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Biomedical subjects

H K Poulsen

Publications and source records attributed to H K Poulsen.

At least 19 recordsLinked to original sources

A double-blind, randomized, comparative study evaluating clinical effects of two sequential estradiol-progestogen combinations containing either desogestrel or medroxyprogesterone acetate in climacteric women.

OBJECTIVES: The aim of this study was to compare a new sequential estradiol-desogestrel (E2-DSG) hormone replacement regimen (Liseta) with one of the standard treatments i.e. estradiol valerate-medroxyprogesterone acetate (E2V-MPA) combination (Klimalet) regarding the alleviation of climacteric symptoms, vaginal bleeding pattern and the occurrence of adverse experiences. METHODS: In a multicenter study performed in Denmark, a total of 376 perimenopausal women with climacteric symptoms were randomly allocated to oral sequential treatment with either E2-DSG (1.5 mg E2 for 24 days with 0.15 mg DSG for the last 12 days followed by a placebo tablet for 4 days) (n = 186) or with E2V-MPA (2 mg E2V for 21 days with 10 mg MPA for the last 10 days) (n = 190). Treatments were administered, using a double-blind, double-dummy technique for 6 cycles of 28 days. RESULTS: Three hundred and seventeen women, 158 in the E2-DSG and 159 in the E2V-MPA group, completed six treatment cycles. Both treatments reduced menopausal symptoms rapidly and to a similar extent. Hot flushes were present in 88% of the women in both groups. After six treatment cycles, hot flushes were no longer present in 71 and 62% of the women in the E2-DSG and E2V-MPA group, respectively. Perspiration decreased from 80 to 65% in the E2-DSG group and from 82 to 63% in the E2V-MPA group. Mood disturbances were present in 82% of the women in the E2-DSG at baseline, and in 52% after six cycles. In the E2V-MPA group the corresponding figures were 68 and 42%, respectively. The bleeding pattern was comparable in both treatment groups. Regular withdrawal (expected) bleeding appeared in 90-92% and in 85-90% of the women in cycles 1-5 with E2-DSG and E2V-MPA, respectively. Irregular bleeding (including spotting) occurred in 15.2% of the women receiving E2-DSG and in 20.1% of the women treated with E2V-MPA in cycle 6. In both treatment groups there was a tendency of a slight decrease in blood pressure. Adverse events were in less than 10% in each group the reason to discontinue treatment. CONCLUSIONS: Both treatments effectively alleviated menopausal complaints and presented good cycle control. Bleeding pattern and mood disturbances appeared to be more favorable influenced by E2-DSG.

Administration, Oral↗

[Patients with early stages of endometrial cancer should be spared adjuvant radiotherapy. Danish Endometrial Cancer Group].

In an attempt to create uniform nationwide guidelines for the management of all stages of endometrial carcinoma, and to limit the use of adjuvant radiation therapy in stage I disease to high-risk patients only, a protocol was developed by the Danish Endometrial Cancer group (DEMCA). From September 1986 through August 1988, 1214 women in Denmark with newly diagnosed carcinoma of the endometrium have been treated according to this protocol. This figure represents all endometrial carcinomas diagnosed in Denmark during this two-year period. The primary treatment was total abdominal hysterectomy and bilateral salpingo-oophorectomy, no preoperative radiation therapy was delivered. In 1039 cases no macroscopic residual tumour and/or microscopic tumor tissue in the resection margins was found following surgery. Based on surgery and histopathology, these patients were classified as: P-stage I low risk (n = 641), P-stage I high risk (n = 235), P-stage II (n = 105) and P-stage III, Group 1 (n = 58). No postoperative radiation therapy was given to P-I low risk cases. P-I high risk, P-II, and P-III (Group 1) cases received external radiation therapy. Recurrence rate at 68-92 months follow-up was 45/641 (7%) in P-I low risk, 36/235 (15%) in P-I high risk, 30/105 (29%) in P-II, and 27/58 (47%) in P-III (Group 1) cases. Fifteen of 17 vaginal recurrences in P-I low risk cases were salvaged (mean observation time 61 months). In this population-based investigation it has been shown that P-stage low-risk patients are adequately treated by total abdominal hysterectomy and bilateral salpingo-oophorectomy, and that no pre- or postoperative radiation therapy is necessary.

Adult↗

Changes in blood levels of proteinase inhibitors, pregnancy zone protein, steroid carriers and complement factors induced by oral contraceptives.

