人消化雜志, 2002; 10(6): 735.
3. 大西冶夫, 小雀浩司, 延原正弘. 蛋白酶抑制劑--烏司他丁的藥理作用. 應用藥理(日), 1986; 31(3): 663.
4. 中華醫(yī)學會外科學會胰腺學組. 急性胰腺炎的臨床診斷及分級標準[J]. 中華外科雜志, 1997; 35(12): 773.
5. 劉鳴, 張世洪. 臨床試驗中的意向處理分析[J]. 英國醫(yī)學雜志中文版, 2001; 4(4): 223～224.
6. 劉全忠, 王永革, 胡琳琳. 烏司他丁治療輕癥急性胰腺炎21例臨床觀察[J]. 胃腸病學和肝病學雜志, 2002; 11(1): 28.
7. 李英, 陳血梅. 烏司他丁治療急性胰腺炎30例[J]. 中國中西醫(yī)結合消化雜志, 2002; 10(5): 311.
8. 李俊權. 烏司他丁治療急性胰腺炎22例臨床分析[J]. 中華醫(yī)學寫作雜志, 2002; 9(18): 1 412.
9. 王化虹, 胡伏蓮, 林三仁. 國產烏司他丁治療急性胰腺炎的療效和安全性[J]. 中國新藥雜志, 2001; 10(3): 204～206.
10. 陳血梅, 馬加. 烏司他丁治療急性胰腺炎的臨床效果[J]. 中國誤診學雜志, 2001; 1(10): 1 486～1 487.
11. 王高彥, 趙廣輝. 烏司他丁治療急性胰腺炎20例療效觀察[J]. 華北煤炭醫(yī)學院學報, 2001; 3(6): 754～755.
12. 侯旭東, 柴琛, 李玉民. 烏司他丁治療急性胰腺炎的臨床研究[J]. 臨床外科雜志, 2001; 9(4): 222～223.
13. 黃宗文, 于迎春, 張穎. 烏司他丁治療急性胰腺炎臨床療效觀察[J]. 臨床外科雜志, 2001; 9(1): 33～35.
14. 劉平, 張小勇, 趙志泉. 烏司他丁治療急性胰腺炎療效的初步觀察[J]. 江蘇醫(yī)藥雜志, 2001; 27(3): 214～215.
15. 上海烏司他丁臨床試驗協(xié)作組. 國產烏司他丁治療急性胰腺炎的多中心臨床研究[J]. 中華消化雜志, 2001; 21(5): 293～296.
16. 李海民, 馮全新, 竇科峰, 等. 烏司他丁治療急性胰腺炎臨床療效觀察[J]. 西北國防醫(yī)學雜志, 2002; 23(3): 183～185.
17. 鄧東, 顧明, 李凌云. 烏司他丁治療急性重癥胰腺炎的臨床效果[A]. 注射用烏司他丁論文匯編[C], 2001: 17～18.
18. 張水軍. 烏司他丁對急性重癥胰腺炎病人的胰腺、肝臟及腎臟功能的作用[A]. 注射用烏司他丁論文匯編[C], 2001: 28～29.
19. 陳曼彤, 崔西玉, 邱小蕾. 烏司他丁治療急性胰腺炎療效觀察[A]. 注射用烏司他丁論文匯編[C], 2001: 37～38.
20. 管強, 熊詠萍. 烏司他丁治療急性胰腺炎臨床小結[A]. 注射用烏司他丁論文匯編[C], 2001: 46～47.
21. 劉文斌, 張海蓉, 段麗平. 烏司他丁治療急性胰腺炎臨床觀察[A]. 注射用烏司他丁論文匯編[C], 2001: 48～49.
22. 朱金照, 張捷, 許其增. 烏司他丁治療胰腺炎的療效分析[J]. 臨床消化病雜志, 2002; 14(40): 153～155.
23. Mckay CJ, Baxter JN, Imrie CW. A randomized, cotrolled trial of octreotide in moderate to severe acute pancreatitis[J]. Int J Pancreatol, 1997; 21(23): 13-21.
24. Uhl W, Malfertheiner P, Adler G. The role of octreotide in human acute pancreatitis. A multicenter study[J]. Digestion, 1997; 58(320): 9(A32).
25. Marton J, Szasz Z, Nagy Z, Jarmay K, Takacs T, Lonovics J, Balogh A, Farkas G Benefical effect of octreotide treatment in acute pancreatitis in rat[J]. Int J Pancreatol, 1998; 24(3): 203-210.
26. Sanchez MJ, Landa GJ, Seco GJ. Octreotide: effects in experimental severe acute pancreatitis. Analysis of survival, biochemical findings and histomorphometry[J]. Rev Esp Enferm Dig, 1997; 89(63): 101-105.
