加减四磨汤治疗慢性便秘气滞型的临床观察

目的：观察加减四磨汤治疗慢性便秘气滞型（Chronic Constipation of Stagnation of QI,CCSQ）的疗效和安全性。方法：将95例CCSQ患者随机分成A组（加减四磨汤治疗组）,B组（普卢卡必利对照组）,首要观察12周治疗后自然完全排便次数（Spontaneous,Complete Bowel Movements,SCBM）≥3次/周的比例,次要观察SCBM增加≥1次/周的患者比例,并比较入组前及第4、6、12周便秘患者生活质量量表（Patient Assessment of Constipation Quality of Life,PAC-QOL）。同时记录不良事件。结果：在12周的疗程中,A组SCBM≥3次/周的比例是42.55%,B组为29.17%,A组显著高于B组（P=0.013）;A组SCBM增加≥1次/周的患者比例是61.70%,B组为43.75%,A组显著高于B组（P=0.004）。通过比较入组前及第4、6、12周PAC-QOL,加减四磨汤在改善CCSQ患者的生活质量方面明显优于普卢卡必利。最常见的不良反应是恶心、头痛、腹泻、腹痛,未出现明显的心血管事件。结论：CCSQ应用加减四磨汤安全、有效。

Clinical Effect of Jiajian Simo Decoction on Chronic Constipation of Qi Stagnation

Objective： To observe the clinical effect of Jiajian Simo decoction on chronic constipation with Qi stagnation type. Methods： 95 patients with CC were divided randomly into two groups as A Group（ Jiajian Simo decoction group） and B Group（ prucalopride group）. The efficacy end points were the proportion of patients who had three or more spontaneous complete bowel movements（ SCBM） per week,averaged over 12 weeks,as well as an increase in the number of SCBM of one or more. Meanwhile,adverse events were monitored. Results： On the primary end point,Jiajian Simo decoction was signicantly more effective than prucalopride with 42. 55% vs 29. 17% and patients had a weekly average of ≥3 SCBMs during the 12- week treatment（ P =0. 013）; Respective percentages were 61. 70%（ A group） vs 43. 75%（ B group） of patients who had an increase in the number of SCBMs of one or more per week on average,（ P =0. 004）. By comparing the patient assessment of constipation quality of life（ PAC- QOL） questionnaire at baseline and at the 4th,6th and 12th,Jiajian Simo decoction significantly improved the disease- related quality of life in patients with CCSQ,which was superior to prucalopride. The most frequent adverse events were nausea,headache,diarrhea and abdominal pain. There were no significant cardiovascular effects of the treatment. Conclusion： Jiajian Simo decoction is effective and safe in the treatment of CCSQ.