中华医学杂志
中華醫學雜誌
중화의학잡지
National Medical Journal of China
2010年
2期
75-78
,共4页
"温胃舒或养胃舒治疗幽门螺杆菌相关性慢性胃炎和消化性溃疡"全国多中心临床研究科研协作组
"溫胃舒或養胃舒治療幽門螺桿菌相關性慢性胃炎和消化性潰瘍"全國多中心臨床研究科研協作組
"온위서혹양위서치료유문라간균상관성만성위염화소화성궤양"전국다중심림상연구과연협작조
胃炎%消化性溃疡%螺杆菌%幽门%中药%随机对照试验
胃炎%消化性潰瘍%螺桿菌%幽門%中藥%隨機對照試驗
위염%소화성궤양%라간균%유문%중약%수궤대조시험
Gastritis%Peptic ulcer%Helicobacter pylori%Chinese patent medicine%Randomized controlled trails
目的 探讨标准三联疗法泮托拉唑+克拉霉素+甲硝唑(PCM)联合温胃舒或养胃舒对幽门螺杆菌(Hp)相关性慢性胃炎和消化性溃疡患者的Hp根除率及症状缓解率,并观察温胃舒或养胃舒对胃溃疡愈合的影响.方法 全国11个中心642例符合标准的患者随机分为PCM组(222例):泮托拉唑40 mg2次/d+克拉霉素500 mg2次/d+甲硝唑400 mg2次/d,疗程7 d;PCM+温胃舒组(196例);PCM+养胃舒组(224例).于治疗停药4周后复查(~14)C-尿素呼气试验,胃溃疡患者治疗结束复查胃镜.结果 按意向治疗(ITT)分析显示,PCM+温胃舒组、PCM+养胃舒组及PCM组Hp根除率分别为62.2%(122/196)、60.3%(135/224)和57.2%(127/222)(与PCM组比较,P=0.295、0.512);按符合方案(PP)分析分别为70.1%(122/174)、65.2%(135/207)和62.3%(127/204)(与PCM组比较,P=0.108、0.532).PP分析3组胃溃疡愈合率分别为100.0%(18/18)、86.4%(19/22)和61.9%(13/21);PCM+温胃舒组胃溃疡愈合率与PCM组比较差异有统计学意义(P=0.004).PCM+养胃舒组及PCM+温胃舒组患者腹痛、腹胀症状缓解率均显著高于PCM组(均P＜0.01).各组均只有少数患者发生不良反应.结论 温胃舒或养胃舒与标准三联疗法联合应用虽不能明显提高Hp的根除率,但可增加慢性胃炎及消化性溃疡患者症状缓解率及溃疡愈合率.
目的 探討標準三聯療法泮託拉唑+剋拉黴素+甲硝唑(PCM)聯閤溫胃舒或養胃舒對幽門螺桿菌(Hp)相關性慢性胃炎和消化性潰瘍患者的Hp根除率及癥狀緩解率,併觀察溫胃舒或養胃舒對胃潰瘍愈閤的影響.方法 全國11箇中心642例符閤標準的患者隨機分為PCM組(222例):泮託拉唑40 mg2次/d+剋拉黴素500 mg2次/d+甲硝唑400 mg2次/d,療程7 d;PCM+溫胃舒組(196例);PCM+養胃舒組(224例).于治療停藥4週後複查(~14)C-尿素呼氣試驗,胃潰瘍患者治療結束複查胃鏡.結果 按意嚮治療(ITT)分析顯示,PCM+溫胃舒組、PCM+養胃舒組及PCM組Hp根除率分彆為62.2%(122/196)、60.3%(135/224)和57.2%(127/222)(與PCM組比較,P=0.295、0.512);按符閤方案(PP)分析分彆為70.1%(122/174)、65.2%(135/207)和62.3%(127/204)(與PCM組比較,P=0.108、0.532).PP分析3組胃潰瘍愈閤率分彆為100.0%(18/18)、86.4%(19/22)和61.9%(13/21);PCM+溫胃舒組胃潰瘍愈閤率與PCM組比較差異有統計學意義(P=0.004).PCM+養胃舒組及PCM+溫胃舒組患者腹痛、腹脹癥狀緩解率均顯著高于PCM組(均P＜0.01).各組均隻有少數患者髮生不良反應.結論 溫胃舒或養胃舒與標準三聯療法聯閤應用雖不能明顯提高Hp的根除率,但可增加慢性胃炎及消化性潰瘍患者癥狀緩解率及潰瘍愈閤率.
