CAJ | 학술논문

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。
목적：관찰편통효낭배합쌍기간균사련활균편치료노년인기허형편비적림상료효급안전성。방법근거납입표준사선문진급주원환자기허형편비노년환자170례，수궤분위시험조、대조조각85례，분별급여편통효낭배합쌍기간균사련활균편화단용편통효낭적간예，복약14천후대료효화안전성진행평고。결과치료후14천평개량조적유현(림상전유+현효)솔，시험조유현솔위91.46%，대조조위65.43%，조간비교차이유현저성(P<0.001)。시험조화대조조환자적배편곤난，분편성상，배편시간，하추、불진、창감，배편빈솔화복창문제교치료전유소개선，시험조치료후편비증상포괄배편곤난，분편성상，하추、불진、창감화복창시험조득분요우우대조조。결론편통효낭배합쌍기간균사련활균편치료노년인기허형편비적료효호、불량반응소。
Objective To observe the clinical efficacy and safety of biantong capsule combined with bifidobacterium tetragenous viable bacteria tablets for the treatment of elderly qi-asthenia 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 cap-sule 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 symp-toms, authorized by Chinese medical association surgery branch anorectal surgery group in 2005, was used to clini-cal 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, te-nesmus 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 defeca-tion, 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 effica-cy and safety in the treatment of elderly qi-asthenia constipation.