A Randomized Controlled，Double-Blind Study on Huaban Jiedu Formulation （化斑解毒方） in the Treatment of Psoriasis Vulgaris with Blood-Heat Syndrome
10.13288/j.11-2166/r.2025.16.010
- VernacularTitle:化斑解毒方治疗寻常型银屑病血热证的随机双盲对照研究
- Author:
Xuewen REN
1
;
Yutong DENG
2
;
Huishang FENG
3
;
Bo HU
2
;
Jianqing WANG
1
;
Zhan CHEN
1
;
Xiaodong LIU
4
;
Xinhui YU
5
;
Yuanwen LI
2
Author Information
1. Shanxi Province Hospital of Traditional Chinese Medicine，Taiyuan，030012
2. Dongfang Hospital，Beijing University of Chinese Medicine
3. Dongzhimen Hospital，Beijing University of Chinese Medicine
4. Jiangyin Tianjiang Pharmaceutical Co.，Ltd.
5. Shenshan Medical Center，Memorial Hospital of Sun Yat-sen University
- Publication Type:Journal Article
- Keywords:
psoriasis vulgaris;
blood-heat syndrome;
psoriasis area and severity index （PASI）;
quality of life;
Huaban Jiedu Formulation （化斑解毒方）
- From:
Journal of Traditional Chinese Medicine
2025;66(16):1679-1686
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the clinical efficacy and safety of Huaban Jiedu Formulation （化斑解毒方， HJF） in treating psoriasis vulgaris with blood-heat syndrome. MethodsA randomized， double-blind， placebo-controlled study was conducted with 60 patients diagnosed with psoriasis vulgaris of blood-heat syndrome. Patients were randomly assigned to either a treatment group or a control group， with 30 cases in each. The treatment group received HJF granules orally， one dose a day， combined with topical Qingshi Zhiyang Ointment （青石止痒软膏）， while the control group received placebo granules， one dose a day， combined with the same topical ointment. Both groups were topically treated twice daily of 28 days treatment cours. Psoriasis area and severity index （PASI）， visual analogue scale for pruritus （VAS）， traditional Chinese medicine （TCM） syndrome scores， dermatology life quality index （DLQI）， and psoriasis life stress inventory （PLSI） were assessed before treatment and on day 14 and day 28. Response rates for PASI 50 （≥50% reduction） and PASI 75 （≥75% reduction）， as well as overall clinical efficacy， were compared between groups. Serum levels of interleukin-6 （IL-6） and interleukin-17 （IL-17） were measured before and after 28 days of treatment. Adverse reactions during treatment were recorded. ResultsAfter 28 days of treatment， both groups showed significant reductions in PASI total score， lesion area score， erythema， scaling， and infiltration scores， pruritus VAS score， TCM syndrome score， DLQI， PLSI， and serum IL-6 and IL-17 levels （P＜0.05）. Compared to the control group， the treatment group had significantly greater improvements in PASI total score and erythema score， TCM syndrome score， serum IL-6 and IL-17 levels， and PASI 50 response rate after 28 days （P＜0.05）. Between-group comparisons of score differences before and after 28-day treatment revealed that the treatment group showed significantly better improvements in PASI total， lesion area score， erythema score， TCM syndrome score， DLQI， PLSI， and inflammatory markers （P＜0.05 or P＜0.01）. The total effective rate on day 14 and day 28 was 40.00% （12/30） and 83.33% （25/30） in the treatment group， versus 6.90% （2/29） and 41.38% （12/29） in the control group， respectively. The clinical efficacy in the treatment group was significantly superior to that in the control group （P＜0.05）. Mild gastric discomfort occurred in 3 patients in the treatment group and 1 in the control group. ConclusionHJF can effectively improve skin lesions and TCM symptoms relieve pruritus， enhance quality of life， and reduce inflammatory markers IL-6 and IL-17， in patients with blood-heat syndrome of psoriasis vulgaris， with a good safety profile.
