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目的评估波生坦起始联合治疗或序贯治疗肺动脉高压患者的长期疗效、安全性及生存预后情况。方法入选自2007年7月至2013年1月在上海市肺科医院心肺循环科住院,明确诊断为第一大类肺动脉高压的患者104例,给予波生坦标准剂量2次/d口服,进行开放性、观察性研究。根据治疗方案分成起始联合治疗组和序贯治疗组,并进行长期随访,截止至2013年6月。评估并比较服药前后病情改善情况及生存率情况。结果波生坦平均治疗(22.6±15.8)个月,68.1%患者WHO肺动脉高压功能分级无明显恶化(明显改善6例,稳定56例)。N末端-脑钠肽前体的对数值(lgNT-proBNP)由2.8±0.8下降至2.5±0.2,但差异无统计学意义(P=0.15)。超声心动图测得肺动脉收缩压(PASP)由(95.2±21.3)mmHg(1mmHg=0.133kPa)下降至(88.6±24.4)mmHg(P=0.009);射血分数(EF)由(73.6±9.3)%升至(77.4±9.0)%(P=0.02);右房横径大小和右室横径大小无明显改变。右心导管检查测得肺动脉平均压和右房平均压无明显改变;肺血管阻力由(16.4±8.4)Wood U/m2降至(13.9±8.0)Wood U/m2,但差异无统计学意义(P=0.06);心排量(CO)由(3.8±2.0)L/min升至(4.8±2.3)L/min(P=0.04)。Kaplan-Meier生存分析显示1、2、3、4和5年生存率分别为92.5%、83.7%、71.7%、67.2%和57.6%。起始联合组1、2、3和4年生存率分别为95.1%、88.9%、84.2%和77.7%;序贯治疗组1、2、3和4年生存率分别为92.3%、79.4%、53.3%和26.6%,两组生存率差异有统计学意义(P=0.038)。仅有1例患者因颜面部水肿明显而停用波生坦。结论长期联合使用波生坦可使患者的心功能无明显恶化,心排出量增加且安全性良好,同时起始联合治疗较序贯治疗对患者预后更有益。
Objective To evaluate the long-term efficacy, safety and survival and prognosis of bosentan combination therapy or sequential therapy in patients with pulmonary hypertension. Methods From July 2007 to January 2013 in Shanghai Pulmonary Hospital Cardiopulmonary Residency, 104 patients were diagnosed as the first major pulmonary hypertension, given a bosentan standard dose of 2 times / d orally, carried out Open, observational studies. According to the treatment plan into the initial combination therapy group and sequential treatment group, and long-term follow-up, as of June 2013. Assessment and comparison of the condition before and after treatment to improve the situation and survival rate. Results Bosentan average treatment (22.6 ± 15.8) months, 68.1% WHO pulmonary hypertension grade no significant deterioration (significantly improved in 6 cases, stable in 56 cases). The logarithm of N-terminal pro-brain natriuretic peptide (lgNT-proBNP) decreased from 2.8 ± 0.8 to 2.5 ± 0.2, but the difference was not statistically significant (P = 0.15). Echocardiography measured pulmonary artery systolic pressure (PASP) decreased from (95.2 ± 21.3) mmHg (1mmHg = 0.133kPa) to (88.6 ± 24.4) mmHg (P = 0.009) % To (77.4 ± 9.0)% (P = 0.02). The size of the right atrium and the diameter of the right ventricle did not change significantly. The mean pulmonary artery pressure and right atrium mean pressure measured by right heart catheterization showed no significant change; pulmonary vascular resistance decreased from (16.4 ± 8.4) Wood U / m2 to (13.9 ± 8.0) Wood U / m2, but the difference was not statistically significant (P = 0.06). Cardiac output (CO) increased from (3.8 ± 2.0) L / min to (4.8 ± 2.3) L / min, P = 0.04. Kaplan-Meier survival analysis showed that the 1, 2, 3, 4 and 5-year survival rates were 92.5%, 83.7%, 71.7%, 67.2% and 57.6%, respectively. The 1,2,3 and 4-year survival rates of the initial combination group were 95.1%, 88.9%, 84.2% and 77.7%, respectively. The 1, 2, 3 and 4-year survival rates of sequential therapy group were 92.3% and 79.4% 53.3% and 26.6% respectively. There was significant difference in survival between the two groups (P = 0.038). Only one patient discontinued bosentan due to marked facial edema. Conclusion Long-term combined use of bosentan can make patients with no significant deterioration of cardiac function, cardiac output increased and good safety, at the same time than the initial combination therapy is more beneficial to the prognosis of patients.