H2受體拮抗劑預防應激性潰瘍出血的系統評價_《中國循證醫學雜志》

作者：

曾超 ,  王一平

四川大學華西醫院消化科(成都 610041);

關鍵詞：

應激性潰瘍出血 H2受體拮抗劑系統評價 Meta分析

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目的　評價 H2受體拮抗劑（H2RA）對預防重危病人應激性潰瘍出血（SUB）的有效性及安全性。
方法　按既定的檢索策略，全面檢索 Cochrane 臨床對照試驗數據庫（2006 年第 4 期）、MEDLINE 光盤數據庫（1980 ～ 2006 年 10月）、EMbase 光盤數據庫（1984 ～ 2006 年 10 月）、中國生物醫學文獻數據庫(1978 ～ 2006 年 10 月 )、維普中刊數據庫（1989 ～ 2006 年 10 月）和中文循證醫學隨機對照試驗數據庫。手工檢索 5 種相關中文期刊、相關會議論文集及所有檢索到試驗的參考文獻。納入H2RA 預防 SUB 的隨機對照試驗。由兩位研究者獨立地對納入試驗進行質量評價和資料提取，并交叉核對。如有分歧，通過討論解決。結局指標包括 SUB 的發生率、醫源性肺炎 (nosocomial pneumonia，NP) 發生率、病死率、藥物不良反應的發生率、胃液 pH 值等指標評價藥物預防SUB 的效果和安全性。采用 RevMan4.2.7 軟件進行 Meta 分析。
結果　共檢索到 18 個可能符合納入標準的臨床試驗，其中 16 個試驗共包括 2 014 例病人符合納入標準，2 個試驗被排除。納入試驗的方法學質量高低不齊。提取數據后，進行 Meta分析或描述性分析。① H2RA能降低SUB的發生率［RR 0.39， 95%CI （0.28，0.56）； P lt;0.000 01，NNT=6］， H2RA（P=0.11），不能降低臨床大出血的發生率［RR 0.51， 95%CI（0.17， 1.53）； P=0.11］。② H2RA與安慰劑相比較， NP發生率差別無統計學意義［RR 1.02， 95%CI（0.55，1.89）； P=0.95］。③ H2RA 能降低病死率［RR 0.68， 95% CI（0.52， 0.90）； P=0.007，NNT=18］。④ H2RA的安全性好。⑤ 藥物預防 SUB 對胃內 pH 值的影響，由于所納入的試驗在 pH 值的測量方法、測量時間上的差異，無法提取資料進行合并分析。所有試驗均未將住院時間作為觀察指標。
結論　現有的有限證據表明，預防性使用 H2RA 均能降低SUB 發生率、病死率但不能降低臨床大出血的發生率。因所發表的臨床研究方法學質量普遍不高，存在多種方法學局限性。故應謹慎看待以上結論。今后有必要進一步開展大樣本、高質量的臨床隨機對照試驗，為 H2RA 預防SUB 提供更為可靠證據。

