Alsaad Abdulaziz M S, Fox Colleen, Koren Gideon
Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Hospital for Sick Children and University of Toronto, 555 University Ave, Toronto, ON, M5G 1X8, Canada.
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College street, Toronto, ON, M5S 3M2, Canada.
BMC Complement Altern Med. 2015 Mar 5;15:40. doi: 10.1186/s12906-015-0585-8.
The rates of muscle aches, sprains, and inflammation are significantly increased during pregnancy. However, women are afraid to use systemic analgesics due to perceptions of fetal risks. Thus, topical products are important alternatives to consider for those women. Of interest, Professional Therapy MuscleCare (PTMC) has shown to be effective in alleviating the myofascial pain as reported in a randomized, placebo-controlled double-blinded comparative clinical study of five topical analgesics. However, to date, there is no complete review or long-term safety studies on the safety of these products during pregnancy and lactation. Thus, the aim of this article was to review toxicological, developmental, and reproductive effects associated with the use of PTMC products.
We performed a systematic review on safety of PTMC from all toxicological articles investigating the effects of PTMC's ingredients. This search was conducted through medical and toxicological databases including, Web of Science, EMBASE, Medline, and Micromedix. Both reported and theoretical adverse effects were extensively reviewed.
Of the 1500 publications reviewed, 100 papers were retrieved and included in the review. Although some ingredients in PTMC products might cause adverse reproductive effects at high systemic doses, these doses are hundreds to thousands fold greater than those systemically available from topical use at the recommended maximum dose (i.e. 10 g/day).
This study provides evidence that, when used as indicated, PTMC is apparently safe for pregnant women and their unborn babies as well as for breastfed infants.
孕期肌肉疼痛、扭伤和炎症的发生率显著增加。然而，由于担心对胎儿有风险，女性不敢使用全身性镇痛药。因此，局部用产品是这些女性可考虑的重要替代选择。有趣的是，在一项对五种局部用镇痛药进行的随机、安慰剂对照双盲比较临床研究中，专业治疗肌肉护理产品（PTMC）已被证明在缓解肌筋膜疼痛方面有效。然而，迄今为止，尚无关于这些产品在孕期和哺乳期安全性的完整综述或长期安全性研究。因此，本文的目的是综述与使用PTMC产品相关的毒理学、发育和生殖影响。
我们对所有研究PTMC成分作用的毒理学文章中PTMC的安全性进行了系统综述。通过包括科学网、EMBASE、医学索引和Micromedix在内的医学和毒理学数据库进行了检索。对已报道的和理论上的不良反应都进行了广泛综述。
在检索的1500篇出版物中，有100篇论文被检索到并纳入综述。尽管PTMC产品中的一些成分在高全身剂量时可能会引起不良生殖影响，但这些剂量比按推荐最大剂量局部使用时全身可获得的剂量大数百至数千倍（即10克/天）。
本研究提供的证据表明，按指示使用时，PTMC对孕妇及其未出生的婴儿以及母乳喂养的婴儿显然是安全的。
