Análise de custo-utilidade da gosserrelina no tratamento de pacientes com leiomioma: uma perspectiva do Sistema Único de Saúde / Cost-utility analysis of goserelin in the treatment of patients with leiomyoma: a perspective from the Unified Health System

Objetivos: Gosserrelina é indicada para mulheres com leiomioma, por reduzir o risco associado às complicações clínicas. Este trabalho realizou uma análise de custo-utilidade comparando o uso e o não uso de gosserrelina em pacientes com leiomioma sob a perspectiva do Sistema Único de Saúde. Métodos: Um modelo de árvore de decisão foi estruturado para reproduzir o impacto clínico e econômico do uso de gosserrelina antes da miomectomia, cujo comparador seria o não uso de gosserrelina em pacientes elegíveis. Foram considerados: custos médicos diretos e eventos clínicos como complicações intra-hospitalares e tempo de internação. A razão de custo-utilidade incremental é representada pelo custo incremental da gosserrelina por anos de vida ajustado pela qualidade (QALY). Resultados: Em um cenário em que o acesso à gosserrelina é de 51% das pacientes, o custo incremental foi de R$ 629,08. Pacientes no grupo gosserrelina apresentaram um incremento de 0,0261 no QALY. A razão de custo-utilidade incremental foi de R$ 24.019,26 por QALY, ficando abaixo do limiar adotado pelo Ministério da Saúde. Ao variar o percentual de pacientes que recebem gosserrelina para 80% antes de um procedimento cirúrgico, houve um aumento de QALY para 0,5013, reduzindo custos de complicações e a razão de custo-utilidade incremental para R$ 10.581,07 por QALY. No cenário em que 100% das pacientes utilizam gosserrelina, há um aumento de QALY para 0,8290, reduzindo custos de complicações e a razão de custo-utilidade incremental para R$ 10.288,28 por QALY. Conclusão: O uso de gosserrelina possui custo-utilidade favorável, considerando os parâmetros utilizados nesta modelagem econômica. Quando o acesso à gosserrelina é maior, há um decremento expressivo no custo por QALY.

Objectives: Goserelin is indicated for women with leiomyoma to reduce the risk associated with clinical complications. This study conducted a cost-utility analysis comparing the use and non-use of goserelin in patients with leiomyoma from the perspective of the Brazilian Unified Health System. Methods: A decision tree model was structured to reproduce the clinical and economic impact of using goserelin before myomectomy, compared to not using it in eligible patients. Direct medical costs and clinical events such as in-hospital complications and length of stay were considered. The incremental cost-utility ratio is represented by the incremental cost of goserelin per quality-adjusted life year (QALY). Results: In a scenario where access to goserelin is 51% of patients, the incremental cost was R$ 629.08. Patients in the goserelin group showed an increase of 0.0261 in QALY. The incremental cost-utility ratio was R$ 24,019.26 per QALY, below the threshold adopted by the Ministry of Health. When the percentage of patients receiving goserelin was increased to 80% before surgery, there was an increase in QALY to 0.5013, reducing complication costs and the incremental cost-utility ratio to R$ 10,581.07 per QALY. In the scenario where 100% of patients use goserelin, QALY increased to 0.8290, reducing complication costs and the incremental cost-utility ratio to R$ 10,288.28 per QALY. Conclusions: The use of goserelin has a favorable cost utility, considering the parameters used in this economic modeling. When access to goserelin is higher, there is a significant decrease in the cost per QALY.

Background cardiovascular risk factors in patients of metastatic prostate cancer on androgen deprivation therapy: A retrospective observational study from a tertiary care hospital of Eastern India

Background: Androgen deprivation therapy (ADT) is indispensable part of treatment for metastatic prostate cancer (MPC) patients. There is documented association between ADT and adverse cardiovascular (CV) events, with variability between the different modes. However, there is dearth of evidence on the background CV risk factors of these group of patients at diagnosis. Aims and Objectives: We envisaged this retrospective observational study in the department of oncology to document the background CV risk factors of MPC patients at diagnosis, to help us better select the available ADTs based on their CV risks. Materials and Methods: Over a period of 2 years, all patients registered for treatment with a diagnosis of MPC, indicated for ADT, and available detailed history and background cardiological evaluation at presentation, were included in the study. As indirect indicators of CV risks, history of smoking, presence and treatment of dyslipidemia, and type 2 diabetes mellitus (T2DM), were documented. As direct indicators of CV risks, presence and treatment of hypertension, ischemic heart disease (IHD), congestive cardiac failure (CCF), ECG, and echocardiography changes suggesting cardiac morbidity were documented and the data were analyzed using descriptive statistical methods. Results: Indirect indicators: dyslipidemia, habit of smoking, and T2DM were found in 74%, 29.3%, and 13.3% patients, respectively. Direct indicators: Presence of hypertension, IHD, CCF, abnormalities in ECG, and echocardiography were found in 38.7%, 10.6%, 4%, 28%, and 34.6% patients, respectively. ST-T changes on ECG, low EF, and IHD on echocardiography were seen in 28.5%, 23%, and 26.9%, respectively. Conclusions: MPC patients have a substantial pre-existing CV risk at diagnosis. Our findings warrant a meticulous screening of all MPC patients for CV risk factors, to help in judicious selection of their ADT.

