世界中医药

目的:观察以致康胶囊为基础配合西药治疗幽门螺杆菌(Hp)的疗效、不良反应和药品费用,以探讨临床较佳的改善溃疡愈合质量的方案。方法:采用分组对照的研究方法,并应用药物经济学方法分析各方案的费用与效果。初次根除Hp共115例，分为A、B、C、D 4组。A组为致康胶囊1次06g，4次/日,阿莫西林胶囊05g,4次/日,克拉霉素025g,2次/日,兰索拉唑30mg,2次/日;疗程为7天。B组为致康胶囊1次06g，4次/日。疗程为7天。C组为阿莫西林胶囊05g,4次/日,克拉霉素025g,2次/日,兰索拉唑30mg,2次/日;疗程为7天。D组为再次根除Hp共27例,方案同A组。疗程为7天。结果:A、B、C组的Hp根除率分别为93%、32%、94%,A、C组间无显著差异(P>005)。D组根除率为81%。不良反应总发生率为162%,C组与A+D组或B组间有非常显著差异(P<001),A组与D组间无显著差异(P>005)。治疗后1年,消化性溃疡发病率及Hp感染的变化,C组与A+D组或B组间有非常显著差异(P<001),A组与D组间无显著差异(P>005)。治疗后1年消化性溃疡费用效益分析,边缘成本效益（IncrC/E）、成本效益（C/E）以A、C2组方案较优,A组方案最优。结论:加用致康胶囊能有效地改善治疗后1年消化性溃疡发病率及Hp感染率,不良反应少。治疗后1年费用效益分析,以A、C2组方案较优,A组方案最优。

English Summary:

To investigate effects and costs of Zhikang Capsule in combination with western Medicine for Helicobacter Pylori (Hp) to design rational corrective regimen for peptic ulcer.Methods:a grouped, positive-controlled study, and Pharmaco economics methods. Hp first eradicated patients(n=115) were grouped and received respective treatments over a period of 7 days: group A received Zhikang Capsule 0.6g Tid, Amoxicillin 0.5g Tid, Clarithromycin 0.25g Bid, Lansoprazol 30mg Bid. Group B: Zhikang Capsule 0.6g Tid. Group C: Group A minus Zhikang Capsule. Group D: 27 second eradiated patients, same regimen as group A. Results:eradicate rates for group A,B,C,D were respectively 93%,32%,94%,81%. Total AE rate= 16.2%. Differences between A and C, A and D were not significant (P>0.05). Differences between C and (A+D), C and B were significant (P<0.01). After 1 year of treatment, C and (A+D), C and B were significantly different in terms of ulcer occurrence rate and Hp infection (P<0.01), A and D not significantly different (P>0.05)。In terms of CEA analysis (IncrC/E, C/E), A was the most cost effective, C was the second best. Conclusion: Zhikang Capsule, as an add-on treatment can reduce ulcer rate and Hp infection rate after 1-year treatment, and A is the most cost effective.

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