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KMID : 0371319930440060938
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Journal of the Korean Surgical Society
1993 Volume.44 No. 6 p.938 ~ p.953
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Clinical Xperience with Opalmon(OP-1206-a-CD, Oral Prostaglandin E1 Preparation) in Buerger's Disease of Lower Extremities
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Abstract
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Most of Buerger's disease is not amenable to reconstructive arterial surgery and many conservative therapies are introduced. If these measures fail to provide adenquate relief, a major amputation will be required to escape from the intractable
rest
pain.
It has been noted that prostaglandin E1(PGE1) has a prominent vasedilating activity as well as an inhibitory effect on platelet aggregation and PGE1 is used widely as a conservative therapy for the patients with chronic arterial occlusive disease
surch
as Berger's disease.
However, PGE1 is administered parenterally by arterial or venous route and can not be used by route because it is inactivated by 15-OH-prostaglandin dehydrogenase in G-I tract.
Recently oral PGE1 derivative, Opalmon(OP-1206-αCD), is developed, and it has been known that it is hardly inactivated in G-I tract and selectively dilates blood vessels and inhibits platelet aggregation like PGE1.
The authors obtained Opalmon(OP-1206-α-CD) from Ono Pharmaceutical Co(Japan) and applied to 30 patients of Buerger's disease of lower extremities.
They had disabled claudications or rest pain with ischemic ulcers or gangrenes.
Ulcers or gangrenes on distal limbs were measured by ruler and color photographs were taken once a week.
Arteriograms were performed in all patients before Opalmon administration.
Opalmon 10㎍ was administered orally 3 times after each meal(30㎍/day) every day for 6 weeks.
All patients were followed up for 2 months~6 months.
@ES The observed results were as follows:
@EN 1) Fontaine classifications before Opalmon treatment were stage II; 12 patients, Stage III; 2 patients and Stage IV; 16 patients. Fontaine classification after Opalmon treatment were stage I; 17 patients, stage II; 7 patients, stage III; 1
patients
and stage IV; 5 patients.
2) Beneficial effect of Opalmon was significant in patients whose arteriogram showed good distal collateral development.
3) Improvement rate was more prominent in patients who had the hisotry of PGE1 infusion therapy previously.
4) Side effects were mild transient abdominal pain, diarrhea, nausea and vomiting which were complained in only 2 patients.
5) Overall improvement gradings were classified as "markedly improved" in 7 patients(23.3%) "improved" in 11 patients(36.7%), "slightly improved" in 1 patients(3.3%), "unchanged" in 8 patients(26.7%) and "aggravated" in 3 patients(10.0%) who
required
eventual B-K amputation.
Overall improvement rate was counted 63.3%.
In summary of this clinical observation, it can be considered that Opalmon(OP-1206-α-CD) is and effective agent for the treatment of Buerger's disease of lower extremities, although this study was done in limited numbers of patients and not
double
blinded.
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