1.Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system
Min JIANG ; Li LIN ; Chenxi GAN ; Wenxiong SUN ; Qingsong XU ; Xiuli ZHAO
China Pharmacy 2025;36(3):275-279
OBJECTIVE To investigate and analyze the current management of drug clinical trial institutions in Jiangxi Province and the situation of undertaking drug clinical trials after the implementation of the filing system. METHODS A survey was conducted on 38 new institutions (obtained qualifications during the implementation of the filing system) and old institutions (obtained qualifications during the implementation of the recognition system) that had completed drug clinical trial institution qualification filing for more than one year in Jiangxi Province. The survey focused on the basic information of the institutions, the number of registered principal investigator (PI), institutional hardware and information construction, personnel allocation and training, and drug registration clinical trials undertaken by the institutions. RESULTS Of 38 institutions surveyed, there were 22 general hospitals and 16 specialized hospitals; there were 24 old institutions and 14 new institutions. Whether in general hospitals or specialized hospitals, the old institutions were better than the new institutions in the number of approved beds, the number of outpatients, the number of inpatients, the number of specialties, and the number of PI; both old and new institutions had separate offices; all new institutions were set up with GCP pharmacy. The adoption of clinical trial management system in new institutions is significantly less than in old institutions. In the general hospital, both the number of full-time managers and the number of quality controllers in old institutions were significantly more than in the new institutions, while the opposite was true at the level of specialized hospitals. In terms of centralized training on GCP, new institutions were all better than the old ones. Whether in general hospitals or specialized hospitals, the number of drug registration clinical trial projects undertaken by new institutions was significantly less than that of old ones. CONCLUSIONS The new institutions are worse than the old institutions in comprehensive strength and information construction of hospitals, and the number of clinical trials undertaken by new institutions is also less than old institutions.
2.Retrospective epidemiological analysis of fungal infection of a hospital from 2018 to 2024
Zhihao LIU ; Yali LIU ; Lina GUO ; Yao WANG ; Ying ZHAO ; Xiuli XIE ; Wenjing LIU ; Renyuan ZHU ; Hongli SUN ; Hongtao DOU ; Dingding LI ; Lingli LIU ; Shuying YU ; Menglan ZHOU ; Qiwen YANG ; Yingchun XU ; Li ZHANG
International Journal of Laboratory Medicine 2025;46(21):2588-2594
Objective To analyze the main epidemiological characteristics of fungal infection in this hospital in the past 7 years,and to provide reference for clinical treatment and prevention and control strategies of fun-gal infection.Methods The fungal data and clinical data of related patients isolated from clinical samples in Peking Union Medical College Hospital from early January 2018 to the end of May 2024 were selected,and the main epidemiological characteristics of fungal infection in this hospital were identified and described through multi-angle statistical analysis.Results A total of 4 479 patients with filamentous fungal infection were en-rolled.The proportion of male patients[57.5%(2 576/4 479)]was higher than that of female patients[42.5%(1 903/4 143)],mainly distributed in internal medicine,Intensive Care Unit(ICU)and emergency de-partment,among which internal medicine accounted for the highest proportion[50.0%(2 241/4 479)].About 90.0%of the specimens were from the lower respiratory tract,in addition to specimens from skin and soft tis-sue,tissue,ear and blood culture.In terms of seasonal distribution,there are more patients in winter.The fun-gi were mainly composed of Aspergillus,Mucor,Cerdosporium,Fusarium and Penicillium,among which As-pergillus was the most abundant,accounting for 74.6%of the total.Aspergillus fumigatus was the most a-bundant Aspergillus,accounting for 42.5%of the total Aspergillus(1 418/3 340).Among the related infec-tions caused by mold,Aspergillus was the most common in the lower respiratory tract,accounting for 76.8%.Among them,Aspergillus fumigatus accounted for the highest proportion(33.6%).98.6%of the molds infected the ear were Aspergillus,of which Aspergillus niger and Aspergillus terreus were the most common.Skin infections are mainly caused by Sporothrix schenckii,Trichophyton rubrum,Microsporum ca-nis.The results of in vitro drug sensitivity test showed that the four common Aspergillus isolated in this hos-pital were sensitive to voriconazole,and amphotericin B had better antifungal activity against Mucorales in vitro.Conclusion Based on the main epidemiological characteristics of fungal infections in this hospital,it is recommended that special attention be paid to the admission of patients in the respiratory department during the peak infection period in autumn and winter.In the treatment of fungal infections in different regions and on different body parts,attention should be paid to the differences in the distribution of bacterial species.
