The Japan Society for Menopause and Women’s Health
Journal of the Japan Society for Menopause and Women’s Health
| V0l.18-1 | V0l.18-2 | V0l.19-1 | vol.19-2 | vol.20-1 |
| vol.20-2 | vol.20-3 | vol.21-1 | vol.21-2 | vol.22-1 |
V0l.18-1
(ORIGINAL)Usefulness of Vascular Age gained from Pulse wave velocity in health care for elderly women with dyslipidemia.
Kobayashi M１, Oｈtani H１, Kobayashi R１, Ao H２, Okabe K２, Huyuki H２
Social Health care Corporation Seichokai,Bell Clinic
１Department of Medical Office, ２Department of Clinical Laboratory
<Summery>
Of the elderly women, nearly half of whom are diagnosed with hyperlipidemia, we examined the usefulness of “vascular age minus actual age(VA)” obtained from pulse wave velocity as an index of progress for the actual extent of atherosclerosis for individualized health care” instead. Of 267 cases of women that were examined by pulse wave velocity in 2008 in our clinic, we analyzed 176 cases（45 years）who had not taken medicine for hyperlipidemia. “VA” in the cases who showed an eyeground atherosclerosis image or ultrasonographic carotid intima-media thickness tended to be high compared to the cases that had no atherosclerotic images. In addition, there was a significant difference between “VA” in cases that had no risk factors for the progression of atherosclerosis and those that had one or more risks. Additionally, high LDL cholesterolemia without other atherosclerotic risk factors revealed advanced “VA”, which suggests the possibility of atherosclerosis progression in elderly women who do not have atherosclerotic risks other than high LDL cholesterolemia. In conclusion, “VA” obtained from pulse wave velocity is useful for individualized health care of elderly women who present only with high LDL cholesterolemia by Ningen Dock.
(ORIGINAL)
Stress urinary incontinence was not influenced by hormone replacement therapy, but had an affect on quality of life in peri-menopausal women
Tomoko ISHIBASHI, Satoshi OBAYASHI, Mihoko AKIYOSHI, Kiyoko KATO, Masakazu TERAUCHI, Teruhito YAGUCHI, Toshiro KUBOTA.
1) Department of gynecology, Kawaguchi Kogyo general hospital
2)Comprehensive Reproductive Medicine andGraduate
School ,
Tokyo
Medical & Dental
University
<Summery>
Objective: Stress urinary incontinence (SUI) is one of important problems to deteriorate quality of life (QOL) in peri-menopausal women, but less information was reported by now. The aim of this study is to estimate the effect of hormone replacement therapy (HRT) and pelvic floor muscle training (PFMT) on peri-menopausal SUI, and to determine the change of QOL.
Methods: The 355 peri-menopausal women in our clinic were involved in this study after informed consent, and assessed with questionnaires, which were prepared to evaluate menopausal symptoms, SUI status and QOL score. The changes of these scores were estimated with or without PFMT, HRT for 3 months.
Results: The SUI was observed in 46.8% of the patients at 1st visit. Meanwhile, SUI ratio had no difference with or without using HRT. After 3 months follow-up, the number of deteriorated women, who were carrying out PFMT exercise, was just one out of 46 women, but HRT had no effect to improve SUI. Furthermore, QOL score after 3 months was significantly higher in women without SUI than with SUI.
Conclusion: SUI was not improved by the use of HRT, but had influenced QOL in peri-menopausal women.
(ORIGINAL)
Clinical Evaluation of Divigel® 1mg on Climacteric Disturbance and Estrogen Deficiency Symptom(Phase III Comparative Study of an Estradiol Gel and an Estradiol Delivering Patch)
Hiroaki OHTA 1)＊; Masahiro NOZAKI 2)＊; Yuji TAKETANI 3)＊; Hideo HONJO 4)＊＊
1) Women'sMedical
Center ,
Sanno
Medical
Center ,
International
University
of health and welfare
2) Department of Obstetrics and Gynecology,
Kyushu
Central
Hospital
3) Department of Obstetrics and Gynecology, Faculty of Medicine, University of
Tokyo
4) Aiseikai-Yamashina-Hospital＊ Medical Expert, ＊＊ Coordinating Investigator
＜Summary＞
To evaluate the efficacy and safety of a new estradiol gel formulation, Divigel® 1 mg (DVG), an open randomized multicenter phase III comparative study was conducted in patients with climacteric disturbance and estrogen deficiency symptoms, using the estradiol-delivering patch (ESR) as the reference drug.
A total of 215 patients with climacteric disturbance and estrogen deficiency symptoms were enrolled in the study and randomly assigned to either the DVG group or the ESR group. Each drug was administered for a period of 8 weeks.
The number of hot flushes per day at the end of treatment was evaluated as the primary end point for efficacy; the analysis was made by using ANCOVA. The results of this study showed that the upper limit of the 95% confidence interval for the mean adjusted difference, 0.71 times per day, did not exceed the set margin of 1.0 per day, indicating the non-inferiority of DVG to ESR in efficacy. In addition, DVG showed similar or superior efficacy to that of ESR for other climacteric symptoms.The incidence of adverse drug reactions (ADR) at the local application site was assessed as the primary end point for safety. The incidence of ADR at the local application site was statistically significantly lower (P = 0.011) in the DVG group than in the ESR group. The incidence of systemic ADRs, e.g., uterine hemorrhage, breast disorder,, in the DVG group was similar to that in the ESR group and to that reported in usual hormone therapy (HT). No ADR specific to was DVG treatment was noted.
