1.Effect of multidisciplinary cooperative continue nursing on the quality of life of patients with chronic obstructive pulmonary disease
Chinese Journal of Practical Nursing 2016;32(10):737-742
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.
2.Challenges in research and development of Traditional Chinese Medicines
Changxiao LIU ; Duanyun SI ; Haitang XIE
Chinese Journal of Clinical Pharmacology and Therapeutics 2007;12(10):1122-1129
In this review, the author analyzed the challenges in modern research and development of Traditional Chinese Medicine (TCM) products. Chinese traditional and herb drugs have gained interest from the international medical, biomedical and pharmaceutical institutions as potential source of valuable medicinal agents. For the researches and development of TCMs, the first challenge is to evaluate the efficacy, pharmacological properties, action mechanism and active chemical constituents. The second one is to summarize the issues for developing safety research methodologies, to improve the quality and enhance the value of research in TCM and to provide appropriate evaluation methods to facilitate the regulation and registration of TCM products, and the third is to study drug metabolism and pharmacokinetics, and the fourth is to apply new "-omics" techniques and tools in new revolution in drug discovery-development and to impact on modern research of TCM products. This interest is needed to apply modern research on the development and exploration of the promising medical potential resources of Chinese traditional and herbal drugs, especially from medicinal plants.
3.Two-stage bioequivalence designs and problems need to focus on
Hua SUN ; Dahu LIANG ; Haitang XIE
Drug Evaluation Research 2017;40(5):593-599
Two-stage designs for the assessment of bioequivalence have been recently accepted in various regulatory authorities.However controlling type Ⅰ error rates around 5% at targeted power is still a great challenge for applying two-stage method.This paper reviewed the feature of present designs of the two-stage bioequivalence.The decision tree,nominal significance level,and sample size recalculation in previously published methods were also introduced in detail,which would be referential for domestic sponsors in the study of two-stage design bioequivalence.
4.Introduction and application of new edition of software of the new drug statistical treatment (NDST-21)
Xiaohui HUANG ; Haitang XIE ; Ruiyuan SUN
Chinese Journal of Clinical Pharmacology and Therapeutics 2000;0(02):-
NDST(New Drug Statistical Treatment)is a powerful tool for treating data of clinical trial and pre-clinical experimentation in the study of new drug. This paper, combined the some examples, introduced the new edition of the software (NDST-21) on the function and characteristics.
5.Computer systems and GCP-site roles and responsibilities for computer systems used in clinical trials
Stokes TERI ; Juan LI ; Haitang XIE ;
Chinese Journal of Clinical Pharmacology and Therapeutics 1999;0(04):-
Many computer systems can be used in the diagnosis and care of subjects in a clinical study,in dispensing drug supplies,and in performing laboratory tests required by the study protocol.It is important that these systems are closely controlled and perform reliably every time they are used.International regulations require that such systems be well documented.Audits and inspections at clinical study sites under Good Clinical Practice(GCP)will check such systems to be sure that they are reliable in performance and that their data is trustworthy.The Principal Investigator in a study is responsible for the quality of all computer systems used to meet the study protocol and for the quality and trustworthiness of all trial data collected either by paper or computer.
6.Simple bracket assist closed reduction percutaneous treatment of children's supracondylar fracture
Zhichao ZENG ; Peng LI ; Zhiping OU ; Haitang LIU ; Peijun XIE
Chinese Journal of Primary Medicine and Pharmacy 2013;20(6):817-818
Objective Describes the use of homemade simple bedside bracket of children supracondylar fracture closed reduction and percutaneous pin fixed surgical methods and clinical effects.Methods 16 cases of children supracondylar fractures Gartland type Ⅱ cases,15 cases Gartland type Ⅲ,13 males and 3 females,with an average age of 6 years old,all patients used our hospital homemade simple bedside shelf assisted closed reduction,percutaneous pin fixation,and fixed with plaster immobilization.Results 16 patients were followed-up,in addition to the two cases of pin tract infection,fracture all were healed smoothly.Without iatrogenic nerve injury and internal fixation loosening,and also no volkmann contracture,and myositis ossificans etc complications.The average fracture healing time for three weeks,no bone delayed union or nonunion occurred.According to Flynn clinical function evaluation,there were excellent in 7 cases,good in 9 cases.Conclusion Useing homemade simple bedside shelf to children supracondylar fractures closed reduction and percutaneous Kirschner wire fixed can ensure the efficacy,and also simplify the surgical procedure,reduce radiation intake,which is the worthy of clinical practice.
