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目的评价布洛伪麻那敏干混悬剂治疗头痛、发热并伴有鼻塞、流涕、打喷嚏等症状的成人感冒的有效性和安全性。方法采用多中心、随机、双盲、双模拟阳性药物平行对照试验设计,分别给予对照组和试验组病人口服氨酚伪麻那敏片Ⅱ或布洛伪麻那敏干混悬剂,每日4次,疗程均为3～5d。治疗结束后分别对病人的症状、体征以及实验室指标进行评估和组间比较。结果纳入全分析集(FAS)222例,其中对照组109例,试验组113例。完成符合方案集(PPS)219例,对照组107例,试验组112例。按FAS或PPS分析,对照组总有效率及总显效率均为99.1%,试验组总有效率及总显效率均为100.0%,2组疗效差异无显著意义(P>0.05)。治疗后,2组受试者的第1组症状(发热、头痛)及第2组症状(鼻塞、流涕、打喷嚏)的积分均显著改善(P<0.05),改善程度组间无显著差异(P>0.05)。药物不良反应多表现为嗜睡、困倦、口干和头晕,对照组和试验组不良反应发生率分别为15.4%和8.8%,组间比较无显著差异(P>0.05),且发生程度均为轻度。结论布洛伪麻那敏干混悬剂治疗成人感冒安全、有效。
Objective To evaluate the efficacy and safety of budesonide and pseudoephedrine suspension in the treatment of headache, fever and nasal congestion, runny nose and sneezing in adults. Methods A multicenter, randomized, double-blind, double-dummy, parallel-controlled trial of positive drugs was designed. Patients in the control group and the test group were given oral aminophenophenanthroline II or bupivacaine hydrochloride suspension 4 times a day , Treatment are 3 ~ 5d. After treatment, the patient’s symptoms, signs and laboratory parameters were evaluated and compared between groups. Results The total analysis set (FAS) was included in 222 cases, including 109 cases in the control group and 113 cases in the test group. A total of 219 cases of PPS, 107 cases of control group and 112 cases of experimental group were completed. According to FAS or PPS analysis, the total effective rate and total effective rate were 99.1% in the control group. The total effective rate and total effective rate in the experimental group were 100.0%. There was no significant difference between the two groups (P> 0.05). After treatment, the scores of group 1 symptoms (fever, headache) and symptoms of group 2 (nasal obstruction, runny nose, sneezing) were significantly improved (P <0.05), and there was no significant difference between the two groups (P> 0.05). Adverse reactions were mostly drowsiness, drowsiness, dry mouth and dizziness. Adverse reactions were 15.4% and 8.8% respectively in the control and experimental groups, with no significant difference between the two groups (P> 0.05) degree. Conclusion Bupi pseudoephedrine Min Suspension is safe and effective in the treatment of adult colds.