【目的】研究实证肠炎方（三黄汤基础上化裁）对湿热下注型肛瘘伴慢性腹泻患者术后肠道功能、不良反应及伤口修复 的影响。【方法】将2021 年6 月至2023 年9 月在上海中医药大学附属曙光医院肛肠科行手术治疗的120 例湿热下注型肛瘘合并 慢性腹泻患者，按随机数字分配法随机分为治疗组和对照组，每组各60 例。所有患者均接受标准肛瘘切除手术治疗，治疗 组于术前1 d 开始给予服用实证肠炎方治疗，对照组于术前1 d 开始给予服用香连片治疗，疗程均为4 周。观察2 组患者术后 不同时间节点的创面愈合情况（创面愈合率、愈合时间）、排便功能状态（排便次数、粪便性状）评分、疼痛程度视觉模拟量 表（VAS）评分、中医证候评分（肉芽组织水肿、创面分泌物）以及治疗前后血清炎症因子[白细胞介素4（IL-4）、白细胞介素17 （IL-17）]及生长因子[表皮生长因子（EGF）、血管内皮生长因子（VEGF）、碱性成纤维细胞生长因子（bFGF）]水平的变化情况， 评价2 组患者的临床疗效和治疗方案的安全性。【结果】（1）疗效方面，治疗周期结束后，治疗组的总有效率为100.00% （60/60），对照组为86.67%（52/60）；组间比较（非参数检验），治疗组的总体疗效明显优于对照组（P＜0.05）。（2）创面愈合情 况方面，治疗组术后21 d 和28 d 的创面愈合率显著高于对照组（P＜0.05），创面愈合时间显著短于对照组（P＜0.05）。（3）排便 功能状态、疼痛程度及中医证候评分方面，治疗组术后14、21、28 d 的排便次数、粪便性状、疼痛程度、肉芽水肿及创面 分泌物量评分均显著低于对照组（P＜0.05）。（4）炎症因子方面，治疗后，2 组患者的血清IL-4 水平均较治疗前显著升高（P＜ 0.05），血清IL-17 水平均较治疗前显著降低（P＜0.05），且治疗组对血清IL-4 水平的升高幅度及对血清IL-17 水平的降低幅 度均显著优于对照组（P＜0.05）。（5）生长因子方面，治疗后，2 组患者的血清EGF、VEGF、bFGF 水平均较治疗前显著升高 （P＜0.05），且治疗组对血清EGF、VEGF、bFGF 水平的升高幅度均显著优于对照组（P＜0.05）。（6）安全性方面，研究期间， 2 组患者均未出现严重不良事件和药物相关不良反应，患者的血常规、肝肾功能指标均保持在正常值范围内，具有较高的安 全性。【结论】实证肠炎方可有效促进湿热下注型肛瘘合并慢性腹泻患者术后恢复，改善临床症状，其作用机制可能与调控 炎症因子及上调生长因子表达有关。

Objective To investigate the effects of Shizheng Changyan Formula（modified from Sanhuang Decoction）on postoperative intestinal function，adverse reactions，and wound repair in patients with anal fistula complicated by chronic diarrhea of damp-heat pouring downward type. Methods A total of 120 patients with anal fistula complicated by chronic diarrhea of damp-heat pouring downward type who underwent surgical treatment in the Anorectal Department of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from June 2021 to September 2023 were randomly divided into a treatment group and a control group using a random number table method，with 60 cases in each group. All patients received standard anal fistula resection surgery. The day before surgery，the treatment group began receiving Shizheng Changyan Formula while the control group began receiving Xianglian Tablets. The treatment course for both groups was 4 weeks. Wound healing conditions（wound healing rate，healing time），defecation function scores（defecation frequency，stool consistency），pain intensity assessed by Visual Analogue Scale（VAS），TCM syndrome scores（edematous granulation tissue，wound exudate）at different postoperative time points，as well as changes in serum levels of inflammatory factors [interleukin-4（IL-4），interleukin-17（IL-17）] and growth factors [epidermal growth factor （EGF），vascular endothelial growth factor（VEGF），basic fibroblast growth factor（bFGF）] were observed before and after treatment in both groups. The clinical efficacy and safety of the treatment regimens were evaluated. Results（1）In terms of efficacy，after the completion of the treatment course，the total effective rate was 100.00% （60/60）in the treatment group and 86.67%（52/60）in the control group；intergroup comparison（by non-parametric test）showed that the overall efficacy of the treatment group was significantly superior to that of the control group （P＜0.05）.（2）Regarding wound healing，the wound healing rates at post-surgery day 21 and 28 were significantly higher in the treatment group compared to the control group（P＜0.05），and the wound healing time was significantly shorter in the treatment group（P＜0.05）.（3）Concerning defecation function，pain intensity， and TCM syndrome scores，the scores for defecation frequency，stool consistency，pain intensity，edematous granulation tissue，and wound exudate volume at post-surgery day 14，21，and 28 were significantly lower in the treatment group than in the control group（P＜0.05）.（4）After treatment，serum IL-4 levels significantly increased（P＜0.05）and serum IL-17 levels significantly decreased（P＜0.05）in both groups compared to before treatment，and the increase in IL-4 and the decrease in IL-17 were significantly greater in the treatment group than in the control group（P＜0.05）.（5）Regarding growth factors，after treatment，serum levels of EGF， VEGF，and bFGF significantly increased in both groups compared to before treatment（P＜0.05），and the increases in these growth factors were significantly greater in the treatment group than in the control group（P＜ 0.05）.（6）In terms of safety，during the study period，no serious adverse events or drug-related adverse reactions occurred in either group. Patients’blood routine parameters and liver and kidney function indicators remained within normal ranges，indicating a favorable safety profile. Conclusion Shizheng Changyan Formula can effectively promote postoperative recovery and improve clinical symptoms in patients with anal fistula complicated by chronic diarrhea of damp-heat pouring downward type. Its mechanism of action may be related to the regulation of inflammatory factors and up-regulation of growth factor expression.

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上海市卫生健康委员会科研课题（编号：20204Y0180）；上海市临床重点专科项目（编号：shslczdzk04302）；上海中医药大学 后备卓越中医人才培养项目（编号：20206）；上海市科技计划项目（编号：21Y 11923200）