1.Practice pathway and effectiveness evaluation of GCP resident pharmacists in the management of dermatolo-gical drug clinical trials
Yunlong WANG ; Limin ZHOU ; Hua ZHANG ; Quanchao LI
China Pharmacy 2025;36(20):2507-2511
OBJECTIVE To explore the practice pathway and evaluate the effectiveness of the resident pharmacists stationed in the Drug Clinical Trial Institution Office (hereinafter referred to as the “GCP resident pharmacist”) in the management of dermatological drug clinical trials. METHODS The practical approach of GCP resident pharmacists participating in dermatological drug clinical trials at our hospital was introduced. A retrospective analysis was conducted on the data of dermatological drug clinical trials from 2021 to 2024, comparing efficiency and quality indicators between dermatological clinical trials and those of other specialties. RESULTS With the involvement of our hospital’s GCP resident pharmacists throughout, the process for dermatology drug clinical trials was constructed and optimized, a dedicated quality control system was established, and the acceleration strategy for subject enrollment was optimized. The number of dermatological drug clinical trials at our hospital showed a compound annual growth rate of 69.56% from 2021 to 2023. In terms of efficiency indicators, the approval waiting time for dermatological drug clinical trials was (12.31±4.99) days, which was significantly shorter than that of other specialties ([ 19.68±6.09) days, P<0.05]. Regarding quality indicators, the enrollment rate for dermatological drug clinical trials was 75.71%(50.00%,114.48%), which was significantly higher than that of other specialties [51.00%(25.00%,174.17%), P<0.05]. The numbers of first quality control issues ([ 8.31±3.25)items vs.( 11.68±4.49)items] and protocol deviations [5.5(2.0,11.0)times vs. 11.0(5.5,17.5)times] were significantly lower than those of other specialties (P<0.05). CONCLUSIONS GCP resident pharmacists significantly enhance the overall efficiency of dermatological drug clinical trials, playing a crucial role in ensuring the reliability and authenticity of drug clinical trials, as well as safeguarding the rights and safety of trial subjects.
2.Expression and clinical implications of Wnt-1 and FZD-1 in small cell lung cancer patients
Lixia LI ; Wenmei SU ; Yalian YUAN ; Min CHEN ; Quanchao LV ; Dong WU
The Journal of Practical Medicine 2017;33(7):1149-1152
Objective To investigate the expressions of Wnt-1 and FZD-1 in small cell lung cancer(SCLC) patients and their relations with chemotherapy resistance,clinical feature and prognosis.Methods Peripheral blood specimens were collected from 41 SCLC patients.The expression of Wnt-1 and FZD-1 in peripheral blood monouclear cells (PBMC) were detected.The relationship among the expression of Wnt-1 and FZD-1,clinicopathologic feature and prognosis was analyzed.Results The relative expression of Wnt-1 and FZD-1 in chemotherapy resistant group was significantly higher than that in chemotherapy sensitive group (all P < 0.05).The expression of Wnt-1was positively correlated with that of FZD-1 (r =0.186,P < 0.05).The FZD-1expression level was not correlated with patients' age,sex and smoking history (all P > 0.05),but closely with clinic-staging (P =0.008).The Wnt-1 expression level was not correlated with patients' clinical features (all P > 0.05).There was statistical difference in median survival time between Wnt-1 and FZD-1 high-expression group and low-expression group.Conclusions Wnt-1 and FZD-1relationships with chemotherapy resistance and prognosis.Wnt-1 and FZD-1 may act as an important role in chemotherapy resistance of SCLC and could be served as indicators for the chemotherapy resistance and outcome assessment of SCLC.
3.Relationships between high altitude de-adaptation syndrome and training burnout of plateau soldiers after returning to the plain
Kui DING ; Quanchao LI ; Yan WANG ; Xingzhen MENG ; Tian QIN
Military Medical Sciences 2016;40(8):661-664,694
Objective To explore the relationship between high altitude de-adaptation syndrome and training burnout of plateau-garrisoned soldiers after returning to the plain.Methods A total of 140 plateau-garrisoned soldiers who had returned to the plain were chosen by random cluster sampling and measured with the Training Burnout Test.They were divided into two groups according to the occurrence of acute mountain sickness.We compared the differences in training burnout between the two groups and analyzed the relationship between acute mountain sickness and training burnout. Results ①The incidence of high altitude de-adaptation syndrome of plateau-garrisoned soldiers was 80.00% after returning to the plain.There was statistically significant difference between plateau soldiers after returning to the plain,the plateau stability-keeping forces that returned to the plain (78.36%) (χ2 =0.188, P=0.664) and plateau migrants who returned to the plain (75.10%) (χ2 =1.279, P=0.258).Main symptoms of high altitude de-adaptation were fatigue (12.86%), dizziness (11.43%) and meakness (10.00%).②Compared with soldiers who had no high altitude de-adaptation syndrome, victims of de-adaptation syndrome had higher scores of training burnout, physical and psychological exhaustion and training-alienation (P<0.01).Compared with soldiers who had normal body mass indexes, those who were overweight had higher incidence of altitude de-adaptation (P<0.05).③The regression equation between plateau de-adaptation syndrome and training burnout of plateau soldiers after returning to the plain (P<0.01) is:Training burnout =0.498 ×plateau de-adaptation syndrome -0.126 ×age+0.038 ×length of military service +0.069 ×educational degree+0.029 ×body mass index.Conclusion There exist correlations between high altitude de-adaptation syndrome and training burnout of plateau soldiers after returning to the plain.Reducing the occurrence of high altitude de-adaptation syndrome can help reduce the degree of training burnout.
4.Optimization based on finite element technique of nitinol stent.
Feng LIN ; Xiangkun LIU ; Nannan HUANG ; Quanchao GAO ; Zhonghua LI ; Tianping YAO ; Qiyi LUO ; Jiahua HUANG
Chinese Journal of Medical Instrumentation 2014;38(2):98-101
The finite element method was used for simulating the mechanical performance and fatigue safety of three different structures of Nitinol stent. According to the actual situation, after proposing reasonable assumptions and simplification, the geometry model and finite element model establishment, material mode selection and boundary condition setting are completed. The strain and fatigue life of different stent edges wide (omega) or strut angle (theta) are computed. The result can provide a valuable reference for the optimal design of stent.
Alloys
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Finite Element Analysis
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Prosthesis Design
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Stents
5.Optimization Based on Finite Element Technique of Nitinol Stent
Feng LIN ; Xiangkun LIU ; Nannan HUANG ; Quanchao GAO ; Zhonghua LI ; Tianping YAO ; Qiyi LUO ; Jiahua HUANG
Chinese Journal of Medical Instrumentation 2014;(2):98-101
The finite element method was used for simulating the mechanical performance and fatigue safety of three different structures of Nitinol stent. According to the actual situation, after proposing reasonable assumptions and simplification, the geometry model and finite element model establishment, material mode selection and boundary condition setting are completed. The strain and fatigue life of different stent edges wide (ω) or strut angle (q) are computed. The result can provide a valuable reference for the optimal design of stent.

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