Sun Jing, Shen Xiao, Dong Jianning, Wang Honggang, Zuo Lugen, Zhao Jie, Zhu Weiming, Li Yi, Gong Jianfeng, Li Jieshou
Department of General Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.
Am J Med Sci. 2015 Nov;350(5):345-51. doi: 10.1097/MAJ.0000000000000591.
The traditional Chinese medicine, Tripterygium wilfordii Hook F (TwHF) is widely used to treat Crohn's disease (CD) in China.
The authors compared different doses of TwHF with mesalazine in 198 patients with CD over a 52-week period. Subjects were randomized to receive mesalazine (3 g/d), low-dose TwHF (1.5 mg·kg·d), or high-dose TwHF (2.0 mg·kg·d).
A total of 137 patients completed the study. At week 52, a significant lower proportion of patients in the high-dose TwHF group (7/71) had clinical recurrence compared with patients in the low-dose TwHF (15/68, P = 0.047) or mesalazine group (17/59, P = 0.006), whereas the difference between the low-dose TwHF group and the mesalazine group was not significant (P = 0.503). Patients receiving mesalazine experienced less adverse events than those receiving high-dose TwHF (P = 0.029) and those receiving low-dose TwHF (P = 0.048), but no significant difference was found about drug adverse events resulted withdrawal in the 3 groups (P > 0.05). In addition, compared with low-dose TwHF and mesalazine, the authors also detected significant superiority of high-dose TwHF arm in the decrease of CDAI and SESCD (P < 0.05).
A 2.0 mg/kg daily TwHF was well tolerated and prolonged remission in patients with CD.
中药雷公藤多苷(TwHF)在中国被广泛用于治疗克罗恩病(CD)。
作者在198例CD患者中比较了不同剂量的TwHF与美沙拉嗪,为期52周。受试者被随机分为接受美沙拉嗪(3 g/d)、低剂量TwHF(1.5 mg·kg·d)或高剂量TwHF(2.0 mg·kg·d)。
共有137例患者完成了研究。在第52周时,高剂量TwHF组(7/71)临床复发的患者比例显著低于低剂量TwHF组(15/68,P = 0.047)或美沙拉嗪组(17/59,P = 0.006),而低剂量TwHF组与美沙拉嗪组之间的差异不显著(P = 0.503)。接受美沙拉嗪的患者发生的不良事件少于接受高剂量TwHF的患者(P = 0.029)和接受低剂量TwHF的患者(P = 0.048),但三组中因药物不良事件导致停药的情况无显著差异(P > 0.05)。此外,与低剂量TwHF和美沙拉嗪相比,作者还发现高剂量TwHF组在降低CDAI和SESCD方面具有显著优势(P < 0.05)。
每日2.0 mg/kg的TwHF耐受性良好,可延长CD患者的缓解期。