Clinical study of self-made Xingqi Jiedu Decoction combined with goserelin in the treatment of endometriosis / 国际中医中药杂志

Objective:To evaluate the curative effect of self-made Xingqi Jiedu Decoction combined with goserelin for endometriosis (EMT).Methods:Randomized controlled trial. A total of 84 patients with EMT in the hospital were enrolled as observation objects between July 2019 and July 2021. According to random number table method, they were divided into the control group (subcutaneous injection of goserelin) and the observation group (self-made Xingqi Jiedu Decoction on basis of control group), 42 in each group. All were treated for 6 months. TCM syndromes were scored before and after treatment. The severity of pelvic pain was evaluated by VAS. The levels of FSH, LH and estradiol (E 2) were detected by full-automatic chemiluminescence immunoassay and corresponding reagents, and levels of serum IL-1β, IL-8 and TNF-α were detected by ELISA. The adverse events were recorded, and clinical curative effect was evaluated. Results:The differences in total response rate between observation group and control group was statistically significant [95.24% (40/42) vs. 80.95% (34/42); χ2=4.09, P=0.043]. After treatment, scores of TCM syndromes and VAS in observation group were significantly lower than those in the control group ( t=14.30, 7.32, P<0.01). After treatment, FSH [(5.36±1.03) U/L vs. (6.20±1.35) U/L, t=3.21], E 2[(230.57±36.84) pmol/L vs. (265.28±37.53) pmol/L, t=4.28] and LH [(8.15±1.18) U/L vs. (9.24±2.01) U/L, t=3.03] in the observation group were significantly lower than those in the control group ( P<0.01). The levels of IL-1β, IL-8 and TNF-α in the observation group were significantly lower than those in the control group ( t=5.05, 5.07, 3.82, P<0.01). During treatment, differences in incidence of adverse reactions between observation group and control group was statistically significant [19.05% (8/42) vs. 4.76% (2/42); χ2=4.09, P=0.043]. Conclusion:The self-made Xingqi Jiedu Decoction combined with goserelin can improve hormone level, inhibit inflammatory response and improve clinical curative effect in EMT patients.

Opciones terapéuticas para una joven nulípara con mioma uterino intramural gigante / Therapeutic options for a nulliparous young woman with a giant intramural uterine myoma

RESUMEN Introducción: Los leiomiomas uterinos son los tumores ginecológicos benignos más comunes; son causa de anemia, infertilidad, alteración en la implantación embrionaria, pérdida gestacional recurrente, parto prematuro e incontinencia urinaria. Su transformación maligna es excepcional. La afectación a la fertilidad, se asocia con miomas entre el 3 % y el 31 % y depende de su ubicación y tamaño, sobre todo en los que distorsionan la cavidad uterina. Objetivo: Describir las opciones terapéuticas para una joven nulípara con un mioma uterino intramural gigante. Caso Clínico: Paciente de 30 años de edad, con antecedentes de mioma uterino intramural, de 5 años de evolución, además anemia ferripriva. Aqueja menstruaciones abundantes y dolorosas, incontinencia urinaria y constipación. El tratamiento fue escalonado, mediante el uso de acetato de goserelina, embolización selectiva de las arterias uterinas y posterior miomectomía. Conclusiones: El tratamiento del mioma uterino en la mujer joven, nulípara, depende del tamaño, localización, sintomatología asociada, edad de la paciente y deseo de engendrar descendencia.

ABSTRACT Introduction: Uterine leiomyomas are the most common benign gynecological tumors; they are a cause of anemia, infertility, altered embryo implantation, recurrent gestational loss, premature delivery and urinary incontinence. Their malignant transformation is exceptional. Fertility impairment is associated with myomas in between 3 % and 31 % and depends on their location and size, especially in those that distort the uterine cavity. Objective: To describe the therapeutic options for a nulliparous girl with a giant intramural uterine fibroid. Clinical Case: A 30-year-old patient with a 5-year history of intramural uterine fibroid, in addition to iron deficiency anemia. She complains of heavy and painful periods, urinary incontinence and constipation. Treatment was staggered, using goserelin acetate, selective embolization of the uterine arteries, and subsequent myomectomy. Conclusions: The treatment of uterine fibroid in young, nulliparous women depends on the size, location, associated symptoms, age of the patient and desire to have offspring.

