Duration of viral shedding of influenza A (H1N1) virus infection treated with oseltamivir and/or traditional Chinese medicine in China: a retrospective analysis

[OBJECTIVE]:H1N1 was a new and potentially serious infectious disease,in human,the severity of influenza can vary from mild to severe,thus to find an effective and safety way to control the influenza pandemic is of crucial importance.This retrospective study describes the duration of viral shedding in H1N1 patients that were hospitalized and treated in China.[METHODS]:Clinical data were collected from May to July,2009 in China for 963 patients with influenza A (H1N1) virus infection.Patients were treated based on the guidelines issued by the Chinese Ministry of Health.The primary outcome was duration of viral shedding and statistical comparisons were performed.[RESULTS]:In the patients with body temperature greater than 38.0°C,there were no differences in virus shedding duration among the patients taking oseltamivir within two days,patients undergoing Traditional Chinese Medicine (TCM) therapy or those receiving no drug therapy.In patients with body temperature≥38.1°C,TCM therapy reduced the viral shedding duration (P＜0.05,vs.oseltamivir therapy).Furthermore,taking oseltamivir two days after onset of symptoms might prolong the virus shedding duration (P＜0.05,vs.taking oseltamivir less than 2 days of onset).[CONCLUSION]:TCM therapy is effective for reducing the length of virus shedding in patients with body temperature≥38.0°C.Oseltamivir used for reducing virus shedding duration should be taken within two days of onset.     

国产奥司他韦治疗甲型H1N1流感患者的疗效与安全性研究

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(0.01P0.05);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(P0.0001);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(P0.0001);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(P0.001)。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(P0.05)。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。     

Oseltamivir-Resistant Influenza Viruses A (H1N1) during 2007�C2009 Influenza Seasons, Japan

To monitor oseltamivir-resistant influenza viruses A (H1N1) (ORVs) with H275Y in neuraminidase (NA) in Japan during 2 influenza seasons, we analyzed 3,216 clinical samples by NA sequencing and/or NA inhibition assay. The total frequency of ORVs was 2.6% (45/1,734) during the 2007–08 season and 99.7% (1,477/1,482) during the 2008–09 season, indicating a marked increase in ORVs in Japan during 1 influenza season. The NA gene of ORVs in the 2007–08 season fell into 2 distinct lineages by D354G substitution, whereas that of ORVs in the 2008–09 season fell into 1 lineage. NA inhibition assay and M2 sequencing showed that almost all the ORVs were sensitive to zanamivir and amantadine. The hemagglutination inhibition test showed that ORVs were antigenetically similar to the 2008–09 vaccine strain A/Brisbane/59/2007. Our data indicate that the current vaccine or zanamivir and amantadine are effective against recent ORVs, but continuous surveillance remains necessary.     

Oseltamivir-resistant pandemic (H1N1) 2009 virus, South Korea

To identify oseltamivir resistance, we analyzed neuraminidase H275Y mutations in samples from 10 patients infected with pandemic (H1N1) 2009 virus in South Korea who had influenza that was refractory to antiviral treatment with this drug. A neuraminidase I117M mutation that might influence oseltamivir susceptibility was detected in sequential specimens from 1 patient.     

Duration of viral shedding of Influenza A(H1N1) virus infection treated with oseltamivir and/or Traditional Chinese Medicine in China:A retrospective analysis

OBJECTIVE:H1N1 was a new and potentially serious infectious disease,in human,the severity of influenza can vary from mild to severe,thus to find an effective and safety way to control the influenza pandemic is of crucial importance.This retrospective study describes the duration of viral shedding in H1N1 patients that were hospitalized and treated in China.METHODS:Clinical data were collected from May to July,2009 in China for 963 patients with influenza A(H1N1) virus infection.Patients were treated based on the guidelines issued by the Chinese Ministry of Health.The primary outcome was duration of viral shedding and statistical comparisons were performed.RESULTS:In the patients with body temperature greater than 38.0℃,there were no differences in virus shedding duration among the patients taking oseltamivir within two days,patients undergoing Traditional Chinese Medicine(TCM) therapy or those receiving no drug therapy.In patients with body temperature 338.1℃,TCM therapy reduced the viral shedding duration(P<0.05,vs.oseltamivir therapy).Furthermore,taking oseltamivir two days after onset of symptoms might prolong the virus shedding duration(P<0.05,vs.taking oseltamivir less than 2 days of onset).CONCLUSION:TCM therapy is effective for reducing the length of virus shedding in patients with body temperature 338.0℃.Oseltamivir used for reducing virus shedding duration should be taken within two days of onset.     

磷酸奥司他韦干混悬剂中杂质谱解析及辅料降解杂质分析

目的 对磷酸奥司他韦干混悬剂中一个未知杂质进行结构鉴定、合成和分析,作为已知杂质控制。方法 通过二维液相色谱-质谱（2D-LC-MS/MS）推导未知杂质的结构,根据产品的处方工艺确定杂质来源,并采用定向合成的方式获得杂质单体。采用2D-LC-MS/MS、核磁共振、红外、紫外、热重分析等技术确证杂质的结构,最后采用HPLC对杂质进行分析方法验证。结果 确证该杂质为奥司他韦与辅料山梨醇反应生成的,杂质与奥司他韦的校正因子为1.5。结论 将该杂质命名为杂质I,作为已知杂质定入标准控制,按照自身对照加校正因子法计算杂质含量。     

Emergence of Oseltamivir-Resistant Pandemic (H1N1) 2009 Virus within 48 Hours

An oseltamivir-resistant influenza A pandemic (H1N1) 2009 virus evolved and emerged from zero to 52% of detectable virus within 48 hours of a patient’s exposure to oseltamivir. Phylogenetic analysis and data gathered by pyrosequencing and cloning directly on clinical samples suggest that the mutant emerged de novo.     

帕拉米韦氯化钠注射液治疗儿童流行性感冒的效果及安全性

目的探讨帕拉米韦氯化钠注射液治疗儿童流行性感冒(流感)的效果及安全性,为临床安全用药提供依据。方法选取2017年1月—2018年12月涿州市医院收治的流感患儿260例,按照随机数字表法将其分为观察组(n=130)和对照组(n=130)。对照组给予磷酸奥司他韦颗粒治疗,观察组给予帕拉米韦氯化钠注射液治疗,观察2组的疗效及安全性。结果观察组治疗后的体温恢复正常时间、咳嗽缓解时间、鼻卡他/鼻塞缓解时间、咽喉痛缓解时间及症状完全缓解时间均明显低于对照组,差异有统计学意义(P均0.05)。观察组治疗后的总有效率明显高于对照组(96.2%vs. 83.8%,P 0.05)。观察组治疗前后血常规各项指标与对照组比较,差异均无统计学意义(P均 0.05)。观察组与对照组治疗后不良反应发生率比较,差异无统计学意义(8.5%vs. 12.3%,P 0.05)。结论采用帕拉米韦氯化钠治疗儿童流感的效果较好,能更快地改善流感症状,且不会增加不良反应。