1.Advances in the application of physiologically-based pharmacokinetic model in EGFR-TKI precision therapy
Yingying YANG ; Jiaqi SHAO ; Qiulin XIANG ; Guoxing LI ; Xian YU
China Pharmacy 2025;36(8):1013-1018
Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) represent a class of small-molecule targeted therapeutics for oncology treatment, and serve as first-line therapy for advanced non-small cell lung cancer (NSCLC) with EGFR- sensitive mutations, with representative agents including gefitinib, dacomitinib, and osimertinib. In clinical practice, dose adjustment of EGFR-TKI may be required for cancer patients under special circumstances such as drug combinations or hepatic/ renal impairment. Physiologically-based pharmacokinetic (PBPK) model, capable of predicting pharmacokinetic (PK) processes in humans, has emerged as a vital tool for clinical dose optimization. This article sorts the modeling methodologies, workflows, and commonly used software tools for PBPK model, and summarizes the current applications of PBPK model in EGFR-TKI precision therapy as of June 30, 2024. Findings demonstrate that PBPK modeling methods commonly employ the “bottom-up” approach and the middle-out approach. The process typically involves four steps: parameter collection, compartment selection, model validation, and model application. Commonly used software for modeling includes Simcyp, GastroPlus, and open-source software such as PK- Sim. PBPK model can be utilized for predicting drug-drug interactions of EGFR-TKI co-administered with metabolic enzyme inducers or inhibitors, acid-suppressive drugs, or traditional Chinese and Western medicines. It can also adjust dosages in conjunction with genomics, predict PK processes in special populations (such as patients with liver or kidney dysfunction, pediatric patients), evaluate the efficacy and safety of drugs, and extrapolate PK predictions from animal models to humans.
2.Clinical trial of brexpiprazole in the treatment of adults with acute schizophrenia
Shu-Zhe ZHOU ; Liang LI ; Dong YANG ; Jin-Guo ZHAI ; Tao JIANG ; Yu-Zhong SHI ; Bin WU ; Xiang-Ping WU ; Ke-Qing LI ; Tie-Bang LIU ; Jie LI ; Shi-You TANG ; Li-Li WANG ; Xue-Yi WANG ; Yun-Long TAN ; Qi LIU ; Uki MOTOMICHI ; Ming-Ji XIAN ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(5):654-658
Objective To evaluate the efficacy and safety of brexpiprazole in treating acute schizophrenia.Methods Patients with schizophrenia were randomly divided into treatment group and control group.The treatment group was given brexpiprozole 2-4 mg·d-1 orally and the control group was given aripiprazole 10-20 mg·d-1orally,both were treated for 6 weeks.Clinical efficacy of the two groups,the response rate at endpoint,the changes from baseline to endpoint of Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Improvement(CGI-S),Personal and Social Performance scale(PSP),PANSS Positive syndrome subscale,PANSS negative syndrome subscale were compared.The incidence of treatment-related adverse events in two groups were compared.Results There were 184 patients in treatment group and 186 patients in control group.After treatment,the response rates of treatment group and control group were 79.50%(140 cases/184 cases)and 82.40%(150 cases/186 cases),the scores of CGI-I of treatment group and control group were(2.00±1.20)and(1.90±1.01),with no significant difference(all P>0.05).From baseline to Week 6,the mean change of PANSS total score wese(-30.70±16.96)points in treatment group and(-32.20±17.00)points in control group,with no significant difference(P>0.05).The changes of CGI-S scores in treatment group and control group were(-2.00±1.27)and(-1.90±1.22)points,PSP scores were(18.80±14.77)and(19.20±14.55)points,PANSS positive syndrome scores were(-10.30±5.93)and(-10.80±5.81)points,PANSS negative syndrome scores were(-6.80±5.98)and(-7.30±5.15)points,with no significant difference(P>0.05).There was no significant difference in the incidence of treatment-related adverse events between the two group(69.00%vs.64.50%,P>0.05).Conclusion The non-inferiority of Brexpiprazole to aripiprazole was established,with comparable efficacy and acceptability.