A review of clinical evidence to assess differences in efficacy and safety of luteinizing hormone杛eleasing hormone (LHRH) agonist (goserelin) and LHRH antagonist (degarelix)

Luteinizing hormone杛eleasing hormone agonist (LHRH?A), goserelin, and antagonist, degarelix, are both indicated for the treatment of advanced prostate cancer (PCa); however, large comparative trials evaluating their efficacy and safety are lacking. In this review, we assessed the available evidence for both the drugs. Although degarelix achieves an early rapid decline in testosterone (T) and prostate?specific antigen (PSA) levels, median T and PSA levels, in addition to prostate volume and International Prostate Symptom Scores, become comparable with goserelin over the remaining treatment period. Degarelix causes no initial flare, therefore it is recommended in patients with spinal metastases or ureteric obstruction. Goserelin achieves lower PSA, improved time to progression, and better survival outcomes when administered adjunctively to radiotherapy compared with radiotherapy alone, with significant results even over long?term follow?up. The evidence supporting adjuvant degarelix use is limited. Goserelin has better injection site safety, single?step delivery, and an efficient administration schedule compared with degarelix, which has significantly higher injection site reactions and less efficient administration mechanism. There is conflicting evidence about the risk of cardiovascular disease (CVD), and caution is required when using LHRH?A in patients with preexisting CVD. There is considerable long?term evidence for goserelin in patients with advanced PCa, with degarelix being a more recent option. The available comparative evidence of goserelin versus degarelix has several inherent limitations related to study design, sample size, conduct, and statistical analyses, and hence warrants robust prospective trials and long?term follow?up.

Gonadotropin?releasing hormone agonists in prostate cancer: A comparative review of efficacy and safety

Androgen deprivation therapy (ADT) using gonadotropin?releasing hormone agonist (s) (GnRH?A) remains the backbone of advanced prostate cancer treatment. In this review, we assessed the efficacy, safety, and convenience of administration of various GnRH?A. All GnRH?A (goserelin, triptorelin, buserelin, histrelin, and leuprorelin) have comparable potential to suppress testosterone (T) levels (?50 ng/dL in a month and ?20 ng/dL in 3 months). However, goserelin has shown better efficacy in maintaining T levels ?50 ng/dL compared with leuprolide. The incidences of T escape are lower with goserelin and leuprolide than buserelin. Goserelin also has maximum benefit in prostate?specific antigen suppression. In neoadjuvant setting, when only goserelin was used, the 10?year overall survival (OS) rate was 42.6% to 86%. When either goserelin or leuprolide was used, the 10?year OS rate was 62%. As an adjuvant to radical prostatectomy, goserelin had a 10?year survival rate of 87%, and triptorelin had an 8?year survival rate of 84.6%. Goserelin further showed an absolute survival rate of 49% when used as an adjuvant to radiotherapy. The survival rates further improved when GnRH?A are used as combined androgen blockade compared with monotherapy. The frequency and severity of adverse events (hot flushes, fatigue, sexual dysfunction) are comparable among the GnRH?A. Goserelin appears to be the most convenient of all the GnRH?A for administration. Lack of conclusive comparative evidence makes it imperative to have a holistic approach of considering the patient profile and the disease characteristics to select the appropriate GnRH?A for ADT in prostate cancer.

Observation of Xiaopi-Zhitong-Poyu decoction combined with gosserin sustained-release implant for the treatment of endometriosis after laparoscopy / 国际中医中药杂志

Objective@#To evaluate the efficacy of Xiaopi-Zhitong-Poyu decoction combined with gosserin sustained-release implant for the treatment of endometriosis after laparoscopy.@*Methods@#A total of 204 patients with endometriosis who met the inclusion criteria were divided into 2 groups by random number table methods, with 102 cases in each group. On the 5th day after the operation, the control group was subcutaneously injected with Gosserin sustained-release implant in the anterior abdominal wall on the basis of routine treatment, the observation group was added with Xiaopi-Zhitong-Poyu soup on the basis of the control group. Both groups were treated for 24 weeks and followed up for 3 years. The World Health Organization Quality of Life Scale-Brief Form Questionnaire (WHOQOL-BREF) was used to evaluate the quality of life of patients. The TCM symptom scores were used to evaluate the menstrual pain, waist sour bloated, thin stool, dizziness and abnormal menstruation. The FSH, E2 and LH was detected by full automatic serum analyzer, and the endomethal antibody (EMAb), matrix metalloproteinase-3 (mmp-3) and carbohydrate antigen 125(ca-125) were detected by enzyme labeling instrument. Clinical efficacy was evaluated and adverse reactions during treatment were recorded.@*Results@#The total effective rate was 93.1% (95/102) in the observation group and 80.4% (82/102) in the control group, with statistically significant differences (χ2=3.871, P=0.039). After treatment, scores in environmental field, life field, physiological field and social relation field in the observation group were all significantly higher than those in the control group (t values were 4.725, 4.930, 4.259, 4.571, all Ps<0.05). Scores of menstrual pain, waist sour bloated, thin stool, dizziness and abnormal menstruation in the observation group were all significantly lower than those of the control group (t values were 3.561, 3.457, 3.421, 3.652, 3.529, all Ps<0.05). After treatment, the serum FSH (1.48 ± 0.15 U/L vs. 2.98 ± 0.29) U/L, t=3.174), E2 (52.17 ± 5.25 pg/ml vs. 88.04 ± 8.23 pg/ml, t=3.141), LH (1.82 ± 0.18 U/L vs. 2.45 ± 0.25 U/L, t=3.372) levels in the observation group were significantly lower (P<0.05); Serum EMAb (0.23 ± 0.02 vs. 0.32 ± 0.03, t=3.763), MMP-3 (69.69 ± 6.68 μg/L vs. 82.57 ± 8.89 μg/L, t=3.890], the CA-125 (25.89 ± 2.78 U/ml vs. 61.43 ± 6.78 U/ml, t=3.652) levels in the observation group were significantly lower (P<0.05). The recurrence rates of the observation group were 4.2% (4/95), 7.4% (7/95), 12.6% (12/95) at 1, 2, and 3 years respectively, while those of the control group were 13.4% (11/82), 18.3% (15/82), 25.6% (21/82), respectively. The differences were statistically significant (χ2 values were 3.309, 3.911, 4.102, all Ps<0.05).@*Conclusions@#The Xiaopi-Zhitong-Poyu decoction combined with gosserin sustained-release implant can reduce the hormone level of patients with endometriosis after laparoscopic surgery, improve the content of markers of endometriosis, improve the quality of life and clinical efficacy of patients, and reduce adverse reactions.

