| 杨波,吴整军,童新元,仝战旗,龚琴,陈丙跃.复方苦参结肠溶胶囊治疗湿热内蕴型溃疡性结肠炎多中心、随机、双盲、对照研究[J].,2011,31(2):172-176 |
| 复方苦参结肠溶胶囊治疗湿热内蕴型溃疡性结肠炎多中心、随机、双盲、对照研究 |
| A Multi-center Randomized Double-blinded,Placebo-controlled Clinical Study on Efficacy of Composite Sophora Colon-soluble Capsules in Treating Ulcerative Colitis of Internal Dampness-Heat Accumulation Syndrome Type |
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| 中文关键词: 复方苦参结肠溶胶囊 美沙拉嗪缓释颗粒 溃疡性结肠炎 湿热内蕴证 多中心临床试验 |
| 英文关键词:Composite Sophora Colon-soluble Capsules mesalazine slow releasing granule ulcerative colitis internal dampness-heat accumulation syndrome multi-center clinical trial |
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| 中文摘要: |
| 目的观察复方苦参结肠溶胶囊治疗溃疡性结肠炎(ulcerative colitis,UC)湿热内蕴证的临床疗效及安全性,并同美沙拉嗪缓释颗粒(艾迪莎)进行比较。方法采用随机、双盲双模拟、阳性药平行对照设计方法,将160例UC湿热内蕴证患者随机分为试验组(120例,完成100例)与对照组(40例,完成36例)。试验组给予复方苦参结肠溶胶囊及艾迪莎颗粒模拟剂,对照组给予艾迪莎及复方苦参结肠溶胶囊模拟剂,疗程均为8周。比较两组治疗前后肠镜下病变改善情况、中医证候积分、中医单项症状评分、UC活动指数及镜下组织学变化,并观察两组综合疗效、证候疗效及用药安全性。结果两组在临床总有效率(92.0%vs83.3%)、中医证候疗效总有效率(91.7%vs85.0%)、肠镜下病变改善总有效率(92.0%vs83.3%)、镜下组织学评估病变改善率(66.7%vs52.0%)及UC活动指数(1.03±1.87vs1.78±2.18)方面比较差异均无统计学意义(P>0.05);与对照组比较,试验组在降低中医证候积分、改善黏液脓血便及大便臭秽单项中医症状的作用方面更显著(P<0.05)。试验期间两组均无严重不良事件发生。结论复方苦参结肠溶胶囊疗效不劣于艾迪莎,且有优于艾迪莎的趋势,可作为艾迪莎等化学药治疗效果不佳时的替代治疗。 |
| 英文摘要: |
| Objective To evaluate the clinical efficacy and safety of Composite Sophora Colon-soluble Capsules (CSCC) in treating patients with ulcerative colitis (UC) of internal dampness-heat syndrome type (IDHS) and compared with that of Mesalazine slow releasing granules (trade name:Etiasa). Methods Adopting randomized double-blinded double-simulated and positive drug controlled clinical design,160 patients with UC of IDHS type were randomly assigned to two groups,120 in the trial group was treated with CSCC plus Etiasa simulated placebo for 8 weeks,while 40 in the control group with Etiasa plus CSCC simulated placebo. Comprehensive therapeutic efficacy,effects on syndrome and safety of treatment were assessed,and changes of endoscopic features,Chinese medical syndrome scores and symptom score,activity index (AI) of UC,microscopic pathology in the two groups were observed and compared before and after treatment. Results After 8-week treatment,the clinical total effective rate in the two groups were 92.0% and 83.3%,the effective rate on Chinese medical syndrome in them were 91.7% and 85.0%,that on endoscopic features 92.0% and 83.3%,on microscopic changes 66.7% and 52.0%,respectively,showing insignificant difference between groups. Difference between groups in AI also showed no significance (1.03±1.87 vs 1.78±2.18,P>0.05). However,the effects of decreasing Chinese medical syndrome score,and improving mucous pus blood stool and foul defecation in the trial group were more significantly (P<0.05). No serious adverse event was seen in the 8-week treatment period. Conclusions The clinical efficacy of CSCC was not inferior to,or even better than that of Etiasa. It could be taken as a substitute of chemicals if with poor effect. |
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