3.Preliminary exploration of the mechanism of action of Brassica rapa L. in treating pulmonary fibrosis based on network pharmacology and animal experiments
Mingyu Sun ; Guihua Liu ; Junting Guo ; Aibin Cheng ; Jing Xin ; Qingfang Miao ; Ruijuan Gao ; Xiuli Men
Acta Universitatis Medicinalis Anhui 2025;60(12):2227-2234
Objective:
To explore the active components, key targets, and mechanism of action of turnip in alleviating pulmonary fibrosis(PF) based on network pharmacology and animal experiments.
Methods:
The active components and targets of Brassica rapa L. were screened using the traditional Chinese medicine systems pharmacology database and analysis platform database, and PF-related targets were obtained from disease databases such as online mendelian inheritance of man(OMIM) and DrugBank. The intersection targets were used to construct a protein-protein interaction(PPI) network to identify core targets, followed by gene oncology(GO)/Kyoto encyclopedia of genes and genomes(KEGG) pathway enrichment analysis. In the animal experiments, a bleomycin-induced PF mouse model was established. Pathological changes in lung tissue were evaluated using HE and Masson staining. qRT-PCR was used to detect the mRNA expression of tumor necrosis factor-α(TNF-α), phosphatidylinositol 3-kinase(PI3K), and akstrain transforming 1(AKT1), and immunofluorescence staining was used to measure the protein expression of TNF-α, PI3K, and AKT1.
Results:
The 68 active components identified in Brassica rapa L. may regulate PI3K-Akt signaling pathway by acting on 89 potential targets such as TNF-α and AKT1. The results of animal experiments showed that polysaccharide of Brassica rapa L.(BRPs) could significantly reduce the degree of bleomycin induced pulmonary fibrosis in mice; HE and Masson staining of lung tissue showed that compared with the model group, the damage of alveolar structure, the infiltration of inflammatory cells and the deposition of collagen fibers in the BRPs treatment group were significantly reduced. Further mechanism studies showed that BRPs could significantly down-regulate the mRNA and protein expression levels of TNF-α, PI3K and AKT1 in lung tissue of pulmonary fibrosis mice.
Conclusion
Brassica rapa L. can synergistically alleviate pulmonary fibrosis through “multi-component, multi-target and multi-channel” approach; BRPs is one of the main active components, and plays an anti-fibrosis role by inhibiting TNF-α/PI3K Akt signaling pathway.
4.Research progress in experimental study on the intervention of Achyranthis Bidentatae Radix in osteoporosis
Xiuli WU ; Xiaoxia YAN ; Zhiqiang REN ; Nan SUN ; Jinju LI
International Journal of Traditional Chinese Medicine 2024;46(5):678-680,F4
The research literature on the mechanism of Achyranthis Bidentatae Radix and its main components in the treatment of osteoporosis was reviewed. It was found that Achyranthis Bidentatae Radix could promote the osteogenic differentiation of bone marrow mesenchymal stem cells, enhance the activity of osteoblasts, inhibit the activity of osteoclasts, regulate estrogen levels, and achieve the effects of preventing and treating osteoporosis. It mainly regulates Wnt/β-catenin, Notch, PI3K/Akt and other signaling pathways. The mechanism of Achyranthis Bidentatae Radix in the treatment of OP shows the characteristics of multi-component, multi-target and multi-pathway.
