PDF(Pubmed)
Abstract：
OBJECTIVE: Vaginal oestrogens can be used to treat genitourinary symptoms in women with early breast cancer. Studies evaluating vaginal oestrogens have commonly measured serum oestrogen levels as a surrogate marker of safety, but methods vary. We sought to summarise the data on serum oestrogen measurement in women with breast cancer using vaginal oestrogens to better understand the methods, levels and reliability.
METHODS: We searched Medline, Embase, CENTRAL, SCOPUS and CINAHL from inception to October 2023 for clinical studies where serum oestrogen was measured in women with a history of early breast cancer using vaginal oestrogens. Studies with a reported testing methodology were included.
RESULTS: Nine studies met the inclusion criteria for this systematic review. Methods used to measure oestradiol and oestriol in selected studies included mass spectrometry and immunoassays; several studies used more than one with variable concordance. Mass spectrometry detected oestradiol levels down to a lower limit between 1.0 pg/mL and 3.0 pg/mL. Immunoassays such as ELISA (enzyme-linked immunosorbent assay), ECLIA (enhanced chemiluminiscence immunoassay) and RIA (radioimmunoassay) had lower detection limits ranging between 0.8 pg/mL and 10 pg/mL. Studies were heterogeneous in testing techniques used, timing of testing, and the population including with subsequent varying results in the effect on oestrogens reported.
CONCLUSIONS: Adopting consistent and standardised methods of measuring oestrogens in clinical trials involving women with early breast cancer on vaginal oestrogens is critical. Serum oestrogens are used as a surrogate marker of safety in this population, and good-quality data are necessary to enable clinicians and patients to feel confident in prescribing and taking vaginal oestrogens. Mass spectrometry, although more expensive, gives more reliable results when dealing with very low levels of oestrogens often found in women on aromatase inhibitors, compared to immunoassays.
METHODS: We searched Medline, Embase, CENTRAL, SCOPUS and CINAHL from inception to October 2023 for clinical studies where serum oestrogen was measured in women with a history of early breast cancer using vaginal oestrogens. Studies with a reported testing methodology were included.
RESULTS: Nine studies met the inclusion criteria for this systematic review. Methods used to measure oestradiol and oestriol in selected studies included mass spectrometry and immunoassays; several studies used more than one with variable concordance. Mass spectrometry detected oestradiol levels down to a lower limit between 1.0 pg/mL and 3.0 pg/mL. Immunoassays such as ELISA (enzyme-linked immunosorbent assay), ECLIA (enhanced chemiluminiscence immunoassay) and RIA (radioimmunoassay) had lower detection limits ranging between 0.8 pg/mL and 10 pg/mL. Studies were heterogeneous in testing techniques used, timing of testing, and the population including with subsequent varying results in the effect on oestrogens reported.
CONCLUSIONS: Adopting consistent and standardised methods of measuring oestrogens in clinical trials involving women with early breast cancer on vaginal oestrogens is critical. Serum oestrogens are used as a surrogate marker of safety in this population, and good-quality data are necessary to enable clinicians and patients to feel confident in prescribing and taking vaginal oestrogens. Mass spectrometry, although more expensive, gives more reliable results when dealing with very low levels of oestrogens often found in women on aromatase inhibitors, compared to immunoassays.
摘要：
目的：阴道雌激素可用于治疗早期乳腺癌女性的泌尿生殖系统症状。评估阴道雌激素的研究通常测量血清雌激素水平作为安全性的替代指标，但是方法各不相同。我们试图总结使用阴道雌激素对乳腺癌女性进行血清雌激素测量的数据，以更好地了解这些方法。水平和可靠性。
方法：我们搜索了Medline，Embase,中部,SCOPUS和CINAHL从开始到2023年10月，用于临床研究，其中使用阴道雌激素测量有早期乳腺癌病史的女性的血清雌激素。包括报告的测试方法的研究。
结果：9项研究符合本系统综述的纳入标准。在选定的研究中，用于测量雌二醇和雌三醇的方法包括质谱法和免疫测定法；几项研究使用了多个具有可变一致性的研究。质谱检测到雌二醇水平低至1.0pg/mL和3.0pg/mL之间的下限。免疫测定，如ELISA（酶联免疫吸附测定），ECLIA（增强化学发光免疫测定）和RIA（放射免疫测定）的检测下限在0.8pg/mL至10pg/mL之间。研究在使用的测试技术上是不同的，测试时间，和人群，包括随后对雌激素的影响的不同结果。
结论：在涉及早期乳腺癌女性的临床试验中，采用一致和标准化的方法测量雌激素对阴道雌激素是至关重要的。血清雌激素被用作该人群安全性的替代标记，高质量的数据对于临床医生和患者在处方和服用阴道雌激素方面有信心是必要的。质谱,虽然更贵,提供更可靠的结果时，处理非常低的雌激素水平经常发现在妇女芳香化酶抑制剂，与免疫测定相比。
方法：我们搜索了Medline，Embase,中部,SCOPUS和CINAHL从开始到2023年10月，用于临床研究，其中使用阴道雌激素测量有早期乳腺癌病史的女性的血清雌激素。包括报告的测试方法的研究。
结果：9项研究符合本系统综述的纳入标准。在选定的研究中，用于测量雌二醇和雌三醇的方法包括质谱法和免疫测定法；几项研究使用了多个具有可变一致性的研究。质谱检测到雌二醇水平低至1.0pg/mL和3.0pg/mL之间的下限。免疫测定，如ELISA（酶联免疫吸附测定），ECLIA（增强化学发光免疫测定）和RIA（放射免疫测定）的检测下限在0.8pg/mL至10pg/mL之间。研究在使用的测试技术上是不同的，测试时间，和人群，包括随后对雌激素的影响的不同结果。
结论：在涉及早期乳腺癌女性的临床试验中，采用一致和标准化的方法测量雌激素对阴道雌激素是至关重要的。血清雌激素被用作该人群安全性的替代标记，高质量的数据对于临床医生和患者在处方和服用阴道雌激素方面有信心是必要的。质谱,虽然更贵,提供更可靠的结果时，处理非常低的雌激素水平经常发现在妇女芳香化酶抑制剂，与免疫测定相比。
