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.
ABSTRACT
<p><b>OBJECTIVE</b>To identify the volatile organic compounds (VOCs) in lung cancer tissue and lung cancer cell lines.</p><p><b>METHODS</b>The lung cancer tissue samples from 18 patients were cultured and 4 lung cell lines (A549, NCI-H446, SK-MES-1, BEAS-2B) were also included in the study. Air samples in the headspace of culture flasks were analyzed for VOCs with solid-phase micro-extraction and gas chromatography-mass spectroscopy technique (SPME-GC/MS).</p><p><b>RESULT</b>Two kinds of VOCs 2-pentadecanone and nonadecane were detected in lung cancer cell lines A549, NCI-H446 and SK-MES-1. The concentration of 2-pentadecanone were (1.382 + or -0.171) X 10(-5)mg/L, (1.681 + or - 0.190) X 10(-4)mg/L and (2.835 + or - 0.401) X 10(-6)mg/L, respectively; the concentrations of nonadecane were (8.382 + or - 0.606 ) X 10(-6)mg/L, (1.845 + or - 0.130) X 10(-5)mg/L and (6.220 + or - 0.362) X 10(-6)mg/L), respectively. The eicosane was detected in A549 and NCI-H446 with the concentration of (8.313 + or - 1.130) X 10(-6)mg/L and (1.020 + or - 0.141) X 10(-5)mg/L), respectively. All the 3 VOCs were not detected in cell line BEAS-2B. The concentrations of 12 VOCs including decane, 2- pentadecanone, nonadecane and eicosane were high in 18 lung cancer tissue samples; the concentrations of 2-pentadecanone were 5.421 X 10(-6)mg/L-3.621 X 10(-5)mg/L,those of nonadecane were 5.805 X 10(-6)mg/L-1.830 X 10(-5)mg/L, those of eicosane were 2.730 X 10(-6)mg/L-2.343 X 10(-5)mg/L. There were no differences of VOCs levels among patients with different cancer differentiation (P>0.05). The concentration of eicosane in the non-squamous carcinoma was higher than that in squamous carcinoma, the same results were confirmed in the lung cancer cell lines.</p><p><b>CONCLUSION</b>This study has identified VOCs produced by lung cancer tissue, which may support to use breath test as a complementary noninvasive diagnostic method for lung cancer.</p>