摘要
目的研究磷酸奥司他韦治疗流感流行季节中临床诊断流感疑似病例的安全性和耐受性。方法多中心随机、对照、开放性研究。入选患者1176例,随机分为2组。治疗组(599例)服用磷酸奥司他韦75mg,每日2次,共5d;对照组(577例)服用症状缓解药物复方盐酸伪麻黄碱缓释胶囊(市售)。结果治疗前两组患者的病情严重程度差异无显著意义(P>005)。治疗后(1)奥司他韦治疗组和对照组发热平均缓解时间分别为(39h±22h)和(64h±29h),差异有显著意义(F=25560,P<00001)。发热持续时间治疗组比对照组平均缩短达25h。(2)两组其他症状总评分AUC差异有显著意义(370分±241分vs.530分±342分,F=8683,P<00001)。治疗组比对照组症状总评分减少16021分(约3021%)。(3)其他流感症状持续时间治疗组比对照组平均缩短达20h。平均缓解时间分别为41h±29h和62h±35h(F=10822,P<00001)。(4)治疗组应用抗生素治疗的比例低于对照组(2153%vs.4301%,χ2=6118,P<00001)。同样使用抗生素治疗,治疗组治疗天数也短于对照组,分别为39d±27d和48d±21d,F=4510,P=0036)。(5)密切接触人群第二代发生率治疗组低于对照组(659%vs.1288%,F=1973,P<00001)(6)两组观察期间并发症发生率差异无显著意义(分别为323%和447%,χ2=1209,P=0272)。
Objective To evaluate the efficacy and safety of oseltamivir in the treatment of suspected influenza patients Methods A randomized, open, control and multiple center trial was conducted among 1176 individuals with suspected influenza They were randomized either to oseltamivir group(oseltamivir 75 mg , twice daily for 5 days) or control group who were given symptom relief medicine Results No difference was found between two groups in influenza symptoms of the patients ( P >0 05) before the treatment (1) Oseltamivir treatment significantly reduced the duration of fever about 25 hours post treatment (2)The AUC score of other symptoms was decreased by 160 21 (about 30 21%), and the duration was shorten by 20 hours (3) The ratio and duration of antibiotic use in oseltamivir group were less than that of control group ( P <0 0001 and P <0 05) (4)The incident rate of second generation influenza in oseltamivir group was also less than that of control group ( P <0 0001) (5)Secondary complications such as bronchitis, sinusitis and pneumonia occurred 3 23% in Oseltamivir group and 4 16% in the control group(χ 2=1 209, P =0 272) (6) Digestive symptom such as light nausea were occur in patients who took oseltamivir ,there was no difference of side effects rate between two groups(5 18% and 4 16%,χ 2=0 680, P =0 410) (7) 75 68%(28)were confirmed with positive result of virus test in 37suspected influenza patients Conclusion Our data suggests that Oseltamivir is effective and well tolerated in suspected influenza patients It can reduces the duration and severity of influenza symptom and fever, decrease the incidence of suspected influenza in the contacted population, antibiotic using, and with light side effect
出处
《中华医学杂志》
CAS
CSCD
北大核心
2004年第24期2132-2136,共5页
National Medical Journal of China
