安宫牛黄丸联合阿加曲班治疗急性脑梗死的临床研究

目的研究安宫牛黄丸联合阿加曲班注射液治疗急性脑梗死的临床疗效。方法选取2017年10月—2019年10月在河南中医药大学第三附属医院治疗的120例急性脑梗死患者为研究对象,将所有患者随机分为对照组和治疗组,每组各60例。对照组患者静脉泵注阿加曲班注射液,10 mg溶于100 mL生理盐水,持续静脉泵注3 h,2次/d。治疗组在对照组基础上口服安宫牛黄丸,1丸/次,1次/d。两组患者接受治疗时间为4周。观察两组的临床疗效,比较两组Barthel指数、美国国立卫生研究院卒中量表(NHISS)评分、大脑平均血流速度和血液学指标[神经元特异性烯醇化酶(NSE)、脑源性神经营养因子(BDNF)、超敏C反应蛋白(hs-CRP)、肿瘤坏死因子-α(TNF-α)和白细胞介素-8(IL-8)]。结果治疗后,治疗组总有效率(95.00%)显著高于对照组(83.33%)(P0.05)。治疗后,两组Barthel指数显著升高,NHISS评分显著降低(P0.05);且治疗组Barthel指数、NHISS评分改善较明显(P0.05)。治疗后,两组患者大脑中动脉、大脑前动脉、大脑后动脉的平均血流速度均明显升高(P0.05);且治疗组患者平均血流速度升高较明显(P0.05)。治疗后,两组患者血清NSE水平明显降低,BDNF水平明显升高(P0.05);且治疗组血清NSE、BDNF水平改善较明显(P0.05)。治疗后,两组患者血清hs-CRP、TNF-α、IL-8水平明显降低(P0.05);且治疗组患者血清hs-CRP、TNF-α和IL-8水平均降低较为明显(P0.05)。结论安宫牛黄丸联合阿加曲班注射液治疗急性脑梗死具有较好的临床疗效,能够改善患者神经功能和生活质量,调节血液学指标,值得在临床上推广应用。     

复方谷氨酰胺联合柳氮磺吡啶治疗溃疡性结肠炎的疗效观察

目的 研究复方谷氨酰胺联合柳氮磺吡啶治疗溃疡性结肠炎的临床疗效。方法 选择2017年1月-2019年1月榆林市星元医院的120例溃疡性结肠炎患者作为研究对象,采用抽签法随机分为对照组和观察组,每组各60例。对照组患者口服柳氮磺吡啶肠溶片,6片/次,3次/d。观察组患者在对照组的基础上口服复方谷氨酰胺肠溶胶囊,3粒/次,3次/d。两组均治疗4周。观察两组患者的临床疗效,比较两组治疗前后的相关症状、评分情况,以及炎性因子水平。结果 治疗后,观察组的总有效率为91.67%,明显高于对照组的71.67%（P<0.05）。治疗后,观察组的黏液脓血便消失时间为（10.13±1.27）d,明显短于对照组的（19.73±2.45）d（P<0.05）。两组治疗后的疾病活动指数和腹痛程度评分均明显降低（P<0.05）,且观察组明显更低（P<0.05）。两组治疗后的血清白细胞介素（IL）-6、肿瘤坏死因子-α（TNF-α）、IL-8、超敏C反应蛋白（hs-CRP）水平均明显降低（P<0.05）,且观察组明显更低（P<0.05）。结论 复方谷氨酰胺联合柳氮磺吡啶对溃疡性结肠炎的疗效较佳,能明显减轻腹痛程度,改善炎症因子水平,降低疾病活动指数。     

利心丸联合沙库巴曲缬沙坦钠治疗慢性心力衰竭的临床研究

目的 观察利心丸联合沙库巴曲缬沙坦钠治疗慢性心力衰竭的临床疗效。方法 选取2018年1月-2019年12月在新野县人民医院治疗慢性心力衰竭患者91例为研究对象,采用随机数字表法将91例慢性心力衰竭患者分为对照组（46例）和治疗组（45例）。对照组口服沙库巴曲缬沙坦钠片,50 mg/次,2次/d,后期根据患者具体病情,每2~4周倍增1次,直至200 mg/次,2次/d。治疗组在对照组基础上口服利心丸,3 g/次,3次/d。两组患者连续治疗4周。观察两组临床疗效,比较两组的6 min步行实验（6 MWT）、心功能指标、血清学指标。结果 治疗后,治疗组总有效率（95.56%）高于对照组（80.43%）（P<0.05）。治疗后,两组6 MWT均较治疗前增加（P<0.05）,且治疗组6 MWT高于对照组（P<0.05）。治疗后,两组左心室射血分数（LVEF）、每搏输出量（SV）、心输出量（CO）较治疗前均升高,且治疗组LVEF、SV、CO高于对照组（P<0.05）。治疗后,两组患者心型脂肪酸结合蛋白（H-FABP）、细胞间黏附分子-1（ICAM-1）水平较治疗前均降低（P<0.05）,且治疗组H-FABP、ICAM-1水平低于对照组（P<0.05）。结论 利心丸联合沙库巴曲缬沙坦钠片治疗慢性心力衰竭疗效确切,可提高运动耐量,改善心功能,降低H-FABP、ICAM-1水平。     

