[논문]혈열형 아토피피부염에 대한 시호청간산의 유효성과 안전성 연구

최인화; 김세현; 김영철; 윤영희

doi:10.6114/jkood.2011.24.1.096

혈열형 아토피피부염에 대한 시호청간산의 유효성과 안전성 연구
A Clinical Study of Shi Ho Cheong Gan-San on Blood Heat Pattern Atopic Dermatitis: a randomized, double-blind clinical trial 원문보기

韓方眼耳鼻咽喉皮膚科學會誌 = The journal of Korean Medicine Ophthalmology & Otolaryngology & Dermatology, v.24 no.1, 2011년, pp.96 - 110

최인화 (Department of Oriental Dermatology, Kyung Hee University Kyung Hee Hospital at Gangdong) , 김세현 (Graduate School of East-West Medical, Kyung Hee University) , 김영철 (Department of Internal Medicine, College of Oriental Medicine, Kyung Hee University) , 윤영희 (Department of Oriental Dermatology, Kyung Hee University Kyung Hee Hospital at Gangdong)

초록
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목적 : 본 임상시험을 통하여 혈열(血熱)형으로 변증된 아토피피부염의 한약 치료 후 임상 효능과 안전성을 관찰함으로써 아토피피부염에 대한 한약치료의 유용성을 평가하고자 한다. 방법 : 본 임상시험은 무작위배정, 이중맹검, 양성대조군, 평행 설계로 진행되었다. 자의에 의해 임상시험 동의서에 서명한 대상자 중 선정기준 및 제외기준에 부합된 36명의 대상자들에게 시험약과 양성대조약 과립제를 1일 3회(5.0g* 3회/ 1일) 4주간 복용하도록 하였다. 36명 중 31명의 환자가 4주간의 치료를 종료하였다(시호청간산 복용군: n = 16, 소풍산 복용군: n =15). 아토피피부염 증상을 평가하기 위해 Scoring atopic dermatitis (SCORAD) index와 Eczemaarea and severity index (EASI) 를 사용하여 시험 시작 전과 4주 후 시험 종료일에 환자들의 피부소견을 평가하였다. 아토피 피부염에 대한 한약치료의 안정성을 평가하기 위하여 치료 전후 혈중 AST, ALT, BUN, creatinine 변화를 검토하여 한약치료의 간/신독성 여부에 대해 조사하였다. 결과 및 결론: 두 군 모두에서 유의하게 SCORAD 점수와 EASI 점수가 감소하였으나 두 군 간의 차이는 유의하지 않았다. 부종/구진, 찰상 항목의 점수에는 두 군 간에 유의한 차이가 관찰되었다. 31명의 환자에게서 한약 치료 후 간장과 신장에 미치는 독성이 발견되지 않았으며 한약투여와 관련된 이상반응은 보고되지 않았다. 위의 결과로부터 시호청간산과 소풍산이 혈열형 아토피피부염에 대한 효과적이고 안전한 치료 방법이 될 수 있을 것으로 생각된다.

주제어

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문제 정의

studied change of external dermal formation, change of leukocytes in vasculature, change of lipid formation in strarum corneum and distribution of ceramide through administering SHCG extract after forcing injury to mice’s back skin. This study shows that SHCG has effect on suppressing the dermal injury through the recovery of lipid protection formation in stratum corneum¹⁹⁾.

제안 방법

1. Outcome: The patients were clinically examined at the beginning of the study, then regularly after 1 week, 2 weeks, and 4 weeks, which marked the end of the study. The evaluation of the efficacy was carried out using three methods.
1. This study examined different combinations of medicine to treat AD but excluded all anti-histamine, steroid, and immune suppressant treatment. After counseling we allowed patients to use emollients, lotions and ointment that did not contain steroids.
2. Patients had blood tests [AST, ALT, BUN, and Creatinine] taken at the beginning of the study and then after 4 weeks. Also their serum total IgE and CBC, D/C were evaluated at the baseline.
3. Safety evaluation The safety of this study was assessed using adverse event reporting throughout this study and with laboratory tests (e.g. AST, ALT. BUN, and Creatinine) at the first and final visits. Also, physical examinations were taken at the beginning of the study, after 1 week, 2 weeks, and 4 weeks.
We prepared SHCG and SP using packages of the same color and size. All participants were given the same identical-looking dose of either 5.0g SHCG, or a dose of 5.0g SP that looked the same and was dispensed in an identical package. The patients did not know which kind of herb-medicine -SHCG, or SP– they had taken.
All patients experiencing adverse events, for example: nausea, vomiting, stomach discomfort, fever, and/or diarrhea, were monitored by clinical examination. Any adverse events were considered as possibly or probably related to the sensitization and the severity of the symptoms.
BUN, and Creatinine) at the first and final visits. Also, physical examinations were taken at the beginning of the study, after 1 week, 2 weeks, and 4 weeks.
Randomization: Randomization was performed using computer-generated random number tables. In order to maintain the randomization, the random number tables and the intervention allocations were exposed after analyzing this study.
investigated the effect of SP on mast cell-mediated anaphylactic reactions and cytokine production in in vivo and in vitro murine models. In this study, SP inhibited the degranulation and histamine release from the rat peritoneal mast cells. SP also showed an inhibitory effect on passive cutaneous anaphylaxis reaction¹⁷⁾.
The comparison the between two groups, and any changes comparison between the baseline and after 4 weeks were performed using the student t-Test except for the SCORAD score. For the SCORAD index, we used an Analysis of Covariance (ANCOVA) after adjusting for the baseline because the SCORAD index of the two groups at the baseline was significantly different based on our analysis using the student t test.
We carried out a parallel group, randomized, active placebo controlled, double-blind trial to assess the efficacy and safety of SHCG compared to SP for the blood-heat pattern atopic dermatitis.

데이터처리

For a categorical variation, we used Fisher’s exact test (version 9.1; SAS Institute, NC, USA).
For the SCORAD index, we used an Analysis of Covariance (ANCOVA) after adjusting for the baseline because the SCORAD index of the two groups at the baseline was significantly different based on our analysis using the student t test.

성능/효과

In conclusion, although we were looking toward the SHCG group showing more effective results than the SP group in bloodheat pattern AD, there was no significant difference. However, both groups of patients showed some improvement in their symptoms and signs without any adverse events, or any hepatic and renal toxicity.

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