Intravenous Lipo-PGE1 $(Eglandin^R)$ Therapy in Peripheral Vascular Diseases Secondary to Systemic Lupus Erythematosus and Systemic Sclerosis

전신성 홍반성 루푸스 및 전신성 경화증에 동반된 말초혈관 질환에 대한 Lipo-PGE1 $(Eglandin^R)$정주 요법

Background ; Prostaglandin El (PCE1), a potent vasodilator and an inhibitor of platelet aggregation, has been reported to be useful in the treatment of peripheral vascular diseases and severe Raynaud's phenomenon. Lipo-PCE1 which is a drug preparation of PCE1 incorporated in lipid microspheres has advantage for its longer action and smaller requirement dosage because of less inactivation in the lung than original PCE1. Methods : We evaluated the efficacy and safety of Lipo-PCE1 in the treatment of peripheral vascular diseases including ulcer, gangrene, and severe Raynaud's phenomenon in systemic lupus erythematosus (SLE) and systemic slcerosis (SSc). The study population included 25 patients mean age : $36.7{\pm}12.8$, F:M=23:2; SLE(13), systemic sclerosis(12)]. Intravenous lipo-PGE1$(10{\mu}g)$ was infused every day for 4 weeks. The assessment of efficacy was monitored by patient's subjective questionnaire, ulcer size and digital hemodynamics using finger systolic pressure. Results : The overall patient's assessment by subjective symtoms including coldness, numbness or rest pain were improved in 17 patients (68%), but not changed in 8 patients. The decreases of ulcer or gangrene size were noted in 21 patients, but 4 patients remained unchanged. There was a significant increase in the finger systolic pressure at 15 minutes following cold stimuli after the treatment (P<0.01). Significant adverse reactions were not found except pain on injected site(2), mild transaminase elevation(1) and fever(1). Conclusion : These data suggested that lipo-PGE1 is relatively safe and beneficial as well as convenient for administration in the treatment of peripheral vascular disease secondary to connective tissue diseases.

연구배경 : Lipo-PCE1은 기존의 PCE1제재를 지방입자에 포접시켜 치료의 효율성을 높인 약제로 폐에서 불활성화를 억제하고 투여량을 줄일 수 있는 잇점이 있어 개발된 약제 이다. 방법 : 수지 궤양 및 괴저와 같은 말초혈관질환을 동반한 25명의 전신성 홍반성 루푸스 및 전신성 경화증 환자를 대상으로 lipo-PGE1을 매일 $10{\mu}g$씩 4주간 주사하여 효과 및 부작용을 조사하였다. 결과 : 전체 환자중 68%에서 증상개선도를 보였고 84%에서 궤양 감소의 치료 효과를 보였다. 냉온 폭로후 15분에 수지 혈류압은 치료전에 비해 유의하게 상승하였다. 부작용은 매우 미미하였으며 주사부위의 혈관동통이 2예, 경미한 간효소치 상승 및 고열이 각각 1예에서만 관찰되었다. 결론: 이상의 결과로 lipo-PGE1제재는 기존 제재에 비해 투여가 간편하여 외래에서 손쉽게 주사할 수 있고, 적은 용량으로도 우수한 치료 효과를 나타내었고, 부작용도 경미하여 말초혈관질환이 합벽된 교원성 질환에서 유용한 치료약제로 여겨진다.