快速高效液相色谱及其应用

快速高效液相色谱法是一种新的高效液相色谱技术,由于其具有较常规HpLC的分析时间短、柱效高和所需费用少等优点,近年来发展较快。本文介绍了有关快速高效液相色谱的发展、特点、对仪器的要求及其在药物分析方面的一些应用。     

糖尿病对抗结核药物血药浓度影响的研究

目的 研究肺结核合并糖尿病对吡嗪酰胺、左氧氟沙星、对氨基水杨酸钠异烟肼、利福喷丁的血药峰浓度的影响,为糖尿病合并肺结核用药提供理论依据.方法 随机选取糖尿病合并肺结核的患者为观察组,单纯肺结核为对照组,服用抗结核药物7d后,用高效液相色谱法(HPLC)测定患者抗结核药 物(吡嗪酰胺、左氧氟沙星、对氨基水杨酸钠异...     

抗结核药物的副作用及其处理

随着抗结核药物的应用增加 ,化疗过程中出现副作用病例数增多。对一线及二线抗结核药物治疗剂量及过量使用的主要副作用及治疗进行了概述。     

抗结核药物使用分析

摘要目的分析抗结核药临床使用情况及用药趋势。方法采用WHO推荐的以限定日剂量为指标的分析方法,对浙江省嘉兴市第一医院2007～2009年抗结核药的使用情况进行回顾分析。结果该院抗结核药的临床使用以口服药为主,乙胺丁醇片、异烟肼片、利福喷丁胶囊和利福平胶囊使用频度（DDDs）居前四位,8种抗结核药DDDs排序表明用药趋势基本一致。总金额构成比前5位分别是利福喷丁胶囊、对氨基水杨酸异烟肼片、乙胺丁醇片、利福平注射剂、利福平胶囊。日用药金额前4位分别是利福平注射剂、对氨基水杨酸异烟肼片、利福喷丁胶囊、异烟肼注射剂。药物利用指数（DUI）均较接近1.0。结论该院抗结核药的临床使用总体合理。     

新型抗结核药物的研究进展

近年来由于全球结核病疫情回升 ,耐药结核菌呈增长趋势 ,尤其是耐异烟肼和 /或利福平的复治病例逐渐增加 ,迫切需要研制新的高效抗结核药。对新的抗结核药的研究进展进行了介绍。     

超高效液相色谱在药物分析中的应用

超高效液相色谱（UPLC）是近年来发展的以超高速度、超高分离度、超高灵敏度为特点的新型液相色谱技术。其应用于复杂体系快速分析所表现出的优势,已引起了药物分析工作者的重视。本文对近年来超高效液相色谱在药物分析中的应用进行了综述。     

抗结核药物使用调查分析

目的：分析住院结核病患者药物使用数据，为临床用药提供参考。方法捕l用医院信息系统数据库。统计2002—2004年2873名住院结核病患者抗结核药物使用数据，分析药物临床使用情况。结果：根据DDDs排序，异烟肼、利福平、吡嗪酰胺、乙胺丁醇和链霉素仍然是抗结核化疗的首选药物；利福霉素类药物使用较广泛；喹诺酮类药物在治疗耐多药结核病方面前景很好，但其高成本影响了该类药物的用药频度；联合用药方案以四联为主，符合WHO推荐的治疗原则。结论：主要抗结核药物的利用情况基本合理，在引入新药时需要考虑耐药性、经济因素和患者的依从性。     

阿昔洛韦片的含量测定

目的:采用《中国药典》2010年版二部、2015年版二部测定阿昔洛韦的含量.方法:高效液相色谱法及紫外分光光度法.结果:两种方法测得阿昔洛韦含量接近.结论:高效液相色谱法测含量精密准确,紫外分光光度法快速较准确,不过略差于高效液相色谱法精密.     

