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Biomedical subjects

M Birkhäuser

Publications and source records attributed to M Birkhäuser.

At least 37 records · Page 2Linked to original sources

[Surveillance of hormone replacement therapy].

The prescription of hormone replacement therapy (HRT) requires a pretherapeutic evaluation and an ongoing surveillance during treatment. Pretherapeutic evaluation identifies the indications and contraindications to HRT. It includes a clinical examination, a Papanicolaou smear, and other tests according to the clinical situation. Monitoring of HRT consists of a first follow-up visit 3 months after beginning treatment to assess the effectiveness, side effects, and compliance with the therapy. Following this, yearly medical examinations should be scheduled. This paper describes the most frequent clinical signs that suggest a modification of treatment or the need to perform further investigations.

Adult↗

Comparison of two estradiol transdermal systems (Oesclim 50 and Estraderm TTS 50). I. Tolerability, adhesion and efficacy.

OBJECTIVES: The objectives were to compare the tolerability, adhesion and efficacy of a new matrix-type estradiol transdermal system, Oesclim 50, with those of Estraderm TTS 50, a reservoir-type system. METHODS: This was an open, randomised, parallel-group, multi-centre clinical trial, performed in six European countries. A total of 143 healthy menopausal women were allocated to treatment with Oesclim 50 and 140 to Estraderm TTS 50. The transdermal systems were applied twice weekly for 24 days out of each 28-day cycle, over a period of four cycles. Oral progestogen treatment was taken by non-hysterectomised patients for the last 12 days of estrogen therapy in each cycle. RESULTS: The local skin tolerability of the Oesclim 50 transdermal system was significantly better than that of Estraderm TTS 50. In the Oesclim 50 group, 4.2% of applications caused a reaction, compared with 9.5% in the Estraderm TTS 50 group (P < 0.001). Safety assessments showed both treatments to be well tolerated. Seven patients in the Oesclim 50 group, and 12 in the Estraderm TTS 50 group, discontinued due to adverse events. Of these discontinuations, one (0.7% of patients) in the Oesclim 50 group and seven (5.1% of patients) in the Estraderm TTS 50 group were due to application site reactions (P < 0.05). There was no statistically significant difference between the two groups in the percentage of patients with signs of hyperestrogenism (29 patients (20.3%) in the Oesclim group and 28 patients (20.0%) in the Estraderm TTS 50 group). Adhesion was significantly better for the Oesclim 50 transdermal system, with 6.0% of Oesclim 50 applications becoming detached compared with 11.3% of Estraderm TTS 50 applications (P < 0.001). The greater adhesion of Oesclim 50 was particularly apparent when the systems were exposed to water, with three times fewer Oesclim 50 systems becoming detached during a shower or bath (P < 0.001 in each case). Both treatments produced significant and comparable improvements in vasomotor symptoms, other menopausal symptoms and gynaecological assessments. A near-maximal effect on vasomotor symptoms was observed after approximately 1 month of treatment, and was maintained for the entire treatment period. CONCLUSION: Overall, Oesclim 50 provided statistically significantly better local skin tolerability and adhesion than Estraderm TTS 50, together with comparable efficacy and safety.

Administration, Cutaneous↗

Comparison of two estradiol transdermal systems (Oesclim 50 and Estraderm TTS 50). II. Local skin tolerability.

OBJECTIVES: The objectives were to compare the local skin tolerability of a matrix-type estradiol transdermal system, Oesclim 50, with that of the reservoir-type system, Estraderm TTS 50. METHODS: Two randomised studies were performed. In the first study, the modified Draize-Shelanski-Jordan method of sensitization was used in an open, parallel-group trial to compare the cutaneous tolerability of repeated applications of Oesclim 50 with that of Estraderm TTS 50 in 24 healthy postmenopausal women. The second study was an open, randomised, parallel-group, multi-centre clinical trial involving 283 healthy menopausal women. A total of 143 women were allocated to treatment with Oesclim 50 and 140 to Estraderm TTS 50. The treatment duration was four months. RESULTS: The first study showed that the treatments, Oesclim 50 and Estraderm TTS 50, had no sensitizing potential and did not induce allergic reactions. In the second study, 4.2% of applications in the Oesclim group provoked reactions compared with 9.5% in the Estraderm group (P < 0.001). Thirty-seven patients (25.9%) treated with Oesclim and 55 patients (39.9%) receiving Estraderm experienced one or more reactions (P < 0.05). Redness and itching were the most frequent types of application site reaction in both treatment groups. The durations of the reactions were significantly shorter in the Oesclim group (P < 0.01), with a higher percentage of durations of less than 1 h and a lower percentage of durations of over 48 h than in the Estraderm TTS 50 group. None of the reactions in the Oesclim group led to premature removal of the patch, compared with 11 (3.4%) in the Estraderm group (P < 0.05). The number of patients who discontinued treatment due to application site reactions was one (0.7%) in the Oesclim group and seven (5.1%) in the Estraderm group (P < 0.05). Efficacy and general safety were comparable in the two treatment groups. CONCLUSIONS: In the first study, neither Oesclim nor Estraderm induced allergic reactions. In the second study, the local skin tolerability of Oesclim was significantly better than that of Estraderm, in terms of the number, duration and severity of the application site reactions.

Administration, Cutaneous↗

Hormone replacement therapy and estrogen-dependent cancers.

