A multi-center, randomized, single-blind, controlled clinical study on the efficacy of composite sophora colon-soluble capsules in treating ulcerative colitis
A multi-center, randomized, single-blind, controlled clinical study on the efficacy of composite sophora colon-soluble capsules in treating ulcerative colitis
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DOI：
10.1007/s11655-010-0562-5
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发表时间：
2010-12-01
影响因子：
2.9
通讯作者：
Zhao Mei-ling
中科院分区：
文献类型：
--
作者：
Tong Zhan-qi;Yang Bo;Zhao Mei-ling
为评价复方苦参结肠溶胶囊治疗溃疡性结肠炎（UC）湿热蕴结证的安全性和有效性，为III期临床试验奠定基础，采用多中心、随机、单盲、阳性药平行对照设计。有126例UC-DHAS患者分层并平均分配到三组。两个CSCC治疗组（T1和T2组）的患者分别口服高剂量（6粒胶囊，每日3次）和低剂量（4粒胶囊，每日3次）CSCC，对照组的患者分别口服美沙拉秦肠溶片（4片，每日3次），均持续8周。通过临床症状观察和结肠镜检查评价治疗的临床疗效和安全性。(1)全分析集（FAS）和符合方案集（PPS）分析显示，T1、T2组和对照组的综合疗效分别为85.7%、92.9%和71.4%三组间差异无统计学意义（P = 0.330）。(2)FAS和PPS分析显示，T1、T2组和对照组对膜性病变的有效性分别为83.3%、92.9%和73.8%（P = 0.063），86.8%、92.7%和75.6%（P = 0.070），三组间差异无统计学意义。(3)FAS分析显示改善里急后重的疗效趋势（P = 0.056）。其他症状的改善无明显变化，三组间差异无统计学意义（P> 0.05）。PPS分析显示T1、T2组单项症状疗效与对照组比较差异无统计学意义（P = 0.082），CSCC治疗UC的综合疗效与美沙拉嗪肠溶片基本相当，但有改善症状的趋势。增加剂量不能提高药效。因此，CSCC的推荐剂量是四粒胶囊，每天三次。
To evaluate the safety and efficacy of composite sophora colon-soluble capsule (CSCC) in treating ulcerative colitis (UC) of the damp-heat accumulation syndrome pattern (DHAS) and to prepare a basis for a phase III clinical trial.A multi-center, randomized, single-blind, and positive drug parallel-controlled design was adopted. There were 126 patients of UC-DHAS stratified and assigned equally to three groups. Patients in two CSCC treated groups, Groups T1 and T2, were treated orally with high (six capsules, thrice a day) and low (four capsules, thrice a day) doses CSCC, and patients in the control group were treated orally with Mesalazine Enteric-coated Tablets (four tablets, thrice a day), respectively, all for eight weeks. The clinical efficacy and safety of treatments were evaluated through clinical symptom observations and colonoscopic examinations.(1) Full analysis set (FAS) and per-protocol set (PPS) analyses showed the comprehensive curative effect in Groups T1, T2, and the control group, obtaining the values of 85.7%, 92.9%, and 71.4% (P=0.330), and 89.5%, 92.7%, and 73.2% (P=0.552), respectively, demonstrating no statistical significance among the three groups. (2) FAS and PPS analysis showed the efficacy on membranous lesions in Groups T1, T2, and the control group, obtaining the values of 83.3%, 92.9%, and 73.8% (P=0.063), and 86.8%, 92.7%, and 75.6% (P=0.070), respectively, showing statistical insignificance among the three groups. (3) FAS analysis showed an efficacy tendency on improving tenesmus (P=0.056). No changes were found in improving the other symptoms, and statistical significance was not shown among the three groups (P > 0.05). PPS analysis showed the efficacy on single item symptom in Groups T1, T2, and the control group was not statistically significant among the three groups (P=0.082).The comprehensive effect of CSCC in treating UC is basically equivalent to that of Mesalazine enteric-coated tablet; however, the tendency was shown to improve symptoms. Its efficacy could not be raised by increasing the dosage used. Therefore, the recommended dosage of CSCC is four capsules, three times a day.