Efficacy, Safety and Immunomodulatory Effect of Intramuscular Injections of Autologous Whole Blood Into Acupoints in Patients With Atopic Dermatitis: A Randomized Controlled Trial

自体全血穴位肌注治疗特应性皮炎患者的疗效、安全性和免疫调节作用:一项随机对照试验

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Abstract

INTRODUCTION: The use of acupoint autohemotherapy (A-AHT) has shown promise in the management of atopic dermatitis (AD); however, the lack of rigorously controlled comparative studies presents a significant obstacle to the establishment of strong clinical evidence. AIM: We aimed to compare the safety and efficacy of A-AHT and subcutaneous Dupilumab injection in AD patients. PATIENTS AND METHODS: Thirty-one patients with moderate-to-severe AD were randomly allocated to receive 8 times of weekly intramuscular autologous whole blood (AWB) injection into bilateral Zusanli (ST36), Xuehai (SP10), Quchi (LI11) and Ashi points (n = 23) or subcutaneous Dupilumab injection with the dosage based on age/weigh (n = 8) for 8 weeks. Changes in SCORAD value, Visual Analog Scale (VAS) scores for pruritus and sleep quality, serum total IgE, cytokines including interleukin (IL)-2, IL-4, IL-6, IL-10, interferon (IFN)-γ, and tumor necrosis factor (TNF)-α levels were assessed at baseline and week 8. RESULTS: Both treatments resulted in a reduction of SCORAD values and serum IgE levels compared to their baseline (p < 0.001 or p < 0.05); however, no significant differences were observed between the two groups. When compared to the Dupilumab group, A-AHT exhibited greater effectiveness in improving the VAS scores for pruritus and sleep quality. Within the A-AHT group, there was a significant improvement in the serum levels of IL-2, IL-6, IL-10, TNF-α, and IFN-γ at week 8 compared to baseline (p < 0.05 or p < 0.01), whereas no changes were noted in the Dupilumab group. Serious adverse events were not observed. CONCLUSIONS: A-AHT appears to be effective in treating moderate-to-severe AD, warranting further studies to validate these results. TRAIL REGISTRATION: ChiCTR2300068163.

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