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特应性皮炎青少年和成年患者肌内注射自体血清:一项初步的随机临床试验。

Intramuscular Injection of Autologous Serum in Adolescent and Adult Patients with Atopic Dermatitis: A Preliminary Randomized Clinical Trial.

机构信息

Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.

Office of Biostatistics, Medical Research Collaborating Center, Ajou Research Institute for Innovative Medicine, Ajou University Medical Center, Suwon, Korea.

出版信息

Yonsei Med J. 2023 Jul;64(7):423-432. doi: 10.3349/ymj.2022.0559.

Abstract

PURPOSE

The favorable clinical efficacies of intramuscular injection of autologous blood in patients with atopic dermatitis (AD) and intramuscular injection of autologous serum in patients with chronic urticaria have been demonstrated by randomized clinical trials. In this study, we assessed the clinical effectiveness and safety of the intramuscular injection of autologous serum in patients with AD.

MATERIALS AND METHODS

In this randomized, placebo-controlled, and double-blind trial, 23 adolescent and adult patients with moderate-to-severe AD were enrolled. The patients were randomized to receive eight intramuscular injections of 5 mL of autologous serum (n=11) or saline (n=12) over 4 weeks, and were followed up until week 8. Changes in the clinical severity scores of AD assessed by SCORing Atopic Dermatitis (SCORAD), patient-reported Dermatology Life Quality Index (DLQI) score, and incidence of adverse events were assessed from baseline to week 8.

RESULTS

One patient in the treatment group and two patients in the placebo group were lost to follow-up before week 8. The intramuscular administration of autologous serum, compared with saline, decreased the SCORAD clinical severity score (-14.8% vs. 10.7%, =0.006) and improved the DLQI score (-32.6% vs. 19.5%, =0.01) from baseline to week 8. Serious adverse events were not observed.

CONCLUSION

Intramuscular injection of autologous serum may be effective in treating AD. Further studies are needed to evaluate the clinical usefulness of this intervention for AD (KCT0001969).

摘要

目的

随机临床试验已经证明,肌内注射自体血治疗特应性皮炎(AD)和肌内注射自体血清治疗慢性荨麻疹具有良好的临床疗效。在这项研究中,我们评估了肌内注射自体血清治疗 AD 的临床疗效和安全性。

材料和方法

在这项随机、安慰剂对照、双盲试验中,纳入了 23 名中重度 AD 的青少年和成年患者。患者被随机分为接受 8 次肌内注射 5 毫升自体血清(n=11)或生理盐水(n=12),共 4 周,并随访至第 8 周。从基线到第 8 周,评估 AD 的临床严重程度评分(SCORing Atopic Dermatitis,SCORAD)、患者报告的皮肤病生活质量指数(Dermatology Life Quality Index,DLQI)评分以及不良反应的发生率变化。

结果

治疗组中有 1 名患者和安慰剂组中有 2 名患者在第 8 周前失访。与生理盐水相比,肌内注射自体血清从基线到第 8 周降低了 SCORAD 临床严重程度评分(-14.8% vs. 10.7%,=0.006)和改善了 DLQI 评分(-32.6% vs. 19.5%,=0.01)。未观察到严重不良事件。

结论

肌内注射自体血清可能对 AD 有效。需要进一步的研究来评估这种干预措施对 AD 的临床实用性(KCT0001969)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d199/10307681/37d38595d19c/ymj-64-423-g001.jpg

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