JP2014065669A - Allergic disease preventive for infants - Google Patents
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本発明は、ビフィズス菌が、妊婦及び新生児又は乳児に投与されるように用いられることを特徴とする、ビフィズス菌を有効成分として含有する乳幼児のアレルギー疾患の予防剤に関し、特に乳幼児におけるアレルギー疾患の発症を予防することでアレルギーマーチを予防する技術に関する。 The present invention relates to a preventive agent for allergic diseases in infants, comprising bifidobacteria as an active ingredient, characterized in that bifidobacteria are used so as to be administered to pregnant women and newborns or infants. The present invention relates to a technique for preventing allergic march by preventing onset.
アレルギーやアトピーになりやすい遺伝的素因を持っている新生児／乳児は、乳児湿疹、アトピー性皮膚炎、食物アレルギー、さらには気管支喘息、花粉症など年齢とともに様々なアレルギー疾患を発症すること（アレルギーマーチ）が知られている。また、これらの疾患は近年増加しつつある。 Neonates / infants with genetic predisposition to predisposition to allergies and atopy develop various allergic diseases such as infant eczema, atopic dermatitis, food allergies, bronchial asthma, and hay fever with age (allergy march) )It has been known. Moreover, these diseases are increasing in recent years.
このようにアレルギー疾患は、１つの疾患を発症すると別のアレルギー疾患に罹患する可能性が高くなるので、乳幼児の段階でアレルギー疾患の発症を抑えることが必要とされている。 As described above, an allergic disease is likely to be affected by another allergic disease when it develops, so that it is necessary to suppress the onset of the allergic disease at the infant stage.
このような背景で、安全性の高い乳酸菌が抗アレルギー素材として注目され、乳酸菌を抗アレルギー剤として使用することが検討されている（特許文献１〜３）。 Against this background, highly safe lactic acid bacteria have attracted attention as antiallergic materials, and the use of lactic acid bacteria as antiallergic agents has been studied (Patent Documents 1 to 3).
先行文献において、ビフィズス菌は、アレルギー症状の軽減に用いられる治療薬として検討されているが、乳幼児のアレルギー疾患の発症を予防できることについては示されていない。 In the prior literature, Bifidobacteria has been studied as a therapeutic agent used for allergic symptoms, but it has not been shown that it can prevent the development of allergic diseases in infants.
本発明は、乳幼児のアレルギー疾患の有効な予防剤を提供することを目的とする。 An object of the present invention is to provide an effective preventive agent for allergic diseases in infants.
前記課題を解決する本開示は、項１〜項６の発明を提供するものである。
項１） ビフィズス菌が、出産予定日の４週前から出産日まで妊婦に投与され、及び出産日から６ヶ月間新生児若しくは乳幼児に投与されるように用いられることを特徴とする、ビフィズス菌を有効成分として含有する乳幼児のアレルギー疾患の予防剤。
項２） ビフィズス菌がビフィドバクテリウム・ロンガム ＡＴＣＣ ＢＡＡ−９９９株及びビフィドバクテリウム・ブレーベ ＬＭＧ ２３７２９株からなる群から選択される少なくとも１種である、項１の予防剤。
項３） 乳幼児が人工栄養中心で育てられた乳幼児及び／又は家族アレルギー歴の無い乳幼児である、項１又は２の予防剤。
項４） アレルギー疾患が乳児湿疹、アトピー性皮膚炎、花粉症、アレルギー性鼻炎、食物アレルギー、気管支喘息、及びアレルギー性結膜炎からなる群から選択される少なくとも１種である、項１〜３のいずれかの予防剤。
項５） 項１〜４のいずれかの予防剤、及び薬学的に許容される担体を含む、乳幼児のアレルギー疾患の予防用医薬組成物。
項６） 項１〜４のいずれかの予防剤を含有する妊産婦・授乳婦用又は乳幼児用の栄養組成物。
This indication which solves the above-mentioned subject provides the invention of claim 1-6.
