Inequalities in enrollment of women and racial minorities in trials testing uric acid lowering drugs

AimsWe investigated sex and racial inequalities in clinical trials testing serum uric acid (SUA) lowering drugs and analyzed the temporal trends of participation among the pre-specified demographic groups.Data were collected from publications of clinical trials testing SUA-lowering drugs. Linear regression analysis was performed to assess the relation between drug approval year and proportion of women and minorities enrolled in clinical studies.Data synthesisThe mean percentage enrollment of women in clinical trials significantly decreased over the time (r = −0.43, P-value = 0.02). Moreover, there was a statistically significant difference in mean percentage enrollment of women among trials testing different SUA-lowering drugs, with the highest representation in rasburicase (71.1%) and the lowest representation of women in dotinurad (0.8%). Over the time, also the mean percentage enrollment of racial minorities decreased, passing from 8.7% to 2.2% in a 10-year period.Women were proportionally underrepresented compared with their share of the population with asymptomatic hyperuricemia, overall (participation-to-prevalence ratio (PPR) = 0.34), in trials testing xanthine oxiase inhibitors (PPR = 0.38) and uricosurics (PPR = 0.29), and in trials with febuxostat, allopurinol, pegloticase, halofenate/arhalofenate, verinurad, lesinurad and dotinurad. Women were proportionally underreppresented also compared with their share of the population with gout, overall (PPR = 0.69) and in trials testing XOIs (PPR = 0.69), uricosurics (PPR = 0.68), and all SUA-lowering drugs excepted for rasburicase, pegloticase and topiroxostat.ConclusionsOur analysis shows that women and racial and ethnical minorities are underrepresented in controlled clinical trials testing SUA-lowering drugs, with similar pattern across drug classes.     

标准化病人对临床教学的意义

目的：利用标准化病人的教学模式，为实习生提供更好的案例学习机会，促进其进步。方法培训通过招募工作后广泛召集的患者，学生全程扮演医生的角色，模仿正规的临床医师完成对新患者的问诊与体检，作用于SP之上。结果利用标准化病人可以有效模拟出临床真实情况的正常人或病人，此种教学模式为实习生创造了许多临床实践机会，在提高实习生临床操作能力方面发挥着重要作用。结论标准化病人又称模拟病人，或者病人指导者，是在征求正常人或者慢性病人同意的基础上，将其划为模拟病人，经训练后，可以有效帮助学生进行临床学习或训练，进而提高学生的临床操作能力。     

多媒体课件在妇产科学示教课中的应用探索

使用多媒体课件进行妇产科学示教课程教学，与传统教学手段相比有着不可替代的优势，有助于培养全面发展的医学人才，能够显著提高妇产科学示教课程教学效果。     

阿托伐他汀钙联合羟乙基淀粉注射液治疗分水岭脑梗死的临床效果研究

目的分析阿托伐他汀钙联合羟乙基淀粉注射液对分水岭脑梗死患者急性期和远期临床治疗效果。方法选取本院2013年2月至2014年6月收治的分水岭脑梗死患者78例为研究对象,采用随机数表法将其分为观察组和对照组,每组各39例,两组患者均给予稳压、降糖、抗血小板聚集等常规治疗,对照组患者在此基础上加用阿托伐他汀钙,观察组患者给予阿托伐他汀钙联合羟乙基淀粉注射液,比较两组患者急性期和远期的临床效果。结果治疗后7天,观察组患者日常生活能力和神经功能恢复均明显优于对照组(P<0.05);治疗后3个月,观察组患者神经功能及日常生活能力恢复均明显优于对照组,且治疗总有效率明显高于对照组(χ2=7.47,P<0.01)。结论阿托伐他汀钙联合羟乙基淀粉注射液在分水岭脑梗死患者急性期和远期均有较好的临床治疗效果。     

Clinical outcomes of catheter ablation of ventricular tachycardia in patients with arrhythmogenic right ventricular cardiomyopathy: Insights from the Johns Hopkins ARVC Program

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Safety and immunogenicity of a quadrivalent inactivated subunit non-adjuvanted influenza vaccine: A randomized,double-blind,active-controlled phase 1 clinical trial

