国产奥司他韦治疗甲型H1N1流感患者的疗效与安全性研究 FREE

目的探讨甲型H1N1流行性感冒（流感）大流行期间，其临床诊断病例应用国产磷酸奥司他韦治疗的效果和安全性。方法收集发病48 h内的甲型H1N1流感临床诊断病例391例，随机分为治疗组（国产磷酸奥司他韦胶囊治疗）199例和对照组（复方盐酸伪麻黄碱缓释胶囊治疗）192例,在试验开始后10 d内，记录有关的症状、体温、药物不良反应、继发性疾病以及合并用药情况（包括抗菌药物等）。结果治疗组和对照组在观察期间需要留观者分别为20例（10.05%）和33例（17.19%），需要住院者分别为5例（2.51%）和13例（6.77%），两两比较，差异均有显著性(0.01＜P＜0.05）；治疗组和对照组发热平均缓解时间分别为（40.15±21.86） h和（65.92±29.08） h，差异有高度显著性（P＜0.0001）；流感症状平均缓解时间分别为（42.21±28.96） h和(63.06±34.85) h，差异亦有高度显著性（P＜0.0001）；流感症状持续时间，治疗组比对照组平均缩短21 h。治疗组密切接触者共 481人，发病92人（19.13%）,对照组密切接触者共415人，发病157人（37.83%），两组密切接触人群甲型H1N1流感第二代发生率差异有高度显著性(P＜0.001)。治疗组与对照组观察期间药物不良反应发生率分别为5.52%和4.92%，差异无显著性(P＞0.05)。结论甲型H1N1流感大流行期间，早期应用国产磷酸奥司他韦能有效地缓解此类患者临床症状，减低留观和住院概率，缩短疗程，有效降低密切接触人群的第二代流感发生率；不良反应发生率低，临床应用安全有效。

Efficacy and safety of oseltamivir in the treatment of patients with influenza A (H1N1) FREE

ObjectiveTo study the efficacy and safety of domestic oseltamivir phosphate in the treatment of patients during pandemic influenza A (H1N1) outbreak.MethodsAmong 391 clinical diagnosed cases within 48 hours after the onset of illness, 199 (treatment group) were given domestic oseltamivir phosphate and 192 (control group) were given compound pseudoephedrine hydrochloride sustained release capsules. In the next 10 days, symptoms, body temperature, adverse reaction of drugs, secondary diseases and combined drug use (including antimicrobial agents) were recorded .ResultsTwenty (10.05%) and 33 cases (17.19%) in treatment and control group needed to stay for observation, 5(2.51%) and 13 cases (6.77%) needed to be hospitalized in treatment and control group respectively, there were significant difference between two groups (0.01＜P＜0.05）; Average fever remission time were (40.15±21.86) h in treatment group and (65.92±29.08) h in control group respectively（P<0.0001）; Average flu symptoms remission time were (42.21±28.96) h in treatment group and (63.06±34.85) h in control group respectively（P<0.0001）; Average duration of flu symptoms in treatment group were 21 h shorter than control group. 92 of 481 (19.13%) close contacts in treatment group and 157 of 415 (37.83%) close contacts in control group developed influenza A (H1N1) (P<0.001), there was significant difference between the treatment and control group（ P＜0.001）. In observation period, the incidence of adverse drug reaction was 5.52% and 4.92% in treatment and control group respectively, there was no significant difference（P＞0.05）.ConclusionDuring pandemic influenza A (H1N1) outbreak, early use of domestic oseltamivir phosphate for treatment can relieve clinical symptoms effectively, reduce the hospitalization and observation rate, shorten treatment course, and reduce the incidence of the second generation influenza A (H1N1) in close contacts. Domestic oseltamivir phosphate has low incidence of adverse reactions, clinical application is safe and effective.