Model informed precision dosing for warfarin is to provide individualized dosing by integrating information related to patient characteristics, disease status and pharmacokinetics /pharmacodynamics of warfarin, through mathematical modeling and simulation techniques based on the quantitative pharmacology. Compared with empirical dosing, it can improve the safety, effectiveness, economy, and adherence of pharmacotherapy of warfarin. This consensus report describes the commonly used modeling and simulation techniques for warfarin, their application in developing and adjusting dosing regimens, medication adherence and economy. Moreover, this consensus also elaborates the detailed procedures for the implementation in the warfarin pharmacy service pathway to facilitate the development and application of model informed precision dosing for warfarin.

Model informed precision dosing (MIPD) is a new concept to guide precision dosing for individual patient by modeling and simulation based on the available information about the individual patient, medications and the disease. Compared to the empirical dosing, MIPD could improve the efficacy, safety, economics and adherence of the pharmacotherapy according to the individual's pathophysiology, genotyping and disease progression. This consensus report provides a brief account of the concept, methodology and implementation of MIPD as well as clinical decision supporting systems for MIPD. The status and future advancing of MIPD was also discussed to facilitate the appropriate application and development of MIPD in China.

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.

Objective To assess quality of life in elderly in Shanghai communities and to analyze relevant influence factors.Methods The quality of life and relevant influence factors of 4 395 residents aged 60 years or older who were registered in the health records of three community healthcare centers in Shanghai were investigated through questionnaire survey.Results Total 4 350 valid questionnaire were retrieved with a response rate of 99.0％.The mean physical component summary scale (PCS) score was (50.1± 10.1) and the mean mental component summary scale (MCS) score was (47.3±7.9).Factors influencing the quality of life in order of importance were depressive symptom(B=-8.41),self-care ability(B=7.45),disease score(B=-1.91),participating in outdoor activities(B=1.89),proportion of medical expenses over income(B=-1.72),social intercourse score(B=-1.48),gender(B=-1.37),education level(B=-1.03) and age(B=-0.93).Conclusion The quality of life in elderly residents of Shanghai is relatively high,but the mental components of quality of life need to be further improved.

Objective: To investigate the impact of immediate cessation of antiviral therapy on postpartum liver function and the factors influencing postpartum abnormality in mothers with chronic hepatitis B virus infection. Methods: A retrospective cohort study was conducted. One hundred eighty-eight pregnant women with HBV DNA level > 2×106 IU/ml were enrolled from June 2014 to June 2018. Demographic information and clinical data of liver function and HBV DNA load during gravidity, intrapartum and postpartum period were collected. According to the antiviral treatment recommendations during pregnancy, the women were divided into three groups, namely, tenofovir (TDF), telbivudine (LdT) and control group. Liver function abnormalities among the three groups were compared within 6 months after delivery, and the factors influencing abnormal liver function were analyzed by unconditional logistic regression. Results: Of the 188 cases, 72 cases were in the TDF group, 80 cases in the LdT group, and 36 cases in the control group. Pregnant women in the TDF and LdT groups received oral TDF (300 mg/d) and LdT (600 mg/d) from 28 ± 4 weeks of gestation till delivery. Among the 188 patients, 30 (16.0%) had abnormal postpartum liver function abnormality. The incidence of postpartum liver function abnormality [alanine aminotransferase (ALT) > 2 × upper limit of normal (ULN)] in the TDF, LdT, and control groups was 19.4%, 12.5%, and 16.7%, respectively. The postpartum peak levels of ALT (median, range) in the three groups were 34.5 (12.0-946.0) U/L, 37.5 (12.0-733.8) U/L, and 39.0 (7.0-513.0) U/L, respectively. There was no significant difference between the two indexes among the three groups (P > 0.05). There was no statistically significant difference in the degree of postpartum liver function abnormalities between the three groups (P = 0.944). Most of the liver function abnormalities were mild to moderate (2 × ULN≤ALT < 10 × ULN), and usually resolved spontaneously or by treatment. Univariate and multivariate analysis showed that baseline ALT level during pregnancy was an independent factor associated with postpartum liver function abnormality (OR = 1.031, CI 95%: 1.005-1.058; χ² = 5.340, P = 0.021), whereas age, antiviral therapy, HBeAg-positivity, baseline HBV DNA levels, gravidity, parity, preterm delivery and delivery mode were not significantly associated with postpartum liver function abnormality. Conclusion Cessation of antiviral therapy after delivery did not significantly increase the risk of postpartum liver function abnormality in pregnant women with chronic HBV infection. The ALT level during pregnancy is a factor influencing postpartum liver function abnormality.