Until a few years ago, every treated breast cancer was an absolute contraindication to hormonal replacement therapy (HRT). However, the very high five-year survival rate in stage I breast cancer observed today brings more and more apparently healthy early postmenopausal women who have been treated for breast cancer in the past and who are suffering from heavy vasomotor symptoms due to estrogen deficiency to gynecological consultation. Usually well informed, the same group of women starts to worry about an increased risk of postmenopausal osteoporosis and of cardiovascular diseases. What attitude should be adopted today? Our approach should be differentiated and respect the staging, the estrogen-receptor status, and the presence or absence of axillary lymph-node metastasis of every patient. In estrogen receptor-negative women, there is no contraindication to continuous combined HRT by a fixed estrogen-progestin combination. In estrogen receptor-positive and lymph-node-negative patients, treatment by a nonaromatizable progestin, such as medrogestone or medroxyprogesterone acetate (MPA), can be introduced to relieve the patient from her postmenopausal syndrome. After 2-3 years of a favorable evolution of the treated cancer, the substitution might be shifted to a fixed-combined continuous HRT. Because estrogen receptor-positive and lymph-node-positive patients today are usually receiving adjuvant treatment with tamoxifen, they profit already from prophylaxis for postmenopausal osteoporosis and, very likely, from decreased cardiovascular risk. If women out of this group continue to suffer from heavy vasomotor symptoms, MPA might be added. However, it must be stressed that every administration of sexual steroids to women who have been treated for breast cancer has to be started only in full agreement with the treating oncologist concerned with the case and only after having obtained the informed consent of the patient. The new ethical dilemma will be our attitude to quality of life in relation to life prolongation.

Breast Neoplasms↗

[Chlamydia and mycoplasma infections in men of couples with involuntary sterility].

There is conflicting evidence on the influence of infections with Chlamydia trachomatis and Mycoplasma hominis on male and female infertility. We studied the prevalence of Chlamydia and Mycoplasma in male partners of 165 infertile couples. 25% of couples with tubal and/or andrological sources of infertility showed positive cultures for Chlamydia and/or Mycoplasma compared with 10% of couples with other causes of infertility. Our data suggest, that screening for Chlamydia and Mycoplasma in infertility patients may be of assistance.

Adult↗

[Osteoporosis].

An exact diagnostic classification in primary or secondary osteoporosis may have therapeutic consequences. This review thus covers clinical, biochemical, radiological and bioptic diagnostic procedures. The most effective prophylactic measures, i.e. physical exercise, nutrition rich in calcium and estrogen-gestagen substitution, are spotlighted. Finally, various current therapeutic modalities are critically discussed, namely calcium supplements, the osteoclast inhibitors, calcitonin and bisphosphonates, as well as the osteoblast stimulators, anabolic steroids and fluorides.

Bone Density↗

[Gynecologic endocrinology].

Today, the specialty gynaecological endocrinology covers a very large field of physiological and pathophysiological mechanisms as well as endocrine diseases related to the ovarian axis. Gynaecological endocrinological processes accompany a wife from pregnancy and birth to the late postmenopause, passing through puberty, irregularities of the menstrual cycle, androgenization and infertility. The present review intends to give an overview on the different ways of investigation and of treatment typical for each endocrine problem in gynaecology and to point to some easily accessible literature.

Diagnosis, Differential↗

[Postmenopausal osteoporosis: pathophysiology and prevention].

Today, it is well known that postmenopausal or type I-osteoporosis can be prevented by an appropriately dosed hormonal substitution. An increased risk for this disease is found approximately in 25% of all women. Consequently, in this high-risk group, there is a clear indication for an oestrogen-progestin-prophylaxis. A high-risk for osteoporosis can be recognized by objective measurements such as bone densitometry or, in a less precise way, by risk factor assessment. The minimal effective oestrogen dose lies by 0.625 mg/day conjugated oestrogens and 2 mg/day oestradiol respectively for oral intake, or 50 micrograms oestradiol daily for supplemented by a progestin either continuously or in a cyclic rate. Prevention of osteoporosis is however not the sole indication for hormonal substitution. Other indications have to be considered in equal rights. In case of doubt, postmenopausal women without counterindications for oestrogen therapy should be permitted to take advantage of hormone substitution.

Bone Density↗

[Prevention of postmenopausal osteoporosis].

The necessity of the hormonal prophylaxis of postmenopausal osteoporosis is generally accepted today. However, there is no real alternative to the classical estrogen-/progestin-substitution. Every hormonal substitution has to be completed by other prophylactic measures be completed by other prophylactic measures such as an equilibrated alimentation or regular physical activity. Unfortunately, the importance of a reliable premenopausal prophylaxis is not yet fully recognized: It has to be guaranteed that every woman reaches her optimal peak bone mass. Although not all postmenopausal women will need a hormonal substitution if the risk of osteoporosis alone is considered, it has always to be realized that osteoporosis is just one aspect of the polysymptomatic climacteric syndrome due to estrogen deficiency.

Adult↗

[Fertility and Turner mosaicism syndrome].

Six patients with a Turner mosaicism are reported. All six women were investigated for sterility or infertility. Four of six patients had a total of nine pregnancies: six abortions, one stillbirth, two normal children. The literature contains reports of 17 pregnancies in 10 women with 45.X karyotype and 106 pregnancies in 48 women with mosaicism. Miscarriages, stillbirths and malformations were common. These women need special counselling and in case of a pregnancy amniocentesis is indicated. We discuss the pathogenesis of reduced fertility with Turner patients and explain the problems related to the cystogenetic diagnosis of the Turner-Mosaic Syndrome.

Abortion, Spontaneous↗