Comparison between bromocriptine and cabergoline as treatment of hyperprolactinemia among sudanese infertile amenorrhic women

مقدم أطروحة جامعية

Ali, Hanadi al-Sirr al-Bashi

مشرف أطروحة جامعية

Garais, Abd al-Salam A. M.
Hamzah, Khalidah M.

الجامعة

جامعة أم درمان الإسلامية

الكلية

كلية المختبرات الطبية

القسم الأكاديمي

قسم الكيمياء السريرية

دولة الجامعة

السودان

الدرجة العلمية

دكتوراه

تاريخ الدرجة العلمية

2012

الملخص الإنجليزي

This was a prospective study attending to compare the efficacy and safety of cabergoline and bromocriptine for the women with hyperprolactinemic amenorrhea recruited from Reproductive Health care center from 2008 to 2010.

One hundred and five women with hyperprolactinemic amenorrhea of age ranged between 18 and 39 years participated in the study.

They were divided randomly, into two groups.

Group A : 54 women treated with bromocriptine (Parlodel, tablets 2.5 mg twice daily) manufactured by NOVARTIS PHARMA S.A.E., Cairo, under license from Novartis Pharma AG., Basle, Switzerland) Group B: 51 women treated by cabergoline (Dostenix, tablets, 0.5 mg weekly) manufactured by Pfizer U.S.A administered randomly 24-week period trial.

Amenorrhea, galactorrhea, and serum prolactin levels were assessed at baseline and at the end of the study.

The study protocol was approved by the local research Ethics Committees of the Sudan Fertility Association Care, Project of Reproductive Research.

The efficacy and safety was evaluated based on normalization of prolactin levels, and menstrual cycle, disappearance of galactorrhea, occurrence of pregnancy and adverse effects with each of these medications.

The demographic characteristics of the two groups, including mean age, duration of infertility, duration of amenorrhea, glactorrhea, FSH levels, LH levels, and initial PRL levels, did not differ significantly.

Serum prolactin was measured at baseline and at 22 weeks after the initiation of therapy (at the end of the trial) with commercially available Kit (enzymatic immunoabsorbance assay) (EIA), Kit, Beckman Coulter Company-Czech Republic.

The upper range of normal serum prolactin level was considered 400 mIU / l by (EIA), Kit.

Progesterone hormone was measured by the same method.

Normalization of serum prolactin level (22 -400mIU / L) was achieved in 84.3 % women receiving cabergoline and of 51.9% women in- group a receiving bromocriptine.

Serum prolactin level drop after treatment from Initial mean values of 1722mIU/L to 277.9 mIU / L at the end of treatment in- group B and from 1698.9mIU/L to 334.0 mIU/L in- group A.

The differences between pre and post treatment was statistically significant for both groups (P < 0.00).

However within 12 week serum prolactin levels increased suddenly and significantly higher in-group A because two women in this study group stopped taking daily doses of bromocriptine before measured prolactin, this clear evidence of one of disadvantage of bromocriptine, which is a short half life about 3.3 h.

Normalization of the menstrual cycle was obtained in 96.1 % in- group B and 83.3 % in-group A.Galactorrhea disappeared in all women (100 %) having galactorrhea in both study groups.

Pregnancy was significantly achieved among women in-group B 67.3% compared to (43.1 %) in the other group.

Two women became pregnant before menstruation in-group B while amenorrhea persisted in three women in-group A after the treatment while none of women in group B.

Any complaint was discussed with the patient, and if it appeared to be drug related, the complaint was reported as drug side effect, severe side effects were recorded during drug administration.

The number of women suffering from severe side effects in-group A of those receiving bromocriptine was 42.6% compared to 19.7% in-group B reported severe side effects of the women receiving cabergoline, the difference was highly significant.

Among the women in group A treated with bromocriptine, fatigue, abdominal pain and, breast pain were highly frequency in group A (90.7 %), (66.7 %) (57.4 %) respectively while in-group B there was (31.4 %, 76.5 % and 49 %)) respectively.

Headache and nausea showed similar frequent in both study groups while in case of bromocriptine vomiting and constipation side effects were more frequent, but insignificantly.

All women in each group were measured blood pressure in each visit, the blood pressure dropped in both study groups after two weeks of the treatment, particularly systolic pressure.

Systolic pressure was decreased significantly in- group A before and after treatment (P < 0.001) respectively.

In conclution although both dopamine agonist therapy lower prolactin levels, and restoring gonadal function, cabergoline was more effective and better tolerated than bromocriptine with less side effect and additionally uses as weekly doses in preference to bromocriptine which has more severe side effects and multiple daily doses.

No data exist about incidence and prevalence of hyperprolactinemia in Sudanese infertile women.

For this perposed study the infertile women visting center was screened, to determine the prevalence of hyperprolactinemia among infertile women was carried out in Reproductive Health Care Center Khartoum state from 2005 to 2010, based on prolactin levels was determined the prevalence of hyperprolactinemia in infertile women with reproductive age (18-45 year).

An overall hyperprolactinemia was represented in 29% of total number (14102) infertile women included in this study.

The prevalence of hyperprolactinemia was 15.2 % among infertile women with menstrual regularities, while in amenorrhic women was 38.4% and 42.6% among Oligoamenorrhric women, while in women with polycystic ovary syndrome was 22.7%, and 13.8% in hypothyroidism women.

The prevalence of hyperprolactinemia among women with galactorrhea was 74.8 %.

These findings raise interesting questions about etiology of infertility and disease course of hyperprolactinemia.

التخصصات الرئيسية

الطب البشري

الموضوعات

• انقطاع الطمث
• السودان

عدد الصفحات

168

قائمة المحتويات

• APA
• MLA
• AMA

لغة النص

الإنجليزية

نوع البيانات

رسائل جامعية

رقم السجل

BIM-364682