阿奇霉素肠溶片联合曲前列尼尔注射液治疗重度肺动脉高压的临床研究

Clinical trial of azithromycin enteric-coated tablets combined with treprostinil injection in the treatment of severe pulmonary hypertension

目的观察阿奇霉素肠溶片联合曲前列尼尔注射液治疗重度肺动脉高压的临床疗效及安全性。方法将60例肺动脉高压患者随机分为对照组和试验组,每组30例。对照组给予曲前列尼尔开始剂量每天0.625 ng·kg^-1·min^-1,最高增加至8.75 ng·kg^-1·min^-1,最低减至0.3 ng·kg^-1·min^-1,皮下输注泵连续注射;试验组在对照组治疗的基础上,给予阿奇霉素肠溶片每次0.25 g,qd,口服。2组患者均治疗24 d。比较2组患者的临床疗效、肺功能,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的好转率分别为60.00%(18例/30例)和26.67%(8例/30例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的用力肺活量分别为(2.14±0.44)和(1.61±0.25)L,第1秒用力呼吸容积分别为(1.49±0.25)和(1.01±0.42)L,差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以头晕头痛、心悸、低血压和腹泻为主。试验组和对照组的总药物不良反应发生率分别为30.00%和33.33%,差异无统计学意义(P>0.05)。结论阿奇霉素肠溶片联合曲前列尼尔注射液治疗重度肺动脉高压的临床疗效确切,其能够有效改善患者的肺功能,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of azithromycin enteric-coated tablets combined with treprostinil injection in the treatment of severe pulmonary hypertension.Methods Sixty patients with pulmonary hypertension were randomly divided into control group and treatment group with 30 cases per group.Control group was given the treprostinil injection at an initial dose of 0.625 ng·kg^-1·min^-1 per day,the highest to 8.75 ng·kg^-1·min^-1,the lowest to 0.3 ng·kg^-1·min^-1,and the subcutaneous infusion pump was injected continuously.Treatment group was given azithromycin enteric-coated tablets 0.25 g per time,qd,orally,on the basis of control group.Two groups were treated for 24 days.The clinical efficacy,pulmonary artery pressure,lung function and adverse drug reactions were compared between two groups.Results After treatment,the improvement rates of treatment and control groups were 60.00%(18 cases/30 cases)and26.67%(8 cases/30 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:forced vital capacity were(2.14±0.44)and(1.61±0.25)L,forced respiratory volume in the first second were(1.49±0.25)and(1.01±0.42)L,the differences were statistically significant(all P<0.05).The adverse drug reactions of two groups were dizziness,headache,palpitations,hypotension and diarrhea.The total incidences of adverse drug reactions in treatment and control groups were 30.00%and 33.33%without significant difference(P>0.05).Conclusion Azithromycin enteric-coated tablets combined with treprostinil injection have a definitive clinical efficacy in the treatment of severe pulmonary hypertension,which can effectively improve lung function,without increasing the incidence of adverse drug reactions.