13-Cis-Retinoic Acid와 Tetracycline 경구투여에 의한 좌창치료에 대한 임상 비교 연구

Abstract

[한글]

좌창의 치료에는 지금까지 많은 방법들이 사용되어 왔으나 더욱 효과적인 치료 방법이 요구되어 이에 대한 임상연구는 끊임없이 진행되고 있다. 최근 vitamin A의 합성 유도체인 13-cis-reti-noic acid는 (13-cis-RA)는 여러가지 점에서 매우 각광을 받는 좌창치료

제로 알려지고 있는데 첫째, 종래의 여러 치료방법으로 잘 치유되지 않았던 심한 염증성 좌창인 낭포성 및 웅괴성좌촹에 경구투여한 결과 안전히 치유된 보고가 있었고( Peck등, 1979; Farrell등, 1980; Plewig등, 1982 ), 둘째, 치료 후 장기간의 추적 관찰 결과 다른

좌창치료법에 비해 재발의 빈도가 매우 낮아 계속적인 치유기간을 유지할 수 있으며 ( Peck등, 1979; Farrell등, 1980 : Goldstein등, 1982 ), 셋째, 현저한 피지 생산의 억제를 치료기간 동안과 치료후의 추적기간에서 관찰하였으며 (Gomez 및 Moskowitz, 1980: Jone

s등, 1980 : Strauss등, 1980: Goldstein등, 1982), 넷째, 무작위 이중맹검법 ( randomized double-blind test )에 의한 임상 연구 결과 이 약제의 효과는 placebo 반응이 아님을 밝혔다(Peck등, 1082).

이에 저자는 한국인 좌창환자 74명을 대상으로 13-cis-RA의 치료효과를 입증하기 위해 종래 좌창치료제로서 널리 알려진 바 있는 tetracycline 치료군을 대조군으로 하여 비교 관찰하였으며, 아울러 13-cis-RA의 부작용을 관찰하여 다음과 같은 결론을 얻었다.

1.개방성 및 폐쇄성면포, 구진, 농포를 합친 총 발진수는 tetracycline 투여군에 비해 13-cis-RA 투여군에서 더 좋은 효과가 있었으며 면포보다는 구진이나 농포에서 현저한 효과를 보였다.

2. 낭포와 결절은 tetracycline 투여군에서는 거의 효과가 없는 반면 13-cis-RA 투여군에서는 90% 이상의 감소율을 보여주어 현저한 효과를 나타내었다.

9. 13-cis-RA 투여군에서 나타난 부작용은 구수염등 전부가 피부 및 점막에 국한되었고 치료를 중단할 정도로 심하지는 않았으며 약물의 감량 혹은 중단시에는 단시일내에 소실되었다. 간기능검사 및 다른 검사상의 이상은 발견되지 않았다.

이상의 실험결과로 보아 13-cis-RA는 tetracycline보다 좌창에 대한 치료효과가 우수하였으며 특히 심한 염증성 병변에 효과가 있어 13-cis-RA는 낭포성 및 응괴성좌창의 치료 선택제로 생각된다.

COMPARATIVE STUDY OF CLINICAL EFFECT BY ORAL ADMINISTRATI0N OF 13-CIS-RETINOIC ACID

AND TETRACYCLINE IN ACNE

Kyung Hee Whang

Department of Medical Science, The Graduate School, Yonsei University

(Directed by Professor Sungnack Lee, M.D.)

A new oral synthetic retinoid, 13-cis-retinoic acid (isotretinoin, Ro 4-3780), is

currently being studied for effectiveness and safety in the treatment of acne

diseases, expecially, severe cystic and conglobate acne. In the present study, we

reported the clinical effectiveness and side effects of 13-cis-retinoic acid

comparing to tetracycline in the treatment of acne.

Seventy-four patients with acne were assigned randomly to one of two teated

groups and were treated for 12 weeks with either tetracycline ( A group ) or

13-cis-retinoic acid (B group ). A maintenance dosage of 250-500 mg/day of

tetracycline was used for A group and 30-60 mg/day of 13-cis-retinoic acid for B

group. The number of closed and open comedones, papules and pustules were counted

biweekly at the 3 specific site on the face, neck, or trunk. But all nodules and

cysts won counted at each visit.

The results are summarized as follows :

1. 13-cis-retinoic acid significantly reduced total numbers of lesions including

open and closed comedone, papule and pustule counts compared to tetracycline.

13-cis-retinoic acid-treated patients was found to be more effective in reducing

the number of papules or pustules than comedones.

2. After 12 weeks of therapy, 13-cis-retinoic acid-treated patients had a 90%

decrease in the number of cysts or nodules vs only as light effect with

tetracycline .

3. Any side effects observed during oral 13-cis-retinoic acid treatment are not

so severe as to discontinue the treatment .The complications are usually limited to

the skin and mucous membranes. All the side effects disappeared entirely following

the cessation or reduction of drug administration.

In our study, no laboratory abnormalities were detect in any patient during the

course of treatment.

From these data, we may concluded that 13-cis-retinoic acid appear to be an very

effective treatment for patients with moderate or severe acne and we suggest that

it is new possible to begin to formulate schemes of management.

[영문]

A new oral synthetic retinoid, 13-cis-retinoic acid (isotretinoin, Ro 4-3780), is currently being studied for effectiveness and safety in the treatment of acne diseases, expecially, severe cystic and conglobate acne. In the present study, we reported the clinical effectiveness and side effects of 13-cis-retinoic acid comparing to tetracycline in the treatment of acne.

Seventy-four patients with acne were assigned randomly to one of two teated groups and were treated for 12 weeks with either tetracycline ( A group ) or 13-cis-retinoic acid (B group ). A maintenance dosage of 250-500 mg/day of tetracycline was used for A group and 30-60 mg/day of 13-cis-retinoic acid for B group. The number of closed and open comedones, papules and pustules were counted biweekly at the 3 specific site on the face, neck, or trunk. But all nodules and cysts won counted at each visit.

The results are summarized as follows :

1. 13-cis-retinoic acid significantly reduced total numbers of lesions including open and closed comedone, papule and pustule counts compared to tetracycline.

13-cis-retinoic acid-treated patients was found to be more effective in reducing the number of papules or pustules than comedones.

2. After 12 weeks of therapy, 13-cis-retinoic acid-treated patients had a 90% decrease in the number of cysts or nodules vs only as light effect with tetracycline .

3. Any side effects observed during oral 13-cis-retinoic acid treatment are not so severe as to discontinue the treatment .The complications are usually limited to the skin and mucous membranes. All the side effects disappeared entirely following

the cessation or reduction of drug administration.

In our study, no laboratory abnormalities were detect in any patient during the course of treatment.

From these data, we may concluded that 13-cis-retinoic acid appear to be an very effective treatment for patients with moderate or severe acne and we suggest that it is new possible to begin to formulate schemes of management.