27. Plusczyk T, Rathgeb D, Westermann S, Feifel G. Somatostatin attenuates microcirculatory impairment in acute sodium taurocholate-induced pancreatitis[J]. Dig Dis Sci, 1998; 43(3): 575-585.
28. Yuan YZ, Zhu Ji, Xia Lu. Effects of somatostatin and emodin on sphincter of oddi in acute necrotizing pancreatitis in dogs[J]. Chin J Dig, 1999; 19(4): 252-255.
29. Buchler M, Malfertheiner P, Uhl W, Scholmerich J, Stockmann F, Adler G, Gaus W, Rolle K, Beger HG. Gabexate mesilate in human acute pancreatitis. German Pancreatitis Study Group[J]. Gastroenterology, 1993; 104(4): 1 165-1 170.
30. Pederzoli P, Cavallini G, Falconi M, Bassi C.Gabexate mesilate vs aprotinin in human acute pancreatitis (GA.ME.P.A.). A prospective, randomized, double-blind multicenter study[J]. Int J Pancreatol, 1993; 14(2): 117-124.
31. Guan Y, Mi J, Xu J. The adverse effects of Aprotinin and prospective observation on rational medication[J]. World Chinese Journal of Digestology, 2002; 10(6): 735.
32. Umknawn Authors. A Protease inhibitor: pharmacology of Ulinastatin (Miraclid) [J]. Application of pharmacology, 1986; 31(3): 663.
33. Edward L. A clinically based classification system for acute pancreatitis[J]. Arch Surg, 1993; 128(5): 586-590.
34. The pancreas group of surgery institute in Chinese Medical Association.The clinical diagnosis and the standard of grading[J]. Chinese Journal of Surgery, 1997; 35(12): 773.
35. Clarke M, Oxman AD, editors. Cochrane Reviewers Handbook 4.1 [updated June 2000]. In: Review Manager (RevMan) [Computer program]. Version 4.1. Oxford, England: The Cochrane Collaboration, 2000.
36. Liu M, Zhang SH. Intention to treat analysis in clinical trials[J]. BMJ (Chinese edition), 2001; 4(4): 223-224.
37. Liu QZ, Wang YG, Hu LL. Clinical observation of Ulinastatin for mild acute pancreatitis in twenty one patients[J]. Chin J Gastro Hepa, 2002; 11(1): 28.
38. Li Y, Chen XM. Observation of Ulinastatin for acute pancreatitis in thirty patients[J]. Chin J Integr Trad West Med Dig, 2002; 10(5): 311.
39. Li JQ. Clinical analysis of Ulinstatin for acute pancreatitis in twenty two patients[J]. Chinese Journal of Medical Writing, 2002; 9(18): 1 412.
40. Wang HH, Hu FL, Lin SR. Effects and safety of Ulinastatin for acute pancreatitis[J]. Chinese Journal of New Medicine, 2001; 10(3): 204-206.
41. Chen XM, Ma J. Clinical effects of Ulinastatin for acute pancreatitis[J]. Chinese Journal of Misdiagnostics, 2001; 1(10): 1 486-1 487.
42. Wang GY, Zhao GH. Observation of effects of Ulinastatin for acute pancreatitis in twenty cases[J]. J North China Coal Medical College, 2001; 3(6): 754-755.
43. Hou XD, Chai C, Li YM. Clinical studies of Ulinastatin for acute pancreatitis[J]. J Clin Surg, 2001; 9(4): 222-223.
44. Huang ZW, Yu YC, Zhang Y. Observation of clinical effects of Ulinastatin for acute pancreatitis[J]. J Clin Surg, 2001; 9(1): 33-35.
45. Liu P, Zhang XY, Zhao ZQ. Primary observation of Ulinastatin for acute pancreatitis[J]. Journal of Jiangsu Medicine, 2001; 27(3): 214-215.
46. Shanghai collbaration group on ulinastatin clinical trial. Multi-center clinical trial on the treatment of acute pancreatitis by Ulinastatin[J]. Chinese Journal of Digestion, 2001; 21(5): 293-296.
47. Li HM, Feng QX, Dou KF, et al. Clinical observation of Ulinastatin for acute pancreatitis[J]. Medical Journal of National Defending Forces In North West China, 2002; 23(3): 183-185.
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49. Zhang SJ. The effects of Ulinastatin on the pancreatic, liver, kidney in the patients of severe acute pancreatitis[A]. Article Collection of Ulinastatin Injection[C], 2001. 28-29.
50. Chen MT, Cui XY, Qiu XL. Clincal observation of Ulinatatin for acute pancreatitis[A]. Article Collection of Ulinastatin Injection[C], 2001: 37-38.
51. Guan Q, Xiong YP. Clinical summary of Ulinastatin for acute pancreatitis[A]. Article Collection of Ulinastatin Injection[C], 2001: 46-47.