Three low-dose oral contraceptives Trinordiol, Gynatrol, and Marvelon, containing ethinylestradiol (EE) in combination with triphasic levonorgestrel (LNg), monophasic levonorgestrel, and monophasic desogestrel (DGS), respectively, were given to 65 healthy women, n = 21-22 in each group. Blood levels of antithrombin III (AT III), alpha 2-macroglobulin (alpha 2M) alpha 1-antitrypsin (alpha 1at), complement factors (factor B, C3, C4), pregnancy zone protein (PZP), corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG) and albumin were measured before treatment and during the first and third treatment cycles. AT III levels decreased and alpha 1at levels increased in all three groups during treatment. alpha 2M increased during cycle 3 in the Trinordiol and Gynatrol groups. CBG, PZP and SHBG levels increased in all 3 groups, the CBG and PZP increase being higher in the Marvelon group than in the Gynatrol group. Increases in SHBG levels were found in the order Marvelon > Trinordiol > Gynatrol. Plasma levels of complement factors B, C3 and C4 remained unchanged. It is concluded that the increase in alpha 1at partly compensates for the fall in AT III, that the rise in PZP presumably enhances fibrinolysis, and that LNg has higher anti-estrogenicity and androgenicity than DSG.

Adolescent↗

Open randomized comparison of prostaglandin E2 given by intracervical gel or vagitory for preinduction cervical ripening and induction of labor.

Intracervical application of prostaglandin E2 (PGE2) in a viscous gel was compared with conventional wax-based PGE2 vagitories (pessaries) for ripening of the cervix prior to induction of labor. A total of 226 healthy pregnant women at term were randomly allocated to receive intracervical gel with an effective dose of 0.5 mg (n = 116) or vagitories containing 2.5 mg PGE2 (n = 110). All women had a modified cervical score of less than or equal to 4. The numbers of cases contributed by each of the three centers were similar. There was no significant difference in parity, gestational length, maternal characteristics, indications for induction or preinduction cervical scores between the treatment groups. The rate of spontaneous birth was 71% in the gel group, compared with 69% in the vagitory group. Successful treatment was defined as active labor within 24 h or a change in cervical dilatation allowing artificial rupture of the membranes with subsequent progressive labor. The success rate was not significantly different in the gel group (82%) compared with the vagitory group (80%). There were no differences in the frequency of fetal distress, outcome of labor, assisted delivery rates or maternal side effects. The cervical scores were not different at 12 and 24 h after application. Intracervical gel and intravaginal application of PGE2 were similar in their efficacy and safety for ripening of the cervix and inducing labor at term.

Administration, Intravaginal↗

Termination of second trimester pregnancy with gemeprost vaginal pessaries and intra-amniotic PGF2 alpha. A comparative study.

152 women admitted for legal abortion in the second trimester of pregnancy were included in an open, randomized, controlled six-centre study. 75 patients received gemeprost 1 mg vaginal pessaries at 3 hours intervals up to a maximum of 5 mg and 66 patients were treated with a single 40 mg intra-amniotic dose of PGF2 alpha. The 24-hour success rate was 81% (n = 61/75) in the gemeprost and 64% (n = 42/66) in the PGF2 alpha group (p less than 0.02). The mean abortion times were 14.3 and 14.8 hours in the gemeprost and the PGF2 alpha groups, respectively. The mean time to onset of pain was shorter and more patients experienced blood loss over 100 ml during the induction in the PGF2 alpha group than in the gemeprost group (p less than 0.02). Apart from that, the nature and severity of side effects were comparable between the two groups. Besides significantly better efficacy, the non-invasive gemeprost treatment was found to be easier and safer as compared to the PGF2 alpha treatment.

Abortifacient Agents↗

The Danish Endometrial Cancer Study (DEMCA).

In an attempt to create uniform nation-wide guidelines for the management of all stages of endometrial cancer, and to limit the use of adjuvant irradiation in stage I disease to high-risk patients only, a protocol was developed by the Danish Endometrial Cancer (DEMCA) group. As histologic grading and degree of myometrial invasion are useful indicators of high risk, it was decided not to deliver preoperative irradiation. In order to evaluate the effect of sequential endocrine treatment with anti-estrogen and progestin in stage IV endometrial cancer and recurrences a phase II protocol was developed. From September 1986, the great majority of women in Denmark with newly diagnosed cancer of the endometrium have been treated according to these protocols. The DEMCA protocols are described, and preliminary data from the first year of the study are presented. Mean follow-up time is still short and does not permit analysis in respect to treatment results.

Adult↗

Measurements of hCG and PAPP-A in uncommon types of ectopic gestation.

Seven out of 54 women with ectopic gestation had uncommon features such as extra-tubal implantation or multiple intratubal pregnancy. Depressed levels (less than 10th centile) or apparent absence of circulating human chorionic gonadotrophin (hCG) and pregnancy-associated plasma protein A (PAPP-A) were seen respectively in 5 and 7 of 7 women studied. Normal levels of hCG were seen in two women, one with an abdominal and one with an angular pregnancy. These data suggest that the synthesis of placental proteins in ectopic pregnancies is independent of the site of implantation and the number of embryos. Measurements of maternal levels of the 2 placental proteins seem to be applicable as auxiliary diagnostic tests for ectopic pregnancy, regardless of the site of implantation.

