开胃健脾膏联合四联疗法治疗脾胃虚弱型幽门螺旋杆菌感染临床研究

Clinical Study of Kaiwei Jianpi Soft Extract Combined with Quadruple Therapy in Treating Helicobacter pylori Infection of Spleen-Stomach Deficiency Type

摘要:

目的：观察开胃健脾膏联合四联疗法治疗脾胃虚弱型幽门螺旋杆菌（Hp） 感染的疗效。方法：采用回顾性队列研究，选取2021年1月—2023年12月深圳市中西医结合医院收治的626例脾胃虚弱证型Hp感染患者，按计算机随机分组系统将受试者等分为对照组及观察组各313例。对照组给予四联疗法治疗，观察组给予开胃健脾膏联合四联疗法治疗。比较2组Hp根除率及不良反应发生率，比较2组治疗前后症状积分的变化。结果：观察组Hp 根除率为92.65% （290/313），对照组为84.35% （264/313），2 组比较，差异有统计学意义（P＜0.05）。治疗后，2组上腹隐痛、痞满、食欲不振、倦怠乏力、手足不温、便溏症状积分均较治疗前下降（P＜0.05），观察组上述6 项症状积分均低于对照组（P＜0.05）。对照组不良反应发生率为20.13% （63/313），观察组不良反应发生率为7.35% （23/313），2组不良反应发生率比较，差异有统计学意义（P＜0.05）。结论：开胃健脾膏联合四联疗法可提升脾胃虚弱型Hp感染的清除效果，缓解症状，安全性高。

Abstract:

Abstract：Objective：To observe the efficacy of Kaiwei Jianpi Soft Extract combined with quadruple therapy in treating Helicobacter pylori （Hp） infection of spleen-stomach deficiency type. Methods： A retrospective cohort study was conducted. A total of 626 patients with Hp infection of spleen-stomach deficiency type admitted to Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine from January 2021 to December 2023 were enrolled and equally assigned by computer-generated randomization into a control group and an observation group ， with 313 cases in each group. The control group received quadruple therapy，while the observation group received additional Kaiwei Jianpi Soft Extract based on the control group's regimen. Hp eradication rates，incidence of adverse reactions， and changes in symptom scores before and after treatment were compared between the two groups. Results： The Hp eradication rate was 92.65%（ 290/313） in the observation group，significantly higher than that of 84.35%（ 264/313） in the control group （P＜0.05）. After treatment，symptom scores for epigastric dull pain，stuffiness and fullness，poor appetite， lassitude and fatigue， cold limbs， and loose stool decreased in both groups compared with those before treatment （P＜0.05）， with lower scores in the observation group （P＜0.05）. The incidence of adverse reactions was 20.13% （63/313） in the control group and 7.35% （23/313） in the observation group， showing a significant difference （P＜0.05）. Conclusion： Kaiwei Jianpi Soft Extract combined with quadruple therapy improves Hp eradication rates， alleviates clinical symptoms， and has a favorable safety profile in patients with Hp infection of spleen-stomach deficiency type.