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Chinese Medical Journal ; (24): 2905-2909, 2020.
Article in English | WPRIM | ID: wpr-877912


BACKGROUND@#Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis.@*METHODS@#We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12.@*RESULTS@#The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported.@*CONCLUSION@#During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis.@*TRIAL REGISTRATION@#Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259;

Double-Blind Method , Follow-Up Studies , Humans , Ointments , Psoriasis/drug therapy , Resorcinols , Severity of Illness Index , Stilbenes , Treatment Outcome
Article in Chinese | WPRIM | ID: wpr-776237


OBJECTIVE@#To compared the therapeutic effect between filiform fire needle assisted 308 nm excimer laser and simple 308 nm excimer laser on vitiligo of different parts.@*METHODS@#Target lesions of 134 patients were divided into an observation group and a control group according to the principle of self-controlled, 201 pieces in each one. In the observation group, filiform fire needle was performed at target lesions. Then target lesions both of the two groups were irradiated with 308 nm excimer laser at the same time. Once every 2 weeks, totally 10 treatments were required. The effective rate and effective rate, color recovery rate and responding time of different parts in the two groups were evaluated 2 weeks after treatment.@*RESULTS@#The effective rate in the observation group was 82.59% (166/201), which was higher than 68.16% (137/201) in the control group (<0.01). The effective rate of face-neck, trunk, limbs and hand-foot were 90.32%, 81.63%, 81.48% and 58.62% respectively in the observation group, which were higher than 82.80%, 69.39%, 51.85% and 31.03% in the control group (<0.01, <0.05). The color recovery rate of different parts in the observation group was higher than the control group, and the effect was faster in the observation group (<0.01, <0.05).@*CONCLUSION@#Filiform fire needle as an adjunctive therapy, combined with 308 nm excimer laser are more effective than simple 308 nm excimer laser for vitiligo of different parts. Combination therapy has a shorter responding time, the face-neck has the best effect and hand-foot has poor effect.

Combined Modality Therapy , Humans , Lasers, Excimer , Neck , Treatment Outcome , Vitiligo , Therapeutics
Chinese Medical Journal ; (24): 1845-1851, 2012.
Article in English | WPRIM | ID: wpr-283707


<p><b>BACKGROUND</b>Tumor necrosis factor-α is a key mediator in the pathogenesis of psoriasis. Infliximab is a monoclonal antibody that specifically binds to tumor necrosis factor-α. The purpose of this study was to validate the efficacy and safety of 5 mg/kg infliximab therapy in Chinese patients with moderate to severe plaque psoriasis.</p><p><b>METHODS</b>In this multicenter, double-blind, placebo-controlled trial, 129 patients with moderate-to-severe psoriasis were randomized to the induction therapy (weeks 0, 2 and 6) with infliximab 5 mg/kg (n = 84) or placebo (n = 45), followed with infliximab 5 mg/kg scheduled at week 14 and week 22 in the infliximab group, and infliximab 5 mg/kg scheduled at weeks 10, 12 and 16 in the placebo group. The primary end point was the proportion of patients who achieved at least 75% improvement in Psoriasis Area and Severity Index (PASI 75 response rate) from baseline at week 10.</p><p><b>RESULTS</b>At week 10, 81.0% of patients treated with infliximab (5 mg/kg) achieved a 75% or greater improvement compared with 2.2% of patients treated with placebo (P < 0.001). A significant improvement in PASI, Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI), was seen from week 6 through week 14 in the infliximab group compared with the placebo group. Through week 22, PASI, PGA, DLQI were well maintained. The incidence of adverse events for the infliximab treatment group was slightly higher in comparison to the placebo treatment group during the first 10 weeks without statistical significance. However, there were 3 cases of tuberculosis that developed during the 26 weeks treatment with infliximal.</p><p><b>CONCLUSIONS</b>Infliximab treatment was effective as induction and maintenance treatments for Chinese patients with moderate to severe plaque psoriasis. Most drug-induced adverse events were mild to moderate, and well tolerated. Screening for tuberculosis is essential and prophylactic treatment should be given if necessary.</p>

Adolescent , Adult , Aged , Anti-Inflammatory Agents, Non-Steroidal , Therapeutic Uses , Antibodies, Monoclonal , Asians , Double-Blind Method , Female , Humans , Infliximab , Male , Middle Aged , Psoriasis , Drug Therapy , Young Adult
Article in Chinese | WPRIM | ID: wpr-674189


Objective To detect the mutations of ATP2C1 gene in patients with Hailey-Hailey dis- ease (HHD).Methods PCR and direct sequencing were performed in 17 patients and 120 healthy controls to screen the mutations in the exons of ATP2C1 gene.Results Eight mutations were identified in nine probands, including three deletion mutations (nt1464-1487 del/nt1462-1485del,1523delAT,2375delTTGT),three splice site mutations (360—2A→G,1415—2A→T,2243+2T→C) and two missence mutations (C920T and G1942T).None of the above mutations was found in the controls.Conclusion Eight specific novel mutations were identified in nine probands of HHD,which could be causative factors of the disease.