In vitro-in vivo correlation of goserelin acetate microspheres / 药学学报

The objective of this paper was to establish a level A in vitro-in vivo correlation (IVIVC) for goserelin acetate extended release microspheres for injection. Three kinds of goserelin acetate microspheres with different release rates were prepared and the critical physicochemical properties, such as drug loading, particle size, glass transition temperature and morphology were characterized. In vitro dissolution test of the prepared goserelin acetate microspheres was performed using sample-and-separate method at 45 ℃ in 5% (v/v) methanol. The morphology of the microspheres and the molecular weight of poly (lactic-co-glycolic acid) (PLGA) of the prepared goserelin acetate microspheres were investigated to research the release mechanism of microspheres. The plasma concentration of goserelin was detected after intramuscular injection of goserelin acetate microspheres to SD rats, and correlated with the in vitro release profiles after processing by percent AUC method. The pharmacokinetic experimental protocol of goserelin acetate microspheres for injection in SD rats was approved by the Animal Ethics Committee of Shandong Luye Pharmaceutical Co., Ltd. The results indicated that the developed sample and separate method was able to detect differences in the release characteristics of the prepared goserelin acetate microspheres, and the in vitro-in vivo correlation of goserelin acetate microspheres was excellent (r > 0.98) and had good predictive ability in SD rats.

Observation of Xiaopi-Zhitong-Poyu decoction combined with gosserin sustained-release implant for the treatment of endometriosis after laparoscopy / 国际中医中药杂志

Objective To evaluate the efficacy of Xiaopi-Zhitong-Poyu decoction combined with gosserin sustained-release implant for the treatment of endometriosis after laparoscopy. Methods A total of 204 patients with endometriosis who met the inclusion criteria were divided into 2 groups by random number table methods, with 102 cases in each group. On the 5th day after the operation, the control group was subcutaneously injected with Gosserin sustained-release implant in the anterior abdominal wall on the basis of routine treatment, the observation group was added with Xiaopi-Zhitong-Poyu soup on the basis of the control group. Both groups were treated for 24 weeks and followed up for 3 years. The World Health Organization Quality of Life Scale-Brief Form Questionnaire (WHOQOL-BREF) was used to evaluate the quality of life of patients. The TCM symptom scores were used to evaluate the menstrual pain, waist sour bloated, thin stool, dizziness and abnormal menstruation. The FSH, E2 and LH was detected by full automatic serum analyzer, and the endomethal antibody (EMAb), matrix metalloproteinase-3 (mmp-3) and carbohydrate antigen 125(ca-125) were detected by enzyme labeling instrument. Clinical efficacy was evaluated and adverse reactions during treatment were recorded. Results The total effective rate was 93.1% (95/102) in the observation group and 80.4% (82/102) in the control group, with statistically significant differences (χ2=3.871, P=0.039). After treatment, scores in environmental field, life field, physiological field and social relation field in the observation group were all significantly higher than those in the control group (t values were 4.725, 4.930, 4.259, 4.571, all Ps<0.05). Scores of menstrual pain, waist sour bloated, thin stool, dizziness and abnormal menstruation in the observation group were all significantly lower than those of the control group (t values were 3.561, 3.457, 3.421, 3.652, 3.529, all Ps<0.05). After treatment, the serum FSH (1.48 ± 0.15 U/L vs. 2.98 ± 0.29) U/L, t=3.174), E2 (52.17 ± 5.25 pg/ml vs. 88.04 ± 8.23 pg/ml, t=3.141), LH (1.82 ± 0.18 U/L vs. 2.45 ± 0.25 U/L, t=3.372) levels in the observation group were significantly lower ( P<0.05); Serum EMAb (0.23 ± 0.02 vs. 0.32 ± 0.03, t=3.763), MMP-3 (69.69 ± 6.68 μg/L vs. 82.57 ± 8.89 μg/L, t=3.890], the CA-125 (25.89 ± 2.78 U/ml vs. 61.43 ± 6.78 U/ml, t=3.652) levels in the observation group were significantly lower (P<0.05). The recurrence rates of the observation group were 4.2% (4/95), 7.4% (7/95), 12.6% (12/95) at 1, 2, and 3 years respectively, while those of the control group were 13.4% (11/82), 18.3% (15/82), 25.6% (21/82), respectively. The differences were statistically significant ( χ 2 values were 3.309, 3.911, 4.102, all Ps<0.05). Conclusions The Xiaopi-Zhitong-Poyu decoction combined with gosserin sustained-release implant can reduce the hormone level of patients with endometriosis after laparoscopic surgery, improve the content of markers of endometriosis, improve the quality of life and clinical efficacy of patients, and reduce adverse reactions.

