【摘要】 [目的]采用荆花胃康胶丸联合铋剂四联治疗幽门螺杆菌(Helicobacter pylor,Hp)阳性慢性胃炎初治患者,观察Hp根除率、临床症状改善情况以及用药安全性,探讨中西药联合对Hp感染的根除率以及Hp阳性慢性胃炎的疗效。[方法]采用前瞻性随机对照多中心临床研究,对象为4个中心经胃镜检查确诊为慢性胃炎并伴有Hp感染的初治患者,采用分层区组随机化分为4个治疗组:A组,艾司奥美拉唑20mg+胶体果胶铋200mg+阿莫西林1 000mg+呋喃唑酮100mg,疗程10d;B组,荆花胃康胶丸240mg+艾司奥美拉唑20mg+胶体果胶铋200mg+阿莫西林1 000mg+呋喃唑酮100mg,疗程10d;C1组:荆花胃康胶丸240mg,前14d;艾司奥美拉唑20mg+胶体果胶铋200mg+阿莫西林1 000mg+呋喃唑酮100mg,后10d,总疗程24d;C2组:艾司奥美拉唑20mg+胶体果胶铋200mg+阿莫西林1 000mg+呋喃唑酮100mg,前10d;荆花胃康胶丸240mg,后14d,总疗程24d;各组服药均为2次/d。治疗结束后评估4组患者Hp根除率、临床症状改善情况和药物不良反应发生情况。治疗结束停药至少28d后以13/14 C-尿素呼气试验结果判断Hp是否根除。[结果]共纳入471例患者,A、B、C1、C2组分别入组124、114、114、119例。4组Hp根除率ITT分析结果分别为82.3%(102/124)、86.0%(98/114)、78.9%(90/114)、79.8%(95/119),组间比较差异无统计学意义(P=0.518);PP分析结果分别为87.9%(102/116)、90.7%(98/108)、86.5%(90/104)、85.6%(95/111),B组根除率高于其他治疗组,但组间比较差异无统计学意义(P=0.677)。各组根除Hp治疗后症状均获明显改善(P<0.01),其中B组症状改善明显优于A组(P=0.007)。共有32例患者出现不良反应,其中A组10例(8.1%),B组7例(6.1%),C1组6例(5.3%),C2组9例(7.6%),组间差异无统计学意义(P=0.819)。[结论]荆花胃康胶丸联合铋剂四联同时服用Hp根除率较高,且症状改善明显优于铋剂四联。中西药联合治疗Hp阳性慢性胃炎具有一定优势,值得进一步研究。更多还原

【Abstract】 [Objective]Patients with Helicobacter pylori(Hp)positive chronic gastritis who haven’t e-radicative treatment were treated by Jinghua Weikang capsule combined with bismuth-containing quadruple therapy.The eradication rate of Hp,the improvement of clinical symptoms and the drug safety were observed.Discussing the treatment of combination of the Traditional Chinese medicine and western medicine for Hp eradication rate and Hp positive chronic gastritis.[Methods]A prospective randomized controlled multicenter clinical trial was performed on patients with chronic gastritis from Hp infection who havn’t eradicative treatment from four hospitals,and all patients were divided into four groups by stratified randomization.The bismuth-containing quadruple therapy group A received esomeprazole 20 mg+amoxicillin1000 mg+furazolidone 100 mg+bismuth 200 mg,twice a day for 10 days(d1-d10).The group B received Jinghua Weikang capsule 240 mg+esomeprazole 20 mg+amoxicillin 1000 mg+furazolidone 100 mg+bismuth 200 mg,twice a day for 10 days(d1-d10).The group C1 received Jinghua Weikang capsule 240 mg(d1-d14)+esomeprazole 20 mg+amoxicillin 1000 mg+furazolidone 100 mg+bismuth 200 mg(d15-d24),twice a day for 24 days.The group C2 received esomeprazole 20 mg+amoxicillin 1000 mg+furazolidone100 mg+bismuth 200 mg(d1-d10)+ Jinghua Weikang capsule 240 mg(d11-d24),twice a day for 24 days.At the end of treatment,the Hp eradication rate,the improvement of clinical symptoms and the adverse drug reaction were evaluated in the four groups.At least 28 days after the end of treatment,the result of 13 C/14 C urea breath test were used to determine whether Hp was eradicated.[Results]A total of 471 patients included in this study,including 211 male and 260 female,whose average age was(45.7±12.1)years.Groups A,B,C1,and C2 were enrolled in 124,114,114,and 119 patients,respectively.The ITT analysis results of four groups of H.pylori eradication rates were 82.3%(102/124),86.0%(98/114),78.9%(90/114),79.8%(95/119),respectively,but there was no statistical difference between the groups(P=0.518);The results of Per-protocol(PP)analysis were 87.9%(102/116),90.7%(98/108),86.5%(90/104),85.6%(95/111),respectively.The Hp eradication rate of group B was higher than that of other treatment groups,but there is no statistical difference between the groups(P=0.677).The symptoms of all groups were significantly improved after H.pylori eradication(P<0.01),and the improvement of group B was significantly better than of group A(P =0.007).There were 32 patients with adverse drug reactions.The adverse reactions rates of the four groups were 8.1%,6.1%,5.3%and 7.6%,respectively,but there is no statistical difference between the groups(P=0.819).[Conclusion]The eradication rate of Jinghua Weikang capsule combined with bismuth-containing quadruple therapy coadministration is higher,and the symptoms improved significantly better than the tincture quadruple.The combination of traditional Chinese medicine and western medicine has some advantages in treating helicobacter pylori positive chronic gastritis,which deserves further study.更多还原