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 imported 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. According 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.
QIU Yuan-Hua,
CHEN ��Guo,
DAI Yuan-Rong etc
.Efficacy and Safety of Domestic Inhaled N-acetyl-L-cysteine Solution in Mucolytic Therapy[J] Chinese Pharmaceutical Journal, 2012,V47(21): 1760-1762
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