口服西地那非治疗肺动脉高压1年疗效观察

The observation of the efficacy of sildenafil to treat pulmonary hypertension in 1 year

目的：观察口服西地那非治疗肺动脉高压的1年疗效。方法：筛选安贞医院呼吸科2011年至2013年,门诊及病房就诊的肺动脉高压患者45例,给予口服西地那非（25mg,每日3次）,观察时间点分别为3、6及12个月,主要观察终点为治疗后各时间点6分钟步行试验（6MWT）中行走距离的改变,次要终点为Borg呼吸困难评分及WHO肺动脉高压患者功能分级（WHO-FC）、超声心动图（UCG）测定的肺动脉收缩压（SPAP）的改变,并随访患者生存情况。结果：1主要终点为6MWT,在3、6及12个月均较基线明显改善,分别增加（106.6±18.8）m,P〈0.001;（96.2±18.8）m,P〈0.001及（46.9±19.0）m,P〈0.05。总体趋势6MWT的改善为下降趋势,3个月与6个月较基线改善距离比较,差异无统计学意义（P〉0.05）。2次要终点为WHO-FC及Borg呼吸困难评分在3个月、6个月及1年较基线均有改善（P〈0.001）,其中3-6个月心功能最佳,呼吸困难改善最明显,6个月后疗效逐渐降低。治疗1年时心功能较前下降,呼吸困难较前有加重;UCG测定的SPAP,在3个月、6个月均较基线明显改善,分别降低（23.2±4.0）mmHg（1mmHg=0.133k Pa,P〈0.001;（20.8±4.0）mmHg,P〈0.001;3个月与6个月改善情况比较,差异无统计学意义（P〉0.05）。1年后UCG测定的SPAP较基线比较,差异无统计学意义（P〉0.05）。结论：口服西地那非25mg,每日3次,治疗肺动脉高压,治疗后1年,其在改善患者症状及心肺功能方面仍有较好疗效,且在治疗后3-6个月时疗效最佳,但对SPAP的改善在3-6个月时较明显,后随着疗程延长,对SPAP改善作用逐渐减弱,治疗后1年SPAP甚至回升至基线水平。

Objective： This study was planned to observe the efficacy of oral administration of Sildenafil on pulmonary hypertension in 1 year. Methods： From 2011 to 2013,hospitalized（ including in-patient and outpatient） pulmonary hypertension patients received oral sildenafil（ 25 mg,tid）. Patients were followed-up at 3months,6 months and 12 months. The primary end points of this study were the improvement in the 6-minute walk test distances at 3 months,6 months and 12 months. The secondary end points were the improvement in Borg scale,WHO classification of pulmonary hypertension,systolic pulmonary arterial pressure evaluated by Doppler echocardiography and the survival of patients. Results： 1 Compared to the result at the baseline,the primary end point was significantly improved. The 6-minute walk test distances were increased by（ 106. 6 ±18. 8） m（ P〈0. 001）,（ 96. 2 ± 18. 8） m（ P〈0. 001）,（ 46. 9 ± 19. 0） m（ P〈0. 05） respectively at 3months,6 months and 12 months. The improvement rate was decreased. There was no difference between the improvement distance at 3 months and the one at 6 months（ P 〉0. 05）. 2Compared to the results at the baseline,the results of Borg scale and WHO classification of pulmonary hypertension were significantly improved at3 months,6 months and 12 months（ P〈0. 001）. The cardiac function and the improvement of dyspnea reached the peak at 3-6 months. The efficacy was declined gradually after 6 months. At 12 months,the cardiac function was declined and dyspnea was aggravated. Compared to the baseline,systolic pulmonary arterial pressure（ SPAP） evaluated by Doppler echocardiography significantly decreased by（ 23. 2 ± 4. 0） mmHg（ P〈0. 001）,（ 20. 8 ± 4. 0） mmHg（ P〈0. 001） respectively at 3 months and 6 months. There was no difference between the decrease at 3 months and the one at 6 months（ P〉 0. 05）. After 12 months,SPAP merely decreased,without statistical difference（ P〉 0. 05）. Conclusion： oral administration of Sildenafil（ 25 mg,tid）to treat pulmonary hypertension can significantly improve clinical symptoms,cardio-pulmonary function in 1year,especial at 3- 6 months. However,after the efficacy for pulmonary artery systdic pressure reached the peak at 3- 6 months,it gradually declined with the course of treatment,and even SPAP reached the baseline after 1year.