乙酰半胱氨酸泡腾片治疗慢性阻塞性肺疾病的临床研究

Clinical trial of acetylcysteine effervescent tablets in the treatment of chronic obstructive pulmonary disease

目的观察乙酰半胱氨酸泡腾片治疗慢性阻塞性肺疾病(COPD)的临床疗效及安全性。方法将174例COPD患者随机分为对照组87例和试验组87例。对照组予以支气管舒张药、抗胆碱药、β2受体激动药、糖皮质激素等常规治疗;试验组在对照组治疗的基础上,予以乙酰半胱氨酸泡腾片每次600 mg,bid,口服。2组患者均治疗4周。比较2组患者的临床疗效、肺功能、血清和诱导痰中白细胞介素-4(IL-4)与IL-6水平、血清氧化应激反应水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为91.95%(80例/87例)和77.01%(67例/87例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的1秒用力呼气容积分别为(1.89±0.21)和(1.47±0.18)L,用力肺活量分别为(2.45±0.17)和(2.21±0.12)L,血清IL-4分别为(0.93±0.07)和(1.17±0.16)ng·L^(-1),血清IL-6分别为(18.44±2.32)和(33.98±3.58)ng·L^(-1),诱导痰IL-4分别为(1.61±0.22)和(2.15±0.27)ng·L^(-1),诱导痰IL-6分别为(65.85±11.34)和(82.18±17.74)ng·L^(-1),血清丙二醛分别为(633.23±76.85)和(715.46±84.36)μmol·m L^(-1),活性氧分别为(49.78±6.35)和(62.77±8.49)U·m L^(-1),超氧化物歧化酶分别为(261.15±25.47)和(218.83±24.34)U·m L^(-1),谷胱甘肽过氧化物酶分别为(29.95±3.07)和(20.74±2.16)μmol·L^(-1),差异均有统计学意义(均P<0.05)。2组患者发生的药物不良反应均以胃肠不适、失眠、头痛和手颤为主。试验组和对照组的总药物不良反应发生率分别为10.35%和6.90%,差异无统计学意义(P>0.05)。结论乙酰半胱氨酸泡腾片治疗COPD的临床疗效确切,其能明显改善患者的肺功能,降低血清和诱导痰中IL-4、IL-6水平,抑制氧化应激反应,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of acetylcysteine effervescent tablets in the treatment of chronic obstructive pulmonary disease （COPD）. Methods One hundred and seventy -four patients with COPD were randomly divided into control and treatment groups with 87 cases per group. Control group was treated with bronchial diastolic, anticholinergic, β2 receptor agonist and glucocorticoid, and so on. Treatment group was given acetylcysteine effervescent tablets 600 mg per time, bid, orally, on the basis of control group. Tow groups were treated for 4 weeks. The clinical efficacy, lung function, the levels of in- terleukin - 4 （ IL - 4） and IL - 6 in serum and induced sputum, serumoxidative stress indexes and adverse drug reactions were compared between two groups. Results After treatment, the total effective rates of treatment and control groups were 91.95% （80 cases / 87 cases） and 77.01% （67 cases / 87 cases） with significant difference （P 〈 0.05）. After treatment, the main indexes in treatment and control groups were compared ： the forced expiratory volume in one second were （ 1.89 ±0.21 ） and （ 1.47 ±0. 18） L, forced vital capacity were（2.45±0.17） and（2.21±0.12）L, serumlL-4were （0.93±0.07） and （1.17±0.16）ng·L-1, serum IL-6 were （18.44 ±2.32） and （33.98 ±3.58）ng·L-1, induced sputum IL-4 were （1.61 ±0.22） and （2. 15 ±0.27）ng·L-1, induced sputum IL-6 were （65.85 ± 11.34） and （82. 18 ± 17.74）ng·L-1 , serum malon- dialdehyde were （633.23 ± 76. 85 ） and （715.46 ± 84. 36） μmol·L-1, reactive oxygen species were （49.78±6.35） and （62.77 ± 8.49）ng·L-1, superoxide dismutase were （261.15 ± 25.47） and （218.83 ±24. 34）μmol·L-1, glutathione peroxidase were （29.95 ±3.07） and （20.74 ±2. 16）μmol·L-1, with sig- nificant differences （ all P 〈 0. 05）. The adverse drug reactions of two groups were stomach upset, insomnia, headache and hand tremor, and there was no significant difference on the incidence of adverse reactions in treatment and control groups （10.35% vs 6. 90% , P 〉 0. 05）. Conclusion Acetylcysteine effervescent tablets have a definitive clinical efficacy in the treatment of COPD, which can improve the lung functions, reduce the levels of IL -4 and IL -6 in serum and induced sputum, inhibit oxidative stress response, without increasing the incidence of adverse drug reactions.