Objective? To investigate the effect of midline catheter in intravenous treatment after renal transplantation. Methods? From May 2018 to February 2019, 84 renal transplant patients were treated with central line catheters, which were placed through cubital fossa or superior superficial cubital vein. The length of catheters was 22-36 cm. During catheterization, the maintenance of catheters was well done, the prevention and treatment of complications were emphasized, and the situation of catheter extraction was observed. Results? Totally 84 patients had catheter indwelling time of 10-41 days, 2 cases of puncture point oozing, 2 cases of tube plugging, 2 cases of shoulder pain, 1 case of upper extremity edema. After careful care and treatment, no serious complications occurred and the effect was satisfactory. Conclusions? The application of midline catheter vein treatment, without repeated venipuncture, reduces the pain of patients′ puncture and the occurrence of phlebitis, achieves the expected treatment effect, and reduces the workload of nurses.

Objective To evaluate the efficacy and safety of ilaprazole sodium for injection in the treatment of peptic ulcer bleeding.Methods It was designed as a multi-center,stratified randomized,double-blind,positive drug parallel controlled and non-inferiority study.From October 2014 to April 2015,at 40 hospitals,patients with peptic ulcer hemorrhage confirmed by gastroendoscopy were enrolled and divided into the ilaprazde sodium group (10 mg ilaprazole sodium for injection every 24 h,the first dose doubled) and the positive control group (40 mg of omeprazole sodium for injection every 12 h).The course of both treatment was 72 h.The hemostasis rate of overall group at 72 h,the clinical rebleeding rate at four to seven days,the blood transfusion rate,the incidence of switching to other treatments and the incidence of adverse reactions were compared between the two groups.A chi-square test or Fisher's exact probability method were performed for statistical analysis.Results A total of 533 patients with peptic ulcer bleeding were enrolled,355 patients in the ilaprazole sodium group and 178 patients in the positive control group.The hemostasis rates of ilaprazole sodium group and positive control group at 72 h were 97.69 ％ (339/347) and 97.14 ％ (170/175),respectively,and the difference was not statistically significant (P＞0.05).There were no rebleeding patients in both groups at four to seven days.The blood transfusion rates of ilaprazole sodium group and positive control group were 5.07 ％ (18/355) and 3.37 ％ (6/178).The incidence of switching to other treatments was 0.56％ (2/355) and 0.56％ (1/178),respectively,and the differences were not statistically significant (both P＞ 0.05).The incidence of adverse reactions in the ilaprazole sodium group was 3.94％ (14/355),which was lower than that of positive control group (8.43％,15/178).And the difference was statistically significant (Fisher's exact probability method,P=0.042).Conclusions The efficacy of ilaprazole sodium for injection in the treatment of peptic ulcer bleeding is similar to that of omeprazole sodium for injection.Moreover,the smaller the dose,the lower the frequency of administration and the better the safety.

