Effect of motorized scooters on physical performance and mobility: a randomized clinical trial

OBJECTIVE: To investigate the effects of providing a motorized scooter on physical performance and mobility. DESIGN: Randomized clinical trial comparing scooter users with usual care. SETTING: One academic and 1 Veterans Affairs medical center. PARTICIPANTS: Ambulatory, community-dwelling outpatients with rheumatoid arthritis or osteoarthritis of the knee. INTERVENTION: Provision of a motorized scooter for 3 months. MAIN OUTCOME MEASURES: Six-minute walk distance (6MWD) and mobility methods in diverse locations at baseline, 1 month, and 3 months, and accidents while using the scooter. RESULTS: The majority of scooter subjects (n=16/22 [72.7%]) used the scooter 4 or more days per week. The difference+/-standard deviation between the 2 groups in change in 6MWD over the study period was not statistically significant (scooter users, 16.9+/-73.0 m [55.5+/-239.6 ft]; usual care, 17.2+/-72.5 m [56.5+/-238.0 ft], P=.55). Four (18.1%) scooter users reported 9 accidents. Over the study period, the proportion of persons reporting use of a scooter (provided by the study or otherwise available) increased in the scooter-users group (eg, food stores, 16.7% to 52.6%; doctor's office, 0% to 35.7%) but not the usual-care group (food stores, 9.1% to 9.5%; doctor's office, 0% to 0%). CONCLUSIONS: Motorized scooters provided to ambulatory persons with arthritis were used intermittently. The greatest short-term risk from scooter usage appeared to be minor collisions.     

中国心肺联合移植操作规范(2019版)

目前,心肺联合移植已成为公认治疗终末期心肺疾病的有效方法。中华医学会器官移植学分会组织心脏和肺移植专家,结合当前国内外心肺联合移植形势,总结国际指南和相关研究最新进展,并结合国内临床实践经验,从心肺联合移植的适应证和禁忌证、手术时机选择、供者选择、供器官获取和保护以及手术要点和术后管理等方面制订《中国心肺联合移植操作规范(2019版)》。     

小儿支气管哮喘中药新药临床试验设计与评价技术指南

《儿科常见疾病中药新药临床试验设计与评价技术指南》是中华中医药学会儿科分会临床评价学组制定的、指导儿科中药Ⅱ期、Ⅲ期临床试验和上市后有效性再评价方案设计的、具有病种特色的系列临床评价技术指南, 旨在推动儿科中药临床试验设计与评价水平的提高, 并为临床提供安全有效的儿童用药。采用世界卫生组织(WHO)推荐的“共识会议法”和美国国立卫生研究院(NIH)发展共识方案(GPP)有关原则, 国内全部18个国家药物临床试验机构中医儿科专业的临床儿科专家以及国内相关临床评价专家参加了急性上呼吸道感染、急性支气管炎、支气管哮喘、反复呼吸道感染、厌食、轮状病毒性肠炎、注意缺陷-多动障碍、抽动障碍、遗尿症、手足口病、湿疹11个儿科常见病种指南的起草或多次提出修改建议, 历经3年反复完善, 最终形成共识, 并由中华中医药学会儿科分会于2013年10月发布。本指南从研究背景、研究目标、总体设计、诊断标准、受试者的选择、给药方案、安全性评价、有效性评价、试验流程、数据管理与统计分析、质量保证、相关伦理学要求、试验结束后的医疗措施、资料保存等方面阐述了小儿支气管哮喘中药新药临床试验的设计与评价技术要点, 期望能为申办者与研究者在临床试验方案设计中提供指导。     

小儿湿疹局部用中药新药临床试验设计与评价技术指南

《儿科常见疾病中药新药临床试验设计与评价技术指南》是中华中医药学会儿科分会临床评价学组制定的、指导儿科中药Ⅱ期、Ⅲ期临床试验和上市后有效性再评价方案设计的、具有病种特色的系列临床评价技术指南,旨在推动儿科中药临床试验设计与评价水平的提高,并为临床提供安全有效的儿童用药。采用世界卫生组织(WHO)推荐的“共识会议法”和美国国立卫生研究院(NIH)发展共识方案(GPP)有关原则,国内全部18 个国家药物临床试验机构中医儿科专业的临床儿科专家以及国内相关临床评价专家参加了急性上呼吸道感染、急性支气管炎、支气管哮喘、反复呼吸道感染、厌食、轮状病毒性肠炎、注意缺陷-多动障碍、抽动障碍、遗尿症、手足口病、湿疹11 个儿科常见病种指南的起草或多次提出修改建议,历经3 年反复完善,最终形成共识,并由中华中医药学会儿科分会于2013 年10 月发布。本指南从研究背景、研究目标、总体设计、诊断标准、受试者的选择、给药方案、安全性评价、有效性评价、试验流程、数据管理与统计分析、质量保证、相关伦理学要求、试验结束后的医疗措施、资料保存等方面阐述了小儿湿疹中药新药临床试验的设计与评价技术要点,期望能为申办者与研究者在临床试验方案设计中提供指导。     

慢性阻塞性肺疾病铜绿假单孢菌感染的药敏分析

目的 回顾分析慢性阻塞性肺疾病(COPD)379株铜绿假单孢菌感染药敏监测资料，为临床经验性治疗参考。方法 收集住院COPD病人下呼吸道痰标本培养、采用K～B低电扩散法对379株分离的铜绿假单孢菌进行药敏试验。结果 其耐药从低到高前10位依次为哌拉西林／他唑巴坦、阿米卡星、美洛西林、头孢吡肟、妥布霉素、亚胺培南、奈替米星、环丙沙星、头孢他啶、哌拉西林。结论 铜绿假单孢菌在COPD肺感染中有重要地位，从亚胺培南、头孢他啶对其抗菌活性下降说明，要重视病原学的检查，药敏检测，根据药敏合理选用抗生素。     