卡泊芬净联合万古霉素治疗肾移植术后肺部感染的疗效观察

目的 评价卡泊芬净联合万古霉素治疗肾移植术后肺部感染患者的疗效。方法 选取西安交通大学第一附属医院2018年8月-2019年10月收治的肾移植术后肺部感染患者122例为研究对象,按照随机数表法将患者分为对照组和观察组,每组各61例。对照组患者静脉滴注注射用盐酸去甲万古霉素,250 mg/次,采用0.9%氯化钠注射液250 mL溶解,滴注时间>1 h,12 h/次。用药3 d后,根据血药浓度谷峰值调整给药剂量。观察组患者在对照组的基础上静脉滴注注射用醋酸卡泊芬净,首次给药剂量为70 mg,使用200 mL葡萄糖溶液溶解,第2天开始以维持剂量为50 mg治疗,1次/d。两组疗程均为14 d。观察两组患者的临床疗效,比较两组治疗前后的肾功能指标、肺功能指标及血气指标水平。结果 治疗后,观察组治疗后总有效率为91.80%,显著高于对照组的77.05%,两组总有效率比较差异具有统计学意义（P<0.05）;治疗后,观察组细菌完全清除率为34.43%,显著高于对照组的14.75%,两组细菌完全清除率比较差异有统计学意义（P<0.05）。两组患者治疗后尿微量白蛋白/肌酐比值（ACR）、血肌酐（Scr）、尿β2-微球蛋白均显著升高（P<0.05）,组间比较观差异无统计学意义。两组患者治疗后肺功能指标第1秒用力呼气容积用力呼气容积（FEV₁）、第1秒用力呼气容积占预计值百分比（FEV₁% pred）和FEV₁/FVC均显著升高（P<0.05）,治疗后,观察组肺功能指标水平显著高于对照组,差异具有统计学意义（P<0.05）。治疗后,两组患者的动脉血氧饱和度（SaO₂）、动脉血氧分压（pO₂）和氧合指数（OI）均显著升高,动脉血二氧化碳分压（pCO₂）显著降低,同组治疗前后比较差异具有统计学意义（P<0.05）;治疗后,观察组患者的SaO₂、pO₂、OI显著高于对照组,pCO₂明显低于对照组（P<0.05）。结论 卡泊芬净联合万古霉素治疗肾移植术后肺部感染具有可靠的应用价值,能够有效抑制患者肺部感染,卡泊芬净与万古霉素联合应用起效迅速,但仍需根据患者实际情况合理选择用药。     

1549例患儿莲必治注射液应用合理性分析及药物利用研究

目的:探讨莲必治注射液在儿童患者中的应用合理性以及中药注射剂在儿童患者中的药物利用研究。方法:对2018年某儿童医院应用莲必治注射液的住院患儿资料进行回顾性分析,结合药品说明书以及患儿年龄、体质量,对给药剂量、给药浓度、用药频次及溶剂选择等方面进行统计分析;计算儿童药物利用指数,初步探讨中药注射剂在儿童患者中的合理评价方法。结果:最终纳入1549例患儿,合理性评分均值为5.43分;适应证合理率最低,仅为45.32%(702/1549);给药浓度均值超过规定范围(0.8~1.5 g/L),最小浓度为0.2 g/L,最大浓度达6.25 g/L。年龄方面,≤1岁患儿的儿童药物利用指数-剂量(cdDUI)>1.1,而>4岁患儿的cdDUI<0.9,不同年龄段患儿的儿童药物利用指数-浓度(ccDUI)均>1,尤以≤6个月为著。体质量方面,≤30 kg患儿的儿童药物利用指数(cDUI)均>1.1,而>30 kg患儿的cDUI均<0.9。结论:从年龄、体质量和平均给药剂量、药物利用指数可见,均存在低年龄或低体重患儿莲必治注射液用药量大,而高年龄或高体质量患儿用药量不足的现象,且均存在给药浓度过高的现象。因此,应加强中药注射剂在儿童中应用的合理性评价。     

Identification and external validation of the optimal FIB‐4 and APRI thresholds for ruling in chronic hepatitis B related liver fibrosis in tertiary care settings