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53. Zhu JZ, Zhang J, Xu QZ. clinical effect of Ulinastatin in treatment of pancreatitis[J]. Journal of Cinical Digestion, 2002; 14(40): 153-155.
  1. 1. 袁耀宗, 諸琦, 夏璐. 生長抑素及大黃素對犬急性壞死性胰腺炎Oddi括約肌的作用[J]. 中華消化雜志, 1999; 19(4): 252～255.
  2. 2. 關英, 米鍵, 許靜. 抑肽酶藥物不良反應與合理性用藥的前瞻性觀察[J]. 世界華人消化雜志, 2002; 10(6): 735.
  3. 3. 大西冶夫, 小雀浩司, 延原正弘. 蛋白酶抑制劑--烏司他丁的藥理作用. 應用藥理(日), 1986; 31(3): 663.
  4. 4. 中華醫(yī)學會外科學會胰腺學組. 急性胰腺炎的臨床診斷及分級標準[J]. 中華外科雜志, 1997; 35(12): 773.
  5. 5. 劉鳴, 張世洪. 臨床試驗中的意向處理分析[J]. 英國醫(yī)學雜志中文版, 2001; 4(4): 223～224.
  6. 6. 劉全忠, 王永革, 胡琳琳. 烏司他丁治療輕癥急性胰腺炎21例臨床觀察[J]. 胃腸病學和肝病學雜志, 2002; 11(1): 28.
  7. 7. 李英, 陳血梅. 烏司他丁治療急性胰腺炎30例[J]. 中國中西醫(yī)結合消化雜志, 2002; 10(5): 311.
  8. 8. 李俊權. 烏司他丁治療急性胰腺炎22例臨床分析[J]. 中華醫(yī)學寫作雜志, 2002; 9(18): 1 412.
  9. 9. 王化虹, 胡伏蓮, 林三仁. 國產烏司他丁治療急性胰腺炎的療效和安全性[J]. 中國新藥雜志, 2001; 10(3): 204～206.
  10. 10. 陳血梅, 馬加. 烏司他丁治療急性胰腺炎的臨床效果[J]. 中國誤診學雜志, 2001; 1(10): 1 486～1 487.
  11. 11. 王高彥, 趙廣輝. 烏司他丁治療急性胰腺炎20例療效觀察[J]. 華北煤炭醫(yī)學院學報, 2001; 3(6): 754～755.
  12. 12. 侯旭東, 柴琛, 李玉民. 烏司他丁治療急性胰腺炎的臨床研究[J]. 臨床外科雜志, 2001; 9(4): 222～223.
  13. 13. 黃宗文, 于迎春, 張穎. 烏司他丁治療急性胰腺炎臨床療效觀察[J]. 臨床外科雜志, 2001; 9(1): 33～35.
  14. 14. 劉平, 張小勇, 趙志泉. 烏司他丁治療急性胰腺炎療效的初步觀察[J]. 江蘇醫(yī)藥雜志, 2001; 27(3): 214～215.
  15. 15. 上海烏司他丁臨床試驗協(xié)作組. 國產烏司他丁治療急性胰腺炎的多中心臨床研究[J]. 中華消化雜志, 2001; 21(5): 293～296.
  16. 16. 李海民, 馮全新, 竇科峰, 等. 烏司他丁治療急性胰腺炎臨床療效觀察[J]. 西北國防醫(yī)學雜志, 2002; 23(3): 183～185.
  17. 17. 鄧東, 顧明, 李凌云. 烏司他丁治療急性重癥胰腺炎的臨床效果[A]. 注射用烏司他丁論文匯編[C], 2001: 17～18.
  18. 18. 張水軍. 烏司他丁對急性重癥胰腺炎病人的胰腺、肝臟及腎臟功能的作用[A]. 注射用烏司他丁論文匯編[C], 2001: 28～29.
  19. 19. 陳曼彤, 崔西玉, 邱小蕾. 烏司他丁治療急性胰腺炎療效觀察[A]. 注射用烏司他丁論文匯編[C], 2001: 37～38.
  20. 20. 管強, 熊詠萍. 烏司他丁治療急性胰腺炎臨床小結[A]. 注射用烏司他丁論文匯編[C], 2001: 46～47.
  21. 21. 劉文斌, 張海蓉, 段麗平. 烏司他丁治療急性胰腺炎臨床觀察[A]. 注射用烏司他丁論文匯編[C], 2001: 48～49.
  22. 22. 朱金照, 張捷, 許其增. 烏司他丁治療胰腺炎的療效分析[J]. 臨床消化病雜志, 2002; 14(40): 153～155.
  23. 23. Mckay CJ, Baxter JN, Imrie CW. A randomized, cotrolled trial of octreotide in moderate to severe acute pancreatitis[J]. Int J Pancreatol, 1997; 21(23): 13-21.
