论文部分内容阅读
目的:评价布洛伪麻那敏片治疗头痛、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,共入组感冒患者225例,其中试验组112例,对照组113例,分别给予试验组和对照组患者口服布洛伪麻那敏片或氨酚伪麻那敏片,每次1片,每日4次,疗程均为3~5 d。治疗结束后分别对患者的症状、体征以及实验室指标进行安全性和有效性评估。结果:对照组和试验组的总有效率分别为96.46%和97.32%(P>0.05);对照组和试验组的总显效率分别为96.46%和96.43%(P>0.05)。治疗后,各组受试者的第一组症状(发热、头痛)及第二组症状(鼻塞、流涕、打喷嚏)明显减轻,治疗前后症状积分改善显著,其差异具统计学意义(两组均P<0.000 1),改善程度组间无显著差异(P>0.05)。各主要单项症状和体征均改善明显。不良反应多表现为嗜睡、口干、转氨酶升高和头晕,对照组和试验组不良反应发生率分别为7.08%(8/113)和4.46%(5/112),组间比较无显著差异(P>0.05),不良反应发生程度均为轻度。结论:布洛伪麻那敏片治疗成人感冒安全、有效,疗效与安全性与氨酚伪麻那敏片相当。
OBJECTIVES: To evaluate the efficacy and safety of brucellin’s tablets in the treatment of headache, fever and nasal congestion, runny nose, sneezing and other symptoms of adult flu. METHODS: A multicenter, randomized, double-blind, double-dummy, parallel-controlled trial of positive drugs was designed. A total of 225 patients were included in the study, including 112 patients in the experimental group and 113 patients in the control group. Patients in the experimental group and the control group were given oral Buluo Pseudomanar tablets or paracetamol pseudoephedrine tablets, each one, 4 times a day, treatment are 3 ~ 5 d. After treatment, the patient’s symptoms, signs and laboratory indicators were evaluated for safety and efficacy. Results: The total effective rates of the control group and the experimental group were 96.46% and 97.32%, respectively. The total effective rates of the control group and the experimental group were 96.46% and 96.43%, respectively (P> 0.05). After treatment, the symptoms of the first group (fever, headache) and the second group of symptoms (nasal obstruction, runny nose, sneezing) were significantly reduced, the symptom scores improved significantly after treatment, the difference was statistically significant (two Group P <0.000 1), there was no significant difference between the improvement groups (P> 0.05). The main symptoms and signs were significantly improved. Adverse reactions were mostly drowsiness, dry mouth, elevated aminotransferases and dizziness. The incidence of adverse reactions in the control and experimental groups were 7.08% (8/113) and 4.46% (5/112) respectively, with no significant difference between the two groups P> 0.05), the degree of adverse reactions were mild. Conclusion: Bupivacaine tablets are safe and effective in treating colds in adults, and its efficacy and safety are comparable to that of paracetamol and pseudoephedrine tablets.