基于哮喘症状控制水平分级管理系统的哮喘患儿药学规范化管理新模式研究

目的:探讨基于哮喘症状控制水平分级管理系统的药学规范化管理新模式对哮喘患儿的临床控制水平、依从性及生活质量的影响。方法:随机抽取2016年10月至2018年10月我院呼吸科门诊或住院部符合纳入标准的学龄前哮喘患儿。将所有患儿资料录入系统,对管理组患儿进行定期随访及药学干预,依据病情变化评估治疗效果,调整治疗方案及随访方案。结果:管理组和对照组1年后哮喘控制水平、转化率和控制率比较差异有统计学意义(P<0.05),管理组的控制率达83.33%,转化率达82.50%。管理组和对照组1年内发作次数、住院次数和急诊就诊次数比较差异有统计学意义(P<0.01)。管理组肺功能指标第1秒用力呼气容积百分比(FEV1%)、最高呼气流速百分比(PEF%)在治疗6个月和12个月后均高于对照组,差异有统计学意义(P<0.01)。管理组和对照组1年后家长知信行水平、患儿用药依从性比较差异均有统计学意义(P<0.01)。结论:基于哮喘症状控制水平分级管理系统的药学规范化管理新模式对控制哮喘患儿临床症状、降低未来风险及提高生命质量等的效果显著,可作为工作模式进一步推广。     

非霍奇金淋巴瘤三种化疗方案成本 效果分析

目的:探讨治疗非霍奇金淋巴瘤联合化疗最佳方案及用药合理性.方法:根据文献选择68例患者,随机分为3组,分别给予以吡喃阿霉素(THP)、表阿霉素(E ADM)、阿霉素(ADM)为主的联合化疗方案,运用药物经济学成本 效果分析方法进行评价.结果:3组不同化疗方案中完全缓解率(CR%)以E ADM组最高,不良反应发生总例次THP组最低,心脏毒性及脱发3组间差异有显著性.结论:应根据患者体质、经济条件等具体情况,适宜地制订给药方案.     

青霉素超敏反应及其诊断技术研究进展

介绍了青霉素的化学结构、抗原决定簇、过敏原的产生、超敏反应的特点以及交叉过敏情况,并对常见的诊断技术（皮试）和体外诊断新方法进行了介绍和比较.     

Small envelope protein E of SARS：cloning,expression, purification, CD determination, and bioinformatics analysis

AIM:To obtain the pure sample of SARS small envelope E protein (SARS E protein), study its properties and analyze its possible functions. METHODS: The plasmid of SARS E protein was constructed by the polymerase chain reaction (PCR), and the protein was expressed in the E coli strain. The secondary structure feature of the protein was determined by circular dichroism (CD) technique. The possible functions of this protein were annotated by bioinformatics methods, and its possible three-dimensional model was constructed by molecular modeling. RESULTS: The pure sample of SARS E protein was obtained. The secondary structure feature derived from CD determination is similar to that from the secondary structure prediction. Bioinformatics analysis indicated that the key residues of SARS E protein were much conserved compared to the E proteins of other coronaviruses. In particular, the primary amino acid sequence of SARS E protien is much more similar to that of murine hepatitis virus(MHV) and other mammal coronaviruses. The transmembrane (TM) segment of the SARS E protein is relatively more conserved in the whole protein than other regions. CONCLUSION: The success of expressing the SARS E protein is a good starting point for investigating the structure and functions of this protein and SARS coronavirus itself as well. The SARS E protein may fold in water solution in a similar way as it in membrane-water mixed environment. It is possible that β-sheet I of the SARS E protein interacts with the membrane surface via hydrogen bonding, this β-sheet may uncoil to a random structure in water solution.     

甲砜霉素缓释片的制备及释放度研究

目的以甲砜霉素为模型药物,考察缓释片的处方及工艺因素对其体外释放的影响。方法以羟丙基甲基纤维素为骨架材料,预胶化淀粉等为填充剂,以体外释放度为指标考察处方及工艺因素对药物溶出度的影响。结果按最优处方制得的缓释片体外释放满足要求;甲砜霉素缓释片的释药过程通过Peppas方程拟合,初步说明甲砜霉素从骨架中的释放是扩散和溶蚀综合作用的结果。结论该缓释片处方设计合理,工艺重现性好,缓释效果好,适合工业生产。     

