Efficacy and Safety of Cold Atmospheric Plasma-Assisted Therapy for Herpes Zoster: A Randomized, Parallel, Positive-Controlled, Non-inferiority Multicenter Clinical Trial

冷大气等离子体辅助疗法治疗带状疱疹的疗效和安全性:一项随机、平行、阳性对照、非劣效性多中心临床试验

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Abstract

INTRODUCTION: There is growing evidence that cold atmospheric plasma (CAP) can boost skin wound healing and inhibit various viruses. Here, we evaluated the effectiveness and safety of CAP as an adjunct treatment for herpes zoster (HZ). We hypothesized that CAP was similar to or better than the helium-neon (He-Ne) laser in promoting HZ wound and pain recovery. METHODS: We recruited 187 patients with acute HZ who received either CAP once per day for at least 2 min per treatment area or He-Ne laser therapy once per day for 20 min per session, in addition to a standard treatment regime. The primary endpoint was the efficacy rate, defined as the percentage of patients in each group whose treated area exhibited drying of blisters in ≥ 50% of the area after the final treatment. Secondary evaluation indicators included treatment duration (in days), onset time of scabbing, scab rate, visual analog scale pain scores, and quality of life scores. RESULTS: Efficacy rates after the last treatment were not significantly different between the CAP and He-Ne laser groups (at 3 ± 1 and 10 ± 2 days after the last treatment, respectively, p > 0.05). Treatment duration, scab formation onset time, and complete scab formation time were shorter in the CAP group than in the He-Ne laser group. No severe adverse events or reactions occurred in the CAP group. CONCLUSION: CAP is an effective and safe therapeutic option for HZ. TRIAL REGISTRATION: This study has been registered at www.chictr.org.cn (ChiCTR2300069993). A graphical abstract is available for this article.

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