便通胶囊配合双歧杆菌治疗老年人气虚便秘的临床研究

A clinical Study of Biantong Capsule Combined with Bifidobacterium Tetragenous Viable Bacteria Tablets for Treatment of Elderly Qi-asthenia

目的观察便通胶囊配合双歧杆菌四联活菌片治疗老年人气虚型便秘的临床疗效及安全性。方法根据纳入标准筛选门诊及住院患者气虚型便秘老年患者170例,随机分为试验组、对照组各85例,分别给予便通胶囊配合双歧杆菌四联活菌片和单用便通胶囊的干预,服药14天后对疗效和安全性进行评估。结果治疗后14天评价两组的愈显(临床痊愈+显效)率,试验组愈显率为91.46%,对照组为65.43%,组间比较差异有显著性(P<0.001)。试验组和对照组患者的排便困难,粪便性状,排便时间,下坠、不尽、胀感,排便频率和腹胀问题较治疗前有所改善,试验组治疗后便秘症状包括排便困难,粪便性状,下坠、不尽、胀感和腹胀试验组得分要优于对照组。结论便通胶囊配合双歧杆菌四联活菌片治疗老年人气虚型便秘的疗效好、不良反应少。

Objective To observe the clinical efficacy and safety of biantong capsule combined with bifidobacterium tetragenous viable bacteria tablets for the treatment of elderly qiasthenia constipation. Method The study enrolled 170 eligible elderly patients of outpatients and inpatientsaccording to inclusion and exclusion criteria. Subjects were randomized in a 1 ： 1 fashion to treatment and control arm. Treatment and control groups were received biantong capsule plus bifidobacterium tetragenous viable bacteria tablets and biantong capsule respectively. Clinical efficacy and safety were evaluated at 14 days visit. The method of assessment questionnaire of efficacy for constipation symptoms, authorized by Chinese medical association surgery branch anorectal surgery group in 2005, was used to clinical efficacy evaluation. Occurrences of adverse events in study process were recorded and described. Result The cure plus obviously efficiency rate in treatment and control arms （91.46% vs. 65.43%, P〈0. 001 ） was significant difference at 14 days visit. Assessment questionnaires including difficult defecation, stool, defecation time, tenesmus or bilge feeling, defecation frequency and abdominal bloating were significantly improved compared to before treatment in both arms. Compared to control group, significant improvements in symptoms including difficult defecation, stool, tenesmus or bilge feeling and abdominal bloating were observed at 14 days visit. Conclusion The use of biantong capsule plus bifidobacterium tetragenous viable bacteria tablets was demonstrated satisfactory clinical efficacy and safety in the treatment of elderly qiasthenia constipation.