【目的】 系统评价益气通秘方加减治疗气虚型功能性便秘患者的临床疗效及安全性。【方法】 选取2022年11月至2023年 12月在广州中医药大学东莞医院就诊的72例气虚型功能性便秘患者为研究对象，按随机数字表法将患者随机分为治疗组和 对照组，每组各 36 例。治疗组给予益气通秘方加减治疗，对照组给予乳果糖口服液治疗，疗程为 4 周，并于疗程结束 后随访 4 周。观察2组患者治疗前后中医证候积分、便秘症状自评量表（PAC-SYM）评分、便秘患者生活质量量表（PAC-QOL） 评分的变化情况，比较2组患者的临床总体疗效，并评估2组患者的复发情况。【结果】（1）脱落情况方面，研究期间共有4例 患者脱落（治疗组1例失访，1例未按规定方案用药；对照组2例未按规定方案用药），最终共有68例患者完成本项临床研究， 其中治疗组和对照组各 34 例。（2）疗效方面，治疗 4 周后，治疗组的总有效率为 91.18%（31/34），对照组为 70.59%（24/34）， 组间比较（Mann-Whitney U 检验），治疗组的总体疗效明显优于对照组，差异有统计学意义（P＜0.05）。（3）相关量表评分方 面，治疗后，2组患者的中医证候积分、PAC-SYM评分和PAC-QOL评分均较治疗前降低（P＜0.01），且治疗组对中医证候积 分、PAC-SYM评分和PAC-QOL评分的降低幅度均明显优于对照组（P＜0.05或P＜0.01）。（4）复发情况方面，治疗组的有效病 例中，28例获得随访，复发率为17.86%（5/28）；对照组的有效病例中，22例获得随访，复发率为45.45%（10/22）；组间比较 （χ2 检验），治疗组的复发率明显低于对照组（P＜0.05）。（5）安全性方面，研究期间，2组患者均未发生药物不良反应和不良事 件，且治疗前后的生命体征和相关安全性指标均无明显异常。【结论】 益气通秘方加减有助于改善气虚型功能性便秘患者的 临床症状及生活质量，具有较好的疗效持续优势，可有效降低复发率，并且安全可靠。

Objective To systematically evaluate the clinical efficacy and safety of the modified Yiqi Tongmi Formula in treating patients with functional constipation of qi deficiency type. Methods Seventy-two patients with functional constipation of qi deficiency type， who presented at Dongguan Hospital of Guangzhou University of Chinese Medicine between November 2022 and December 2023， were enrolled as study subjects. They were randomly assigned into a treatment group and a control group （n=36 cases） according to a random number table method. The treatment group received the modified Yiqi Tongmi Formula， while the control group received lactulose oral solution. The treatment course was 4 weeks， followed by a 4-week follow-up period. Changes in traditional Chinese medicine （TCM） syndrome scores， Patient Assessment of Constipation Symptoms （PAC-SYM） scores，and Patient Assessment of Constipation Quality of Life （PAC-QOL） scores were observed before and after treatment. The overall clinical efficacy was compared between the two groups，and recurrence rates were also assessed. Results（1） Drop-out： a total of 4 patients dropped out during the study （1 lost to follow up and 1 due to protocol violation in the treatment group；2 due to protocol violation in the control group）. Ultimately， 68 patients completed the clinical study，with 34 cases in each group.（2） Therapeutic effect：after 4 weeks of treatment，the total effective rate was 91.18% （31/34） in the treatment group and 70.59% （24/34） in the control group. Intergroup comparison （by Mann-Whitney U test） indicated that the overall efficacy of the treatment group was significantly superior to that of the control group，with a statistically significant difference （P＜0.05）.（3）Relevant scale scores：after treatment，both groups showed significant reductions in TCM syndrome scores，PAC-SYM scores，and PAC-QOL scores compared to those before treatment （P＜0.01）. Furthermore，the reduction in TCM syndrome scores，PAC-SYM scores，and PAC-QOL scores was significantly greater in the treatment group than in the control group （P＜0.05 or P＜0.01）.（4） Recurrence rate：among the effective cases，28 in the treatment group were followed up with a recurrence rate of 17.86% （5/28），while 22 in the control group were followed up with a recurrence rate of 45.45% （10/22）. Intergroup comparison （by chi-square test） revealed that the recurrence rate in the treatment group was significantly lower than that in the control group （P＜0.05）.（5）Safety：no adverse drug reactions or adverse events occurred in either group during the study period. Vital signs and relevant safety indicators showed no significant abnormalities before and after treatment. Conclusion The modified Yiqi Tongmi Formula helps improve clinical symptoms and quality of life in patients with functional constipation of qi deficiency type. It demonstrates a sustained-efficacy advantage， effectively reduces the recurrence rate， and is safe and reliable.

R256.35

广东省中医药局科研项目（编号：20232196）；东莞市卫健局“黄绍刚东莞市名中医传承工作室”建设项目（东卫涵号[2021]134号）