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《Vaccine》2019,37(41):6102-6111
Loss of airway microbial diversity is associated with non-typeable Haemophilus influenzae (NTHi) infection and increased risk of exacerbation in chronic obstructive pulmonary disease (COPD). We assessed the safety and immunogenicity of an investigational vaccine containing NTHi antigens, recombinant protein D (PD) and combined protein E and Pilin A (PE-PilA), and AS01 adjuvant in adults with moderate/severe COPD and prior exacerbations.In this phase 2, observer-blind, controlled trial (NCT02075541), 145 COPD patients aged 40–80 years randomly (1:1) received two doses of NTHi vaccine or placebo 60 days apart, on top of standard care.Reactogenicity in the 7-day post-vaccination period was higher following NTHi vaccine than placebo. Most solicited adverse events (AEs) were mild/moderate. At least one unsolicited AE was reported during the 30-day post-vaccination period by 54.8% of NTHi vaccine and 51.4% of placebo recipients. One serious AE (placebo group) was assessed by the investigator as vaccine-related. Anti-PD, anti-PE and anti-PilA geometric mean antibody concentrations increased up to 30 days after each NTHi vaccine dose, waned thereafter, but remained higher than baseline (non-overlapping confidence intervals) up to 13 months post-dose 2. The frequency of specific CD4+ T cells increased following two doses of NTHi vaccine and remained higher than baseline. Exploratory analysis showed a statistically non-significant lower yearly rate of moderate/severe exacerbations in the NTHi vaccine group than following placebo (1.49 versus 1.73) in the one-year period post-dose 2, with estimated vaccine efficacy of 13.3% (95% confidence interval −24.2 to 39.5; p = 0.44).The NTHi vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in adults with COPD. 相似文献
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ABSTRACT Purpose: To describe a case of bilateral panuveitis in the setting of IgA nephropathy. Methods: Retrospective review of clinical records, fundus, and optical coherence tomographic (OCT) images, and fluorescein angiography. Results: A 36-year-old female presented with IgA nephropathy and contemporaneous ocular manifestations of one-year duration. Clinical exam demonstrated bilateral panuveitis, 3+ anterior chamber (AC) cell in the right eye (OD), and 0.5+ AC cell in the left eye (OS). Funduscopic exam demonstrated diffuse yellow drusenoid deposits bilaterally (OU), accentuated on fundus autofluorescence as focal areas of hyperautofluorescence. Deposits correlated with retinal pigment epithelium hyper-reflectivity on OCT, and choroidal hypo-fluorescence on fluorescein angiography. The patient was managed with oral prednisone. Conclusion: IgA nephropathy is a systemic autoimmune disease that may be associated with uveitis. Immunosuppression with corticosteroids appears to be an effective therapy. 相似文献
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吕聪 《中国中医药现代远程教育》2020,(1):124-126
目的研究辨证分型联合西药治疗免疫球蛋白a(Ig A)肾病的临床效果。方法选取收治的74例Ig A肾病患者,采用均衡分组法分为西药组和联合组,各37例。西药组采用氯沙坦钾片治疗,联合组辅以辨证分型治疗,治疗6个月后开展随访观察疗效。结果联合组治疗总有效率94.59%高于西药组的64.86%,联合组并发症发生率2.70%低于西药组的21.62%,联合组不良反应发生率2.70%低于西药组的24.32%,对比差异有统计学意义(P<0.05)。治疗后,联合组血肌酐高于西药组和治疗前,尿红细胞、尿蛋白指标低于西药组和治疗前,对比有统计学意义(P<0.05)。结论辨证分型联合西药治疗Ig A肾病的临床效果显著,可降低并发症及不良反应发生风险,改善其血液指标,具有较高临床推广价值。 相似文献
