瑞替普酶溶栓治疗中危急性肺血栓栓塞症的临床研究
发布时间：2018-09-11 13:20
【摘要】：背景随着临床医师诊断意识的提高和诊断技术的发展，急性肺血栓栓塞症(APTE)己经成为我国常见的心血管疾病，APTE死亡率高，未治疗的APTE死亡率高达30%。目前已得到临床各科医师的高度重视。溶栓和抗凝是APTE主要自勺治疗方法，而APTE危险分层为中危的APTE患者(有右心室功能不全和/或心肌损伤的证据而血流动力学稳定)是台溶栓治疗存在争议，争议的焦点是溶栓治疗存在出血风险。新一代的溶栓药物瑞件炸酶(r-PA)，因具有纤维蛋白特异性强，对血小板无影响，引起出血不良反应低，半衰期长，溶栓作用强，可静脉推注给药，使用方便等优点。目前国内关于中危APTE患者应用r-PA溶栓治疗的溶栓方案、临床疗效、预后影响及安全性方面的研究很少。 目的探讨中危八PTE患者应用r-PA溶栓治疗的临床疗效、安全性；通过随访了解及评价患者的近期预后，为中危APTE患者的临床治疗提供依据。 方法 1.选择2010月个2011年1月至2111年11月于安阳市人民医院行双源CT肺动脉造影(DSCT-PA)确诊为APTE的住院患者45例，随机分为两组，其中溶栓组23例，单纯抗凝组(简称抗凝组)22例，所有患者均符合2008欧洲心脏病协会(ESC)《APTE诊断治疗指南》危险分层—中危APTE诊断标准。 2.溶栓组患者应用r-PA(18mg)静脉推注溶栓后，应用低子量肝素(LMWH)和华法林抗凝治疗，两者重叠应用3-5d,华法林服用至少3个月。抗凝组患者仅应用LMWH和华法林抗凝治疗，用法同溶栓组。同时观察患者生命体征，监测临床指标。3d后复晒心脏彩超及DSVT-PA. 3.以治愈、显效、进步、无效、恶化和死亡6级判断标准对患者进行疗效评价，以治愈＋显效＋进步为有效，计算有效率，以恶化＋死亡计算严重事件发生率，统计出血并发症。 4.出院后随访3个月，统计患者出血．、复发、死亡等事件发生率。 5．应用SPSS17.0统计学软件进行数据分析，P0.05表示差异有统计学意义，P0.01表示差异有极显著统计学意义。 结果 1.两组患者患者般情况、基本病因比较无统计学差异(P0.05)。 2.两组患者治疗3d后，溶栓组呼吸困难，胸痛等临床症状改善比抗凝组更明显。两组患者治疗3d后肺栓寨面积(段数)减小，PASP明显下降，HR和RF明显减慢，PaO2、PaCO2和SaO2亦明显改善，差异有统计学意义护(P0.05或P0.01)；但抗凝组不如溶栓组差异显著(P0.05)。 3.两组患者治疗3d后，溶栓组治愈率26.09%(6/23)高于抗凝组治愈率4.55%(1/22)，两组比较有统计学差异(P=0.0460.05);济栓组总有效率86.96%(20/23)高于抗凝组总有效率50.00%(11/22)，，两组比较有极显著统计差异(P=0.0070.01)；抗凝组恶化3例(13.63%)，给予补救性济栓治疗后症状缓解，康复出院，死亡1例(4.55%)，抗凝组严垂事件发生率18.18%(4/22)，济栓组无恶化和死亡份病例，两组严重事件发生率比较差异有统计学意义(P=0.0320.05)。 4.两组患者治疗3d后各有2例轻度出血,出血生生率分别为8.70%和9.09%,两组均无严重出血事件。两组出血发生率比较无统计学差异(P=0.9630.05)。 5.从入院治疗到3个朋随访结束，抗凝组恶化3例(13.64%)、复发1例(4.55%)、死亡1例(4.55%)，严重事件发生率22,72%(5/22)，溶栓组无严重事件(恶化、复发和死亡)发生，两组严重事件发生率比较有统计学意义(P=0.0150.05)；抗凝组轻度出血2例(9.09%)，溶栓组轻度出血3例(13.04%)，两组均无严重出血病例，两组总出血发生率比较无统计学差异(P=0.6730.05)；溶栓组事件发生率86.96%(20/23)高于抗凝组无事件发生率68.18%(15/22)，两组比较无统计学差异(P=0.1300.05). 结论 1.中危APTE患者应用r-PA溶栓治疗与单纯抗凝治疗相比可迅速改善患者的临床症状，深解血栓，改善肺血流动力学，纠正有心室功能。 2.中危APTE(?)应用r-PA溶栓治疗与单纯抗凝治疗相比不仅治愈率高,总有效率高,而且可降低近期严重事件发生率(恶化+复发十死亡)：而出血风险并未增加。 3.r-PA溶栓治疗中,危APTE安全有效,r-PA溶栓方案在中危APTE治疗上值得临床推广
[Abstract]:BACKGROUND With the improvement of clinicians'diagnostic awareness and the development of diagnostic techniques, acute pulmonary thromboembolism (APTE) has become a common cardiovascular disease in China. The mortality rate of APTE is high, and that of untreated APTE is as high as 30%. Thrombolytic therapy is controversial in APTE patients with moderate risk stratification (with evidence of right ventricular dysfunction and/or hemodynamic stability due to myocardial injury). The focus of controversy is the risk of bleeding in thrombolytic therapy. There are few studies on the clinical efficacy, prognosis and safety of r-PA thrombolytic therapy for moderate-risk APTE patients.
