Objective To assess the risk of malnutrition in elder home-care patients through mini nutritional assessment (MNA) and study the correlations between total MNA score and 18 individual questions in this patient group.Methods In May 2011,62 elder home-care patients from our center answered the MNA questionnaire.And the results were used to analyze the correlations between total MNA score and individual questions and the correlations among MNA classifications and body mass index(BMI),mid-arm muscle circumference (MAMC) and calf circunference (CC).Results According to MNA,18％ were malnourished ( 11/62 ),47％ at risk of malnutrition ( 29/62 ) and 35％ well-nourished ( 22/62 ) ; BMI,independence,mobility,neuropsychological problems,ingesting method,MAMC,CC and selfperceived nutritional status,self-perceived health status showed strong correlations with total MNA score (0.601,0.600,0.666,0.611,0.627,0.618,0.726,0.612,0.672,P ＜0.05).And weight loss within a month,number of daily meals and intake of drinks showed weak correlations with total MNA score (0.35,0.319,0.288,P ＜ 0.05 ).Positive correlations existed among MNA classifications and BMI,MAMC,CC (15.45,19.85,31.89,P＜0.05).Conclusions The elder home-care patients have a high risk for malnutrition.Half of 18 individual questions are strongly correlated with total MNA score in this patient group.

Objective:To establish and validate an LC-MS/MS method for simultaneous determination of Aβ 1-42, Aβ 1-40, and Aβ 1-38 in cerebrospinal fluid. Additionally, the consistency between this method and three mainstream detection methods was evaluated.Methods:This study involved method establishment, validation, and consistency evaluation. The N15 labeled β-amyloid protein was used as the internal standard. Extraction was performed using Waters MCX 96-wells solid phase extraction plate, and the eluent was collected to QuanRecovery MaxPeak 700 μl plate. At the positive ion mode, the multi-reaction ion monitoring mode based on electric spray ionization is chosen for the determination of CSF Aβ 1-42, Aβ 1-40, and Aβ 1-38. Referring to the CLSI C62-A and EP-15A3 guidelines, the method is evaluated and verified, including quantitation of limit (LOQ), linearity, recovery, precision, and accuracy. In addition, a total of 57 clinical residual CSF samples were collected and the concentrations of Aβ 1-42 and Aβ 1-40 were determined based on manual INNOTEST ELISA assay and Lumipulse G and Roche Elecsys fully automated biochemical analyzers. The comparison analysis and deviation evaluation were conducted by passing-bablok and Bland Altman methods.Results:The analysis time of this method is 8 min, and the LOQ of Aβ 1-42, Aβ1-40 and Aβ1-38 is 0.1 ng/ml, 0.5 ng/ml, and 0.1 ng/ml, respectively, and the linear range can meet the needs of clinical detection. Respectively, the recovery is 86.2%-93.8%, 100.9%-103.9% and 103.3%-107.1%; the total imprecision is 4.7%-7.4%, 3.5%-4.6% and 5.2%-10.9%. The measured values of Aβ 1-42 certified reference materials are all within the allowable uncertainty requirements. Moreover, the carryover rate of three analytes was all≤0.11%. In addition, the correlations of Aβ 1-42 and Aβ1-40 in CSF between this LC-MS/MS method and the INNOTEST ELISA method, Lumipulse G and Roche Elecsys fully automated biochemical analyzers were all deemed good, with correlation coefficient (r) ranging from 0.920 to 0.970. However, the measured values between the four methods were remarkably different.Conclusion:We established and validated a robust method based on LC-MS/MS technology for simultaneous determination of Aβ 1-42, Aβ 1-40, and Aβ 1-38 in CSF. The method is accurate, simple, and suitable for clinical measurements. However, despite good correlations, there were substantial differences in the measurement results of Aβ 1-42 and Aβ 1-40 among different analytical platforms, indicating the need for further promotion of harmonization and standardization processes for AD classic biomarkers.

With the increasing cost of drug development and clinical trials, it is of great value to make full use of all kinds of data to improve the efficiency of drug development and to provide valid information for medication guidelines. Model-based meta-analysis (MBMA) combines mathematical models with meta-analysis to integrate information from multiple sources (preclinical and clinical data, etc.) and multiple dimensions (targets/mechanisms, pharmacokinetics/pharmacodynamics, diseases/indications, populations, regimens, biomarkers/efficacy/safety, etc.), which not only provides decision-making for all key points of drug development, but also provides effective information for rational drug use and cost-effectiveness analysis. The classical meta-analysis requires high homogeneity of the data, while MBMA can combine and analyze the heterogeneous data of different doses, different time courses, and different populations through modeling, so as to quantify the dose-effect relationship, time-effect relationship, and the relevant impact factors, and thus the efficacy or safety features at the level of dose, time and covariable that have not been involved in previous studies. Although the modeling and simulation methods of MBMA are similar to population pharmacokinetics/pharmacodynamics (Pop PK/PD), compared with Pop PK/PD, the advantage of MBMA is that it can make full use of literature data, which not only improves the strength of evidence, but also can answer the questions that have not been proved or can not be answered by a single study. At present, MBMA has become one of the important methods in the strategy of model-informed drug development (MIDD). This paper will focus on the application value, data analysis plan, data acquisition and processing, data analysis and reporting of MBMA, in order to provide reference for the application of MBMA in drug development and clinical practice.

OBJECTIVETo observe treatment response, survival, safety and the improvement of ECOG in patients with refractory multiple myeloma (MM) with serious heart failure after the administration of continuous low-dose of cyclophosphamide combined with prednisone (CP).

METHODSFrom January 2005 to September 2013, a total of 75 patients were treated by metronomic chemotherapy with continuous low-dose cyclophosphamide (50 mg/d) and prednisone (15 mg/d).

RESULTSAmong the 75 patients, 2 were lost for follow-up. In the 73 available patients, the overall response was 64.4%, including 2 patients (2.7%) with complete remission (CR), 4 cases (5.5%) very good partial remission (VGPR), and 24 patients (32.9%) partial remission (PR). The median survival was 12 months (1-70 months) with a median onset time of 90 days (16-120) and a median progressive freedom survival of 12 months (1-60). The level of B-type natriuretic peptide in responders declined significantly, as compared to no responders [(336.6 ± 30.3) ng/L vs (906.4 ± 104.8) ng/L, P<0.01]. Common adverse events were as follows: 32 (43.8%) cases of bone marrow suppression, 26 (35.6%) cases of infection, 8 cases of dizzy as well as sleepiness (11.0%), 7(9.6%) cases of Cushing syndrome, 4 (5.5%) cases of secondary diabetes mellitus, and 3 (4.1%) cases of edema respectively.

CONCLUSIONThe metronomic chemotherapy of cyclophosphamide combined with prednisone had satisfactory impact on the treatment outcome, including the improvement of cardiac functions and physical capacities, better survival and safety in refractory MM with serious heart failure. It provides a novel regimen for such patients.

Antineoplastic Combined Chemotherapy Protocols ; Clinical Protocols ; Cyclophosphamide ; Heart Failure ; Humans ; Multiple Myeloma ; Prednisone ; Remission Induction ; Treatment Outcome