机构地区:[1]四川大学华西医院中国循证医学中心,成都610041
出 处:《中国循证医学杂志》2012年第8期930-938,共9页Chinese Journal of Evidence-based Medicine
基 金:"十一五"国家科技支撑计划重点项目"不同类型乡镇卫生院科技综合示范及相关产品开发"--"乡镇卫生院药物配置与物流关键技术研究与产品开发"课题(编号:2008BAI65B22)
摘 要:目的基于疾病负担,循证评价与遴选我国乡镇卫生院合理治疗成人和儿童急、慢性胃炎的基本药物。方法按本系列研究之二制定的方法、标准和流程,参考国内外循证或权威指南的推荐意见,结合国内相关临床研究证据,循证评价并推荐相关药物。结果①共纳入急性胃炎治疗指南5个、慢性胃炎治疗指南7个。推荐药物包括奥美拉唑、雷尼替丁、多潘立酮。②3个非随机对照试验(CCT,n=315,低质量)表明,奥美拉唑缓解成人慢性胃炎患者上腹痛/不适、反酸/烧心、上腹饱胀等症状总有效率优于法莫替丁、雷尼替丁[71.2%vs.47.3%;94.4%vs.84.3%,P<0.05)]。1个RCT(n=100,低质量)及2个CCT(n=213,低质量)表明,奥美拉唑三联疗法与对照组HP根除率差异无统计学意义[OR=1.09,95%CI(0.44,2.70),P>0.05]。1个RCT(n=100,低质量)未见不良反应,5个CCT(n=528,低质量)报告食欲减退2人,恶心、呕吐4人,头痛/头晕1人,转氨酶升高1人。药费片剂8元/d、胶囊4元/d。③HP根除率,1个系统评价(15个RCT,n=3 638,高质量)指出,雷尼替丁联合枸橼酸铋(RBC)疗效优于对照组[OR=2.05,95%CI(1.29,3.25),P=0.002]。15个RCT(n=3 638,高质量)均报告了以消化道症状为主的不良反应。1个RCT(n=100,低质量)表明RBC与奥美拉唑三联法比较差异无统计学意义(P>0.05),未见不良反应。雷尼替丁片剂药费0.36元/d,胶囊0.40元/d,注射剂2.7~5.4元/d。④与对照组相比,2个CCT(n=133,低质量)表明多潘立酮治疗消化不良症状、促进胃排空效应、缓解上腹疼痛发胀、嗳气、返酸较优(P<0.01);未发现不良事件发生,药费1~1.3元/d。⑤上述药品及其剂型均被中国药典(2010)、CNF(2010)收载,具有合法性。⑥上述药品应严格按中国国家药物处方集、国家基本药物临床应用指南处方。结论急、慢性胃炎消化不良和HP根除治疗:①强推荐奥美拉唑口服常释剂型10 mg/片,但儿童、老人、孕期妇女、哺乳期�Objective To evaluate and select essential medicine for acute and chronic gastritis using evidence-based approaches based on the burden of disease for township health centers located in eastern,central and western regions of China.Methods By means of the approaches,criteria,and workflow set up in the second article of this series,we referred to the recommendations of evidence-based or authority guidelines from inside and outside China,collected relevant evidence from domestic clinical studies,and recommended essential medicine based on evidence-based evaluation.Data were analyzed by Review Manager(RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence.Results (1) Five guidelines for acute gastritis and seven guidelines for chronic gastritis were included.The recommended included omeprazole,ranitidine and domperidone.(2) A result of three CCTs(n=315,low quality) indicated that omeprazole was superior to famotidine and ranitidine in alleviating symptoms of chronic gastritis such as pain or discomfort in the upper abdomen,regurgitation,a burning sensation in the heart,distention and fullness in the upper abdomen(71.2% vs.47.3%,94.4% vs.84.3%,P〈0.05).A result of one RCT(n=100,low quality) and two CCTs(n=213,low quality) indicated that in HP eradication rates,omeprazole triple therapy and the control intervention had no significant difference(OR=1.09,95%CI 0.44 to 2.70,P〉0.05).A result of one RCT(n=100,low quality) indicated that omeprazole caused no adverse reaction.A result of five CCTs(n=528,low quality) indicated that adverse reaction of omeprazole included poor appetite(two cases),nausea and vomiting(four cases),headache or vertigo(one case) and increased transaminase(one case).Omeprazole cost eight yuan(tablet) or four yuan(capsule) daily.(3) HP eradication rates of ranitidine bismuth citrate was higher than the control group(OR=2.05,95%CI 1.29 to 3.25,P=0.002).A result of 15 RCTs(n=3 638,high quality) indicated adverse r
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