共同研究

第一回症例登録調査（1994年1月～1997年10月）

• 第4回肺塞栓症研究会 発表
• 第48回日本心臓病学会 発表
• 第67回日本循環器学会 発表
• Therapeutic Research 19: 14751-1478, 1997掲載
• Therapeutic Research 20: 993-998, 1999掲載
• Clinical Cardiology 24, 132-138, 2001掲載
• Circulation Journal 66, 257-260, 2002掲載

Clinical Characteristics of Acute Pulmonary Thromboembolism in Japan: Results of a Multicenter Registry in the Japanese Society of Pulmonary Embolism Research

（Clin. Cardiol. 24, 132-138, 2001）

Background: Although the incidence of acute pulmonary thromboembolism (APTE) has been increasing in Japan, patient characteristics, management strategies, and outcome have not yet been assessed in large series.

Hypothesis: The present study was designed to investigate the current status of APTE in Japan.

Methods: Of a total of 533 registry patients with pulmonary thromboembolism, 309 with APTE were analyzed with respect to clinical symptoms and signs, predisposing factors, diagnostic procedures, estimation of deep venous thrombosis, treatment, and clinical course.

Results: Main risk factors were recent major surgery, cancer, prolonged immobilization, and obesity; only a few patients had coagulopathy and 36% were in cardiogenic shock at presentation. The majority of registry patients underwent lung scans or pulmonary angiography; 30% were diagnosed only by lung scanning. Venous ultrasonography was used in only 34 patients, while 188 patients underwent at least one diagnostic procedure for deep venous thrombosis. Thrombolysis was more frequently performed in patients with cardiogenic shock, and only a few patients received thromboembolectomy. In-hospital mortality rate was 14%. In patients with cardiogenic shock, the mortality rate was reduced by thrombolysis. The predictors of in-hospital mortality were male gender, cardiogenic shock, cancer, and prolonged immobilization.

Conclusions: The patients in this registry had almost the same findings as those in Western patients, except for some points that had the possibility of demonstrating a difference between Westerners and Japanese in the development of APTE. These results can prove especially helpful in planning prospective, randomized trials that will clarify the impact of widely used treatment modalities on the outcome of patients with APTE.

Incidence and Clinical Characteristics of Chronic Pulmonary Thromboembolism in Japan Compared With Acute Pulmonary Thromboembolism. Results of a Multicenter Registry of the Japanese Society of Pulmonary Embolism Research

（Circ J 2002; 66: 257-260）

The incidence of acute pulmonary thromboembolism (APTE) in Japan is quoted as being extremely low compared with the United States, and the incidence and clinical characteristics of chronic pulmonary thromboembolism (CPTE) in Japan is unknown, so this study investigated these aspects of CPTE in 309 patients with APTE and 68 patients with CPTE. The ratio of the incidence of CPTE to APTE was 0.22 and there was no significant difference in age or sex between the APTE and CPTE patients. All of the predisposing factors for pulmonary thromboembolism, except for thrombophilia, were more frequently seen in the patients with APTE. There are some differences in the incidence and clinical characteristics of CPTE compared with APTE between Japanese and American patients in Japan, suggesting that the pathogenesis of CPTE in Japan may differ from that in the USA.

第二回症例登録調査（1997年11月から2000年9月）

• 第7回肺塞栓症研究会 発表
• 第8回肺塞栓症研究会 発表
• Therapeutic Research 22: 1481-1486, 2001掲載
• 第66回日本循環器学会総会 発表
• 第67回日本循環器学会総会 発表
• 第43回日本脈管学会総会シンポジウム 発表
• 脈管学2003; 43: 207-209掲載
• Intern Med 2003; 42: 470-476掲載

肺塞栓症研究会（JaSPER）の症例登録研究を通して見た診断，治療の課題：新しい医療戦略をめざして．

（J Jpn Col. Angiol 2003; 43: 207-209.）

日本における肺塞栓症は，人口動態統計や臨床診断数において増加が見られる。肺塞栓症の診断面ではCTの急激な使用の増加が特徴的であった。抗凝固療法は以前より実施される頻度が増し，下大静脈フィルター留置の頻度も増加している。しかしながら，死亡率の改善は得られておらず，一部の症例にはさらに積極的な治療法も考慮すべきと考えられた。深部静脈血栓症の検索は 6 割程度にしか実施されておらず，今後の課題と考えられた。

Shirato K; Japanese Society of Pulmonary Embolism Research. Recent developments in diagnostic imaging techniques and management for acute pulmonary embolism: multicenter registry by the Japanese Society of Pulmonary Embolism Research.

(Intern Med. 2003 Jun;42(6):470-6.)

OBJECTIVE: There are many reports on the diagnosis and management of acute pulmonary embolism (APE), but there have been no investigations concerning the actual conditions in which recent developments in diagnostic imaging techniques and therapies have been applied in clinical practice. The present study was designed to investigate the changes in diagnostic imaging techniques and therapies for APE.

METHODS AND PATIENTS: Three hundred and nine APE patients diagnosed during January 1994-October 1997 (Group 1) were compared with 257 APE patients diagnosed during November 1997-October 2000 (Group 2) in terms of the diagnostic imaging techniques and therapies for APE.

RESULTS: Compared with Group 1, pulmonary angiography and contrast-enhanced computed tomography were more frequently performed for diagnosis in Group 2 [45.3% vs 56.8% (p = 0.0069) and 13.9% vs 57.6% (p < 0.0001), respectively]. Heparin and vena cava filter were used more often in Group 2 [74.4% vs 82.1% (p = 0.033) and 18.4% vs 33.9% (p < 0.0001), respectively]. The frequency of thrombolytic therapy was unchanged between the two groups. Warfarin use in discharged patients increased from 71.9% to 83.8% (p = 0.0022). However, the examination rates for deep vein thrombosis (DVT) were low (60.8% in Group 1 and 65.4% in Group 2, p = 0.29) and unchanged using any imaging techniques.

