不同时间应用荆花胃康胶丸治疗幽门螺杆菌感染慢性胃炎的临床研究

Clinical Research of Jinghua Weikang Capsule Given at Different Times on Patients with Chronic Gastritis Infected by Helicobacter Pylori

目的探讨不同时间应用荆花胃康胶丸治疗幽门螺杆菌(Hp)感染慢性胃炎患者的Hp根除率及消化道症状缓解情况。方法选择2015年7月—2016年12月全科医学科门诊收治的慢性胃炎且伴有Hp感染的360例患者为研究对象。采用随机、平行对照的方法,将360例患者分为4组,每组90例。A组:埃索美拉唑+阿莫西林+呋喃唑酮+枸橼酸铋钾,疗程10 d(d1～d10);B组:埃索美拉唑+阿莫西林+呋喃唑酮+枸橼酸铋钾+荆花胃康胶丸,疗程10 d(d1～d10);C组:荆花胃康胶丸,疗程14 d(d1～d14),埃索美拉唑+阿莫西林+呋喃唑酮+枸橼酸铋钾,疗程10 d(d15～d24);D组:埃索美拉唑+阿莫西林+呋喃唑酮+枸橼酸铋钾,疗程10 d(d1～d10),荆花胃康胶丸,疗程14 d(d11～d24)。所有患者疗程结束后28 d接受13C尿素呼气试验,检测Hp的根除情况;并在治疗前、治疗后及疗程结束后28 d采用计分的方法对消化道症状进行评估。对疗效进行意向性治疗(ITT)分析和符合方案数据(PP)分析。比较4组Hp根除率、消化道症状指数及不良反应发生情况。结果 A组88例完成研究,Hp根除64例(72.7%);B组90例完成研究,Hp根除70例(77.8%);C组86例完成研究,Hp根除73例(84.9%);D组88例完成研究,Hp根除79例(89.8%)。4组患者在ITT分析、PP分析中的Hp根除率差异均无统计学意义(P>0.05)。治疗后及停药28 d后,4组患者消化道症状指数比较差异均有统计学意义(P<0.05)。4组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论与传统的四联疗法相比,加用荆花胃康胶丸能更好地缓解患者的消化道症状。

Objective To investigate eradication rate of Helicobacter pylori(Hp)and remission of digestive tract symptoms with Jinghua Weikang Capsule given at different times on patients with chronic gastritis infected by Hp.Methods A total of 360 patients with chronic gastritis accompanied by Hp infection admitted to the outpatient department of general medicine from July 2015 to December 2016 were selected as subjects.A total of 360 patients were divided into 4 groups by using random parallel control method.Group A:Esomeprazole+Amoxicillin+Furazolidone+Colloidal Bismuth Subcitrate,treatment course for 10 days(d1-d10).Group B:Esomeprazole+Amoxicillin+Furazolidone+Colloidal Bismuth Subcitrate+Jinghua Weikang Capsule,treatment course for 10 days(d1-d10).Group C:Jinghua Weikang Capsule,14 days(d1-d14);Esomeprazole+Amoxicillin+Furazolidone+Colloidal Bismuth Subcitrate,treatment course for 10 days(d15-d24).Group D:Esomeprazole+Amoxicillin+Furazolidone+Colloidal Bismuth Subcitrate,treatment course for 10 days(d1-d10);Jinghua Weikang Capsule,14 days(d11-d24).All patients took 13C urea breath test to check eradication of Hp in 28 days after all treatment courses.Digestive tract symptom assessment was used before,after treatment and 28 days after all treatment courses.Intention to Treat(ITT)analysis and Per-Protocol(PP)analysis were performed.Hp eradication rate,digestive tract symptom index and incidence of adverse reactions were compared between the 4 groups.Results In group A,88 cases completed the study and 64 cases eradicated Hp(72.7%);in group B,90 cases completed and 70 cases eradicated Hp(77.8%);86 cases completed the study and 73 cases eradicated Hp(84.9%)in group C;in group D,88 cases completed and 79 cases(89.8%)eradicated Hp.ITT analysis and PP analysis showed no significant difference in Hp eradication rate between the 4 groups(P>0.05).After treatment and 28 days of drug withdrawal,there were statistically significant differences in gastrointestinal symptoms index between the 4 groups(P<0.05).There was no significant difference in the incidence of adverse reactions between the 4 groups(P>0.05).Conclusion Compared with traditional quadruple therapy,Jinghua Weikang Capsule can relieve more digestive tract symptoms.