1.Practice innovation in pharmaceutical management for infusion safety in hospitalized patients
Jie CHEN ; Man YOU ; Pengfei CAO ; Wenfeng TAI ; Lu MENG ; Hong ZHANG ; Guanghong HE
China Pharmacy 2025;36(10):1238-1242
OBJECTIVE To establish a pharmaceutical management model for infusion safety in hospitalized inpatients and ensure the safety of drug use. METHODS Our hospital established the standardized management process for infusion scheme, formulated rules for compatibility contraindications in drug combinations. In the form of embedded hospital official account, the infusion scheme and medication guidance WeChat developed by pharmacists are pushed to the mobile phone of inpatients, providing electronic medication guidance services for patients, and forming a pharmaceutical management model for infusion safety of inpatients. RESULTS Our hospital provided a total of 45 291 inpatients with pharmaceutical services including the formulation of individualized infusion scheme and WeChat push infusion scheme and medication guidance as of December 2023. After the implementation of the management model, the intervention rate of pharmacists on the compatibility contraindications in drug combination of long-term medical orders for inpatients increased from 18.25% before implementation to 90.58% (P<0.01), and the satisfaction rate of inpatients increased from 87.50% to 94.50% (P<0.05). CONCLUSIONS The pharmaceutical management model for infusion safety of hospitalized patients integrates pharmaceutical services throughout the entire process of intravenous medication treatment. Pharmacists can participate in the management of infusion usage while providing qualified finished infusion products, achieving closed-loop management of pharmaceutical services, improving the hospital’s pharmaceutical service capabilities and patient satisfaction, and providing guarantees for the safety and effectiveness of patient medication.
2.Textual analysis of China’s traditional Chinese medicine emergency management policy based on three-dimensional analysis framework
Guowei XIAN ; Hang ZHAO ; Yunna GONG ; Wenfeng HE ; Xiaolin ZHANG ; Chunxiao MA ; Jing ZHANG ; Yong MA
China Pharmacy 2024;35(9):1039-1043
OBJECTIVE To analyze the traditional Chinese medicine (TCM) emergency management policy texts in China, reveal the characteristics, problems and improvement directions of Chinese medicine emergency management policies in China, and provide references and lessons for improving the level of Chinese medicine emergency management. METHODS Twenty-four TCM emergency management policy texts issued at the central level from 2016 to 2023 were coded and analyzed using Nvivo11 software to construct a three-dimensional analysis framework based on policy tools, stakeholders and policy strength. RESULTS In the policy tools dimension, the environmental type was the most (46.74%), the supply type was the second (31.80%), and the demand type was the least (21.46%); in the stakeholder dimension, there were more healthcare institutions (40.63%) and government departments (31.25%), and fewer healthcare workers (14.84%) and residents (13.28%); in the policy strength dimension, the overall policy strength was poor, and the differences in effectiveness across policy instruments and stakeholders were more significant. The cross-cutting results showed that there was a certain degree of mismatch in policy instruments, stakeholders and policy strength. CONCLUSIONS The use of supply-oriented policy tools is slightly lacking, and the use of policy tools should be optimized in a coordinated manner; the distribution of stakeholders is relatively unbalanced, and synergies among stakeholders should be enhanced; the overall strength of policies is poor, and the top-level design of relevant policies should be improved.
3.Real-world Study of the Safety and Efficacy of Pembrolizumab in the Treatment of Advanced Non-small Cell Lung Cancer
WAN NING ; WANG BING ; GUO YA ; HE ZIJIAN ; YANG CHEN ; YANG NING ; LU LIQING ; LIANG HONGYI ; XIAO WEIBIN ; YANG DANDAN ; CHEN ZHUOJIA ; FANG WENFENG ; LIANG WEITING
Chinese Journal of Lung Cancer 2024;27(10):745-754
Background and objective Pembrolizumab(PEM)has been shown to be effective in clinical trials for the treatment of advanced non-small cell lung cancer(NSCLC),but clinical trials were based on cohorts of patients selected on specific criteria,and whether the findings are consistent with real-world patients is debatable.The aim of this study is to evaluate the efficacy and safety of PEM in the treatment of advanced NSCLC based on real-world data.Methods A retro-spective collection of real-world data from patients with advanced NSCLC receiving PEM was conducted.Propensity score matching was used to eliminate inter-group differences and assess the efficacy and safety of PEM compared to chemotherapy.Results Among 450 matched patients,the incidence rates of any-grade adverse events were 79.87%in the PEM group and86.71%inthe chemotherapy group,while the incidence rates of grade>3 adverse events were 4.03%and 7.31%,respectively.The objective response rates were 48.63%for PEM and 36.00%for chemotherapy(P=0.011).The median progression-free survival was 15.5 months for PEM and 8.8 months for chemotherapy(P<0.001),and the median overall survival was not reached for PEM and 26.2 months for chemotherapy(P<0.001).Conclusion PEM treatment for advanced NSCLC demonstrates favorable survival outcomes and acceptable safety in real-world clinical practice.