引用本文： 曾超,王一平. H2受體拮抗劑預防應激性潰瘍出血的系統評價. 中國循證醫學雜志, 2007, 07(9): 658-668. doi: 復制

1.	Xiao SD, Xu GM, Li ZS, et al.Suggest on prevention for stress ulcer. National Medical Journal of China, 2002, 82(14): 1000-1001.
2.	Liu HY. Stress ulcer. Modern Gastroenterology, 1994, 83: 951-95.
3.	Liu M, Zhang SH. Intention to treat in clinical trial. BMJ (Chinese edition), 2001, 4(4): 223-224.
4.	Hu YP, Chen MJ. Clinical research on Omeprazole and Ranitidine for postoperative of acute cerebral vascular disease with stress ulcer bleeding. New Chinese Medicine, 2001, 32(10): 598-599.
5.	Wei DS. Omeprazole and Cimetidine for acute cerebral vascular disease with stress ulcer bleeding. Journal of Modern Clinical Medical Bioengineering, 2002, 8(2): 130-132.
6.	Zhu T. The observation of omeprazole in prevention of upper gastrointestinal bleeding in severe head injury. Communication Medicine, 2003, 17(5): 530-534 .
7.	Xu M. The observation of Cimetidine in prevention of stress ulcer in respiratory failure. Practice Pharmaceutical Sciences of Zhejiang, 2001, 6(1): 14 .
8.	Gui JW. Cimetidine preventing cerebral hemorrhage with stress ulcer in old patients. Hengyang Journal of Medical University, 1997, 25(4): 404-405 .
9.	Peng XL, Tang BS, Yang QD, et al . Clinical observation of prevention of cerebral hemorrhage with stress ulcer. Chinese Journal of Modern Medicine, 1997, 7(2): 67-68 .
10.	Wang GQ, Chen TF, Lei PJ, et al. Clinical research on Cimetidine in prevention of stress ulcer in post-prostatectomy (103 reports). Clinical Medicine Magazine of China, 2003, 90: 8802-8803 .
11.	Xu ZQ. The observation of Famotidine in prevention of stress ulcer bleeding in stroke. Clinical New Medicine of China, 2002, 2(12): 1127-1128 .
12.	Huang YF, Huang AZ, Wei HL. Effect of famotidine preventing stroke with stress ulcer bleeding. Huaxia Medicine, 2003, 16(3): 315-316 .
13.	Fu XJ, Xu XL. Prevention of stress ulcer in postoperative of severe head injury. Emergency Medicine, 1999, 8(6): 432-433 .
14.	Lu YH. Cimetidine preventing for cerebral hemorrhage resulted of high pressure with stress ulcer. Chinese Emergency Disease Medicine, 1998, 10(7): 446 .
15.	Wang Y, Chen BH, Wu TF. The observation of Tagament effect on the prevention from stress ulcer in patients with acute cerebrovascular disease. Clinical Medicine Journal of China, 2000, 7(4): 422-423.
16.	蕭樹東, 許國銘, 李兆申, 等. 應激性潰瘍防治建議. 中國醫學雜志, 2002, 82(14): 1000-1001.
17.	Mitchell J, Spirt MD. Stress related mucosal disease: risk factors and prophylactic therapy. Clinical Therapeutics, 2004, 26(2): 197-231.
18.	Cook DJ, Fuller HD, Guyatt GH, et al. For the Canadian critical care trials group. Risk factors for gastrointestinal bleeding in critically ill patients. N Engl J Med, 1994, 330(6): 377-381.
19.	Zuckerman GR, Shuman R. Therapeutic goals and treatmeat options for prevention of stress ulcer syndrom. Am J Med, 1987, 83(Supple 6A): 29-35.
20.	劉厚鈺. 應激性潰瘍. 現代胃腸病學, 1994, 83: 951-95.
21.	Beejay U, Wolfe MM. Acute gastrointestinal bleeding in the intensive care unit. The gastroenterologist’ s perspective. Gastroenterol Clin North Am, 2000, 29(2): 309-336.
