Modified formulation of CPDA for storage of whole blood, and of SAGM for storage of red blood cells, to maintain the concentration of 2,3-diphosphoglycerate

BACKGROUND AND OBJECTIVES: A dramatic decrease in the level of 2,3-diphosphoglycerate (2,3-DPG) takes place during the storage of whole blood (WB) in CPDA (citrate-phosphate-dextrose-adenine) and a similar decrease occurs during the storage of red blood cells (RBCs) in SAGM (saline-adenine-glucose-mannitol). The aim of the present study was to prevent this decrease by modifying CPDA and SAGM. MATERIALS AND METHODS: The pH of WB anticoagulant or RBC preservative solution was maintained at 7.6 by autoclaving the dextrose solution separately, by incorporating ascorbic acid and nicotinic acid into both CPDA and SAGM (to produce modified CPDA and SAGM solutions), and by reducing the concentration of adenine and adding citrate to the modified SAGM solution. The concentration of 2,3-DPG in WB after 28 days of storage in modified CPDA, and in RBCs stored in modified SAGM, was compared with that in WB or RBCs stored in unmodified solutions. RESULTS: The initial 2,3-DPG levels were maintained after 28 days in the modified formulations [10.63 +/- 2.58 microM/g of haemoglobin (Hb) in the case of modified CPDA and 12.07 +/- 1.47 microM/g of Hb in the case of modified SAGM], whereas in standard CPDA and SAGM solutions, the concentration of 2,3-DPG decreased to very low levels (0.86 +/- 0.97 microM/g Hb for CPDA and 0.12 +/- 0.008 for SAGM). CONCLUSIONS: Our modification in the formulation of CPDA or SAGM is effective in arresting the dramatic decrease in the level of 2,3-DPG that occurs during storage of WB and RBCs in unmodified solutions.     

Comparative Safety,Bioavailability, and Pharmacokinetics of Oral Dexamethasone, 4-mg and 20-mg Tablets,in Healthy Volunteers Under Fasting and Fed Conditions: A Randomized Open-label, 3-way Crossover Study

BackgroundGlucocorticoids, particularly dexamethasone, are often used in combination with novel agents in multiple myeloma. This study compared the safety, rate, and extent of absorption of a single dose of an orally administered 20-mg dexamethasone tablet to five 4-mg tablets (total, 20 mg).Patients and MethodsThis was a single-center, open-label, randomized, 3-way crossover comparative study. Thirty-six volunteers received at least 1 dose of either a single 20-mg dexamethasone tablet, under fasting or fed conditions, or five 4-mg dexamethasone tablets (total, 20 mg). Blood samples were collected before study drug administration and at 21 time points for up to 36 hours after drug administration.ResultsMean area under the concentration-time curve from time zero to the time of last non-zero concentration (AUC_0–t), mean area under the concentration-time curve from time zero to infinity (extrapolated) (AUC_0–∞), and maximum observed concentration (C_max) were 1314.38 ng × h/mL, 1329.24 ng × h/mL, and 257.22 ng/mL, respectively for fasting test formulation (single dexamethasone 20-mg tablet), 1339.74 ng × h/mL, 1358.07 ng × h/mL, and 194.56 ng/mL, respectively, for the fed test formulation (single dexamethasone 20-mg tablet), and 1325.12 ng × h/mL, 1342.12 ng × h/mL, and 244.12 ng/mL, respectively, for the reference formulation (5 dexamethasone 4-mg tablets). The median time of observed C_max was 0.997 hours for the fasting and 2.502 hours for the fed test formulation, compared with 1.495 hours for the reference. Mean plasma elimination half-lives (t_1/2) were 4.0 hours (test fasting), 4.03 hours (test fed), and 3.96 hours (reference). The point estimates and 90% confidence intervals (CIs) for AUC_0-t, AUC_0-∞, and C_max were 99.37% (90% CI, 95.65%-103.24%), 99.24% (90% CI, 95.47%-103.16%), and 106.28% (90% CI, 97.69%-115.62%), respectively, satisfying the bioequivalence criteria of the United States Food and Drug Administration guidelines.ConclusionThe 2 formulations were well-tolerated, and one 20-mg tablet or five 4-mg tablets of dexamethasone are bioequivalent under fasting conditions and thus may be prescribed interchangeably.     

