1.Formulation and Analysis of Clinical Pharmacist Teacher Training Standard
Ping LIN ; Jiancun ZHEN ; Wei ZHANG ; Zhuo WANG ; Yangui XU ; Pinfang HUANG ; Xin HUANG ; Qingchun ZHAO ; Ying ZHOU ; Jin LU ; Jing LIU ; Li YOU
Herald of Medicine 2025;44(3):404-407
Clinical pharmacist teacher training is an important mean to improve the quality of clinical pharmacy talent cultivation and ensure the service ability and level of the clinical pharmacist team.The Pharmacy Administration and Pharmacy Practice in Healthcare Institutions-Part 4-8-2:Pharmacy Administration-Pharmacy Training Management-Clinical Pharmacist Teacher Training was based on the newly revised management document for clinical pharmacist teacher training of the Chinese Hospital Association.After sorting out relevant materials,such as standards,policies and regulations,technical specifications,liter-ature,documents of the Chinese Hospital Association,expert opinions,and the current situation of clinical pharmacist teacher training in China,the standard was formulated.In the standard,12 key elements,which can be divided into 3 parts of base manage-ment,training process and assessment,quality management and evaluation improvement,were standardized.This article aimed to introduce the construction method and content of the standard,to facilitate the understanding of the standard content for medical institutions which joined or willing to join the clinical pharmacist teacher training base,and to provide a reference for other medi-cal institutions to carry out related work.
2.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
4.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
5.Formulation and Analysis of Clinical Pharmacist Teacher Training Standard
Ping LIN ; Jiancun ZHEN ; Wei ZHANG ; Zhuo WANG ; Yangui XU ; Pinfang HUANG ; Xin HUANG ; Qingchun ZHAO ; Ying ZHOU ; Jin LU ; Jing LIU ; Li YOU
Herald of Medicine 2025;44(3):404-407
Clinical pharmacist teacher training is an important mean to improve the quality of clinical pharmacy talent cultivation and ensure the service ability and level of the clinical pharmacist team.The Pharmacy Administration and Pharmacy Practice in Healthcare Institutions-Part 4-8-2:Pharmacy Administration-Pharmacy Training Management-Clinical Pharmacist Teacher Training was based on the newly revised management document for clinical pharmacist teacher training of the Chinese Hospital Association.After sorting out relevant materials,such as standards,policies and regulations,technical specifications,liter-ature,documents of the Chinese Hospital Association,expert opinions,and the current situation of clinical pharmacist teacher training in China,the standard was formulated.In the standard,12 key elements,which can be divided into 3 parts of base manage-ment,training process and assessment,quality management and evaluation improvement,were standardized.This article aimed to introduce the construction method and content of the standard,to facilitate the understanding of the standard content for medical institutions which joined or willing to join the clinical pharmacist teacher training base,and to provide a reference for other medi-cal institutions to carry out related work.
6.Diagnostic value of CT plain scan for isolated superior mesenteric artery dissection
Shun QIU ; Yueqi HUANG ; Guanghua LUO ; Qiulin HUANG ; Qingchun LI
Journal of Practical Radiology 2024;40(6):922-925,930
Objective To investigate the diagnostic value of CT plain scanning for isolated superior mesenteric artery dissection(ISMAD).Methods This study retrospectively investigated CT plain images of the superior mesenteric artery(SMA)in 45 patients with ISM AD and 45 patients without ISMAD.The imaging manifestations of ISMAD were analyzed,and the sensitivity and specificity of these manifestations were analyzed using receiver operating characteristic(ROC)curve.Results There were statistically significant differences in both the trunk diameter and standardized trunk diameter of the SMA between the two groups(P<0.001,P=0.001).Additionally,the area under the curve(AUC)for the SMA trunk diameter in diagnosing ISMAD was determined to be 0.988,with a statistically significant P-value of less than 0.001.Furthermore,when the diameter of the SMA trunk reached 8.20 mm,the diagnostic sensitivity was 97.8%and the specificity was 93.3%.The AUC for the standardized diameter of the SMA trunk was determined to be 0.976.Additionally,when the standardized diameter of the SMA trunk reached 70.33%,the diagnostic sensitivity was 95.6%and the specificity was 82.2%.There was no statistically significant difference observed in the luminal CT value and standardized CT value of the SMA between the two groups(P>0.05).Additionally,the presence of the"crescent sign"and peritubular fat blurring in the SMA demonstrated some level of diagnostic significance.Conclusion CT scanning has the capability to identify the enlarged diameter of the SMA trunk,as well as plain the"crescent sign"and related manifestations.This finding holds significant value in diagnosing ISMAD.Furthermore,it provides the basis for the necessity of subsequent computed tomography angiography(CTA)examinations.
