@article{oai:dmu.repo.nii.ac.jp:00000140,
 author = {谷口, 勲 and Yaguchi, Isao},
 issue = {2},
 journal = {Dokkyo journal of medical sciences},
 month = {Jul},
 note = {急性心筋梗塞発症後早期に閉塞冠動脈の再灌流により充分な血流(TIMI 3)を得ることは短期および長期予後を決定する。この治療方法としてCOMA(Combining Monteplase with Angioplasty)Trialは冠動脈形成術(percutaneous coronary intervention, PCI)実施前にmutant t-PA(monteplase)の通常量単回静脈先行投与の有用性を検討する前向き無作為試験である。1998年9月から2002年12月までの急性心筋梗塞299例中規定に合った126例がPCI前にmonteplaseを投与しない対照群(P群 : n = 68)とmonteplase(27,500 IU/kg)を先行投与した群(M群 : n = 58)とに無作為に割付けられた。PCI前の初回冠動脈造影でTIMI3が得られたのはP群で7%,M群で34%であった(P<0.0001)。出血性合併症はM群で1例のみであった。左心機能は1ヶ月,6ヶ月後の追跡調査でM群とP群で有意差はなかった。しかしM群をPCI前に早期再灌流されたTIMI3群とTIMI2以下群とに分けて比較すると,6ヶ月後の左室拡張終期容量はTIMI3群ではTIMI2以下群に比べ有意に低値であった(70.1 ± 3.3ml/m^2 vs 86.8 ± 3.5ml/m^2, P<0.01)。また左室駆出率はTIMI3群ではP群に比べ有意に高値を示した(64.4±2.7% vs 58.1±1.3%, P<0.05)。冠動脈病変については責任病変部の最小血管径(MLD)はPCI直後よりM群で有意に大きく,6ヶ月後まで持続していた。晩期損失径(late lumen loss)は,M群0.57 ± 0.10mm,P群0.80 ± 0.10mmとM群で少ない傾向を示した(P = 0.0611)。以上の結果より急性心筋梗塞発症時におけるPCI前にmutant t-PA(monteplase)の通常量の単回静脈注射先行投与は,より早期の再灌流が可能であり,安全で6ヶ月後の心機能を維持し,再狭窄の予防にも有用である。, INTRODUCTION & HYPOTHESIS: In the treatment of acute myocardial infarction, rapid reperfusion of the infarct-related artery is important to improve mortality and the long-term prognosis. But there is still controversy over whether we should select thrombolysis or PCI (percutaneous coronary intervention) as the method of reperfusion. The Combining Monteplase (a mutant t-PA developed in Japan) with Angioplasty (COMA) trial is a prospective, randomized trial for evaluating the effectiveness of monteplase administration prior to emergent PCI in acute myocardial infarction. METHOD: Out of 299 consecutive acute myocardial infarction from 1998 to 2002, we enrolled into the COMA trial 126 patients who were under 75 years of age and had been admitted within 12 hrs after the onset of AMI. Patients were randomly assigned to receive direct PCI (control, group P, n = 68) or PCI followed by pre-treatment with intravenous monteplase (27,500 lU/kg, group M, n = 58). RESULTS: Primary end-point of this trial was left ventricular function at 6 months follow-up. In the initial CAG before PCI, TIMI-3 flow was obtained in 34% of group M, but in only 7% of group P (P < 0.0001). There was no significant difference in the PCI success rate, major cardiac or bleeding complications in both groups. No-reflow phenomenon in group P was observed more frequently than group M (21 % vs 6%, P < 0.05). There was no significant difference in EF between both groups. Thus, we divided the group M into sub -groups according to whether or not TIMI-3 flow was observed at initial CAG. In the group M with TIMI-3 flow, LVEDVI was smaller and the EF was greater than Group P (64.4 +/ -2.7 vs 58.1 +/ -1.3, P < 0.05). QCA results showed that the minimal lumen diameter was larger in the monteplase group M immediately after PCI, and the difference was even greater at 6 months. CONCLUSION: Intravenous injection of monteplase can promote rapid reperfusion and appears to maintain LV function, to suppress LV remodeling and late restenosis. We propose a combination therapy of PCI with monteplase injection in order to achieve reperfusion as early as possible., 原著, Original},
 pages = {163--171},
 title = {急性心筋梗塞の経皮的冠動脈形成術におけるmutant t-PAの先行投与の有用性についての無作為比較試験(Combining Monteplase with Angioplasty Trial, COMA Trial)},
 volume = {30},
 year = {2003},
 yomi = {ヤグチ, イサオ}
}