Item 1) Bifidobacteria, characterized in that bifidobacteria are administered to pregnant women from 4 weeks before the expected date of birth to the date of delivery, and to be administered to newborns or infants for 6 months from the date of delivery. A preventive agent for allergic diseases of infants and toddlers as an active ingredient
Item 2) The preventive agent according to Item 1, wherein the Bifidobacterium is at least one selected from the group consisting of Bifidobacterium longum ATCC BAA-999 strain and Bifidobacterium breve LMG 23729 strain.
Item 3) The preventive agent according to Item 1 or 2, wherein the infant is an infant raised with an artificial nutrition center and / or an infant with no family allergy history.
Item 4) Any one of Items 1 to 3, wherein the allergic disease is at least one selected from the group consisting of infant eczema, atopic dermatitis, hay fever, allergic rhinitis, food allergy, bronchial asthma, and allergic conjunctivitis Preventive agent.
Item 5) A pharmaceutical composition for preventing allergic diseases in infants, comprising the preventive agent according to any one of Items 1 to 4 and a pharmaceutically acceptable carrier.
Item 6) A nutritional composition for a pregnant or lactating woman or infant containing the preventive agent according to any one of Items 1 to 4.
本発明によれば、乳幼児のアレルギー予防に有効な薬剤、食品などを提供することができる。 ADVANTAGE OF THE INVENTION According to this invention, the chemical | medical agent, foodstuff, etc. which are effective in the prevention of allergies of infants can be provided.
また、本発明は、乳幼児、特に乳児においてアレルギーの発症を予防することができる。 In addition, the present invention can prevent the development of allergy in infants, particularly infants.
アレルギー体質やアトピー素因を持っている乳幼児は、乳児湿疹、アトピー性皮膚炎、食物アレルギーから、気管支喘息、アレルギー性鼻炎、アレルギー性結膜炎など年齢が進むにつれ、アレルギー性疾患を次から次へ発症（アレルギーマーチ）していく可能性が大きいが、本発明では乳幼児のアレルギー疾患の発症を抑制できるので、アレルギー体質やアトピー素因を持っている乳幼児でもアレルギー疾患の罹患率を低減することができる。 Infants with an allergic predisposition or atopic predisposition develop allergic diseases from one to the next as their age progresses from infant eczema, atopic dermatitis, food allergies, bronchial asthma, allergic rhinitis, allergic conjunctivitis ( However, in the present invention, since the onset of allergic diseases in infants can be suppressed, the prevalence of allergic diseases can be reduced even in infants having an allergic constitution or atopic predisposition.
特に家族アレルギー歴がないの乳幼児の場合、有病率が極めて低く、生後４ヶ月の時点では１０％程度であるが、生後１０ヶ月或いは１歳６ヶ月の時点では、アレルギー疾患の有病率をほぼゼロに抑制できる。 Especially in infants who have no history of family allergies, the prevalence is very low, about 10% at the age of 4 months, but at the age of 10 months or 1 year and 6 months, the prevalence of allergic diseases It can be suppressed to almost zero.
また、妊産婦にアレルギー歴がない場合でも、乳幼児の有病率を大幅に低下することができる。 Moreover, even if the pregnant woman has no history of allergies, the prevalence of infants can be greatly reduced.
さらに、本発明の予防剤は、人工栄養（粉ミルク）中心で育てられた乳幼児の有病率を大きく低下させることができる。従って、本発明の予防剤は、人工栄養と組み合わせて使用した場合により有効である。 Furthermore, the preventive agent of the present invention can greatly reduce the prevalence of infants raised mainly in artificial nutrition (powdered milk). Therefore, the preventive agent of the present invention is more effective when used in combination with artificial nutrition.
次に、本発明の好ましい実施形態について詳細に説明する。ただし、本発明は以下の好ましい実施形態に限定されず、本発明の範囲内で自由に変更することができるものである。尚、本明細書において百分率は特に断りのない限り質量による表示である。 Next, a preferred embodiment of the present invention will be described in detail. However, the present invention is not limited to the following preferred embodiments, and can be freely changed within the scope of the present invention. In the present specification, percentages are expressed by mass unless otherwise specified.
