The quality of spontaneous adverse drug reaction reports from the pharmacovigilance centre in western China

Background: High-quality adverse drug reaction (ADR) reports are essential for conducting drug safety monitoring in pharmacovigilance. The study aim was to assess the current quality of ADR reports in western China, and to identify problems with ADR report quality.

Research design and methods: A sample of 1139 reports received by the Shaanxi ADR Monitoring Center from January 2015 to December 2017 was selected. ADR report quality was evaluated using an ADR report quality evaluation system.

Results: None of the reports were rated as excellent and 1.40% (n = 16) as good. Report quality was better for new and serious reports than for general reports. Medical institutions generated higher quality reports than pharmaceutical manufacturers. Nurses generated higher quality reports than doctors, pharmacists, and other professionals. Reporters of different occupations showed significant differences in the quality of the indicators Reporting time limit, Intervention ADR time, ADR termination time, ADR intervention measures, Original disease, and Cause of medication (P = 0.000).

Conclusions: The ADR data quality was poor in western China, and of lower quality than reported data from previous research in other regions. Improvements in the quality and availability of ADR reports are urgently needed.     

The effect of Benson’s relaxation response on sleep quality and anorexia in cancer patients undergoing chemotherapy: A randomized controlled trial

Background and objectivesPatients with cancer experience many side effects due to its nature and usual treatments. Sleep disorders and anorexia are the most commonly reported symptoms in cancer patients undergoing chemotherapy. The present study aimed to investigate the effect of Benson's Relaxation Response (BRR) on sleep quality and anorexia in cancer patients undergoing chemotherapy.Methodology and participantsIn the present clinical trial, a total of 84 patients were enrolled and randomly divided into two groups of experimental and control. Benson's relaxation response was administered to the experimental group twice a day over 5 consecutive days. Data was collected using St. Mary's Hospital Sleep Questionnaire (SMHSQ) and anorexia questionnaire with Visual Analog Scale (VAS).ResultsThe results of our study showed a significant improvement in the sleep quality in the experimental group at 24 (p = 0.02) and 48 (p = 0.001) hours after the intervention compared to the control group. Benson's relaxation response (BRR) also had a significant effect on the anorexia in the experimental group at 24 (7.5 ± 1.6) and 48 (6.9 ± 2.1) hours after the intervention compared to the control group. No side effects were reported during the study and follow-up period.ConclusionBenson's relaxation response as a complementary method may improve sleep quality and anorexia in cancer patients undergoing chemotherapy. Further studies with greater sample size and longer follow-up period are needed to confirm the current findings.     

六西格玛在肿瘤标志物质量目标选择上的应用

目的应用6σ理论对肿瘤标志物项目的分析性能进行评价，并初步确定各项目的质量目标。 方法收集本实验室2018年1至12月室内质控数据和国家卫生健康委临床检验中心室间质量评价结果，以生物学变异导出的质量规范和国家室间质量评价标准作为允许总误差(TEa)计算6项肿瘤标志物的σ水平，并依据质量目标选择流程图和肿瘤标志物分析性能验证图评价肿瘤标志物的分析性能，进而为肿瘤标志物选择合适的质量目标。 结果应用不同层级的生物学变异导出的质量规范和国家室间质量评价标准，肿瘤标志物项目的σ水平存在显著差异；依据质量目标选择流程图：选择生物学变异导出的"适当的"质量规范作为CA125项目的质量目标，选择生物学变异导出的"最低的"质量规范作为t-PSA、CEA、AFP、CA199和CA153项目的质量目标。 结论6σ能够客观评价肿瘤标志物的分析性能，并为实验室质量目标的选择提供重要的参考价值。     

持续质量改进在体检科护理质量管理中的应用效果探讨

目的探究持续质量改进在体检科护理质量管理中的应用效果。方法该次将该院在2018年7-12月的体检者200名作为研究的对象,视为对照阶段,采取常规护理管理方法;将该院2019年1-6月的体检者200名作为观察阶段对象,在护理管理工作中采取持续质量改进管理模式,进一步对比两个阶段患者对于体检科工作质量的评分。结果在体检工作质量、服务态度、体检满意度这3个模块,观察阶段评分对照阶段比较均明显更高,差异有统计学意义(P<0.05)。结论持续质量改进应用于体检科护理质量管理中,可有效提升体检服务品质,值得推广应用。     

