胃通颗粒治疗功能性消化不良临床研究.pdf

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1、2013年4月第3卷第7期·药物与临床·胃通颗粒治疗功能性消化不良临床研究侯雪梅劳绍贤林英勇’张崇泉金鑫1．丽珠集团丽珠医药研究所，广东珠海519020；2．广州中医药大学，广东广州510405；3．湖南省中医药研究院，湖南长沙410608【摘要】目的研究胃通颗粒对功能性消化不良(痞满证)属于脾胃气滞兼热证的临床疗效及安全性。方法对448例患者采用随机双肓双模拟和开放的临床试验。胃通颗粒组(甲)与木香顺气丸组、胃通颗粒组(乙)与多潘立酮组采用完全随机分组、双肓双模拟对照法(293例)，开放组采用自身前后对照(155例)各治疗组均按双盲双模拟对照

2、法编号用药，而开放组则服用不编号的胃通颗粒，以上各组均每次1包，温水冲服，每日3次，疗程为7d。结果主症的总有效率治疗组、对照组、开放组三者相近；显效率治疗组、开放组优于对照组(P0．05)；中医证候的总有效率、显效率，治疗组、开放组均明显优于对照组(P<0．05，P<0．01o结论胃通颗粒治疗功能性消化不良具有安全、良好的临床疗效。[关键词】胃通颗粒；消化不良；痞满证；木香顺气丸；多潘立酮【中图分类号】R259【文献标识码】B【文章编号】2095—0616(2013

3、)O7—91—03MulticentralclinicaltrialofweitonggranulesforfunctionaldyspepsiaHOUXuemeiLAOShaoxian‘LINYmon琶ZHANGChongqua~aINX／n‘1．Lizhu(Group)PharmaceuticalResearchInstituteofZhuhaiCityinGuangdongProvince，Zhuhai519020，China；2．TraditionalChineseMedicineUniversityofGuangzhou，Guangz

4、hou510405，China；3．HunanAcademyofChineseMedicine，Changsha410608，China【Abstract]0bjectiveToinvestigatetheeficacyandsafetyofweitonggranulesintreatmentoffunctionaldyspepsia．MethodsTherandomizedcontrolled—muhicenterandopenclinicaltrailswasconductedin448patientswithfunctionaldyspe

5、psia．GroupweitonggranulesandmuxinshunqiPills，groupweitonggranulesanddomperidonewereusingcompletelyrandomized，double—blinddouble-dummycontrolledmethod(293patients)，opencontrolgroupwasusingbeforeandafteroftheirowncontrolmethod(155patients)．Thetreatmentgroupswereadministratedby

6、double-blinddouble-dummyCOntrollednumbers，andopengroupwasadministratedtheonmarkednumberofgranules．Theabovegroupswereadministratedonepackageonetimewithwarmwater，threetimesaday．Durationoftreatmentwassevendays．ResultsThetreatmentgroup，controlgroupandopengroupweresimilarofmainsy

7、mptomsoftotalefectiverate．Markedlyeffectiverateoftreatmentgroup．opengroupwerebetterthancontrolgroup(P<0．O1)．Thefunctionalgastricemptyingoftotaleffectiverateandmarkedlyeffectiveratewerenosignificantdifference>0．05)．Thetraditionalchinesemedicine(TCM)syndromeoftotaleffectiverat

8、eandmarkedlyeffectiverate，thetreatmentgroupandopengroupwerebetterthancontro