Quadrivalent influenza inactivated vaccine (IIV4) is more likely to provide wider protection against yearly circulating influenza viruses than trivalent inactivated influenza vaccine (IIV3). In this study, a total of 320 participants were allocated to four age cohorts (6–35 months, 3–8 years, 9–17 years, and ≥ 18 years; 80 participants/cohort) according to their actual date of birth. Participants in each cohort were randomly assigned to two groups to receive intramuscular injection of the trial vaccine or the comparative vaccine in a one-dose (3–8 years, 9–17 years,and ≥ 18 years) schedule on day 0 or two-dose (6–35 months cohort) schedule on day 0 and 28. The first objective is to evaluate the safety and immunogenicity of the full-dose subunit non-adjuvanted IIV4 (FD-subunit NAIIV4) we developed versus an active-control, China-licensed split-virion NAIIV4, in people ≥ 3 years. The second objective is to evaluate the safety and immunogenicity of FD-subunit NAIIV4 versus the half-dose (HD-subunit NAIIV4) in toddlers aged 6–35 months. Results showed that all adverse reactions noted were rare, mild, and self-limited. In ≥ 3 years cohorts, systemic adverse reactions in FD-subunit NAIIV4 groups were less than the active control split-virion NAIIV4 groups ([Systemic adverse reaction rates (95%CI)], 15.0 (8.6–21.4) versus 19.2(12.1–26.2), p = 0.391). The overall seroprotection efficacy after vaccination were comparable between FD-subunit NAIIV4 and the active control split-virion NAIIV4([Seroprotection rates (95%CI)], H1N1, 99.2(81.3–100.0) versus 94.9(90.9–98.9), p = 0.117; H3N2, 81.7(74.7–88.6) versus 82.1(75.1–89.0), p = 0.939; BV, 75.8(68.2–83.5) versus 74.4(66.4–82.3), p = 0.793; BY, 94.2(90.0–98.4) versus 92.3(87.5–97.1), p = 0.568). Additionally, FD-subunit NAIIV4 has comparable safety and better seroprotection versus that of the half-dose in 6–35 months toddlers groups ([Total adverse reaction rates (95%CI)], 37.5(18.5–56.5) versus 47.5(26.1–68.9), p = 0.366) ([Seroprotection rates (95%CI)], H1N1, 85(56.4–100.0) versus 75.7(47.6–100.0), p = 0.117; H3N2, 50(28.1–71.9) versus 29.7(12.2–47.3), p = 0.070; BV, 75(48.2–100.0) versus 29.7(12.2–47.3), p < 0.001; BY, 75(48.2–100.0) versus 56.8(32.5–81.0), p = 0.091). As a result, the FD-subunit NAIIV4 we developed is safe and effective to provide broader and adequate protection against the circulating influenza viruses during 2018–2019, which could be an essential component of the global preventive strategy for influenza pandemic.     

Thalamic deep brain stimulation for Tourette Syndrome: A naturalistic trial with brief randomized,double-blinded sham-controlled periods

BackgroundThere is still a lack of controlled studies to prove efficacy of thalamic deep brain stimulation for Tourette's Syndrome.ObjectivesIn this controlled trial, we investigated the course of tic severity, comorbidities and quality of life during thalamic stimulation and whether changes in tic severity can be assigned to ongoing compared to sham stimulation.MethodsWe included eight adult patients with medically refractory Tourette's syndrome. Bilateral electrodes were implanted in the centromedian-parafascicular-complex and the nucleus ventro-oralis internus. Tic severity, quality of life and comorbidities were assessed before surgery as well as six and twelve months after. Short randomized, double-blinded sham-controlled crossover sequences with either active or sham stimulation were implemented at both six- and twelve-months’ assessments. The primary outcome measurement was the difference in the Yale Global Tic Severity Scale tic score between active and sham stimulation. Adverse events were systematically surveyed for all patients to evaluate safety.ResultsActive stimulation resulted in significantly higher tic reductions than sham stimulation (F = 79.5; p = 0.001). Overall quality of life and comorbidities improved significantly in the open-label-phase. Over the course of the trial two severe adverse events occurred that were resolved without sequelae.ConclusionOur results provide evidence that thalamic stimulation is effective in improving tic severity and overall quality of life. Crucially, the reduction of tic severity was primarily driven by active stimulation. Further research may focus on improving stimulation protocols and refining patient selection to improve efficacy and safety of deep brain stimulation for Tourette's Syndrome.     

急诊一体化救治护理急危重症患者中临床路径的应用

目的探讨危急重症患者实施护理过程中通过对患者进行急诊一体化救治护理方法的临床疗效。方法选取我院2014年10月~2015年10月收治的危急重症患者800例,将患者分为观察组以及对照组,对比两组患者护理效果、死亡率及满意度。结果观察组临床护理效果高于对照组,患者的死亡率以及患者的临床满意程度有差异,P0.05,差异具有统计学意义。结论实施急诊一体化救治护理,能够提升临床护理效果,是一种安全有效的救治方法 .     

中医医案方剂多维相似度算法设计与探索＊

中医医案方剂具有多维度的特性，单独采用一种相似度算法难以展现方剂数据在各维度的相似情况，具有一定的局限性。本研究基于中医医案方剂的多维数据特点，结合中医临床遣方用药的思维过程，设计了中医医案方剂的多维相似度算法，并以七则国医大师医案为示例，详细展示了该算法的计算过程，同时将多维相似度算法计算结果与传统算法计算结果进行了对比分析。通过对比可以看出本算法能够相对全面地反映不同方剂间的相似度，且结果更为合理也更贴合中医临床实际。     

Medical decision making for older patients during multidisciplinary oncology team meetings

Objectives

Multidisciplinary team meetings aim to facilitate efficient and accurate communication surrounding the complex process of treatment decision making for older patients with cancer. This process is even more complicated for older (≥70?years) patients as the lack of empirical evidence on treatment regimens in patients with age-related problems such as comorbidity and polypharmacy, necessitates a patient-centred approach.This study investigates the decision making process for older patients with cancer during multidisciplinary team meetings and the extent to which geriatric evaluation and geriatric expertise contribute to this process.