Objective To explore the characteristic of fractional amplitude of low frequency fluctuation (fALFF) and the relationship with the severity of depression, suicidal ideation and suicide risk in depression patients with suicidal ideation with resting-state functional magnetic resonance imaging (rs-fMRI). Methods Resting state functional magnetic resonance imaging maps were conducted using fractional amplitude of low frequency fluctuation (fALFF) in 52 depression patients (30 with suicidal ideation and 22 without) and 21 healthy controls (HCs). The severity of depression was evaluat-ed by using Hamilton Depression scale(HAMD). The suicidal ideation, the suicide risk in depression patients with sui-cidal ideation were both assessed by the Beck Scale for Suicide Ideation. The correlation between the fALFF value and the score of HAMD and the Beck Scale for Suicide Ideation was analyzed. Results MRI revealed significant differences in fALFF in the left superior/middle occipital gyrus and the right middle/inferior occipital gyrus (P<0.05, AlphaSim cor-rected)between depression patients with suicidal ideation and the HCs. Compared to the HCs, depression patients with-out suicidal ideation showed a higher fALFF in the left middle occipital gyrus (P<0.05, AlphaSim corrected). MRI re-vealed significant differences in fALFF in the left middle occipital gyrus (P<0.01, AlphaSim corrected)and the right mid-dle occipital gyrus (P<0.01, AlphaSim corrected) between depression patients with suicidal ideation and without. The fALFF of left middle occipital gyrus (r=0.366, P=0.046) and right middle occipital gyrus (r=0.513, P=0.004) were posi-tively correlated with the scores of HAMD, respectively whereas were not correlated with suicidal ideation and suicide risk. Conclusions Depression patients with suicidal ideation have an abnormal spontaneous activity in their left and right middle occipital gyrus. The increased activity in these brain areas are probably associated with the severity of de-pression whereas are not associated with suicidal ideation or suicide risk.

Objective To explore the effects of the multidisciplinary cooperative continue nursing on the quality of life of patients with chronic obstructive pulmonary disease (COPD). Methods From December 2012 to December 2014, hospitalized COPD patients who were in the stable stage of disease and would soon be discharged and met the criteria standards were chosen. Convenient extraction of 64 patients were set as the experimental group in one ward and 50 patients as the control group in the other ward. The conventional discharge guidance was employed in the control group. While the continuation of care before discharge and 1, 3, 6 months after discharge was employed in the experimental group. The indexes such as the quality of life and 6 min walking test distance (6MWD) were observed and compared. Results The total scores and symptoms, activities, influence scores of the quality of life were 48.53±15.78, 35.38± 18.61, 57.95 ±23.69, 52.28 ±15.27 after 6 months intervention in the experimental group and 60.24 ±10.14, 52.76 ±12.36, 68.34 ±15.59, 58.55 ±11.79 in the control group, and there were significant differences (t=-5.69--2.38, P<0.05). 6MWD was (267.46 ±64.64) m after 6 months intervention in the experimental group,which was more than that before intervention (169.42±48.46) m, and there was significant difference (t=-9.71, P<0.01). 6MWD was (201.32±53.93) m after 6 months intervention in the control group, which was not significantly better than that in the experimental group (t=5.82, P<0.01). Conclusions The quality of life of patients with COPD can be significantly improved by the multidisciplinary cooperative continue nursing education after discharge.

OBJECTIVE:To evaluate the economic value of Shenqi fuzheng injection combined with chemotherapy vs. chemo-therapy alone for non-small lung cancer(NSCLC),and to provide reference for drug payment and clinical treatment. METHODS:By prospective cohort design,516 patients with non-small cell lung cancer from 11 hospitals were selected as subjects according to the sale distribution of Shenqi fuzheng injection in district and hospital;267 cases of Shenqi fuzheng injection combined with che-motherapy and 249 cases of chemotherapy alone formed naturally according the clinical therapy plan. The cost-effectiveness and cost-utility analysis were conducted using FACT-L score,KPS score and ZPS score as effect index,QALYs as effectiveness index observation period of 21 d. RESULTS:5 dimensions FACT-L score:the patients of Shenqi fuzheng injection combined with chemo-therapy group could be effectively improved,and the cost-effectiveness ratio was lower than chemotherapy alone group;KPS score:the cost-effectiveness ratio of Shenqi fuzheng injection combined with chemotherapy group was lower than chemotherapy alone group (1 632.44 vs. 11 145.30),and incremental cost-effectiveness ratio was 448.69. ZPS score:Shenqi fuzheng injection combined with chemotherapy group was lower than chemotherapy alone(-17 398.77 vs. 384 513.00). Shenqi fuzheng injection combined with chemotherapy group was lower than chemotherapy alone group in average cost per 1 QALYs(1 313 326 yuan vs. 13 374 365 yuan). CONCLUSIONS:Compared with chemotherapy alone group,Shenqi fuzheng injection combined with chemo-therapy can effectively improve the quality of life,and it is worth of spending more money on Shenqi fuzheng injection from the perspective of the pharmacoeconomics.