灵菇胶囊与灵菇合剂治疗功能性便秘的临床研究

Clinical Study on the Therapeutical Efficacy of Linggu Capsule and Linggu Mixture in the Treatment of Functional Constipation

为验证灵菇合剂和胶囊剂型对功能性便秘的临床疗效、安全性及耐受性，为功能性便秘（虚证型）患者提供一种新型药物，我们将63例功能性便秘患者分为治疗组与对照组，治疗组32例采用灵菇胶囊口服，3次／d，4粒／次，对照组31例采用灵菇合剂口服，3次／d，10ml／次。1个疗程后通过对患者一般体检项目及排便间隔时间、便质、排便费力情况、中医证候相关症状、舌象及脉象的变化、胃肠道反应等进行疗效评定。结果显示，治疗组总有效率93．8％，对照组总有效率90．3％（P〉0．05），灵菇胶囊改善患者大便干结、排便费力、排便不尽感等症状疗效比较明显，而且治疗组服药后无腹痛、恶心、头晕及水泻样大便等不良反应。结果表明，剂型改良后的灵菇胶囊疗效肯定，患者治疗过程中亦无明显的不良反应；胶囊型药物具有口味淡香，利于贮存、运输，方便携带及服用等特点。

The objective of the study was to evaluate the therapeutic efficacy of linggu capsule and linggu mixture in the treatment of functional constipation. Sixty three patients with functional constipation were divided into two group,patients in the study group（ n =32） took linggu capsule（4 capsule/time,tid）,and patients in the controlled groups（ n= 31） took linggu mixture（10ml/time, tid）. Physical examination, interval of defecation, stool contour, difficulty in defecation, symptoms and signs of TCM, picture of the tongue sign and type of pulse,gastrointestinal reaction were chosen as the contents of observation and evaluation. As results, the general improvement rate in the study group and controlled group was 93.8% and 90.3%（ P 〉0.05） respectively;linggu capsule had a better efficacy in the improvement of hardened stool, dysporia and sensation of defection insuficiency,and had no such adverse reactions as abdominal pain,nausea,dizziness and watery diarrhea. It is concluded that linggu capsule has a definite therapeutic efficacy and has no notable adverse reactions, light taste; besides, it is convenient in storage, transportation, personal carrying and medication.