5.Efficacy and safety of dienogest on ovarian endometrioma
Jiafan SUN ; Xianglian WANG ; Wennian YU ; Siyi PAN ; Yan DING ; Huihua DAI ; Xiuli WANG
Chinese Journal of Obstetrics and Gynecology 2024;59(9):692-701
Objective:To observe the effects and safety of dienogest on the volume and symptoms of ovarian endometrioma (OMA).Methods:The clinical data of 75 patients with OMA who underwent treatment with dienogest (2 mg/day) at the First Affiliated Hospital of Nanjing Medical University from July 1st 2020 to March 31st 2024 were retrospectively analysed, mainly comparing the changes in the volume of OMA and the visual analogue scale (VAS) scores of endometriosis-related pain before and after the treatment, as well as observing the changes in the blood biological indicators, liver and kidney function, coagulation function and changes in breast.Results:The median cyst volumes of the OMA patients at 3, 6 and 12 months of dienogest treatment were 13.21 cm 3 (volume reduction rate: 36.00%), 8.33 cm 3 (volume reduction rate: 56.00%) and 4.10 cm 3 (volume reduction rate: 77.62%), respectively, which were all significantly decreased from the pre-treatment period (all P<0.05). The VAS scores of pain of the OMA patients at 3, 6 and 12 months of dienogest treatment all were 0 mm. Blood cancer antigen 125 (CA 125) and cancer antigen 19-9 (CA 19-9) levels decreased progressively during treatment (all P<0.05). There were no statistical differences in the coagulation indexes, liver and kidney function indexes of the patients during dienogest treatment compared with those before treatment (all P>0.05). During the follow-up period, there were a few patients with changes in the growth sites or lesion category of the breast nodules, but there were no occurrence of breast cancer or precancerous lesions. Conclusion:Dienogest is effective in reducing OMA volume and alleviating endometriosis-related pain with few adverse effects.
6.Meta-Analysis of the Efficacy and Safety of Dienogest Compared to Other Drugs in the Treatment of Nonsurgical and Postoperative Endometriosis
Qiqin WANG ; Liang YU ; Jiafan SUN ; Xianglian WANG ; Wennian YU ; Siyi PAN ; Xiuli WANG
Journal of Practical Obstetrics and Gynecology 2024;40(10):847-853
Objective:To compare the efficacy and safety of Dienogest(DNG)with other drugs in non-surgi-cal pharmacologic treatment and long-term management of drugs after conservative surgery for endometriosis(EMT).Methods:We searched PubMed,Embase,Medline,Google Scholar,Cochrane Library,China National Knowledge Infrastructure,Wanfang,and Weipu databases from the establishment of the database until December 31,2023 for relevant literature on EMT pharmacotherapy.Meta-analysis was performed using Stata 18.0 software to assess the efficacy of DNG,gonadotropin-releasing hormone agonist(GnRH-a),compound short-acting oral contraceptive(COC)and levonorgestrel intrauterine sustained-release system(LNG-IUS)in reducing the diameter of ovarian endometrioma(OMA),relieving pelvic pain and preventing EMT postoperative recurrence in EMT pa-tients after non-surgical drug treatment and conservative surgery,as well as the adverse reactions of drugs.Re-sults:①During non-surgical medication treatment of EMT,there was no statistically significant difference(P>0.05)between DNG and GnRH-a in reducing OMA diameter and relieving pelvic pain.Compared with COC,DNG was superior to COC in reducing the diameter of OMA(WMD 10.44 mm,P=0.017)and relieving pelvic pain(WMD 12.20 mm,P<0.001).②During long-term medication management after conservative EMT surger-y:there was no statistically significant difference(P>0.05)between DNG,GnRH-a,COC and LNG-IUS in re-ducing postoperative recurrence and controlling pelvic pain significant(P>0.05).③Adverse drug reactions:com-pared with GnRH-a,DNG had a reduced risk of bone loss(bone density WMD2.78 g/cm3,P=0.038),hot fla-shes(OR 0.07,P<0.001),and an increased risk of irregular vaginal bleeding(OR 19.10,P<0.001);com-pared with COC,the risk of weight gain,mood abnormalities,and breast tenderness,nausea and vomiting,and sleep disorders in DNG were reduced(OR<1,P<0.05);compared with LNG-IUS,the risk of abnormalities of mood in DNG was increased(OR 9.87,P=0.033).Conclusions:DNG treatment is more effective than COC in non-surgical drug therapy for EMT.When supplemental medication was given after conservative EMT surgery,DNG,like other drugs,can effectively prevent postoperative recurrence and control pelvic pain.The safety of DNG is superior to GnRH-a and COC,slightly inferior to LNG-IUS.
