目的 系统评价中草药与西药治疗功能性消化不良的疗效、安全性差异.方法 计算机检索MEDLINE、OVID、SpringerLink、Cochrane 图书馆、中国生物医学文献数据库(CBM)及CNKI 数据库,检索年限均从建库至2008 年12 月.手工检索纳入研究的参考文献及相关杂志、会议论文集、学位论文汇编等.按Cochrane系统评价方法 筛选试验、评价质量、提取资料,并用RevMan 4.2.8 软件进行Meta 分析.结果 共纳入7 个随机对照试验,981 例患者,其中治疗组647 例,对照组334 例.纳入试验的方法 学质量均较高(Jadad 计分≥ 3 分),3 个A级,2 个B 级,2 个C 级.Meta 分析结果 显示:①达立通颗粒与西沙必利比较,两组临床总有效率[RR=1.03,95%CI(0.97,1.09),P=0.36]、痞满证疗效[RR=1.06,95%CI(0.96,1.18),P=0.23]、胃排空疗效[RR=1.05,95%CI(0.76,1.45),P=0.78]、中医证候积分[WMD=0.41,95%CI(-1.05,1.87),P=0.58]、舌脉象变化[RR=1.00,95%CI(0.69,1.45),P=0.98]及不良反应发生情况[RR=1.00,95%CI(0.69,1.45),P=0.46]差异均无统计学意义;②胃舒安颗粒与西沙必利比较,两组临床总有效率[RR=1.02,95%CI(0.96,1.07),P=0.53]、痞满证疗效[RR=1.06,95%CI(0.97,1.15),P=0.19]、胃排空疗效[RR=1.05,95%CI(0.86,1.28),P=0.63]、中医证候积分[WMD=0.70,95%CI(0.11,1.29),P=0.02]及不良反应发生情况[RR=0.33,95%CI(0.02,5.28),P=0.44]差异亦无统计学意义;③健脾益气方剂[RR=1.16,95%CI(1.00,1.34),P=0.05]、理气复胃口服液[RR=1.00,95%CI(0.91,1.11),P=0.94]和健脾消胀冲剂[RR=0.88,95%CI(0.76,1.00),P=0.06]与莫沙必利比较,其临床总有效率差异均无统计学意义;④和胃消痞胶囊与吗丁啉比较,其临床总有效率[RR=1.11,95%CI(0.87,1.41),P=0.42]、痞满证疗效[RR=1.07,95%CI(0.93,1.24),P=0.35]的差异也无统计学意义.结论 现有证据表明,中草药治疗功能性消化不良的疗效、安全性与西药组相当,各疗效指标无明显差异.由于纳入研究方法 学质量不均,及各研究间诊断标准、评价方法 、失访描述等方面存在的差异,上述结论 尚需更多设计严格的高质量RCT 研究加以证实.
目的 繫統評價中草藥與西藥治療功能性消化不良的療效、安全性差異.方法 計算機檢索MEDLINE、OVID、SpringerLink、Cochrane 圖書館、中國生物醫學文獻數據庫(CBM)及CNKI 數據庫,檢索年限均從建庫至2008 年12 月.手工檢索納入研究的參攷文獻及相關雜誌、會議論文集、學位論文彙編等.按Cochrane繫統評價方法 篩選試驗、評價質量、提取資料,併用RevMan 4.2.8 軟件進行Meta 分析.結果 共納入7 箇隨機對照試驗,981 例患者,其中治療組647 例,對照組334 例.納入試驗的方法 學質量均較高(Jadad 計分≥ 3 分),3 箇A級,2 箇B 級,2 箇C 級.Meta 分析結果 顯示:①達立通顆粒與西沙必利比較,兩組臨床總有效率[RR=1.03,95%CI(0.97,1.09),P=0.36]、痞滿證療效[RR=1.06,95%CI(0.96,1.18),P=0.23]、胃排空療效[RR=1.05,95%CI(0.76,1.45),P=0.78]、中醫證候積分[WMD=0.41,95%CI(-1.05,1.87),P=0.58]、舌脈象變化[RR=1.00,95%CI(0.69,1.45),P=0.98]及不良反應髮生情況[RR=1.00,95%CI(0.69,1.45),P=0.46]差異均無統計學意義;②胃舒安顆粒與西沙必利比較,兩組臨床總有效率[RR=1.02,95%CI(0.96,1.07),P=0.53]、痞滿證療效[RR=1.06,95%CI(0.97,1.15),P=0.19]、胃排空療效[RR=1.05,95%CI(0.86,1.28),P=0.63]、中醫證候積分[WMD=0.70,95%CI(0.11,1.29),P=0.02]及不良反應髮生情況[RR=0.33,95%CI(0.02,5.28),P=0.44]差異亦無統計學意義;③健脾益氣方劑[RR=1.16,95%CI(1.00,1.34),P=0.05]、理氣複胃口服液[RR=1.00,95%CI(0.91,1.11),P=0.94]和健脾消脹遲劑[RR=0.88,95%CI(0.76,1.00),P=0.06]與莫沙必利比較,其臨床總有效率差異均無統計學意義;④和胃消痞膠囊與嗎丁啉比較,其臨床總有效率[RR=1.11,95%CI(0.87,1.41),P=0.42]、痞滿證療效[RR=1.07,95%CI(0.93,1.24),P=0.35]的差異也無統計學意義.結論 現有證據錶明,中草藥治療功能性消化不良的療效、安全性與西藥組相噹,各療效指標無明顯差異.由于納入研究方法 學質量不均,及各研究間診斷標準、評價方法 、失訪描述等方麵存在的差異,上述結論 尚需更多設計嚴格的高質量RCT 研究加以證實.