本発明の乳幼児のアレルギー疾患の予防剤の有効成分は、ビフィズス菌（ビフィドバクテリウム属細菌）からなる群から選ばれる少なくとも１種であり、２種以上のビフィズス菌を用いることがより好ましい。 The active ingredient of the preventive agent for infant allergic diseases of the present invention is at least one selected from the group consisting of bifidobacteria (bifidobacteria), and it is more preferable to use two or more bifidobacteria.
ビフィズス菌としては、ビフィドバクテリウム・インファンティス（Bifidobacterium infantis）、ビフィドバクテリウム・ブレーベ（Bifidobacterium breve）、ビフィドバクテリウム・ロンガム（Bifidobacterium longum）、ビフィドバクテリウム・ビフィダム（Bifidobacterium bifidum）などに属するビフィズス菌が挙げられる。 Bifidobacterium includes Bifidobacterium infantis, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium bifidum Bifidobacteria belonging to the above and the like.
例示されるビフィズス菌の菌株としては、具体的には、ビフィドバクテリウム・ロンガム ＡＴＣＣ ＢＡＡ−９９９（製品名：Ｂｉｆｉｄｏｂａｃｔｅｒｉｕｍ ｌｏｎｇｕｍ ＢＢ５３６、森永乳業社製。）、ビフィドバクテリウム・ブレベ ＬＭＧ ２３７２９（製品名：Ｂｉｆｉｄｏｂａｃｔｅｒｉｕｍ ｂｒｅｖｅ Ｍ−１６Ｖ、森永乳業社製。）等を使用することが好ましい。 Specific examples of Bifidobacterium strains include Bifidobacterium longum ATCC BAA-999 (product name: Bifidobacterium longum BB536, manufactured by Morinaga Milk Industry Co., Ltd.), Bifidobacterium breve LMG 23729 (product) Name: Bifidobacterium breve M-16V, manufactured by Morinaga Milk Industry Co., Ltd.) is preferably used.
本発明の有効成分であるビフィズス菌は、生菌、死菌又はその菌体処理物のいずれでもよいが、生菌であるのが好ましい。ビフィズス菌は、発酵物（乳酸菌飲料、ヨーグルトなど）として摂取してもよいが、菌体の凍結乾燥物又はこれを含むタブレット等のサプリメント等として摂取するのが好ましい。 The bifidobacteria which is an active ingredient of the present invention may be live bacteria, killed bacteria or treated cells thereof, but is preferably live bacteria. Bifidobacteria may be ingested as a fermented product (lactic acid bacteria beverage, yogurt, etc.), but is preferably ingested as a lyophilized product of a bacterial cell or a supplement such as a tablet containing the same.
また、ビフィズス菌は、１種の菌株を単独で摂取してもよく、２種以上の菌株を組み合わせて摂取してもよい。 In addition, bifidobacteria may be ingested as a single strain alone or in combination of two or more strains.
本発明の乳幼児のアレルギー疾患の予防剤は、有効成分であるビフィズス菌を、出産予定日の４週前から出産日まで妊産婦に投与され、及び出産日から６ヶ月間新生児若しくは乳児に投与されるように用いられることが好ましい。 In the preventive agent for infant allergic diseases of the present invention, bifidobacteria, which is an active ingredient, is administered to pregnant women from 4 weeks before the expected date of birth to the date of delivery, and is administered to newborns or infants for 6 months from the date of delivery. It is preferable to be used.
すなわち、本発明の予防剤は、従来のような適用対象である出生後の新生児又は乳幼児にのみ投与されるのではなく、出産前の妊産婦にも投与され、継続的に出生後の新生児又は乳幼児にも投与されることによって、乳幼児のアレルギー疾患の発症を効果的に予防できることを特徴としている。 That is, the prophylactic agent of the present invention is not only administered to a newborn or infant after birth, which is a target for application as in the prior art, but is also administered to a pregnant woman before birth, and is continuously administered to a newborn or infant after birth. Is also characterized in that it can effectively prevent the onset of allergic diseases in infants.
投与の頻度は、毎日（１日１回、２回又は３回）、２日に１回、３日に１回、４日に１回、１週間に１回程度の割合で投与されることが好ましい。 The frequency of administration should be daily (once, twice or three times a day), once every two days, once every three days, once every four days, once a week. Is preferred.