7.Meta-Analysis of the Efficacy and Safety of Dienogest Compared to Other Drugs in the Treatment of Nonsurgical and Postoperative Endometriosis
Qiqin WANG ; Liang YU ; Jiafan SUN ; Xianglian WANG ; Wennian YU ; Siyi PAN ; Xiuli WANG
Journal of Practical Obstetrics and Gynecology 2024;40(10):847-853
Objective:To compare the efficacy and safety of Dienogest(DNG)with other drugs in non-surgi-cal pharmacologic treatment and long-term management of drugs after conservative surgery for endometriosis(EMT).Methods:We searched PubMed,Embase,Medline,Google Scholar,Cochrane Library,China National Knowledge Infrastructure,Wanfang,and Weipu databases from the establishment of the database until December 31,2023 for relevant literature on EMT pharmacotherapy.Meta-analysis was performed using Stata 18.0 software to assess the efficacy of DNG,gonadotropin-releasing hormone agonist(GnRH-a),compound short-acting oral contraceptive(COC)and levonorgestrel intrauterine sustained-release system(LNG-IUS)in reducing the diameter of ovarian endometrioma(OMA),relieving pelvic pain and preventing EMT postoperative recurrence in EMT pa-tients after non-surgical drug treatment and conservative surgery,as well as the adverse reactions of drugs.Re-sults:①During non-surgical medication treatment of EMT,there was no statistically significant difference(P>0.05)between DNG and GnRH-a in reducing OMA diameter and relieving pelvic pain.Compared with COC,DNG was superior to COC in reducing the diameter of OMA(WMD 10.44 mm,P=0.017)and relieving pelvic pain(WMD 12.20 mm,P<0.001).②During long-term medication management after conservative EMT surger-y:there was no statistically significant difference(P>0.05)between DNG,GnRH-a,COC and LNG-IUS in re-ducing postoperative recurrence and controlling pelvic pain significant(P>0.05).③Adverse drug reactions:com-pared with GnRH-a,DNG had a reduced risk of bone loss(bone density WMD2.78 g/cm3,P=0.038),hot fla-shes(OR 0.07,P<0.001),and an increased risk of irregular vaginal bleeding(OR 19.10,P<0.001);com-pared with COC,the risk of weight gain,mood abnormalities,and breast tenderness,nausea and vomiting,and sleep disorders in DNG were reduced(OR<1,P<0.05);compared with LNG-IUS,the risk of abnormalities of mood in DNG was increased(OR 9.87,P=0.033).Conclusions:DNG treatment is more effective than COC in non-surgical drug therapy for EMT.When supplemental medication was given after conservative EMT surgery,DNG,like other drugs,can effectively prevent postoperative recurrence and control pelvic pain.The safety of DNG is superior to GnRH-a and COC,slightly inferior to LNG-IUS.