목적 계통평개중초약여서약치료공능성소화불량적료효、안전성차이.방법 계산궤검색MEDLINE、OVID、SpringerLink、Cochrane 도서관、중국생물의학문헌수거고(CBM)급CNKI 수거고,검색년한균종건고지2008 년12 월.수공검색납입연구적삼고문헌급상관잡지、회의논문집、학위논문회편등.안Cochrane계통평개방법 사선시험、평개질량、제취자료,병용RevMan 4.2.8 연건진행Meta 분석.결과 공납입7 개수궤대조시험,981 례환자,기중치료조647 례,대조조334 례.납입시험적방법 학질량균교고(Jadad 계분≥ 3 분),3 개A급,2 개B 급,2 개C 급.Meta 분석결과 현시:①체립통과립여서사필리비교,량조림상총유효솔[RR=1.03,95%CI(0.97,1.09),P=0.36]、비만증료효[RR=1.06,95%CI(0.96,1.18),P=0.23]、위배공료효[RR=1.05,95%CI(0.76,1.45),P=0.78]、중의증후적분[WMD=0.41,95%CI(-1.05,1.87),P=0.58]、설맥상변화[RR=1.00,95%CI(0.69,1.45),P=0.98]급불량반응발생정황[RR=1.00,95%CI(0.69,1.45),P=0.46]차이균무통계학의의;②위서안과립여서사필리비교,량조림상총유효솔[RR=1.02,95%CI(0.96,1.07),P=0.53]、비만증료효[RR=1.06,95%CI(0.97,1.15),P=0.19]、위배공료효[RR=1.05,95%CI(0.86,1.28),P=0.63]、중의증후적분[WMD=0.70,95%CI(0.11,1.29),P=0.02]급불량반응발생정황[RR=0.33,95%CI(0.02,5.28),P=0.44]차이역무통계학의의;③건비익기방제[RR=1.16,95%CI(1.00,1.34),P=0.05]、리기복위구복액[RR=1.00,95%CI(0.91,1.11),P=0.94]화건비소창충제[RR=0.88,95%CI(0.76,1.00),P=0.06]여막사필리비교,기림상총유효솔차이균무통계학의의;④화위소비효낭여마정람비교,기림상총유효솔[RR=1.11,95%CI(0.87,1.41),P=0.42]、비만증료효[RR=1.07,95%CI(0.93,1.24),P=0.35]적차이야무통계학의의.결론 현유증거표명,중초약치료공능성소화불량적료효、안전성여서약조상당,각료효지표무명현차이.유우납입연구방법 학질량불균,급각연구간진단표준、평개방법 、실방묘술등방면존재적차이,상술결론 상수경다설계엄격적고질량RCT 연구가이증실.
Objective To assess the efficacy and safety of Chinese herbal medicine for the treatment of functional dyspepsia (FD) and compare the difference of efficacy between Chinese herbal medicine and western medicine. Methods Based on the principles and methods of Cochrane systematic reviews, we searched the Cochrane Central Register of Controlled Trials, MEDLINE, CBMdisc and CNKI from inception to Dec. 2008. And we also handsearched relevant journals and conference proceedings. We evaluated the risk of bias in the included randomized controlled trials(RCTs) according to the Cochrane Handbook for Systematic Reviews. The Cochrane Collaboration's software RevMan 4.2.8 was used for meta-analysis. Results Seven studies involving 981 patients were identified. The results of meta-analysis showed that: (1) There was no significant difference between Dalitong granule and cisaprid in effective rates (RR=1.03, 95%CI 0.97 to 1.09, P=0.36), piman syndrome (RR=1.06, 95%CI 0.96 to 1.18, P=0.23), gastric emptying function (RR=1.05, 95%CI 0.76 to 1.45, P=0.78), syndromes of TCM (WMD=0.41, 95%CI ?.05 to 1.87, P=0.58), pulse and tongue picture (RR=1.00, 95%CI 0.69 to 1.45, P=0.98), and adverse reaction (RR=1.00, 95%CI 0.69 to 1.45, P=0.46). (2) There was no significant difference between Weishuan pellet and cisaprid on effective rates (RR=1.02, 95%CI 0.96 to 1.07, P=0.53), piman syndrome (RR=1.06, 95%CI 0.97 to 1.15, P=0.19), gastric emptying function (RR=1.05, 95%CI 0.86 to 1.28, P=0.63), syndromes of TCM (WMD=0.70, 95%CI 0.11 to 1.29, P=0.02) and adverse reaction (RR=0.33, 95%CI 0.02 to 5.28, P=0.44).(3) There was no significant difference among Jianpiyiqi prescription (RR=1.16, 95%CI 1.00 to 1.34, P=0.05), Liqifuwei oral liquid (RR=1.00, 95%CI 0.91 to 1.11, P=0.94) and Jianpixiaozhang granules (RR=0.88, 95%CI 0.76 to 1.00, P=0.06)compared with cisaprid in effective rates (P>0.05). (4) There was no significant difference between Hewei Xiaopi Capsule and domperidone on effective rates (RR=1.11, 95%CI 0.87 to 1.41, P=0.42) and piman syndrome (RR=1.07, 95%CI 0.93 to 1.24, P=0.35). Conclusion Chinese herbal medicine has a better clinical cure rate and marks of TCM syndrome on FD than western medicine. But we have no adequate evidence to confirm whether western medicine can be substituted by Chinese herbal medicine for the treatment of FD. Therefore, we need more high quality RCTs to confirm this conclusion.
