目的 評價達立通顆粒治療痞滿證(功能性消化不良)的療效和安全性.
方法 根據(jù)本研究的納入與排出標準,選取痞滿證(功能性消化不良)患者120例,按3:1隨機分為達立通顆粒組(治療組)90例和西沙必利組(對照組)30例,進行隨機對照雙盲雙模擬試驗.治療組口服達立通顆粒,每日3次,每次6 g;對照組口服西沙必利片,每日3次,每次5 mg,療程均為2周.
結果 對中醫(yī)證候療效而言,意向性治療(intention-to-treat,ITT)分析結果顯示,治療組總顯效率62.37%,總有效率99.55%;對照組總顯效率58.08%,總有效率90.33%.符合方案數(shù)據(jù)分析(per-protocol population,PP)結果顯示,治療組總顯效率為64.45%,總有效率96.67%;對照組總顯效率為60.00%,總有效率為93.33%.兩組中醫(yī)證候療效比較無統(tǒng)計學意義(P＞0.05).對痞滿證候療效而言,ITT分析顯示,治療組總顯效率53.76%,總有效率86.02%;對照組的總顯效率48.38%,總有效率80.64%.PP分析顯示治療組的總顯效率55.56%,總有效率88.89%;對照組總顯效率50.00%,總有效率為83.33%.兩組痞滿證療效比較無統(tǒng)計學意義(P＞0.05).胃排空試驗(PP人群)顯示,治療組總顯效率72.42%,總有效率為79.32%;對照組顯效率64.28%,總有效率64.28%.兩組比較無統(tǒng)計學意義(P＞0.05).ITT分析與PP分析結果一致.臨床觀察中未發(fā)現(xiàn)明顯不良反應.
結論 達立通顆粒療效與西沙必利相當,未發(fā)現(xiàn)明顯的毒副作用.
引用本文： 王蕾,李廷謙,張瑞明,毛兵,常靜,張穎. 達立通顆粒治療痞滿證(功能性消化不良)的隨機對照雙盲試驗. 中國循證醫(yī)學雜志, 2004, 04(4): 239-243. doi: 復制
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- 1. ［1］Principle of clinical research for new traditional herbs [ R ]. 1st issue. Ministry of health P. R. China. August, 1993;88-90.
- 2. 中華人民共和國衛(wèi)生部:中藥新藥臨床研究指導原則[R].第1輯,1993年8月;88～90.
- 3. ［2］Ye RG, Chief -editor. Internal medicine [ M ]. Fifth edition.Beijing : People’ s medical publishing house, 1999 ;440 -444.
- 4. 葉仁高.內科學[M]第5版北京:人民衛(wèi)生出版社,1999;440～444.
- 5. ［3］He MR, Song YG, He CR. The therapeutic effect of fluoxetine on nonuclear dyspepsia patients with delayed gastric emptying[ J ]. Clinical Medicine of China, 2002; 18 ( 9 ): 798 -799.
- 6. 何美蓉,宋于剛,何春容.氟西丁治療胃排空延緩的非潰瘍性消化不良得療效觀察[J].中國綜合臨床,2002;18(9):798～799.
- 7. ［4］Su BH, Chief-editor. New insights of statistics for clinical trials of new drugs [ M ]. Shanghai publishing house of science,technology and literrature , 1999 ;43-44.
- 8. 蘇炳華主編.新藥臨床試驗統(tǒng)計新進展[M].第2版上海:上海科技文獻出版社,1999;43～44.
- 9. ［5］Fang YZ, chief-editor. Practical medicine of traditional Chinese medicine [ M ]. Shanghai publishing house of science,technology, 1985 ;211-215.
- 10. 方藥中主編.實用中醫(yī)內科學[M].第3版上海:上?？茖W技術出版社,1985;211～215.
- 11. ［6］Liu XG. Functional dyspepsia and abnormality of gastrointestinal mobility [ J ]. Chinese Journal of Digestion, 2002; 22 ( 1 ): 44 -45.
- 12. 劉新光.功能性消化不良與胃腸動力異常[J]中華消化雜志,2002;22(1):44～45.
- 13. ［7］Scott AM, Kellow JE, Shuter B. Intragastric distribution and gastric emptying of solids and liquids in functional dyspepsia[J].Dig Dis Sci, 1993;38(12) :2 247-2 254.
- 14. ［8］Rosch W. Chronic functional dyspepsia: short- and mediumterm outcome of a therapeutic trial with cisapride [J ]. Clin Ther, 1994;16(3) :437-445.