美沙拉秦治疗溃疡性结肠炎的疗效观察

目的研究美沙拉秦（惠迪）治疗溃疡性结肠炎（uc）的治疗疗效。方法收集2007年3月-2008年6月在我院治疗的活动性UC病人112例,随机分为治疗组62人和对照组50人。治疗组患者服用惠迪每次1．0g,4次／d,疗程4周,缓解后改为2g,继续服用4周;对照组服用柳氮磺胺吡啶（SASP）每次1．0g,4次／d,疗程4周,缓解后改为2g,继续服用4周。比较治疗组和对照组患者的临床症状、生化和免疫学指标,以及肠镜下的改变。结果治疗8周后,发现惠迪和柳氮磺胺吡啶（SASP）都可有效控制UC患者的临床症状（总有效率为88．7％和80．O％）,治疗2周后,惠迪比SAsP能更迅速缓解患者的临床症状。惠迪对患者的肝、肾功能无影响,治疗后血细胞沉降率和C反应蛋白的水平显著降低（P〈0．05）,而且不良反应发生率明显低于SASP（P〈0．01）。结论惠迪是一种能有效控制活动性UC的药物,不良反应少。     

复原通络方治疗下肢血栓性浅静脉炎的临床观察

[目的]观察复原通络方治疗瘀血阻络型下肢血栓性浅静脉炎的临床疗效。[方法]选取72例瘀血阻络型下肢血栓性浅静脉炎患者,随机分为对照组和治疗组各36例,对照组服用阿司匹林肠溶片每次1片,每日1次;治疗组同时加用复原通络方,每日1剂。观察时间为8周,比较用药前后两组患者的红肿、疼痛、色素沉着、条索状物等恢复情况及血液流变学相关指标的改变。[结果]治疗组的总有效率明显高于对照组,治疗组肿痛症状及血液流变学指标的改善也很明显(P0.05)。[结论]复原通络方在治疗瘀血阻络型下肢血栓性浅静脉炎时,具有良好的疗效。     

Fungal infections in solid organ transplantation: An update on diagnosis and treatment

Invasive fungal infections constitute an important cause of morbidity and mortality in solid organ transplantation recipients. Since solid organ transplantation is an effective therapy for many patients with end-stage organ failure, prevention and treatment of fungal infections are of vital importance. Diagnosis and management of these infections, however, remain difficult due to the variety of clinical symptoms in addition to the lack of accurate diagnostic methods. The use of fungal biomarkers can lead to an increased diagnostic accuracy, resulting in improved clinical outcomes. The evidence for optimal prophylactic approaches remains inconclusive, which results in considerable variation in the administration of prophylaxis. The implementation of a standard protocol for prophylaxis remains difficult as previous treatment regimens, which can alter the distribution of different pathogens, affect the outcome of antifungal susceptibility testing. Furthermore, the increasing use of antifungals also contributes to incremental costs and the risk of development of drug resistance. This review will highlight risk factors, clinical manifestations and timing of fungal infections and will focus predominately on the current evidence for diagnosis and management of fungal infections.     

穿琥宁氯化钠注射液的工艺研究

目的：为提高穿琥宁氯化钠注射液的质量，优选穿琥宁氯化钠注射液的最佳处方和制备工艺。方法：采用氯化钠调节等渗、磷酸盐缓冲液对调节pH值、活性炭吸附热原、筛选合适的抗氧剂等手段优化穿琥宁氯化钠注射液的制备工艺，采用高效液相色谱法测定穿琥宁氯化钠注射液的含量。结果：每100m1注射液中含0．193gNa2HP0a和0．131gNaH2PO4时注射液最稳定；抗氧剂为0．1％L-半胱氨酸盐酸盐；45℃为主药的溶解温度；浓配液先加热煮沸15min，再稀配、灭菌，注射液澄明度达到要求；整个制备过程通高纯度N2以隔离空气中的O2。结论：优选的处方和制备工艺，可提高穿琥宁氯化钠注射液的质量。     

姜黄素抗肿瘤新剂型研究进展

姜黄素是从姜科植物根茎中提取的相对分子量较小的多酚类物质,具有抗肿瘤抗炎、抗病毒、抗氧化等多种药理作用,随着现代医学发展,姜黄素抗肿瘤方面药理作用的分子机制被不断认识。肿瘤的形成和发展是一个多阶段的过程,药物干预可作用于其中的任何阶段,人类希望能找到安全、高效的肿瘤预防与治疗药物。食物来源的天然药物姜黄素因其具备较低的毒副作用、较高的安全性和较高的依从性,可被各类人群尤其是中低风险人群长期服用,而倍受关注。然而姜黄素的一些理化性质决定了其应用不尽理想,如何改善这些缺陷逐渐成为当今研究姜黄素的热点。该文将从天然食物来源的预防肿瘤药物姜黄素应用新剂型进行综述。     

左金丸胃漂浮缓释片的制剂配方研究

目的 优选左金丸胃内漂浮缓释片的制剂配方。 方法 以辅料羟丙基甲基纤维素(HPMC K4MCR)、卡泊姆(Carbopol)934P、十八醇和NaHCO3为L9(34)正交试验4个因素,干法压片,优化左金丸体外漂浮性能,在此基础上设计F1～F5 5个方案,对处方体外释药性能进行优选;并研究左金丸胃漂浮缓释片体外评价方法。 结果 选择以A3B3C3D3和F4作为左金丸胃漂浮缓释片处方的最优制剂配方组合。初步建立了左金丸胃漂浮缓释片体外评价方法。结论 该剂型符合该药物药理作用特点,有助于延长药物在胃内的治疗作用时间,且制剂配方稳定可靠,可为左金丸新剂型的开发和应用提供参考。