背景:掌plant脓疱病(PPP),一个慢性的,复发性脓疱性皮肤病与红斑相关,scales,手掌和脚底上的无菌脓疱,是皮肤科诊所经常遇到的。PPP是牛皮癣的变体还是独特的疾病仍在争论中。尽管生物制剂已成功用于治疗中度至重度银屑病,关于PPP的现有文献仅限于病例报告或小病例系列。缺乏有据可查的临床研究使得很难为这种情况选择理想的治疗方法。这篇综述旨在基于随机对照试验讨论生物制剂在PPP治疗中的有效性和安全性,以期激发皮肤科临床医生提出新的治疗方法。
目的:本综述旨在获得高水平的证据,以评估生物制剂在治疗PPP患者中的有效性和安全性。
方法:我们搜索了PubMed,Embase,和截至2023年5月18日的Cochrane数据库,用于高质量的随机对照试验,这些试验报告了在年龄>18岁的患者中,使用生物制剂进行PPP治疗后至少发生了一次不良事件。采用RevMan5.3软件进行Meta分析。
结果:分析中纳入了9项涉及799名参与者的试验。我们使用ppPASI75作为主要疗效指标。在第16周和第12周,抗IL-23和抗IL-17A药物的治疗效果分别比安慰剂好4.14倍和1.95倍(P值=0.009,RR=4.14,95%置信区间[CI;1.43-11.98];P值=0.02,RR=1.95,95%CI[1.11-3.42])。此外,抗IL-23药物在100毫克的剂量比200毫克更有效,这表明100毫克可能是抗IL-23药物的最佳剂量。接下来,我们调查了用于PPP治疗的生物制剂的安全性。生物制剂的总不良事件(AE)发生率是对照组的1.25倍,表明安全性良好(RR=1.25,P值<0.00001,95%CI[1.13,1.37])。此外,我们将常见的不良事件分为16类,发现抗IL-23药物更有可能诱发感染.总之,我们在综合比较中评估了安全性和有效性,发现抗IL-23药物具有良好的临床疗效,不良事件发生率低,建议谨慎使用.
结论:只有少数相关,高品质,本研究纳入了随机对照试验.
结论:这项研究表明,生物制剂可用于治疗PPP患者,具有良好的疗效;然而,不能忽视AE。多中心,需要大样本量的高质量临床研究来进一步评估生物制剂在PPP治疗中的效果和安全性.
BACKGROUND: Palmoplantar pustulosis (PPP), a chronic, recurrent pustular dermatosis associated with erythema, scales, and sterile pustules on the palms and soles, is commonly encountered in dermatology clinics. Whether PPP is a variant of psoriasis or a distinct condition is still debated. Although biological agents have been successfully used to treat moderate-to-severe psoriasis, existing literature on PPP is limited to case reports or small case series. The lack of well-documented clinical studies makes it difficult to select the ideal treatment for this condition. This
review aims to discuss the efficacy and safety of biological agents in PPP treatment based on randomized controlled trials with the hope of inspiring dermatologist clinicians to propose new therapeutic approaches.
OBJECTIVE: This
review aims to obtain high-level evidence to assess the efficacy and safety of biological agents in the treatment of patients with PPP.
METHODS: We searched the PubMed, Embase, and Cochrane databases up to May 18, 2023, for high-quality randomized controlled trials that reported at least one adverse event after PPP treatment with biological agents in patients > 18 years of age. RevMan 5.3 software was used for the meta-analysis.
RESULTS: Nine trials involving 799 participants were included in the analysis. We used ppPASI 75 as the primary efficacy measure. Anti-IL-23 and anti-IL-17A agents afforded 4.14-fold and 1.95-fold better outcomes than placebo treatment at weeks 16 and 12, respectively (P-value = 0.009, RR = 4.14, 95% confidence interval [CI; 1.43-11.98]; P-value = 0.02, RR = 1.95, 95% CI [1.11-3.42]). Moreover, anti-IL-23 agents at a dose of 100 mg were more effective than at 200 mg, indicating that 100 mg may be the best dose for anti-IL-23 agents. Next, we investigated the safety of biological agents for PPP treatment. The incidence of total adverse events (AEs) was 1.25 times higher for biological agents than for controls, indicating a good safety profile (RR = 1.25, P-value < 0.00001, 95% CI [1.13, 1.37]). Additionally, we divided the common AEs into 16 categories and found that anti-IL-23 agents were more likely to induce infections. In conclusion, we evaluated safety and efficacy in a comprehensive comparison and found that anti-IL-23 agents conferred good clinical efficacy with a low incidence of AEs and could be recommended with caution.
CONCLUSIONS: Only a few relevant, high-quality, randomized controlled trials were included in the study.
CONCLUSIONS: This study showed that biological agents can be used to treat patients with PPP with good efficacy; however, AEs cannot be ignored. Multi-center, high-quality clinical studies with large sample sizes are needed to further evaluate the effects and safety of biological agents in PPP treatment.