また、ビフィズス菌の投与量は、妊産婦及び乳幼児１回当たり１×１０7〜１×１０13個（CFU）程度であり、好ましくは１×１０9〜１×１０11個（CFU）程度であることが好ましい。 The dose of bifidobacteria is about 1 × 10 7 to 1 × 10 13 (CFU), preferably about 1 × 10 9 to 1 × 10 11 (CFU) per pregnant woman and infant. It is preferable.
本発明の予防剤の投与期間は、妊産婦に投与される場合は、出産予定日前約１ヶ月間（約４週間）、乳幼児に投与される場合には、出生後、例えば１日、１週間、１ヶ月、２ヶ月、３ヶ月、４ヶ月、５ヶ月、６ヶ月、７ヶ月、８ヶ月、９ヶ月、１０ヶ月、１１ヶ月、１２ヶ月、１８ヶ月（１．５年）、２４ヶ月（２年）、３６ヶ月（３年）、４８ヶ月（４年）、６０ヶ月（５年）、或いはそれ以上の期間が挙げられ、特に妊産婦の出産予定日前１ヶ月間（４週間）、乳児の出生後６ヶ月間の期間に投与されることが好ましい。 The administration period of the prophylactic agent of the present invention is about 1 month (about 4 weeks) before the expected delivery date when administered to a pregnant woman, and after birth, for example, 1 day, 1 week, when administered to an infant. 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 18 months (1.5 years), 24 months (2 years) ), 36 months (3 years), 48 months (4 years), 60 months (5 years) or longer, especially one month (4 weeks) before the expected delivery date of the pregnant woman, after the baby's birth Preferably it is administered in a period of 6 months.
なお、本発明の予防剤は、出産後の授乳婦においても、引き続き投与を継続しても良い。 The prophylactic agent of the present invention may be continuously administered even to a lactating woman after delivery.
これらの期間において、ビフィズス菌が投与されることで、乳児湿疹／アトピー性皮膚炎の発症を予防でき、その後の一連のアレルギー疾患の罹患（アレルギーマーチ）を予防することができる。 By administering bifidobacteria during these periods, it is possible to prevent the development of infant eczema / atopic dermatitis, and the subsequent series of allergic diseases (allergy march).
なお、本発明の予防剤は、出産前の妊婦の段階から投与を開始し、出生後の新生児又は乳児に継続的に投与されることが好ましいが、既にアレルギー疾患を発症しているヒト（乳幼児）に投与することで、現在の症状を緩和したり、それ以上のアレルギー疾患の発症を予防し、もしくは発症した場合であってもその症状を軽減・緩和することができる。 It should be noted that the prophylactic agent of the present invention is preferably administered to a newborn or infant after birth starting from the stage of a pregnant woman before childbirth. ) Can be used to alleviate current symptoms, prevent further allergic diseases from occurring, or reduce or alleviate the symptoms even if they occur.
本発明の予防剤の剤形としては、例えば経口投与の場合、散剤、顆粒剤、錠剤、カプセル剤などの固形製剤；溶液剤、シロップ剤、懸濁剤、乳剤などの液剤；等が挙げられる。また、非経口投与の場合、座剤、軟膏剤、噴霧剤等が挙げられる。 Examples of the dosage form of the preventive agent of the present invention include, for example, oral preparations, solid preparations such as powders, granules, tablets and capsules; solutions such as solutions, syrups, suspensions and emulsions; . In the case of parenteral administration, suppositories, ointments, sprays and the like can be mentioned.
妊婦に投与される場合は、前記剤形のいずれの態様であっても可能であり、乳幼児に投与される場合であれば、シロップ剤等の液剤、錠剤、顆粒剤、カプセル剤、散剤、丸剤等の剤形で投与されることが好ましい。 When administered to pregnant women, any form of the above-mentioned dosage forms is possible, and when administered to infants, liquids such as syrups, tablets, granules, capsules, powders, rounds It is preferably administered in a dosage form such as an agent.
