食品药品检验检测信息化建设发展现状与经营介绍——以山东省食品药品检验研究院为例

本文总结了我院2016~2018信息化全面建设工作,包括机房、网络和应用系统建设,重点介绍实验室信息管理系统（LIMS）建设情况、经验和教训,以期为全国食品药品检验检测单位的信息化建设工作提供参考。     

辐射影响细胞色素P450的研究进展

随着科学的进步,核能和核技术已经广泛应用于医疗、能源、军事、食品加工等国防和国民生活的方方面面。可能受到辐射损伤的人群主要有接受放疗的癌症病人、从事与放射相关的工作人员和生活在高原地区的人们等。辐射条件下机体产生一系列生理性变化,部分为病理性变化,从而影响药物在体内的吸收、分布、代谢和排泄,导致药物代谢动力学特征发生改变。关注这些人群的个体化用药,逐渐成为医学和药学科研人员研究的重点。本文综述了环境及临床治疗的电离及非电离辐射对细胞色素P450的影响。     

冠心病合并2型糖尿病患者冠状动脉多支病变PCI与CABG术后5年随访

目的比较冠状动脉粥样硬化性心脏病(冠心病)合并2型糖尿病冠状动脉多支病变患者经皮冠状动脉介入治疗(PCI)置入药物涂层支架(DES)与冠状动脉旁路移植术(CABG)后远期疗效。方法连续入选2002年12月至2008年12月住院期间的冠心病合并2型糖尿病患者,并成功行择期血运重建的多支冠状动脉病变患者,分为CABG组(n=270),DES组(n=285)。随访5年,从术后30 d开始到5年止结束,随访包括全因死亡、心源性死亡、非致死性卒中、非致死性心肌梗死、心绞痛复发和再次血运重建的主要不良心脑血管事件(MACE)。结果入选患者随访率100%。CABG组与DES组两组间5年全因死亡率(1.11%vs.1.40%)、心源性死亡率(0%vs.0%)、非致死性卒中发生率(2.22%vs.2.81%)无统计学差异(P0.05)。DES组非致死性心肌梗死发生率(3.15%)、心绞痛复发率(17.89%)、再次血运重建率(12.28%)均高于CABG组(分别为1.11,5.56%,0.74%),差异均有统计学意义(P0.05~0.01)。结论多支冠状动脉病变合并2型糖尿病患者CABG与PCI治疗5年生存率无明显差异,但多支冠状动脉病变合并2型糖尿病患者DES支架置入远期心绞痛复发率、再次血运重建率,非致死性心肌梗死发生率高于CABG组。     

Lower Extremity Revascularization Using Directional Atherectomy: 12-Month Prospective Results of the DEFINITIVE LE Study

ObjectivesThe aim of this study was to assess the safety and effectiveness of directional atherectomy (DA) for endovascular treatment of peripheral arterial disease (PAD) in infrainguinal arteries in patients with claudication or critical limb ischemia.BackgroundTo date, no prospective, multicenter, independently-adjudicated study has evaluated the effectiveness and durability of DA in the treatment of PAD. Previous DA studies have not been prospectively powered to evaluate any differences in outcomes in patients with and without diabetes.MethodsDEFINITIVE LE (Determination of EFfectiveness of the SilverHawk® PerIpheral Plaque ExcisioN System (SIlverHawk Device) for the Treatment of Infrainguinal VEssels / Lower Extremities) prospectively enrolled subjects at 47 multinational centers with an infrainguinal lesion length up to 20 cm. Primary endpoints were defined as primary patency at 12 months for claudicants and freedom from major unplanned amputation for critical limb ischemia (CLI) subjects. A pre-specified statistical hypothesis evaluated noninferiority of primary patency in diabetic versus nondiabetic claudicants. Independent angiographic and sonographic core laboratories assessed outcomes, and events were adjudicated by a clinical events committee.ResultsA total of 800 subjects were enrolled. The 12-month primary patency was 78% (95% confidence interval: 74.0% to 80.6%) in claudicants, with a 77% rate in the diabetic subgroup versus 78% in the nondiabetic subgroup (noninferior, p < 0.001). The rate of freedom from major unplanned amputation of the target limb at 12 months in CLI subjects was 95% (95% confidence interval: 90.7% to 97.4%). Periprocedural adverse events included embolization (3.8%), perforation (5.3%), and abrupt closure (2.0%). The bail-out stent rate was 3.2%.ConclusionsThe DEFINITIVE LE study demonstrated that DA is a safe and effective treatment modality at 12 months for a diverse patient population with either claudication or CLI. Furthermore, DA was shown to be noninferior for treating PAD in patients with diabetes compared with those without diabetes. (Study of SilverHawk/TurboHawk in Lower Extremity Vessels [DEFINITIVE LE]; NCT00883246).     