7.New software for carrying out data analysis of bioavailability and bioequivalence testing
Zhiyang CHEN ; Haitang XIE ; Ruiyuan SUN ; Gang HU
Chinese Journal of Clinical Pharmacology and Therapeutics 2007;12(4):448-454
Generic drug products (test products: drug A, B...) are bioequivalent to an innovator product (reference product) when their bioavailabilities in the same molar dose are similar. Bioavailability is usually expressed by following pharmacokinetic parameters: the area under plasma concentration-time curve (AUC), the maximum plasma concentration (Cmax) and the time of maximum plasma concentration (tmax). This paper used a two period crossover bioequivalence study to develop convenient, friendly user interface software, BA&BE Analysis to statistically process data in clinical pharmacology studies and other areas. The method involves user input of data for analysis into a grid format, setting variables and parameters, followed by one-way analysis of variance (ANOVA), bioavailability and bioequivalence analysis of the data. The software developed in the present study should help scientists to carry out data analysis of bioavailability and bioequivalence testing quickly and easily.
8.Absolute bioavailability of compound G004 in rats
Xiaoyu LI ; Guangji WANG ; Guanzhong WU ; Haitang XIE ; Jianguo SUN ; Xuan WANG
Chinese Pharmacological Bulletin 1986;0(06):-
Aim To establish an analytical method for determination of compound G004 concentration in plasma and investigate its application to pharmacokinetics and absolute bioavailability in rats.Methods 5.0 and 2.5 mg?kg~(-1) compound G004 were given via ig and iv respectively to SD rats.Blood samples were collected at various time points after administration.Plasma concentration of compound G004 in rats was determined by LC-ESI-MS.Pharmacokinetic parameters were calculated by DAS program and absolute bioavailability was also calculated.Results The method was linear over the range of 0.02~5 mg?L~(-1)(r~2=0.9995).The recovery of compound G004 in rat plasma was more then 87%.Intra-and inter-day precision,expressed as the relative standard deviation(RSD) was less than 15%.After iv compound G004,the main pharmacokinetic parameters T_(2),CLs,V_d,AUC_((0-∞)) were(1.91?0.65) h,(0.36?0.22) L?h~(-1),(0.78?0.36) L ?kg~(-1),(9.52?3.53) mg?L~(-1)?h~(-1) respectively.The major pharmacokinetic parameters T_(max),C_(max),T_(2),AUC_((0-∞)),MRT_((0-12h)) were 0.83 h,(3.33?0.80) mg?L~(-1),(1.77?0.21) h,(10.04?2.43) mg?L~(-1)?h~(-1) and(2.75?0.31)h after ig compound G004.The absolute bioavailability was 52.69% after correction of dosage.Conclusion The method is sensitive and specific which is applicable to pharmacokinetic analysis of compound G004 in rats.
9.Constructing an expression vector for human lncRNA H19 and the effect of its overexpression on MCF-7 cell proliferation
Yan PENG ; Haitang XIE ; Hong SUN ; Ying ZENG ; Qiongni ZHU ; Tailin LI ; Guo WANG ; Yuanshan ZHU
Chinese Pharmacological Bulletin 2015;(4):555-559,560
Aims To construct an expression vector of human lncRNA H 1 9 ,and to determine the effect of H1 9 overexpression on MCF-7 cell proliferation. Methods Total RNA was extracted from MCF-7 cells,and the full-length of H1 9 lncRNA was amplified by RT-PCR and subcloned into pcDNA3.1 (-)ex-pression vector.The constructed H1 9 expression vector was transfected into HEK-293T and COS-7 cells and the H1 9 lncRNA expression was evaluated by real-time PCR.Following the transfection of H1 9 expression vec-tor into MCF-7 cells for 0,24h and 48h and H1 9 siR-NA interference fragment into MCF-7 cells for 24h, MCF-7 cell proliferation was determined by MTS as-say.Results A hH1 9-pcDNA3.1 (-)expression vector was successfully constructed. At Forty-eight hours after the transfection with H1 9 expression vector in to MCF-7 cells,cell proliferation was significantly increased in the transfected group compared to those without transfection and to those transfected with a neg-ative control vector,while twenty-four hours after the transfection with H1 9 siRNA interference fragment into MCF-7 cells,cell proliferation was significantly de-creased in the transfected group compared to those transfected with a negative control vector.Conclusion Ectopic overexpression of H1 9 lncRNA can promote breast cancer MCF-7 cell proliferation.
10. Model informed precision dosing of warfarin: China expert consensus report (2022 version)
Jinhua ZHANG ; Maobai LIU ; Mingzhi CAI ; Yingli ZHENG ; Haiyan LAO ; Qian XIANG ; Liping DU ; Zhu ZHU ; Jing DONG ; Xiaocong ZUO ; Xingang LI ; Dewei SHANG ; Bing CHEN ; Yanrong YE ; Yuzhu WANG ; Jianjun GAO ; Jian ZHANG ; Wansheng CHEN ; Haitang XIE ; Zheng JIAO
Chinese Journal of Clinical Pharmacology and Therapeutics 2022;27(11):1201-1212
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.