摘要
目的评价复方苦参结肠溶胶囊治疗湿热内蕴型溃疡性结肠炎(UC)的有效性、安全性。方法采用随机、单盲、阳性药平行对照方法进行研究,并做非劣效性检验。将16例UC患者随机分为2组:试验组服用复方苦参结肠溶胶囊,对照组服用柳氮磺胺吡啶片,均连用8周,将患者临床症状、结肠镜检查结果、病理变化及粪便常规作为有效性指标进行疗效评价,根据患者血尿常规、肝肾功能及心电图的变化结合不良事件进行安全性评价。结果治疗8周后,试验组与对照组总有效率分别为88%(7/8)和75%(6/8),临床疗效试验组与对照组总有效率均为88%(7/8),中医证候疗效试验组与对照组总有效率分别为100%和88%。试验组1例发生不良反应,对照组无一例发生不良反应。结论复方苦参结肠溶胶囊能有效治疗湿热内蕴型UC,并且具有良好的安全性。
Objective It is to evaluate the therapeutic effect and safety of Fufangkushen colon-release capsule（FFKS） for patients with ulcertive eolitis（UC）of endo-rctcntion of damp heat type. Methods Multi center, randomized, single blind, positive medicine parallel controlled method was adopted, and non-inferiority test was carried on. 16 cases of patients were randomly allocated into therapy group treated with FFKS and control group treated with salicylazosulfapyridinc （SASP）. After 8 weeks＇ treatment, the effective indexes such as clinical symptom, result of coloscopy, pathological changes and stool test for routine were used to evaluate curative effect. The security of FFKS was assessed according to blood and urine normal examination, liver-kidney function, changes of ECG and records of adverse events. Results The total effective rates of colon mucosal changes in therapy group and control group were 88 % （7/8） and 75 % （6/8） respectively. The total effective rates of clinical effect of the two groups were both 88% （7/8）, and the total effective rates of TCM syndromes were 100% and 88% respectively. 1 cases of side effect was found in therapy groups. No side effect and adverse event was found in control group. Conclusion FFKS can effectively treat for UC of endo-retention of damp heat type, and has a favorable security.
出处
《现代中西医结合杂志》
CAS
2009年第13期1453-1455,共3页
Modern Journal of Integrated Traditional Chinese and Western Medicine
关键词
复方苦参结肠溶胶囊
溃疡性结肠炎
湿热内蕴型
Fufangkushen colon-release capsule
ulcerative colitis
Endo-retention of Damp Heat type