4.Study on IL-18 level in patients with anti-melanoma differentiation-associated gene 5 antibodies positive dermatomyositis
Tongjun MAO ; Qian HE ; Lanlan JIA ; Xinyue ZHAO ; Yuqi XIN ; Wenfeng TAN
Chinese Journal of Rheumatology 2024;28(6):367-373
Objective:To explore the role of interleukin-18 (IL-18) in the pathogenesis of dermatomyositis (DM) associated with positive anti-melanoma differentiation-associated gene 5 antibodies(MDA5-DM).Methods:Twenty-eight cases of MDA5-DM in the department of rheumatology and immunology, the first hospital of Nanjing medical university and the first affiliated hospital od Wannan medical colledge from August 2018 to December 2011 were included in this study, comprising 15 cases with combined rapidly progressive interstitial pneumonia (RPILD) and 13 cases without RPILD (nonRPILD). Additionally, 28 cases of antisynthetase syndrome (ASS) and 28 healthy volunteers (HC) were included for comparison. Clinical, laboratory, and imaging data were collected for both the DM and ASS groups. Serum IL-18 levels were measured using ELISA. Independent t test, Mann-whitney U test, χ2 test and Fisher′s exact probability method were used for analysis. Results:Significant differences were observed in LDH, hydroxybutyrate dehydrogenase (HBDH), ESR, CRP, serum ferritin (SFE), and IL-18 levels between the MDA5-DM group, the ASS group and the HC group ( F=46.65, 43.19, 31.28, 23.94, 30.94, 49.44, all P<0.001). Additionally, lymphocyte counts and hemoglobin levels differed significantly among the three groups( F=35.26, P<0.001; F=18.59, P<0.001). MDA5-DM patients exhibited higher incidences of Gottron′s sign, helitrope rash, periungual erythema, skin ulcers, and RPILD compared to ASS patients ( χ2=20.96, P<0.001; χ2=5.85, P=0.016; χ2=13.69, P<0.001; χ2=9.16, P=0.002; χ2=4.79, P=0.029). However, the incidence of mechanic′s hand was lower in MDA5-DM patients ( χ2=3.90, P=0.048). The level of IL-18 significantly decreased in MDA5-DM after treatment[(104.28(71.96,151.10)pg/ml vs. 78.30(56.20, 94.80)pg/ml, =2.27, P=0.023)]. Similar reductions were observed in the ASS group[(72.30(61.39, 95.94)pg/ml vs. 45.30(29.00,84.10)pg/ml, Z=2.691, P=0.007]. The IL-18 level changes in the MDA5-DM combined with RPILD group were not statistically significant [99.49 (77.65, 130.87)pg/ml vs. 89.40(54.80, 120.20)pg/ml, Z=0.65, P=0.515]. In the MDA5-DM survival group, IL-18 levels decreased significantly after treatment [59.45(53.58, 81.63)pg/ml vs. 106.37(83.62, 152.07)pg/ml, Z=2.80, P=0.005], while the changes in the IL-18 levels of patients in the MDA5-DM death group were not statistically significant [99.49(56.70, 140.15)pg/ml vs. 94.80(71.40, 155.45)pg/ml, Z=1.75, P=0.080]. Conclusion:MDA5-DM patients are different from the ASS patients in clinical manifestations and indicators involved in laboratory tests. The expression level of IL-18 tends to increase during the active phase of MDA5-DM and ASS, and decrease with remission of the disease. MDA5-DM may play an important role in the pathogenesis, and persistent high level of IL-18 is responsible for RPILD and death of MDA5-DM. Sustained high level of IL-18 can be used as a potential biomarker for the estimating development of MDA5-DM into RPILD.
5.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone
6.Clinical characteristics of acute lobar nephronia in renal allograft.