3.Effects of CYP3A5 gene polymorphism and Wuzhi capsule on early postoperative tacrolimus exposure and adverse reactions in renal transplant patients
Qiulin XIANG ; Ling LIU ; Yi YANG ; Guoxing LI ; Song CHEN ; Yingying YANG ; Xian YU
China Pharmacy 2024;35(14):1765-1769
OBJECTIVE To investigate the effects of CYP3A5 gene polymorphism and Wuzhi capsule (WZ) on early postoperative tacrolimus exposure and adverse reactions in renal transplant patients. METHODS A total of 132 patients who underwent renal transplantation and received tacrolimus + mycophenolic acids + prednisone after operation in our hospital from September 2021 to September 2023 were selected and divided into four groups according to genotypes (CYP3A5*1 or CYP3A5*3/*3) and with or without WZ (“ +WZ” meant drug combination, “ +NO WZ” meant without combination). The blood trough concentration/daily dose (c0/D) values of the four groups were analyzed on the 14th day, 1 month and 3 months after renal transplantation. The incidence of acute rejection and the incidence of tacrolimus-related adverse reactions within 3 months after transplantation were compared among 4 groups. RESULTS On the 14th day, 1 month and 3 months after surgery (except for the CYP3A5*1+WZ group), c0/D values of CYP3A5*1 genotype patients were significantly lower than those of CYP3A5*3/*3 genotype patients regardless of whether they were treated with WZ additionally (P<0.05). Within 3 months after surgery, although there was no significant difference in the incidence of acute rejection and tacrolimus-related adverse reactions among the four groups (P> 0.05), the incidence of hyperglycemia in patients with CYP3A5*3/*3 was higher (41.67%). CONCLUSIONS CYP3A5 gene polymorphism is significantly related to tacrolimus c0/D in kidney transplant patients. Under the premise of c0 monitoring of tacrolimus, patients with CYP3A5*1 genotype should be given WZ as soon as possible after surgery to accelerate tacrolimus to reach the therapeutic concentration range, while CYP3A5*3/*3 genotype is not recommended to be given WZ because of the higher risk of hyperglycemia.
4.Identification and expression analysis of flavonoid O -methyltransferase gene family in Polygonum capitatum
Jiang-li LUO ; Chang LIU ; Xian-fa ZENG ; Na-na WU ; Xiao-xue WANG ; Ying TANG ; Xiang PU
Acta Pharmaceutica Sinica 2024;59(5):1467-1477
italic>Polygonum capitatum is a characteristic Miao medicine in Guizhou, commonly used in clinical practice to treat gastrointestinal and urinary tract infections. Research has found that it has good antibacterial and anti-inflammatory effects, and its main active ingredient is flavonoids. Lavonoid
5.Research Advance on Smartphone-based Visual Biosensor in Point-of-Care Testing
Xian-Xin XIANG ; Hua-Yue SUN ; Hui-Ning CHAI ; Kun YU ; Li-Jun QU ; Guang-Yao ZHANG ; Xue-Ji ZHANG
Chinese Journal of Analytical Chemistry 2024;52(2):145-156
Human physiological indicators have become an important standard for assessing health in modern society.Traditional detection methods often require a separate laboratory,complex operation process and long detection time,so it is urgent to develop portable,fast and accurate on-site detection technologies for bioanalysis.Point-of-care testing(POCT),which differs from traditional laboratory testing,can realize the rapid in situ detection of biomarkers without the complicated analytical process of the laboratory.Smartphones,which are an essential tool in our daily life,not only have independent operating systems and built-in storage functions,but also have high-definition cameras,which have great application potential in POCT visualization.The combination of various biosensing technologies and smartphones has developed into a new direction in the field of POCT.This review mainly introduced the research progress of smartphone-based visual biosensors in POCT in recent years,including colorimetric sensors,fluorescence sensors,chemiluminescence sensors and electrochemiluminescence sensors.Finally,the problems faced by smart-phone-based visual biosensors in the application of POCT were summarized,and their future development was prospected.