BackgroundWith the initially defined thresholds, the most widely used serum biomarkers for staging liver fibrosis (ie, APRI and FIB‐4 scores) proved to be ineffective among patients with chronic hepatitis B virus infection (CHB). Whether optimizing the FIB‐4 and APRI thresholds could improve their diagnostic accuracy requires further research.MethodsUsing data of treat‐naïve CHB patients from three tertiary hospitals, we explored the optimal FIB‐4 and APRI thresholds to rule in liver fibrosis accurately. Subsequently, we validated the applicability of the newly defined thresholds to the CHB patients from another two tertiary hospitals.ResultsThe fibrosis stages between discovery cohort (n = 433) and the external validation cohort (n = 568) were statistically different (P < .001). When ruling in significant fibrosis and advanced fibrosis by the newly defined FIB‐4 thresholds (2.25 and 3.00, respectively), 24.0% and 14.3% of patients, respectively, could be classified with excellent accuracy (PPVs of 91.3% and 80.6%, respectively; misdiagnosis rates of 6.0% and 5.4%, respectively), supported by the internal and external validation tests. Regrettably, the more accurate and robust thresholds of APRI score for ruling in significant fibrosis and advanced fibrosis could not be found. Besides, the FIB‐4 and APRI scores should not be recommended for ruling in cirrhosis because of poor clinical diagnostic performance.ConclusionThe newly defined FIB‐4 thresholds for ruling in significant fibrosis and advanced fibrosis showed superior and reproducible clinical diagnostic accuracy. The well‐validated threshold (≥2.25) of FIB‐4 score could aid in antiviral treatment decisions for treat‐naïve adult CHB patients by accurately ruling in significant fibrosis in tertiary care settings.     

Evaluation of the analytical performance of endocrine analytes using sigma metrics

Background(a) To evaluate the clinical performance of endocrine analytes using the sigma metrics (σ) model. (b) To redesign quality control strategies for performance improvement.MethodsThe sigma values of the analytes were initially evaluated based on the allowable total error (TEa), bias, and coefficient of variation (CV) at QC materials level 1 and 2 in March 2018. And then, the normalized QC performance decision charts, personalized QC rules, quality goal index (QGI) analysis, and root causes analysis (RCA) were performed based on the sigma values of the analytes. Finally, the sigma values were re‐evaluated in September 2018 after a series of targeted corrective actions.ResultsBased on the initial sigma values, two analytes (FT3 and TSH) with σ > 6, only needed one QC rule (1_3S) with N2 and R500 for QC management. On the other hand, seven analytes (FT4, TT4, CROT, E2, PRL, TESTO, and INS) with σ < 4 at one QC material level or both needed multiple rules (1_3S/2_2S/R_4S/4_1S/10_X) with N6 and R10‐500 depending on different sigma values for QC management. Subsequently, detailed and comprehensive RCA and timely corrective actions were performed on all the analytes base on the QGI analysis. Compared with the initial sigma values, the re‐evaluated sigma metrics of all the analytes increased significantly.ConclusionsIt was demonstrated that the combination of sigma metrics, QGI analysis, and RCA provided a useful evaluation system for the analytical performance of endocrine analytes.     

VE1 immunohistochemistry is an adjunct tool for detection of BRAF V600E mutation: Validation in thyroid cancer patients

Papillary thyroid carcinoma (PTC) is the most common endocrine malignancy among other endocrine tumors, and BRAF ^V600E is a frequent genetic mutation occurring in the disease. Although different molecular techniques, most importantly sequencing has been widely recognized as a gold standard but molecular diagnosis remains an expensive, laborious, and time‐intensive process. Recently, immunohistochemistry (IHC) with anti‐BRAF V600E (VE1) antibody has increased practical utility and implemented clinically for the detection of BRAF ^V600E mutation. Therefore, the study aimed to evaluate diagnostic accuracy of VE1 IHC for detecting the BRAF ^V600E mutation frequency and clinical implementation in diagnostic laboratories. In this study, 72 formalin fixed paraffin‐embedded tissues (FFPE) were used to determine the BRAF ^V600E mutation status using IHC and Sanger sequencing. The mutation was found in 29% and 28% cases using IHC and Sanger sequencing, respectively. Furthermore, the results showed 100% sensitivity, 98.07% specificity, 95.2% positive predictive value, and 100% negative predictive value. Notably, significant associations were found between BRAF ^V600E status and tumor stage, tumor focality, and extrathyroidal extensions, respectively. VE1 IHC was found to be a highly sensitive, specific, and diagnostically accurate method in this cohort. Therefore, BRAF ^V600E detection through IHC has been considered as the best tailored technique for routine pathology laboratories.     

超声误诊甲状腺双侧叶不典型髓样癌1例

患者女,28岁,因“发现左颈部包块2个月”就诊,既往无特殊病史。查体:甲状腺左侧叶Ⅱ度肿大,右叶大小正常。实验室检查:降钙素>2000 pg/ml,癌胚抗原67.16 ng/ml。超声:甲状腺右叶上份见14 mm×12 mm×12 mm低回声结节(图1A),边界不清,形态不规则,纵横比>1,内部见微钙化,Adler血流分级1级(图1B),弹性成像质硬(图1C),超声造影表现为不均匀低增强(图1D);左叶40 mm×22 mm×27 mm囊实混合回声结节(图2A),边界清楚,形态规则,纵横比<1,Adler血流分级2级(图2B),弹性成像质软(图2C),超声造影不均匀等增强(图2D),双侧颈部淋巴结未见异常;考虑右侧甲状腺乳头状癌、左侧结节性甲状腺肿伴腺瘤样结节。