MR-safety in clinical practice at 7T: Evaluation of a multistep screening process in 1819 subjects

IntroductionMR facilities must implement and maintain adequate screening and safety procedures to ensure safety during MR examinations. The aim of this study was to evaluate a multi-step MR safety screening process used at a 7T facility regarding incidence of different types of safety risks detected during the safety procedure.MethodsSubjects scheduled for an MR examination and having entered the 7T facility during 2016–2019 underwent a pre-defined multi-step MR safety screening process. Screening documentation of 1819 included subjects was reviewed, and risks identified during the different screening steps were compiled. These data were also related to documented decisions made by a 7T MR safety committee and reported MR safety incidents.ResultsPassive or active implants (n = 315) were identified in a screening form and/or an additional documented interview in 305 subjects. Additional information not previously self-reported by the subject, regarding implants necessitating safety decisions performed by the staff was revealed in the documented interview in 102 subjects (106 items). In total, the 7T MR safety committee documented a decision in 36 (2%) of the included subjects. All of these subjects were finally cleared for scanning.ConclusionA multi-step screening process allows a thorough MR screening of subjects, avoiding safety incidents. Different steps in the process allow awareness to rise and items to be detected that were missed in earlier steps.Implications for practiceSafety questions posed at a single timepoint during an MR screening process might not reveal all safety risks. Repetition and rephrasing of screening questions leads to increased detection of safety risks. This could be effectively mitigated by a multi-step screening process. A multi-disciplinary safety committee is efficient at short notice responding to unexpected safety issues.     

Tracking Spinal Cord Injury Functional Outcomes Across the Lifespan: Validation of Linking Coefficients

ObjectiveValidation of linking coefficients to transform Pediatric Spinal Cord Injury Activity Measure (PEDI-SCI/AM) scores to adult Spinal Cord Injury-Functional Index (SCI-FI) scores.DesignThis cross-sectional study administered PEDI-SCI/AM and SCI-FI computerized adaptive tests (CATs) and short forms (SFs) to children with SCI and parents or caregivers.SettingHospitals, university, and rehabilitation institute.ParticipantsAbout 107 children with SCI and 96 parent or caregivers.InterventionsNot applicable.Main Outcome MeasuresLinking coefficients estimated SCI-FI (est-SCI-FI) scores from PEDI-SCI/AM scores for matched domains. Correlations between est-SCI-FI and actual SCI-FI scores were calculated. If correlations exceeded the criterion linking (0.866), the following analyses to compare est-SCI-FI and actual SCI-FI scores were conducted: paired t tests, intraclass correlation coefficients (ICCs 3, 1), percent of cases with absolute score differences at different thresholds.ResultsTwo matched domains, PEDI-SCI/AM Daily Routine/SCI-FI Self-Care and PEDI-SCI/AM General Mobility/SCI-FI Basic Mobility, met the linking criterion for both respondent-types (parent and child) and administration modes (CAT and SF). PEDI-SCI/AM Daily Routine and SCI-FI Fine Motor Function did not meet linking criterion for respondent type or mode. The linking criterion was met for wheelchair domains (child SF and CAT) and ambulation domains (child SF only). Significant differences between est-SCI-FI and actual SCI-FI scores were noted for all matched domains except Daily Routine/Self-Care (child SF only; parent SF and CAT). ICC values showed excellent agreement (range=0.75-0.89). Absolute differences between est-SCI-FI and actual SCI-FI scores were less than 1 standard deviation (except wheelchair CAT child).ConclusionsLinking coefficients applied to PEDI-SCI/AM scores can provide valid SCI-FI estimates that vary by domain, mode, and respondent type.     

Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older

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.     

林洁从“阳化气,阴成形”论治多囊卵巢综合征

多囊卵巢综合征(polycystic ovary syndrome,PCOS)患者的卵泡发育异常与"阳化气,阴成形"功能失衡密切相关。在PCOS患者的月经周期变化中,"阳化气"与"阴成形"的功能失调常见两种阴阳失衡表现。其一是"阴成形"不足,"阳化气"相对过盛;其二是"阴成形"太过,"阳化气"乏力。林洁教授将PCOS患者从胖、瘦两种体型辨证施治,瘦型PCOS患者的发病之本为"阳化气"太过,其标为"阴成形"不足,多辨为心肝火旺证,采用以丹栀逍遥散为基础方化裁的多囊Ⅰ号方治疗;胖型PCOS患者发病之本为"阳化气"乏力,其标为"阴成形"太过,采用以导痰汤为基础化裁的多囊Ⅱ号方治疗。另外,属患者养成健康的饮食习惯和良好的生活习惯,选择适合的运动方式,病情严重者进行必要的心理疏导。     

基于中医古籍文献的升降散应用溯源及探析

通过对中医古籍中有关升降散论述的文献梳理,全面探讨其内涵。本方是在大黄、僵蚕为雏形的基础上增加蝉蜕、姜黄而成方,几经易名,终在杨璿《伤寒瘟疫条辨》中为后人所熟知。本方广泛用于治疗瘟疫,以丸剂、散剂为主,方便携带,便于服用;重用大黄旨在祛邪、逐秽;应用时视人之体质强弱和量其毒之轻重而判断用药多寡,并辅以米酒、生蜜等以顾护正气。杨璿将其由治疗“热疫”的专方扩展为治疗“表里三焦大热”的通用方剂,扩大了本方治疗疾病范围。     

