环孢素治疗药物监测质控规则的比较与评价

目的通过不同质量控制方法的比较,确定本院实验室条件下环孢素治疗药物监测的质量控制规则,及时发现测定误差成因,确保血药浓度监测质量。方法对本院实验室2009年质控数据进行统计学分析,并使用不同的质控方法评价,根据临床检验质控设计评价方法选择最佳质控规则。结果 Levey-Jennings控制方法的结果均在控,累计和质量控制方法检出3次失控,Z-分数控制图法检出8次失控,修改的Westgard多规则控制方法达到了极高的误差检出率和较低的假失控概率。结论修改的Westgard多规则控制方法简便易行,误差检出率高,成本低,符合本院实验室的质量控制要求,提高了实验室测定数据的准确性,能为临床提供更加真实有效的数据。     

肝移植术后环孢素治疗药物监测

目的:研究肝移植受者环孢素A临床药动学特点,优化环孢素A治疗药物监测方案。方法:采用荧光偏振免疫法测定环孢素A血药浓度,计算临床药动学参数。建立AUC0-12h与浓度变量回归模型。对C0、C2常规监测数据进行分析。结果:环孢素代谢呈二房室开放模型。C0 C2与AUC0-12h相关较为强烈,C2与AUC0-4h和AUC0-12h的相关性高于C0。在估算AUC0→12h的回归模型中,C0 C2最好,SE和R-sq分别为501.0和94.7,其后是C6,C2,C9,C4和C0。结论:环孢素A临床药动学个体差异大。C0 C2两点监测是环孢素A最好的监测方法,可客观评价环孢素A体内药物暴露(AUC0-12h),减少急性排斥和药物中毒发生。C2/C0可以作为评价移植肝功能恢复的灵敏指标。     

10606例次环孢素治疗药物监测结果分析

目的对我院2010年8月-2012年12月的10606例次环孢素治疗药物监测（TDM）数据进行统计分析．指导临床合理用药和减少药物不良反应。方法对我院1888例患者10606次符合入选条件的环孢素监测结果进行统计分析。,结果首次治疗药物监测结果在治疗窗内的仅占40．3％;治疗药物监测次数为1、2、3以及超过10次者分别占总人数的29．2％、13．7％、8．9％、14．8％;在监测次数为3次～5次的患者中,第1、2、3、4、5次治疗药物监测结果在治疗窗内的分别占总人数的38．2％、43．8％、45．9％、40．4％、33．9％。结论环孢素的药动学参数个体差异大．及时监测患者的环孢素血药浓度,可以指导临床合理用药。但目前监测次数偏少,达标情况不理想,即使监测多次也不能达到很好的效果,这可能与环孢索血药浓度受多种因素影响有关。     

1812例/次环孢素治疗药物监测结果分析

目的:评价1812例/次环孢素治疗药物监测和临床用药情况。方法:对我院502例患者1812次符合入选条件的环孢素监测结果进行统计分析。结果:首次治疗药物监测结果在有效治疗窗内的仅占41.4%;治疗药物监测次数为1、2、3次者分别占总人数的44.8%、16.3%、11.6%;在所有监测次数为3次～4次的患者中,第1、2、3、4次治疗药物监测结果在治疗窗内的分别占总人数的40.6%、48.0%、50.0%、57.9%。结论:治疗药物监测虽然广泛应用,但监测次数偏少;即使监测多次,达标情况仍不理想,应高度重视这种不能很好调整患者用药的现象;同时,这与药费昂贵等因素有关。     

环孢素治疗药物监测的质量控制

目的考察荧光偏振免疫（FPIA）法测定环孢素A（CsA）血药浓度的可行性及本实验室条件下CsA的治疗药物监测质量控制水平。方法以标准质控为样本,考察FPIA法测定CsA血药浓度的方法学性质,对本实验室2008年质控数据进行统计分析。结果方法低、中、高浓度回收率为92.83%～100.43%,RSD为2.49%～6.12%;本院2008年度随行质控低、中、高浓度RSD分别为5.85%,5.41%,4.95%,符合中国药典要求。质控图基本符合正态分布,存在一定程度的趋势性变化。结论 FPIA法具有良好的准确度和精密度,在长期的检测中稳定性较好,适合临床开展治疗药物监测,但应建立合理质控体系。     

