布洛伪麻那敏胶囊治疗成人普通感冒的多中心随机双盲对照临床研究

发布时间：2018-03-26 03:51

本文选题：普通感冒　切入点：布洛芬　出处：《临床肺科杂志》2016年01期

【摘要】：目的评价天圣制药集团股份有限公司研制生产的布洛伪麻那敏胶囊治疗成人普通感冒的疗效和安全性。方法采用多中心、随机、双盲、双模拟、阳性药物平行对照的临床试验方法,对照药为通和制药有限公司生产的氨酚伪麻那敏片。试验组和对照组分别口服布洛伪麻那敏胶囊和氨酚伪麻那敏片,每次1粒(片),每日3次,疗程均为3~5 d。结果实验组和对照组纳入全分析集(FAS)分别为119和119例,总有效率分别为98.32%和97.48%,控制率分别为86.55%和93.28%;符合方案集(PPS)分别为117和115例,总有效率分别为98.29%和98.26%,控制率分别为86.32%和93.91%;两组以上疗效指标比较差异均无统计学意义(P0.05);两组单项症状(发热、头痛、肢体酸痛、鼻塞、打喷嚏、流鼻涕)终点有效率及控制率比较差异均无统计学意义(P0.05)。两组药物不良反应发生率分别为13.45%和11.76%,差异无统计学意义(P0.05),主要为轻度嗜睡、头晕、乏力、口干,无严重不良事件发生。结论布洛伪麻那敏胶囊治疗成人普通感冒安全、有效;其疗效和安全性与氨酚伪麻那敏片相近。
[Abstract]:Objective to evaluate the efficacy and safety of bulobo-Manamin capsule developed by Tiansheng Pharmaceutical Group Co., Ltd for the treatment of common cold in adults. The clinical trial method of parallel control of positive drugs was controlled by Tonghe Pharmaceutical Co., Ltd. The experimental group and the control group were treated with bulobo-manamin capsules and paracetamol pseudo-monamine tablets, respectively. Results the FASs of the experimental group and the control group were 119 and 119 respectively, the total effective rates were 98.32% and 97.48%, the control rates were 86.55% and 93.28%, respectively, and the PPSs were 117 and 115 cases, respectively. The total effective rates were 98.29% and 98.26%, respectively, and the control rates were 86.32% and 93.91%, respectively. The incidence of adverse drug reactions in the two groups was 13.45% and 11.76%, respectively. There was no significant difference between the two groups in the incidence of adverse drug reactions, mainly mild lethargy, dizziness, fatigue and dry mouth. Conclusion buprofen Manamin capsule is safe and effective in the treatment of adult common cold, and its efficacy and safety are similar to those of aminophenol pseudomanamine tablet.
【作者单位】：泸州医学院附属医院呼吸内科;第二炮兵总医院呼吸内科;中南大学湘雅三医院呼吸内科;成都军区总医院呼吸内科;第三军医大学大坪医院呼吸内科;
【分类号】：R511.6

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