The effect of "Buserelin" on the female body
The effect of “Buserelin” for uterine fibroids depends on the type of myomatous nodes and the individual characteristics of the patient’s body. It is worth noting that reviews of taking this drug are not always positive, since it causes a number of side effects. At the same time, it is worth noting that when using Buserelin in the form of a nasal spray. Negative manifestations were practically not noticed. Numerous studies show that after therapy with Buserelin, many women develop early menopause. The drug has found wide use in the postoperative period to eliminate the risk of fibroid recurrence.
Results and discussion
List of efficiency parameters
The protocol provided for the following performance criteria:
1. Studies of hormone levels in the blood:
— decrease in LH level to 7.4±7.3 mIU/ml;
— decrease in FSH level to 7.0±5.6 mIU/ml;
- decrease in estradiol level <110 pmol/l.
2. Instrumental research:
- transvaginal ultrasound examination of the uterus and appendages - reducing the thickness of the median uterine echo to 4-6 mm. Changes in the pathological structures of the myometrium with varying degrees of adenomyosis during treatment;
- aspiration biopsy of the endometrium - changes in pathological structures in the endometrium or endometrial atrophy.
3. Assessment of health using the “Patient Questionnaire” - assessment of complaints, general condition, emotional state, physical condition, menopausal symptoms.
Dynamics of LH levels
. At the screening visit, as well as at visits 2–5, patients' blood was tested to determine LH levels (Fig. 1).
Rice.
1. Dynamics of LH levels during the use of the drug “Buserelin-long FS”. Achieving the target LH level <7.4±7.3 mIU/ml was achieved in 100% of patients by visit 2 after starting therapy with Buserelin-long FS.
By visit 5, there was a decrease in LH levels in all patients by an average of more than 6 times compared to the visit during the screening period.
Thus, 50 (100%) of 50 patients met the effectiveness criterion “Decrease in LH levels to 7.4±7.3 mIU/ml.”
Dynamics of FSH levels
. At the screening visit, as well as at visits 2–5, patients' blood was tested to determine FSH levels.
When analyzing the level of FSH during therapy with the drug "Buserelin-long FS" (Fig. 2), a statistically significant decrease in the level of this hormone was revealed at visits 2, 3, 4 and 5.
Rice. 2. Dynamics of FSH levels during the use of the drug “Buserelin-long FS”.
Thus, the patient population ( n
=50) generally satisfied the criterion “Decrease in FSH level to 7.0±5.6 mIU/ml”: the average FSH level in patients at visit 5 was 4.54±2.5 mIU/ml. A decrease in FSH levels by visit 5 was observed in 33 (66%) of 50 patients. Since, based on the literature, therapy with GnRH analogues does not always lead to a decrease in FSH levels in patients with endometriosis, other parameters of effectiveness should be taken into account when presenting a conclusion about the effectiveness of the drug.
Dynamics of estradiol levels
. At the screening visit, as well as at visits 2–5, patients' blood was tested to determine estradiol levels.
Already by visit 2, a statistically significant decrease in estradiol levels was registered, which persisted throughout the entire course of therapy (Fig. 3).
Rice. 3. Dynamics of estradiol levels during the use of the drug “Buserelin-long FS”.
Of the 50 patients, 32 (64%) achieved target estradiol levels of ≤110 pmol/L. In a study by U. Cirkel et al. [12] the level of estradiol in patients with endometriosis treated with buserelin decreased to an average of 164±32 pmol/l after 3 months of treatment, and in a study by W. Dmowski et al. [13] - up to 132±18 pmol/l, which is slightly higher than the 110 pmol/l value chosen as the end point in this study.
In 4 patients, a significant increase in estradiol levels was detected by visit 5, with a significant decrease in its levels by visits 3-4. In 1 patient, there was no significant increase/decrease in estradiol levels by visit 5, with a significant decrease in its level by visits 3-4. The reason could be a deviation in the date of visit 5 or the so-called “rebound effect,” when a short-term significant increase in the concentration of sex hormones is observed shortly after stopping the use of GnRH agonists.
Thus, 32 (64%) of 50 patients met the effectiveness criterion “Decrease in estradiol levels ≤110 pmol/l.” In general, for 45 (90%) patients out of 50, treatment with Buserelin-long FS was effective in terms of reducing estradiol levels, based on a significant decrease in estradiol levels relative to the initial level.
M-echo parameters
. At the visit during the screening period, as well as at visits 2–5, a transvaginal ultrasound examination of the uterus and appendages was performed to identify changes in the pathological structures of the myometrium in various degrees of endometriosis during treatment.
During treatment with Buserelin-long FS, a statistically significant decrease in endometrial thickness was observed already by visit 2 (Fig. 4).
Rice. 4. Changes in endometrial thickness during therapy with Buserelin-long FS.
Thus, 49 (98%) of 50 patients met the effectiveness criterion “Reducing the thickness of the median uterine echo to 4-6 mm.”
Results of endometrial aspiration biopsy
. To identify changes in the endometrium or endometrial atrophy during treatment with Buserelin-long FS, an endometrial biopsy was performed in patients during the screening visit and at visit 5. Based on the results of aspiration biopsy, in 33 out of 50 patients at visit 5, it can be concluded that in the majority of patients - 29 (88%) out of 33 - endometrial atrophy or a decrease in the degree of endometrial hyperplasia was observed at visit 5 in relation to the visit during the screening period.
Patient survey data.
At each visit, including the screening visit, patients completed a questionnaire. The questionnaire consisted of several questions, some of which made it possible to assess changes in the subjective perception of pain symptoms, in the physical and emotional state of the patients’ own health (“1. How would you rate the state of your health?”, “2. How would you rate the state of your health now compared to 4 weeks ago?", "3.1. To what extent does your health condition limit you from performing strenuous physical activities (lifting and carrying heavy objects, running, climbing several flights of stairs, walking several kilometers)? ", "3.2. To what extent does your health condition limit you from performing moderate physical activity (climbing one flight of stairs, walking several hundred meters, vacuuming or mopping the floor yourself)?", "3.3. To what extent does your health condition limits you from performing light physical activities (walking 100 m, dusting, getting dressed)?”, “4. How would you rate your physical condition now compared to 4 weeks ago?”, “5. How would you rate your emotional state compared to what it was 4 weeks ago?”, “6. How much physical pain have you experienced over the past 4 weeks?"). Patients could choose only one answer to each question.
Contraindications:
- Allergic reaction to buserelin acetate or additional substances;
- Pregnancy and lactation;
- Kidney failure;
- Depression;
- Diabetes mellitus along with two or more complications.
