Efficacy of dienogest versus gonadotropin-releasing hormone agonist combined with dienogest sequential therapy in the treatment of adenomyosis / 中华妇产科杂志

Objective:To investigate the efficacy and safety of dienogest (DNG) alone and gonadotropin-releasing hormone agonist (GnRH-a) combined with DNG sequential treatment to adenomyosis.Methods:The clinical data of 110 patients with adenomyosis attending the First Affiliated Hospital of Nanjing Medical University from December 2019 to March 2022 were retrospectively analyzed, including 40 patients treated with DNG (2 mg/day) alone (DNG group) and 70 patients treated with sequential DNG (2 mg/day) after 3-6 injections of GnRH-a (GnRH-a+DNG group). The clinical data before and after treatment were compared between the two groups.Results:(1) The dysmenorrhea visual analogue scale (VAS) scores, cancer antigen 125 (CA 125) and cancer antigen 19-9 (CA 19-9) levels at different time periods after treatment were significantly lower than before treatment in both groups (median before treatment: DNG group 70.0 mm, 68.55 kU/L, 22.45 kU/L respectively, GnRH-a+DNG group 80.0 mm, 151.50 kU/L, 20.44 kU/L respectively; all P<0.001). (2) The hemoglobin (Hb) levels of patients in both groups at different time periods after treatment were significantly higher than those before treatment (median: DNG group 102.00 g/L, GnRH-a+DNG group 94.00 g/L; all P<0.001). (3) Treatment with DNG alone did not have a significant effect on uterine volume in patients of DNG group ( P>0.05), and uterine volume decreased significantly in the 15th-24th months of GnRH-a+DNG group compared with that before treatment (median: 167.76 vs 227.77 cm 3; P<0.05). (4) There were no significant differences in hepatic and renal function and coagulation indexes between the two groups before and after treatment (all P>0.05), and no significant abnormal lesions were observed in breast tissue during the follow-up period. (5) The incidence of amenorrhea of GnRH-a+DNG group was higher than that of DNG group, and the incidences of irregular spotting bleeding and breakthrough hemorrhage were lower than those in DNG group. Conclusions:Whether DNG is used alone or in combination with GnRH-a in sequence, it could significantly relieve dysmenorrhea symptoms, improve the level of Hb, reduce the levels of CA 125 and CA 19-9 in patients with adenomyosis, with no adverse effects on coagulation and hepatic or renal function. GnRH-a sequential DNG therapy is superior to DNG alone in improving uterine bleeding patterns and controlling the growth of uterine volume in patients with adenomyosis.

The efficacy of dienogest combined with traditional Chinese medicine in the treatment of endometriosis and its influence on pregnancy and recurrence / 中国医师进修杂志

Objective:To analyze the efficacy of dienogest combined with traditional Chinese medicine(TCM) in the treatment of endometriosis (EMs) and its influence on pregnancy and recurrence.Methods:A total of177 patients with EMs admitted to Affiliated Hospital of Shandong University of Chinese Medicine and Linyi Hospital of Traditional Chinese Medicine from December 2018 to June 2019 were divided into the observation group (88 cases) and the control group (89 cases) according to the random number table method. The control group was treated with dienogest 25 mg once a day, and the observation group was treated with dienogest combined with TCM decoction. They all were treated for 6 months. The clinical efficacy, pregnancy and recurrence of the two groups were compared, and EMs health profile-5 (EHP- 5) of the Chinese version was used to evaluate patients′ quality of life of the two groups.Results:The total effective rate in the observation group was higher than that in the control group: 92.04%(81/88) vs. 79.78%(71/89), and the difference was statistically significant ( χ2 = 5.492, P<0.05). The time of ovulation recovery and menstrual recovery in the observation group were shorter than those in the control group: (13.38 ± 3.60) d vs. (14.69 ± 3.15) d, (26.48 ± 4.23) d vs. (28.72 ± 3.40) d, and the differences were statistically significant ( P<0.05). There was no statistically significant difference in the 1-year pregnancy rate between the two groups ( P>0.05). The 1-year recurrence rate in the observation group was lower than in the control group: 1.14%(1/88) vs. 10.11%(9/89), and the difference was statistically significant ( P<0.05). The scores of pain, emotional state, sense of control, sexual life, doctor-patient relationship , infertility, and treatment effect in EHP-5 in the observation group after the treatment were lower than those in the control group, and the differences were statistically significant ( P<0.05). Conclusions:Compared with dienogest treatment alone, the combination of TCM treatment can further improve the efficacy. It is beneficial to pregnancy. It can reduce the recurrence rate, improve the quality of life more significantly, and has great safety.