22.	Haglund U. Stress ulcers. Scand J Gastroenterol, 1990, 35(Suppl 175): 27-33.
23.	Nardino RJ, Vender RJ, Herbert PN. Overuse of acid-suppressive therapy in hospitalized patients. Am J Gastroenterol, 2000, 95(11): 3118-3122.
24.	Andrew S, Jon I. Peptic ulcer disease: epidemiology , pathophyslology, clinical manifestations and diagnosis. Cecil Textbook of Medicine, 2003, Chapt126: 671-675.
25.	ASHP. Commission on therapeutic guidelines on stress ulcer prophylaxis. AM J Health Syst Pharm, 1999, 56(15): 347-379.
26.	ASHP. Stress ulcer prophylaxis in the postoperative period. AM J Health Syst Pharm, 2004, 61(15): 588-596.
27.	Kohka H, Nishibori M, Iwagaki H, et al. Histamine is a potent inducer of IL-18 and IFN-gamma in human peripheral blood mononuclear cells. J Immunol, 2000, 164(12): 6640-6646.
28.	Hellstrand K, Asea A, Hermodsson S. Role of histamine in natural killer cell-mediated resistance against tumor cells. J Immunol, 1990, 145(12): 4365-4370.
29.	Zantac [package insert]. Research Triangle park. NC GlaxoSmithKl ine, 2001.
30.	Cook DJ, Reeve BK, Guyatt GH, et al. Stress ulcer prophylaxis in critically ill patients: Resolving discordant meta-analyses. Journal of the American Medical Association, 1996, 275(4): 308-314 .
31.	Ernst W, Hanisch MD, Encke MD, et al. A randomized , double-blind trial for stress ulcer prophylaxis shows no evidence of increased pneumonia. American Journal of Surgery, 1998, 176(5): 453-457 .
32.	劉鳴, 張世洪. 臨床試驗中的意向處理分析. 英國醫學雜志中文版, 2001, 4(4): 223-224 .
33.	胡義平, 陳明建. 奧美拉唑與雷尼替丁用于預防高血壓并發腦出血術后應激性潰瘍出血的臨床研究. 新醫學, 2001, 32(10): 598-599 .
34.	魏端生. 洛賽克與西咪替丁預防急性腦血管病并應激性潰瘍出血的臨床研究. 現代臨床醫學生物工程學雜志, 2002, 8(2): 130-132 .
35.	朱濤. 奧美拉唑預防重型顱腦損傷后上消化道出血的療效觀察. 交通醫學, 2003, 17(5): 530-534 .
36.	徐敏. 西咪替丁預防呼吸衰竭并發應激性潰瘍療效觀察. 浙江實踐藥學, 2001, 6(1): 14 .
37.	桂建偉. 西咪替丁對老年人腦出血并發應激性潰瘍的預防. 衡陽醫學院學報, 1997, 25(4): 404-405 .
38.	彭曉蘭, 唐北沙, 楊期東, 等. 腦出血應激性潰瘍預防性治療的臨床觀察. 中國現代醫學雜志, 1997, 7(2): 67-68 .
39.	王國強, 陳鐵峰, 雷鵬舉, 等. 甲氰咪呱預防前列腺術后并發應激性潰瘍臨床研究 (附103例報告). 中國臨床醫藥研究雜志, 2003, 90: 8802-8803 .
40.	許志強. 法莫替丁預防腦卒中應激性潰瘍出血的療效觀察. 中華臨床新醫學, 2002, 2(12): 1127-1128 .
41.	黃永鋒, 黃愛珍, 韋海玲. 法莫替丁預防腦出血并發應激性潰瘍出血的效果觀察. 華夏醫學, 2003, 16(3): 315-316 .
42.	傅小君, 許信龍. 重型顱腦損傷術后應激性潰瘍的預防. 急診醫學, 1999, 8(6): 432-433 .
43.	陸億華. 泰胃美注射液預防高血壓性腦出血后應激性潰瘍. 中國危重病急救醫學, 1998, 10(7): 446 .
44.	王英, 陳百華, 吳同發. 泰胃美預防急性腦血管病性應激性潰瘍的療效觀察. 中國臨床醫學, 2000, 7(4): 422-423.
45.	Kantorova I, Svoboda P, Scheer P, et al. Stress ulcer prophylaxis in critically ill patients : a randomized controlled trial . Hepatogastroenterology, 2004, 51(57): 757-761 .
46.	Kaushal S, Midha V, Sood A, et al. A comparative study of the effects of famotidine and sucralfate in prevention of upper gastrointestinal bleeding in patients of head injury. Indian Journal of Pharmacology, 2000, 32(2): 246-249 .
47.	Halloran LG, Zfass AM, Gayle WE, et al. Prevention of acute gastrointestinal complications after severe head injury: A controlled trial of cimetidine propylaxis. American Journal of Surgery, 1980, 139(1): 44 -48.
48.	Priebe HJ, Skillman JJ, Bushnell LS, et al. Antacid versus cimetidine in preventing acute gastrointestina bleeding. N EngI J Med, 1980, 302(8): 426-427.

