The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology (한방안이비인후피부과학회지)

The Society of Korean Medicine Ophthalmology, Otolaryngology & Dermatology (대한한방안이비인후피부과학회)
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A Clinical Study of Shi Ho Cheong Gan-San on Blood Heat Pattern Atopic Dermatitis: a randomized, double-blind clinical trial

혈열형 아토피피부염에 대한 시호청간산의 유효성과 안전성 연구

  • Choi, In-Hwa (Department of Oriental Dermatology, Kyung Hee University Kyung Hee Hospital at Gangdong) ;
  • Kim, Se-Hyun (Graduate School of East-West Medical, Kyung Hee University) ;
  • Kim, Young-Chul (Department of Internal Medicine, College of Oriental Medicine, Kyung Hee University) ;
  • Yun, Young-Hee (Department of Oriental Dermatology, Kyung Hee University Kyung Hee Hospital at Gangdong)
  • Received : 2011.03.02
  • Accepted : 2011.04.07
  • Published : 2011.04.25
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Abstract

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.

Keywords

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