• 四川大學(xué)華西醫(yī)院中西醫(yī)結(jié)合科 (成都610041);

目的　 評價痛瀉寧顆粒治療腹瀉型腸易激綜合征（irritable bowel syndrome,IBS）的有效性及安全性.
方法 　采用隨機雙盲、安慰劑平行對照臨床試驗設(shè)計,共納入60例腹瀉型IBS受試者,隨機分為試驗組（n=30）和安慰劑組（n=30）,療程3周,并對痊愈顯效的受試者隨訪4周.
結(jié)果 　試驗組與安慰劑組腹痛療效比較,痊愈率分別為57.7%vs 16.0%（符合方案分析,PP）與31.0%vs 7.1%（意向性治療分析,ITT）,總有效率分別為92.3%vs 44.0%（PP）與82.7%vs 39.3%（ITT）（P均＜0.05）.兩組腹瀉療效比較,痊愈率分別為46.2%vs 20.0%（PP）與41.4%vs 17.9%（ITT）,總有效率分別為96.2% vs 48.0%（PP）與86.2%vs 42.9%（ITT）（P均＜0.05）.中醫(yī)證候療效比較,兩組痊愈率分別為30.8%vs 4.0%（PP）與27 6%vs 3.6%（ITT）,總有效率分別為92.3%vs48.0%（PP）與82.7%vs 42.9%（ITT）（P均＜0.05）.試驗組腹痛緩解時間明顯短于安慰劑組（7.6±4.6d vs 14 4±4.3d,P=0.0125）.經(jīng)治療痊愈和顯效的受試者停藥后4周的隨訪結(jié)果表明,試驗組腹瀉復(fù)發(fā)或加重時間明顯長于安慰劑組（11.5±5 3 d vs 6.2±6.9 d,P=0.019）.未發(fā)現(xiàn)試驗藥物的不良反應(yīng).
結(jié)論 　痛瀉寧顆粒治療腹瀉型IBS（肝氣乘脾證）安全有效.

引用本文： 王 剛,李廷謙,王 蕾,夏 慶,陳 雁,張瑞明. 痛瀉寧顆粒治療腹瀉型腸易激綜合征（肝氣乘脾證）的隨機雙盲安慰劑對照試驗. 中國循證醫(yī)學(xué)雜志, 2006, 06(2): 84-89. doi: 復(fù)制

1. Thompson WG,Longstreth GF,Drossman DA,et al.Funtional bowel disorders and functional abdominal pain.Gut,1999; 45 (suppl2):43 -47.
2. Talley NJ,Zinsmeister AR,Melton LJ 3rd.Irritable bowel syn drome in a community:symptom subgroups,risk factors,and health care utilization.Am J Epidemiol,1995; 142 (1):76-83.
3. Heaton KW,ODonnell LJ,Braddon FE,et al.Symptoms of irritable bowel syndrome in a Brithish urban community:consulters and nonconsulters.Gastroenterology,1992; 102(6):1962-1927.
4. Heaton KW,Radvan J,Cripps H,et al.Defection frequency and timing,and stool form in the general population:a prospective stud y.Gut,1992; 33(6):818 -824.
5. Chen LY,Ho kY,Phua kH.Normal bowel habits and prevalence of functional bowel disorders in Singaporean adults-findings from a community based study in Bishan.Community Medicine GI Study Group.Singapore Med J,2000; 41(6):255-258.
6. Chang L.Review article:epidemiology and quality of life in func tional gastrointestinal disorders.Aliment Pharmacol Ther,2004; 20(Suppl 7):31-33.
7. Pan GZ,Lu SC,Ke MY,et al.An epidemiologic study of irritable bowel syndrome in Beijing-As tratified randomized study by clustering sampling.Chinese Journal of Epidemiology,2000; 21 (1):26 -29.潘國宗,魯素彩,柯美云,等北京地區(qū)腸易激綜合征的流行病學(xué)研究:一個整群、分層、隨機調(diào)查中華流行病學(xué)雜志,2000;21(1):26～29.
8. Quartero AO,Meineche-Schmidt V,Muris J,et al.Bulking a gents,antispasmodic and antidepressant medication for the treatment of irritable bowel syndrome[M/CD].Cochrane Database Syst Rev,2005; (2):CD003460.
9. Evans BW,Clark WK,Moore DJ,et al.Tegaserod for the treat ment of irritable bowel syndrome[M/CD].Cochrane Database Syst Rev,2004; (1):CD003960.
10. LacknerJM,Mesmer C,Morley S,et al.Psychological treatments for irritable bowel syndrome:a systematic review and meta-analysis.J Consult Clin Psychol,2004; 72 (6):1100-1113.
11. Lesbros-Pantoflichova D,Michetti P,Fried M,et al.Meta-analysis:the treatment of irritable bowel syndrome.Aliment Pharmacol Ther,2004; 20(11 -12):1253 -1269.
12. Talley NJ.Evaluation of drug treatment in irritable bowel syndrome.Br J Clin Pharmacol,2003; 56 (4):362-369.
13. Spanier JA,Howden CW,Jones MP.A systematic review of alternative therapies in the irritable bowel syndrome.Arch Intern Med,2003; 163(3):265 -274.