8.Meta-Analysis of the Efficacy and Safety of Dienogest Compared to Other Drugs in the Treatment of Nonsurgical and Postoperative Endometriosis
Qiqin WANG ; Liang YU ; Jiafan SUN ; Xianglian WANG ; Wennian YU ; Siyi PAN ; Xiuli WANG
Journal of Practical Obstetrics and Gynecology 2024;40(10):847-853
Objective:To compare the efficacy and safety of Dienogest(DNG)with other drugs in non-surgi-cal pharmacologic treatment and long-term management of drugs after conservative surgery for endometriosis(EMT).Methods:We searched PubMed,Embase,Medline,Google Scholar,Cochrane Library,China National Knowledge Infrastructure,Wanfang,and Weipu databases from the establishment of the database until December 31,2023 for relevant literature on EMT pharmacotherapy.Meta-analysis was performed using Stata 18.0 software to assess the efficacy of DNG,gonadotropin-releasing hormone agonist(GnRH-a),compound short-acting oral contraceptive(COC)and levonorgestrel intrauterine sustained-release system(LNG-IUS)in reducing the diameter of ovarian endometrioma(OMA),relieving pelvic pain and preventing EMT postoperative recurrence in EMT pa-tients after non-surgical drug treatment and conservative surgery,as well as the adverse reactions of drugs.Re-sults:①During non-surgical medication treatment of EMT,there was no statistically significant difference(P>0.05)between DNG and GnRH-a in reducing OMA diameter and relieving pelvic pain.Compared with COC,DNG was superior to COC in reducing the diameter of OMA(WMD 10.44 mm,P=0.017)and relieving pelvic pain(WMD 12.20 mm,P<0.001).②During long-term medication management after conservative EMT surger-y:there was no statistically significant difference(P>0.05)between DNG,GnRH-a,COC and LNG-IUS in re-ducing postoperative recurrence and controlling pelvic pain significant(P>0.05).③Adverse drug reactions:com-pared with GnRH-a,DNG had a reduced risk of bone loss(bone density WMD2.78 g/cm3,P=0.038),hot fla-shes(OR 0.07,P<0.001),and an increased risk of irregular vaginal bleeding(OR 19.10,P<0.001);com-pared with COC,the risk of weight gain,mood abnormalities,and breast tenderness,nausea and vomiting,and sleep disorders in DNG were reduced(OR<1,P<0.05);compared with LNG-IUS,the risk of abnormalities of mood in DNG was increased(OR 9.87,P=0.033).Conclusions:DNG treatment is more effective than COC in non-surgical drug therapy for EMT.When supplemental medication was given after conservative EMT surgery,DNG,like other drugs,can effectively prevent postoperative recurrence and control pelvic pain.The safety of DNG is superior to GnRH-a and COC,slightly inferior to LNG-IUS.
9.Meta-Analysis of the Efficacy and Safety of Dienogest Compared to Other Drugs in the Treatment of Nonsurgical and Postoperative Endometriosis
Qiqin WANG ; Liang YU ; Jiafan SUN ; Xianglian WANG ; Wennian YU ; Siyi PAN ; Xiuli WANG
Journal of Practical Obstetrics and Gynecology 2024;40(10):847-853
Objective:To compare the efficacy and safety of Dienogest(DNG)with other drugs in non-surgi-cal pharmacologic treatment and long-term management of drugs after conservative surgery for endometriosis(EMT).Methods:We searched PubMed,Embase,Medline,Google Scholar,Cochrane Library,China National Knowledge Infrastructure,Wanfang,and Weipu databases from the establishment of the database until December 31,2023 for relevant literature on EMT pharmacotherapy.Meta-analysis was performed using Stata 18.0 software to assess the efficacy of DNG,gonadotropin-releasing hormone agonist(GnRH-a),compound short-acting oral contraceptive(COC)and levonorgestrel intrauterine sustained-release system(LNG-IUS)in reducing the diameter of ovarian endometrioma(OMA),relieving pelvic pain and preventing EMT postoperative recurrence in EMT pa-tients after non-surgical drug treatment and conservative surgery,as well as the adverse reactions of drugs.Re-sults:①During non-surgical medication treatment of EMT,there was no statistically significant difference(P>0.05)between DNG and GnRH-a in reducing OMA diameter and relieving pelvic pain.Compared with COC,DNG was superior to COC in reducing the diameter of OMA(WMD 10.44 mm,P=0.017)and relieving pelvic pain(WMD 12.20 mm,P<0.001).②During long-term medication management after conservative EMT surger-y:there was no statistically significant difference(P>0.05)between DNG,GnRH-a,COC and LNG-IUS in re-ducing postoperative recurrence and controlling pelvic pain significant(P>0.05).③Adverse drug reactions:com-pared with GnRH-a,DNG had a reduced risk of bone loss(bone density WMD2.78 g/cm3,P=0.038),hot fla-shes(OR 0.07,P<0.001),and an increased risk of irregular vaginal bleeding(OR 19.10,P<0.001);com-pared with COC,the risk of weight gain,mood abnormalities,and breast tenderness,nausea and vomiting,and sleep disorders in DNG were reduced(OR<1,P<0.05);compared with LNG-IUS,the risk of abnormalities of mood in DNG was increased(OR 9.87,P=0.033).Conclusions:DNG treatment is more effective than COC in non-surgical drug therapy for EMT.When supplemental medication was given after conservative EMT surgery,DNG,like other drugs,can effectively prevent postoperative recurrence and control pelvic pain.The safety of DNG is superior to GnRH-a and COC,slightly inferior to LNG-IUS.