环孢素A治疗药物监测研究进展

<正>环孢素A(Cyclosporine A,CsA)是1971年瑞士Sandoz公司从真菌(Tolypocladium Inflatum Gams)分离提取出来的一种由11个氨基酸组成的亲脂性环形多肽。1976年Borel首先报     

治疗药物监测与药物基因组学在优化抗结核治疗中的作用

结核病仍然是一个全球性的重大社会问题。化学治疗是控制结核病的主要手段。对结核病治疗的反应受到与宿主-病原体相互作用有关的多种因素的影响,治疗药物监测(TDM)是一种以药物治疗期间血清药物浓度为指导的个体化药物治疗手段;而基于药物基因组学的抗结核药物个体化给药,可以减少药物不良反应的发生率,并增加治疗成功的可能性。优化目前的治疗方案对提高结核病治疗的有效性至关重要。本文对当前关于TDM临床实用性,药物基因组学在结核病治疗中作用予以综述,以优化治疗。     

肾移植患者口服国产环孢素A软胶囊后治疗药物监测指标的选择

目的:探讨肾移植患者口服国产环孢素A(CsA)软胶囊后治疗药物监测的适宜指标。方法:采集10例肾移植术后稳定期患者口服国产CsA软胶囊后12h内不同时间点的血样,以单克隆荧光偏振免疫(mFPIA)法测定血药浓度。计算各采样点CsA浓度与AUC0～12和AUC0～4的相关系数,考察相关系数间的差异性。结果:除0.5、0.75h外,其余各时间点与0h的相关系数两两间检验未显示有统计学意义的差异(P>0.05)。结论:对于肾移植术后稳定期口服国产CsA软胶囊患者,谷浓度(c0)仍然可以作为适宜的治疗药物监测指标之一。     

难治性肾病综合征环孢素A血药浓度监测结果分析

目的:对济南军区总医院3年期间住院难治性肾病综合征患者全血中环孢素A(Cs A)浓度的监测结果加以分析,以便探讨其临床有效性和安全性,为更好地开展Cs A浓度监测提供参考。方法:采用荧光偏振免疫法测定92例肾病综合征患者的224次环孢素谷浓度,分析Cs A血药浓度与临床疗效及合并用药之间的关系。结果:92例难治性肾病综合征患者监测Cs A浓度共224例次,平均血药浓度为(134.78±65.26)ng·m L-1(·x±s),达有效浓度(100~150ng·m L-1)152例次(67.86%),低于100 ng·m L-1有60例次(26.79%),高于150 ng·m L-1有12例次(5.36%)。结论:Cs A血药浓度受多种因素的影响,对肾病综合征患者进行Cs A浓度监测具有重要的临床意义。     

Efficacy of inactivated vaccines in patients treated with immunosuppressive drug therapy

Inactivated vaccines are generally considered safe in immunocompromised patients but the ability of immunocompromised patients to generate an effective immune response to vaccines is uncertain. Although recent reviews have focused on the effects of vaccines in patients who are immunocompromised due to various disease states (primary immunodeficiency), the effects of immunosuppressive drug therapy (secondary immunodeficiency) has received relatively less attention. This review evaluates evidence regarding the efficacy of inactivated vaccines against influenza, COVID-19, and other diseases in patients treated with immunosuppressive oncologic agents, immunosuppressants used for transplant recipients, and immunosuppressants used for autoimmune disorders. Although evidence is mixed for many immunosuppressive agents and vaccines, most studies have found an attenuated immune response to inactivated vaccines, with the majority of data indicate anti-B-cell antibodies have a more severe and prolonged negative effect on vaccine efficacy.     

肾移植术后受者环孢素的血药浓度监测

目的 观察环孢素血药浓度与肾移植效果间关系。方法 对９７例接受同种异体肾脏移植术受者术后８周内２０６例次环孢素血药浓度监测结果进行回顾性分析，按照受者术后的临床表现、生化指标将其分为术后正常组、急性排斥组、急性毒性组，采用荧光偏振免疫测定法，以单克隆抗体试剂测定环孢素血药浓度。结果 术后正常组６２例移植肾功能良好，环孢素的给药剂量为５２±１．９ ｍｇ／ｋｇ·ｄ，１７１例次环孢素血药浓度的平均值为３０９．８５±１３１．６９μｇ／Ｌ；术后急性排斥组 ２６例，距发生排斥反应最近一次的环孢素血药浓度平均为１６５．８０±１２３．１３μｇ／Ｌ，环孢素的给药剂量为 ４．８±１．６ｍｇ／ｋｇ·ｄ；术后急性毒性组９例，距发生毒性反应最近一次的环孢素血药浓度平均为５５６．５１±１０２．５０μｇ／Ｌ，环孢素的给药剂量为６．２±１．０ｍｇ／ｋｇ·ｄ。三组之间环孢素的给药剂量无显著性差异（Ｐ＞０．０５），但环孢素血药浓度却相差很大，两两之间有显著性差异（正常组与排斥组 Ｐ＜ ０．０５；正常组与毒性组Ｐ＜ ０．０５；排斥组与毒性组Ｐ＜ ０．０１）。结论 环孢素浓度较低时，出现排斥反应的可能性较大；而环孢素浓度较高时，发生毒性反应的机会较多。     

