RESUMEN
AIM:To perform a multidimensional analysis of the clinical study characteristics of endo-metriosis based on the ClinicalTrials.gov,providing comprehensive and objective information for re-searchers,clinicians,and clinical pharmacists.METHODS:A thorough investigation was conduct-ed on clinical trials related to endometriosis,regis-tered on the ClinicalTrials.gov from its inception to October 20,2023.Relevant trial data were extract-ed and statistically analyzed using bibliometrics and comparative research methods.RESULTS:A to-tal of 667 endometriosis clinical studies were regis-tered globally,showing an annual increase.The United States(127 trials),France(70 trials),and Ita-ly(57 trials)had the highest number of registered trials.Interventional studies were predominant(416 trials,62.4%),followed by observational stud-ies(251 trials,37.6%).Within interventional stud-ies,drug therapy was the primary intervention(223 trials,53.6%).Despite endometriosis being a female condition,male subjects were also consid-ered,with 6 trials specifically requiring male partici-pants and 37 trials not restricting gender.Compa-nies/corporations were the main funding sources,while public and governmental organizations pro-vided relatively less funding.CONCLUSION:Clinical trial research on endometriosis is in a phase of growth,with drug therapy being the main treat-ment approach.However,there is a relative lack of investment and attention from public funds and governmental organizations.
RESUMEN
AIM:To evaluate the clinical effective-ness and safety of generic and branded dienogest in the treatment of endometriosis.so as to provide the basis for clinical use of dienogest.MEHTODS:The data of patients admitted to Third Affiliated Hospital of Zhengzhou University from August 2022 to August 2023 who received dienogest(2 mg/d,orally,for 6 months)for treatment of endometrio-sis were collected.The clinical efficacy and adverse reactions of generic drugs and original drugs in the treatment of endometriosis-related pain were com-pared through follow-up surveys of the two groups of patients at 3 months and 6 months respectively.RESULTS:There was highly significant reduction in pelvic pain in both groups with mean of similar in generic group(34.0±3.0)mm and branded group(34.5±3.9)mm.The most frequent drug-related ad-verse effects in generic dienogest was vaginal bleeding(93%)which was no statistical difference with branded dienogest(90%).CONCLUSION:The generic and branded dienogest have the same clini-cal effectiveness and similar safety.