| 引用本文:路越1，张虹玺1，韩宝2，张志云3，于永铎4，田振国1.首荟通便胶囊治疗功能性便秘的临床疗效研究[J].世界中医药,2020,(22):. |
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| 首荟通便胶囊治疗功能性便秘的临床疗效研究 |
| Study on the Clinical Efficacy of Shouhui Tongbian Capsule in The Treatment of Functional Constipation |
| 投稿时间：2020-07-15 |
| DOI：10.3969/j.issn.1673-7202.2020.22.013 |
| 中文关键词: 首荟通便胶囊 功能性便秘 临床疗效 多中心研究 前瞻性研究 |
| English Keywords:Shouhui Tongbian Capsule Functional constipation Clinical efficacy Multicenter study Prospective study |
| 基金项目:国家重点研发计划项目（2019YFC1711200） |
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| 中文摘要: |
| 目的：观察首荟通便胶囊对不同年龄功能性便秘患者的临床疗效，评价首荟通便胶囊的安全性。方法：选取2018年5月至2019年6月100余家医疗机构收治的功能性便秘患者2 396例作为研究对象，根据年龄分为3组：18~40岁组（n=683），41~60岁组（n=1 018）及61岁以上组（n=695）。观察3组患者服用首荟通便胶囊14 d后的疗效、治疗前后肠功能Wexner评分的变化及安全性的评价。评价首荟通便胶囊对患者生命质量的影响，观察首荟通便胶囊服用后1个月、2个月和3个月的长期疗效和安全性。结果：首荟通便胶囊能改善患者排便次数、困难程度和排便时间。组内比较结果显示，服用首荟通便胶囊14 d后的改善效果优于7 d（P<0.001）。组间比较显示，年龄小的患者较年长的患者有更好的改善效果（P<0.001），首荟通便胶囊能提高患者的生命质量和满意度。组内比较显示，患者的长期改善效果优于短期改善效果（P<0.001）。组间比较显示，年龄小的患者较年长的患者有更好的改善效果（P<0.001）。结论：本试验结果表明，首荟通便胶囊治疗不同年龄功能性便秘患者的临床疗效显著，为首荟通便胶囊上市后的疗效和安全性再评价提供了有力的依据。 |
| English Summary: |
| To observe the improvement of symptoms,quality of life and satisfaction of patients with functional constipation of different ages,and to evaluate the safety of Shouhui Tongbian Capsule.Methods:A total of 2 396 patients with functional constipation were divided into 3 groups:18～40 years old,41～60 years old and over 61 years old.The main index of this study was to observe the therapeutic effect of Shouhui Tongbian Capsule after 14 days,the change of Wexner score of intestinal function before and after treatment and the evaluation of safety.The secondary index of this study was to record the impact of Shouhui Tongbian Capsule on the quality of life of patients,and to observe the long-term efficacy and safety of Shouhui Tongbian Capsule 1 month,2 months and 3 months after taking.Results:Shouhui Tongbian Capsule could improve the defecation frequency,difficulty degree and defecation time.The results showed that the improvement effect of 14 days after taking the capsule was better than 7 days(P<0.001).The comparison between groups showed that the younger patients had better improvement effect than the older patients(P<0.001).Similarly,Shouhui Tongbian Capsule can improve the quality of life and satisfaction of patients.The long-term improvement effect was better than the short-term improvement effect(P<0.001).The comparison between groups showed that the younger patients had better improvement effect than the older patients(P<0.001).Conclusion:The results of this study provide a strong basis for the reevaluation of the efficacy and safety of Shouhui Tongbian Capsule after it is put on the market. |
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