毒理性
◉ 母乳喂养期间使用概述：羊毛脂是一种从羊毛衣中提取的黄色脂肪。它传统上被局部用于治疗母乳喂养期间的疼痛、裂开的乳头。高度纯净的羊毛脂产品（例如，HPA羊毛脂、Lansinoh）去除了农药和洗涤剂残留，并将天然游离醇降低到1.5%以下，以提高安全性和减少过敏潜力。然而，即使是高度纯净的羊毛脂也应该避免用于已知对羊毛过敏的患者。
羊毛脂似乎对预防母乳喂养期间的乳头疼痛和治疗有效，但不是作为分娩前的预防措施。大多数使用Lansinoh的研究并未发现羊毛脂在疗效上始终与涂抹母乳、水凝胶敷料、薄荷凝胶、芦荟或热敷有所不同。一项荟萃分析得出结论，涂抹无物或母乳可能优于羊毛脂，但缺乏良好研究。一项小型非盲研究发现，与羊毛脂相比，橄榄油更能预防乳头疼痛，另一项小型单盲研究发现，与常规护理相比，涂抹羊毛脂到疼痛乳头上并未减少乳头疼痛。一项针对乳头受伤和疼痛的妇女进行研究，比较了每次喂养后涂抹羊毛脂与涂抹母乳加乳头壳的效果，发现母乳和壳比羊毛脂更有效。一项随机研究比较了高度纯净的羊毛脂（Lansinoh）与180位母亲的挤奶母乳，发现羊毛脂在7天内减少疼痛和乳头创伤评分方面优于母乳。两项中等质量的研究发现，芦荟和马齿苋在治疗母乳喂养期间的乳头疼痛方面比羊毛脂更有效。
一项比较各种高度纯净羊毛脂产品的研究发现，HPA羊毛脂（Lansinoh Laboratories Inc.）、Purelan（Medela AG）和两种符合欧盟专论的羊毛脂成分（Pharmalan PH EU-SO-(RB) 和 Corona-8 SO-(RB)（Croda, Goole, UK））。欧盟专论合规成分的污染物水平最低。HPA羊毛脂含有极低水平的游离羊毛脂醇，表明其净化水平很高，比Purelan低四倍。HPA羊毛脂不含有任何可检测的农药残留。Purelan含有多项农药残留（地亚农、胡椒基丁氧基、三氟甲脲）；然而，这些水平很低且在允许的限度内。
◉ 对母乳喂养婴儿的影响：截至修订日期，未找到相关信息。
◉ 对泌乳和母乳的影响：在一项随机双盲试验中，羊毛脂与一种含有1%莫匹罗星、0.05%倍他米松和2%咪康唑的全效乳头软膏进行了比较，用于治疗产后前两周哺乳时的疼痛乳头。两种治疗方法在减少乳头疼痛、乳头愈合时间、母乳喂养持续时间、母乳喂养专一率、乳腺炎和乳头症状、副作用或对治疗的满意度方面同样有效。
一项针对哺乳期妇女进行的随机试验比较了涂抹羊毛脂与常规护理，后者是教育或由卫生专业人员提供的援助、涂抹温暖或冷敷料、止痛药、空气干燥乳头或使用乳房护盾的可变混合。一名盲观察者通过电话多次联系母亲以评估愈合情况。在随机分组后4至7天内，两组之间未发现乳头疼痛的差异。在随机分组后4天，未发现母乳自我效能的差异，或在产后4周和12周，两组的母乳喂养率无差异。接受羊毛脂的妇女对护理的满意度更高。
◉ Summary of Use during Lactation:Lanolin is a yellow fat obtained from sheep's wool. It has traditionally been used topically to treat sore, cracked nipples during breastfeeding. Highly purified lanolin products (e.g., HPA lanolin, Lansinoh) have the pesticide and detergent residues removed and the natural free alcohols reduced to below 1.5% to improve safety and reduce the allergic potential. However, even highly-purified lanolin should be avoided in patients with a known allergy to wool.
Lanolin appears to be effective for the prevention and treatment of nipple pain during breastfeeding, but not as a preventative initiated before delivery. Studies, most of which used Lansinoh, have not found lanolin to be consistently different in efficacy from application of breastmilk, hydrogel dressings, peppermint gel, aloe vera or warm compresses. A meta-analysis concluded that application of nothing or breastmilk may be superior to lanolin, but good studies are lacking. One small nonblinded study found olive oil to be superior to lanolin for prevention of sore nipples, and another small, single-blinded study found that lanolin application to painful nipples did not decrease nipple pain compared to usual care. A study in women with nipple trauma and pain comparing application of lanolin after each feeding to application of breastmilk plus a nipple shell found that the breastmilk and shell were more effective than lanolin. A randomized study comparing highly purified lanolin (Lansinoh) to expressed breastmilk in 180 mothers, found lanolin to be superior to breastmilk over a 7-day period in reducing pain and the nipple trauma score. Two studies of moderate quality found aloe vera and purslane to be more effective than lanolin in treating sore nipples during breastfeeding.
A study comparing the various highly purified lanolin products found that HPA lanolin (Lansinoh Laboratories Inc.), Purelan (Medela AG) and two lanolin EU monograph compliant ingredients (Pharmalan PH EU-SO-(RB) and Corona-8 SO-(RB) (Croda, Goole, UK). The EU monograph compliant ingredients had the lowest level of contaminants. HPA lanolin contained an extremely low level of free lanolin alcohols, indicating a high level of purification, which was fourfold lower than Purelan. The HPA lanolin did not contain any detectable pesticide residues. Purelan contained a number of pesticide residues (diazinon, piperonyl butoxide, triflumuron); however, the levels were low and within the permitted limits.
◉ Effects in Breastfed Infants:Relevant published information was not found as of the revision date.
◉ Effects on Lactation and Breastmilk:In a randomized, double-bind trial, lanolin was compared to an all-purpose nipple ointment containing mupirocin 1%, betamethasone 0.05%, and miconazole 2% for painful nipples while nursing in the first 2 weeks postpartum. The two treatments were equally effective in reducing nipple pain, nipple healing time, breastfeeding duration, breastfeeding exclusivity rate, mastitis and nipple symptoms, side effects or maternal satisfaction with treatment.
A randomized trial in nursing women with damaged, painful nipples compared lanolin application to usual care, which was a variable mix of education or assistance by health professional, application of warm or cool compresses, analgesics, air drying the nipples or the use of breast shields. A blinded observer assessed healing via telephone calls to the mothers several times after randomization. No differences were found in nipple pain between the groups 4 to 7 days after randomization. No difference was found in breastfeeding self-efficacy at 4 days post-randomization or in the breastfeeding rates of the two groups at 4 and 12 weeks postpartum. Patient satisfaction with care was higher in the women who received lanolin.
来源:Drugs and Lactation Database (LactMed)
