摘要
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 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.
关键词
吸入用乙酰半胱氨酸溶液 /
祛痰 /
多中心 /
临床试验
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Key words
inhaled N-acetyl-L-cysteine solution /
mucolytic therapy /
multi-centre /
clinical trial
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邱园华,陈恩国,戴元荣,任振义,周新,施敏骅,蒋汉梁,应可净.
国产吸入用乙酰半胱氨酸溶液祛痰的疗效和安全性评价[J]. 中国药学杂志, 2012, 47(21): 1760-1762
QIU Yuan-hua, CHEN En-guo, DAI Yuan-rong, REN Zhen-yi, ZHOU Xin, SHI Min-hua, JIANG Han-liang, YING Ke-jing .
Efficacy and Safety of Domestic Inhaled N-acetyl-L-cysteine Solution in Mucolytic Therapy[J]. Chinese Pharmaceutical Journal, 2012, 47(21): 1760-1762
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参考文献
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脚注
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