利妥昔单抗联合糖皮质激素治疗天疱疮临床疗效和安全性评价

Clinical Efficacy and Safety Evaluation of Rituximab Combined with Corticosteroids in the Treatment of Pemphigus

目的评价利妥昔单抗(RTX)联合糖皮质激素(CS)治疗天疱疮的近期疗效和安全性。方法开展前瞻性研究,纳入2020年10月-2021年11月在昆明医科大学第一附属医院及大理大学附属医院就诊的37例天疱疮患者,试验组(n=18)采用利妥昔单抗联合糖皮质激素治疗,对照组(n=19)予以单独糖皮质激素或糖皮质激素联合环孢素(CsA)治疗。观察和比较治疗24周后的完全缓解率、人均累积糖皮质激素剂量、不良反应、抗体值变化等。结果24周后试验组完全缓解率(50.00%)高于对照组(10.53%)(P<0.05),人均累积糖皮质激素剂量低(P<0.05),糖皮质激素相关不良反应少。感染为本次研究中最常见不良反应,利妥昔单抗联合糖皮质激素组共发生5例次(27.78%),对照组发生9例次(47.37%);试验组2例利妥昔单抗治疗后皮损加重,合并多形红斑、松弛性大疱、表皮松解坏死,考虑并发药疹。基线时两组抗Dsg1、Dsg3抗体值差异无统计学意义(P>0.05),24周后试验组的抗Dsg1、Dsg3抗体值较对照组低(P<0.05)。结论利妥昔单抗联合糖皮质激素治疗天疱疮能够提高治疗24周后的完全缓解率,减少患者糖皮质激素用药量,同时减少大剂量糖皮质激素和免疫抑制剂相关不良反应,但应谨防感染和相关药疹的发生。

Objective To evaluate the short-term efficacy and safety of rituximab(RTX) combined with corticosteroids(CS) in the treatment of pemphigus.Methods A prospective study was conducted, including 37 patients with pemphigus who were treated in the first Affiliated Hospital of Kunming Medical University and the Affiliated Hospital of Dali University from October 2020 to November 2021.The experimental group(n=18) were treated with RTX combined with CS.The control group(n=19) was treated with CS alone or CS combined cyclosporin A(CsA).Complete response(CR) rate, per capita cumulative CS dose, adverse reactions, antibody level were observed and compared before and after 24 weeks of treatment.Results After 24 weeks, the complete response rate of experimental group(50.00%) was higher than that of control group(10.53%)(P<0.05), the cumulative dose of CS per capita was lower(P<0.05), and CS-related adverse reactions were less.Infection was the most common adverse reaction in this study, with 5 cases(27.78%) in RTX combined with CS group and 9 cases(47.37%) in control group.In the experimental group, 2 cases of skin lesions were aggravated after RTX treatment, complicated with erythema multiforme, flabby bullae and epidermal necrolysis, and drug eruption was considered.At baseline, the anti-Dsg1 and anti-Dsg3 antibody values of the two groups had no significant difference(P> 0.05), but after 24 weeks, the anti-Dsg1 and anti-Dsg3 antibody values of the experimental group were lower than those of the control group(P<0.05).Conclusion RTX combined with CS in the treatment of pemphigus can improve the complete response rate after 24 weeks of treatment, reduce the dosage of CS, and reduce the adverse reactions associated with high-dose glucocorticoid and immunosuppressant. However, infection and related drug eruption should be noticed.