麻仁软胶囊治疗2型糖尿病患者便秘的临床观察(1)
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2010年11月5日
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[摘要] 目的：探讨麻仁软胶囊治疗2型糖尿病患者便秘的临床疗效。方法：将129例2型糖尿病便秘患者，随机分为治疗组65例，应用麻仁软胶囊3粒/次，3次/d；对照组64例，用莫沙必利5 mg/次，3次/d，疗程4周，疗程结束后再随访4周，观察两组的疗效情况。结果：两组比较，治疗组排便起效时间、疗效、出现不良反应、停药后需要继续服用助排便药情况4个方面均明显优于对照组(P<0.01)。结论：麻仁软胶囊相对于莫沙必利治疗糖尿病患者便秘有较好的临床疗效。
[关键词] 麻仁软胶囊；2型糖尿病；便秘；疗效
[中图分类号] R256.35 [文献标识码]B[文章编号]1674-4721(2010)11(a)-054-02
Clinical observation of MAREN soft capsule for the treatment of type 2 diabetes mellitus patients with constipation
HUANG Yu, LIU Jianping
(The People′s Hospital of Guangzhou Liwan District, Guangzhou 510370, China)
[Abstract] Objective: To study the clinical efficacy of MAREN soft capsule for the treatment of type 2 diabetes mellitus patients with constipation. Methods: Divided 129 cases of diagnosed diabetes mellitus patients of type 2 with constipation into two groups randomly, the treatment group with 65 cases of patients took 3 capsules of the MAREN soft capsule per time, 3 times per day; And the control group with 64 cases of patients took 5 mg of mosapride per time, 3 times per day. After 4 weeks of treatment, another 4 weeks of follow-up observation was executed to watch the curative effect of the two groups. Results: Compared with the control group and treatment group in 4 aspects, such as the defecation time, the efficacy, the adverse reactions occurred, and the requirement for continued taking drugs to help defecation after stopped taking medicine, the treatment group was obviously superior than the control group (P<0.01). Conclusion: MAREN soft capsule has better clinical efficacy than the mosapride in treatment of constipation for patients with type 2 diabetes.
[Key words] MAREN soft capsule; Type 2 diabetes; Constipation; Clinical efficacy
糖尿病便秘属于顽固难治性便秘，2型糖尿病患者常见便秘，在糖尿病神经病变中发病率高达60%以上[1]。治疗上尚无特效药，西医多采用缓泻剂、胃动力药，严重便秘者采用定期灌肠或肛门直肠肌切断术，效果均不够理想[2]；中药汤剂有一定的优势，但长期煎药不太方便[3]。2008年6月～2010年5月笔者运用中成药麻仁软胶囊治疗2型糖尿病便秘患者，做了临床疗效观察。现报道如下：
1 资料与方法
1.1 诊断标准
根据《中药新药治疗消渴病(糖尿病)的临床研究指导原则》和《中药新药治疗便秘的临床研究指导原则》有关标准[4] 选择病例。
1.2 纳入标准
2型糖尿病患者，①持续不愈之便秘。②大便干结及排便困难，排便时间延长，每次排便间隔3 d以上，病程3个月以上。
1.3 排除标准
①妊娠，合并心肝肾等严重并发症、酮症酸中毒及感染者；②因结肠、直肠、肛门器质性病变等所致肠道狭窄者；③不合作及资料不全者。
1.4 一般资料 ......
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