1. Xiao SD, Xu GM, Li ZS, et al.Suggest on prevention for stress ulcer. National Medical Journal of China, 2002, 82(14): 1000-1001.
2. Liu HY. Stress ulcer. Modern Gastroenterology, 1994, 83: 951-95.
3. Liu M, Zhang SH. Intention to treat in clinical trial. BMJ (Chinese edition), 2001, 4(4): 223-224.
4. Hu YP, Chen MJ. Clinical research on Omeprazole and Ranitidine for postoperative of acute cerebral vascular disease with stress ulcer bleeding. New Chinese Medicine, 2001, 32(10): 598-599.
5. Wei DS. Omeprazole and Cimetidine for acute cerebral vascular disease with stress ulcer bleeding. Journal of Modern Clinical Medical Bioengineering, 2002, 8(2): 130-132.
6. Zhu T. The observation of omeprazole in prevention of upper gastrointestinal bleeding in severe head injury. Communication Medicine, 2003, 17(5): 530-534 .
7. Xu M. The observation of Cimetidine in prevention of stress ulcer in respiratory failure. Practice Pharmaceutical Sciences of Zhejiang, 2001, 6(1): 14 .
8. Gui JW. Cimetidine preventing cerebral hemorrhage with stress ulcer in old patients. Hengyang Journal of Medical University, 1997, 25(4): 404-405 .
9. Peng XL, Tang BS, Yang QD, et al . Clinical observation of prevention of cerebral hemorrhage with stress ulcer. Chinese Journal of Modern Medicine, 1997, 7(2): 67-68 .
10. Wang GQ, Chen TF, Lei PJ, et al. Clinical research on Cimetidine in prevention of stress ulcer in post-prostatectomy (103 reports). Clinical Medicine Magazine of China, 2003, 90: 8802-8803 .
11. Xu ZQ. The observation of Famotidine in prevention of stress ulcer bleeding in stroke. Clinical New Medicine of China, 2002, 2(12): 1127-1128 .
12. Huang YF, Huang AZ, Wei HL. Effect of famotidine preventing stroke with stress ulcer bleeding. Huaxia Medicine, 2003, 16(3): 315-316 .
13. Fu XJ, Xu XL. Prevention of stress ulcer in postoperative of severe head injury. Emergency Medicine, 1999, 8(6): 432-433 .
14. Lu YH. Cimetidine preventing for cerebral hemorrhage resulted of high pressure with stress ulcer. Chinese Emergency Disease Medicine, 1998, 10(7): 446 .
15. Wang Y, Chen BH, Wu TF. The observation of Tagament effect on the prevention from stress ulcer in patients with acute cerebrovascular disease. Clinical Medicine Journal of China, 2000, 7(4): 422-423.
16. 蕭樹東, 許國銘, 李兆申, 等. 應激性潰瘍防治建議. 中國醫學雜志, 2002, 82(14): 1000-1001.
17. Mitchell J, Spirt MD. Stress related mucosal disease: risk factors and prophylactic therapy. Clinical Therapeutics, 2004, 26(2): 197-231.
18. Cook DJ, Fuller HD, Guyatt GH, et al. For the Canadian critical care trials group. Risk factors for gastrointestinal bleeding in critically ill patients. N Engl J Med, 1994, 330(6): 377-381.
19. Zuckerman GR, Shuman R. Therapeutic goals and treatmeat options for prevention of stress ulcer syndrom. Am J Med, 1987, 83(Supple 6A): 29-35.
20. 劉厚鈺. 應激性潰瘍. 現代胃腸病學, 1994, 83: 951-95.
21. Beejay U, Wolfe MM. Acute gastrointestinal bleeding in the intensive care unit. The gastroenterologist’ s perspective. Gastroenterol Clin North Am, 2000, 29(2): 309-336.
22. Haglund U. Stress ulcers. Scand J Gastroenterol, 1990, 35(Suppl 175): 27-33.