7.Study on the effects of total resistance core strength training on the therapy of nonspecific low back pain in flying personnel
Qiqi YANG ; Qingchun ZHU ; Yanjie ZHAO ; Baozhen HUANG ; Yinong LIAO
Chinese Journal of Aerospace Medicine 2023;34(2):97-101
Objective:To investigate the effect of core strength training based on total resistance exercise (TRX) for the flying personnel with nonspecific low back pain (NLBP).Methods:Flying personnel with NLBP who recuperated in Air Force Healthcare Center for Special Services Hangzhou from October of 2019 to June of 2021 were selected. They were divided into test group and control group by simple random sampling. The test group received 4 weeks of TRX core strength training, and the control group received 4 weeks of traditional core strength training. The isokinetic muscle strength testing instrument was used to measure the muscle strength characteristics of lumbar and abdominal flexor and extensor muscle groups of the subjects. The differences in Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI) were compared between 2 groups before and after training.Results:A total of 40 subjects were included with 20 cases in the test group and 20 cases in the control group, all of them were helicopter flying personnel. After training, the scores of VAS in both groups were lower than those before training ( t=22.01, 17.15, both P<0.001), and the VAS score of the test group was lower than that of the control group, with a significant difference ( t=6.55, P<0.001). After training, the ODI scores of subjects in both groups were lower than those before training ( t=32.05, 27.45, both P<0.001), and the score of the test group was lower than that of the control group, with a significant difference ( t=4.85, P<0.001). After training, the relative peak moment of lumbar and abdominal flexor and extensor muscle groups of the test group were higher than those of control group, and the differences were significant ( t=2.65, 2.41, 2.04, 3.31, P=0.026, 0.037, 0.047, 0.005). Conclusions:TRX core strength training can significantly improve the muscle strength of the lumbar and abdominal flexor and extensor muscle groups of flying personnel with NLBP, which can be used as a training program to prevent NLBP for flying personnel.
8.Study on the effects of total resistance core strength training on the therapy of nonspecific low back pain in flying personnel
Qiqi YANG ; Qingchun ZHU ; Yanjie ZHAO ; Baozhen HUANG ; Yinong LIAO
Chinese Journal of Aerospace Medicine 2023;34(2):97-101
Objective:To investigate the effect of core strength training based on total resistance exercise (TRX) for the flying personnel with nonspecific low back pain (NLBP).Methods:Flying personnel with NLBP who recuperated in Air Force Healthcare Center for Special Services Hangzhou from October of 2019 to June of 2021 were selected. They were divided into test group and control group by simple random sampling. The test group received 4 weeks of TRX core strength training, and the control group received 4 weeks of traditional core strength training. The isokinetic muscle strength testing instrument was used to measure the muscle strength characteristics of lumbar and abdominal flexor and extensor muscle groups of the subjects. The differences in Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI) were compared between 2 groups before and after training.Results:A total of 40 subjects were included with 20 cases in the test group and 20 cases in the control group, all of them were helicopter flying personnel. After training, the scores of VAS in both groups were lower than those before training ( t=22.01, 17.15, both P<0.001), and the VAS score of the test group was lower than that of the control group, with a significant difference ( t=6.55, P<0.001). After training, the ODI scores of subjects in both groups were lower than those before training ( t=32.05, 27.45, both P<0.001), and the score of the test group was lower than that of the control group, with a significant difference ( t=4.85, P<0.001). After training, the relative peak moment of lumbar and abdominal flexor and extensor muscle groups of the test group were higher than those of control group, and the differences were significant ( t=2.65, 2.41, 2.04, 3.31, P=0.026, 0.037, 0.047, 0.005). Conclusions:TRX core strength training can significantly improve the muscle strength of the lumbar and abdominal flexor and extensor muscle groups of flying personnel with NLBP, which can be used as a training program to prevent NLBP for flying personnel.