生後間もない乳児に投与される場合には、サシェなどに包装されたビフィズス菌を含む予防剤（菌体）の粉末を、乳児の口内に指などで塗りつけてもよい。また、坐剤として投与してもよく、粉ミルクなどに混合してその他の栄養成分とともに乳児に摂取させてもよい。 When administered to an infant shortly after birth, a powder of a preventive agent (bacteria) containing bifidobacteria packaged in a sachet or the like may be applied to the infant's mouth with a finger or the like. Alternatively, it may be administered as a suppository, or mixed with powdered milk or the like and taken by an infant together with other nutritional components.
本発明の予防剤において、発症予防の対象となるアレルギー疾患としては、乳児湿疹、アトピー性皮膚炎、花粉症、アレルギー性鼻炎、食物アレルギー、気管支喘息、アレルギー性結膜炎、アレルギーマーチなどが挙げられる。予防の対象は、アレルギーマーチの阻止のためには、新生児／乳児の段階でのアレルギー疾患の予防が特に重要であり、乳児湿疹、アトピー性皮膚炎、食物アレルギーなどを発症させないことが重要であり、気管支喘息の予防も重要である。 In the prophylactic agent of the present invention, examples of allergic diseases to be prevented from onset include infant eczema, atopic dermatitis, hay fever, allergic rhinitis, food allergy, bronchial asthma, allergic conjunctivitis, and allergy march. For prevention of allergy march, prevention of allergic diseases at the neonatal / infant stage is particularly important, and it is important not to cause infant eczema, atopic dermatitis, food allergies, etc. Prevention of bronchial asthma is also important.
花粉症は３歳前後で発症例が徐々に増加するが、出生後すぐにビフィズス菌の投与を開始することで、出生後６ヶ月程度でビフィズス菌の投与を中止した場合であっても、アレルギーマーチを予防でき、花粉症などのアレルギー疾患に罹りにくい体質にすることが可能である。 Although hay fever gradually increases around 3 years old, administration of bifidobacteria starts immediately after birth, and even if bifidobacteria administration is discontinued about 6 months after birth, allergies can occur. The march can be prevented, and it is possible to make the constitution less susceptible to allergic diseases such as hay fever.
従って、少なくとも妊婦或いは新生児（生後６ヶ月程度まで）にビフィズス菌を投与することで、気管支喘息、花粉症、アレルギー性鼻炎、アレルギー性結膜炎など子供の成長に伴って増え始めるアレルギー疾患を長期にわたって予防可能である。 Therefore, by administering bifidobacteria to at least pregnant women or newborns (up to about 6 months after birth), long-term prevention of allergic diseases that begin to increase with the growth of children such as bronchial asthma, hay fever, allergic rhinitis, and allergic conjunctivitis Is possible.
本発明の予防剤は、両親、兄弟姉妹、祖父、祖母などの近親者にアレルギー疾患の患者がいるような高リスクの被験体に対する十分な予防効果を有する。なかでも、近親者にアレルギー患者のいない（家族アレルギー歴のない）乳幼児に対し、特に強力な予防効果を有する。 The prophylactic agent of the present invention has a sufficient preventive effect on high-risk subjects such as parents, siblings, grandfathers, grandmothers and other close relatives who have patients with allergic diseases. Especially, it has a particularly powerful preventive effect on infants whose relatives do not have allergic patients (no history of family allergies).
例えば図２に示すように、家族アレルギー歴の無い妊婦（出産前４週間）と乳児（生後６ヶ月間）にビフィズス菌を投与することで、生後１０ヶ月、生後１８ヶ月（１．５歳）の時点でアレルギー疾患の罹患が完全に抑制できるという驚くべき効果が得られる。 For example, as shown in FIG. 2, 10 months after birth and 18 months after birth (1.5 years) by administering bifidobacteria to pregnant women (4 weeks before childbirth) and infants (6 months after birth) who have no family allergies As a result, the surprising effect that the allergic disease can be completely suppressed can be obtained.
さらに妊産婦にアレルギー歴が無い場合であっても、顕著なアレルギー予防効果が得られる。 Furthermore, even if the pregnant woman has no history of allergy, a significant allergy prevention effect can be obtained.