10.Meta-Analysis of the Efficacy and Safety of Dienogest Compared to Other Drugs in the Treatment of Nonsurgical and Postoperative Endometriosis
Qiqin WANG ; Liang YU ; Jiafan SUN ; Xianglian WANG ; Wennian YU ; Siyi PAN ; Xiuli WANG
Journal of Practical Obstetrics and Gynecology 2024;40(10):847-853
Objective:To compare the efficacy and safety of Dienogest(DNG)with other drugs in non-surgi-cal pharmacologic treatment and long-term management of drugs after conservative surgery for endometriosis(EMT).Methods:We searched PubMed,Embase,Medline,Google Scholar,Cochrane Library,China National Knowledge Infrastructure,Wanfang,and Weipu databases from the establishment of the database until December 31,2023 for relevant literature on EMT pharmacotherapy.Meta-analysis was performed using Stata 18.0 software to assess the efficacy of DNG,gonadotropin-releasing hormone agonist(GnRH-a),compound short-acting oral contraceptive(COC)and levonorgestrel intrauterine sustained-release system(LNG-IUS)in reducing the diameter of ovarian endometrioma(OMA),relieving pelvic pain and preventing EMT postoperative recurrence in EMT pa-tients after non-surgical drug treatment and conservative surgery,as well as the adverse reactions of drugs.Re-sults:①During non-surgical medication treatment of EMT,there was no statistically significant difference(P>0.05)between DNG and GnRH-a in reducing OMA diameter and relieving pelvic pain.Compared with COC,DNG was superior to COC in reducing the diameter of OMA(WMD 10.44 mm,P=0.017)and relieving pelvic pain(WMD 12.20 mm,P<0.001).②During long-term medication management after conservative EMT surger-y:there was no statistically significant difference(P>0.05)between DNG,GnRH-a,COC and LNG-IUS in re-ducing postoperative recurrence and controlling pelvic pain significant(P>0.05).③Adverse drug reactions:com-pared with GnRH-a,DNG had a reduced risk of bone loss(bone density WMD2.78 g/cm3,P=0.038),hot fla-shes(OR 0.07,P<0.001),and an increased risk of irregular vaginal bleeding(OR 19.10,P<0.001);com-pared with COC,the risk of weight gain,mood abnormalities,and breast tenderness,nausea and vomiting,and sleep disorders in DNG were reduced(OR<1,P<0.05);compared with LNG-IUS,the risk of abnormalities of mood in DNG was increased(OR 9.87,P=0.033).Conclusions:DNG treatment is more effective than COC in non-surgical drug therapy for EMT.When supplemental medication was given after conservative EMT surgery,DNG,like other drugs,can effectively prevent postoperative recurrence and control pelvic pain.The safety of DNG is superior to GnRH-a and COC,slightly inferior to LNG-IUS.


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