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.

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.

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.

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.

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.

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.

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.

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.

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.

Objective:To construct a machine-learning model for predicting the progression of pancreatic cystic lesions (PCLs) based on clinical and CT features, and to evaluate its predictive performance in internal/external testing cohorts.Methods:Baseline clinical and radiological data of 200 PCLs in 177 patients undergoing abdominal thin slice enhanced CT examination at Peking Union Medical College Hospital from July 2014 to December 2022 were retrospectively collected. PCLs were divided into progressive and non-progressive groups according to whether the signs indicated for surgery by the guidelines of the European study group on PCLs were present during three-year follow-up. 200 PCLs were randomly divided into training (150 PCLs) and internal testing cohorts (50 PCLs) at the ratio of 1∶3. 15 PCLs in 14 patients at Jinling Affiliated Hospital of Medical School of Nanjing University from October 2011 to May 2020 were enrolled as external testing cohort. The clinical and CT radiological features were recorded. Multiple feature selection methods and machine-learning models were implemented and combined to identify the optimal machine-learning model based on the 10-fold cross-validation method. Receiver operating characteristics (ROC) curve was drawn and area under curve (AUC) was calculated. The model with the highest AUC was determined as the optimal model. The optimal model's predictive performance was evaluated on testing cohort by calculating AUC, sensitivity, specificity and accuracy. Permutation importance was used to assess the importance of optimal model features. Calibration curves of the optimal model were established to evaluate the model's clinical applicability by Hosmer-Lemeshow test.Results:In training and internal testing cohorts, the progressive and non-progressive groups were significantly different on history of pancreatitis, lesions size, main pancreatic duct diameter and dilation, thick cyst wall, presence of septation and thick septation (all P value <0.05) In internal testing cohort, the two groups were significantly different on gender, lesion calcification and pancreatic atrophy (all P value <0.05). In external testing cohort, the two groups were significantly different on lesions size and pancreatic duct dilation (both P<0.05). The support vector machine (SVM) model based on five features selected by F test (lesion size, thick cyst wall, history of pancreatitis, main pancreatic duct diameter and dilation) achieved the highest AUC of 0.899 during cross-validation. SVM model for predicting the progression of PCLs demonstrated an AUC of 0.909, sensitivity of 82.4%, specificity of 72.7%, and accuracy of 76.0% in the internal testing cohort, and 0.944, 100%, 77.8%, and 86.7% in the external testing cohort. Calibration curved showed that the predicted probability by the model was comparable to the real progression of PCLs. Hosmer-Lemeshow goodness-of-fit test affirmed the model's consistency with actual PCLs progression in testing cohorts. Conclusions:The SVM model based on clinical and CT features can help doctors predict the PCLs progression within three-year follow-up, thus achieving efficient patient management and rational allocation of medical resource.