Gallo M, Sarkar M, Au W, Pietrzak K, Comas B, Smith M, Jaeger T V, Einarson A, Koren G
The Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, Canada M5G 1X8.
Arch Intern Med. 2000 Nov 13;160(20):3141-3. doi: 10.1001/archinte.160.20.3141.
Echinacea products are among the most popular phytomedicines on the North American market. Since at least half of all pregnancies are unplanned, many women inadvertently use echinacea in their first trimester. Presently, there is a paucity of information regarding the gestational safety of this herb. The primary objective of this study was to evaluate the safety of echinacea in pregnancy when used for upper respiratory tract ailments.
The study group consisted of women who were prospectively followed up after contacting the Motherisk Program regarding the gestational use of echinacea. This cohort was disease-matched to women exposed to nonteratogenic agents by maternal age, alcohol, and cigarette use. Rates of major and minor malformations between the groups were compared.
A total of 206 women were enrolled in the study group after using echinacea products during pregnancy; 112 women used the herb in the first trimester. There were a total of 195 live births, including 3 sets of twins, 13 spontaneous abortions, and 1 therapeutic abortion. Six major malformations were reported, including 1 chromosomal abnormality, and 4 of these malformations occurred with echinacea exposure in the first trimester. In the control group, there were 206 women with 198 live births, 7 spontaneous abortions, and 1 therapeutic abortion. Seven major malformations were reported. There were no statistical differences between the study and control groups for any of the end points analyzed.
This first prospective study suggests that gestational use of echinacea during organogenesis is not associated with an increased risk for major malformations.
紫锥菊产品是北美市场上最受欢迎的植物药之一。由于至少一半的怀孕是意外怀孕，许多女性在孕早期无意中使用了紫锥菊。目前，关于这种草药在妊娠期的安全性信息匮乏。本研究的主要目的是评估紫锥菊在孕期用于上呼吸道疾病时的安全性。
研究组由在联系Motherisk项目咨询紫锥菊孕期使用情况后接受前瞻性随访的女性组成。该队列根据产妇年龄、饮酒和吸烟情况与接触非致畸剂的女性进行疾病匹配。比较两组之间严重和轻微畸形的发生率。
共有206名女性在孕期使用紫锥菊产品后纳入研究组；112名女性在孕早期使用了这种草药。共有195例活产，包括3对双胞胎，13例自然流产和1例治疗性流产。报告了6例严重畸形，包括1例染色体异常，其中4例畸形发生在孕早期接触紫锥菊的情况下。对照组有206名女性，198例活产，7例自然流产和1例治疗性流产。报告了7例严重畸形。研究组和对照组在所分析的任何终点方面均无统计学差异。
这项首次前瞻性研究表明，在器官形成期孕期使用紫锥菊与严重畸形风险增加无关。