本発明の予防剤は、アレルギーの予防効果を高めるために、特に新生児あるいはそれに近い段階からの摂取又は投与が望まれる。また、ペットの飼育や性別（男の子にアレルギー疾患は多く発症する）などもアレルギー疾患の発症のリスクファクターになる。 The preventive agent of the present invention is particularly desired to be taken or administered from a newborn or a stage close thereto in order to enhance the effect of preventing allergy. Breeding and sex of pets (allergic diseases are more common among boys) are also risk factors for the development of allergic diseases.
本発明の予防剤は、医薬品又は医薬部外品等の医薬組成物、飲食品、育児用ミルク、乳幼児用調製粉乳、妊産婦用食品、健康食品、栄養機能食品、サプリメント、ペットフード又はペット用サプリメント、飼料等に含有させて有利に用いることができる。 The preventive agent of the present invention is a pharmaceutical composition such as pharmaceuticals or quasi-drugs, food and drink, infant milk, infant formula, maternal food, health food, nutritional functional food, supplement, pet food or pet supplement. It can be advantageously used by containing it in feed.
特に、育児用ミルク、乳幼児用調製粉乳等の乳幼児用の栄養組成物、及び妊産婦授乳婦用の栄養組成物、例えば、乳児用粉ミルク、フォローアップミルク、アレルギー用ミルク等の特殊ミルク、ビフィズス菌（生菌）利用食品、妊娠授乳期のお母さん用ペプチドミルク・タブレット、マタニティー食品等に本発明の予防剤の有効成分であるビフィズス菌を添加することによって、乳幼児、特に乳児においてアレルギーの発症を効果的に予防することが可能な栄養組成物を提供することが可能である。 In particular, nutritional compositions for infants, such as infant formula, infant formula, and other nutritional compositions for pregnant and lactating women, such as infant formula, follow-up milk, special milks such as allergy milk, bifidobacteria ( By adding bifidobacteria, the active ingredient of the preventive agent of the present invention, to foods used, peptide milk tablets for mothers in pregnancy and lactation, maternity foods, etc., it is effective for allergies in infants, especially infants It is possible to provide a nutritional composition that can be prevented.
本発明の予防剤をアレルギー疾患の予防用の医薬組成物、栄養組成物、又はサプリメントとして用いる場合は、薬学的に許容される通常の担体、結合剤、安定化剤、賦形剤、希釈剤、ｐＨ緩衝剤、口腔崩壊剤、可溶化剤、溶解補助剤、等張剤などの各種調剤用配合成分を添加することができる。 When the preventive agent of the present invention is used as a pharmaceutical composition, a nutritional composition, or a supplement for preventing allergic diseases, a normal pharmaceutically acceptable carrier, binder, stabilizer, excipient, diluent Various formulation ingredients such as pH buffering agents, oral disintegrating agents, solubilizers, solubilizing agents, and isotonic agents can be added.
また、本発明の予防剤の投与形態として用いられる食品や食品素材の種類としては特に制限されず、例えば、ヨーグルト、ドリンクヨーグルトなどの乳酸菌もしくはビフィズス菌の発酵飲料、発酵食品などが挙げられる。 Moreover, it does not restrict | limit especially as the kind of foodstuff and food material used as a dosage form of the preventive agent of this invention, For example, fermented drinks, fermented foods, etc. of lactic acid bacteria or bifidobacteria, such as yogurt and a drink yogurt, etc. are mentioned.
以下に実施例を用いて本発明をさらに詳しく説明するが、本発明はこれら実施例に限定されるものではない。 Hereinafter, the present invention will be described in more detail using examples, but the present invention is not limited to these examples.
＜実施例１＞
妊婦及び新生児に対するビフィズス菌介入試験
１６０名の妊婦および生まれてきた１６０名の乳幼児を対象に下記の試験を行った。
<Example 1>
Bifidobacteria intervention test for pregnant women and newborns The following tests were conducted on 160 pregnant women and 160 newborn infants.
ビフィズス菌製剤：ビフィドバクテリウム・ロンガム（B. longum）BB536 （森永乳業社製）及びビフィドバクテリウム・ブレーベ（B. breve）M-16V（森永乳業社製）の凍結乾燥物を、各々１包あたり約５０億（5×10９）の菌数が含まれる。 Bifidobacteria preparations: Bifidobacterium longum BB536 (Morinaga Milk Industry) and B. breve M-16V (Morinaga Milk Industry) About 5 billion (5 × 10 9 ) bacteria are included per pack.
