Background: Dienogest is a potential treatment for pelvic pain associated with endometriosis, a condition of significant concern in gynaecology. The current study was conducted as a crossover-randomized bioequivalence...Background: Dienogest is a potential treatment for pelvic pain associated with endometriosis, a condition of significant concern in gynaecology. The current study was conducted as a crossover-randomized bioequivalence assessment of two oral Dienogest 2 mg formulations, aiming to provide valuable insights for healthcare professionals and researchers in this field. Objective: The primary aim of this research was to evaluate and compare the pharmacokinetic characteristics of Dienogest 2 mg tablets. Dinogest (Dienogest 2 mg) tablets, manufactured by Nuvista Pharma Limited in Bangladesh, and Visanne (Dienogest 2 mg) tablets, manufactured by Bayer Pharma in Germany, were the test and reference formulations, respectively. Materials and Method: The study was an open-label, balanced, randomized, two treatments, two sequences, two periods, two-way crossover, laboratory blind, single oral dose bioequivalence study conducted in healthy adult females under fasting conditions. The study was carried out on 13 healthy, non-pregnant female subjects, and all the subjects completed both study periods with a 15-day washout in between. Randomization was used to assign the test and reference formulations to the subjects. Following each oral administration, a series of blood samples were obtained at different time intervals from pre-dose to 72 hours post-dose and analyzed for Dienogest concentrations using a validated bio-analytical method. A standard non-compartmental model was used to analyze the pharmacokinetic parameters. The primary pharmacokinetic parameters were peak plasma drug concentration (C<sub>max</sub>), the area under the plasma concentration-time curve from time zero to time t (AUC<sub>0–t</sub>), and AUC from t = 0 to infinity (AUC<sub>0–∞</sub>). The other PK parameters included time to reach C<sub>max</sub> (T<sub>max</sub>), terminal elimination rate constant (K<sub>el</sub>), and half-life (t<sub>1/2</sub>). Result: The ratios and 90% CI for the geometric mean test/reference were 95.53% (86.70% - 105.26%) for C<sub>max</sub>, 101.75% (95.42% - 108.49%) for AUC<sub>0</sub><sub>−</sub><sub>t</sub>, and 101.54% (95.59%% - 107.87%) for AUC<sub>0</sub><sub>−</sub><sub>∞</sub>. The formulations were bioequivalent since the 90% CIs for the geometric mean test/reference ratios were 80% to 125%, according to the predetermined range of US Food and Drug Administration (FDA) requirements. Conclusion: This single-dose investigation shows that the Dienogest test and reference formulations exhibited a rate and degree of absorption that met the regulatory requirements for bioequivalence.展开更多
BACKGROUND Currently,the use of dienogest in clinical practice has increased significantly,and many studies have focused on its effectiveness and safety in the treatment of endometriosis and adenomyosis;however,the ef...BACKGROUND Currently,the use of dienogest in clinical practice has increased significantly,and many studies have focused on its effectiveness and safety in the treatment of endometriosis and adenomyosis;however,the effects of treatment with dienogest on uterine fibroid size in patients with endometriosis or adenomyosis have not been investigated.AIM To explore changes in fibroid size in patients with concomitant uterine fibroids undergoing dienogest treatment for endometriosis or adenomyosis and to evaluate the effectiveness and safety of the drug.METHODS The clinical data of patients with uterine fibroids treated with dienogest for endometriosis or adenomyosis at Peking University First Hospital from January 2021 to January 2023 were retrospectively analyzed.RESULTS The maximum uterine fibroid diameter and volume increased after 3 months,6 months and 1 year of dienogest treatment compared with those before treatment(P<0.01).The maximum diameter and volume of the uterine adenomyoma increased after 3 months of dienogest treatment but decreased after 6 months and 1 year of treatment compared with those before treatment,but the difference was not significant(P>0.05).Endometrial thickness and antigen 125 levels were significantly thinner and decreased,respectively,after dienogest treatment(P<0.01).Pearson's correlation analysis revealed that the increase in uterine fibroid volume after 3 months of dienogest treatment was positively correlated with the basic uterine fibroid volume(r=0.792,P<0.01).Among 64 patients with dysmenorrhea,63 experienced significant relief of dysmenorrhea after 6 months of treatment with dienogest,and all patients experienced significant relief of dysmenorrhea after 12 months.Patients were able to tolerate the drugs,with an average drug tolerance score of 8.73.CONCLUSION The use of dienogest in patients with endometriosis or adenomyosis combined with uterine fibroids can effectively relieve the patient's pain symptoms and significantly reduce the sizes of ovarian endometriotic cysts,but it cannot inhibit uterine fibroid growth.展开更多
