Non-linear Wave Propagation and Safety Standards for Diagnostic Ultrasound Devices

Safety standards for clinical diagnostic ultrasonic devices were developed for use in relatively low-frequency systems (1–10 MHz), under the assumption that non-linear effects would be negligible. This article reviews ways in which neglecting non-linear wave propagation affects the measurements and calculations required to comply with safety standards and U.S. Food and Drug Administration guidance that recognizes these standards. An attempt is made to evaluate whether ignoring non-linear effects could result in significant error in the exposure quantities defined in these standards at either low or high frequencies, based on published literature. This article maintains that although non-linear effects have been considered in some parts of safety standards related to hydrophone requirements, the coverage is inadequate, especially for modern equipment with high working frequencies. A new approach is required to assess the magnitude of thermal heating for recently developed high-frequency systems to incorporate non-linear effects. In contrast, the current approach for evaluating the risk of cavitation can be used after appropriate modifications.     

膝关节镜术后结合活血祛瘀汤内服对膝关节炎患者骨代谢指标及炎性指标的影响

目的:研究膝关节镜术后结合活血祛瘀汤内服对膝关节炎患者骨代谢指标及炎性指标的影响。方法:选取2013年6月至2016年5月抚顺市中医院骨科住院部收治的进行关节镜清理术的膝骨关节炎患者68例进行回顾性分析,按照术后治疗方法的不同分为观察组和对照组,每组34例。观察组内服活血祛瘀汤(58膝),对照组行单纯关节镜清理术(62膝)。将2组患者术后6个月随访疗效结果进行比较。结果:6个月治疗结束后,观察组总有效率81. 02%,显著高于对照组的48. 55%,差异有统计学意义(P 0. 05),观察组治疗后夜间卧床休息时疼痛、晨僵或起床后疼痛加重、绞锁、肿胀以及跛行优于对照组,差异有统计学意义(P 0. 05)。观察组治疗后TNF-α、IL-6改善显著,与对照组比较,差异有统计学意义(P 0. 05),观察组与对照组治疗后COMP、CTX-Ⅱ、CTX-Ⅰ、MMP-3治疗后效果显著,且观察组优于对照组,差异有统计学意义(P 0. 05)。结论:活血祛瘀汤可明显降低膝关节术后患者炎性反应递质水平,患者COMP,CTX-Ⅱ,CTX-Ⅰ和MMP-3指标亦有显著改善,患者综合治疗疗效优于患者单纯使用关节镜下清理术疗效。     

足头向穿刺路径在膈肌下方肝肿瘤消融治疗中的CT模拟测量研究

【摘要】 目的 对足头向穿刺路径进行模拟测量并评价在膈肌下方肝肿瘤热消融治疗中的临床应用价值。方法 重建患者上腹部CT图像，选取有代表性的3个矢状面和1个冠状面作为标准层面，在各层面建立膈下标准病灶模型，并采用足头向穿刺路径进行模拟穿刺。测量各平面上膈肌高度、穿刺路径长度及间距。采用可到达性评价模拟穿刺时穿刺针分布于标准病灶中的最理想的位置情况。结果 纳入86例患者行测量研究，多数患者矢状2、3面的膈肌高度低于2cm，仅分别对平面内1511%的病灶e和813%的病灶f进行了测量。标准病灶a、b、c、d、b’的完全到达比例分别为5243%、6097%、3837%、5294%、6353%，中位路径长度分别为1039cm、1337cm（背侧，腹侧1266cm）、1315cm、888cm、1126cm，中位穿刺路径间距分别为21cm、209cm（背侧，214cm腹侧）、206cm、211cm、2145cm。结论 采用足头向穿刺路径进行穿刺，标准病灶a、b、d、b’有较高的完全到达比例，穿刺宽容度较高，有进一步在临床中应用的价值。标准病灶c的完全到达率不高。标准病灶e、f需要采用该路径穿刺的比例不高。     

神经内镜与显微镜下经鼻蝶入路手术切除无功能性垂体腺瘤疗效和安全性的Meta分析

目的 系统评价神经内镜与显微镜下经鼻蝶入路手术切除无功能性垂体腺瘤的疗效和安全性。方法 计算机检索PubMed 、Embase、Cochrane Center、中国生物医学文献数据库、维普中文科技期刊全文数据库、万方数据库、中国知网等中英文数据库有关神经内镜、显微镜下经鼻蝶入路无功能性垂体腺瘤切除术的文献，时限为2018年7月之前。指标包括肿瘤切除率、脑脊液渗漏发生率和视力恢复率。结果 共纳入19篇文献，2 383例。Meta分析结果:神经内镜手术全切除率比显微镜手术要高（75% vs 62%，P<0.001），神经内镜组视力恢复率也高于显微镜组（82% vs 59%，P<0.001）。两组脑脊液漏发生率无统计学差异（4%vs 6%，P=0.078）。结论 与显微镜下手术相比，神经内镜手术切除无功能性垂体腺瘤的疗效更好。     

Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized,double-blind,placebo-controlled clinical trial among Chinese women during 90 months of follow-up

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.

