Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1996-10-07
2000-02-22
Housel, James C.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
435 71, 435 792, 436501, 436518, 436531, 436811, 436815, G01N 3353
Patent
active
060279087
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to a method for differentiating the vaginal secretory fluid or cervical mucus of a pregnant woman suffering from threatened premature delivery, which method is useful for the detection of premature delivery.
BACKGROUND ART
Premature delivery is one of the abnormalities which occur accompanied with pregnancy. It is caused by various reasons but ascendens infection, intrauterine infection and abruption of placenta are considered as main reasons.
In the case where the premature delivery occurs because of an infectious disease or chorionic amnionitis, the concentration of C-reactive protein (CRP) and the leukocyte count both in the blood of the mother's body show an increase so that premature delivery is checked by measuring these values.
It is however difficult to say that the CRP concentration and the leukocyte count are specific to the premature delivery, because they are the values available from the blood and show an increase even by the factors other than the premature delivery. In addition, the CRP is accompanied with the problem that it can be detected only in a trace amount in the blood so the sensitivity of the measurement is low. Thus, it is difficult to make diagnosis as premature delivery at early stages of pregnancy by measuring the CRP concentration or the leukocyte count in the blood.
On the contrary, a method of making diagnosis as abortion or premature delivery by measuring Interleukin-6 (IL-6) in the blood has recently been reported (Japanese Patent Application No. 209882/1993). This method however uses the blood from the mother's body as a specimen and therefore is not fully satisfactory from the viewpoints of inferiority both in sensitivity and specificity.
An object of the present invention is therefore to search a substance which will be an indication of premature delivery and to establish a method for differentiating it.
With the forgoing in view, the present inventors have conducted an extensive investigation. As a result, it has been found that an increase in Interleukin-8 (IL-8) in the vaginal secretory fluid or cervical mucus is specific to a pregnant woman suffering from the threatened premature delivery and the vaginal secretory fluid or cervical mucus of the pregnant woman suffering from the threatened premature delivery can be differentiated by measuring the IL-8 amount, leading to the completion of the invention.
DISCLOSURE OF THE INVENTION
The present invention relates to a method for differentiating the vaginal secretory fluid or cervical mucus of a pregnant woman suffering from threatened premature delivery, which comprises measuring an amount of Interleukin-8 in the vaginal secretory fluid or cervical mucus.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a comparison in the IL-8 concentration in the vaginal secretory fluid between the normal pregnant women group (left) and the threatened premature delivery group (right).
FIG. 2 illustrates fluctuations in the IL-6 and IL-8 concentrations in the vaginal secretory fluid and the CRP concentration in the serum, each obtained from pregnant women who were diagnosed as threatened premature delivery, received treatment but lead to premature delivery.
FIG. 3 illustrates fluctuations in the IL-6 and IL-8 concentrations in the vaginal secretory fluid and the CRP concentration in the serum, each obtained from pregnant women who were diagnosed as threatened premature delivery but as a result of treatment, recovered and lead to full-term normal delivery.
BEST MODE FOR CARRYING OUT THE INVENTION
As the specimen usable in the present invention, either a vaginal secretory fluid or cervical mucus can be used. No particular limitation is imposed on the sampling method of it insofar as the sampling can be conducted without giving a damage to the vagina or the uterine cervix. Examples include the method in which sampling is conducted by attaching a tube such as silicone tube or a needle to the end of a syringe and then inserting it in the vagina; a method in which sampling is cond
REFERENCES:
patent: 4919889 (1990-04-01), Jones et al.
patent: 5516702 (1996-05-01), Senyei et al.
Laham et al., "Interleukin 8 concentrations in amniotic fluid and peripheral venous plasma during human pregnancy and parturition," Acta Endocrinologica, vol. 129, pp. 220-224 (1993).
Shimoya et al., "Human Placenta Constitutively Produces Interleukin-8 during Pregnancy and Enhances Its Production in Intrauterine Infection," Biology of Reproduction, vol. 47, pp. 220-226 (1992).
Solberg E. H. in : Textbook of Clinical Chemistry, (ed) N. W. Tietz, W.B. Saunders Company, Philadelphia. 1986. Chapter 2b, pp. 356-363.
ACTA Obstetrica et Gynaecologica Japonica, vol. 46, Feb. 1994, "The 46th Lecture Meeting of the Japanese Obstetrics and Gynecology Society", pp. 1-9.
Steinborn et al., "Cytokines in the diagnosis of amniotic infection syndrome," Zeitschrift fuer Gevurtshilfe und Perinatologie, vol. 198, No. 1, pp. 1-5, (Jan-Feb. 1994).
Morrison et al., "Oncofetal Fibronectin in Patients with False Labor as a Predictor of Preterm Delivery," American Journal of Obstetrics and Gynecology, vol. 168, No. 2, pp. 538-542 (1993).
Saito et al., "Elevation of Amniotic Fluid Interleukin 6 IL-6 IL-8 and Granulocyte Colony Stimulating Factor G-CSF in Term and Preterm Parturition," Cytokine, vol. 5, No. 1, pp. 81-88 (1993).
Ichijo Motohiko
Maeda Makiko
Nozawa Masayuki
Saito Shigeru
Daiichi Pure Chemicals Co. Ltd.
Housel James C.
Phan Quang N.
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