목적 탐토표준삼련요법반탁랍서+극랍매소+갑초서(PCM)연합온위서혹양위서대유문라간균(Hp)상관성만성위염화소화성궤양환자적Hp근제솔급증상완해솔,병관찰온위서혹양위서대위궤양유합적영향.방법 전국11개중심642례부합표준적환자수궤분위PCM조(222례):반탁랍서40 mg2차/d+극랍매소500 mg2차/d+갑초서400 mg2차/d,료정7 d;PCM+온위서조(196례);PCM+양위서조(224례).우치료정약4주후복사(~14)C-뇨소호기시험,위궤양환자치료결속복사위경.결과 안의향치료(ITT)분석현시,PCM+온위서조、PCM+양위서조급PCM조Hp근제솔분별위62.2%(122/196)、60.3%(135/224)화57.2%(127/222)(여PCM조비교,P=0.295、0.512);안부합방안(PP)분석분별위70.1%(122/174)、65.2%(135/207)화62.3%(127/204)(여PCM조비교,P=0.108、0.532).PP분석3조위궤양유합솔분별위100.0%(18/18)、86.4%(19/22)화61.9%(13/21);PCM+온위서조위궤양유합솔여PCM조비교차이유통계학의의(P=0.004).PCM+양위서조급PCM+온위서조환자복통、복창증상완해솔균현저고우PCM조(균P＜0.01).각조균지유소수환자발생불량반응.결론 온위서혹양위서여표준삼련요법연합응용수불능명현제고Hp적근제솔,단가증가만성위염급소화성궤양환자증상완해솔급궤양유합솔.
Objective To evaluate the efficacy of Chinese patent medicine wenweishu (温胃舒)/yangweishu(养胃舒) in the treatment of Helicobacter pylori ( H. priori ) positive patients with chronic gastritis and peptic ulcer. Methods A randomized, controlled and multicenter trial was conducted in 642H. pylori positive patients with chronic gastritis or peptic ulcer. They were randomized to three groups : PCM group (n = 222, pantoprazole 40 mg twice a day, clarithromycin 500 mg twice a day, metronidazole 400 mg twice a day, for 7 days) ; PCM plus wenweishu(温胃舒) group (n = 196) ; and PCM plus yangweishu(养胃舒) group (n =224).~(14)C breath test was performed 4 weeks after therapy. For the patients with gastric ulcer, ulcer healing was determined by endoscopy after therapy. Results Intention-to-treat H. pylori eradication rate for PCM group, PCM plus wenweishu(温胃舒) group, and PCM plus yangweishu(养胃舒)group were 57. 2% ( 127/222), 62. 2% ( 122/196), 60. 3% ( 135/224), respectively (P =0. 295, 0. 512). Per-protocol H. pylori eradication rates were 62. 3% ( 127/204), 70. 1% (122/174), 65.2% ( 135/207), respectively ( P = 0. 108, 0. 532 ). Per-protocol analysis gastric ulcer healing rate were 61.9% ( 13/21 ) 100.0% (18/18) ,86.4% ( 19/22 ) respectively. The healing rate in PCM plus wenweishu ( 温胃舒)groups was statistically significantly higher than the rate in PCM group (P = 0. 004). The rates of symptom relief in PCM plus wenweishu (温胃舒) groups and PCM plus yangweishu (养胃舒) were statistically significantly higher than the rate in PCM group ( both P＜0. 01 ). Side-effects were rare and comparable between groups. Conclusion Although PCM combined with wenweishu(温胃舒) or yangweishu(养胃舒) in the treatment of H. pylori positive patients with chronic gastritis and peptic ulcer can not reach a significantly higher eradication rate, it can increase the rates of both gastric ulcer healing and symptom relief.