抗结核固定剂量复方制剂有关物质的测定

建立了高效液相色谱法测定抗结核固定剂量复方制剂(FDC)品种异福片、异福酰胺片及乙胺吡嗪利福异烟片中的有关物质.采用C18色谱柱,以0.01 mol/L磷酸盐缓冲液-甲醇(40∶60)为流动相,检测波长254 nm.经专属性试验、系统适用性试验、耐用性试验和溶液稳定性试验证实方法可行,增加有关物质的测定方法有利于其复方制剂药品质量的控制.     

抗结核药物固定剂量复方制剂概况及其申报中常见问题分析

分析国内外抗结核药物固定剂量复方制剂研发情况,对国内申报该类制剂中存在的常见问题进行分析,为开发此类制剂提供一些参考。     

The challenges of pharmacokinetic variability of first-line anti-TB drugs

Introduction: Inter-individual variations in the pharmacokinetics (PK) of anti-TB drugs are known to occur, which could have important therapeutic implications in patient management.

Areas covered: We compiled factors responsible for PK variability of anti-TB drugs reported from different settings that would give a better understanding about the challenges of PK variability of anti-TB medications. We searched PubMed data base and Google scholar from 1976 to the present using the key words ‘Pharmacokinetics’, ‘pharmacokinetic variability’, ‘first-line anti-TB therapy’, ‘Rifampicin’, ‘Isoniazid’, ‘Ethambutol’, ‘Pyrazinamide’, ‘food’, ‘nutritional status’, ‘HIV’, ‘diabetes’, ‘genetic polymorphisms’ and ‘pharmacokinetic interactions’. We also included abstracts from scientific meetings and review articles.

Expert commentary: A variety of host and genetic factors can cause inter-individual variations in the PK of anti-TB drugs. PK studies conducted in various settings have adopted different designs, PK sampling time points, drug estimation methodologies. Hence comparison and interpretation of these results should be done with caution More phamacogenomic studies in different patient populations are needed for further understanding.     

抗结核药物不良反应110例的临床分析

目的探析应用抗结核药物导致的不良反应的特点。方法选择笔者所在医院2009年1月～2011年6月应用诊断为肺结核病的患者110例,应用抗结核药物治疗的,并对治疗过程中出现的不良反应情况进行总结。结果应用抗结核药物所致的不良反应以胃肠道反应最高,其次是肝功能损害、过敏反应、肾功能损害和神经损害,所有患者经对症治疗后均治愈。结论应用抗结核药物治疗的过程中应密切关注患者病情,以及时发现不良反应,并给与相应的治疗,及时调整治疗方案,以免给患者带来不必要的痛苦。     

河南省免费抗结核药品库房管理评价

目的:评价河南省免费抗结核药品的管理水平,总结经验,寻找差距。方法:按照《中国结核病防治规划-免费抗结核药品管理手册》要求,制定了包含17个考评项目的问卷,随机选择了河南省20个县市的抗结核药品库房进行现场调查。结果:75%的药品库房有制订年度药品需求计划,但只有35%的库房药品库存水平达到要求,95%的库房没有出现过期药品;90%的药品库房有出入库凭单和每一笔出入库的明细账目,但只有25%的库房做到账物相符;药品库房条件和药品摆放还未达到要求。结论:免费抗结核药品的管理还未得到各级结核病防治机构的足够重视,应当从为国家节约财产和确保患者用药质量角度,提高药品管理者的责任心。     

Adverse reactions of anti-tuberculosis drugs in hospitalized patients: incidence, severity and risk factors