Objective To investigate the clinical efficacy and safety of r-PA thrombolysis in the treatment of moderate-risk patients with PTE.
Method
1. Forty-five hospitalized patients with APTE diagnosed by DSCT-PA in Anyang People's Hospital from January 2011 to November 2011 were randomly divided into two groups: thrombolytic group (23 cases) and anticoagulant group (22 cases). All patients met the risk score of Euro Heart Association (ESC)< APTE Diagnostic and Therapeutic Guidelines > and all patients were in accordance with the risk score. The diagnostic criteria for intermediate risk APTE.
2. Thrombolytic group was treated with r-PA (18mg) intravenous thrombolysis, low-dose heparin (LMWH) and warfarin anticoagulant therapy, the two overlap for 3-5 days, warfarin for at least 3 months. The anticoagulant group was treated with LMWH and warfarin anticoagulant therapy only, the use of the same thrombolytic group. At the same time, the vital signs of patients were observed and the clinical indicators were monitored. Color Doppler ultrasound and DSVT-PA.
3. Evaluate the curative effect of the patients according to the criteria of cure, marked effect, progress, inefficiency, deterioration and death, and calculate the effective rate with the criterion of cure + marked effect + progress, calculate the incidence of serious events with the criterion of deterioration + death, and count the complications of bleeding.
4. the patients were followed up for 3 months after discharge, and the incidence of bleeding, recurrence and death were recorded.
5. Statistical software SPSS17.0 was used to analyze the data. The difference between P 0.05 and P 0.01 was statistically significant.
Result
1. there was no statistically significant difference between the two groups in terms of patients' condition and underlying causes (P0.05).
2. After 3 days of treatment, the clinical symptoms such as dyspnea and chest pain in the thrombolytic group were improved more significantly than those in the anticoagulant group. Significant (P0.05).
3. After 3 days of treatment, the cure rate of thrombolysis group was 26.09% (6/23) higher than that of anticoagulation group (4.55% (1/22), there was significant difference between the two groups (P = 0.0460.05); the total effective rate of Jishuan group was 86.96% (20/23) higher than that of anticoagulation group (50.00% (11/22), there was significant difference between the two groups (P = 0.0070.01); the deterioration of anticoagulation group was 3 (13.63%) and the treatment was given. After treatment, the symptoms were relieved, and one patient was discharged from hospital. The incidence of severe droop was 18.18% (4/22) in anticoagulant group. There was no deterioration or death in the Jishuan group. The incidence of severe events between the two groups was statistically significant (P = 0.0320.05).
4. There were 2 cases of mild hemorrhage in each group 3 days after treatment. The incidence of hemorrhage was 8.70% and 9.09% respectively. There was no serious hemorrhage in both groups. There was no significant difference in the incidence of hemorrhage between the two groups (P=0.9630.05).
5. From hospitalization to the end of follow-up, 3 cases (13.64%) deteriorated in anticoagulation group, 1 case (4.55%) recurred, 1 case (4.55%) died, the incidence of serious events was 22.72% (5/22), no serious events (deterioration, recurrence and death) occurred in thrombolysis group, the incidence of serious events was statistically significant between the two groups (P = 0.0150.05); 2 cases (9.09%) in anticoagulation group, and 2 cases (9.09%) in thrombolysis group. There were 3 cases (13.04%) with mild hemorrhage in the thrombolytic group and 68.18% (15/22) with no severe hemorrhage in the anticoagulant group.
conclusion
1. Compared with anticoagulant therapy alone, r-PA thrombolytic therapy can rapidly improve the clinical symptoms, deep thrombolysis, improve pulmonary hemodynamics and correct ventricular function.
2. Medium-risk APTE (?) Thrombolytic therapy with r-PA is not only more effective than anticoagulant therapy, but also can reduce the incidence of recent serious events (deterioration + recurrence of 10 deaths): and the risk of bleeding did not increase.
In 3.r-PA thrombolytic therapy, APTE is safe and effective. R-PA thrombolysis regimen is worthy of clinical promotion in the treatment of APTE.
