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摘要：
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.
Abstract：
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.
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