中药配方精油——一种中药入药新形式的思考

饮片是中医临床用药的主体,随着中医用药现代化,中药配方颗粒逐步发展并初具规模。虽有中药注射剂、口服液等的加工形式,但只占中药市场的少部分,并以内服为主。而脂溶性成分口服时,溶出受限,吸收相对较少,且具有刺激胃肠道的副作用,造成患者耐受性低。虽有水提、醇提等加工制成的外用制剂,但多为粗制剂,且剂量随意,在一定程度上造成了脂溶性成分的浪费。而中药的脂溶性成分大多具有较好的生物活性,如五味子乙素、丹参酮、绿原酸甲酯等,但却没有合适的药用形式。若想"药"尽其用,就必须对中药的脂溶性成分进行系统研究,在提取、分离和收集工艺均相当成熟的基础上,研发以脂溶性成分为主的,药理药效确切的,又利于其吸收的药用形式。中药精油具有抗衰老、抗痴呆、抗氧化等多种活性,已广泛应用于临床、药妆、保健品等领域。但单方精油作用有限,配伍既可增强药效、降低毒性,也可扩大精油应用范围。因此,可将中药配方精油作为中药入药新形式,并以外用为主、内服为辅,以弥补中药外用多为粗制剂、剂量随意的不足和内服吸收少、刺激胃肠道的劣势,满足临床用药需求,更快、更准、更好、更强地发挥脂溶性成分的药效。     

不同氮素形态和浓度水平对浙贝母产量和品质的影响

目的:研究不同氮素形态配施对浙贝母产量和品质的影响,为浙贝母氮肥的科学施用及重庆地区的迁地引种提供依据。方法:采用盆栽试验法,研究了2种氮素形态的5种浓度水平即硝态氮(NO_3~--N)-铵态氮(NH_4~+-N)为15∶0(N1),12∶3(N2),7. 5∶7. 5(N3),3∶12(N4),0∶15(N5)处理下,引种栽培的浙贝母生长及生理生化、土壤因子、生物碱含量及产量的变化。结果:与不施氮(CK)处理组相比,不同氮素营养配施对浙贝母生长和品质均有显著提高,相互间存在差异。其中,随着铵态氮浓度的增加:①在硝态氮-铵态氮比为3∶12时,株高、超氧化物歧化酶(SOD)活性达到最大,较CK组分别增加了9. 27%,206. 62%;②在硝态氮-铵态氮比为0∶15时,叶长,叶宽,茎粗,叶绿素a,叶绿素b,叶绿素总量,速效磷含量,有机质含量、总生物碱含量/产量达到最大,分别高于CK处理组14. 02%,16. 44%,13. 68%,40. 75%,45. 31%,41. 72%,77. 70%,14. 70%,24. 61%/47. 39%;随着硝态氮浓度的增加;③在硝态氮-铵态氮比为7. 5∶7. 5时,叶形指数、可溶性蛋白含量、贝母辛含量/产量、贝母素乙产量、鳞茎干重均达到最大,分别高于CK处理组2. 54%,5. 92%,21. 76%/54. 55%,60. 61%,26. 93%;④在硝态氮-铵态氮比为12∶3时,类胡萝卜素含量、色素含量、过氧化物酶(POD)活性、过氧化氢酶(CAT)活性、贝母素甲含量/产量、贝母素乙含量、贝母素(甲+乙)含量/产量、贝母素(甲+乙)+贝母辛含量/产量、鳞茎湿重均达到最大,分别高于CK处理组45. 39%,45. 31%,271. 38%,67. 45%,39. 82%/64. 87%,36. 01%,38. 90%/63. 80%,37. 03%/61. 57%,20. 29%。结论:较高比例的铵态氮利于浙贝母的生长;而较高比例的硝态氮利于浙贝母鳞茎的生长以及代谢产物生物碱的积累。氮素配比施用(硝态氮-铵态氮比为12:3)较单一形态氮素更有利于提高浙贝母的产量和品质。     

Nitric oxide donors offer protection to RBC from storage lesion

BackgroundRed blood cell (RBC), which is the most commonly transfused blood component, due to its ability to save a life in absence of any other blood components, can be stored up to maximum 6 weeks by following standard preservation procedure. During storage, RBC undergoes various biophysical and biochemical changes (commonly known as storage lesion) for which blood transfusion with “old RBC” shows a lot of clinical problems especially relevant to critically ill patients. Recent research on S-nitrosylation of haemoglobin to improve oxygen delivery of banked blood revealed the important role of nitric oxide (NO) in protecting storage lesion.Materials and methodsIn the present study, we used various “NO donating” chemicals with different NO release dynamics and chemistries in RBC storage cocktails to test the effects of NO on storage lesion. Changes in different storage markers were evaluated after 7 days storage of pre-treated RBC.ResultsAll the NO donors have shown protection against hemolysis. However, S-nitroso glutathione (GSNO) ranks first in shielding RBCs from storage lesion and additionally, it helps in elevating the value of 2, 3-di phosphoglycerate (2, 3-DPG), improving the RBC membrane fluidity and decreasing the adhesion towards endothelial monolayer.DiscussionPresent study reveals that NO released from NO donors confers protection against storage lesions of the RBC. Further, the study confirms that pre-treatment with GSNO, a NO donor and a nitrosylating agent, ensures the best protection to RBC during low temperature storage, when compared to other NO donor treatments.