黑升麻治疗更年期症状的疗效及安全性的特异性证据的差.pdfVIP

黑升麻治疗更年期症状的疗效及安全性的特异性证据的差 异化评估 Differentiated Evaluation of Extract-Specific Evidence on Cimicifuga racemosa´s Efficacy and Safety for Climacteric Complaints A.-M. Beer 1, A. Neff 2 1 Department of Naturopathy, Blankenstein Hospital, Im Vogelsang 5-11, 45527 Hattingen, Germany 2 Department of Gynecology, Lübbecke-Hospital, Virchowstr. 65, 32312 Lübbecke, Germany 摘要 既往关于黑升麻 （Cimicifuga racemosa，CR ）的综述并未根据萃取物种类、质量及 适应症进行分类，故数据前后不一致。在整合了萃取物、药品质量(反映在药品管理状 态)及适应症等信息后，我们首次系统地进行了循证医学研究。 我们检索了CR治疗更年期症状疗效和安全性的临床研究相关文献。结果按萃取物、 药品管理状态及适应症进行分类，最后确定相应的牛津证据等级(Oxford Levels of Evidence ，LOE)和推荐等级（Grades of Recommendation，GR ）。 总体来说CR 萃取物对于雌激素敏感脏器及肝脏的安全性良好或非常好。然而，只 有已注册的CR 药品能够证实其疗效。最佳证据来自黑升麻提取物（iCR ）：大量研究 共包括了超过11000 例患者，结果一致证实其证据等级为1b （安全性LOE 为1a），推 荐等级为A 。乙醇提取物BNO 1055 的相关研究包括了超过500 例患者，证据等级为仍 有待进一步确认的2b ，推荐等级为B 。 CR 产品获准上市以治疗更年期症状的获益-风险比大于1 但仍证据有限。 关键词：黑升麻-疗效-安全性-更年期症状-证据 Abstract Past reviews on Cimicifuga racemosa (CR) without differentiation between extracts, quality and indication altogether led to inconsistent data. Therefore, for the first time, we meet the requirements of the system´s logic of evidence-based phytotherapy by taking into consideration extracts, pharmaceutical quality (reflected in a regulatory status as medicinal product) and indication. A literature search for clinical studies examining CR´s efficacy and safety for menopausal complaints was conducted. The results were sorted by type of extract, regulatory status and indication. Accordingly, Oxford Levels of Evidence (LOE) and Grades of Recommendation (GR) were determined. CR-extracts demonstrated a good to very good safety in general, on estrogen-sensitive organs and the liver. However, only registered CR medicinal products were able to prove their efficacy. Best evidence was provided by the isopropanolic CR extract (iCR): the multitude of studies including more than 11,000 patients demonstrated consistent confirmat