1.Early neurovascular repair in femoral fractures combined with knee joint injuries:evaluation of ligament healing and knee joint function
Lei HE ; Yongxing AO ; Haitang MA
Chinese Journal of Tissue Engineering Research 2015;(33):5254-5258
BACKGROUND:Femoral fractures easily cause damages to patient’s blood vessels and nerves. If there is no proper treatment, it is easy to result in physical disabilities in patients. Early neurovascular repair may have a positive impact on the patients. OBJECTIVE: To compare and analyze the clinical effects of early neurovascular repair on femoral fractures combined with knee joint injuries. METHODS: Eighty patients with femoral fractures combined with knee joint injuries were selected and equaly divided into control group (the injury time was > 8 hours but≤ 48 hours) and observation group (the injury time≤ 8 hours) prior to early neurovascular repair. Amputation rate and the time of femur and knee ligament healing in patients with no amputation were analyzed in the two groups, and Lysholm scores were measured to assess the knee function of patients without amputation in the two groups. RESULTS AND CONCLUSION: The amputation rate was 22% in the control group and 5% in the observation group, and there was a significant difference between the two groups (P < 0.05). The time of femoral and ligament healing in the observation group was significantly lower than that in the control group (P < 0.05). Lysholm scores were also better in the observation group than the control group (P < 0.05). These findings indicate that early neurovascular repair is preferred for patients with confirmed femoral fractures combined with knee joint injuries as soon as possible.
2. Model informed precision dosing: China expert consensus report
Zheng JIAO ; Xingang LI ; Dewei SHANG ; Jing DONG ; Xiaocong ZUO ; Bing CHEN ; Jianmin LIU ; Yan PAN ; Tianyan ZHOU ; Jing ZHANG ; Dongyang LIU ; Lujin LI ; Yi FANG ; Guangli MA ; Junjie DING ; Wei ZHAO ; Rui CHEN ; Xiaoqiang XIANG ; Yuzhu WANG ; Jianjun GAO ; Haitang XIE ; Pei HU ; Qingshan ZHENG
Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(11):1215-1228
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.
3. General considerations of model-based meta-analysis
Lujin LI ; Junjie DING ; Dongyang LIU ; Xipei WANG ; Chenhui DENG ; Shangmin JI ; Wenjun CHEN ; Guangli MA ; Kun WANG ; Yucheng SHENG ; Ling XU ; Qi PEI ; Yuancheng CHEN ; Rui CHEN ; Jun SHI ; Gailing LI ; Yaning WANG ; Yuzhu WANG ; Haitang XIE ; Tianyan ZHOU ; Yi FANG ; Jing ZHANG ; Zheng JIAO ; Bei HU ; Qingshan ZHENG
Chinese Journal of Clinical Pharmacology and Therapeutics 2020;25(11):1250-1267
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.