【摘 要】
：
目的 运用随机对照观察的研究方法,探究本研究团队原创开发的中药制剂溃克灵治疗克罗恩病的临床治疗效果及其药物安全性,为溃克灵的临床指导治疗及进一步的开发利用提供临床依据.方法 随机选取门诊及住院中度活动克罗恩病患者58例纳入本研究.人选病例随机分成中药溃克灵组和西药对照组,其中中药溃克灵组28例,西药对照组30例.中药溃克灵组用药为中药溃克灵+氨基水杨酸类(柳氮磺吡啶或5-氨基水杨酸)；西药对照组用
【机 构】
：
210008 南京大学医学院附属鼓楼医院消化科
【出 处】
：
The 14th Congress of Gastroenterology China(第十四届全国消化系病学术会议)
论文部分内容阅读
目的 运用随机对照观察的研究方法,探究本研究团队原创开发的中药制剂溃克灵治疗克罗恩病的临床治疗效果及其药物安全性,为溃克灵的临床指导治疗及进一步的开发利用提供临床依据.方法 随机选取门诊及住院中度活动克罗恩病患者58例纳入本研究.人选病例随机分成中药溃克灵组和西药对照组,其中中药溃克灵组28例,西药对照组30例.中药溃克灵组用药为中药溃克灵+氨基水杨酸类(柳氮磺吡啶或5-氨基水杨酸)；西药对照组用药为氨基水杨酸类(柳氮磺吡啶或5-氨基水杨酸)+泼尼松.每组疗程均为4周.临床观察指标主要为治疗前后患者腹痛、腹泻、便血、并发症情况及简化克罗恩病活动指数(CDAI)评分等；实验室观察指标主要有WBC计数、Hb、PLT计数、ALT、AST、白蛋白、血尿素氮、血肌酐、ESR、CRP等.有效性评价主要根据治疗前后CDAI计分的减少差值.安全性评价主要根据治疗前后的肝功能、肾功能等.结果 中药溃克灵组和西药对照组治疗后简化CDAI值均较治疗前下降(6.78±1.09比5.33±1.00,6.57±1.40比5.50±0.86),差异具统计学意义(P均＜0.01),但组间差异无统计学意义(P=0.67),差值差异亦无统计学意义(P=0.32)；各组治疗后的Hb、PLT、ESR、CRP、白蛋白均较治疗前有明显改善,在血小板改善方面中药组优于西药对照组(P=0.04)；各组治疗前后肝、肾功能无明显异常.结论 中药溃克灵联合氨基水杨酸类药物治疗中度克罗恩病与氨基水杨酸类药物联合泼尼松治疗均可降低简化CDAI指标、总体疗效相似.中药溃克灵能改善部分克罗恩病患者的实验室指标,且较氨基水杨酸类药物联合泼尼松治疗具有更好的降低PLT效果,并对肝功能、肾功能无明显影响.
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