14. Tan S,Tillisch K,Bolus SR,et al.Traditional Chinese medicine based subgrouping of irritable bowel syndrome patients.Am J Chin Med,2005; 33(3):365-379.
15. Sung JJ,Leung WK,ChingJY,et al.Agreements among traditional Chinese medicine practitioners in the diagnosis and treatment of irritable bowel syndrome.Aliment Pharmacol Ther,2004; 20 (10):1205-1210.
16. Bensooussan A,Talley NJ,Hing M,et al.Treatment of irritable bowel syndrome with Chinese herbal medicine:a randomized conrolled trial.JAMA,1998; 280(18):1585 -1589.
17. Yuan R,Lin Y.Traditional Chinese medicine:an approach to scientific proof and clinical validation.Pharmacol Ther,2000; 86 (2):191-198.
18. Chinese Society of Grstroenerology.The uniform on irritable bowel syndrome.Chinese Journal of Internal Medicine,2003; 42 (9):669-670.中華醫(yī)學(xué)會消化病學(xué)分會.腸易激綜合征診治的共識意見.中華內(nèi)科雜志,2003;42(9):669～670.
19. Cheng ZS,Zhang WD,Wei BH.Schedule for Diagnosis and Treatment of Irritable Bowel Syndrome with Integrative Chinese and Western Medicine (Draft).Chinese Journal of Integrated Traditional and Western Medicine,2005; 25 (3):282-284.陳治水,張萬岱,危北海.腸易激綜合征中西醫(yī)結(jié)合診治方案(草案).中國中西醫(yī)結(jié)合雜志,2005;25(3):282 284.
20. World Medical Association Declaration of Helsinki:ethical principles for medical research involving human subjects.JAMA,2000; 284:3043-3045.
21. Pittler MH,Ernst E.Peppermint oil for irritable bowel syndrome:a critical review and meta-analysis.Am J Gastroenterol,1998; 93 (7):1131 -1135.
22. Grigoleit HG,Grigoleit P.Peppermint oil in irritable bowel syndrome.Phytomedicine,2005; 12 (8):601-606.
23. Brinkhaus B,Hentschel C,Von Keudell C,et al.Herbal medicine with curcuma and fumitory in the treatment of irritable bowel syndrome:a randomized,placebo-controlled,double-blind clinical trial.Scand J Gastroenterol,2005; 40 (8):936-943.
24. Bundy R,Walker AF,Middleton R W,et al.Artichoke leaf extract reduces reduces symptoms of irritable bowel syndrome and improves quality of life in otherwise healthy volunteers suffering from concomitant dyspepsia:a subset analysis.J Altern Complenent Med,2004; 10(4):667-669.
25. Madisch A,Holtmann G,Plein K,et al.Treatment of irritable bowel syndrome with herbal preparations:results of a double-blind,randomized,placebo-controlled,multi-centre trial.Aliment Pharma col Ther,2004; 19(3):271 -279.
26. Baer N.Debate about placebos points to issue surrounded by many shades of grey.CMA J,1996; 155 (10):1475-1476.
27. Patel SM,Stason WB,Legedza A,et al.The placebo effect in irri table bowel syndrome trials:a meta-analysis.Neurogastroenterol Motil,2005; 17 (3):332-340.
28. Moher D,Schulz KF,Altman D,et al.The CONSORT statement:revised recommendations for improving the quality of reports of parallel-group randomized trials.JAMA,2001; 285 (15):1987-1991.
  1. 1. Thompson WG,Longstreth GF,Drossman DA,et al.Funtional bowel disorders and functional abdominal pain.Gut,1999; 45 (suppl2):43 -47.
  2. 2. Talley NJ,Zinsmeister AR,Melton LJ 3rd.Irritable bowel syn drome in a community:symptom subgroups,risk factors,and health care utilization.Am J Epidemiol,1995; 142 (1):76-83.
  3. 3. Heaton KW,ODonnell LJ,Braddon FE,et al.Symptoms of irritable bowel syndrome in a Brithish urban community:consulters and nonconsulters.Gastroenterology,1992; 102(6):1962-1927.
  4. 4. Heaton KW,Radvan J,Cripps H,et al.Defection frequency and timing,and stool form in the general population:a prospective stud y.Gut,1992; 33(6):818 -824.
  5. 5. Chen LY,Ho kY,Phua kH.Normal bowel habits and prevalence of functional bowel disorders in Singaporean adults-findings from a community based study in Bishan.Community Medicine GI Study Group.Singapore Med J,2000; 41(6):255-258.
  6. 6. Chang L.Review article:epidemiology and quality of life in func tional gastrointestinal disorders.Aliment Pharmacol Ther,2004; 20(Suppl 7):31-33.
  7. 7. Pan GZ,Lu SC,Ke MY,et al.An epidemiologic study of irritable bowel syndrome in Beijing-As tratified randomized study by clustering sampling.Chinese Journal of Epidemiology,2000; 21 (1):26 -29.潘國宗,魯素彩,柯美云,等北京地區(qū)腸易激綜合征的流行病學(xué)研究:一個整群、分層、隨機調(diào)查中華流行病學(xué)雜志,2000;21(1):26～29.
