通秘合剂方治疗气阴两虚型便秘

Clinical Study of Tongmi Mixture in Treatment of Constipation with Qi and Yin Deficiency

目的:观察通秘合剂方治疗气阴两虚型便秘的临床疗效及安全性。方法:采用多中心、双盲、随机对照的研究方法,将132例诊断为气阴两虚证的便秘患者随机分为治疗组69例和对照组63例;最终符合标准123例,其中治疗组65例,对照组58例。治疗组给予通秘合剂方颗粒制剂口服治疗;对照组给予比沙可啶肠溶片口服治疗。为保证盲法,二者均装入相同的胶囊中。治疗1个月后比较两组患者西医症状积分、中医证候疗效评分及临床综合疗效。结果:治疗组西医症状积分的全分析集和符合方案集评分均显著低于对照组(P<0.05);治疗组中医证候积分的全分析集和符合方案集评分均显著低于对照组(P<0.05);治疗组有效率的全分析集和符合方案集分析分别为95.38%和95.65%,均显著高于对照组的82.76%和84.13%(P<0.05)。两组患者治疗过程均无不良事件发生。结论:通秘合剂方可有效改善气阴两虚型便秘患者的西医症状和中医证候,临床疗效显著,且安全性好。

Objective:To evaluate the clinical efficacy and safety of Tongmi Mixture in treating constipation with deficiency of both qi and yin.Methods:Using a multi-center,double-blind,randomized controlled research method,132 patients with constipation diagnosed with Qi and Yin deficiency were randomly divided into a treatment group of 69 cases and a control group of 63 cases.Finally,123 cases met the criteria,65 cases in the mid-term treatment group,and 58 cases in the control group.The treatment group was treated with Tongmi Mixture Prescription Granules orally and the control group was treated with bisacodyl enteric-coated.To ensure the blinding method,the tablets were put into the same capsule for oral treatment.After one month of treatment,the two groups of patients were evaluated for Western medicine symptoms,TCM syndrome curative effect scores,and treatment efficiency.Results:The scores of full analysis set and compliance scheme set of Western medicine symptom scores in the treatment group were significantly lower than those in the control group(P<0.05);The scores of full analysis set and compliance scheme set of TCM syndrome scores in the treatment group were significantly lower than those in the control group(P<0.05);The effective rates of the full analysis set and the compliance scheme set in the treatment group were 95.38% and 95.65% respectively,which were significantly higher than 82.76% and 84.13% in the control group(P<0.05).There were no adverse events during the treatment of the two groups.Conclusion:Tongmi Mixture can effectively improve the Western medicine symptoms and TCM syndromes of constipation with Qi and Yin deficiency,and it has a significant clinical curative effect and good safety.