中医杂志

目的 探讨滋脾增液方治疗功能性便秘气阴两虚证的临床疗效和安全性。方法 74例功能性便秘气阴两虚证患者随机分为治疗组与对照组各37例。治疗组予滋脾增液方颗粒剂口服，每次60 g，每日2次；对照组予乳果糖口服液治疗，每次15 ml，每日2次。两组疗程均为4周。比较两组患者临床疗效和安全性结果；观察两组治疗前及治疗第7、14、21、28天便秘症状总积分、中医证候评分，治疗前及治疗第7、28天胃肠道生活质量指数（GIQLI）评分。结果 治疗组临床疗效总有效率（94.59%,35/37）明显高于对照组（75.68%,28/37,P<0.05）。两组治疗第7、14、21、28天便秘症状总积分、中医证候评分均较本组治疗前降低（P<0.05）。两组治疗第21、28天，治疗组便秘症状总积分明显低于对照组（P<0.01）。治疗组治疗第14、21、28天中医证候评分均低于对照组（P<0.01）。两组患者治疗第7、28天GIQLI评分均高于本组治疗前，且治疗组高于对照组（P<0.05或P<0.01）。结论 滋脾增液方可明显缓解功能性便秘气阴两虚证患者的便秘症状，改善中医证候，提高生活质量，且安全性好。

Objective To evaluate the therapeutic effects and safety of Zipi Zengye Formula （滋脾增液方, ZZF） on functional constipation with deficiency of both qi and yin. Methods A total of 74 patients with functional constipation and deficiency of qi and yin syndrome were randomly divided into a treatment group and a control group, with 37 cases in each group. The treatment group received ZZF granules orally, 60 g per dose, twice a day, while the control group received lactulose oral solution, 15 ml per dose, twice a day. The treatment course for both groups was 4 weeks. Changes in the total constipation symptom score, traditional Chinese medicine(TCM) syndrome score before treatment and on day 7, 14, 21, and 28 of treatment, as well as the Gastrointestinal Quality of Life Index(GIQLI) score before and on day 7 and 28 were observed; the clinical efficacy and safety outcomes of the two groups were compared. Results The total clinical effective rate in the treatment group(94. 59%, 35/37) was significantly higher than that in the control group(75. 68%, 28/37, P<0. 05). The total constipation symptom scores and TCM syndrome scores of both groups decreased on day 7, 14, 21, and 28 of treatment(P<0. 05). On day 21 and 28, the treatment group had significantly lower total constipation symptom score than the control group(P<0. 01). TCM syndrome scores on day 14, 21 and 28 in the treatment group were lower than those in the control group(P<0. 01). After treatment, the GIQLI scores in both groups on day 7 and 28 increased, with higher scores in the treatment group than in the control group(P<0. 05 or P<0. 01). Conclusion ZZF demonstrates significant clinical benefits for qiyin deficiency functional constipation by alleviating constipation symptoms, and can improve TCM syndrome, enhance quality of life with safety.