阿昔洛韦静脉滴注致婴幼儿血管坏死及周边皮肤溃烂临床分析

病毒性脑炎是指由各种病毒感染导致的颅内脑实质炎症,是小儿重症病房内常见的中枢神经系统感染性疾病。阿昔洛韦是一种广谱高效的抗病毒药物,是目前临床上治疗儿童病毒性脑炎的首选药物,其可明显改善患儿的临床症状,降低并发症的发生率。然而药物在使用过程中,偶尔伴有轻重不一的不良反应,其中最常见的不良反应包括肾脏损害、胃肠道反应、过敏反应以及静脉炎。本文通过报道2例病毒性脑炎患儿在使用阿昔洛韦静脉滴注治疗过程中,发生的较为罕见的血管坏死及周边皮肤溃烂情况,分析并总结该不良反应发生的原因及可能的药物机制,同时为临床上今后应对类似的不良反应提供护理经验,改善患儿的预后。     

利妥昔单克隆抗体不宜作为继发性难治性肾病的挽救治疗措施

背景　利妥昔单克隆抗体（RTX）用于肾小球疾病的治疗已近20年,近年来其在治疗原发性和继发性肾病方面积累了一些循证医学证据,但对于较为明显的肾功能不全患者是否适合应用RTX进行挽救性治疗,目前尚无相关研究。目的　观察RTX挽救性治疗继发性难治性肾病患者的有效性和安全性。方法　回顾性选取2018-2019年北京大学国际医院收治的所有住院使用RTX治疗的成年难治性肾病患者48例。根据原发病诊断结果将患者分为原发性肾病（PN）组和继发性肾病（SN）组,再将SN组依据RTX治疗前血肌酐（Scr）分为SN-NST亚组（Scr<300 μmol/L）和SN-ST亚组（Scr≥300 μmol/L）。收集所有患者的一般资料（包括性别、年龄、体质量、身高、体表面积、原发病）,RTX治疗前、后实验室检查结果〔24 h尿蛋白（Upro）、白细胞计数（WBC）、红细胞计数（RBC）、血小板计数（PLT）、白蛋白（Alb）、Scr、CD4+细胞计数〕,计算CD4+细胞计数/WBC比例,记录RTX治疗期间严重不良事件〔包括严重感染全身（应用抗生素≥7 d或联合应用2种及以上抗感染药物）、肾脏替代治疗（RRT）、多脏器功能衰竭综合征（MODS）、死亡等〕,RTX末次治疗后3个月肾脏转归情况（即是否行维持性血液透析）。结果　48例使用RTX治疗的难治性肾病患者均进行肾穿刺活检;PN组19例（39.6%）,SN-NST亚组14例（29.2%）,SN-ST亚组15例（31.2%）。SN-ST亚组患者年龄小于PN组和SN-NST亚组（P<0.05）。PN组患者RTX治疗前24 hUpro、RBC、PLT高于SN-NST亚组、SN-ST亚组,Alb低于SN-NST亚组、SN-ST亚组（P<0.05）;SN-ST亚组患者RTX治疗前Scr高于PN组、SN-NST亚组,CD4+细胞计数低于PN组、SN-NST亚组（P<0.05）。SN-ST亚组患者RTX治疗后Scr高于PN组、SN-NST亚组（P<0.05）。PN组、SN-NST亚组患者RTX治疗后24 hUpro较同组治疗前降低（P<0.05）。SN-NST亚组、SN-ST亚组患者RTX治疗后WBC较同组治疗前降低（P<0.05）。SN-ST亚组患者RTX治疗后RBC较同组治疗前升高（P<0.05）。PN组患者RTX治疗后PLT较同组治疗前降低,SN-ST亚组患者RTX治疗后PLT较同组治疗前升高（P<0.05）。PN组、SN-NST亚组患者RTX治疗后Alb较同组治疗前升高（P<0.05）。三组患者RTX单位时间体表面积的累积剂量比较〔PN组、SN-NST亚组、SN-ST亚组依次为（437±322）、（503±344）、（331±312）mg?月-1?（m2）-1〕,差异无统计学意义（F=1.048,P=0.359）。SN-ST亚组患者RTX治疗期间严重感染发生率、行RRT者比例及RTX末次治疗后3个月行维持性血液透析者比例高于PN组（P<0.05）;SN-ST亚组患者RTX治疗期间行RRT者比例、RTX末次治疗后3个月行维持性血液透析者比例高于SN-NST亚组（P<0.05）。结论　Scr≥300 μmol/L的继发性难治性肾病患者应用RTX治疗对其肾病改善作用不明显,且会明显增加其严重感染和肾衰竭发生风险,故RTX不应作为这部分患者的挽救治疗措施。     

