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排序方式: 共有654条查询结果,搜索用时 15 毫秒
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《Vaccine》2022,40(12):1872-1878
BackgroundThe MenB-FHbp vaccine (Trumenba®) is licensed in various countries for the prevention of meningococcal serogroup B disease in individuals ≥ 10 years of age. The clinical development program included 11 completed trials where, in each trial, MenB-FHbp had an acceptable safety profile after a primary vaccination series was administered to individuals 10–65 years of age. However, the detection of potential rare events was limited because of individual clinical trial size. The current safety analysis evaluates pooled reactogenicity and other adverse events (AEs) reported in these trials to identify new safety signals not detectable in individual trials.MethodsEleven trials contributed safety data, of which 10 recorded local and systemic reactogenicity events; 8 of the trials were controlled, and reactogenicity data were pooled for 7 of these 8 trials. Additional AE evaluations included immediate AEs (IAEs), medically attended AEs (MAEs), serious AEs (SAEs), newly diagnosed chronic medical conditions (NDCMCs), and autoimmune or neuroinflammatory conditions.ResultsLocal and systemic reactions were more frequent in the MenB-FHbp group (n = 15,294) compared with controls (n = 5509), although most reactions were transient and mild to moderate in severity. Frequencies of IAEs, SAEs, MAEs, NDCMCs, and autoimmune or neuroinflammatory conditions were similar between the MenB-FHbp and control groups.ConclusionsMenB-FHbp demonstrated a favorable safety and tolerability profile in the clinical development program of > 15,000 vaccine recipients ≥ 10 years of age. No new safety signals were identified in the pooled analysis compared with data from the individual trials. Continued postmarketing safety surveillance is important for the identification of rare events.Clinicaltrials.gov: NCT01299480; NCT000808028; NCT00879814; NCT00780806; NCT01352845; NCT01352793; NCT01461993; NCT01323270; NCT01830855; NCT01461980; NCT01768117. 相似文献
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The metastasis of cervical cancer has always been a clinical challenge. We investigated the effects of low-dose naltrexone (LDN) on the epithelial mesenchymal transition of cervical cancer cells in vitro as well as its influence on macrophage polarization and associated cytokines in vivo. The results suggested that LDN supressed the proliferation, migration and invasion abilities and promote their apoptosis in Hela cells, whereas the opioid growth factor receptor (OGFr) silenced significantly reversed these effects in vitro. Knockdown the expression of OGFr, the inhibitory of LDN on EMT was weakened. LDN could inhibit cervical cancer progression in nude mice. In additon, LDN indirectly reduced the number of tumor-associated macrophages (TAMs), mainly M2 macrophages, and decreased expression of anti-inflammatory factor IL-10 in the serum of nude mice. These findings demonstrate that LDN could be a potential treatment for cervical cancer. 相似文献
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Jinmei Chen Jinsheng Hong Xi Zou Wenlong Lv Feibao Guo Hualan Hong Weijian Zhang 《Journal of radiation research》2015,56(6):883-888
The aim of this study was to investigate the association between absolute volumes of lung spared from low-dose irradiation and radiation-induced lung injury (RILI) after intensity-modulated radiotherapy (IMRT) for lung cancer. The normal lung relative volumes receiving greater than 5, 10, 20 and 30 Gy (V5–30) mean lung dose (MLD), and absolute volumes spared from greater than 5, 10, 20 and 30 Gy (AVS5–30) for the bilateral and ipsilateral lungs of 83 patients were recorded. Any association of clinical factors and dose–volume parameters with Grade ≥2 RILI was analyzed. The median follow-up was 12.3 months; 18 (21.7%) cases of Grade 2 RILI, seven (8.4%) of Grade 3 and two (2.4%) of Grade 4 were observed. Univariate analysis revealed the located lobe of the primary tumor. V5, V10, V20, MLD of the ipsilateral lung, V5, V10, V20, V30 and MLD of the bilateral lung, and AVS5 and AVS10 of the ipsilateral lung were associated with Grade ≥2 RILI (P < 0.05). Multivariate analysis indicated AVS5 of the ipsilateral lung was prognostic for Grade ≥2 RILI (P = 0.010, OR = 0.272, 95% CI: 0.102–0.729). Receiver operating characteristic curves indicated Grade ≥2 RILI could be predicted using AVS5 of the ipsilateral lung (area under curve, 0.668; cutoff value, 564.9 cm3; sensitivity, 60.7%; specificity, 70.4%). The incidence of Grade ≥2 RILI was significantly lower with AVS5 of the ipsilateral lung ≥564.9 cm3 than with AVS5 < 564.9 cm3 (P = 0.008). Low-dose irradiation relative volumes and MLD of the bilateral or ipsilateral lung were associated with Grade ≥2 RILI, and AVS5 of the ipsilateral lung was prognostic for Grade ≥2 RILI for lung cancer after IMRT. 相似文献
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目的:探讨口服小剂量异维A酸联合外用2%超分子水杨酸治疗中重度痤疮的临床疗效。方法:共选取74例中重度痤疮患者作为研究对象,口服小剂量异维A酸10mg,1次/d。治疗组:37例,联合外用2%新型超分子水杨酸治疗;对照组:37例,联合外用夫西地酸乳膏及阿达帕林凝胶治疗。对两组患者治疗前后的皮损数量变化及治疗效果进行对比分析。结果:经过8周的治疗,两组研究对象的总皮损数量较治疗前均显著减少(P<0.05),且治疗组与对照组比较,无明显差异(P>0.05)。针对不同类型的皮损,治疗组对粉刺的疗效比对照组更具优势,对丘疹与结节的疗效无明显差异。结论:治疗中重度痤疮,小剂量异维A酸联合外用2%超分子水杨酸临床疗效较好,副作用小,可作为痤疮治疗的新选择。 相似文献
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目的 对早产儿进行持续小剂量铁剂补充,为其健康发育推荐更佳补充铁剂的方式。方法 于2010-2016年前瞻性纵向队列方法收集530例早产高危儿,234例足月健康婴儿,共分为三组采用不同剂量与时间补充铁剂治疗,采用盖赛尔发展量表(GDS)评估智能发育,监测体格发育,观察各组发育情况到12月龄。结果 到12月龄时早产儿组间(A组和B组)比较,GDS量表中粗大运动发育(GMD),个人-社会能区(PS)、解决问题能区(CG)、言语能区(CM)的发育商值(DQ)以及睡眠规律性,差异有统计学意义(P<0.05);而观察组(A组)与正常对照组(C组)在以上方面比较均无明显差异(P>0.05)。体格发育评估到12月龄时两组早产儿组间(A组和B组)出现差异(P<0.05),而且A组与C组差异亦有统计学意义(P<0.05)。结论 持续小剂量补充铁剂对生长发育高峰期的早产儿在神经运动言语认知发育、睡眠方面影响更大。而对体格发育有一定影响但没有达到追赶生长。 相似文献
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阿替普酶静脉溶栓是目前医治急性缺血性脑卒中的最佳措施.虽然各大指南推荐的阿替普酶应用剂量为0.9 mg/kg(最大剂量90 mg),但近年来越来越多的观察性研究认为,低剂量阿替普酶(0.6 mg/kg)溶栓治疗可取得与标准剂量同样的疗效,并可减少症状性颅内出血的发生,不过目前循证医学证据不足.本文围绕低剂量阿替普酶治疗急性缺血性脑卒中现有研究进行综合阐述,希望为临床医生提供参考. 相似文献
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