This article discussed characteristics of current off-label drug use in China and other countries,and analyzed the current administration and future development,making valuable reference for off-label drug use.

The study aims to develop an LC-MS/MS method for the simultaneous determination of amygdalin and paeoniflorin in urine samples, and to investigate their urinary excretion characteristics in healthy volunteers after intravenous infusion administration of Huoxue-Tongluo lyophilized powder for injection (HTLPI). The urine samples were extracted by methanol, and then separated on a Hedera ODS-2 column with a mobile phase of acetonitrile and 5 mmol · L(-1) ammonium acetate buffer solution containing 0.05% formic acid (20:80). Electrospray ionization source was applied and operated in the positive ion mode using MRM. The method exhibited good linearity over the concentration range of 0.03 -40 µg · mL(-1). The values on both the occasions (intra- and inter-day) were all within 15% at three concentration levels. No matrix effect and carry-over effect were observed. Amygdalin and paeoniflorin were stable in human urine under different storage conditions. Approximately 79.6% of the administered amount of amygdalin was excreted unchanged in urine within 24 h and which was 48.4% for paeoniflorin. The developed LC-MS/MS method can be applied to evaluate the urinary excretion of amygdalin and paeoniflorin.

OBJECTIVE:To ensure a long-term medication in children with asthma,prevent the attack of asthma and ensure safe,effective and correct drug use in these patients.METHODS:The pharmaceutical care for the asthma children was carried out through pharmacists’ involvement in assisting doctors to establish the treatment plan,carrying out medicine-use education and drug use consultation for patients,setting up the medicine-use record and so on.RESULTS & CONCLUSION:The practice of pharmaceutical care can markedly improve the compliance,safety and efficacy of drug use in asthma children as well as improving their quality of life.

To improve the effect of teaching practice of blood cell morphology,typical cases of peripheral blood erythrocyte,granulocyte and platelet were chosen,case show and problem-based teaching way were applied to encourage students to find information of autonomous learning.Then teacher organized the class discussion,and the information was analyzed and summarized.In the implementation of the case teaching,we should pay attention to improving students' learning initiative.At the same time,teachers need to have knowledge,comprehensive ability and ability in organization and leadership,to promote students' active participation in discussion in the teaching,pay attention to the information feedback,and improve the teaching details

Objective To evaluate a model for axillary lymph node involvement combining CK19 mRNA with contrast enhanced ultrasound sonography (CEUS) score in operable breast cancer.Methods Operable breast cancer patients planned for sentinel lymph node (SLN) biopsy were enrolled.Preoperative CK19mRNA expressions in peripheral blood and CEUS score of axillary lymph nodes were tested before surgery.In the training set,postoperative sentinel lymph node (SLN) and non-sentinel lymph node (nSLN) pathological results were taken as the gold standard,effective modeling variables were screened,logistic regression was used to establish the prediction model.Parallel control studies were conducted between the validation set and the MSKCC model to evaluate the prediction accuracy and prediction efficiency.Results From Oct 2015 to Nov 2016,359 cases (training set) were enrolled and mathematical formulas for predicting SLN and nSLN were established,respectively.The sensitivity,specificity and AUC of predicting SLN involvement were 91.36％,94.92％ and 0.979 respectively.The sensitivity,specificity and AUC of predicting nSLN metastasis were 91.04％,90.53％ and 0.932 respectively.From Dec 2016 to Jul 2017,219 cases (verification set) were included.The sensitivity of SLN metastasis predicted by the model was 91.84％,the specificity was 96.69％,and the AUC was 0.979,significantly superior to the MSKCC model (0.739).The sensitivity,specificity and AUC of predicting nSLN metastasis were 95.35％,92.73％ and 0.945 respectively,significantly superior to the MSKCC model (0.873).Concolusions Combined with peripheral blood CK19 mRNA and CEUS score,the prediction model for axillary lymph node involvement for operable breast cancer,SLN/nSLN involvement probability can be calculated and qualitative judgment can be made.The overall accuracy and AUC of this model are better than the prediction model of MSKCC.

