阿莫西林氨溴索胶囊治疗急性轻度细菌性下呼吸道感染的多中心研究

发布时间：2019-08-16 07:17

【摘要】：目的评价阿莫西林氨溴索胶囊治疗我国成人急性轻度细菌性下呼吸道感染伴痰液黏稠患者的临床疗效和安全性。方法采用多中心、随机、双盲双模拟、阳性药物平行对照的研究设计,给予试验组患者口服阿莫西林氨溴索胶囊和阿莫西林胶囊的模拟剂各1粒,对照组患者口服阿莫西林胶囊和阿莫西林氨溴索胶囊的模拟剂各1粒,每日3次,疗程7~14 d,治疗前后对患者的症状、体征以及血常规、痰培养等实验室指标进行评估和比较。结果实际入选病例268例;纳入全分析集(FAS)255例,对照组128例,试验组127例;纳入符合方案集(PPS)243例。根据PPS分析,对照组和试验组祛痰有效率分别为63.6%和90.2%,临床治愈率分别为63.6%和88.5%,细菌培养阳性病例的痊愈率分别为55%和78%,试验组在祛痰疗效、临床总体疗效和综合疗效上均明显优于对照组(P0.05)。药物不良事件主要表现为丙氨酸转氨酶升高、呕吐、尿蛋白阳性、白细胞计数下降、腹泻,程度均为轻度,对照组和试验组不良事件的发生率无显著差异(2.3%vs.0.8%,P0.05)。结论阿莫西林氨溴索胶囊治疗我国成人急性轻度细菌性下呼吸道感染安全、有效,其祛痰疗效优势明显。
[Abstract]:Objective to evaluate the clinical efficacy and safety of amoxicillin ambroxol capsule in the treatment of acute mild bacterial lower respiratory tract infection with sputum viscosity in Chinese adults. Methods A multicenter, random, double-blind, parallel control study was designed. The patients in the experimental group were given one oral amoxicillin ambroxicillin capsule and one amoxicillin capsule simulator, respectively, and the control group was treated with amoxicillin capsule and amoxicillin ambroxicillin capsule 3 times a day for 7 to 14 days. The symptoms, signs and blood routine of the patients before and after treatment were given. The patients were treated with amoxicillin capsule and amoxicillin ambroxicillin capsule respectively, and the patients in the control group were treated with amoxicillin capsule and amoxicillin capsule three times a day. The laboratory indexes such as sputum culture were evaluated and compared. Results 268 cases were included in the total analysis set (FAS), 128 cases in the control group, 127 cases in the experimental group, and 243cases in the consistent scheme set (PPS) were included in the total analysis set, the control group (n = 128) and the experimental group (n = 127). According to PPS analysis, the effective rate of expectoration was 63.6% and 90.2%, the clinical cure rate was 63.6% and 88.5%, and the cure rate of bacterial culture positive cases was 55% and 78%, respectively. The main adverse events were elevated alanine transaminase, vomiting, positive urine protein, decreased white blood cell count and mild diarrhea. There was no significant difference in the incidence of adverse events between the control group and the experimental group (2.3% vs. 0.8%, P 0.05). Conclusion amoxicillin ambroxol capsule is safe and effective in the treatment of acute mild bacterial lower respiratory tract infection in adults in China, and its expectorant effect is obvious.
【作者单位】：中南大学湘雅三医院
【分类号】：R56

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