Efficacy of Combined Aromatase Inhibitor and Luteinizing Hormone-Releasing Hormone Agonist in Premenopausal Metastatic Breast Cancer

PURPOSE: Endocrine therapy is the preferred treatment for hormone receptor (HR)-positive metastatic breast cancer (MBC). We investigated the efficacy of combined aromatase inhibitor (AI) and luteinizing hormone-releasing hormone (LHRH) agonist in premenopausal patients with HR-positive MBC. METHODS: We retrospectively analyzed the medical records of 21 HR-positive premenopausal MBC patients treated with combined AI and LHRH agonist therapy. RESULTS: The median follow-up period was 32.9 months. The overall response rate was 47.6%, with three complete responses (14.3%) and seven partial responses (33.3%). Nine patients (42.9%) achieved stable disease lasting more than 6 months; thus, the clinical benefit rate was 90.4%. The median time to progression was 45.4 months. No patients experienced grade 3 or 4 toxicity. CONCLUSION: Combined AI and LHRH agonist treatment safely and effectively induced remission or prolonged disease stabilization, suggesting that this could be a promising treatment option for HR-positive premenopausal patients with MBC.

Therapeutic Efficacy of Goserelin Acetate Sustained-release Implants Combined with Bicalutamide in the Treatment of Elderly Prostate Cancer Patients and Cognitive Function and Short-term Survival Rate Study / 中国药房

OBJECTIVE: To investigate therapeutic efficacy of Goserelin acetate sustained-release implants combined with bicalutamide in the treatment of elderly (≥70 years old) prostate cancer patients, and its effects on cognitive function and short-term survival rate. METHODS: A total of 56 prostate cancer patients treated in our hospital from Nov. 2014 to Nov. 2016 were divided into observation group and control group according to random number table, with 28 cases in each group. Observation group was given maximal androgen blokage (MAB) treatment which was Goserelin acetate sustained-release implant (subcutaneous injection of abdominal wall, 3. 6 mg/ times, once) combined with Bicalutamide tablet (orally, 50 mg/times, qd). Control group received surgical castration, and then was given docetaxel (intravenous dripping on 1st day) combined with Prednisone acetate tablets (lst-21st day, orally, 5 mg/time, bid) after surgery for adjuvant therapy. Treatment course of 2 groups lasted for 3 weeks, and all patients were followed up for 12 months. Clinical efficacy, Montreal cognitive function assessment table (MoCA) score, serum prostate specific antigen (PSA) levels and 12-month survival rate were observed in 2 groups. RESULTS: The total response rate of observation group was significantly higher than that of control group, with statistical significance (P<0. 05). Before treatment, there was no statistical significance in MoCA score and serum PSA levels between 2 groups (P>0. 05). After treatment, MoCA scores of 2 groups were decreased significantly, and the observation group was higher than the control group, with statistical significance (P<0. 05). 6 and 12 months after treatment, serum PSA levels of 2 groups were decreased significantly, and the observation group was significantly lower than the control group, with statistical significance (P<0. 05); 12-month survival rate of observation group (92. 86％) was significantly higher than that of control group (64. 29％), with statistical significance (P< 0. 05). CONCLUSIONS: Nonsteroidal anti-androgen drugs show significant therapeutic efficacy for elderly prostate cancer, reduce cognitive function damage, improve serum PSA levels, therapeutic efficacy and short-term survival rate.

