CAJ | 학술논문

目的观察荆花胃康胶丸(主要成分:土荆芥和水团花)联合质子泵抑制剂(PPI)三联疗法对幽门螺杆菌(H.pylori)阳性慢性萎缩性胃炎患者的H.pylori根除率及症状缓解情况.方法采用前瞻性多中心随机对照研究,研究对象为因上胃肠道症状而接受胃镜检查确诊为慢性萎缩性胃炎且伴有H.pylori感染(快速尿素酶试验阳性或胃镜前后7d内呼气试验阳性)的患者,于2012年9月至2013年4月从北京大学第一医院、东方医院、宣武中医医院纳入90例符合入选标准的患者,其中男46例、女44例,平均年龄(54±10)岁,所有患者既往均未接受过正规H.pylori根除治疗.采用分层随机方法将患者分为荆花胃康组和铋剂四联组(各45例).荆花胃康组:兰索拉唑30 mg+阿莫西林1000 mg+克拉霉素500 mg+荆花胃康胶丸240 mg,口服,2次/d,疗程10 d(d1～ 10);之后荆花胃康胶丸240 mg,口服,2次/d,疗程14 d(d11 ～24).铋剂四联组:兰索拉唑30 mg+阿莫西林1000 mg+克拉霉素500 mg+枸橼酸铋钾220 mg,口服,2次/d,疗程10 d(d1 ～d10).治疗结束至少28 d后所有患者均行13C尿素呼气试验检测.所有患者于治疗前、治疗后10或24 d、停药后28 d记录症状积分.结果荆花胃康组、铋剂四联组H.pylori根除率符合方案数据分析(PP)和意向性分析(ITT)分别为70.5％ (31/44)和68.9％ (31/45)、83.3％ (35/42)和77.8％(35/45),差异均无统计学意义(均P ＞0.05).两组患者治疗后10或24 d及停药后28 d的上消化道症状(上腹胀、嗳气、上腹痛、纳差)均较治疗前明显缓解(均P ＜0.05).荆花胃康组患者上腹胀、嗳气、上腹痛症状与基线比降低值的中位数均比铋剂四联组高,但差异均无统计学意义(均P ＞0.05).结论荆花胃康胶丸联合PPI三联疗法对慢性萎缩性胃炎患者有较好的H.pylori根除率,且不良反应少,其对患者症状的缓解优于铋剂四联组.
목적 관찰형화위강효환(주요성분:토형개화수단화)연합질자빙억제제(PPI)삼련요법대유문라간균(H.pylori)양성만성위축성위염환자적H.pylori근제솔급증상완해정황.방법 채용전첨성다중심수궤대조연구,연구대상위인상위장도증상이접수위경검사학진위만성위축성위염차반유H.pylori감염(쾌속뇨소매시험양성혹위경전후7d내호기시험양성)적환자,우2012년9월지2013년4월종북경대학제일의원、동방의원、선무중의의원납입90례부합입선표준적환자,기중남46례、녀44례,평균년령(54±10)세,소유환자기왕균미접수과정규H.pylori근제치료.채용분층수궤방법장환자분위형화위강조화필제사련조(각45례).형화위강조:란색랍서30 mg+아막서림1000 mg+극랍매소500 mg+형화위강효환240 mg,구복,2차/d,료정10 d(d1～ 10);지후형화위강효환240 mg,구복,2차/d,료정14 d(d11 ～24).필제사련조:란색랍서30 mg+아막서림1000 mg+극랍매소500 mg+구연산필갑220 mg,구복,2차/d,료정10 d(d1 ～d10).치료결속지소28 d후소유환자균행13C뇨소호기시험검측.소유환자우치료전、치료후10혹24 d、정약후28 d기록증상적분.결과 형화위강조、필제사련조H.pylori근제솔부합방안수거분석(PP)화의향성분석(ITT)분별위70.5％ (31/44)화68.9％ (31/45)、83.3％ (35/42)화77.8％(35/45),차이균무통계학의의(균P ＞0.05).량조환자치료후10혹24 d급정약후28 d적상소화도증상(상복창、애기、상복통、납차)균교치료전명현완해(균P ＜0.05).형화위강조환자상복창、애기、상복통증상여기선비강저치적중위수균비필제사련조고,단차이균무통계학의의(균P ＞0.05).결론 형화위강효환연합PPI삼련요법대만성위축성위염환자유교호적H.pylori근제솔,차불량반응소,기대환자증상적완해우우필제사련조.
Objective To observe the efficacy of Jinghuaweikang gelatin pearls plus proton pump inhibitor (PPI)-based triple regimen in the treatment of chronic atrophic gastritis (CAG) patients with Helicobacter pylori (H.pylori) infection.Methods For this multicenter,randomized,controlled clinical study,90 patients of endoscopically confirmed CAG with positive H.pylori (13C or 14C-urea breath test (UBT) or rapid urease test)were enrolled.There were 46 males and 44 females with an age range of (54 ±10) years.None of them had H.pylori eradication background.They were randomly divided into 2 groups,Group LACJ (n =45) received lansoprazole 30 mg+ amoxicillin 1000 mg + clarithromycin 500 mg +jinghuaweikang gelatin pearls 240 mg,twice daily,for 10 days (d1-10) plus another 14 days (d1 1-24)only with jinghuaweikang gelatin pearls 240 mg,twice daily.Group LACB (n =45) had standard quadruple regimen treatment:lansoprazole 30 mg + amoxicillin 1000 mg + clarithromycin 500 mg + bismuth potassium citrate 220 mg,twice daily for 10 days (dl-10).The status of H.pylori was detected by 13C-UBT at least 28 days after therapy.Results The eradication rates in Groups LACJ and LACB were as follows:per-protocol (PP):70.5 ％ (31/44) and 83.3 ％ (35/42),intention-to-treat (ITT):68.9％ (31/45)and 77.8％ (35/45) (both P ＞ 0.05).The symptomatic improvements of bloating in upper abdomen,belching and epigastric pain after treatment in both groups.And those in Group LACJ was higher than those of Group LACB,but no statistical difference existed between two groups (all P ＞ 0.05).Conclusions The efficacy of LACJ for the treatment of CAG patients with H.pylori infection is similar to LACB.And the symptomatic improvement of patients is better than LACB.