BACKGROUND: Tuberculosis (TB) has been a common chronic infectious disease in human communities. Besides disease-related complications, there could be serious adverse reactions due to anti-tuberculosis (anti-TB) drug therapy. OBJECTIVES: To assess the incidence and severity of adverse drug reactions (ADRs) induced by anti-TB drugs. To determine possible covariates associated with detected ADRs. METHODS: All patients with respiratory TB admitted to a teaching hospital who received anti-TB drugs during the research period entered the study and were monitored for ADRs. Socio-demographic and medical history of patients were used as independent covariates. The relationship between independent covariates with frequency and severity of ADRs was analysed using multivariate logistic regression. Preliminary analyses of the Mann-Whitney, Chi-square, Kruskal-Wallis and the Fisher's exact tests were applied to determine factors unlikely associated with the independent variables. RESULTS: Among 204 patients admitted, there were 92 patients (45.1%) with ADRs induced by anti-TB drugs. Patients with a previous history of anti-TB drugs usage (OR = 5.81, 95% confidence interval [95%CI]: 1.31-25.2), patients with a history of drug allergy (OR = 6.68, CI: 1.28-36.2), those from Afghani ethnic (OR = 4.91, 95%CI: 1.28-18.30) as well as smoker patients with concurrent diseases (OR = 19.67, CI: 1.24-341.51) had a higher rate of ADR incidence. Being female (OR = 1.63, 95%CI: 1.96-36.40) and having previous history of ADR (OR = 17.46, 95%CI: 1.96-20.42) were identified as risk factors. CONCLUSION: Anti-TB drugs could cause severe and frequent adverse effects. Females, those with a previous history of ADRs to anti-TB drugs and Afghani patients, should be considered as high-risk groups.     

抗结核药物HPLC快速确证方法的研究

目的建立抗结核药物中异烟肼、吡嗪酰胺、对氨基水杨酸钠、乙硫异烟胺、丙硫异烟胺、利福平、利福喷丁、利福布丁等化合物的HPLC快速确证方法。方法采用AlltimaTMHP C18Rocket TM色谱柱;将以上化合物按物理性质分为3组,分别确定每组化合物的色谱分离体系;采用相对容量因子和紫外光谱相似度双指标进行定性;相对容量因子法进行定量分析。结果根据化合物的物理性质或结构,将其分组,确定每组化合物的色谱分离体系,以实现尽可能用较少的色谱体系分离较多化合物,减少HPLC分析过程中流动相的切换,加快药物分析速度;采用双指标进行定性,增加了HPLC定性的准确性;相对校正因子含量测定法,能有效减少对照品的使用,加快HPLC分析速度。结论抗结核药物HPLC快速确证方法快速、简便,适用于药品的快速检测,为HPLC法快速检测药品提供了指导原则。     

抗结核药的快速鉴别方法

目的研究抗结核药物快速鉴别方法。方法通过颜色反应和薄层色谱展开系统的筛选，寻找最佳方法。结果抗结核药物选用三种试剂进行颜色反应鉴别加以初步区分，再结合一种展开系统的鉴别则可将抗结核药物相互之间的区分进一步完善。结论该方法设备简单，样品消耗量小，具有操作简捷、准确、快速的特点，特别适用于基层打假使用。     

利福霉素类药物治疗结核病的临床应用研究进展

结核病是由结核分枝杆菌复合群引起的传染性疾病，是全球主要的流行病种之一。利福平是当前最主要的一线抗结核药物，因其长期应用和不规范治疗，利福平耐药逐渐增加，利福喷丁、利福布汀等利福霉素类衍生物在抗结核治疗方面起到了重要作用。基于利福霉素类药物的药理及药动学特性，对该类药物在结核病治疗中进行最优用药选择分析，并对该类药物与其他抗结核药物联用进行综述，旨在为利福霉素类抗结核药物的临床用药提供文献依据。     