Tratamiento con goserelina y tasa de embarazos de pacientes con infertilidad debida a endometriosis leve-moderada / Goserelin treatment and pregnancy rate of patients with infertility due mild-moderate endometriosis

El objetivo de la investigación fue determinar la utilidad del tratamiento con goserelina en la tasa de embarazos en pacientes con infertilidad debida a endometriosis leve-moderada. Se realizó un estudio prospectivo, en el que se incluyó a 76 mujeres con diagnóstico de infertilidad y endometriosis leve-moderada que asistieron al Hospital Central Dr. Urquinaona. El grupo de estudio (grupo A; n = 42 pacientes) que fueron tratadas con goserelina de depósito por vía subcutánea, una vez al mes por 3 meses. Al reiniciar los ciclos menstruales, se realizó hiperestimulación ovárica controlada / inseminación intrauterina. En el grupo de control (grupo B; n = 34 pacientes) solo se realizó hiperestimulación ovárica controlada / inseminación intrauterina. Se analizó la tasa de embarazos. La tasa de embarazos en el grupo A fue de 35,7 % por paciente y 24,5 % por ciclo estimulado. En el grupo B, la tasa fue de 32,3 % por paciente y del 23,9 % por ciclo estimulado. La tasa en el grupo de pacientes tratadas con goserelina fue más alta en el grupo de pacientes no tratadas, pero estas diferencias no son estadísticamente significativas (p = ns). Se concluye que el tratamiento con goserelina por 3 meses no es útil en pacientes con infertilidad debida a endometriosis leve-moderada, ya que no produce un aumento significativo en la tasa de embarazos.

The objective of research was to determine the usefulness of goserelin in the pregnancy rate in patients with infertility due mild - moderate endometriosis. A prospective study was conducted in which 76 women with a diagnosis of infertility and mild-moderate endometriosis was included, who attended the Central Hospital Dr. Urquinaona. The study group (group A; n = 42 patients) were treated with goserelin depot subcutaneously once monthly for 3 months. Upon restarting menstrual cycles, controlled ovarian hyperstimulation / intrauterine insemination was performed. In the control group (group B, n = 34 patients), only controlled ovarian hyperstimulation / intrauterine insemination was performed. The pregnancy rate was analyzed. The pregnancy rate in group A was 35,7 % per patient and 24,5 % per stimulated cycle. In group B, the rate was 32,3 % per patient and 23,9 % per stimulated cycle. The rates in the group of patients treated with goserelin were higher in the group of untreated patients, but these differences were not statistically significant (p = ns). It is concluded that treatment with goserelin for 3 months is not useful in patients with infertility due mild - moderate endometriosis, as it does not produce a significant increase in the rate of pregnancy.

Effects of human umbilical cord mesenchymal stem cells combined with goserelin on repairing rat ovarian damage / 天津医药

Objective To observe the repairing effect of human umbilical cord mesenchymal stem cells (hUC-MSCs) and goserelin on chemotherapy-induced ovarian injury, and the distribution and growth of hUC-MSCs transplanted in rat chemotherapy-induced ovarian injury. Methods A total of 120 SD rats were randomized into group A-E:A normal group, B NS control group, C goserelin group, D hUC-MSCs group and E hUC-MSCs+goserelin group. The rat premature ovarian failure (POF) model was established by given a loading dose of cyclophosphamide (CTX, 50 mg/kg) followed by daily intraperitoneal injection of CTX (8 mg/kg) for consecutive 14-day. The hUC-MSCs were injected through caudal vein, and goserelin was given by subcutaneous injection 4 days before POF model established. The serum level of estrogen was detected and numbers of follicles were counted. After GFP was transfected by lentivirus, the distribution and growth of stem cells transplanted in rats were observed by animal in vivo imaging system. Results At day 46, the serum level of estrogen showed no significant difference between group A and group E (P > 0.05). There were no significant differences in the counted follicles between group A and group E (P>0.05). After tail vein injection of the transfected cells, GFP positive cells were found in injury ovarian. Conclusion There is a repairing effect of hUC-MSCs and goserelin on ovarian injury.

Effects of Goserelin on Vascular Growth Factor and Immune Function of Rats with Prostatic Hyperplasia / 中国药房

OBJECTIVE:To study the effects of goserelin on vascular growth factor and immune function of rats with prostatic hyperplasia. METHODS:Rats were selected to establish prostatic hyperplasia model and randomly divided into model group,gose-relin low-dose,medium-dose and high-dose groups (0.4,0.8,1.2 mg/kg);normal rats were selected as normal control group, with 10 rats in each group. Normal control group and model group were given normal saline intragastrically,and goserelin groups were given relevant dose of drugs intragastrically,once a day,for consecutive 25 days. The prostate volume,wet weight,prostatic index of rats were detected as well as positive cell area of VEGF,TGF-β1,FGF,CD4 and CD8 in prostate tissue. RESULTS:Compared with normal control group,prostate volume,wet weight,prostatic index,positive cell area of VEGF,TGF-β1,FGF, CD4 and CD8 were all increased in model group (P0.05). CONCLUSIONS:Gosere-lin can relieve prostatic hyperplasia of rats,reduce the expression of VEGF in prostate tissue and regulate immune function.

