Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from camellia
Reexamination Certificate
2002-04-09
2004-03-30
Padmanabhan, Sreeni (Department: 1617)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from camellia
C424S439000, C426S597000, C426S655000
Reexamination Certificate
active
06713093
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a agent capable of protecting, reducting or preventing alopecia which frequently occurs as the side effect of anticancer agents. More particularly, it relates to an antialopecia agent characterized by containing oolong tea extract as the active ingredient.
A case of cancer has been on the remarkable increase, various anticancer agents have been developed and the new developed anticancer agents administered to the patients. On the other hand, there arises a serious problem of alopecia as the side effect of these anticancer agents. The alopecia occurring as the side effect of anticancer agents rarely causes the discontinuance or alleviation of the dosing schedule of the anticancer agents, since the administration of the anticancer agents affect life and death for the patients, while the alopecia is no fatal side effect. However, alopecia occurs at a high incidence and ranks high as painful side effects, following vomiting and nausea, on patients under the treatment with anticancer agents. Also, there is no doubt about that patients with alopecia have perturbation and uneasiness. Namely, alopecia causes serious mental anguish.
Human hair grows through the differentiation of hair-matrix cells in hair follicles distributed in the whole body. It is known that hair follicles on the head (i.e., scalp hair organs) have the highest growth rate and the longest growth period and involve those in the growth stage at a high ratio, which makes the hair on the head the longest among all. From a clinical viewpoint, alopecia can be roughly classified into male pattern baldness, alopecia areata, alopecia senilis, alopecia congenitalis, alopecia accompanying dysbolism (for example, endocrinopathy), trophopathy, shock or systemic diseases (for example, prolonged high fever), secondary alopecia following various cutaneous disease on the scalp, and drug-induced alopecia. That is to say, the head hair follicles (scalp hair organs) are damaged by various factors including hereditary ones and diseases. Although the mechanism of alopecia induced by anticancer agents has not been fully clarified so far, it seemingly proceeds as follows. Because of having much higher biological activities than other hair organs, the scalp hair organs are liable to be damaged by anticancer agents similar to bone marrow lymphoid tissues and digestive tract mucosal epithelial tissues. Thus the hair-matrix cells in the hair follicles are damaged. As a result, the growth of the functions of the hair-matrix cell is ceased and hair bulbs are deformed. Thus the hair becomes atrophic or poor and falls off. Alternatively, the hair organs rapidly rush into the resting phase and thus the hair falls off.
Among anticancer agents, anthracycline derivatives typified by adriamycin, endoxan (cyclophosphamide) and etoposide induce severe alopecia at a high frequency. In addition, alopecia is induced by nitrosourea, 5-fluorouracil, cisplatin, interferon, etc. It is pointed out in many papers that adriamycin or etoposide causes alopecia at a ratio of 60 to 80%. It is further pointed out that the administration of each anticancer agent in a higher single dose results in the higher incidence of alopecia.
To cope with the alopecia occurring as the side effect of anticancer agents, attempts have been made to administer an anticancer agents together with an antagonist (for example, Co-enzyme Q
10
) specific thereto; to select an administration route other than oral or intravenous administration so as to reduce the amount of an anticancer agents reaching the scalp hair organs (for example, intraarterial or intraperitoneal administration); or to reduce the blood flowing into the scalp with the use of avascularization belts to thereby inhibit the access of an anticancer agents to hair roots (i.e., the scalp blood stream blocking method). However, none of these method can achieve any satisfactory effect. In the case of the selection of the administration route, for example, intraarterial administration is usable only in cancers being under arterial control definitely (for example, liver tumors), which restricts the application range thereof. On the other hand, the scalp blood stream blocking method suffers from a problem that it causes intense pain. Another method for inhibiting alopecia comprises regulating the scalp temperature to 22° C. or below, i.e., the skull (head) cooling method. However the evaluation of the efficacy of this method is divided into two. It is reported that this method exerts no effect, in particular, when an anticancer agents is used in an increased dose or administered orally. Moreover, this method has disadvantageous in that the prolonged cooling period demands that the patient could not move for long time and the appearance makes the patient unpleasant. In addition, troublesome nursing care is also needed therefor. Other known methods for coping with alopecia are limited to preventive means such as the application of hair growth creams (for example, hair nourishing protein creams) not stimulating the scalp and having no vasodilator effect, keeping the head clean, maintaining the whole body in a good nutritional status, easy mental state, etc. Anyway, no remarkable and fundamental means has been established therefor hitherto.
There has been reported nothing but the oral administration of tocopherol as a means for preventing drug-induced alopecia via the administration of medicines. It is reported that the oral administration of tocopherol exerts a preventive effect on alopecia induced by adriamycin. However, it is also reported that tocopherol exerts no effect on alopecia induced by the combined use of adriamycin with other anticancer agents. In the alopecia induced by the administration of anticancer agents, hair-matrix cells are not completely broken. Namely, it is a temporary or reversible symptom. In recent years, therefore, a number of patients suffering from alopecia wear wigs for medical use until the effect of the anticancer agents disappears and hair newly grows after the termination of the administration of anticancer agents.
Accordingly, it has been urgently desired to develop a safe and efficacious antialopecia agent which inflicts neither any pain nor unpleasantness on patients under the administration of anticancer agents and has no side effects.
SUMMARY OF THE INVENTION
To develop a agent for alopecia caused by anticancer agents, the present inventors have examined a number of substances and conducted extensive studies. As a result, they have successfully found out that the application of oolong tea extract can achieve an effect of protecting, reducing or preventing alopecia. The present invention has been completed based on this new finding. Moreover, the present inventors have confirmed that the oolong tea extract is also efficacious against alopecia caused by the cessation of the growth of the hair-matrix cell function or by the resting phase of the hair-matrix cell induced by anticancer agents. Thus, it is also efficacious against alopecia caused by a number of other factors.
Accordingly, the present invention provides an antialopecia agent characterized by containing oolong tea extract as the active ingredient.
The present invention further provides a foods or beverages containing the above-mentioned antialopecia agent.
DETAILED DESCRIPTION
Oolong tea is a semi-fermented tea originating in China. It has been widely taken in China from ancient times. With the spread of Chinese dishes, it is now taken all over the world. In these days, there are a number of oolong tea-lovers in Japan too. Because of being a tea beverage, it is taken in a large amount everyday for a long time. Nevertheless, no harmful effect of oolong tea has been found out so far. On the contrary, animal experiments with the use of rats and rabbits indicate that the continuous intake of oolong tea for a long time causes no problem in safety. That is to say, oolong tea is a highly safe beverage and, therefore, can be given to human with a high safety. From the standpoint of patients, ool
Matsui Yokichi
Takahata Kyoya
Padmanabhan Sreeni
Suntory Limited
Wells Lauren Q.
White, Jr. Paul E.
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