Yao Dan-Ni, Lu Chuan-Jian, Wen Ze-Huai, Yan Yu-Hong, Lu Li-Ming, Wu Hui-Mei, He Zi-Yang, Deng Hao, Deng Jing-Wen
Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China; Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.
Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China; Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China; Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou, China; State Key Laboratory of Dampness Syndrome of Chinese Medicine; Guangdong-Hong Kong-Macau Joint Lab on Chinese Medicine and Immune Disease Research.
Ann Palliat Med. 2021 Feb;10(2):2036-2047. doi: 10.21037/apm-20-2575. Epub 2021 Feb 3.
To compare the efficacy and safety of PSORI-CM01 granules with Yinxieling tablets in patients with chronic plaque psoriasis (CPP), we plan to conduct a multicentre, randomized, double-blinded, double-dummy, controlled trial. This pilot study was conducted to determine the feasibility and the potential of the protocol for the full-scale randomized controlled trial (RCT).
This pilot study was conducted in three centers, and compared PSORI-CM01 granules with Yinxieling tablets in patients with CPP during a 12-week treatment and 3-month follow-up period. The primary efficacy endpoint was the decrease of the psoriasis area severity index (PASI) at week 12. The secondary outcome measures included reduction rates of PASI, pruritus scores on the Visual Analogue Scale (VAS), body surface area (BSA), and the Dermatology Life Quality Index (DLQI). Safety was assessed via the incidence of adverse events (AEs) in each treatment group.
A total of 211 patients were screened, and 63 subjects who met the inclusion criteria were randomised to PSORI-CM01 granule group (N=31) or Yinxieling tablets group (N=32) while 39 subjects finished the study. The primary outcome measure showed a mean decrease of PASI of 2.03 in the PSORICM01 group compared to 0.89 in the Yinxieling group at week 12. Except for the VAS score (t=-2.261, P=0.027), the secondary outcomes showed no significant improvement from baseline in both groups at week 12. No safety or tolerability concerns related to the drugs were observed in either group.
This pilot study showed that the RCT is feasible for randomization, patient recruitment, and assessment. Major strategies are necessary to reduce the patient dropout rate before conducting the full RCT. In this pilot study, the PSORI-CM01 granule exhibited greater potential for development compared to its original formula (Yinxieling tablets) for the treatment of CPP.
为比较银屑病中药复方颗粒剂（PSORI-CM01）与银屑灵片治疗慢性斑块状银屑病（CPP）的疗效和安全性，我们计划开展一项多中心、随机、双盲、双模拟、对照试验。本预试验旨在确定该方案用于大规模随机对照试验（RCT）的可行性和潜力。
本预试验在三个中心开展，比较了PSORI-CM01颗粒剂与银屑灵片治疗CPP患者12周及随访3个月的疗效。主要疗效终点为第12周时银屑病面积和严重程度指数（PASI）的降低。次要结局指标包括PASI降低率、视觉模拟量表（VAS）瘙痒评分、体表面积（BSA）及皮肤病生活质量指数（DLQI）。通过各治疗组不良事件（AE）发生率评估安全性。
共筛选211例患者，63例符合纳入标准的受试者被随机分为PSORI-CM01颗粒剂组（N = 31）或银屑灵片组（N = 32），39例受试者完成研究。主要结局指标显示，第12周时PSORI-CM01组PASI平均降低2.03，银屑灵组为0.89。除VAS评分（t = -2.261，P = 0.027）外，两组次要结局指标在第12周时与基线相比均无显著改善。两组均未观察到与药物相关的安全性或耐受性问题。
本预试验表明，该RCT在随机分组、患者招募和评估方面是可行的。在开展全面RCT之前，需要采取主要策略降低患者脱落率。在本预试验中，与原方（银屑灵片）相比，PSORI-CM01颗粒剂治疗CPP显示出更大的开发潜力。
