Abstract
Objective. To investigate the efficacy and safety of the combination of salbutamol (Nebutamol®, “Yuria-Pharm”) and hypertonic sodium chloride solution with sodium hyaluronate (Lorde® gial, “Yuria-Pharm”) in complex nebulizer therapy of bronchiectasis with concomitant bronchoobstruction.
 Materials and methods. As a result of initial screening, 74 patients with confirmed bronchiectasis using high-resolution computed tomography of thoracic organs were selected for further study of 45 patients who had <90 % postbronchodilation forced expiratory volume in 1 sec (FEV1) at the first visit. Patients on the second visit (V2) were prescribed 14-day nebulizer therapy with the bronchodilator salbutamol at a dosage of 2 mg / 2 ml and mucolytic sodium chloride solution 3 % with sodium hyaluronate 30 mg and respiratory gymnastics. Inhalation of mucolytic was prescribed 20 min after inhalation of bronchodilators. Subjective assessment of the severity of cough and sputum was performed using the scales of V.M. Savchenko (2001), assessment of the severity of dyspnea – on a modified scale of dyspnea of the Medical Research Council (mMRC). The daily amount of sputum (DAS) was measured by laboratory scales of high accuracy (MOMERT Model 6000). The respiratory function (RF) was measured using computer spirometry MasterLab (Viasis, Germany). Indicators were evaluated before and 15 min after inhalation of 400 μg salbutamol using a metered aerosol inhaler through a spacer. Indicators such as DAS, the severity of cough and sputum according to the Savchenko questionnaire, the severity of shortness of breath according to the mMRC and RF were determined at the first (screening – V1), the third (day 14 – V3), the fourth (day 28 – V4) and the fifth (day 42 – V5) visits. The safety of this therapy was assessed by recording all adverse events and further processing of the data.
 Results and discussion. The average age of patients was 58 (43; 66) years, 14 of them (31.1 %) were men. A comparison of all clinical and laboratory characteristics of patients on four visits was performed using Friedman’s rank analysis of variance (ANOVA). Among patients, no statistically significant differences were found between visits in the severity of dyspnea on the mMRC scale (p=0.05), FEV1 (p=0.22) and the ratio of FEV1/FVCpost (p=0.61). However, there were statistically significant differences in such indicators: subjective assessment of the severity of cough on the scale of Savchenko (F29.3=22.5; p=0.00005) was statistically significantly lower by V3 compared with V1 (p=0.0003), on V4 in comparison with V1 (p=0.006), on V5 in comparison with V1 (p=0.008). Subjective assessment of the amount of sputum on the scale of Savchenko (F29,3=22,2; p=0,00009) was significantly higher before treatment than after: on V1 in comparison with V3 (p=0,0005), on V1 in comparison with V4 (p=0.0005) and on V1 in comparison with V5 (p=0.002). DAS was also lower after treatment (F29.3=26.4; p=0.00001): V3 compared to V1 (p=0.000013), V4 compared to V1 (p=0.000006) and on V5 in comparison with V1 (p=0,00005). The following side effects were identified during therapy: tachycardia – in 4 patients (8.9 %), throat irritation after inhalation – in 2 patients (4.4 %), heartburn – in 1 patient (2.2 %).
 Conclusions. The use of salbutamol in a dosage of 2 mg / 2 ml and a solution of sodium chloride 3 % with sodium hyaluronate 30 mg by inhalation for 14 days had statistically and clinically significant effectiveness in reducing DAS, subjective feelings of the patient regarding the severity of cough and sputum in patients with bronchial obstruction. The use of Nebutamol® and Lorde® gial in complex nebulizer therapy of bronchiectasis has shown its effectiveness and safety, which is confirmed by the results of the study.
Highlights
IntroductionДослідити ефективність і безпечність застосування комбінації сальбутамолу (Небутамол®, «Юрія-Фарм») та гіпертонічного розчину натрію хлориду з натрію гіалуро натом (Лорде® гіаль, «Юрія-Фарм») у комплексній небулайзерній терапії бронхоектазії із супутньою бронхообструкцією
Indicators were evaluated before and 15 min after inhalation of 400 μg salbutamol using a metered aerosol inhaler through a spacer. Indicators such as daily amount of sputum (DAS), the severity of cough and sputum according to the Savchenko questionnaire, the severity of shortness of breath according to the mMRC and respiratory function (RF) were determined at the first, the third, the fourth and the fifth visits
No statistically significant differences were found between visits in the severity of dyspnea on the mMRC scale (p=0.05), forced expiratory volume in 1 sec (FEV1) (p=0.22) and the ratio of FEV1/FVCpost (p=0.61)
Summary
Дослідити ефективність і безпечність застосування комбінації сальбутамолу (Небутамол®, «Юрія-Фарм») та гіпертонічного розчину натрію хлориду з натрію гіалуро натом (Лорде® гіаль, «Юрія-Фарм») у комплексній небулайзерній терапії бронхоектазії із супутньою бронхообструкцією. Суб’єктивна оцінка вираженості кашлю та кількості мокротиння здійснювалася за допомогою шкал В.М. Як ДБК, вираженість кашлю та кількість мокротиння за опитувальником Савченка, вираженість задишки за опитувальником mMRC і ФЗД, визначалися на першому (скринінговому – В1), третьому (14 та доба – В3), четвертому (28-ма доба – В4) та п’ятому (42-га доба – В5) візитах. Застосування сальбутамолу в дозуванні 2 мг / 2 мл і розчину натрію хлориду 3 % з натрію гіалуронатом 30 мг інгаляційно протягом 14 днів мало статистично та клінічно значущу ефективність щодо зменшення ДКМ, суб’єктивних відчуттів хворого щодо вираженості кашлю та кількості мокротиння в пацієнтів із бронхоектазією із супутньою бронхообструкцією. State Institution “Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine”, Dnipro, Ukraine
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