Clinical experience of long-term use of dienogest after surgery for ovarian endometrioma

OBJECTIVE: Endometriosis is a common and recurring gynecologic disease which have afflicting females of reproductive age. We investigated the efficacy of long-term, post-operative use of dienogest for ovarian endometrioma. METHODS: We studied 203 patients who had undergone laparoscopic or robotic surgery for ovarian endometrioma, and were administrated dienogest 2 mg/day beginning in July of 2013, and continuing. We evaluated side effects of dienogest and ultrasonography was performed every 6 months to detect potential recurrence of endometrioma (2 cm) in these post-surgical patients. RESULTS: The follow-up observation periods were 30.2±20.9 months from surgery. The mean age was 34.1±7.2 years old. The mean diameter of pre-operative endometrioma was 5.6±3.0 cm2. One hundred eighty-two (89.7%) women received dienogest continuously for 12.0±7.1 months. Of the subjects, 21 (10.3%) patients discontinued dienogest at 2.4±1.0 months. The most common side effect when dienogest was discontinued was abnormal uterine bleeding. The occurrence rate of vaginal bleeding was 15.8%, a number which did not differ significantly in patients with/without post-operative gonadotropin releasing hormone agonist administration. The other side effects were gastrointestinal trouble including constipation, acne, headache, depression, hot flush, weight gain, and edema. However, no serious adverse events or side effects were documented and recurrent endometriomas were diagnosed in 3 patients (1.5%). CONCLUSION: The data indicates that dienogest was both tolerable and safe for long-term use as prophylaxis in an effort to obviate the recurrence of ovarian endometrioma post-operatively, as well as potential need for surgical re-intervention.

Efficacy and safety of dienogest in patients with endometriosis: A single-center observational study over 12 months / 대한생식의학회지

OBJECTIVE: To evaluate the efficacy and safety of dienogest treatment in patients who had received dienogest for 12 months or more to treat endometriosis. METHODS: We analyzed the clinical data of 188 women with endometriosis who had been treated with 2 mg of dienogest once a day for 12 months or more at a single institute. We evaluated changes in endometriosis-associated pain and endometrioma size, recurrence rate, and adverse events following dienogest administration. Bone mineral density (BMD) was measured in patients who were prescribed dienogest for more than 18 months. RESULTS: Pain was significantly reduced at 12 months after dienogest medication. In those treated with dienogest due to recurrent endometrioma, the size of the endometrioma was significantly decreased at the 12-month and 18-month follow-ups. We found only one case of sonographic recurrence during dienogest administration among those who were treated postoperatively to prevent recurrence (1 of 114, 0.9%). The most common adverse drug reaction was uterine bleeding (3.2%), and other adverse events were generally tolerable and associated with low discontinuation rates (5.2%). Among the 50 patients in whom BMD was measured, 10 patients (20%) had a Z-score below the expected range for age. CONCLUSION: The administration of dienogest for a year or more seems to be highly effective in preventing recurrence after surgery, reducing endometriosis-associated pain, and decreasing the size of recurrent endometrioma, with a favorable safety and tolerability profile. However, BMD should be checked in patients on long-term medication due to possible bone loss in some women.

Study of dienogest for dysmenorrhea and pelvic pain associated with endometriosis

OBJECTIVE: To evaluate the effect of orally administered dienogest (DNG) for dysmenorrhea and pelvic pain associated with endometriosis. METHODS: For this study we recruited 89 patients with dysmenorrhea and pelvic pain associated with endometriosis diagnosed by laparoscopy. All patients complained of persistent dysmenorrhea and pelvic pain despite surgical treatment 6 months previously. After 6 months of DNG treatment, we used a 0 to 3 point verbal rating scale to measure the severity of disability in daily life due to dysmenorrhea and pelvic pain, and the use of analgesics. Weight gain, serum lipid and liver enzyme tests were performed before treatment and after 6 months of DNG treatment. RESULTS: Total dysmenorrhea scores assessed by the verbal rating scale significantly decreased by the end of treatment (P<0.001). The mean (±standard deviation) pain score for dysmenorrhea before and after treatment were 1.42±1.1 and 0.1±0.3, respectively. The mean non-menstrual pelvic pain scores before and after treatment were 0.52±0.6 and 0.18±0.3, respectively, showing a significant difference (P<0.001). The use of analgesics significantly decreased by the end of the treatment (P<0.001). The associated adverse effects were weight gains (in 56 of 89 patients, 63%) and uterine bleeding (in 28 of 89 patients, 31.5%). The weight gain (before treatment, 57.9±9.7; after treatment, 61.1±12.6) was statistically significant (P<0.040). CONCLUSION: This study demonstrated that orally administered DNG could be used to effectively treat dysmenorrhea and pelvic pain associated with endometriosis although the side effects of weight gain and uterine bleeding should be considered.

