毒理性
◉ 母乳喂养期间使用概述:牡丹(芍药属)根部含有芍药苷,被认为是降低血清催乳素的主要成分。其他成分包括白芍药苷、苯甲酰芍药苷、甘草素、黄酮类、原花青素、单宁、萜类、三萜类和复杂多糖。牡丹没有特定的与哺乳有关的用途。它最常用于治疗心脏病、月经不调、子宫肌瘤、关节炎和咳嗽,尽管支持这些用途的数据很薄弱。没有关于牡丹任何成分排入母乳的数据,也没有关于牡丹在哺乳母亲或婴儿中的安全性和有效性的数据。牡丹通常耐受性良好,但偶尔可能导致胃肠道不适,以及皮肤过敏反应,特别是在外用时。牡丹可以降低血清催乳素,因此可能会抑制泌乳;因此,在哺乳期间最好避免使用牡丹。
膳食补充剂不需要美国食品药品管理局的广泛市场前批准。制造商负责确保产品的安全性,但不需要在上市前证明膳食补充剂的安全性和有效性。膳食补充剂可能含有多种成分,标签成分和实际成分或其含量之间经常存在差异。制造商可以与独立组织签订合同,以验证产品或其成分的质量,但这并不证明产品的安全性和有效性。由于上述问题,一个产品的临床测试结果可能不适用于其他产品。关于膳食补充剂的更详细信息可以在LactMed网站的其它地方找到。
◉ 对哺乳婴儿的影响:截至修订日期,没有找到相关已发表的信息。
◉ 对泌乳和母乳的影响:一种传统的、非标准化的牡丹和甘草根煎剂,在中国称为芍药甘草汤,在日本称为芍薬甘草汤,在一项研究中用于治疗因长期(>6个月)摄入利培酮而导致血清催乳素升高的女性。患者接受溴隐亭5毫克/日,连续服用4周,随后服用22.5克/日的牡丹甘草煎剂,连续服用4周,或者相反的药物顺序。评估血清催乳素发现,两种治疗方式在4周和8周时都将血清催乳素从基线降低了21%至28%。在已经建立泌乳的母亲中,催乳素水平可能不会影响她的哺乳能力。
◉ Summary of Use during Lactation:Peony (Paeonia sp.) root contains paeoniflorin which is thought to be the primary ingredient that decreases serum prolactin. Other ingredients include albiflorin, benzoylpaeoniflorin, liquiritin, flavonoids, proanthocyanidins, tannins, terpenoids, triterpenoids, and complex polysaccharides. Peony has no specific lactation-related uses. It is most commonly used to treat heart disease, menstrual irregularities, uterine fibroids, arthritis, and cough, although data supporting these uses is poor. No data exist on the excretion of any components of peony into breastmilk or on the safety and efficacy of peony in nursing mothers or infants. Peony is generally well tolerated, but can occasionally cause gastrointestinal upset, and allergic skin reactions, especially when applied topically. Peony can lower serum prolactin, so it might suppress lactation; therefore, it is probably best to avoid peony during breastfeeding.
Dietary supplements do not require extensive pre-marketing approval from the U.S. Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to prove the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does not certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information about dietary supplements is available elsewhere on the LactMed Web site.
◉ Effects in Breastfed Infants:Relevant published information was not found as of the revision date.
◉ Effects on Lactation and Breastmilk:A traditional, nonstandardized decoction of peony and licorice roots called Shaoyao-Gancao-Tang in Chinese and Shakuyaku-Kanzo-To in Japanese was studied in women with elevated serum prolactin caused by long-term (>6 months) ingestion of risperidone. Patients received either bromocriptine 5 mg daily for 4 weeks followed by 4 weeks of 22.5 grams daily of the peony-licorice decoction, or the same drugs in the reverse order. Evaluation of serum prolactin found that both treatments reduced serum prolactin by 21 to 28% from baseline at 4 and 8 weeks. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
来源:Drugs and Lactation Database (LactMed)