6.Correlation between irritable bowel syndrome as well as its subtype and gallbladder stones
Guang-Xiang WANG ; Chang-Hao DONG ; Chao LI ; Rui XIAN ; Li-Hong CUI
Medical Journal of Chinese People's Liberation Army 2024;49(2):159-164
Objective To analyze the correlation between irritable bowel syndrome(IBS)as well as its subtypes and gallbladder stone.Methods Collected the clinical data of 556 patients who were treated in Department of Gastroenterology of the Sixth Medical Center of Chinese PLA General Hospital from January 2019 to March 2023.The patients were divided into IBS group(n=161)and non-IBS group(n=395).The subjects were investigated by questionnaire,physical examination and blood examination,and the data of gender,age,height,weight,blood pressure and blood biochemical indexes were obtained and compared between two groups.The relation between gallbladder stone and IBS were evaluated by logistic regression analysis.Results There were 90 cases of gallbladder stone in the total population,accounting for 16.2%,including 37 cases of gallbladder stone in IBS group(23.0%)and 53 cases in non-IBS group(13.4%).The prevalence rate of gallbladder stone in IBS group was significantly higher than that in non-IBS group(P<0.05).There were 6 cases of gallbladder muddy stones(3.7%)in IBS group and 3 cases(0.8%)in non-IBS group.And the prevalence rate of gallbladder muddy stones in IBS group was also significantly higher than that in non-IBS group(P<0.05).Logistic regression analysis showed that the age,BMI,total bile acids(TBA),total cholesterol(TC)and combined IBS were independently related to the occurrence of gallbladder stone(P<0.05).In the 161 IBS patients,there were 114 cases of diarrhea-predominant IBS(IBS-D group),including 26 cases(22.8%)of gallbladder stone in IBS-diarrhea(IBS-D,n=114)group and 47 cases of constipation-predominant IBS(IBS-C group),including 11 cases(23.4%)of gallbladder stone.And there were 53 cases(13.4%)of gallbladder stone in the non-IBS group(n=395).Further analysis showed that the prevalence rate of gallbladder stone in IBS-D group was significantly higher than that in non-IBS group(P<0.05).There was no significant difference in gallbladder stone prevalence rate between IBS-C group and non-IBS group(P>0.05).Conclusions There is a correlation between IBS and gallbladder stones.In addition,among the two subtypes of IBS,IBS-D patients may have an increased risk of gallbladder stone compared with non-IBS patients.
7.A comparative study with real-world data of different surgery for lung malignancies in the context of DRG payment
Yuanlin WU ; Yao LIU ; Lanlan GAN ; Guiyuan XIANG ; Chen LI ; Shigeng CHEN ; Qiuwan XIAN
Chongqing Medicine 2024;53(11):1645-1649
Objective To compare the safety,effectiveness and affordability of robotic-assisted thoracic surgery and video-assisted thoracic surgery in the treatment of malignant pulmonary tumors,and provide ref-erences for the management of selection of different surgical strategies for malignant pulmonary tumors in hospitals and medical insurance departments.Methods The medical records homepages and information sys-tem data of patients with malignant pulmonary tumors who underwent major thoracic surgery in this hospital and discharged from January 1 to December 31,2022 were obtained.The patients were divided into the robotic-assistedthoracic surgery group and video-assisted thoracic surgery group according to the surgical methodolo-gies.After performing propensity score matching (PSM),no statistically significant difference was observed in baseline data between the two groups (117 cases in each group).Then the indicators of safety,effectiveness and affordability were compared between the two groups.Results Concerning the safety,the postoperative in-cision infection rate in the robotic-assisted thoracic surgery group was significantly lower than that in the vide-o-assisted thoracic surgery group (P<0.05),and the amount of intraoperative blood loss and postoperative complication rate were not significantly different between the two groups (P>0.05).Regarding the effective-ness,the average surgical duration in the robotic-assisted thoracic surgery group was appreciably shorter than that in the video-assisted thoracic surgery group (P<0.05),no patient in the two groups was converted to open thoracotomy,and there was no statistically significant difference in the average length of hospital stay and postoperative hospital stay between the two groups (P>0.05).With regard to the affordability,the aver-age inpatient expenditure per case and average daily inpatient expenditure per case in the robotic-assisted tho-racic surgery group were significantly higher than those in the video-assisted thoracic surgery group (P<0.05),and there were disparities in the cost structure between the two procedures.The medical cost,adminis-tration cost and consumables cost in the robotic-assisted thoracic surgery group were significantly higher than those in the video-assisted thoracic surgery group (P<0.05).The cost of medical technology in the robotic-assisted thoracic surgery group was significantly lower than that in the video-assisted thoracic surgery group (P<0.05).Conclusion Physicians should comprehensively consider the clinical efficacy and cost burden of patients when selecting the robotic-assisted thoracic surgery or the video-assisted thoracic surgery,and the monitoring and evaluation of the utilization of clinical robotic-assisted thoracic surgery should be strength-ened.
