Hassan Mohamed Ismail, Laz Nabila Ibrahim, Madney Yasmin M, Abdelrahim Mohamed E A, Harb Hadeer S
Department of Pharmacy Practice, Faculty of Pharmacy, Sinai University-Al Arish Campus, North Sinai, Egypt.
Department of Chest Diseases, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.
Clin Ther. 2024 Dec;46(12):e16-e24. doi: 10.1016/j.clinthera.2024.09.016. Epub 2024 Sep 30.
Suboptimal peak inspiratory flow rate (PIFR) is highly prevalent in patients with chronic obstructive pulmonary disease (COPD) owing to the mismatch of their PIFR with the corresponding inhaler-device resistance. This study aimed to investigate the impact of a preliminary dose of pressurized metered dose inhalers (pMDIs) on patients with COPD with suboptimal PIFR using Diskus dry powder inhalers (DPIs).
A prospective, randomized, case-control study included 24 patients with COPD. PIFR was measured using the In-Check Dial G16 with low-to-medium resistance. Spirodoc was used to measure baseline spirometric data and compare it before and 30 minutes after the administration of Diskus DPI. On a different day, the study dose was given to each suboptimal patient by the same aerosol generator with preceded 2 puffs of salbutamol pMDI and re-evaluated for spirometric parameters 30 minutes after the study dose.
There was a significant difference between the optimal and suboptimal groups in peak expiratory flow (2.38 ± 1.20 vs 1.49 ± 1.06 L/s, P = 0.050). PIFR showed a statistically significant difference between the optimal and suboptimal groups (71.66 ± 6.15 vs 41.25 ± 9.79 L/min, P < 0.0001). There was a significant difference in forced vital capacity (ΔFVC) between optimal and suboptimal groups without a preliminary dose (0.42 ± 0.21 vs 0.16 ± 0.11 L, P = 0.002), forced expiratory volume in 6 seconds (ΔFEV) (0.53 ± 0.49 vs 0.17 ± 0.11 L, P = 0.022), forced expiratory volume in 3 seconds (ΔFEV) (0.41 ± 0.38 vs 0.1 ± 0.16 L, P = 0.013), forced expiratory volume in 1 second (ΔFEV)/FVC (-2.38 ± 8.41 vs 2.96% ± 2.95%, P = 0.033), and ΔFEV/FEV (-4.32 ± 11.23 vs 2.91% ± 4.35%, P = 0.015). There was a significant difference in ΔFVC between optimal and suboptimal groups with a preliminary dose (0.42 ± 0.21 vs 0.23 ± 0.18 L, P = 0.046), ΔFEV/FVC (-2.38 ± 8.41 vs 5.67% ± 6.53%, P = 0.009), ΔFEV/FEV (-4.32 ± 11.23 vs 5.16% ± 4.99%, P = 0.008), and forced expiratory time (ΔFET) (0.28 ± 0.45 vs -0.31 ± 0.70 seconds, P = 0.022). The only parameter that showed a significant difference between suboptimal groups without and with a preliminary dose is Δ peak expiratory flow (0.24 ± 0.59 vs 0.65 ± 0.68 L/s, P = 0.004).
Administering a preliminary dose of pMDI can minimally enhance the effectiveness of DPIs in patients with COPD with suboptimal PIFR and health outcomes.
由于慢性阻塞性肺疾病（COPD）患者的吸气峰流速（PIFR）与相应吸入装置阻力不匹配，次优PIFR在COPD患者中非常普遍。本研究旨在调查使用都保干粉吸入器（DPI）时，预充剂量的压力定量吸入器（pMDI）对PIFR次优的COPD患者的影响。
一项前瞻性、随机、病例对照研究纳入了24例COPD患者。使用中低阻力的In-Check Dial G16测量PIFR。使用肺功能仪测量基线肺功能数据，并在使用都保DPI前和给药30分钟后进行比较。在不同日期，由同一雾化发生器给每位次优患者给予研究剂量，之前先喷2喷沙丁胺醇pMDI，并在研究剂量给药30分钟后重新评估肺功能参数。
最佳组和次优组在呼气峰流速方面存在显著差异（2.38±1.20 vs 1.49±1.06 L/s，P = 0.050）。最佳组和次优组的PIFR在统计学上有显著差异（71.66±6.15 vs 41.25±9.79 L/min，P < 0.0001）。在没有预充剂量时，最佳组和次优组的用力肺活量（ΔFVC）（0.42±0.21 vs 0.16±0.11 L，P = 0.002）、6秒用力呼气容积（ΔFEV）（0.53±0.49 vs 0.17±0.11 L，P = 0.022）、3秒用力呼气容积（ΔFEV）（0.41±0.38 vs 0.1±0.16 L，P = 0.013）、1秒用力呼气容积（ΔFEV）/FVC（-2.38±8.41 vs 2.96%±2.95%，P = 0.033）以及ΔFEV/FEV（-4.32±11.23 vs 2.91%±4.35%，P = 0.015）存在显著差异。在有预充剂量时，最佳组和次优组的ΔFVC（0.42±0.21 vs 0.23±0.18 L，P = 0.046）、ΔFEV/FVC（-2.38±8.41 vs 5.67%±6.53%，P = 0.009）、ΔFEV/FEV（-4.32±11.23 vs 5.16%±4.99%，P = 0.008）以及用力呼气时间（ΔFET）（0.28±0.45 vs -0.31±0.70秒，P = 0.022）存在显著差异。在没有预充剂量和有预充剂量的次优组之间，唯一显示出显著差异的参数是呼气峰流速差值（0.24±0.59 vs 0.65±0.68 L/s，P = 0.004）。
给予预充剂量的pMDI可在一定程度上提高DPI对PIFR次优的COPD患者的有效性和健康结局。
