麻杏润肠素治疗功能性便秘的疗效与安全性：一项随机对照试验
Efficacy and Safety of Maxing Xianchang Su in the Treatment of Functional Constipation: A Randomized Controlled Trial.
作者信息
Li Mi, Zhao Lijuan, Ma Li, Zhang Wen, Huang Hua, Wei Jun, Sun Jun, Lu Fenying, Ji Lijiang
机构信息
Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu 215500, Jiangsu, China.
Yueyang Hospital of Integrative Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.
出版信息
Evid Based Complement Alternat Med. 2021 Nov 25;2021:3685440. doi: 10.1155/2021/3685440. eCollection 2021.
BACKGROUND
Functional constipation FC) is one of the prevalent gastrointestinal disorders that affect people of all ages. Long-term FC has significant effects on the quality of life of patients. Although commonly used drugs have reliable short-term effects, they are easily addictive and have side effects. Therefore, pursuing a convenient drug-food homogenous program is critical for FC patients. Maxing Xianchang Su is a functional food based on traditional Chinese medicine. To investigate the efficacy and safety of Maxing Xianchang Su in FC treatment, we conducted a randomized controlled trial.
METHODS
We carried out a prospective multicenter randomized parallel controlled study in three hospitals in Jiangsu Province, China, from January 2020 to March 2021, which included 206 FC patients. All patients were arbitrarily assigned into a treatment group and a control group at a ratio of 1 : 1; 103 cases in each group. The treatment group was given oral Maxing Xianchang Su, whereas the control group was treated with lactulose oral solution. The course of treatment was two weeks. The two groups of patients were evaluated after six weeks for symptom improvement before and after taking the drug. Furthermore, the safety of Maxing Xianchang Su was assessed.
RESULTS
Both groups of patients successfully completed the study without shedding cases. The effective rates of the treatment group and control group after two weeks were 90.6% and 67.0%, respectively. The treatment group had a better curative effect than the control group ( < 0.05). The symptom score of the two groups improved compared with that before the treatment. The difference between the two groups was statistically significant ( < 0.05). During the treatment process, neither group experienced abnormal changes in blood lipid, blood glucose, routine hematuria, or liver and kidney functions. There were no adverse reactions in both groups.
CONCLUSION
Maxing Xianchang Su has a positive effect on FC treatment with reliable mid-term effect and a high level of safety.
背景
功能性便秘（FC）是一种影响各年龄段人群的常见胃肠道疾病。长期的功能性便秘对患者的生活质量有显著影响。尽管常用药物有可靠的短期疗效，但它们容易成瘾且有副作用。因此，寻求一种方便的药食同源方案对功能性便秘患者至关重要。麻杏润肠素是一种基于传统中药的功能性食品。为了研究麻杏润肠素治疗功能性便秘的疗效和安全性，我们进行了一项随机对照试验。
方法
2020年1月至2021年3月，我们在中国江苏省的三家医院开展了一项前瞻性多中心随机平行对照研究，纳入206例功能性便秘患者。所有患者按1∶1的比例随机分为治疗组和对照组，每组103例。治疗组口服麻杏润肠素，对照组口服乳果糖口服液。疗程为两周。两组患者在服药六周后评估服药前后症状改善情况。此外，对麻杏润肠素的安全性进行评估。
结果
两组患者均顺利完成研究，无脱落病例。治疗组和对照组两周后的有效率分别为90.6%和67.0%。治疗组疗效优于对照组（P<0.05）。两组症状评分均较治疗前改善。两组间差异有统计学意义（P<0.05）。治疗过程中，两组患者血脂、血糖、血尿常规及肝肾功能均未出现异常变化。两组均未出现不良反应。
结论
麻杏润肠素治疗功能性便秘有积极作用，中期疗效可靠，安全性高。
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