乳果糖联合枯草杆菌二联活菌治疗功能性便秘的临床观察

Clinical Observation of Lactulose Combined with Bacillus subtilis Bifarous Viable Bacteria in the Treatment of Functional Constipation

目的:观察乳果糖联合枯草杆菌二联活菌治疗功能性便秘的临床疗效与安全性。方法:采用随机单盲对照研究,将60例功能性便秘患者随机分为治疗组28例与对照组32例。两组患者均口服乳果糖,治疗组患者加服枯草杆菌二联活菌,对照组患者加服安慰剂,2周后均停用乳果糖,加服药物直至第4周再停用。比较两组患者治疗前与治疗后第2、4周的排便次数、粪便性状、便秘症状、生活质量及不良反应。结果:两组患者在第2周的排便次数、粪便性状、便秘症状均较治疗前明显改善,差异有统计学意义(P<0.05);停服乳果糖后,治疗组患者在第4周的上述便秘各项指标改善情况明显优于对照组,差异有统计学意义(P<0.05);两组患者的生活质量各指标在第4周均较治疗前改善,差异有统计学意义(P<0.05),其中治疗组在躯体不适、满意度评分及总分方面较对照组改善明显,差异有统计学意义(P<0.05);两组患者均未出现严重不良反应。结论:乳果糖联合枯草杆菌二联活菌能有效缓解功能性便秘,改善腹部症状,减缓便秘的复发,安全可靠。

OBJECTIVE： To observe the clinical efficacy and safety of lactulose combined with Bacillus subtilis bifarous via- ble bacteria in the treatment of functional constipation （FC）. METHODS： In a randomized single blind controlled stud,, 60 FC pa- tients were randomly assigned into treatment group （28 cases） and control group （32 cases）. Both groups received lactulose orally. Treatment group additionally receive B. subtilis bifarous viable bacteria, and control group additionally received placebo continually. 2 weeks later, both groups stopped taking lactulose but continued to take adjunctive drug till 4th week. The defecate frequencies, stool property, constipation symptoms, quality of life and ADR were compared between 2 groups before treatment and 2nd, 4th week coffer treatment. RESULTS： In the second week , the defecate frequencies, stool property and constipation symptoms of both groups were significantly improved, with statistical significance （P〈0.05）. Compared with the control group in the fourth week, these constipation symptoms of treatment group were improved more significantly, with statistical significance （P〈0.05）. In the fourth week, aspects of quality of life in both groups were significantly improved, with statistical significance （P〈0.05）; physical discomfort scores, satisfaction scores and total scores of treatment group were irnproved significantly, compared with the control group, there was statistical significance （P〈0.05）. There were no severe ADR in both groups. CONCLUSIONS： Lactulose com- bined with B. subtilis bifarous viable bacteria can effectively relieve FC, improve abdominal symptoms and slow the recurrence of constipation, which is safe and reliable.