儿童3种免疫抑制药的药物监测

免疫抑制剂是一类特殊的专科用药,虽然在儿童中应用较成人少,但药品的作用机制导致不良反应发生率高,许多免疫抑制剂在药动学和药效学上又存在着明显的个体差异,所以对服用免疫抑制剂的儿童患者,药物监测同样需得到重视。本文选取了最有代表性的微生物来源免疫抑制剂,分别对其药物特点、适应证以及可行的分析方法进行综述,希望对开展儿童免疫抑制药物的治疗监测起到借鉴作用。     

Practical aspects of drug treatment in elderly patients with mobility problems

Elderly people with impaired mobility frequently experience difficulty with medication administration and compliance. Many medications are dispensed in packages or in containers which are difficult to access by older people with disabilities. Attending a medical centre, activating an inhaler, applying eyedrops or opening medication containers can prove major obstacles to medication compliance for older people with impaired function. Assessment of each patient's ability to physically comply with medication regimens by the physician is therefore recommended. Contact with the care giver or support person should also be made where appropriate. Compliance aids such as some calendar packages for medications, metered dose inhalers (MDIs) or eyedrop aids should be prescribed where indicated. Because of their close contact with many elderly patients when dispensing, pharmacists can also play an important role in ensuring adherence with medication regimens. Some medications may improve mobility as seen in the treatment of Parkinson's disease whereas other medications such as phenothiazines may impair mobility and contribute to falls. Several drug classes including antipsychotics, antidepressants, antihypertensives and benzodiazepines have been recognised as having an association with falls and impaired mobility. Multiple medications have also been found to be a risk factor in falls. Medications should be reviewed regularly and rationalised where possible. If mobility problems or unexplained falls are occurring, medications should be closely scrutinized as they may be responsible. Where possible, domiciliary visits for older people should be undertaken by health professionals as they often provide critical information about a patient's functional status, their medication compliance and their ability to cope at home. Emphasis must be placed on older people maintaining their independence and mobility. This is best achieved through a multidisciplinary approach.     

The effective therapy of cyclosporine A with drug delivery system in experimental colitis

Cyclosporine A (CyA) is a useful immunosuppressive agent for steroid-dependent or steroid-refractory ulcerative colitis. However, side effects have been reported in clinical trials of ulcerative colitis treated with CyA. Biodegradable microspheres (MS) have been investigated as drug delivery system. We evaluated the effect of a drug delivery system with poly(d,l-lactic acid)-MS containing CyA. Colitis was induced in C57BL/6 mice by 3% dextran sulfate sodium (DSS). Mice with DSS-induced colitis were treated with oral administration of CyA or CyA-MS: CyA (0.2?mg/kg/day)-MS; CyA (2?mg/kg/kg)-MS). Serum levels of CyA were significantly less elevated after oral administration of CyA (2?mg/kg/day)-MS compared with CyA (2?mg/kg/day) (CyA (2?mg/kg/day), 44.7 ± 0.8?ng/ml; CyA (2?mg/kg/day)-MS, 7.7 ± 1.3?ng/ml). The body weight at day 10 was significantly recovered in the mice treated with CyA (0.2?mg/kg/day)-MS and CyA (2?mg/kg/day)-MS compared with CyA (0). The histological score and myeloperoxidase activity in the mice treated with CyA-MS was significantly lower than CyA (0). Gene expressions of interleukin-1β (IL-1β), IL-6, and CXCL1 in the mice treated with CyA (0.2?mg/kg/day)-MS and CyA (2?mg/kg/day)-MS were downregulated compared with CyA (0)-MS. CyA-MS might be possible to treat ulcerative colitis effectively by decreasing the total dosage without the elevation of the serum level or the side effects of CyA.