Objective:This paper aims to investigate the efficacy of desogestrel in the treatment of endometriosis.Methods:In this study,61 patients with endometriosis in our hospital from January 2023 to December 2023 were selec...Objective:This paper aims to investigate the efficacy of desogestrel in the treatment of endometriosis.Methods:In this study,61 patients with endometriosis in our hospital from January 2023 to December 2023 were selected and divided using the random sampling method.All the patients were treated with desogestrel and the pain symptom scores and HDL-C(high-density lipoprotein cholesterol)levels of the patients were compared before and after the treatment.The treatment effects and adverse effects during the administration of the drug were closely observed.Results:After the patients were treated with desogestrel,the effective rate of treatment was as high as 98.36%,and the incidence of adverse reactions during treatment was 6.55%.Compared with the pre-treatment period,the scores of various pain symptoms were significantly reduced and the HDL-C level was improved after treatment,with P<0.05.Conclusion:Desogestrel showed significant efficacy in the treatment of endometriosis,effectively relieving patients’pain while elevating HDL-C levels.In addition,the incidence of adverse reactions to this drug is relatively low,which is worth utilizing.展开更多
In this paper, Finite Difference Time Domain (FDTD) is utilized to simulate metamaterials of Double Negative (DNG) origin that refers to those materials having simultaneous negative permittivity and permeability. The ...In this paper, Finite Difference Time Domain (FDTD) is utilized to simulate metamaterials of Double Negative (DNG) origin that refers to those materials having simultaneous negative permittivity and permeability. The problem regarding space formulation is achieved by means of auxiliary differential equation method (ADE), which is easy, reliable and also causal process in nature thus making it proficient. It uses fair approximations to explicate the model. Mur’s boundary condition is used for 1-D problem space and convolution perfectly matched layer boundary is implemented for 2-D problem space. The properties of metamaterial conform their speculations of energy absorption, enhancement and backward propagation property with the aid of graphs engineered by Matlab simulation both in 1-D and 2-D. Also, the interaction of fields on DNG and Double Positive (DPS) layers is contrasted. The results achieved elucidate the validity and effectiveness of the ADE method and the Convolution Perfectly Match Layer (CPML) in designing DNG metamaterials.展开更多
BACKGROUND The quality of life of women with endometriosis is substantially adversely affected by the pelvic pain caused by this disease.However,the choice of medication for endometriosis remains controversial,and no ...BACKGROUND The quality of life of women with endometriosis is substantially adversely affected by the pelvic pain caused by this disease.However,the choice of medication for endometriosis remains controversial,and no drug has been clearly proven to be superior to others.AIM To assess the efficacy and safety of dienogest,a synthetic progestin,in the treatment of women with painful symptoms of endometriosis.METHODS PubMed,EMBASE,the Cochrane Library,and the Web of Science databases were searched from their inceptions to January 21,2020 for randomized controlled trials(RCTs)that compared dienogest with other popular prescription drugs for the treatment of endometriosis.Two reviewers extracted the data.Mean difference(MD)values and risk ratios(RRs)with 95%confidence intervals(CIs)were calculated.RESULTS Ultimately,seven RCTs with a total of 1493 participants met the requirements for this review.Dienogest was found to more effective than placebo in alleviating endometriosis-related pain(MD=-32.93,95%CI:-44.63 to-21.23),but led to a more significant decline in plasma estradiol concentrations than placebo(MD=-44.7,95%CI:-62.24 to-24.69).Dienogest was superior to gonadotropin-releasing hormone analogues(GnRH-a)in relieving pain(MD=-2.41,95%CI:-3.58 to-1.24).Moreover,compared with dienogest,GnRH-a were significantly more likely to lead to the loss of bone mineral density(MD=2.77,95%CI:0.16 to 5.37)and were significantly associated with a higher incidence of headaches(RR=0.68,95%CI:0.52 to 0.91)and hot flushes(RR=0.43,95%CI:0.18 to 1.02).CONCLUSION This meta-analysis demonstrated that dienogest may be a better pain-relief treatment for endometriosis patients,due to its high efficacy and tolerability.展开更多