Based on the results of this comparative study, it was concluded that Divigel® 1 mg had non-inferior efficacy and caused less irritation at the local application site, compared with the estradiol-delivering patch, in patients with climacteric disturbance and estrogen deficiency symptoms.
Given the trend in drug selection in HT that favors transdermal formulations because of their greater safety, Divigel® 1 mg is expected to improve treatment continuity with HT due to improved QOL and convenience, since Divigel® 1 mg offers the advantages of not peeling off the application site (resulting in loss of the drug), of being invisible, and of causing less irritability at the application site.
Kobayashi M１, Oｈtani H１, Kobayashi R１, Ao H２, Okabe K２, Huyuki H２
Social Health care Corporation Seichokai,Bell Clinic
１Department of Medical Office, ２Department of Clinical Laboratory
<Summery>
Of the elderly women, nearly half of whom are diagnosed with hyperlipidemia, we examined the usefulness of “vascular age minus actual age(VA)” obtained from pulse wave velocity as an index of progress for the actual extent of atherosclerosis for individualized health care” instead. Of 267 cases of women that were examined by pulse wave velocity in 2008 in our clinic, we analyzed 176 cases（45 years）who had not taken medicine for hyperlipidemia. “VA” in the cases who showed an eyeground atherosclerosis image or ultrasonographic carotid intima-media thickness tended to be high compared to the cases that had no atherosclerotic images. In addition, there was a significant difference between “VA” in cases that had no risk factors for the progression of atherosclerosis and those that had one or more risks. Additionally, high LDL cholesterolemia without other atherosclerotic risk factors revealed advanced “VA”, which suggests the possibility of atherosclerosis progression in elderly women who do not have atherosclerotic risks other than high LDL cholesterolemia. In conclusion, “VA” obtained from pulse wave velocity is useful for individualized health care of elderly women who present only with high LDL cholesterolemia by Ningen Dock.
(ORIGINAL)
Stress urinary incontinence was not influenced by hormone replacement therapy, but had an affect on quality of life in peri-menopausal women
Tomoko ISHIBASHI, Satoshi OBAYASHI, Mihoko AKIYOSHI, Kiyoko KATO, Masakazu TERAUCHI, Teruhito YAGUCHI, Toshiro KUBOTA.
1) Department of gynecology, Kawaguchi Kogyo general hospital
2)Comprehensive Reproductive Medicine and
Objective: Stress urinary incontinence (SUI) is one of important problems to deteriorate quality of life (QOL) in peri-menopausal women, but less information was reported by now. The aim of this study is to estimate the effect of hormone replacement therapy (HRT) and pelvic floor muscle training (PFMT) on peri-menopausal SUI, and to determine the change of QOL.
Methods: The 355 peri-menopausal women in our clinic were involved in this study after informed consent, and assessed with questionnaires, which were prepared to evaluate menopausal symptoms, SUI status and QOL score. The changes of these scores were estimated with or without PFMT, HRT for 3 months.
Results: The SUI was observed in 46.8% of the patients at 1st visit. Meanwhile, SUI ratio had no difference with or without using HRT. After 3 months follow-up, the number of deteriorated women, who were carrying out PFMT exercise, was just one out of 46 women, but HRT had no effect to improve SUI. Furthermore, QOL score after 3 months was significantly higher in women without SUI than with SUI.
Conclusion: SUI was not improved by the use of HRT, but had influenced QOL in peri-menopausal women.
Clinical Evaluation of Divigel® 1mg on Climacteric Disturbance and Estrogen Deficiency Symptom(Phase III Comparative Study of an Estradiol Gel and an Estradiol Delivering Patch)
Hiroaki OHTA 1)＊; Masahiro NOZAKI 2)＊; Yuji TAKETANI 3)＊; Hideo HONJO 4)＊＊
1) Women's
2) Department of Obstetrics and Gynecology,
To evaluate the efficacy and safety of a new estradiol gel formulation, Divigel® 1 mg (DVG), an open randomized multicenter phase III comparative study was conducted in patients with climacteric disturbance and estrogen deficiency symptoms, using the estradiol-delivering patch (ESR) as the reference drug.
A total of 215 patients with climacteric disturbance and estrogen deficiency symptoms were enrolled in the study and randomly assigned to either the DVG group or the ESR group. Each drug was administered for a period of 8 weeks.
The number of hot flushes per day at the end of treatment was evaluated as the primary end point for efficacy; the analysis was made by using ANCOVA. The results of this study showed that the upper limit of the 95% confidence interval for the mean adjusted difference, 0.71 times per day, did not exceed the set margin of 1.0 per day, indicating the non-inferiority of DVG to ESR in efficacy. In addition, DVG showed similar or superior efficacy to that of ESR for other climacteric symptoms.The incidence of adverse drug reactions (ADR) at the local application site was assessed as the primary end point for safety. The incidence of ADR at the local application site was statistically significantly lower (P = 0.011) in the DVG group than in the ESR group. The incidence of systemic ADRs, e.g., uterine hemorrhage, breast disorder,, in the DVG group was similar to that in the ESR group and to that reported in usual hormone therapy (HT). No ADR specific to was DVG treatment was noted.
Based on the results of this comparative study, it was concluded that Divigel® 1 mg had non-inferior efficacy and caused less irritation at the local application site, compared with the estradiol-delivering patch, in patients with climacteric disturbance and estrogen deficiency symptoms.
Given the trend in drug selection in HT that favors transdermal formulations because of their greater safety, Divigel® 1 mg is expected to improve treatment continuity with HT due to improved QOL and convenience, since Divigel® 1 mg offers the advantages of not peeling off the application site (resulting in loss of the drug), of being invisible, and of causing less irritability at the application site.