Objective:To understand the correlation of different ultrasound characteristics with thyroid cancer, and evaluate the effect and safety of different surgical strategies in pathological suspected cancer and highly suspected cancer by pure ultrasound.Methods:The clinical data of 679 patients (787 thyroid nodules) underwent thyroid surgery from August 2016 to December 2019 in Beijing Daxing District People′s Hospital were retrospectively analyzed, including ultrasound characteristics (echo, margin, form, ratio of tall to wide, calcification), surgery data (operation time, surgical strategies, whether the second surgery), recovery process (whether combined with secondary injury, including hoarse voice and choking on drinking water; drainage tube retention time and postoperative drainage), pathological examination results (pathological types, whether included parathyroid gland in the submitted specimen and whether lymph node metastasis). The effect and safety were compared between dissection and non-dissection of central group lymph nodes in pathological suspected cancer patients and highly suspected cancer by pure ultrasound patients.Results:Among the 787 thyroid nodules, 316 nodules (40.2%) were malignant nodules, including 308 papillary carcinomas; 471 nodules (59.8%) were benign nodules. The rates of low echo, unclear margin, form irregularity, ratio of tall to wide >1 and microcalcification in malignant nodules were significantly higher than those in benign nodules: 90.5% (286/316) vs. 38.9% (183/471), 52.5% (166/316) vs. 11.5% (54/471), 53.8% (170/316) vs. 11.5% (54/471), 30.4% (96/316) vs. 5.5%(26/471) and 65.5% (207/316) vs. 8.7% (41/471), and there were statistical differences ( P<0.01). Among 26 patients with pathological suspected cancer, there were no statistical difference in operation time, drainage tube retention time, postoperative drainage, surgical complications and paraffin pathology result between patients with dissection of central group lymph nodes (17 cases) and patients without dissection of central group lymph nodes (9 cases) ( P>0.05); the patients with dissection of the central group lymph nodes were all proved to be cancer by paraffin pathology examination. The highly suspected cancer by pure ultrasound was in 57 cases, there were no statistical difference in operation time, drainage tube retention time, postoperative drainage, choking on drinking water or hoarse voice between patients with dissection of central group lymph nodes (23 cases) and patients without that dissection (34 cases) ( P>0.05); the incidence of parathyroid gland in the submitted specimen and malignant rate of paraffin pathology result in patients with dissection of central group lymph nodes were significantly higher than those without that dissection: 39.1% (9/23) vs. 2.9% (1/34) and 30.4% (7/23) vs. 8.8% (3/34), and there were statistical differences ( P<0.01 or <0.05). Conclusions:Thyroid ultrasound characteristics have important predictive value. It is recommended to clean central group lymph node in most cases of pathological suspected cancer; while when highly suspected cancer by pure ultrasound happens, it is recommended to clean lymph node only when lymph node metastasis is highly suspected.

Objective The objective of this study was to analyze the longitudinal trend of multidimensional treatment quality of breast cancer based on the latent growth mixture model(LGMM),identify potential change patterns and influencing factors,and pro-vide scientific basis for improving treatment quality and patient prognosis.Methods The quality monitoring data of breast cancer from four consecutive years were obtained in the National"Quality Monitoring System for Specific(single)Disease";Based on the item response theory(IRT),the treatment quality of breast cancer in the three dimensions of preoperative examination,treatment,and out-come was calculated;LGMM was constructed to analyze the independent and joint change trend of breast cancer treatment quality in all dimensions,and the optimal model was determined based on practical significance and statistical indicators.Results In the inde-pendent trend analysis,2 potential categories were identified for preoperative examination,treatment,and outcome dimensions.Among them,9%showed a rapid upward trend in the preoperative examination dimension,and 91%showed a relatively stable trend;The sta-ble growth accounted for 23%and slow decline accounted for 77%in the treatment dimension;13%of the outcome dimensions showed an upward trend,while 87%showed a downward trend.In the joint trend analysis of changes,2 potential categories were identified:the first category accounted for about 8%,and the preoperative examination dimension of this category had a good treatment quality,with mean intercepts and slopes of 3.326 and 3.367,respectively.The treatment quality in the treatment and outcome dimensions had steadily improved;The second category accounted for about 92%,and the treatment quality in this dimension was relatively good.Its mean intercept and slope were 0.548 and 0.018,respectively.There is still room for improvement in the treatment quality of the pre-operative examination and outcome dimensions;BMI and M stage in patient characteristics are important influencing factors on the trend of combined changes in treatment quality.Conclusion The treatment quality of breast cancer during this study period has im-proved to varying degrees in all dimensions of preoperative examination,treatment and outcome;In the joint trend analysis of the three dimensions,the improvement of treatment quality in the preoperative examination dimension can provide feasible references for subse-quent treatment and achieve the goal of reducing complications.