Clinical Observation of Acetic Acid Goserelin Sustained-release Implants in the Treatment of Ovary Endo-metrium Cyst Recurrence after Surgery / 中国药房

OBJECTIVE:To investigate therapeutic efficacy and safety of Acetic acid goserelin sustained-release implants (AGRI) in the treatment of ovary endometrium cyst (OEC) recurrence after laparoscopic enuleation of ovarian cyst. METHODS:Totally of 60 patients with OEC recurrence after laparoscopic enuleation of ovarian cyst in Zhangjiagang First People's Hospital dur-ing Jan. 2013-Jan. 2015 were divided into control group and observation group according to random number table,with 30 cases in each group. Both groups were given Mifepristone tablets orally 25 mg,qd. Control group was given Gestrinone capsules orally 2.5 mg,twice a week. Observation group was given AGRI subcutaneously 3.6 mg,once a month. Both groups were treated for consec-utive 6 months. Clinical efficacies of 2 groups were observed as well as the levels of serum follicle stimulating hormone(FSH),lu-teinizing hormone(LH)and estradiol(E2),VAS scores of dysmenorrheal and chronic pelvic pain before treatment,3,6 months af-ter treatment. The occurrence of ADR and the prognosis of 12-month follow-up were observed in 2 groups. RESULTS:Total re-sponse rate of observation group was 86.67%,which was significantly higher than 70.00%of control group,with statistical signifi-cance(P0.05);after 6 months of treatment,the levels of FSH,LH and E2 in 2 groups were decreased significantly,and the observation group was significantly lower than the control group,with statistical significance(P0.05). The recovery rate of men-struation in observation group was 86.67%,the rate of dominant follicle formation was 60.00% and pregnancy rate was 53.33%, which were significantly higher than 46.67%,46.67% and 33.33% of control group,with statistical significance(P<0.05). CON-CLUSIONS:AGRI shows significant therapeutic efficacy for OEC recurrence after laparoscopic enuleation of ovarian cyst,can ef-fectively relieve dysmenorrhea and chronic pelvic pain,increase the rate of pregnancy. There is still recurrent cases after drug with-drawal. The incidence of ADR is high,but the symptoms are mild.

Goserelin protects ovarian function of premenopausal women with breast cancer / 实用医学杂志

Objective To investigate the effect of Goserelin in protection of the ovarian function of pre-menopausal breast cancer patients. Methods Eighty premenopausal patients with breast cancer randomly divided equally into study group and control group. The two groups were compared in terms of the menstrual status and the levels of E2,FSH,LH before and after chemotherapy. Results The menstrual recovery rates of the study group and the control group were 90% and 57.5%,respectively ,with statistically significant difference between them (P = 0.018). In the study group,the serum E2 decreased gradually to the postmenopausal level,and the serum levels of FSH and LH were also significantly decreased during the treatment. While in the control group ,the E2 levels gradually decreased ,but the levels of FSH and LH significantly increased during the chemotherapy. Conclusions Goserelin can effectively prevent the injury of ovarian function caused by chemotherapy.

Clinical Observation of Goserelin in the Treatment of Adenomyosis Complicated with Severe Dysmenor-rhea before Placing Levonorgestrel Intrauterine System / 中国药房

OBJECTIVE:To investigate clinical efficacy and safety of goserelin in the treatment of adenomyosis complicated with severe dysmenorrheal before placing levonorgestrel intrauterine system (LIS). METHODS:A total of 140 adenomyosis pa-tients with severe dysmenorrheal were selected from Sanya Family Planning Technology Service Center during Jan. 2014-Jan. 2016, and then divided into control group and observation group according to lottery method,with 70 cases in each group. Both groups re-ceived LIS within first 7 d of menstruation,and observation group was given Goserelin acetate sustained-release implant 10.8 mg subcutaneously via anterior abdominal wall one week before placing. Therapeutic efficacy was evaluated 6 months later. The im-provement of dysmenorrhea was compared between 2 groups. The uterine volume,COX dysmenorrhea score (CMSS),menstrual volume,hemoglobin (Hb) and CA125 content were compared between 2 groups before and after treatment. The occurrence of ADR was also compared. RESULTS:The rate of dysmenorrheal improvement in observation group was 95.71％,which was signifi-cantly higher than 81.43％of control group,with statistical significance(P0.05). Compare to before treatment,CMSS score,menstrual volume and CA125 content of 2 groups were decreased significantly after treatment,while Hb content was increased significantly;the observation group was significantly better than the control group,with statistical significance(P0.05). There was no statistical significance in the incidence of ADR(10.00％ vs. 14.29％)between 2 groups(P>0.05). CONCLUSIONS:Goserelin in the treatment of adenomyosis complicated with severe dysmenorrheal before placing LIS can effectively relieve dysmenorrheal,reduce menstrual volume and improve Hb and CA125 levels,but do not increase the risk of ADR.