8.Status quo of pain catastrophizing in patients with diabetic peripheral neuropathic pain and influencing factors analysis
Ziqiang LI ; Guifen FU ; Yanping ZHANG ; Xiang LI ; Xin ZHANG ; Lin ZENG ; Qiuping ZHENG ; Xiaomin XIAN ; Miao WANG
Chongqing Medicine 2024;53(22):3389-3395,3400
Objective To investigate the status quo of pain catastrophizing(PC)in the patients with di-abetic peripheral neuropathic pain(DPNP),and to analyze the influencing factors to provide reference for for-mulating clinical preventive intervention strategies.Methods A total of 206 patients with DPNP admitted and treated in the People's Hospital of Guangxi Zhuang Autonomous Region were selected as the research sub-jects by convenience sampling method.The general data questionnaire,Numerical Rating Scale(NRS),Pain Catastrophizing scale(PCS),Perceived Social Support Scale(PSSS)and diabetes distress scale(DDS)were used to conduct the investigation.Results The incidence rate of PC in 206 cases of DPNP patients was 44.66%(92/206),and the total score of PCS was(30.10±5.16)points.The results of multiple linear regres-sion analysis showed that the gender,duration of diabetes(≥10 years),multiple drug use,number of compli-cations(>5),NRS score,PSSS score and scores of DDS dimensions were the main influencing factors of PC(all P<0.05),which could explain 92.3%of the total variation of PC.Conclusion The PC incidence rate in the patients with DPNP is high.Clinical healthcare workers should pay attention to the evaluation of PC in these patients,and formulate the scientific and effective targeted intervention measures according to the main influen-cing factors to help the patients to reduce the pain burden in order to reduce the level of PC.
9.Expert Consensus on Standard Terminology for Hair Transplantation (2024 Edition)
Yong MIAO ; Wei WU ; Zhenyu GONG ; Wenjie JIANG ; Yufei LI ; Zhiqi HU ; Hua XIAN ; Xiang XIE ; Weiqi YANG ; Dongyi ZHANG ; Jufang ZHANG ; Jiaxian ZHANG ; Chunhua ZHANG ; HAIR TRANSPLANTATION EXPERT GROUP OF PLASTIC AND AESTHETIC NATIONAL MEDICAL QUALITY CONTROL CENTER
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1301-1310
In order to promote the development of hair transplantation, particularly the establishment of standards, the Hair Transplantation Expert Group of Plastic and Aesthetic National Medical Quality Control Center invited experts in the field of hair transplantation across China and formed a draft of the
10.Expert Consensus on Standard Terminology for Hair Transplantation (2024 Edition)
Yong MIAO ; Wei WU ; Zhenyu GONG ; Wenjie JIANG ; Yufei LI ; Zhiqi HU ; Hua XIAN ; Xiang XIE ; Weiqi YANG ; Dongyi ZHANG ; Jufang ZHANG ; Jiaxian ZHANG ; Chunhua ZHANG
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1301-1310
In order to promote the development of hair transplantation, particularly the establishment of standards, the Hair Transplantation Expert Group of Plastic and Aesthetic National Medical Quality Control Center invited experts in the field of hair transplantation across China and formed a draft of the

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