Yuchen WANG ; Yu HE ; Yanna LIU ; Ziyan YAN ; Wenli ZENG ; Wenfeng DENG ; Yiling FANG ; Genxia WEI ; Jian XU ; Yun MIAO
Chinese Medical Journal 2022;135(7):863-865
7.Application value of three risk assessment models of venous thromboembolism in hospitalized stroke patients
Yueping ZHENG ; Meiling HU ; Liqian WANG ; Ailan HE ; Hongying TANG ; Wenfeng CHEN
Journal of Chinese Physician 2022;24(1):44-48
Objective:To compare the value of Caprini, Padua and Autar risk assessment models in the risk assessment of venous thromboembolism in hospitalized stroke patients.Methods:A retrospective case-control study were used to collect hospitalized stroke patients in the neurology department of Xiangya Hospital from January 1, 2018 to June 30, 2020. 75 patients with venous thromboembolism (VTE) were VTE group and 75 patients without VTE were control group. The risk of thrombosis was assessed by Caprini risk assessment model, Padua risk assessment model and Autar risk assessment model respectively. The predictive value of each model on the risk of VTE formation in stroke patients was analyzed by receiver operating characteristic (ROC) curve and area under the curve (AUC).Results:The areas under the curve of Caprini, Padua and Autar risk assessment models for predicting the risk of VTE formation in stroke patients were 0.768±0.039, 0.746±0.040 and 0.710±0.042 respectively. The sensitivity, specificity and accuracy were 81.3%, 61.3%, 71.3%(Caprini), 72.0%, 72.0%, 72.0%(Padua), 66.7%, 68.0% and 67.3%(Autar) respectively. There was no significant difference in the prediction value of the three models on the formation risk of stroke VTE (all P>0.05). The technique for order preference by similarity to ideal solution (TOPSIS) method was used to comprehensively evaluate the AUC, sensitivity, specificity and accuracy of the three risk assessment models. Padua risk assessment model was the best, followed by Caprini risk assessment model and Autar risk assessment model. Conclusions:The Caprini, Padua, and Autar risk assessment scales can well predict the risk of VTE in stroke patients. The Caprini scale has the highest sensitivity and the Padua scale has the highest specificity. There is no significant difference in the predictive value of the three scales. Comprehensive evaluation of predictive value: Padua risk assessment scale is the best.
8.Clinical evidence-based guideline for the diagnosis and treatment of anterior cruciate ligament injury (2022 version)
Lunhao BAI ; Jiwu CHEN ; Jian CHEN ; Dongyang CHEN ; Xuesong DAI ; Zhenpeng GUAN ; Shengwei HE ; Jia JIANG ; Qing JIANG ; Hai LAN ; Ting LI ; Ning LIU ; Wei LU ; Yi QIAO ; Luning SUN ; Weiguo WANG ; Weiming WANG ; Bin XU ; Honggang XU ; Yongsheng XU ; Wenfeng XIAO ; Liang YANG ; Hongbo YOU ; Jiakuo YU ; Tengbo YU ; Xintao ZHANG ; Hui ZHANG ; Song ZHAO ; Weihong ZHU ; Jinzhong ZHAO
Chinese Journal of Trauma 2022;38(6):492-503
The anterior cruciate ligament (ACL) injury is a common sports injury that has a significant impact on knee function and patients′ mobility. With the popularity of national fitness campaign in China, the incidence of ACL injury is increasing year by year. Currently, there still lacks clinical standards or guidelines on how to choose appropriate treatment methods, surgical plans and rehabilitation protocols for ACL injury. In order to timely reflect the new treatment concept of ACL injury, standardize its diagnosis and treatment and improve the curative effect, the Sports Medicine Society of Chinese Research Hospital Association and the Editorial Board of Chinese Journal of Trauma organized domestic orthopedic and sports medicine experts to formulate the "clinical evidence-based guideline for the diagnosis and treatment of anterior cruciate ligament injury (2022 version)" based on the level of evidence-based medicine and in compliance with the principle of scientificity, practicability and advancement. The present guideline includes 12 recommendations for the diagnosis, treatment and rehabilitation of ACL injury in order to provide guidance and assistance for the clinical diagnosis and treatment of ACL injury in China.
9.Application of two-photon imaging technology in the repair evaluation of radiation-induced skin injury in rats
Gaiying HE ; Wenfeng GOU ; Yi WANG ; Wenbin HOU ; Jinghui TANG ; Shuhua MA ; Yanan SUN ; Weifeng YANG ; Qiang FANG ; Yiliang LI
Chinese Journal of Radiological Medicine and Protection 2021;41(12):926-930
Objective:To evaluate the skin development and repair process of X-ray radiation damage in rat with non-invasive two-photon excitation fluorescence (TPEF) imaging technology in vivo. Methods:Totally 24 SD rats were randomly divided into four groups including X-ray irradiated group (25, 35 and 45 Gy) and non-irradiation control group. At different times after irradiation, the degree of skin injury was evaluated, and the pathological changes of nicotinamide adenine dinucleotide (phosphate) [NAD(P)H] and collagen fiber fluorescence signals in epidermal cells were detected in vivo by TPEF imaging technology. Results:At 10 d post-irradiation, the skin of irradiation groups showed erythema and desquamation. At 15-20 d post-irradiation, the skin of radiation groups developed progressive exudation, edema and ulcers with increasing radiation dose. On day 25, the skin began to repair in the 25 Gy group, however, the skin of other groups still had exudation and ulcers. On day 10, NAD(P)H fluorescence signal in epidermal cells of irradiation groups decreased and the fluorescence signal of collagen fibers in papillary layer and reticular layer of irradiation groups reduced, which were significantly lower than that of normal control group ( t=24.145, 28.303, 26.989, 6.654, 7.510, 7.997, P<0.05). On day 30, fluorescence signal of NAD(P)H and collagen fibers in epidermal cells and dermis began to repair, the cell from stratum granulosum, stratum spinosum, and stratum basale in the 25 Gy group showed fluorescence signal, the other groups did not show. The fluorescence signal of collagen fibers in the 25 Gy group were gradually increased in papillary layer and reticular layer, however, they were significantly lower than normal control group ( t=115.133, 17.431, P<0.05), the skin of 45 Gy group did not show fluorescence signal of collagen fibers. Conclusions:The damage and repair process of epidermal cells and dermal collagen fiber can be detected noninvasively by TPEF imaging technology after X-ray irradiation in vivo.