Skin toxicity predicts efficacy to sorafenib in patients with advanced hepatocellular carcinoma

AIM:To study the relationship between adverse events(AEs),efficacy,and nursing intervention for sorafenibtherapy in patients with hepatocellular carcinoma(HCC).METHODS:We enrolled 37 consecutive patients withadvanced HCC who received sorafenib therapy.Relationships among baseline characteristics as well as AEoccurrence and tumor response,overall survival(OS),and treatment duration were analyzed.The nursingintervention program consisted of education regardingself-monitoring and AEs management,and telephoneRESULTS:A total of 37 patients were enrolled in the study,comprising 30 males(81%) with a median age of 71 years.The disease control rate at 3 mo was 41%,and the median OS and treatment duration were 259 and 108 d,respectively.Nursing intervention was given to 24 patients(65%).Every patient exhibited some kinds of AEs,but no patients experienced G4 AEs.Frequently observed AEs G2 included anorexia(57%),skin toxicity(57%),and fatigue(54%).Factors significantly associated with longer OS in multivariate analysis demonstrated that age ≤ 70 years,presence of G2 skin toxicity,and absence of G2 hypoalbuminemia.The disease control rate in patients with G2 skin toxicity was 13/20(65%),which was significantly higher compared with that in patients with no or G1 skin toxicity.Multivariate analysis revealed that nursing intervention and G2 skin toxicity were independent significant predictors for longer treatment duration.CONCLUSION:Skin toxicity was associated with favorable outcomes with sorafenib therapy for advanced HCC.Nursing intervention contributed to better adher-ence,which may improve the efficacy of sorafenib.     

Drug resistance pattern of Mycobacterium tuberculosis isolates from patients of five provinces of Iran

Objective:To determine the patterns of resistance to first line anti-tuberculosis(TB)drugs among a collection of Mycobacterium tuberculosis(MTB)isolates from 5 provinces of Iran.Methods:A total of the 6 426 clinical specimens from patients suspected of active TB were collected from March 2010 to June 2012.All specimens were subjected for microscopy and culture tests in the TB centers of studies provinces.Drug susceptibility testing to the first line anti-TB drugs for culture positive MTB was performed on Lwenstein-Jensen(LJ)medium using proportion method.Results:Of 6 426 clinical specimens,261 were culture positive for mycobacteria,of which 252 were MTB and 9 were MOTT(mycobacteria other than tuberculosis).Of 252 MTB isolates.211(83.7%)were pan-susceptible and 41(16.3%)were resistant to at least one drug.Resistance was most common to streptomycin.30 isolates(12.0%),followed by isoniuzid,20isolates(8.0%),rifampin,15 isolates(6.0%)and ethambutol,14 isolates(5.5%).Sixteen(6.3%)MTB isolates were MDR.A clear evidence of heterogeneity amongst the 5 provinces in the proportions with resistance to one or more drugs was observed[χ~2=12.209(4 degrees of freedom),P values=0.015 9].Conclusions:The prevalence of drug resistance in this study area underscoring the need for further enforcement of TB control strategies in the Iran.Drug susceptibility testing for all TB cases to provide optimal treatment,establishing advanced diagnostic facilities for rapid detection of MDR-TB and continuous monitoring of drug resistance are recommended for prevention and control of drug-resistant TB.     

