国产吸入用乙酰半胱氨酸溶液祛痰的疗效和安全性评价

Efficacy and Safety of Domestic Inhaled N-acetyl-L-cysteine Solution in Mucolytic Therapy

目的与市售进口品乙酰半胱氨酸注射液(富露施)雾化吸入比较,评价国产吸入用乙酰半胱氨酸溶液祛痰的有效性和安全性。方法本试验采用多中心、随机、双盲、阳性药平行对照设计。选用已经上市的同种进口药物富露施作为对照。共收集急慢性下呼吸道感染患者234例,试验药物组117例,对照组117例。各取3 mL药物,雾化吸入,bid,总疗程5～7 d。统计学上采用非劣效检验及双侧检验。结果试验组的有效率为74.8%(PPS),74.1%(FAS),与对照组比较差异无统计学意义(P>0.05)。在研究过程中,没有发生严重不良事件和重要不良事件。试验组不良事件发生率为14.5%,与对照组比较差异无统计学意义(P>0.05)。根据预设的非劣界值15%,两组非劣效结论成立。结论吸入用乙酰半胱氨酸溶液与富露施比较,祛痰疗效和安全性相当。

ABSTRACT ： OBJECTIVE To evaluate the clinical efficacy and safety of domestic inhaled N-acetyl-L-cysteine （NAC） solution in mucolytic therapy. METHODS This was a multi-centre, randomized, double blinded and positive parallel trial. Fluimucil, an im- ported drug with the same active ingredient was used as control. Two hundred and thirty-four patients suffering from acute and chronic lower respiratory tract infection were enrolled, 117 patients in study group and control group respectively. Both groups were treated by respective drug 3 mL given by inhalation, bid, for 5 - 7 d. Non-inferiority test and two-sided test were used to analyze the statistic difference. RESULTS The effective rates of the study group were 74. 8% （PPS） and 74. 1% （FAS）. There was no significant difference （P 〉 0. 05 ） between the two groups. There were no serious adverse events and major adverse events during the study. The incidence of adverse events in study group was 14. 5%. There was no significant difference （P 〉0. 05 ） between the two groups. Ac- cording to the preset non-inferior creteria, ie 15%, the non-inferiority of the test drug was established. CONCLUSION The clinical efficacy and safety of the domestive inhaled N-acetyl-L-cysteine solution in mucolytic therapy are equal to fluimucil. KEY WORDS ： inhaled N-acetyl-L-cysteine solution ; mucolytic therapy ; multi-centre ; clinical trial