利胆清微丸治疗慢性胆囊炎湿热蕴结兼血瘀证临床研究

【】　目的　观察利胆清微丸治疗慢性胆囊炎湿热蕴结兼血瘀证患者的疗效及安全性，进一步为临床研究提供依据。　方法　2001年4―7月，采用双盲、双模拟、随机平行对照临床试验，将40例患者随机分为试验组（20例）及对照组（20例）。试验组服用利胆清微丸3.5g/次，3次/d，同时服用胆宁片模拟剂；对照组服用胆宁片3片/次，3次/d，同时服用利胆清微丸模拟剂。　结果　试验组痊愈1例，显效12例，有效5例，无效2例，显效率65%，有效率90%；对照组痊愈2例，显效10例，有效7例，无效1例，显效率60%，有效率95%，两组疗效比较差异无统计学意义（P>0.05）。试验过程中未发现明显不良反应。　结论　利胆清微丸对于治疗慢性胆囊炎湿热蕴结兼血瘀证有良好效果，是一种安全有效的药物。【Abstract】　Objective　ToobservethesafetyandefficacyofLidanqingpelletonchroniccholecystitiswithdampandhotaccumulateknotincludingbloodstasis,andtoprovideabasisforfurtherclinicaltrials.　Methods　Adouble-blind,doubledummy,randomized,andcontrolledclinictrialwasundertakenbetweenAprilandJuly2001.Atotalof40patientswererandomlydividedintotrailgroupandcontrolgroup.ThetrialgroupwasgivenLidanqinpellet3.5gpertime,andthreetimesperday;simultaneouslytakingDanningtabletsimulationagent.Thecontrolgroupwasgiven3tabletsofDanningtabletpertimeandthreetimesperday;simultaneouslytakingtakingLidanqingpelletssimulationagent.　Results　Inthetrailgroup,onepatientwascured,thetherapeuticeffectwasobviousin12,basicallyeffectiveinfiveandinvalidintwo(withtherateofobviouseffectof65.00%andrateofbasiceffectof90.00%).Inthecontrolgroup,twopatientswascured,thetherapeuticeffectwasobviousin12,basicallyeffectivein10,effectiveinsevenandinvalidinone(withtherateofbasiceffectof60.00%andtherateofobviouseffectof95.00%).Thedifferencebetweenthetwogroupswassignificant(P>0.05).Adversereactionwasnotfoundinthetrialgroup.　Conclusion　Lidanqingpellet,asafemedication,iseffectiveonchroniccholecystitiswithdampandhotaccumulateknotincludingbloodstasis.