Differences in distribution and drug sensitivity of pathogens in lower respiratory tract infections between general wards and RICU

Background

Lower respiratory tract infections (LRTIs) are common among patients in hospitals worldwide, especially in patients over the age of 60. This study investigates the differences in distribution and drug sensitivity of pathogens in LRTIs.

Methods

The clinical and laboratory data of 4,762 LRTI patients in the general ward and respiratory intensive care unit (RICU) of Xiangya Hospital (Changsha) were retrospectively analyzed.

Results

The infection rate of Gram-negative bacteria was significantly higher than that of Gram-positive bacteria in both the general ward and RICU (P<0.05). The incidence of Gram-negative bacteria infection was significantly higher in the RICU than in the general ward (P<0.05), whereas the incidence of Gram-positive bacteria infection is less in the RICU than in the general ward (P<0.05). In the general ward, the incidence of Gram-negative bacteria infection significantly increased (P<0.05) over time, whereas the incidence of Gram-positive bacteria infection significantly decreased from 1996 to 2011 (P<0.05). In the RICU, the incidence of Gram-positive bacteria infection decreased, while Gram-negative bacteria infections increased without statistical significance (P>0.05). Staphylococcus pneumoniae and Staphylococcus aureus were found to be the predominant Gram-positive strains in the general ward (34.70-41.18%) and RICU (41.66-54.87%), respectively (P>0.05). Pseudomonas aeruginosa and Acinetobacter baumannii were the predominant gram negative strains in the general ward (19.17-21.09%) and RICU (29.60-33.88%), respectively (P>0.05). Streptococcus pneumoniae is sensitive to most antibiotics with a sensitivity of more than 70%. Staphylococcus aureus is highly sensitive to vancomycin (100%), linezolid (100%), chloramphenicol (74.36-82.19%), doxycycline (69.57-77.33%), and sulfamethoprim (67.83-72.46%); however, its sensitivity to other antibiotics is low and decreased each year. Sensitivity of Pseudomonas aeruginosa to most β-lactam, aminoglycoside, and quinolone group antibiotics decreased each year.

Conclusions

The distribution and drug sensitivity of LRTI pathogens exhibit a high divergence between the general ward and RICU. Streptococcus pneumoniae may not be the predominant pathogen in LRTIs in some areas of China.     

导尿管长期留置患者尿培养病原菌分布及耐药性探讨

目的 探讨导尿管长期留置患者尿培养病原菌分布及耐药性。方法 回顾性分析我院2019年1～6月收集的导尿管长期留置患者共101例尿液培养资料,共含菌株181株,分析病原菌分布特点,同时检测耐药性。结果①101例送检尿培养标本病原菌阳性率为98.02%(99/101),其中单一病原菌感染46例,包括细菌31例,真菌15例;混合病原菌感染53例,其中混合细菌感染30例,混合真菌感染3例,细菌伴真菌感染20例。②全部标本共分离病原菌株181株,其中革兰阴性杆菌105株,以大肠埃希菌为主,占比达33.333%(35/105);革兰阳性球菌36株,以屎肠球菌为主,占比达38.889%(14/36);真菌40株,以白色念球菌为主,占比达42.500%(17/40)。③101例送检尿培养标本分离病原菌中,革兰氏阴性菌、革兰氏阳性菌及真菌分别以大肠埃希菌、屎肠球菌为主、念珠菌为主;导尿管留置时间2年标本常用抗菌药物耐药率显著高于1年,1～2年标本(P0.05);导尿管留置时间1～2年标本常用抗菌药物耐药率显著高于1年(P0.05)。结论 导尿管长期留置患者尿培养病原菌种类繁多,多重细菌和多重耐药比例较高;故临床应重视对导尿管长期留置患者尿路感染防治工作。