应用精细化管理提高GMP模拟车间实训课教学质量

目的通过对GMP模拟车间实训课学生评教数据分析,探讨精细化管理对其教学质量的影响,从而提高GMP模拟车间实训课教学质量。方法通过对管理前后学生教学质量评价进行对比,选取最适合GMP模拟车间的管理方法。结果采取精细化管理后,学生教学质量评价从35.71%提高到96.42%。结论对GMP模拟车间精细化管理能够有效提高该课程的教学质量,给社会带来更大的经济效益和社会效益。     

高效液相色谱串联质谱法测定氯沙坦钾中的遗传毒性杂质N-亚硝基-N-甲基-4-氨基丁酸

目的建立了一种高效液相色谱-三重四极杆串联质谱法,对氯沙坦钾原料药中遗传毒性杂质N-亚硝基-N-甲基-4-氨基丁酸(NMBA)进行测定。方法色谱柱为岛津Shim-pack XR-ODSⅡ色谱柱(2.0 mm×150 mm,2.2μm),流动相为0.1%甲酸水溶液(A)和甲醇(B),进行梯度洗脱,流速0.3 mL·min^-1,柱温为40℃,采用ESI离子化-三重四极杆质谱多反应监测(MRM)正离子模式检测,碰撞电压分别为-11,-13和-13 V,碰撞气氩气270 kPa,NMBA的离子对分别为m/z 147.15→117.10,147.15→87.10和147.15→44.10。结果该方法中NMBA在1~100 ng·mL^-1内线性关系良好,日内和日间的保留时间和峰面积的重复性良好(RSD均小于1.10%,n=6和n=18),低、中、高3个浓度的平均回收率在94.40%~98.04%之间。结论本方法简单方便,可快速有效的对氯沙坦钾原料药中NMBA进行限度检查并实现定量分析。     

The role of cardiopulmonary exercise testing in evaluating children with exercise induced dyspnoea

Exercise induced dyspnoea (EID) is a common manifestation in children and adolescents. Although EID is commonly attributed to exercise induced bronchoconstriction, several conditions other than asthma can cause EID in otherwise healthy children and adolescents. Cardiopulmonary exercise testing (CPET) offers a non-invasive comprehensive assessment of the cardiovascular, ventilatory and metabolic responses to exercise and is a powerful diagnostic and prognostic tool. CPET is a reproducible, non-invasive form of testing that allows for comparison against age- and gender-specific norms. CPET can assess the child’s exercise capacity, determine the limiting factors associated with this, and be used to prescribe individualised interventions. EID can occur due to asthma, exercise induced laryngeal obstruction, breathing pattern disorders, chest wall restriction and cardiovascular pathology among other causes. Differentiating between these varied causes is important if effective therapy is to be initiated and quality of life improved in subjects with EID.     

Prospective comparative study of intraoperative “Towel clip test” and “Vertical patella test” assessing lateral retinaculum tightness in patients undergoing TKA

BackgroundProper patellar tracking is one of the most important aspect of TKA to ensure good functional outcome. A patellar tracking problem noted intraoperatively serves as a warning sign and should prompt the surgeon to reassess position of each component. Various tests are there to assess lateral retinaculum tightness viz. "No thumb test", "Towel clip test". A new test "Vertical patella test" is described to assess lateral retinaculum tightness. A study was conducted to assess the effectiveness, correlation and validity of two techniques.Materials & MethodsPatients >50 years of age and with diagnosis of Osteoarthritis knee having less than 30 varus and flexion deformity going in for primary TKA were selected with a sample size of 100 knees in a tertiary care centre. Revision cases or patients with flexion contracture more than 30, complex knee surgery; with pre existing patellar tilt were excluded from study.ResultsResults of both tests were found to correlate in 75% of case with sensitivity of 96.65% and specificity of 75.00%. Kappa came out to be 0.634 which shows good agreement of vertical patella test and towel clip test. Result was computed using excel and SPSS and was found to be significant with p value< 0.05. Lateral retinaculum release was done in 8 knees.ConclusionsVertical patella test correlates with towel clip test, is easy to perform and saves time. The limitation of our study was small sample size.