CONCLUSION: The diagnostic imaging techniques for APE increased in variety and the management has improved, while the diagnosis for DVT remains unchanged.

急性肺血栓塞栓症の治療に関する検討

• 第8回肺塞栓症研究会 発表
• 第99回日本内科学会総会 発表
• 第66回日本循環器学会総会Futured Research Session 発表
• 第22回日本静脈学会総会シンポジウム 発表
• Int J Cardiol 2005; 99, 83-89掲載

わが国における急性肺血栓塞栓症の治療の現状とその評価

（静脈学13：335-342，2002）

　肺塞栓症研究会共同研究の急性肺血栓塞栓症の治療に関する検討結果を解説した．1994年1月から1997年10月の調査で抗凝固療法は多くの症例に用いられ，さらに1997年11月から2000年1月までの調査においてはより多数例に用いられていた．一方，血栓溶解療法は重症度を問わず約5割の症例で行われていた．そこで，血栓溶解療法の有用性と安全性を，治療開始時点の循環動態で分類して検討した．ショックが治療開始時まで遷延する症例は少なく，biasが大きいため検討には適さなかった．ショックを呈さず右心機能不全のない症例では，抗凝固療法のみで十分治療可能であった．しかし，非ショック例のうち右心機能不全を有する症例では，有意差はないが血栓溶解療法で予後が良い傾向にあった．さらに出血の合併症に両治療間で有意差は認めなかった．今回の解析からは，右心機能不全合併例においては血栓溶解療法を考慮すべきとの印象を得たが，さらに前向き試験を行い明らかなevidenceを作る必要があると考える．

Nakamura M, Nakanishi N, Yamada N, Sakuma M, Miyahara Y, Okada O, Tanabe N, Kuriyama T, Kunieda T, Shirato K, Sugimoto T, Nakano T. Effectiveness and safety of the thrombolytic therapy for acute pulmonary thromboembolism: results of a multicenter registry in the Japanese Society of Pulmonary Embolism Research.

(Int J Cardiol 2005; 99: 83-89)

Objective: To assess the effectiveness and safety of thrombolytic treatment for acute pulmonary thromboembolism(APTE), especially in the hemodynamically stable patients with right ventricular afterload stress.

Methods and Results: In a total of 221 patients with APTE, the association between thrombolytic treatment and the clinical outcomes were investigated. Thrombolysis was given to 121 patients (Thrombolytic Group), and the remaining 100 patients were treated with anticoagulation alone (Anticoagulation Group). In both patients with prolonged shock and patients who were hemodynamically stable without right ventricular afterload stress, the rate of death and recurrence of APTE in Anticoagulation Group were similar to those in Thrombolytic Group. In patients with right ventricular afterload stress, better outcomes were observed in Thrombolytic Group than in Anticoagulation Group, although the difference did not reach statistical significance. There was no significant difference in the rate of major bleeding episode between these two groups.

Conclusion: Our results suggested that performing thrombolytic treatment in APTE patients with right ventricular afterload stress should be considered even in Japan.

肺血栓塞栓症の追跡調査

• 第8回肺塞栓症研究会 発表
• 第66回日本循環器学会総会 発表

一時型下大静脈フィルターに関する現状調査

• 第7回肺塞栓症研究会 発表
• 第7回肺塞栓症研究会 発表
• 第66回日本循環器学会総会･学術集会 発表
• 第21回静脈学会総会パネルディスカッション 発表
• 第14回world Conference of International Union of Phlebology発表
• Therapeutic Research 22: 1439-1441, 2001掲載

第三回症例登録調査（2000年10月から2003年8月）

• 第10回肺塞栓症研究会 発表
• 第68回日本循環器学会総会･学術集会 発表
• 第45回日本脈管学会総会ワークショップ 発表
• Circulation Journal 68, 816-821, 2004掲載

Sakuma M, Nakamura M, Nakanishi N, Miyahara Y, Tanabe N, Yamada N, Kuriyama T, Kunieda T, Sugimoto T, Nakano T, Shirato K: Inferior vena cava filter is a new additional therapeutic option to reduce mortality from acute pulmonary embolism.

(Circ J. 2004 Sep;68(9):816-21.)

BACKGROUND: There are few reports that examine the current imaging and management techniques according to the severity of acute pulmonary embolism (APE) or that clarify whether the management strategy ameliorated the mortality from APE.

METHODS AND RESULTS: The study group were 456 patients with APE who were clinically diagnosed before their death. The severity at diagnosis, and the imaging and management techniques were analyzed. Mortality from APE was 0.8% in patients without shock nor right ventricular overload, 2.7% in patients with right ventricular overload without shock, 15.6% in patients with shock, and 52.4% in patients with cardiopulmonary arrest (p < 0.0001) In the more severe cases, pulmonary angiography and trans-thoracic echocardiography were used more frequently, whereas both ventilation and perfusion lung scans were used less frequently. Computed tomography was used widely, regardless of the severity. Thrombolytic therapy and catheter therapy were used more frequently in the more severe cases, but an inferior vena cava filter was the only management strategy that reduced the mortality from APE.

CONCLUSIONS: The severity of APE at diagnosis affected the selection of both the diagnostic techniques and the type of management. Implantation of inferior vena cava filters reduced the mortality from APE.