目的:研究细菌培养法、免疫层析法及实时荧光定量PCR法在孕晚期B族链球菌(Group B Streptococcus,GBS)筛查中的应用价值。方法:选取2021年3月至2023年5月在我院接受产检的孕晚期孕妇154例。以病理活检为金标准,分析GBS筛查结果;对比细...目的:研究细菌培养法、免疫层析法及实时荧光定量PCR法在孕晚期B族链球菌(Group B Streptococcus,GBS)筛查中的应用价值。方法:选取2021年3月至2023年5月在我院接受产检的孕晚期孕妇154例。以病理活检为金标准,分析GBS筛查结果;对比细菌培养法、免疫层析法及实时荧光定量PCR法单独及联合诊断孕晚期GBS的效能;分析细菌培养法、免疫层析法及实时荧光定量PCR法单独及联合筛查与病理筛查结果的一致性。结果:154例孕晚期孕妇中,经病理活检检出39例孕妇GBS为阳性;三者联合诊断GBS的灵敏度、特异度、准确率、阳性预测值以及阴性预测值均高于细菌培养法、免疫层析法与实时荧光定量PCR法单独检测(P<0.05);三者联合检测与病理结果的Kappa值为0.936,均高于细菌培养法、免疫层析法、实时荧光定量PCR法单独检测。结论:在筛查孕晚期孕妇GBS中,实时荧光定量PCR法联合细菌培养法、免疫层析法诊断效能高于单独检测,可通过三者联合检测为早期诊断孕妇是否感染GBS提供依据。展开更多
Background Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B(CHB),but it has a limited effect on cirrhosis.Chinese medicines(CMs),particularly Fuzheng Huayu Tablet(扶正化瘀片,FZHY),have an an...Background Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B(CHB),but it has a limited effect on cirrhosis.Chinese medicines(CMs),particularly Fuzheng Huayu Tablet(扶正化瘀片,FZHY),have an antifibrotic effect in patients with CHB.Objective To observe the safety and efficacy of adjunctive FZHY in patients with hepatitis B virus(HBV)cirrhosis,this study was designed as a randomized,placebo-controlled,double-blind,parallel assignment,multicenter trial at 20 centers in China.The total 700 naive patients will be enrolled with compensate cirrhosis due to HBV,and randomly assigned into 2 groups,receiving entecavir(0.5 mg,daily)and FZHY placebo(1.6 g,3 times a day),or entecavir(0.5 mg,daily)and FZHY(1.6 g,3 times a day),respectively.The primary endpoint was histological improvement at week 48.The secondary outcome is the decline values of liver fibrosis using the noninvasive methods from baseline to week 48 in each arm of the study.Adverse events such as stomach upset,headache,fatigue,dizziness,nausea will be strictly recorded.Discussion Through this study,we hope to generate a solid evidence for the therapeutic strategy of HBV cirrhosis with a combination of anti-viral such as ETV and anti-fibrotic herbal product such as FZHY.Protocol version:Version 1.3,Date:2014.12.4.Trial registration number:NCT02241590.展开更多
文摘目的:研究细菌培养法、免疫层析法及实时荧光定量PCR法在孕晚期B族链球菌(Group B Streptococcus,GBS)筛查中的应用价值。方法:选取2021年3月至2023年5月在我院接受产检的孕晚期孕妇154例。以病理活检为金标准,分析GBS筛查结果;对比细菌培养法、免疫层析法及实时荧光定量PCR法单独及联合诊断孕晚期GBS的效能;分析细菌培养法、免疫层析法及实时荧光定量PCR法单独及联合筛查与病理筛查结果的一致性。结果:154例孕晚期孕妇中,经病理活检检出39例孕妇GBS为阳性;三者联合诊断GBS的灵敏度、特异度、准确率、阳性预测值以及阴性预测值均高于细菌培养法、免疫层析法与实时荧光定量PCR法单独检测(P<0.05);三者联合检测与病理结果的Kappa值为0.936,均高于细菌培养法、免疫层析法、实时荧光定量PCR法单独检测。结论:在筛查孕晚期孕妇GBS中,实时荧光定量PCR法联合细菌培养法、免疫层析法诊断效能高于单独检测,可通过三者联合检测为早期诊断孕妇是否感染GBS提供依据。
基金Supported by Ministry of Science and Technology of the People’s Republic of China(No.2014ZX10005001)。
文摘Background Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B(CHB),but it has a limited effect on cirrhosis.Chinese medicines(CMs),particularly Fuzheng Huayu Tablet(扶正化瘀片,FZHY),have an antifibrotic effect in patients with CHB.Objective To observe the safety and efficacy of adjunctive FZHY in patients with hepatitis B virus(HBV)cirrhosis,this study was designed as a randomized,placebo-controlled,double-blind,parallel assignment,multicenter trial at 20 centers in China.The total 700 naive patients will be enrolled with compensate cirrhosis due to HBV,and randomly assigned into 2 groups,receiving entecavir(0.5 mg,daily)and FZHY placebo(1.6 g,3 times a day),or entecavir(0.5 mg,daily)and FZHY(1.6 g,3 times a day),respectively.The primary endpoint was histological improvement at week 48.The secondary outcome is the decline values of liver fibrosis using the noninvasive methods from baseline to week 48 in each arm of the study.Adverse events such as stomach upset,headache,fatigue,dizziness,nausea will be strictly recorded.Discussion Through this study,we hope to generate a solid evidence for the therapeutic strategy of HBV cirrhosis with a combination of anti-viral such as ETV and anti-fibrotic herbal product such as FZHY.Protocol version:Version 1.3,Date:2014.12.4.Trial registration number:NCT02241590.