盐酸多西环素羧甲基壳聚糖微球的体外释放研究

目的:探讨各因素对盐酸多西环素羧甲基壳聚糖微球体外释放度的影响。方法:采用乳化-交联固化法制备盐酸多西环素羧甲基壳聚糖微球(doxycycline hydrochloride-carboxymethyl chitosan-microspheres,DXY-CMCTS-MS),采用动态透析法测定体外释药性能,用紫外分光法测定盐酸多西环素浓度,绘制其释放曲线。结果:释放介质pH越大,交联剂量越大,固化时间越长,药物/载体比例越小,药物的释放则越慢。结论:该制剂制备工艺切实可行,所得DXY-CMCTS-MS具有明显的缓释效果。     

Effect of hepatic impairment on the pharmacokinetics of pasireotide (SOM230): results from a multicenter phase I study

Pasireotide is a novel, multireceptor-targeted somatostatin analogue with high affinity for sst(1,2,3) and sst(5) under clinical evaluation in tumors of neuroendocrine origin, including Cushing's disease, acromegaly, and neuroendocrine tumors. In this phase I, open-label, multicenter study, the pharmacokinetics and safety of a single subcutaneous (SC) injection of pasireotide 600 μg were evaluated in adults with normal hepatic function (n = 15) and mild (n = 6), moderate (n = 7), or severe hepatic impairment (n = 6). Following a single dose of pasireotide SC 600 μg, there were no significant differences in the plasma exposure of pasireotide between participants with normal hepatic function or mild hepatic impairment. Subjects with moderate and severe hepatic impairment showed an increase in AUC(∞) by 56% and 42%, respectively; this increase was 60% and 79% respectively, after adjusting for differences in age, BMI, and baseline serum albumin level between treatment groups. The incidence and severity of adverse events were similar across cohorts, with no clinically relevant differences in type or frequency of adverse events between cohorts. In conclusion, a single dose of pasireotide SC 600 μg was well tolerated in subjects with hepatic impairment. Drug exposure in subjects with mild hepatic impairment was similar to that seen in healthy volunteers, whereas subjects with moderate and severe hepatic impairment experienced higher exposure to pasireotide. Adjustment of the pasireotide dose may be required for patients with moderate and severe hepatic impairment.     

中药注射液中高分子物质初步研究

目的:应用凝胶色谱法对几种中药注射液中的高分子物质进行测定。方法:采用TSK GEL 2000 SWxl(7.8 mm×300mm,5μm)色谱柱,流动相为乙腈-0.83%三氟乙酸溶液(40∶60),流量为0.7 mL.min-1,检测波长214 nm,进样量为20μL。结果:清开灵注射液和黄芪注射液中均检出高分子物质,而参芪扶正注射液中未检出。结论:凝胶色谱法测定中药注射液中高分子物质操作简便,结果准确可靠,可作为中药注射液的质量控制方法,为中药注射液的安全性评价提供了思路。     

耐碳青霉烯类肺炎克雷伯杆菌肺部感染患者不同抗菌药物联合治疗方案的疗效与安全性分析

目的：探讨不同联合抗感染方案在治疗耐碳青霉烯类肺炎克雷伯杆菌（CRKP）肺部感染中的疗效与安全性。方法：2017年1月~2019年12月在南京医科大学第二附属医院诊断为CRKP肺部感染的165例患者,根据不同药物治疗方案分为：①替加环素组（85例）：替加环素首剂200 mg,维持剂量100 mg q12h,静脉滴注;②多粘菌素B组（80例）：多粘菌素B首剂2.5 mg·kg-1,维持剂量1.25 mg·kg-1,静脉滴注;两组患者均根据临床需要联合亚胺培南西司他丁或美罗培南,治疗时间超过7天;分析两组患者的疗效和安全性。结果与结论：患者首次痰培养的CRKP均对替加环素和多黏菌素B敏感,对美罗培南耐药。两组患者一般情况无统计学差异。临床总有效率：替加环素组为89.4%,多粘菌素B为92.5%,差异无统计学意义（P＞0.05）。肝功能损害：替加环素组11例（12.9%）,多黏菌素B组8例（10%）,差异无统计学意义;肾功能损害：替加环素组3例（3.5%）,多黏菌素B组4例（5.0%）,差异无统计学意义（P＞0.05）;胃肠道反应：替加环素组4例（4.7%）,多黏菌素B组0例,差异有统计学意义（P＜0.05）。多粘菌素B组细菌清除率及临床疗效略高。替加环素大剂量使用需警惕肝功能损害及胃肠道不良反应。     

生物药物检定

从生物药物的概念、来源、种类及前途等方面着手 ,根据国际通用及WHO的有关法则 ,依据国家的有关规定 ,参照有关同类药品的质量标准对生物药物的检定进行了较系统的论述。