磷酸奥司他韦治疗流行性感冒疑似患者的临床研究

Clinical Study on Oseltamivir Treating Suspected Influenza Patients

目的研究流行型感冒(流感)季节磷酸奥司他韦治疗临床诊断的流感疑似患者的安全性和耐受性。方法采用随机、对照、开放性研究,入选病例52例,随机分为2组。治疗组(26例)服用磷酸奥司他韦75mg,bid,共5天;对照组(26例)服用症状缓解药物复方盐酸伪麻黄碱缓释胶囊。结果治疗前两组患者的病情严重程度无显著性差异(P>0.05)。治疗后:(1)治疗组发热持续时间比对照组平均缩短25h,平均缓解时间分别为39.49±21.87h和63.63±29.47h,有显著性差异(F=255.60,P<0.0001)。(2)两组其他症状总评分AUC有显著性差异(F=86.83,P<0.0001),治疗组比对照组症状总评分减少160.21分(30.21%)。(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41.45±28.58h和61.78±35.24h(F=108.22,P<0.0001)。(4)治疗组应用抗生素治疗的比例低于对照组(分别为21.53%和43.01%,χ2=61.18,P<0.0001)。应用抗生素总天数治疗组少于对照组。(5)密切接触人群第二代发生率治疗组低于对照组(分别为6.59%和12.88%,F=19.73,P<0.0001)。(6)两组观察期间并发症发生率无显著性差异(分别为3.23%和4.47%,χ2=1.209,P=0.272)。以气管-支气管炎为主要并发症,另外还包括鼻窦炎、化脓性扁桃体炎、肺炎等。(7)两组观察期间不良反应发生率无显著性差异,分别为3.7%和4.2%,χ2=0.680,P=0.410。治疗组以胃肠道反应恶心、呕吐、上腹部不适等为主要症状。结论磷酸奥司他韦治疗临床诊断的流感疑似患者可以快速有效缓解症状,减少抗生素的应用,有效降低第二代的发病率,且不良反应少,应用安全。

Objective To evaluate the efficacy and safety of oseltamivir in the treatment of suspected influenza patients in influenza seasons.Method A randomized,open,control trial was conducted among 52 individuals with suspected influenza.They were divided randomly to treatment group(Oseltamivir 75 mg,bid for 5 days) and control group(given symptom relieving medicine pseudoephedrine).Results No difference was found between two groups in severity of the disease before the treatment(P>0.05).(1)Duration of fever in treatment group reduced about 25 hours than that in cortrol group after treatment.There was a significant difference in the average relief time (39.49±21.87h and 63.63±29.47h respectively,F=255.60,P<0.0001).(2)The AUC score of other symptoms decreased 160.21 scores(about 30.21%) in treatment group and the difference was significant(F=86.83,P<0.0001).(3)The duration of other symptoms was shortened about 20 hours in treatmment group.The average relief time was 41.45±28.58h and 61.78±35.24h(F=108.22,P<0.0001).(4)The ratio and duration of using antibiotics in treatment group were less than those in control group(21.53% vs 43.01%,χ2=61.18,P<0.0001).(5)The incident rate of second generation influenza in treatment group was also less than that in control group(6.5% vs 12.88%,F=19.73,P<0.0001).(6)There was on significant difference between two groups in the incidence of secondary complications such as bronchitis,sinusitis and pneumonia(3.23% vs 4.16%,χ2=1.209,P=0.272).(7)Digestive symptoms such as light nausea occurred in treatment group.There was no significant difference in incident rate of side effects between two groups(3.7% vs 4.2%,χ2=0.680,P=0.410).Conclusions Oseltamivir can quickly and effectively relieve influenza symptoms in suspected influenza patients and decrease the incidence of secondary complications and antibiotic usage.With little side effects,it is safe.