阿托伐他汀联合前列地尔对慢性阻塞性肺疾病合并肺动脉高压患者的临床研究

Clinical trial of atorvastatin combined with alprostadil in the treatment of patients with chronic obstructive pulmonary disease combined with pulmonary arterial hypertension

目的观察阿托伐他汀联合前列地尔对慢性阻塞性肺疾病(COPD)合并肺动脉高压(PAH)患者的临床疗效及安全性。方法选取我院呼吸内科收治的COPD合并PAH患者166例,随机分为对照组和试验组,各83例。对照组给予前列地尔注射液,每次10μg,每天1次,静脉滴注;试验组在对照组基础上给予阿托伐他汀钙片,每次20 mg,每天1次,口服。2组患者均连续治疗14 d。比较2组患者的临床疗效、6 min步行距离(6MWD)、肺动脉压(PAP)、肺功能指标、动脉血气分析指标及药物不良反应发生情况。结果治疗后,试验组和对照组的总有效率分别为89. 16%(74例/83例)和77. 11%(64例/83例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的6MWD分别为(311. 14±37. 64)和(290. 46±34. 59) m,PAP分别为(37. 75±4. 58)和(45. 65±5. 22) mm Hg,用力肺活量(FVC)分别为(3. 37±0. 36)和(2. 94±0. 33)L,第1秒用力呼气容积占用力肺活量之比(FEV1/FVC)分别为(63. 57±7. 26)%和(57. 46±7. 12)%,最大呼气峰流速(PEF)分别为(5. 73±0. 38)和(4. 96±0. 64) L·s-1,动脉血血氧饱和度(SaO_2)分别为(98. 42±11. 15)%和(90. 03±11. 77)%,氧分压(PO_2)分别为(71. 15±8. 94)和(65. 32±8. 26)mm Hg,二氧化碳分压(PCO_2)分别为(41. 63±5. 11)和(50. 83±6. 29) mm Hg,差异均有统计学意义(均P <0. 05)。试验组的药物不良反应为恶心、呕吐、腹泻及注射部位疼痛,对照组的药物不良反应为恶心、呕吐、腹泻;试验组和对照组的药物不良反应发生率分别为8. 43%和6. 02%,差异无统计学意义(P> 0. 05)。结论阿托伐他汀联合前列地尔能明显降低COPD合并PAH患者的肺动脉压力,改善肺功能及动脉血气指标,临床疗效及安全性均较高。

Objective To investigate the clinical efficacy and safety of atorvastatin combined with alprostadil in patients with chronic obstructive pulmonary disease （COPD） combined with pulmonary arterial hyperten- sion（PAH）. Methods A total of 166 patients with COPD. combined with PAH in our hospital were randomly divided into treatment group and control group, 83 cases in each group. Control group was given alpros- tadil injection 10 μg per time, qd, intravenous drip. Treatment group was given atorvastatin calcium tablets 20 mg, qd, orally on the basis of control group. The two groups were treated for 14 d. The clinicalefficacy, 6 min walking distance （6MWD）, pulmonary arterial pressure （PAP）, pulmonary function indexes, arterial blood gas analysis indexes and incidence of adverse drug reactions were compared in two groups. Results After treat- ment, the total effective rates of treatment group and control group were 89. 16% （74 cases/83 cases） and 77.11% （64 cases/83 cases）, with significant difference （P 〈 0. 05 ）. After treatment, the 6MWD in treatment group and con- trol group were （311.14 ±37.64） and （290. 46 ±34. 59）m, PAPwere （37.75 ±4. 58） and （45.65 ±5.22） mmHg, forced vital capacity （ FVC ） were （ 3.37 ± O. 36 ） and （ 2.94 ± 0. 33 ） L, forced expiratory volume in first second accounted for the ratio of forced vital capacity （FEV1/FVC） were （63.57 ± 7.26）% and （57.46 ＋7.12）%, peak expiratory flow （PEF） were （5.73 ± 0. 38 ） and （ 4. 96 ± 0. 64 ） L·s^-1 , arterial blood oxygen saturation （ SaO2 ） were （98.42 ± 11.15）% and （90.03 ± 11.77）%, oxygen partial pressure （PO2） were （71.15＋8.94） and （65.32 ± 8.26） mmHg, partial pressure of carbon dioxide （ PCOz ） were （41.63 ± 5.11 ） and （50. 83 ± 6. 29 ） mm- Hg, all with significant differences （all P 〈 0. 05 ）. The adverse drug reactions in treatment group were nausea, vomiting, diarrhea and injection site pain, the adverse drug reactions in control group were nausea, vomiting, diarrhea. The total incidence of adverse drug reactions in treatment group and control group were 8.43% and 6.02%, with no signifi- cant difference （P 〉 0. 05 ）. Conclusion Atorvastatin combined with alprostadil can significantly reduce the pulmonary artery pressure in patients with COPD combined with PAH, the clinical efficacy and safety are high. improve pulmonary function and arterial blood gas indexes,