  8. 8. Quartero AO,Meineche-Schmidt V,Muris J,et al.Bulking a gents,antispasmodic and antidepressant medication for the treatment of irritable bowel syndrome[M/CD].Cochrane Database Syst Rev,2005; (2):CD003460.
  9. 9. Evans BW,Clark WK,Moore DJ,et al.Tegaserod for the treat ment of irritable bowel syndrome[M/CD].Cochrane Database Syst Rev,2004; (1):CD003960.
  10. 10. LacknerJM,Mesmer C,Morley S,et al.Psychological treatments for irritable bowel syndrome:a systematic review and meta-analysis.J Consult Clin Psychol,2004; 72 (6):1100-1113.
  11. 11. Lesbros-Pantoflichova D,Michetti P,Fried M,et al.Meta-analysis:the treatment of irritable bowel syndrome.Aliment Pharmacol Ther,2004; 20(11 -12):1253 -1269.
  12. 12. Talley NJ.Evaluation of drug treatment in irritable bowel syndrome.Br J Clin Pharmacol,2003; 56 (4):362-369.
  13. 13. Spanier JA,Howden CW,Jones MP.A systematic review of alternative therapies in the irritable bowel syndrome.Arch Intern Med,2003; 163(3):265 -274.
  14. 14. Tan S,Tillisch K,Bolus SR,et al.Traditional Chinese medicine based subgrouping of irritable bowel syndrome patients.Am J Chin Med,2005; 33(3):365-379.
  15. 15. Sung JJ,Leung WK,ChingJY,et al.Agreements among traditional Chinese medicine practitioners in the diagnosis and treatment of irritable bowel syndrome.Aliment Pharmacol Ther,2004; 20 (10):1205-1210.
  16. 16. Bensooussan A,Talley NJ,Hing M,et al.Treatment of irritable bowel syndrome with Chinese herbal medicine:a randomized conrolled trial.JAMA,1998; 280(18):1585 -1589.
  17. 17. Yuan R,Lin Y.Traditional Chinese medicine:an approach to scientific proof and clinical validation.Pharmacol Ther,2000; 86 (2):191-198.
  18. 18. Chinese Society of Grstroenerology.The uniform on irritable bowel syndrome.Chinese Journal of Internal Medicine,2003; 42 (9):669-670.中華醫(yī)學(xué)會消化病學(xué)分會.腸易激綜合征診治的共識意見.中華內(nèi)科雜志,2003;42(9):669～670.
  19. 19. Cheng ZS,Zhang WD,Wei BH.Schedule for Diagnosis and Treatment of Irritable Bowel Syndrome with Integrative Chinese and Western Medicine (Draft).Chinese Journal of Integrated Traditional and Western Medicine,2005; 25 (3):282-284.陳治水,張萬岱,危北海.腸易激綜合征中西醫(yī)結(jié)合診治方案(草案).中國中西醫(yī)結(jié)合雜志,2005;25(3):282 284.
  20. 20. World Medical Association Declaration of Helsinki:ethical principles for medical research involving human subjects.JAMA,2000; 284:3043-3045.
  21. 21. Pittler MH,Ernst E.Peppermint oil for irritable bowel syndrome:a critical review and meta-analysis.Am J Gastroenterol,1998; 93 (7):1131 -1135.
  22. 22. Grigoleit HG,Grigoleit P.Peppermint oil in irritable bowel syndrome.Phytomedicine,2005; 12 (8):601-606.
  23. 23. Brinkhaus B,Hentschel C,Von Keudell C,et al.Herbal medicine with curcuma and fumitory in the treatment of irritable bowel syndrome:a randomized,placebo-controlled,double-blind clinical trial.Scand J Gastroenterol,2005; 40 (8):936-943.
  24. 24. Bundy R,Walker AF,Middleton R W,et al.Artichoke leaf extract reduces reduces symptoms of irritable bowel syndrome and improves quality of life in otherwise healthy volunteers suffering from concomitant dyspepsia:a subset analysis.J Altern Complenent Med,2004; 10(4):667-669.
  25. 25. Madisch A,Holtmann G,Plein K,et al.Treatment of irritable bowel syndrome with herbal preparations:results of a double-blind,randomized,placebo-controlled,multi-centre trial.Aliment Pharma col Ther,2004; 19(3):271 -279.
  26. 26. Baer N.Debate about placebos points to issue surrounded by many shades of grey.CMA J,1996; 155 (10):1475-1476.
  27. 27. Patel SM,Stason WB,Legedza A,et al.The placebo effect in irri table bowel syndrome trials:a meta-analysis.Neurogastroenterol Motil,2005; 17 (3):332-340.
  28. 28. Moher D,Schulz KF,Altman D,et al.The CONSORT statement:revised recommendations for improving the quality of reports of parallel-group randomized trials.JAMA,2001; 285 (15):1987-1991.