Chorionic Gonadotropin↗

Placental proteins in peripheral blood and tissues of ectopic pregnancies.

Circulating human chorionic gonadotrophin (hCG), Schwangerschaftsprotein 1 (SP-1) and pregnancy-associated plasma protein A (PAPP-A) were examined in 10 women with ectopic gestation in relation to distribution and intensity of staining for these molecules using immunohistochemical techniques applied to matched trophoblastic and decidualized endometrial tissues. All 10 women revealed strong staining for hCG and SP-1 in the syncytiotrophoblast, which was apparently unrelated to maternal levels of hCG and SP-1, levels being less than the 10th centile of the normal range in 9/10 and 7/10 women, respectively. By contrast maternal PAPP-A levels seemed to correlate with the intensity and the distribution of staining for PAPP-A. Circulating PAPP-A was undetectable (less than 5 mIU/l) in 4 patients, and below the 10th centile in the remaining 6. Using immunohistochemical techniques hCG, SP-1 and PAPP-A could not be demonstrated in any of the decidualized endometrial tissues studied.

Chorionic Gonadotropin↗

Persistent bladder dysfunction after surgical and combination therapy of cancer of the cervix uteri stages Ib and IIa.

The present study is a urologic follow-up investigation of 27 women 17 to 32 months after treatment for carcinoma of the cervix stage Ib and IIa. In 10 women treatment had been exclusively with surgery, while 17 women had received treatment with cesium before surgery. Two patients had major urologic problems with severe stress incontinence and persistent bladder infection, respectively, while 19 had minor urologic complaints on questioning. Nine of twenty-two women (41%) subjected to denervation supersensitivity tests had positive tests. No correlation between a positive denervation test and urologic complaints or findings at cystometrograms could be found. No differences in urologic complaints or results of denervation tests and cystometrograms were found between women treated with surgery exclusively or with cesium before surgery. All treated women had unimpaired renal function judged by serum creatinine and isotopic renography.

Adult↗

Nuclear thyroxine and 3,5,3'-triiodothyronine receptors in human mononuclear blood cells during pregnancy.

Serum free T4, free T3, TSH and maximal nuclear binding capacity for T4 and T3 in mononuclear blood cells were measured in 12 control women, in 12 normal pregnant women in the first and in 12 women in the third trimester. Serum free T4 and T3 were decreased in late pregnancy compared to control women, serum free T4: 9.1 pmol/l(mean) vs 12.9 pmol/l(mean); serum free T3: 4.0 pmol/l(mean) vs 6.2 pmol/l(mean), without any change in TSH levels: 2.2 mU/l(mean) vs 1.8 mU/l (mean). Concomitantly, the maximal nuclear binding capacity for both T4 and T3 increased, T4: 2.7 fmol T4/100 micrograms DNA vs 1.8 fmol T4/100 micrograms DNA; T3:2.8 fmol T3/100 micrograms DNA vs 2.0 fmol T3/100 micrograms DNA. These data, obtained from healthy women during a normal pregnancy are compatible with mild compensated hypothyroidism. We suggest that euthyroidism are maintained by the increased maximal nuclear binding capacity for these hormones.

Adolescent↗

Prophylactic metronidazole or suction drainage in abdominal hysterectomy.

The efficacy of a two-dose perioperative course of oral metronidazole or suction drainage of the vaginal vault was evaluated in a randomized study of 150 patients undergoing abdominal hysterectomy. Patients receiving metronidazole demonstrated a significant reduction in febrile morbidity (from 48 to 8%), infectious morbidity (from 46 to 16%), urinary tract infections (from 30 to 10%), and pelvic and/or abdominal wound infections (from 18 to 2%). The patients managed with suction drainage showed a marked reduction in febrile and infectious morbidity; however, this reduction was not significant. Overall, 17% of all specific postoperative infections were first diagnosed after discharge from the hospital. No adverse side effects of metronidazole were encountered.

Adult↗

Flow cytometric classification of biopsy specimens from cervical intraepithelial neoplasia.

The distribution of single-cell DNA content was investigated in biopsy specimens from the human cervix of 121 women suspected of having intraepithelial neoplasia. Comparison of the results of the histopathological examination with the ploidy level showed that all normal specimens were diploid. Thus, no false-positive results occurred. Most of the specimens classified as mild and moderate dysplasia were diploid as well. Aneuploid cell populations occurred in 78% of the lesions classified as severe dysplasia and carcinoma in situ. The ploidy level distribution permitted a natural division of the aneuploid cell populations into two groups with DNA indices either above or below 1.5. The importance of the aneuploidy in carcinogenesis is discussed.

Aneuploidy↗