All procedures performed in studies involving human participants were implemented in accordance with the ethical standards of the Second Hospital of Jilin University research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. A total of 48 patients with PPP were recruited from the Department of Dermatology of the Second Hospital of Jilin University between June 2017 and March 2018. There were 8 males and 40 females, with a mean age of 49.8 years (range 18–79 years). The mean course of the disease was 2 years (range 15–20 years). 24 patients were smokers. The inclusion criteria were as follows: (1) patients were 18 years or older; (2) patients were diagnosed with PPP; (3) informed consent was obtained before inclusion in the study. The exclusion criteria were as follows: (1) uncontrollable hypertension; (2) severe renal dysfunction; (3) severe infectious diseases; (4) a history of malignant tumors; (5) current malignant tumors (excluding basal cell carcinoma); (6) patients were receiving PUVA treatment; (7) patients received simultaneous active vaccine immunization.
Cyclosporine Treatment and Evaluation of Therapeutic Efficacy
The patients were treated with oral cyclosporine at 3 mg/kg/day, twice daily. At the same time, moisturizer (WINONA’s Hyaluronic Acid Repair Biomask) was applied externally. Treatment lasted for 8 weeks, and the skin lesions were photographed before treatment and after 8 weeks of treatment. The symptoms and signs (pustules, erythema, scars, and lesion area) were scored using the Palmoplantar Pustulosis Area and Severity Index (PPPASI) score system (Table 1) [2, 3]. Before treatment, the PPPASI score was 0.6–47.4 (average 12.8). The reduction in the total score after 8 weeks of treatment was used to evaluate the therapeutic efficacy . The therapeutic efficacy was classified as complete remission (reduction ≥ 90%), remission (60–89%), improvement (20–59%), or treatment ineffectiveness (< 20%). The complete remission rate was calculated as (number of patients in complete remission/total number of patients) × 100%, and the overall l effectiveness was evaluated as the complete remission rate plus the remission rate.
All the patients were tested for liver and kidney function, underwent full blood count and urine tests, and had their serum electrolytes, lipids, glucose, and blood pressure monitored before and during treatment (at 4, 8, 12, and 16 weeks) to assess treatment safety. During the treatment, the patients were asked to report adverse effects [blood pressure, kidney dysfunction, gastrointestinal reactions (anorexia, nausea, and vomiting), gingival hyperplasia with bleeding and pain].
Detection of Serum IL-17, IL-23, and TNF-α Concentrations
In the present study, ELISA was employed to detect the serum concentrations of IL-17, IL-23, and TNF-α before and after cyclosporine treatment. Data are expressed as the mean ± standard deviation (mean ± SD) and the t test was used for comparisons between groups. P < 0.05 was considered to indicate statistical significance. The blood was collected from 4 patients in complete remission, 12 in remission, and 8 with improvement.
Statistical analysis was performed with SPSS version 21 (Oracle Co., USA). Data are expressed as the mean ± standard deviation (mean ± SD) and the t test was used for comparisons between groups. P < 0.05 was considered to indicate statistical significance.