Agoraphobia and Follicle-Stimulating Hormone Levels between Tamoxifen and Goserelin versus Tamoxifen Alone in Premenopausal Hormone Receptor-Positive Breast Cancer: A 12-Month Prospective Randomized Study

OBJECTIVE: Tamoxifen is an estrogen receptor antagonist used to prevent recurrence of breast cancer, which may provoke depression and anxiety and increase follicle-stimulating hormone (FSH) to patients. We compared anxiety and depression symptoms and FSH levels who received conventional tamoxifen alone and combination treatment of goserelin, a gonadotropin-releasing hormone (GnRH) analogue, with tamoxifen. METHODS: Sixty-four premenopausal women with hormone receptor-positive early-stage breast cancer were included and were assigned randomly to receive either tamoxifen and goserelin combination or tamoxifen alone for 12 months. The participants were evaluated blindly using the Hamilton Depression and Anxiety Rating Scale, the Beck Depression Rating Scale, and the Albany Panic and Phobia Questionnaire (APPQ). Blood FSH levels were assessed at baseline, 6 and 12 months. RESULTS: A significant time×group difference was detected in the agoraphobia trends subscale of the APPQ and in FSH levels. The combination group showed significantly less increases in agoraphobia subscale of APPQ and greater decreases in FSH level than those in the tamoxifen-alone group from baseline to 12 months of treatment. No significant differences for age, tumor grade, body mass index, or family history were found at baseline between the two groups. CONCLUSION: Our results suggest that the combination treatment of tamoxifen and goserelin resulted in less agoraphobia than tamoxifen alone in premenopausal women with breast cancer, which may associated with FSH suppression of goserelin.

Analysis of clinical curative effect of the therapy of goserelin combined with microwave on postoperative patients of endometriosis / 中国基层医药

Objective To observe the clinical efficacy of therapy of application of goserelin(Zoladex)com-bined with microwave on patients with endometriosis after laparoscopic surgery.Methods 188 patients with endome-triosis were randomly divided into two groups according to the randomized digital table method,with 94 cases in each group,as the observation group(Zoladex combined with microwave therapy group)and the control group(Zoladex treatment group).Among them there were 80 patients with infertility,45 cases in the observed group and 35 cases in the control group.After treatment,the clinical efficacy rate,recurrence rate and pregnancy rate of patients with infertil-ity were compared between the two groups.Results The efficiency of the observation group was significantly higher than that of the control group(80.12% vs.65.31%,χ2 =5.338,P <0.05),and the recurrence rate of the observa-tion group was lower than that of the control group(22.34% vs.38.56%,χ2 =8.325,P <0.05),the difference was statistical significance.The pregnancy rate of patients with infertility in the observation group were significantly higher than that of the control group,and the difference was statistically significant[64.38%(29 /45)vs.44.46%(16 /35)χ2 =4.531,P <0.05].Conclusion As for patients with endometriosis after laparoscopic surgery,the therapy of Zoladex drug treatment assisted with microwave treatment at the same time,could achieve good clinical curative effect and low recurrence rate,and could improve the pregnancy rate of patients with infertility.

The clinical effect observation of assisted goserelin in treatment of the severe ovarian endometriosis after laparoscopic surgery / 中国基层医药

Objective To investigate the clinical curative effect of laparoscopic surgery assisted gonadotropin-releasing hormone agonist ( GnRH -a ) goserelin in the treatment of the severe ovarian endometriosis ( OEM ) . Methods The clinical data of 300 patients with severe OME who received the laparoscopic conservative surgery were retrospectively analyzed.The patients were divided into three groups according to whether assisted the postoperative drug treatment:goserelin group 100 cases, gestrinone group 100 cases, no drug group 100 cases.All patients were followed up for 2 years,the relief situation of pelvic pain,the recurrence rate,pregnancies situation of the patients who had fertility requirements and drug adverse reaction were observed.Results ( 1 ) The pelvic pain remission rates of the GnRH-a group,gestrinone group and no drug group were 98.0%,89.0%,74.0% respectively,the GnRH-a group,gestrinone group were obviously higher than that of no drug group,the differences were statistically significant (χ2 =4.723,4.182,all P0.05).Follow-up 2 years,the recurrence rates of the goserelin group,gestrinone group and no drug group were 6.0%,14.0%,29.0% respectively,the goserelin group was significantly less than gestrinone group and the no drug group,the gestrinone group was lower than that of the no drug group,the differences were statistically sig-nificant (χ2 =4.982,4.667,all P0.05).(3)The incidence rate of the tidal fever and night sweating of the goserelin group was higher than the gestrinone group,the incidence rate of the vaginal bleeding, acne and elevated aminotransferase was lower than that in gestrinone group, with statistically significant differences (χ2 =5.028,4.876,4.394,4.876,all P<0.05).Conclusion The laparoscopic conservative surgery assisted gose-relin in the treatment of severe OME can improve the treatment effect,reduce the postoperative recurrence rate,and have less adverse reaction,but cannot increase natural pregnancy rate.