9.A nomogram for predicting the risk of multidrug-resistant tuberculosis
Qinglin CHENG ; Gang ZHAO ; Li XIE ; Le WANG ; Min LU ; Qingchun LI ; Yifei WU ; Yinyan HUANG ; Qingjun JIA ; Zijian FANG
Chinese Journal of Infectious Diseases 2021;39(7):415-423
Objective:To construct a simple, precise and personalized comprehensive nomogram for prediction the risk of multidrug-resistant tuberculosis (MDR-TB) and to evaluate its prediction value among individuals with previous tuberculosis history (PTBH).Methods:A matched case-control study (1∶2 ratios) was performed in 1 881 patients with PTBH treated in 12 designated tuberculosis hospitals in Hangzhou City between January 1, 2005 and December 31, 2019, and there were 1 719 patients in training set, and 162 in validation set. A multivariable Cox regression analysis was used to evaluate independent predictors for the incident of MDR-TB in individuals with PTBH. A comprehensive nomogram was developed based on the multivariable Cox model. The accuracy of the prediction was assessed using concordance index (C-index), calibration curve and area under the receiver operator characteristic (ROC) curve.Results:The nomogram constructed based on the multivariable Cox regression model incorporated 10 independent predictors of the risk of MDR-TB. A history of direct contact (grade 1, 0-100.0 points) ranked on the top of all risk factors, followed by duration of positive sputum culture (grade 2, 0-84.5 points), unfavorable treatment outcome (grade 3, 0-52.0 points), human immunodeficiency virus infection (grade 4, 0-48.5 points), retreated tuberculosis history (grade 5, 0-40.0 points), non-standardized treatment regimens of retreated tuberculosis (grade 6, 0-32.5 points), duration of pulmonary cavities (grade 7, 0-31.0 points), passive mode of tuberculosis case finding (grade 8, 0-25.0 points), age<60 years (grade 9, 0-17.5 points), and standard frequencies of chest X-ray examination (grade 10, 0-14.0 points). The C-indexes of this nomogram for the training and validation sets were 0.833 (95% confidence interval ( CI) 0.807-0.859) and 0.871 (95% CI 0.773-0.969), respectively, indicating that the nomogram had good fitting effect. The calibration curves for the risk of incident MDR-TB showed an optimal agreement between nomogram prediction and actual observation in the training and validation sets, respectively.The areas under ROC curve of the 1-year, 5-year, and 10-year MDR-TB risk probability of the training set were 0.904, 0.921, and 0.908, respectively, and those of the validation set were 0.954, 0.970, and 0.919, respectively. Conclusion:Through this nomogram model, clinicians could precisely predict the risk of incident MDR-TB among individuals with PTBH in the clinical practice.
10.Interpretation of Implementation Plan for Enrollment and Assessment of Clinical Pharmacist Teacher Training Project of Chinese Hospital Association (Trial)
Li YOU ; Jing BIAN ; Yangui XU ; Zhuo WANG ; Qingchun ZHAO ; Xin HUANG ; Jing LIU ; Jin LU ; Jiancun ZHEN
China Pharmacy 2021;32(21):2561-2566
OBJECTIVE:To interpret the new version of the Implementation Plan for Enrollment and Assessment of Clinical Pharmacist Teacher Training Project of Chinese Hospital Association (Trial)(hereinafter referred to as the “New Plan ”)officially announced by the Chinese Hospital Association in Sept. 2021,in order to provide guidance and reference for smoothly promoting the implementation of the New Plan and realizing the original intention of the reform. METHODS :The New Plan was interpreted from four aspects ,including the background of the formulation of the New Plan ,the main features presented ,the innovations and the issues that need to be paid attention to in the next implementation. RESULTS & CONCLUSIONS :The formulation and release of the New Plan marks the beginning of a new round of reform of the clinical pharmacist teacher training program of the Chinese Hospital Association. It is mainly based on the actual problems encountered in the operation of the current clinical pharmacist teacher training system ,the importance of clinical pharmacistteacher training itself ,and the opportunities and challenges that the development of the times has brought to our country ’s 163.com clinical pharmacy business. Research foundation , problem orientation and professional demonstration present important characteristics. Compared with the old plan ,the New Plan adds a substantive selection mechanism for majors ,which intends to achieve the necessary “strictness”in the enrollment process ;it reconstructs the overall training goal of the benchmarking project and the three-in-one assessment system ,which intends to achieve a reasonable “lax”of assessment link ;it removes restrictions on off-site training ,advocates wide-ranging professional docking,and improves the flexibility of the training system and process management. The implementation of the New Plan is a complex work involving multiple parties and is affected by many factors. It requires multiple teams to perform their duties and promote together. The teacher training base and expert team must understand the spirit of reform and achieve the stable implementation of the New Plan ;at the same time ,the communication between the project working group and the teaching base and experts should be strengthened ,and finally realize the original intention of the reform of cultivating more high-quality clinical pharmacy teachers.

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