甲状腺癌患者行~(131)I治疗后体外辐射剂量变化研究

目的了解分化型甲状腺癌术后行~(131)I治疗的患者体外辐射剂量变化,探讨患者出院日及临床过程中的辐射防护方法。方法选取分化型甲状腺癌术后进行~(131)I治疗的患者74例,在治疗后24 h、48 h、72 h、96 h,使用放射性核素治疗监护机器人测量距患者颈部及1 m处的体外辐射剂量水平,并与出院参考标准进行比较。结果行~(131)I治疗后24 h、48 h、72 h、96 h,距患者1 m处辐射剂量为270.11(202.46,427.18)、64.02(39.01,101.19)、16.74(10.07,27.69)、5.28(3.41,10.40);行~(131)I治疗后24 h、48 h、72 h、96 h,辐射剂量符合出院要求的患者分别为0例、2例(2.7%)、52例(70.3%)、70例(94.6%)。结论甲状腺癌患者行~(131)I治疗后体外辐射剂量变化差异性较大,建议动态检测患者行~(131)I治疗后1 m处的体外辐射剂量,按照辐射剂量要求执行个体化出院时间。医护人员接触患者时要做好防护,可使用放射性核素治疗监护机器人完成部分工作。     

131I-间碘苄胍显像联合血浆游离甲氧基肾上腺素诊断嗜铬细胞瘤

本文回顾性分析31例疑诊嗜铬细胞瘤的131I-MI-BG显像及血游离三甲氧基肾上腺素(fMN)和三甲氧基去甲肾上腺素(fNM)检测结果,探讨两者在嗜铬细胞瘤诊断中的价值。1资料与方法1.1临床资料收集我院2008年5月—2010年10     

泊沙康唑新型固体口服制剂：研究健康受试者中单剂和多剂剂量递增给药的药动学特性和安全性的随机临床试验

目的：泊沙康唑是一种有效治疗和预防真菌感染的三唑类广谱抗真菌药物。市售的口服混悬液需与食物同服以使药物达到最大吸收。现已研发出一种生物利用度高且不需同时进食的新型固体口服片剂。本研究旨在评价健康受试者中该新制剂单剂和多剂剂量递增给药后的药动学特性、安全性以及耐受性。方法：该试验是单中心、随机、安慰剂对照、单次和多次给药剂量递增的I期临床试验。筛选18～65岁的健康受试者,共24名,分为2组,每组12名（9名服用试验药物,3名服用安慰剂）。第1组受试者接受200mg每天1次和每天2次给药,第2组受试者接受400mg每天1次和每天2次给药。     

Use of 131I-MIBG scintigraphy in the evaluation of suspected pheochromocytoma

Studies at the University of Michigan have shown that 131I-metaiodobenzylguanidine (131I-MIBG) is an effective agent for the diagnosis and localization of pheochromocytomas and paragangliomas. We conducted a study that confirmed and expanded that finding. From January 1983 to March 1984, 48 patients at our institution had 51 131I-MIBG scans during the workup of suspected sporadic or metastatic pheochromocytoma. Scintigrams were obtained after 500 microCI of 131I-MIBG had been administered intravenously. The final diagnosis (true-positive, false-negative, or false-positive result) was made at operation and pathologic examination. A true-negative diagnosis was confirmed by normal plasma and fractionated urinary levels of catecholamines and metabolites and, in most patients, computed tomography (CT). There were 20 true-positive studies (6 pheochromocytomas, 4 paragangliomas, and 10 metastatic or recurrent pheochromocytomas) and 24 true-negative studies. One patient with a suspected recurrent paraganglioma near the bladder had a false-positive 131I-MIBG scan (and also a false-positive (CT). Among six patients with false-negative scintigrams (three pheochromocytomas, one paraganglioma, and two metastatic lesions), one also had a false-negative CT. The overall sensitivity of 131I-MIBG scanning was 77%, specificity was 96%, and accuracy was 86%. This test is fairly sensitive in the workup of patients with known or suspected recurrent or metastatic pheochromocytoma. It may also be helpful in the evaluation of suspected sporadic pheochromocytoma when CT findings are normal.     

Assessment and implication of the allergic sensitivity to a single dose of recombinant human hyaluronidase injection: a double-blind, placebo-controlled clinical trial.

Animal-extracted injectable hyaluronidases have been used safely for more than 50 years to increase the dispersion and absorption of coadministered drugs and fluids; however, concern still exists about the allergic and immunological risks of these products. Hylenex recombinant, a novel formulation of recombinant human hyaluronidase, has been developed as an alternative to these animal-derived hyaluronidases. Because recombinant human hyaluronidase is a human (nonforeign) protein manufactured into a purer preparation than the animal extracts, it is expected to convey reduced allergic and immunologic risks. The recombinant human hyaluronidase product was well tolerated in this double-blind, placebo-controlled, single-dose study. No allergic reactions were observed among the 100 volunteer subjects who were injected intradermally. These findings supported the US Food and Drug Administration approval of the recombinant human hyaluronidase product.     

