摘要：

目的 觀察荊花胃康膠丸(主要成分:土荊芥和水團(tuán)花)聯(lián)合質(zhì)子泵抑制劑(PPI)三聯(lián)療法對(duì)幽門螺桿菌(H.pylori)陽(yáng)性慢性萎縮性胃炎患者的H.pylori根除率及癥狀緩解情況.方法 采用前瞻性多中心隨機(jī)對(duì)照研究,研究對(duì)象為因上胃腸道癥狀而接受胃鏡檢查確診為慢性萎縮性胃炎且伴有H.pylori感染(快速尿素酶試驗(yàn)陽(yáng)性或胃鏡前后7d內(nèi)呼氣試驗(yàn)陽(yáng)性)的患者,于2012年9月至2013年4月從北京大學(xué)第一醫(yī)院,、東方醫(yī)院、宣武中醫(yī)醫(yī)院納入90例符合入選標(biāo)準(zhǔn)的患者,其中男46例,、女44例,平均年齡(54±10)歲,所有患者既往均未接受過(guò)正規(guī)H.pylori根除治療.采用分層隨機(jī)方法將患者分為荊花胃康組和鉍劑四聯(lián)組(各45例).荊花胃康組:蘭索拉唑30 mg 阿莫西林1000 mg 克拉霉素500 mg 荊花胃康膠丸240 mg,口服,2次/d,療程10 d(d1～ 10);之后荊花胃康膠丸240 mg,口服,2次/d,療程14 d(d11 ～24).鉍劑四聯(lián)組:蘭索拉唑30 mg 阿莫西林1000 mg 克拉霉素500 mg 枸櫞酸鉍鉀220 mg,口服,2次/d,療程10 d(d1 ～d10).治療結(jié)束至少28 d后所有患者均行13C尿素呼氣試驗(yàn)檢測(cè).所有患者于治療前,、治療后10或24 d、停藥后28 d記錄癥狀積分.結(jié)果 荊花胃康組,、鉍劑四聯(lián)組H.pylori根除率符合方案數(shù)據(jù)分析(PP)和意向性分析(ITT)分別為70.5％ (31/44)和68.9％ (31/45),、83.3％ (35/42)和77.8％(35/45),差異均無(wú)統(tǒng)計(jì)學(xué)意義(均P ＞0.05).兩組患者治療后10或24 d及停藥后28 d的上消化道癥狀(上腹脹,、噯氣、上腹痛,、納差)均較治療前明顯緩解(均P ＜0.05).荊花胃康組患者上腹脹,、噯氣、上腹痛癥狀與基線比降低值的中位數(shù)均比鉍劑四聯(lián)組高,但差異均無(wú)統(tǒng)計(jì)學(xué)意義(均P ＞0.05).結(jié)論 荊花胃康膠丸聯(lián)合PPI三聯(lián)療法對(duì)慢性萎縮性胃炎患者有較好的H.pylori根除率,且不良反應(yīng)少,其對(duì)患者癥狀的緩解優(yōu)于鉍劑四聯(lián)組.

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.