Clinical Observation Laparoscopy Combined with Dienogest and TCM in the Treatment of Endometriosis / 中国药房

OBJECTIVE:To compare therapeutic efficacy and safety of laparoscopy combined with dienogest and laparoscopy combined with dienogest and TCM in the treatment of endometriosis. METHODS:126 endometriosis patients were selected and divid-ed into control group and observation group,with 63 cases in each group. Control group received combined with dienogest(25 mg/time,qd);observation group was additionally given TCM on the basis of control group. Therapeutic efficacy,recovery time of ovula-tion,menstrual recovery time and ADR were compared between 2 groups,and recurrence and pregnancy of them were followed up for 2 years. RESULTS:The total effective rate of observation group (93.65%) was significantly higher than that of control group (80.96%),with statistical significance (P<0.05). The menstrual recovery time and recovery time of ovulation in observation group were significantly shorter than control group,with statistical significance (P<0.05). The incidence of ADR in observation group (9.52%)was significantly lower than control group(26.98%),with statistical significance(P<0.05);the recurrence rate of observa-tion group (4.76%) was significantly lower than that of control group (17.46%),with statistical significance (P<0.05). In 2-year follow-up,there were 23 pregnancy patients in observation group,which was significantly higher than that of control group (9 cas-es),with statistical significance (P<0.05). CONCLUSIONS:Laparoscopy combined with dienogest and TCM in the treatment of endometriosis have better clinical effect,higher safety and lower recurrence rate. The patients are easily pregnant.

The effect of dienogest on apoptosis of the ectopic endometrial stroma cells and its mechanism / 重庆医学

Objective To explore the effect of dienogest on apoptosis of ectopic endometrial stroma cells and its mechanism . Methods We examine ectopic endometrial stroma cell proliferation induced by dienogest with MTT assay ,cell apoptosis by flow cytometry method and check NF‐κB ,Bcl‐2 and Bcl‐XL protein levels by Western Blot assay .Results MTT assay shows that inhibi‐tion cell proliferation induced by dienogest on ECSC is stronger than NSCS cells(P<0 .05) .Flow cytometry test shows apoptosis induced by dienogest on ECSC is stronger than NSCS cells(P<0 .05) .Western blot shows a significant reduction induced by dien‐ogest in ECSC cells of NF‐κB ,Bcl‐2 and Bcl‐XL protein levels .Conclusion Dienogest can effectively inhibit ectopic endometrial stroma cell proliferation and induce cell apoptosis by reducing expression of NF‐κB and attenuating levels of anti‐apoptotic factors such as Bcl‐2 and Bcl‐XL .

The efficacy of oestradiol valerate combined with dienogest for menorrhagia without organic pathology / 中国医师进修杂志

Objective To investigate the efficacy and safety of oestradiol valerate (E2V) combined with dienogest (DNG) for menorrhagia without organic pathology.Methods Sixty-two menorrhagia without organic pathology patients were randomized divided into observation group (31 cases ) and control group (31cases).E2V combined with DNG were given in observation group while control group with E2V only.Both of the treatment lasted for 3 cycles.The changes in menstrual blood loss was assessed by the pictorial blood loss assessment chart (PBAC).The time of control bleeding,stop bleeding,the level of hemoglobin and adverse reaction were compared.Results The time of control bleeding,stop bleeding in observation group were significantly lower than those in control group[ ( 16.5 ± 2.2) h vs.(23.4 ± 2.9) h,(23.3 ± 8.4) h vs.(40.9 ±4.6) h] (P＜0.01).The level of hemoglobin and PBAC scores between two groups had no significant difference before treatment (P＞0.05).After treatment for 3 cycles,the level of hemoglobin in observation group was higher than that in control group,but had no significant difference (P＞0.05 ),the PBAC scores in observation group was lower than that in control group after treatment for 1,2,3 cycles(P＜0.01 ).Both of the rate of adverse reaction in two groups was 12.9％ (4/31 ).No severe adverse reaction happened in two groups.Conclusions E2V combined with DNG is more rapid and effective in reducing menstrual blood loss.It does not increase the rate of adverse reaction and worthy of clinical application.