【学位授予单位】：新乡医学院
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R563.5
本文编号：2236800
[Abstract]:BACKGROUND With the improvement of clinicians'diagnostic awareness and the development of diagnostic techniques, acute pulmonary thromboembolism (APTE) has become a common cardiovascular disease in China. The mortality rate of APTE is high, and that of untreated APTE is as high as 30%. Thrombolytic therapy is controversial in APTE patients with moderate risk stratification (with evidence of right ventricular dysfunction and/or hemodynamic stability due to myocardial injury). The focus of controversy is the risk of bleeding in thrombolytic therapy. There are few studies on the clinical efficacy, prognosis and safety of r-PA thrombolytic therapy for moderate-risk APTE patients.
Objective To investigate the clinical efficacy and safety of r-PA thrombolysis in the treatment of moderate-risk patients with PTE.
Method
1. Forty-five hospitalized patients with APTE diagnosed by DSCT-PA in Anyang People's Hospital from January 2011 to November 2011 were randomly divided into two groups: thrombolytic group (23 cases) and anticoagulant group (22 cases). All patients met the risk score of Euro Heart Association (ESC)< APTE Diagnostic and Therapeutic Guidelines > and all patients were in accordance with the risk score. The diagnostic criteria for intermediate risk APTE.
2. Thrombolytic group was treated with r-PA (18mg) intravenous thrombolysis, low-dose heparin (LMWH) and warfarin anticoagulant therapy, the two overlap for 3-5 days, warfarin for at least 3 months. The anticoagulant group was treated with LMWH and warfarin anticoagulant therapy only, the use of the same thrombolytic group. At the same time, the vital signs of patients were observed and the clinical indicators were monitored. Color Doppler ultrasound and DSVT-PA.
3. Evaluate the curative effect of the patients according to the criteria of cure, marked effect, progress, inefficiency, deterioration and death, and calculate the effective rate with the criterion of cure + marked effect + progress, calculate the incidence of serious events with the criterion of deterioration + death, and count the complications of bleeding.
4. the patients were followed up for 3 months after discharge, and the incidence of bleeding, recurrence and death were recorded.
5. Statistical software SPSS17.0 was used to analyze the data. The difference between P 0.05 and P 0.01 was statistically significant.
Result
1. there was no statistically significant difference between the two groups in terms of patients' condition and underlying causes (P0.05).
2. After 3 days of treatment, the clinical symptoms such as dyspnea and chest pain in the thrombolytic group were improved more significantly than those in the anticoagulant group. Significant (P0.05).
3. After 3 days of treatment, the cure rate of thrombolysis group was 26.09% (6/23) higher than that of anticoagulation group (4.55% (1/22), there was significant difference between the two groups (P = 0.0460.05); the total effective rate of Jishuan group was 86.96% (20/23) higher than that of anticoagulation group (50.00% (11/22), there was significant difference between the two groups (P = 0.0070.01); the deterioration of anticoagulation group was 3 (13.63%) and the treatment was given. After treatment, the symptoms were relieved, and one patient was discharged from hospital. The incidence of severe droop was 18.18% (4/22) in anticoagulant group. There was no deterioration or death in the Jishuan group. The incidence of severe events between the two groups was statistically significant (P = 0.0320.05).
4. There were 2 cases of mild hemorrhage in each group 3 days after treatment. The incidence of hemorrhage was 8.70% and 9.09% respectively. There was no serious hemorrhage in both groups. There was no significant difference in the incidence of hemorrhage between the two groups (P=0.9630.05).
5. From hospitalization to the end of follow-up, 3 cases (13.64%) deteriorated in anticoagulation group, 1 case (4.55%) recurred, 1 case (4.55%) died, the incidence of serious events was 22.72% (5/22), no serious events (deterioration, recurrence and death) occurred in thrombolysis group, the incidence of serious events was statistically significant between the two groups (P = 0.0150.05); 2 cases (9.09%) in anticoagulation group, and 2 cases (9.09%) in thrombolysis group. There were 3 cases (13.04%) with mild hemorrhage in the thrombolytic group and 68.18% (15/22) with no severe hemorrhage in the anticoagulant group.
conclusion
1. Compared with anticoagulant therapy alone, r-PA thrombolytic therapy can rapidly improve the clinical symptoms, deep thrombolysis, improve pulmonary hemodynamics and correct ventricular function.
2. Medium-risk APTE (?) Thrombolytic therapy with r-PA is not only more effective than anticoagulant therapy, but also can reduce the incidence of recent serious events (deterioration + recurrence of 10 deaths): and the risk of bleeding did not increase.
In 3.r-PA thrombolytic therapy, APTE is safe and effective. R-PA thrombolysis regimen is worthy of clinical promotion in the treatment of APTE.
【学位授予单位】：新乡医学院
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R563.5
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