10.Analysis on the investigation results of plague natural foci in Yulong County of Yunnan Province in 2017
Zhengxiang LIU ; Wenfeng CAI ; Zongti SHAO ; Ying GUO ; Jianwen ZHANG ; Wei HE ; Wenqing YANG ; Qiongguang HE
Chinese Journal of Endemiology 2021;40(12):983-989
Objective:To investigate and determine the epidemic scope of plague natural foci in Yulong County of Yunnan Province, and to assess its epidemic risk, so as to providing basis for monitoring, prevention and control of plague.Methods:In 2017, 2 - 3 natural villages were selected from 8 villages and towns in Yulong County according to geographical landscape, altitude, population and area. During October and November, small mammal hosts and their parasitic fleas were captured by the night trap (cage) method, Yersinia pestis was isolated from host animal organs, and plague F1 antigen and antibody were detected by colloidal gold test. Plague specific antigen was detected by reverse indirect hemagglutination test (RIHA) in self-dead small mammals. Animal serum from dogs, cats and mice were collected for detection of plague F1 antibody by indirect hemagglutination test (IHA). Results:A total of 1 019 host animals including self-dead small mammals were collected, belonging to 22 species, 12 genera, 6 families, 4 orders. Among them, 1 016 small mammals were captured by tools and 996 were outdoors, with the capture rate of 25.28% (996/3 940). The dominant species of small mammals outdoors were Apodemus chevrieri, Rattus (R.) rattus, Eothenomys miletus and Crocidura attenuate, which accounted for 30.32% (302/996), 22.09% (220/996), 17.37% (173/996) and 12.35% (123/996). The common species were Niviventer confucianus, R.nitidus and R.norvegicus, which accounted for 8.13% (81/996), 4.02% (40/996) and 1.81% (18/996). A total of 20 small mammals of 9 species were captured indoors in the residential area, and the capture rate was 1.11% (20/ 1 800). The dominant species were R.norvegicus, R.nitidus and Mus musculus, which accounted for 30.00% (6/20), 25.00% (5/20) and 10.00% (2/20). Eighteen small mammals of 8 species were infected with 67 parasitic fleas, belonging to 5 species, 5 genera, 3 families. The total flea infection rate was 1.77% (18/1 019) and the total flea index was 0.070. Among them, 49 parasitic fleas from 4 small mammals of 3 species were collected indoors. The flea infection rate was 19.05% (4/21) and the flea index was 2.333. Leptopsylla segnis had the highest flea infection rate of 9.52% (2/21) and flea index of 0.571. Ctenocephalides felis had the highest flea index of 1.571 and flea infection rate of 4.76% (1/21). They were the main flea species on the body surface of small mammals in residential areas. There were 14 small mammals infected with parasitic fleas outdoors, and 18 fleas in 5 species were collected with flea infection rate of 1.40% (14/998) and flea index of 0.018. Among them, Leptopsylla segnis had the highest flea infection rate was 0.50% (5/998) and the flea index was 0.005. The flea infection rate of Neopsylla specialis specialis was 0.40% (4/998), and the flea index was 0.004. Ctenophthalmus quadratus had the highest flea index of 0.007, and the flea infection rate ranked the third with 0.30% (3/998). The flea infection rate and flea index of Frontopsylla spadix spadix were the lowest, which were 0.20% (2/998) and 0.002, respectively. Ctenophthalmus quadratus, Leptopsylla segnis and Neopsylla specialis specialis were the dominant parasitic fleas on the surface of outdoor small mammals. A total of 419 indicator animal sera were collected, including 402 dog sera. One of them was positive by IHA, with a positive rate of 0.25% (1/402). Seventeen serum samples were collected from cats and mice, and IHA test results were negative. Yersinia pestis was isolated and cultured from the organs of small mammals and the detection of Yersinia pestis by colloidal gold test was negative. RIHA test of self-dead small mammals was negative. Conclusion:A plague indicator animal positive spot is newly found in the plague natural foci in Yulong County, and the plague epidemic monitoring, prevention and control in this region should be strengthened.

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