  24. 24. Uhl W, Malfertheiner P, Adler G. The role of octreotide in human acute pancreatitis. A multicenter study[J]. Digestion, 1997; 58(320): 9(A32).
  25. 25. Marton J, Szasz Z, Nagy Z, Jarmay K, Takacs T, Lonovics J, Balogh A, Farkas G Benefical effect of octreotide treatment in acute pancreatitis in rat[J]. Int J Pancreatol, 1998; 24(3): 203-210.
  26. 26. Sanchez MJ, Landa GJ, Seco GJ. Octreotide: effects in experimental severe acute pancreatitis. Analysis of survival, biochemical findings and histomorphometry[J]. Rev Esp Enferm Dig, 1997; 89(63): 101-105.
  27. 27. Plusczyk T, Rathgeb D, Westermann S, Feifel G. Somatostatin attenuates microcirculatory impairment in acute sodium taurocholate-induced pancreatitis[J]. Dig Dis Sci, 1998; 43(3): 575-585.
  28. 28. Yuan YZ, Zhu Ji, Xia Lu. Effects of somatostatin and emodin on sphincter of oddi in acute necrotizing pancreatitis in dogs[J]. Chin J Dig, 1999; 19(4): 252-255.
  29. 29. Buchler M, Malfertheiner P, Uhl W, Scholmerich J, Stockmann F, Adler G, Gaus W, Rolle K, Beger HG. Gabexate mesilate in human acute pancreatitis. German Pancreatitis Study Group[J]. Gastroenterology, 1993; 104(4): 1 165-1 170.
  30. 30. Pederzoli P, Cavallini G, Falconi M, Bassi C.Gabexate mesilate vs aprotinin in human acute pancreatitis (GA.ME.P.A.). A prospective, randomized, double-blind multicenter study[J]. Int J Pancreatol, 1993; 14(2): 117-124.
  31. 31. Guan Y, Mi J, Xu J. The adverse effects of Aprotinin and prospective observation on rational medication[J]. World Chinese Journal of Digestology, 2002; 10(6): 735.
  32. 32. Umknawn Authors. A Protease inhibitor: pharmacology of Ulinastatin (Miraclid) [J]. Application of pharmacology, 1986; 31(3): 663.
  33. 33. Edward L. A clinically based classification system for acute pancreatitis[J]. Arch Surg, 1993; 128(5): 586-590.
  34. 34. The pancreas group of surgery institute in Chinese Medical Association.The clinical diagnosis and the standard of grading[J]. Chinese Journal of Surgery, 1997; 35(12): 773.
  35. 35. Clarke M, Oxman AD, editors. Cochrane Reviewers Handbook 4.1 [updated June 2000]. In: Review Manager (RevMan) [Computer program]. Version 4.1. Oxford, England: The Cochrane Collaboration, 2000.
  36. 36. Liu M, Zhang SH. Intention to treat analysis in clinical trials[J]. BMJ (Chinese edition), 2001; 4(4): 223-224.
  37. 37. Liu QZ, Wang YG, Hu LL. Clinical observation of Ulinastatin for mild acute pancreatitis in twenty one patients[J]. Chin J Gastro Hepa, 2002; 11(1): 28.
  38. 38. Li Y, Chen XM. Observation of Ulinastatin for acute pancreatitis in thirty patients[J]. Chin J Integr Trad West Med Dig, 2002; 10(5): 311.
  39. 39. Li JQ. Clinical analysis of Ulinstatin for acute pancreatitis in twenty two patients[J]. Chinese Journal of Medical Writing, 2002; 9(18): 1 412.
  40. 40. Wang HH, Hu FL, Lin SR. Effects and safety of Ulinastatin for acute pancreatitis[J]. Chinese Journal of New Medicine, 2001; 10(3): 204-206.
  41. 41. Chen XM, Ma J. Clinical effects of Ulinastatin for acute pancreatitis[J]. Chinese Journal of Misdiagnostics, 2001; 1(10): 1 486-1 487.
  42. 42. Wang GY, Zhao GH. Observation of effects of Ulinastatin for acute pancreatitis in twenty cases[J]. J North China Coal Medical College, 2001; 3(6): 754-755.
  43. 43. Hou XD, Chai C, Li YM. Clinical studies of Ulinastatin for acute pancreatitis[J]. J Clin Surg, 2001; 9(4): 222-223.
  44. 44. Huang ZW, Yu YC, Zhang Y. Observation of clinical effects of Ulinastatin for acute pancreatitis[J]. J Clin Surg, 2001; 9(1): 33-35.
  45. 45. Liu P, Zhang XY, Zhao ZQ. Primary observation of Ulinastatin for acute pancreatitis[J]. Journal of Jiangsu Medicine, 2001; 27(3): 214-215.
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