The General Hospital of Shenyang Military Region, Liaoning, China.
J Ethnopharmacol. 2012 Jun 1;141(2):592-8. doi: 10.1016/j.jep.2011.08.057. Epub 2011 Sep 6.
Fufangkushen colon-coated capsule (FCC) was a newly developed herbal drug for treating ulcerative colitis (UC) patients with traditional Chinese medicine (TCM) pattern of damp-heat accumulating in the interior.
To explore the efficacy and safety of FCC in the treatment of active UC compared with Huidi (HD, mesalazine enteric-coated tablets) were evaluated in a double-blinded and randomized clinical trial.
In the double-blind, double-dummy, multicenter, randomized and controlled study, 320 active UC patients with TCM pattern of damp-heat accumulating in the interior were assigned to two groups: 240 treated with FCC plus HD placebo treatment, 80 with HD plus FCC placebo. The drugs and their corresponding placebos were administrated at advised dosage for 8 weeks. The primary endpoint was a positive clinical response at week 8, and Mayo scoring system was employed for assessment of UC activity.
At the 8th week, 72.50% of patients in FCC group (170 of 234) and 65.00% of patients in HD group (52 of 80) had achieved a clinical response. There was no statistically significance between the 2 groups (P>0.05). The proportions of patients who had a clinical remission was similar in 2 groups (41.50% in FCC group, 41.25% in HD group, P>0.05), mucosal healing rate at week 8 in the two groups were also without significant difference (55.13% in FCC group, 55.00% in HD group, P>0.05). Mayo scores at week 8 showed no statistically difference in the two groups. No significant differences were observed between the safety profiles of the 2 groups (P>0.05). No severe AEs were reported in either group. The latent class analysis indicated that FCC was superior applicable for the left hemicolon involved patients than HD.
Compared with HD, a mesalamine enteric-coated tablet, FCC is similarly effective and safe in the treatment of active UC with TCM pattern of damp-heat accumulation interior pattern. In addition, FCC indicates superior effect in the treatment of UC with inflamed area of the left hemicolon than HD.
复方苦参结肠胶囊（FCC）是一种新开发的用于治疗中医湿热积聚型溃疡性结肠炎（UC）患者的草药药物。
在一项双盲、随机临床试验中，评估 FCC 治疗活动期 UC 的疗效和安全性，与 Huidi（HD，美沙拉嗪肠溶片）进行比较。
在这项双盲、双模拟、多中心、随机对照研究中，将 320 例中医湿热积聚型活动期 UC 患者分为两组：240 例接受 FCC 加 HD 安慰剂治疗，80 例接受 HD 加 FCC 安慰剂治疗。两组均按建议剂量给药 8 周。主要终点是第 8 周的阳性临床反应，采用 Mayo 评分系统评估 UC 活动度。
第 8 周时，FCC 组 72.50%（234 例中的 170 例）和 HD 组 65.00%（80 例中的 52 例）的患者达到临床缓解。两组之间无统计学意义（P>0.05）。两组的临床缓解率相似（FCC 组 41.50%，HD 组 41.25%，P>0.05），第 8 周时两组的黏膜愈合率也无显著差异（FCC 组 55.13%，HD 组 55.00%，P>0.05）。第 8 周时两组的 Mayo 评分无统计学差异。两组的安全性特征无显著差异（P>0.05）。两组均未报告严重不良事件。潜在类别分析表明，FCC 比 HD 更适用于左半结肠受累的患者。
与美沙拉嗪肠溶片 HD 相比，复方苦参结肠胶囊在治疗中医湿热积聚型活动期 UC 方面同样有效且安全。此外，FCC 治疗左半结肠炎症面积较大的 UC 效果优于 HD。