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IntroductionWe aimed to assess, in patients with Parkinson's disease (PD), the association between obstructive sleep apnea (OSA), progression of motor dysfunction and the effect of OSA treatment.MethodsData were analysed from a prospective cohort study of idiopathic PD patients from a movement disorders clinic. Patients found to have OSA on polysomnography (apnea-hypopnea index [AHI] ≥15 events/h, OSA+) were offered treatment using continuous positive airway pressure (CPAP). CPAP+ was defined as an average ≥ 2 h/night use at each follow-up. Motor symptoms were assessed using the motor section of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (mUPDRS) and the Timed-Up-And-Go (TUG). Follow-up times were 3, 6 and 12 months. Mixed models were constructed, adjusting for age, sex, body mass index, levodopa equivalent dose and comorbidities.ResultsWe studied 67 individuals (61.2% male) of mean age 64.7 years (SD = 10.1). Baseline mUPDRS was higher in OSA+ compared to OSA- (24.5 [13.6] vs. 16.2 [7.2], p < 0.001). Motor dysfunction increased at comparable rates in OSA- and OSA+CPAP-. However, in OSA+CPAP+, mUPDRS change was significantly lower compared to OSA- (β = −0.01 vs. 0.61, p = 0.03; p = 0.12 vs. OSA+CPAP- [β = 0.39]) and TUG change was lower compared to OSA+CPAP- (β = −0.01 vs. 0.13, p = 0.002; p = 0.05 vs. OSA- [β = 0.02]).ConclusionsIn this PD cohort, OSA was associated with higher baseline mUPDRS. In those with OSA, CPAP use was associated with stabilization of motor function (mUPDRS and TUG) over 12 months. These observations support further research to clarify the role of OSA in PD pathophysiology and motor dysfunction. 相似文献
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目的探讨阻塞性睡眠呼吸暂停低通气综合征(OSAHS)CYP3A4基因的多态性,了解其对芬太尼类药物的敏感性及不同基因型的人群分布特征,指导临床个体化用药。方法对50例OSAHS患者进行CYP3A4基因的多态性检测,采静脉血,通过DNA抽提-PCR扩增-焦磷酸测序方法检测CYP3A4基因。结果野生纯合型型34例(68%),突变杂合型15例(30%),突变纯合型型1例(2%)。结论OSAHS患者中约2%为AA型,该型对芬太尼类药物极其敏感,术后有易发生窒息的风险,应高度警惕芬太尼类药物呼吸抑制的潜在风险。 相似文献
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目的:IgA肾病是以系膜区IgA沉积为主要特征的原发性肾小球疾病,异常IgA1的免疫复合物沉积及RAAS系统激活与其发病关系密切。目前主要使用ACEI或ARB类药物及糖皮质激素或联合免疫抑制剂治疗。近年来中医药在IgA肾病的防治中发挥了巨大的作用,其中祛风除湿法治疗IgA肾病成为关注的焦点,在西医治疗基础上联用祛风除湿的中药在提高临床疗效、减少蛋白尿、减轻血尿、保护肾功能方面效果显著,同时也可减轻激素及免疫抑制剂所产生的不良反应,逐渐被临床认可。但由于目前现有的研究样本量小,文献质量较低,很难被广泛接受,迫切需要科学的研究方法为临床提供充分的证据支持,所以本研究拟通过Meta分析,综合分析祛风除湿法治疗IgA肾病的临床疗效及安全性评估。方法:检索中文数据库包括中国知网、万方、维普及英文数据库包括PubMed、Cochrane Library及手工检索相关领域期刊杂志中关于祛风除湿法治疗风湿内扰型IgA肾病的随机对照试验。采用Cochrane协助网提供的RevMan 5.3软件进行Meta分析,主要研究指标为有效率、24 h尿蛋白定量、血肌酐、血清白蛋白、肾小球滤过率、中医证候积分评估及不良反应发生率。结果:通过计算机检索中英文数据库及手工检索中医肾病相关领域期刊杂志,共检索出197篇文献,然后逐一阅读题目及摘要、泛读及精读全文后排除主题不相关文献,排除回顾性研究、假随机、半随机、重复文献、会议论文、不符合纳入标准文献,最后纳入8篇随机对照试验,共826例患者进行研究。Meta分析结果显示在西医治疗基础上联合祛风除湿的方药比单纯西医治疗在提高临床疗效(OR=3.35,95%CI[2.20,5.10],P<0.000 01)、降低24 h尿蛋白定量(MD=-0.46,95%CI[-0.76,-0.17],P=0.002)、提高白蛋白(MD=4.95,95%CI[3.62,6.28],P<0.000 01),减少不良反应发生率方面(OR=0.42,95%CI[0.22,0.80],P=0.008)效果显著,差异均有统计学意义。而血肌酐(MD=-4.82,95%CI[-12.27,2.63],P=0.20)、肾小球滤过率(MD=-0.63,95%CI[-4.26,2.99],P=0.73)、中医证候积分方面(MD=-1.96,95%CI[-3.98,0.05],P=0.06)差异均无统计学意义。结论:在西医基础上联合祛风除湿的方药治疗IgA肾病比单纯西医治疗,在提高临床有效率、降低蛋白尿、提高白蛋白、减少不良反应的发生方面效果显著,差异均有统计学意义。但此次纳入文献样本量小,文献质量均不高,未来需要更科学可靠的循证医学方法进一步完善祛风除湿法治疗IgA肾病的临床研究。 相似文献