ビフィズス菌製剤の投与は、妊婦の場合には出産予定日の４週間前から出産日まで、新生児は出生１週後から６ヶ月まで毎日した。 In the case of a pregnant woman, the bifidobacteria preparation was administered from 4 weeks before the expected date of birth to the date of birth, and for newborns from 1 week after birth until 6 months.
ビフィズス菌製剤は、妊婦では１日２包を投与し、乳幼児の場合には、１日１包を投与した。ビフィズス菌製剤の投与は、妊婦は牛乳または水に溶かして飲むか、または直接粉末を口に入れて牛乳または水で飲むかで行い、乳児は母乳または育児粉乳またはお白湯に溶かして飲ませた。乳幼児は、サシェの菌体凍結乾燥物を口内粘膜に塗りつけることにより投与した。 The bifidobacteria preparation was administered in two pills per day for pregnant women, and in the case of infants, one pill was administered per day. Bifidobacteria preparations were administered by dissolving pregnant women in milk or water, or by directly putting powder in their mouth and drinking with milk or water, and infants dissolved in breast milk, infant formula or white water . Infants were administered by applying a sachet lyophilized product to the oral mucosa.
アレルギー疾患の発症は、生後４ヶ月、１０ヶ月、１８ヶ月（１．５歳）の時点で問診により行った。 The onset of allergic diseases was conducted through interviews at the age of 4 months, 10 months, and 18 months (1.5 years).
ビフィズス菌製剤の投与を受け入れた妊婦の新生児はビフィズス菌製剤の投与を継続し、ビフィズス菌製剤の投与を断った妊婦の新生児はビフィズス菌製剤を投与しない比較対照とした。アレルギー疾患の発症の有無は、医師による問診・診察を併用して行った。 Newborn infants who received bifidobacteria preparations continued to receive bifidobacterial preparations, and newborn infants who refused to administer bifidobacteria preparations served as comparative controls that did not receive bifidobacteria preparations. The presence or absence of allergic diseases was determined by a doctor's interview and medical examination.
アンケート又は診断を行った乳幼児の数を以下に示し、結果を図１〜３に示す。 The number of infants who conducted a questionnaire or diagnosis is shown below, and the results are shown in FIGS.
図１の結果から、妊婦及び新生児におけるビフィズス菌の投与は、１０ヶ月以降の乳児における乳児湿疹／アトピー性皮膚炎の発症率（有病率）を有意に抑えることが明らかになった。 From the results of FIG. 1, it became clear that administration of bifidobacteria in pregnant women and newborns significantly suppressed the incidence (prevalence) of infant eczema / atopic dermatitis in infants after 10 months.
図２の結果から、妊婦及び新生児におけるビフィズス菌の投与は、家族アレルギー歴を持っていない乳幼児、及び妊婦アレルギー歴のない乳幼児において、特にアレルギーの予防に効果があることが明らかになった。湿疹・アトピー性皮膚炎歴を持たない妊婦から生まれてきた乳幼児に対して、ビフィズス菌の効果がより顕著であった。 From the results of FIG. 2, it became clear that administration of bifidobacteria in pregnant women and newborns is particularly effective in preventing allergies in infants who have no family allergy history and infants who have no history of allergy to pregnant women. The effect of bifidobacteria was more pronounced for infants born to pregnant women who had no history of eczema / atopic dermatitis.
図３の結果から、妊婦及び新生児におけるビフィズス菌の投与は、母乳栄養中心の乳幼児ではアレルギー予防について有意な差はなかったが、人工栄養中心の場合には有病率を劇的に低下させることが明らかになった。従って、本発明のアレルギー予防剤は、粉ミルクなどの人工栄養と組み合わせて摂取するのが特に有効である。 From the results of FIG. 3, the administration of bifidobacteria in pregnant women and newborns did not significantly differ in allergy prevention in breastfeeding infants, but dramatically reduced the prevalence in the case of artificial nutrition. Became clear. Therefore, the allergy preventing agent of the present invention is particularly effective when taken in combination with artificial nutrition such as powdered milk.
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