Phenobarbital influences the development of sodium retention in liver disease induced by bile duct ligation in the rat

The onset of sodium retention in phenobarbital/carbon tetrachloride-induced cirrhosis in rats is preceded by a linear decrease in hepatic function as assessed by the aminopyrine rate constant of elimination. Sodium retention occurs when liver function decreases below a critical aminopyrine rate constant of elimination threshold of 1 min-1 x 10(-3). The objective of this study was to investigate this relationship in a different experimental model of cirrhosis in rats and to learn whether alteration of drug-metabolizing activity by hepatic enzyme induction changes the threshold for urinary sodium retention. Cirrhosis was induced in untreated and phenobarbital-treated rats by bile duct excision. Liver function, assessed by the aminopyrine breath test, and urinary sodium excretion on a constant salt diet were measured weekly for up to 4 wk. In untreated rats, the aminopyrine breath test rate constant of elimination was reduced by about 40% within 1 wk of surgery. Aminopyrine rate constant of elimination then decreased more slowly, but linearly. Urinary sodium excretion was initially unchanged, but sodium retention occurred after 2.5 wk and was maintained until the end of the experiment. Phenobarbital-treated rats had greater initial aminopyrine rate constant of elimination, but we saw a similar fall in aminopyrine rate constant of elimination of about 40% within 1 wk of bile duct excision to a value still above baseline aminopyrine rate constant of elimination of untreated controls. Aminopyrine rate constant of elimination remained at a plateau for 3.5 wk without changes in urinary sodium excretion. After 3.5 wk, a sudden decrease in aminopyrine rate constant of elimination was associated with the sudden onset of sodium retention.(ABSTRACT TRUNCATED AT 250 WORDS)     

The development of cellular immunity to Epstein-Barr virus after allogeneic bone marrow transplantation

Epstein-Barr virus-induced lymphoproliferative disease (EBV-LPD) is a potentially lethal complication during the first 6 months after allogeneic bone marrow transplantation (BMT). To determine whether deficiencies of EBV-specific cellular immunity contribute to EBV-LPD susceptibility and distinguish patients at risk, we performed limiting dilution analysis to quantify anti-EBV cytotoxic T-lymphocyte precursor (CTLp) frequencies in 26 recipients of unmodified or T-cell-depleted (TCD) grafts from EBV-seropositive donors. At 3 months post-BMT (n = 26), only five patients had EBV CTLp frequencies in the range of seropositive normal controls, irrespective of the type of transplant administered. By 6 months post-BMT, 9 of 13 patients tested had EBV CTLp frequencies within the normal range. The time period in which these patients had deficient cellular immunity to EBV corresponds to the period in which we have observed EBV-LPD in most prior patients. One patient with a low EBV CTLp frequency at 4 months post-BMT developed an EBV-LPD. Within 2 weeks of receiving an infusion of donor peripheral blood mononuclear cells (PBMC) providing less than 1,200 EBV- specific cytotoxic T-cell precursors, populations of EBV-specific CTL in the circulation were restored to levels detected in normal seropositive adults. Concurrently, the patient achieved a regression of the EBV-LPD, which has been sustained without further therapy. These studies indicate that recipients of both unmodified and TCD marrow grafts have profound deficiencies of EBV-specific T cell-mediated immunity early posttransplant, and that the period of risk for EBV-LPD closely corresponds to this interval of severe deficiency. Treatment of one patient with EBV-LPD with marrow donor-derived PBMC induced a rapid expansion of EBV-specific cytotoxic T-cell populations that occurred contemporaneously with the clinical regression of disease.     

An inhibitory monoclonal antibody to factor X that blocks prothrombin activation but not prothrombinase enzyme assembly

A monoclonal antibody (designated alpha BFX-2b) prepared against bovine factor X inhibited factor X activity in human, bovine, porcine, rabbit, and canine plasma. In assays using purified prothrombinase components, factor Xa, factor Va, phospholipid vesicles, and calcium ion with the fluorescent active site thrombin inhibitor dansylarginyl-N-(3-ethyl-1,5- pentanediyl)amide, the antibody inhibited the conversion of prothrombin to thrombin. Antibody alpha BFX-2b also blocked prothrombinase cleavage of the macromolecular substrates prethrombin 1 and prethrombin 2 but did not inhibit factor Xa hydrolysis of the synthetic substrate benzoyl- Ile-Glu-Gly-Arg-p-nitroanilide. The antibody also prevented the inactivation of factor Xa by antithrombin III but did not prevent the inactivation by soybean trypsin inhibitor. Antibody alpha BFX-2b bound factor Xa with a stoichiometry of 1:1 and an apparent dissociation constant of 9.0 x 10(-11) mol/L as estimated from its inhibition of prothrombinase activity. Antibody alpha BFX-2b did not prevent binding of factor Xa to factor Va-phospholipid as measured by using fluorescence polarization or high-pressure liquid gel chromatography with the fluorescent Factor Xa analogue dansyl-glutamyl-glycyl-arginyl- Xa. Immunoblotting of factor X following electrophoresis on sodium dodecyl sulphate-polyacrylamide gels and transfer to nitrocellulose indicated that the antigenic determinant recognized by antibody alpha BFX-2b was found on the heavy chain of factors X and Xa. From these observations it can be concluded that antibody alpha BFX-2b recognizes a highly conserved epitope on the factor X heavy chain that is remote from the topographic sites required for prothrombinase complex assembly and substrate hydrolysis but may be located at or near a portion of the macromolecular substrate binding site.