Objective Based on polynomial logistic regression model,this study aimed to analyze the optimal length of hospi-tal stay for patients with non-small cell lung cancer(NSCLC)at different stages to achieve the best treatment quality,providing refer-ence for improving treatment quality and formulating relevant policies.Methods The data of NSCLC cases were collected and 16 di-agnosis and treatment process indicators were selected.Patients were stratified according to the stage of lung cancer.A polynomial lo-gistic regression model was constructed,including patient characteristics to analyze the impact of first hospitalization days on the quali-ty of comprehensive treatment.Results A total of 10,053 patients with NSCLC were collected in this study,with a median compre-hensive treatment quality score of 0.60.According to the staging of lung cancer,patients were divided into the early stage group(stageⅠ-Ⅱ),locally advanced stage group(stage Ⅲ),and advanced stage group(stage Ⅳ).The first hospitalization days and treatment quality of each subgroup showed a non-linear relationship.The polynomial model results showed that after adjusting the characteristics of patients,the length of hospitalization day and the quadratic term of hospital stay had a statistically significant impact on treatment quality in each subgroup:early patients had a first hospital stay of 18 days,and locally advanced and advanced patients had a first hos-pital stay of 22 days,with the highest probability of achieving high treatment quality.Conclusion Patients in different stages have va-rying degrees of illness and treatment plans,resulting in different first hospitalization days corresponding to the highest probability of obtaining high-quality treatment.Hospitals can improve the treatment quality and medical efficiency by implementing standardized di-agnosis and treatment guidelines,strengthening the management of the diagnosis and treatment process,and reasonably controlling the first hospitalization time of patients in different stages.

Objective The aim of this study was to estimate the causal effects of non-small cell lung cancer(NSCLC)treat-ment process on in-hospital mortality based on the double robust estimation(DR)method,and provide a reference basis for reducing in-hospital mortality of NSCLC.Methods According to the quality evaluation system of NSCLC treatment,the utilization rate of treatment process indicators was calculated,and patients were divided into the high-quality or low-quality groups based on the aver-age score of treatment process quality.In-hospital mortality was used as the outcome indicator,Kaplan-Meier method and Cox regres-sion adjusted for propensity score inverse probability of treatment weighting(IPTW)correction were used to analyze the impact of treat-ment process quality on in-hospital mortality in NSCLC.DR was combined to estimate the causal effects of the treatment process on in-hospital mortality.Results The median utilization rate of treatment process indicators was 66.88%,and the mean and standard de-viation of patients′ treatment process quality scores were 0.270±0.124,including 0.358±0.069 in the high-quality group,and 0.158±0.081 in the low-quality group.After the IPTW weighting,the standardized mean difference(SMD)of patients′baseline characteris-tics decreased;The difference in survival curves between the two groups of patients before and after ITPW was statistically significant(P<0.05),and the prognosis of patients in the high-quality group was better than that of patients in the low-quality group(pre-IPTW:HR=0.367,95%CI:0.275-0.491;post-IPTW:HR=0.228,95%CI:0.167-0.312).Compared with the low-quality group,the average causal effect of treatment process on in-hospital mortality was-0.026 in the high-quality group.Conclusion DR can compensate for the shortcomings of logistic or IPTW,avoid the risk of model error,and obtain for the causal effect of treatment process on in-hospital mortality.In medical practice,the utilization rate of treatment process indicators should be increased to improve patient prognosis;The study of causal effects suggests that besides the treatment process,other factors that affect in-hospital mortality cannot be ignored.

Adult ; Asparaginase ; Humans ; Hypertriglyceridemia