Abstract:

Objective　To investigate the clinical efficacy of total glucoside of paeony capsules combined with probiotic aloe vera fermentation gel in the treatment of patients with recurrent aphthous ulcer. Methods　Eighty patients with recurrent aphthous ulcer treated at Xi'an Honghui Hospital from January to December 2023 were selected for the randomized controlled trial, and were divided into a control group and an observation group by the random number table method, with 40 cases in each group. There were 22 males and 18 females in the control group; they were (31.88±6.12) years old; their disease course was (11.15±2.70) months. There were 20 males and 20 females in the observation group; they were (31.76±6.00) years old; their disease course was (11.22±2.16) months. The control group were treated with probiotic aloe vera fermentation gel, and the observation group with probiotic aloe vera fermentation gel and total glucoside of paeony capsules, for 2 weeks. The clinical efficacies, pain scores of Visual Analogue Scale (VAS), ulcer areas, levels of inflammatory factors [tumor necrosis factor-α (TNF-α), interleukin-2 (IL-2), and interferon-γ (IFN-γ)], and incidences of adverse reactions were compared between the two groups by t and χ² tests. Results　The total effective rate of the observation group was higher than that of the control group [95.00% (38/40) vs. 80.00% (32/40)], with a statistical difference (χ²=4.114; P=0.043). Before the treatment, there were no statistical differences in the score of VAS, ulcer area, and levels of inflammatory factors between the two groups (all P>0.05). After the treatment, the score of VAS and levels of TNF-α and IL-2 in the observation group were lower than those in the control group [(1.30±0.22) vs. (2.20±0.36), (3.58±0.81)g/L vs. (5.35±1.48)g/L, and (0.30±0.07) g/L vs. (0.62±0.10) g/L]; the ulcer area in the observation group was smaller than that in the control group [(0.68±0.12) cm² vs. (1.45±0.28) cm²]; the level of IFN-γ in the observation group was higher than that in the control group [(77.50±12.97) mmol/L vs. (63.68±12.49) mmol/L]; there were statistical differences (t=13.492, 6.635, 16.580, 15.986, and 4.854; all P<0.05). There was no statistical difference in the incidence of adverse reactions between the two groups (χ²=0.263; P=0.608). Conclusion　Total glucoside of paeony capsules combined with probiotic aloe vera fermentation gel in the treatment of patients with recurrent aphthous ulcer can improve the therapeutic effect and reduce their pain, inflammatory reaction, and ulcer area, and does not significantly increase the occurrence of adverse reactions.

Key words:

Recurrent aphthous ulcer, Total glucosides of paeony capsules, Probiotic aloe Vera fermentation gel, Inflammatory response, Pain degree, Ulcer area

摘要：

目的　探讨白芍总苷胶囊联合益生菌芦荟发酵凝胶治疗复发性阿弗他溃疡的临床疗效。方法　选取2023年1月至12月在西安市红会医院治疗的复发性阿弗他溃疡患者80例进行随机对照试验，采用随机数字表法分为两组，各40例。对照组男22例、女18例，年龄（31.88±6.12）岁，病程（11.15±2.70）个月，采用益生菌芦荟发酵凝胶治疗，共治疗2周；观察组男20例、女20例，年龄（31.76±6.00）岁，病程（11.22±2.16）个月，采用白芍总苷胶囊联合益生菌芦荟发酵凝胶治疗，共治疗2周。对比两组患者临床疗效、用药后疼痛评分［采用视觉模拟评分法（VAS）］、溃疡面积、炎性因子［肿瘤坏死因子-α（TNF-α）、白细胞介素-2（IL-2）、γ干扰素（IFN-γ）］与不良反应发生情况。统计学方法采用t检验、χ²检验。结果　观察组治疗总有效率为95.00%（38/40），高于对照组的80.00%（32/40），差异有统计学意义（χ²=4.114，P=0.043）。治疗前，两组患者VAS评分、溃疡面积及炎性因子水平比较，差异均无统计学意义（均P>0.05）。治疗后，观察组VAS评分及TNF-α、IL-2水平均低于对照组［（1.30±0.22）分比（2.20±0.36）分、（3.58±0.81）g/L比（5.35±1.48）g/L、（0.30±0.07）g/L比（0.62±0.10）g/L］，溃疡面积小于对照组［（0.68±0.12）cm²比（1.45±0.28）cm²］，FN-γ水平高于对照组［（77.50±12.97）mmol/L比（63.68±12.49）mmol/L］，差异均有统计学意义（t=13.492、6.635、16.580、15.986、4.854，均P<0.05）。两组患者不良反应发生率比较，差异无统计学意义（χ²=0.263，P=0.608）。结论　白芍总苷胶囊联合益生菌芦荟发酵凝胶治疗复发性阿弗他溃疡可提高治疗效果，减轻疼痛程度与炎性反应，缩小溃疡面积，且不会明显增加不良反应的发生。

关键词:

复发性阿弗他溃疡, 白芍总苷胶囊, 益生菌芦荟发酵凝胶, 炎性反应, 疼痛度, 溃疡面积