23. Nardino RJ, Vender RJ, Herbert PN. Overuse of acid-suppressive therapy in hospitalized patients. Am J Gastroenterol, 2000, 95(11): 3118-3122.
24. Andrew S, Jon I. Peptic ulcer disease: epidemiology , pathophyslology, clinical manifestations and diagnosis. Cecil Textbook of Medicine, 2003, Chapt126: 671-675.
25. ASHP. Commission on therapeutic guidelines on stress ulcer prophylaxis. AM J Health Syst Pharm, 1999, 56(15): 347-379.
26. ASHP. Stress ulcer prophylaxis in the postoperative period. AM J Health Syst Pharm, 2004, 61(15): 588-596.
27. Kohka H, Nishibori M, Iwagaki H, et al. Histamine is a potent inducer of IL-18 and IFN-gamma in human peripheral blood mononuclear cells. J Immunol, 2000, 164(12): 6640-6646.
28. Hellstrand K, Asea A, Hermodsson S. Role of histamine in natural killer cell-mediated resistance against tumor cells. J Immunol, 1990, 145(12): 4365-4370.
29. Zantac [package insert]. Research Triangle park. NC GlaxoSmithKl ine, 2001.
30. Cook DJ, Reeve BK, Guyatt GH, et al. Stress ulcer prophylaxis in critically ill patients: Resolving discordant meta-analyses. Journal of the American Medical Association, 1996, 275(4): 308-314 .
31. Ernst W, Hanisch MD, Encke MD, et al. A randomized , double-blind trial for stress ulcer prophylaxis shows no evidence of increased pneumonia. American Journal of Surgery, 1998, 176(5): 453-457 .
32. 劉鳴, 張世洪. 臨床試驗中的意向處理分析. 英國醫學雜志中文版, 2001, 4(4): 223-224 .
33. 胡義平, 陳明建. 奧美拉唑與雷尼替丁用于預防高血壓并發腦出血術后應激性潰瘍出血的臨床研究. 新醫學, 2001, 32(10): 598-599 .
34. 魏端生. 洛賽克與西咪替丁預防急性腦血管病并應激性潰瘍出血的臨床研究. 現代臨床醫學生物工程學雜志, 2002, 8(2): 130-132 .
35. 朱濤. 奧美拉唑預防重型顱腦損傷后上消化道出血的療效觀察. 交通醫學, 2003, 17(5): 530-534 .
36. 徐敏. 西咪替丁預防呼吸衰竭并發應激性潰瘍療效觀察. 浙江實踐藥學, 2001, 6(1): 14 .
37. 桂建偉. 西咪替丁對老年人腦出血并發應激性潰瘍的預防. 衡陽醫學院學報, 1997, 25(4): 404-405 .
38. 彭曉蘭, 唐北沙, 楊期東, 等. 腦出血應激性潰瘍預防性治療的臨床觀察. 中國現代醫學雜志, 1997, 7(2): 67-68 .
39. 王國強, 陳鐵峰, 雷鵬舉, 等. 甲氰咪呱預防前列腺術后并發應激性潰瘍臨床研究 (附103例報告). 中國臨床醫藥研究雜志, 2003, 90: 8802-8803 .
40. 許志強. 法莫替丁預防腦卒中應激性潰瘍出血的療效觀察. 中華臨床新醫學, 2002, 2(12): 1127-1128 .
41. 黃永鋒, 黃愛珍, 韋海玲. 法莫替丁預防腦出血并發應激性潰瘍出血的效果觀察. 華夏醫學, 2003, 16(3): 315-316 .
42. 傅小君, 許信龍. 重型顱腦損傷術后應激性潰瘍的預防. 急診醫學, 1999, 8(6): 432-433 .
43. 陸億華. 泰胃美注射液預防高血壓性腦出血后應激性潰瘍. 中國危重病急救醫學, 1998, 10(7): 446 .
44. 王英, 陳百華, 吳同發. 泰胃美預防急性腦血管病性應激性潰瘍的療效觀察. 中國臨床醫學, 2000, 7(4): 422-423.
45. Kantorova I, Svoboda P, Scheer P, et al. Stress ulcer prophylaxis in critically ill patients : a randomized controlled trial . Hepatogastroenterology, 2004, 51(57): 757-761 .
46. Kaushal S, Midha V, Sood A, et al. A comparative study of the effects of famotidine and sucralfate in prevention of upper gastrointestinal bleeding in patients of head injury. Indian Journal of Pharmacology, 2000, 32(2): 246-249 .
47. Halloran LG, Zfass AM, Gayle WE, et al. Prevention of acute gastrointestinal complications after severe head injury: A controlled trial of cimetidine propylaxis. American Journal of Surgery, 1980, 139(1): 44 -48.
48. Priebe HJ, Skillman JJ, Bushnell LS, et al. Antacid versus cimetidine in preventing acute gastrointestina bleeding. N EngI J Med, 1980, 302(8): 426-427.

《中國循證醫學雜志》

H2受體拮抗劑預防應激性潰瘍出血的系統評價

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《中國循證醫學雜志》

H2受體拮抗劑預防應激性潰瘍出血的系統評價

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