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Background

A quadrivalent human papillomavirus (qHPV) vaccine (HPV6/11/16/18) has demonstrated efficacy and acceptable safety in international studies. However, these studies did not include participants from mainland China, which has a substantial burden of HPV-related disease. This is the first safety report with a follow-up period of up to 90?months from a randomized, double-blind, placebo-controlled trial of qHPV vaccine in Chinese women 20–45?years of age.

Methods

Participants were randomized 1:1 to receive three doses of qHPV vaccine or placebo (Day 1, Month 2, and Month 6). Efficacy outcomes are reported elsewhere. Injection-site and systemic adverse events (AEs) were collected using vaccination report cards (VRCs) for 15?days following each vaccination. Serious AEs (SAEs), pregnancy outcomes, new medical conditions, and fetal/infant SAEs were collected during the entire study.

Results

Of 3006 participants randomized, AEs were reported by 926 (61.8%) qHPV vaccine recipients and 856 (57.1%) placebo recipients over the entire study. Four participants (two in each group) discontinued the study vaccination due to AEs that were considered vaccination-related. Within 15?days following any vaccination, injection-site AEs prompted for on the VRC were more frequent among qHPV vaccine recipients (37.6% vs 27.8%), and systemic AEs prompted for on the VRC were similar in frequency between qHPV vaccine and placebo groups (46.8% vs 45.1%). Thirty-eight and 43 participants reported SAEs in qHPV vaccine and placebo groups, respectively. No SAE was considered qHPV vaccine-related. Pregnancy outcomes, fetal/infant SAEs, and new medical conditions were generally similar in frequency between the qHPV vaccine and placebo groups, and within normal ranges.

Conclusion

The qHPV vaccine was well tolerated and demonstrated a favorable safety profile in Chinese women 20–45?years of age, consistent with findings from global trials and safety surveillance studies.Trial registration: clinicaltrials.gov; NCT00834106.  相似文献   
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前列腺穿刺存在漏诊前列腺癌的可能,重复穿刺有其必要性。本文对前列腺重复穿刺独立危险因素、穿刺途径选择和穿刺新技术进展方面进行综述,以提高临床医生对前列腺重复穿刺适应证的认识。对符合前列腺重复穿刺的患者,推荐使用mpMRI靶向穿刺,以提高有临床意义前列腺癌的检出率,减少无临床意义前列腺癌的检出率。  相似文献   
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Introduction

A systematic review and meta-analysis were conducted to report combined and individual weighted pooled outcome rates for crown resection (CR) and root resection (RR) procedures.

Methods

Three electronic databases (PubMed [MEDLINE], Scopus, and the Cochrane Library) were searched to identify human studies in 12 languages on CR (hemisection, trisection, and premolarization) and RR (amputations and RRs without removal of crown portions). Five peer-reviewed journals, references of relevant publications, and reviews were hand searched. Assessment by 3 independent reviewers was based on the following predefined Population, Intervention, Comparison, Outcome, Study Design question: “For teeth in patients undergoing surgical therapy by CR versus RR, what is the expected probability of survival according to longitudinal studies with strictly defined outcome measurements and inclusion/exclusion criteria?” Clinical investigations with at least 12 months of follow-up were included. Studies and level of evidence were appraised using the Newcastle-Ottawa Scale and Grading of Recommendations, Assessment, Development and Evaluations.

Results

Thirty-four articles were obtained for final analysis. Data could be extracted from 19 studies (CR and RR OVERALL: N = 2667 [19 studies], CR: n = 111 [3 studies], and RR: n = 1127 [9 studies]). A random effects model showed weighted mean survival rates of 85.6% (95% confidence interval [CI], 76.7–91.5) for CR and RR procedures OVERALL. Individual data showed weighted mean survival rates of 81.9% (95% CI, 72.0–88.8) for CR and 87.2% (95% CI, 71.7–94.8) for RR. There was no statistically significant difference between CR and RR (P = .89, odds ratio calculation) or between maxillary and mandibular molars (P = .81, Fisher exact test).

Conclusions

Overall, CR and RR procedures showed good outcome rates. Large-scale randomized controlled trials should be conducted to strengthen the evidence.  相似文献   
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目的探讨术中胃减压对行神经内镜经鼻颅底手术患者手术后恶心呕吐(PONV)的影响。方法回顾性分析2019年1—8月在复旦大学附属华山医院神经外科接受神经内镜经鼻颅底手术的357例患者的临床资料。根据术中是否进行胃减压,分为胃减压组(146例)和对照组(211例)。比较两组的临床特征和术后24 h内PONV发生率的差异。对于包括胃减压在内的各因素对行神经内镜经鼻颅底手术患者PONV发生的影响,采用单因素和多因素logistic回归分析法探讨。结果所有患者术后24 h内的PONV发生率为11.8%(42/357)。胃减压组的女性比例[58.2%(85/146)对比46.4%(98/211),P=0.029]和Apfel评分为2~3分的比例[64.4%(94/146)对比50.2%(106/211),P=0.008]均高于对照组,而胃减压组PONV的发生率低于对照组[7.5%(11/146)对比14.7%(31/211),P=0.039]。单因素logistic回归分析结果提示,术中采用脂肪填塞修补脑脊液漏、术中采用黏膜瓣修补脑脊液漏、术中胃减压和术中失血量是神经内镜经鼻颅底手术患者PONV发生的影响因素(均P<0.05)。多因素logistic回归分析结果提示,术中胃减压(OR=0.397,95%CI:0.185~0.852,P=0.018)和术中失血量(OR=1.133,95%CI:1.026~1.250,P=0.013)为神经内镜经鼻颅底手术患者PONV发生的独立影响因素。结论实施术中胃减压可降低神经内镜经鼻颅底手术患者PONV的发生率。  相似文献   
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B超测量胎儿腹围预测胎儿体重的价值   总被引:4,自引:0,他引:4  
目的 研究B超测量胎儿腹围预测巨大胎儿的临床价值。方法 选择184例宫高+腹围≥140cm的足月单胎孕妇,应用B超测量胎儿双顶径(BPD),头围(HC)腹围(AC),股骨长度(FL);根据新生儿体重将孕妇分为巨大儿组及非巨大儿组,比较两组间差异;分析腹围与新生儿体重的关系。结果 胎儿腹围与新生儿体重的相关性最好(r=0.84),当胎儿腹围≥35.0cm时,可以预测85.7%的巨大胎儿。结论 超声测量胎儿腹围能准确预测巨大胎儿的体重。  相似文献   
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目的 探讨脑膜瘤99Tcm MIBI和99Tcm ECDSPECT脑显像的影像特征 ,并评价其应用价值。方法 对 10例正常对照者及 18例脑膜瘤患者进行99Tcm MIBI和99Tcm ECDSPECT脑显像 ;分析病灶的影像特征。结果 正常对照者99Tcm MIBI显像脑实质内均无核素浓聚 ;99Tcm ECD显像脑实质内放射性核素分布大致均匀 ,左右侧基本对称。 18例脑膜瘤99Tcm MIBI显像见肿瘤处均表现为均匀的圆形或卵圆形放射性核素浓聚 ,其阳性率为 10 0 % ;而99Tcm ECD显像 18例中有 17例示肿瘤处表现为形态规整、边缘整齐的圆形或卵圆形内凹缺损 ,其形态与99Tcm MIBI显像所示的浓聚区相吻合 ,另1例为假阴性结果 ,其阳性率为 94.4%。结论 99Tcm MIBI结合99Tcm ECDSPECT脑显像可用于脑膜瘤的辅助诊断  相似文献   
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