抗结核药物致药物性肝损害临床诊治分析

目的总结抗结核药物所致药物性肝炎的临床特点,探讨抗结核药致肝损害的诊断与及其预防和合理的治疗。方法根据临床用药史、临床症状、肝功能检查、影像学检查及药物性肝病诊断标准,对本站2004年至2006年管治的肺结核患者抗结核治疗后出现肝损害的61例患者进行回顾性分析。结果348例结核病人接受抗结核药物治疗后,有61例病人出现药物性肝病,药物性肝病发生率17．53％,348例病人中HBsAg阳性32例,其中13例出现药物性肝损害,占40．63％。结论抗结核药所致肝损害多见于具有危险因素的患者,且多发生在用药的第1～8周。在进行抗结核治疗前应常规检查肝功能、HBsAg,在治疗过程中应定期检查肝功能、对抗结核药致肝损害的早期诊断和及时合理的治疗,可以使患者肝功能恢复正常,帮助患者顺利完成抗结核治疗疗程。     

利福平致药物热1例报告

目的 认识利福平导致的药物热的临床特征,提高对该不良反应的认识.方法 回顾分析1例服用利福平导致药物热病人的临床资料及药物治疗情况.结果 1例57岁女性病人因结核性胸腔积液给予异烟肼0.3 g,1 d 1次,口服,利福平0.45 g,1 d 1次,口服,乙胺丁醇0.75 g,1 d 1次,口服,吡嗪酰胺0.5 g,1 d 3次,口服,四联抗结核方案.用药15 d后,病人无明显诱因下出现畏寒发热,体温39~40.3 ℃,伴腹泻4次/天,恶心、呕吐、头晕.停用利福平、乙胺丁醇、吡嗪酰胺1 d后,体温恢复至正常,体温37.4 ℃.再次加用利福平、乙胺丁醇、吡嗪酰胺,病人再次发热,体温39 ℃.考虑抗结核药导致的药物热,遂停用所有抗感染药物,病人体温平.第2次停药5 d后,根据药物热发生率从小到大依次加用阿米卡星、乙胺丁醇、异烟肼、吡嗪酰胺、左氧氟沙星,在加药的过程中和加药后,病人体温维持在36.8~37.4 ℃.结论 病人的药物热很可能与利福平的使用相关.     

Tuberculosis pharmacotherapy: strategies to optimize patient care

Introduction: The treatment of tuberculosis (TB) is a mature discipline, with more than 60 years of clinical experience accrued across the globe. The requisite Multi-drug treatment of drug-susceptible TB, however, lasts 6 months and has never been optimized according to current standards. Multi-drug resistant TB and TB in individuals coinfected with HIV present additional treatment challenges. Objective: This article reviews the role that existing drugs and new compounds could have in shortening or improving treatment for TB. The key to treatment shortening seems to be sterilizing activity, or the ability of drugs to kill mycobacteria that persist after the initial days of multi-drug treatment. Results: Among existing anti-TB drugs, the rifamycins hold the greatest potential for shortening treatment and improving outcomes, in both HIV-infected and HIV-uninfected populations, without dramatic increases in toxicity. Clinical studies underway or being planned, are supported by in vitro , animal and human evidence of increased sterilizing activity - without significant increases in toxicity - at elevated daily doses. Fluoroquinolones also seem to have significant sterilizing activity. At present, at least two class members are being evaluated for treatment shortening with different combinations of first-line drugs. However, in light of apparent rapid selection for fluoroquinolone-resistant mutants, relative frequency of serious adverse events and a perceived need to ‘reserve’ fluoroquinolones for the treatment of drug-resistant TB, their exact role in TB treatment remains to be determined. Other possible improvements may come from inhaled delivery or split dosing (linezolid) of anti-TB drugs for which toxicity (ethionamide) or lack of absorption (aminoglycosides and polypeptides) precludes delivery of maximally effective, oral doses, once daily. New classes of drugs with novel mechanisms of action, nitroimidazopyrans and a diarylquinoline, among others, may soon provide opportunities for improving treatment of drug-resistant TB or shortening treatment of drug-susceptible TB. Conclusion: More potential options for improved TB treatment currently exist than at any other time in the last 30 years. The challenge in TB pharmacotherapy is to devise well-tolerated, efficacious, short-duration regimens that can be used successfully against drug-resistant and drug-resistant TB in a heterogeneous population of patients