马昔腾坦联合他达拉非治疗肺动脉高压有效性和安全性研究

Efficacy and Safety of Bosentan Combined with Treprostinil in the Treatment of Pulmonary Arterial Hypertension

目的:探讨马昔腾坦联合他达拉非治疗肺动脉高压有效性和安全性。方法:将80例肺动脉高压患者作为本次前瞻性研究的研究对象,病例收集时间为2021年3月至2022年3月,所有纳入的病例均根据纳入和排除标准进行筛选。将80例受试患者分为对照组和试验组,每组均为40例,分组方法采用简单随机分组方法。对照组采用口服他达拉非片进行治疗,观察组在对照组的基础上服用马昔腾坦片,两组患者均连续治疗12周。对比两组患者治疗前后肺动脉平局压(MPAP)、平均体循环动脉压(MSAP)、体循环阻力(SVR)和肺循环阻力(PVR)等超声心动图指标,对比两组患者6min步行距离试验(6MWD)和Borg呼吸困难评分,对比两组患者血清血管内皮因子-1(ET)以及C反应蛋白(CRP)含量。对比两组患者治疗期间安全性情况。结果:治疗结束后对照组和试验组MPAP、MSAP、SVR、PVR相较于治疗前均降低,且试验组MPAP、MSAP、SVR、PVR相较于对照组治疗前后差异值更显著(P<0.05);治疗结束后对照组和试验组Borg评分相较于治疗前均降低,且试验组Borg评分相较于对照组治疗前后差异值更显著(P<0.05),治疗结束后对照组和试验组6MWD相较于治疗前均升高,且试验组6MWD相较于对照组治疗前后差异值更显著(P<0.05);治疗结束后对照组和试验组血清ET-1、CRP含量相较于治疗前均降低,且试验组血清ET-1、CRP含量相较于对照组显著更低(P<0.05);治疗期间两组均无不良反应事件。结论:马昔腾坦联合他达拉非治疗肺动脉高压可显著降低血流动力学指标,改善呼吸症状,减轻炎性反应,且治疗安全性较好。

Objective:To investigate the efficacy and safety of macitentan combined with tadalafil in the treatment of pulmonary arterial hypertension.Methods:80 patients with pulmonary arterial hypertension were selected as the research subjects of this prospective study.The case collection time was from March 2021 to March 2022.All included cases were screened according to the inclusion and exclusion criteria.The 80 patients were divided into a control group and an experimental group of 40 patients each,and the grouping method was a simple randomized grouping method.The control group was treated with oral tadalafil tablets,and the observation group was treated with macitentan tablets on top of the control group.Both groups were treated for 12 consecutive weeks.The echocardiographic indexes such as pulmonary artery flat pressure(MPAP),mean systemic arterial pressure(MSAP),systemic circulation resistance(SVR)and pulmonary circulation resistance(PVR)were compared between the two groups before and after treatment,and the six-minute walk distance test(6MWD)and the Borg dyspnoea score were compared,and serum vascular endothelial factor-1(ET)and C-reactive protein(CRP)levels were compared between the two groups of patients.The safety of the two groups of patients during treatment was compared.Results:MPAP,MSAP,SVR and PVR were lower in both the control and test groups at the end of treatment compared to the pre-treatment period,and the difference in MPAP,MSAP,SVR and PVR was more significant in the test group compared to the control group before and after treatment(P<0.05).After treatment,MPAP,MSAP,SVR,PVR in the control group and the test group were lower than those before treatment,and MPAP,MSAP,SVR,PVR in the test group were more significant than those before treatment(P<0.05).After treatment,Borg scores of the control group and the test group decreased compared with those before treatment,and Borg scores of the test group were more significant than those of the control group before and after treatment(P<0.05).After treatment,6MWD of the control group and the test group increased compared with those before treatment,and 6MWD of the test group was more significant than those of the control group before and after treatment(P<0.05).After treatment,the levels of serum ET-1 and CRP in the control group and the test group were lower than those before treatment,and the levels of serum ET-1 and CRP in the test group were significantly lower than those in the control group(P<0.05).There were no adverse events in both groups during the treatment.Conclusion:Macitentan combined with tadalafil in the treatment of pulmonary hypertension can significantly reduce hemodynamic indexes,improve respiratory symptoms,reduce inflammatory response,and the treatment is safe.