加减苏神方联合三联疗法治疗小儿幽门螺杆菌相关性胃炎的疗效：一项前瞻性随机对照研究

doi:10.3760/cma.j.cn441417-20241105-13026

摘要/Abstract

摘要：

目的　探究加减苏神方联合三联疗法治疗小儿幽门螺杆菌（HP）相关性胃炎的疗效。方法　本研究为前瞻性随机同期对照研究。选取2022年1月至2023年6月西安市中医医院收治的80例HP相关性胃炎患儿作为研究对象，采用随机信封法分为单一组和联用组，各40例。单一组男23例，女17例，年龄（10.25±1.55）岁，病程（6.12±1.03）月；实施三联疗法（奥美拉唑肠溶片+克拉霉素片+阿莫西林胶囊），均饭后30 min口服，持续治疗3周。联用组男22例，女18例，年龄（10.58±1.21）岁，病程（6.27±0.97）月；在单一组基础上联合加减苏神方治疗，每日1剂，每剂水煎100～150 ml，分别于早、晚餐后30 min温服，持续治疗3周。评估两组患儿的临床疗效、临床症状改善情况、中医证候评分、血清炎症因子［C反应蛋白（CRP）、白细胞介素（IL-6）和可溶性白细胞介素2受体（sIL-2R）］水平、免疫功能［血清免疫球蛋白M（IgM）、免疫球蛋白G（IgG）和CD4⁺、CD8⁺］水平、HP转阴率和主要症状复发率。采用χ²检验、t检验、Fisher精确概率、Mann-Whitney U检验进行统计分析。结果　联用组的治疗总有效率高于单一组［97.2%（39/40）比82.5%（33/40）］，差异有统计学意义（χ²=5.000，P=0.025）。治疗3周后，联用组的临床症状和中医证候评分、血清CRP、IL-6、sIL-2R、CD8⁺水平均低于单一组，IgM、IgG、CD4⁺水平均高于单一组（均P<0.05）。随访3个月期间，联用组的HP转阴率高于单一组［77.5%（31/40）比55.0%（22/40）］、主要症状复发率低于单一组［5.0%（2/40）比20.0%（8/40）］，差异均有统计学意义（χ²=4.528、4.331，P=0.033、0.037）。结论　加减苏神方联合三联疗法治疗小儿幽门螺杆菌相关性胃炎效果显著，有助于减轻患儿炎症，增强免疫功能，提高HP转阴率，降低主要症状复发风险。

关键词: 幽门螺杆菌, 胃炎, 苏神方, 三联疗法, 小儿, 疗效

Abstract:

Objective　To explore the efficacy of Sushen decoction combined with triple therapy in the treatment of Helicobacter pylori (HP) -related gastritis. Methods　This study is a prospective, randomized, concurrent control study, 80 children with HP-associated gastritis at Xi'an Traditional Chinese Medicine Hospital from January 2022 to June 2023 were selected as research subjects and randomly divided into a single therapy group and a combined therapy group, with 40 cases in each group. The single therapy group included 23 males and 17 females, aged (10.25±1.55) years and the disease duration was (6.12±1.03) months; they received triple therapy (omeprazole enteric-coated tablets + clarithromycin tablets + amoxicillin capsules), all taken orally 30 minutes after meals for 3 weeks. The combined therapy group included 22 males and 18 females, aged (10.58±1.21) years and the disease duration was (6.27±0.97) months; they received SuShen decoction in addition to the treatment in the single therapy group, at a dose of 1 dose per day, prepared with 100-150 ml of water, taken warm 30 minutes after breakfast and dinner for 3 weeks. The clinical efficacy, improvement of clinical symptoms, traditional Chinese medicine syndrome scores, serum inflammatory factors [C-reactive protein (CRP), interleukin (IL)-6, and soluble interleukin-2 receptor (sIL-2R)] levels, immune function [serum immunoglobulin M (IgM), immunoglobulin G (IgG), and CD4⁺, CD8⁺ levels], HP eradication rates, and recurrence rates of major symptoms were assessed in both groups. Statistical analysis was conducted using χ² test, t test, Fisher's exact probability test, and Mann-Whitney U test. Results　The total effective rate in the combined therapy group was higher than that in the single therapy group [97.2% (39/40) vs. 82.5% (33/40)], with a statistically significant difference (χ²=5.000, P=0.025). After 3 weeks of treatment, the clinical symptoms and traditional Chinese medicine syndrome scores, as well as serum levels of CRP, IL-6, sIL-2R, and CD8⁺ in the combined therapy group were lower than those in the single therapy group (all P<0.05), while levels of IgM, IgG, and CD4⁺ were higher (all P<0.05). During the 3-month follow-up, the HP eradication rate in the combined therapy group was higher than that in the single therapy group [77.5% (31/40) vs. 55.0% (22/40)], and the recurrence rate of major symptoms was lower [5.0% (2/40) vs. 20.0% (8/40)], with both differences being statistically significant (χ²=4.528, 4.331; P=0.033, 0.037). Conclusion　Sushen decoction combined with triple therapy is effective in treating pediatric HP-related gastritis, helping to reduce inflammation, enhance immune function, increase HP negative rate, and lower the risk of recurrence of major symptoms.

Key words: Helicobacter pylori, , Gastritis, , Sushen , decoction, , Triple therapy, , Children, , Efficacy

陈耀华尤晰樱张敏涛.

加减苏神方联合三联疗法治疗小儿幽门螺杆菌相关性胃炎的疗效：一项前瞻性随机对照研究 [J]. 国际医药卫生导报, 2025, 31(13): 2242-2247.

Chen Yaohua, You Xiying, Zhang Mintao.

Efficacy of Sushen decoction combined with triple therapy on helicobacter pylori-associated gastritis in children: a prospective randomized controlled study [J]. International Medicine and Health Guidance News, 2025, 31(13): 2242-2247.

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