A pharmacokinetic study on two sustained-release formulations of indomethacin in normal subjects following a single dose administration

A single dose pharmacokinetic study was conducted on two sustained-release formulations (75 mg) of indomethacin (Indocid capsules ‘A’ and Indogesic tablets ‘B’). The study was carried out on 22 healthy male volunteers, who received a single oral dose (75 mg) of each product according to a randomized crossover design. Blood samples were obtained over a 24 h period, and drug concentrations were determined by an HPLC assay. The two products were not found to be statistically different with respect to the lag time between dosing and first appearance of the drug in the serum (1.0 ± 0.1 and 0.9 ± 0.1 h for A and B, respectively), or in the time needed to attain the peak concentrations (3.3 ± 0.3 and 3.3 ± 0.5 h for A and B, respectively). The two products, however, varied significantly in the peak serum concentrations (2721 ± 220 and 1797 ± 129 ng/ml for A and B, respectively). In terms of the extent of absorption, assessed by estimating the area under the concentration-time curve over 24 h, the two products were not found to be significantly different (11,575 ± 630 and 10,212 ± 556 ng. h/ml for A and B, respectively). Based on these findings, the two formulations can be considered bioequivalent in the extent but not in the rate of drug absorption.     

米库氯铵对比罗库溴铵对快速顺序诱导气管插管条件影响的非劣效性临床试验

目的 比较米库氯铵分次给药与罗库溴铵常规给药快速顺序诱导气管插管(rapid sequence induction and intubation, RSII)过程中气管插管条件和血流动力学变化，以优化米库氯铵在RSII方案中的应用。方法 选择在复旦大学附属中山医院择期手术患者158例，随机分为米库氯铵组(M组, n=79)和罗库溴铵组(R组, n=79)，麻醉诱导给予米库氯铵0.25 mg/kg(分次给药)或罗库溴铵0.9 mg/kg，联合异丙酚、利多卡因、瑞芬太尼和麻黄碱。采用Cooper’s气管插管条件量表评估两组患者气管插管条件的优秀率，根据非劣效界值(﹣10%)分析差异(主要终点指标)；比较诱导后0～10 min(T_0～10)两组患者的平均动脉压(MAP)、心率(HR)变化及不良事件发生率(次要终点指标)。结果 两组患者气管插管条件优秀率差异(M组-R组)为﹣5.06%(94.94%vs 100%,单侧97.5%CI﹣9.96%～∞)，CI下限大于非劣效性界值(﹣10%)，满足非劣效性假设(P=0.024)。M组患者T₃的MAP和T<...     

Efficacy and safety profile of a single dose of hydromorphone compared with morphine in older adults with acute,severe pain: A prospective,randomized, double-blind clinical trial

Background: Older adults (ie, those aged ≥65 years) are the fastest growing segment of the US population, with an estimated ~71 million expected by 2030. Over the past 10 years, there has been an 11% increase in the number of emergency department (ED) visits by older adults, and pain is their most common chief complaint.Objective: The goal of this study was to compare weight-based IV hydromorphone and IV morphine in adults aged ≥65 years presenting to the ED with acute, severe pain.Methods: This was a prospective, randomized, double-blind clinical trial of older adults with acute, severe pain at an adult, urban academic ED. Patients were randomly allocated to receive a single dose of 0.0075-mg/kg IV hydromorphone or 0.05-mg/kg IV morphine. The primary outcome was the between-group difference in decrease in pain from baseline to 30 minutes after the medications were infused. Patients' degree of pain was measured on a numerical rating scale (NRS) where “0” was defined as “no pain” and “10” was defined as “the worst pain possible.” Adverse effects, pain reduction at 10 minutes and 2 hours postbaseline, patient evaluations of satisfaction and pain relief at 30 minutes postbaseline, and use of additional analgesics and antiemetics were tracked as secondary outcomes.Results: A total of 194 patients were randomized to treatment; 183 patients (hydromorphone group, n = 93; morphine group, n = 90 [overall mean (SD) age, 75 (8) years]) had sufficient data for analysis at the primary end point of 30 minutes postbaseline. The mean decrease in pain from baseline to 30 minutes in patients allocated to IV hydromorphone was 3.8 versus 3.3 NRS units in patients allocated to IV morphine. This difference of 0.5 NRS unit (95% CI, ?0.2 to 1.3) was neither clinically nor statistically significant. A majority of patients in both groups (57.0% randomized to hydromorphone and 58.9% randomized to morphine) failed to achieve a ≥50% reduction in pain within 30 minutes of treatment. The incidence of adverse effects from baseline to 30 minutes was not statistically different in the 2 groups.Conclusions: A single dose of IV hydromorphone at 0.0075 mg/kg was neither clinically nor statistically different from IV morphine at 0.05 mg/kg for the treatment of acute, severe pain at 30 minutes postbaseline in these older adults in the ED. The incidence of adverse effects was not statistically different. Our data suggest that hydromorphone and morphine in the doses given had similar efficacy and safety profiles in these older adults. Neither regimen provided ≥50% pain relief for the majority of patients. Future investigations of acute pain management in older adults should examine the efficacy and safety of higher initial (loading) doses of opioids titrated at frequent intervals until adequate analgesia is achieved.