A review of the safety of vaccines used in routine immunization in Africa

BackgroundDespite the significant role played by vaccines in global health, concerns over vaccine safety have increased tremendously over the years. There have been occasions where vaccines have caused rare, adverse reactions some of which have led to hospitalizations and even death. It is therefore important to establish the safety profile of routinely used vaccines in order to allay fears pertaining to their use.ObjectivesThis review was aimed at pooling together the safety data of selected vaccines used for routine immunization in Africa, a region of the world with paucity of vaccine safety data.MethodsAdverse Events Following Immunization safety data was searched for rotavirus, yellow fever, measles, rubella, tuberculosis (Bacillus Calmette Guerin-BCG), pneumococcal, Haemophilus Influenza type b, polio, meningococcal and the influenza A (H1N1) vaccines in PUBMED, Google Scholar, Clinical trials.gov and Cochrane controlled register of trials databases.ResultsA total of twenty-four serious AEFIs and twenty-three minor AEFIs were identified from the review. The strength of association between AEFIs and vaccine was high for tuberculosis vaccine and moderate for all other vaccines.ConclusionEven though AEFIs (including mild and severe) were identified in the review, all the vaccines studied were generally well tolerated.     

替格瑞洛对比氯吡格雷治疗东亚ACS患者有效性和安全性的Meta分析

目的:系统性评价替格瑞洛对比氯吡格雷治疗东亚急性冠状动脉综合征(ACS)患者的有效性和安全性,旨在为临床用药提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国知网、万方数据库等,收集替格瑞洛(试验组)对比氯吡格雷(对照组)治疗东亚ACS患者的随机对照试验(RCT)。筛选文献、提取数据后采用Cochrane系统评价员手册5.1.0推荐的偏倚风险评估工具对纳入文献进行质量评价,采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入5项RCT,共计4511例患者。Meta分析结果显示,两组患者主要心血管不良事件发生率[OR=0.85,95%CI(0.68,1.04),P=0.12]、心血管原因死亡率[OR=0.76,95%CI(0.57,1.03),P=0.08]、脑卒中发生率[OR=0.77,95%CI(0.48,1.24),P=0.28]比较,差异均无统计学意义;试验组患者主要出血事件发生率[OR=1.54,95%CI(1.19,1.99),P=0.001]、次要出血事件发生率[OR=1.80,95%CI(1.40,2.32),P<0.00001]均显著高于对照组。结论:替格瑞洛在降低东亚ACS患者的主要心血管不良事件、心血管原因死亡以及脑卒中的发生风险等方面的作用与氯吡格雷相当,但该药会增加患者主要出血、次要出血事件的发生风险。     

Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myeloma

BackgroundIn countries where frontline drug approval is limited to first-generation proteasome inhibitors or immunomodulatory drugs, relapses have been both more frequent and less durable. We investigated real world data on the efficacy and safety of daratumumab monotherapy among patients with relapsed refractory multiple myeloma (RRMM) from Turkey using a prospective early access program.Patients and MethodsA total of 42 patients with RRMM after a minimum of 3 previous lines of proteasome inhibitor/immunomodulatory drug-based treatments were included from 25 centers across Turkey. Daratumumab monotherapy was administered intravenously at a dose of 16 mg/kg weekly (cycles 1-2), on alternate weeks (cycles 3-6), and monthly thereafter.ResultsThe median daratumumab monotherapy duration was 5.5 months (range, 0.2-28.7 months). The overall response rate was 45.2%, including 14 (33.3%) partial responses, 4 (9.5%) very good partial responses, and 1 (2.4%) complete response. The median duration of response was 4.9 months. The median progression-free survival (PFS) was 5.5 (95% confidence interval, 2.6-8.4 months) with 12- and 18-month PFS rates of 35.7% and 31.0%, respectively. The median overall survival was not reached; the 12- and 18-month overall survival rates were 64.3% and 59.5%, respectively. The depth of response had a significant effect on PFS (log-rank test, P = .026). Overall, of the 76 adverse events reported, 33 (43.4%) were grade ≥ 3; only 4 (9.52%) were grade 3 infusion-related reactions. No infusion-related reactions or adverse events led to treatment discontinuation.ConclusionThe present findings from our daratumumab early access program have confirmed the efficacy and safety profile of daratumumab monotherapy in heavily pretreated Turkish patients with RRMM.     

腹腔镜手术应用于子宫内膜癌治疗中的效果观察及安全性评价

目的 探究腹腔镜手术应用于子宫内膜癌治疗中的效果及安全性。方法 本研究中的观察对象均为本院接收的210 例子宫内膜癌患者，上述患者入院时间均在2015 年1 月～2019 年6 月。分析上述患者的病历资料，依据治疗方案分为对照组和观察组，其中对照组105例患者接受传统开腹手术治疗，观察组105例患者给予腹腔镜手术治疗。比较两组患者手术指标、手术效果、复发率、无瘤生存率及并发症发生情况。结果 观察组手术耗时[（208.81±8.36）min]长于对照组，术中出血量[（204.15±20.72）mL]、术后肛门排气时间[（36.41±3.32）d]、导尿管留置时间[（2.03±0.46）d]及住院时间[（9.58±2.76）d]均明显少于对照组（P＜0.05）；观察组盆腔淋巴结切除数目[（24.71±1.19）枚]和腹主动脉旁淋巴结切除数目[（4.09±0.96）枚]同对照组[（24.95±1.26）枚、（4.24±1.08）枚]比较，差异无统计学意义（P＞0.05）；观察组并发症总发生率（1.90%）明显低于对照组（P＜0.05）；两组复发率（1.90% vs 0.00%）、无瘤生存率（96.19% vs 99.05%）比较，差异无统计学意义（P＞0.05）。结论 腹腔镜手术应用于子宫内膜癌治疗中的效果显著，且术后并发症发生风险较低。