文摘Background: Dienogest is a potential treatment for pelvic pain associated with endometriosis, a condition of significant concern in gynaecology. The current study was conducted as a crossover-randomized bioequivalence assessment of two oral Dienogest 2 mg formulations, aiming to provide valuable insights for healthcare professionals and researchers in this field. Objective: The primary aim of this research was to evaluate and compare the pharmacokinetic characteristics of Dienogest 2 mg tablets. Dinogest (Dienogest 2 mg) tablets, manufactured by Nuvista Pharma Limited in Bangladesh, and Visanne (Dienogest 2 mg) tablets, manufactured by Bayer Pharma in Germany, were the test and reference formulations, respectively. Materials and Method: The study was an open-label, balanced, randomized, two treatments, two sequences, two periods, two-way crossover, laboratory blind, single oral dose bioequivalence study conducted in healthy adult females under fasting conditions. The study was carried out on 13 healthy, non-pregnant female subjects, and all the subjects completed both study periods with a 15-day washout in between. Randomization was used to assign the test and reference formulations to the subjects. Following each oral administration, a series of blood samples were obtained at different time intervals from pre-dose to 72 hours post-dose and analyzed for Dienogest concentrations using a validated bio-analytical method. A standard non-compartmental model was used to analyze the pharmacokinetic parameters. The primary pharmacokinetic parameters were peak plasma drug concentration (C<sub>max</sub>), the area under the plasma concentration-time curve from time zero to time t (AUC<sub>0–t</sub>), and AUC from t = 0 to infinity (AUC<sub>0–∞</sub>). The other PK parameters included time to reach C<sub>max</sub> (T<sub>max</sub>), terminal elimination rate constant (K<sub>el</sub>), and half-life (t<sub>1/2</sub>). Result: The ratios and 90% CI for the geometric mean test/reference were 95.53% (86.70% - 105.26%) for C<sub>max</sub>, 101.75% (95.42% - 108.49%) for AUC<sub>0</sub><sub>−</sub><sub>t</sub>, and 101.54% (95.59%% - 107.87%) for AUC<sub>0</sub><sub>−</sub><sub>∞</sub>. The formulations were bioequivalent since the 90% CIs for the geometric mean test/reference ratios were 80% to 125%, according to the predetermined range of US Food and Drug Administration (FDA) requirements. Conclusion: This single-dose investigation shows that the Dienogest test and reference formulations exhibited a rate and degree of absorption that met the regulatory requirements for bioequivalence.
基金the National Key R&D Program of Reproductive Health and Women's and Children's Health Assurance Special Fund,No.2022YFC2704004.
文摘BACKGROUND Currently,the use of dienogest in clinical practice has increased significantly,and many studies have focused on its effectiveness and safety in the treatment of endometriosis and adenomyosis;however,the effects of treatment with dienogest on uterine fibroid size in patients with endometriosis or adenomyosis have not been investigated.AIM To explore changes in fibroid size in patients with concomitant uterine fibroids undergoing dienogest treatment for endometriosis or adenomyosis and to evaluate the effectiveness and safety of the drug.METHODS The clinical data of patients with uterine fibroids treated with dienogest for endometriosis or adenomyosis at Peking University First Hospital from January 2021 to January 2023 were retrospectively analyzed.RESULTS The maximum uterine fibroid diameter and volume increased after 3 months,6 months and 1 year of dienogest treatment compared with those before treatment(P<0.01).The maximum diameter and volume of the uterine adenomyoma increased after 3 months of dienogest treatment but decreased after 6 months and 1 year of treatment compared with those before treatment,but the difference was not significant(P>0.05).Endometrial thickness and antigen 125 levels were significantly thinner and decreased,respectively,after dienogest treatment(P<0.01).Pearson's correlation analysis revealed that the increase in uterine fibroid volume after 3 months of dienogest treatment was positively correlated with the basic uterine fibroid volume(r=0.792,P<0.01).Among 64 patients with dysmenorrhea,63 experienced significant relief of dysmenorrhea after 6 months of treatment with dienogest,and all patients experienced significant relief of dysmenorrhea after 12 months.Patients were able to tolerate the drugs,with an average drug tolerance score of 8.73.CONCLUSION The use of dienogest in patients with endometriosis or adenomyosis combined with uterine fibroids can effectively relieve the patient's pain symptoms and significantly reduce the sizes of ovarian endometriotic cysts,but it cannot inhibit uterine fibroid growth.
文摘Objective:This paper aims to investigate the efficacy of desogestrel in the treatment of endometriosis.Methods:In this study,61 patients with endometriosis in our hospital from January 2023 to December 2023 were selected and divided using the random sampling method.All the patients were treated with desogestrel and the pain symptom scores and HDL-C(high-density lipoprotein cholesterol)levels of the patients were compared before and after the treatment.The treatment effects and adverse effects during the administration of the drug were closely observed.Results:After the patients were treated with desogestrel,the effective rate of treatment was as high as 98.36%,and the incidence of adverse reactions during treatment was 6.55%.Compared with the pre-treatment period,the scores of various pain symptoms were significantly reduced and the HDL-C level was improved after treatment,with P<0.05.Conclusion:Desogestrel showed significant efficacy in the treatment of endometriosis,effectively relieving patients’pain while elevating HDL-C levels.In addition,the incidence of adverse reactions to this drug is relatively low,which is worth utilizing.
文摘In this paper, Finite Difference Time Domain (FDTD) is utilized to simulate metamaterials of Double Negative (DNG) origin that refers to those materials having simultaneous negative permittivity and permeability. The problem regarding space formulation is achieved by means of auxiliary differential equation method (ADE), which is easy, reliable and also causal process in nature thus making it proficient. It uses fair approximations to explicate the model. Mur’s boundary condition is used for 1-D problem space and convolution perfectly matched layer boundary is implemented for 2-D problem space. The properties of metamaterial conform their speculations of energy absorption, enhancement and backward propagation property with the aid of graphs engineered by Matlab simulation both in 1-D and 2-D. Also, the interaction of fields on DNG and Double Positive (DPS) layers is contrasted. The results achieved elucidate the validity and effectiveness of the ADE method and the Convolution Perfectly Match Layer (CPML) in designing DNG metamaterials.
基金the Science and Technology Department of Henan Province,No.132300410352.
文摘BACKGROUND The quality of life of women with endometriosis is substantially adversely affected by the pelvic pain caused by this disease.However,the choice of medication for endometriosis remains controversial,and no drug has been clearly proven to be superior to others.AIM To assess the efficacy and safety of dienogest,a synthetic progestin,in the treatment of women with painful symptoms of endometriosis.METHODS PubMed,EMBASE,the Cochrane Library,and the Web of Science databases were searched from their inceptions to January 21,2020 for randomized controlled trials(RCTs)that compared dienogest with other popular prescription drugs for the treatment of endometriosis.Two reviewers extracted the data.Mean difference(MD)values and risk ratios(RRs)with 95%confidence intervals(CIs)were calculated.RESULTS Ultimately,seven RCTs with a total of 1493 participants met the requirements for this review.Dienogest was found to more effective than placebo in alleviating endometriosis-related pain(MD=-32.93,95%CI:-44.63 to-21.23),but led to a more significant decline in plasma estradiol concentrations than placebo(MD=-44.7,95%CI:-62.24 to-24.69).Dienogest was superior to gonadotropin-releasing hormone analogues(GnRH-a)in relieving pain(MD=-2.41,95%CI:-3.58 to-1.24).Moreover,compared with dienogest,GnRH-a were significantly more likely to lead to the loss of bone mineral density(MD=2.77,95%CI:0.16 to 5.37)and were significantly associated with a higher incidence of headaches(RR=0.68,95%CI:0.52 to 0.91)and hot flushes(RR=0.43,95%CI:0.18 to 1.02).CONCLUSION This meta-analysis demonstrated that dienogest may be a better pain-relief treatment for endometriosis patients,due to its high efficacy and tolerability.
文摘目的:系统评价地诺孕素治疗子宫腺肌病的疗效及安全性,为临床用药提供循证依据。方法:计算机检索PubMed、EMbase、Cochrane Library、中国生物医学文献数据库、CNKI和万方数据库,检索时限均为建库至2023年7月30日,纳入地诺孕素(试验组)对比阳性药物或安慰剂(对照组)治疗子宫腺肌病的随机对照研究(RCT)。筛选文献、提取资料后采用Cochrane 5.1.0偏倚风险评估工具对纳入文献质量进行评价,采用Rev Man 5.3统计软件进行meta分析。结果:纳入10篇RCT研究,共820例患者。Meta分析结果显示,试验组较对照组VAS评分显著降低(SMD=-2.50,95%CI为-4.73~-0.27,P=0.03),对于子宫体积变化疗效相当(MD=0.24,95%CI为-0.87~1.36,P=0.67),试验组的临床有效率显著高于对照组(RR=1.30,95%CI为1.19~1.41,P<0.01),患者的CA125水平两者差异不大(MD=-4.25,95%CI为-13.16~4.66,P=0.35),两者的潮热副反应发生率(RR=0.72,95%CI为0.03~15.53,P=0.83)、异常子宫出血发生率(RR=2.11,95%CI为0.87~5.15,P=0.10)相当。结论:地诺孕素组的疼痛缓解较安慰剂组有明显优势,与阳性对照组相比,疗效差别不大;临床有效率显著高于阳性对照组,子宫体积变化、CA125水平与阳性对照组和安慰剂组疗效均相当;安全性方面,潮热副反应发生率与阳性对照组和安慰剂组均相当,异常子宫出血的发生率与阳性对照组相当,但显著高于安慰剂组,因此应用地诺孕素时要警惕子宫出血的风险。未来仍需大规模随机对照研究去验证。
