中国临床药学杂志

目的 构建妊娠期缺铁性贫血患者使用口服铁剂的临床综合评价指标体系，为临床合理使用口服铁剂提供参考。方法 以《药品临床综合评价管理指南（2021年版试行）》为依据，以相关文献为参考，结合妊娠期缺铁性贫血的疾病特点设计专家咨询问卷，采用德尔菲法对妊娠期缺铁性贫血患者使用口服铁剂的临床综合评价指标体系进行2轮专家咨询，确定最终的指标体系。结果 经过2轮专家咨询和专家共识会议，最终确定包括一级指标6个，二级指标13个、三级指标31个的妊娠期缺铁性贫血患者使用口服铁剂的临床综合评价指标体系。一级指标安全性、有效性、经济性、适宜性、可及性和创新性的权重分别为0.176 6、0.184 1、0.166 7、0.159 2、0.164 2和0.149 3。2轮专家函询的专家积极系数均为100%，专家权威系数分别为0.93和0.96,Kendall协调系数的差异有统计学意义（P<0.01）。结论 构建的妊娠期缺铁性贫血患者使用口服铁剂的临床综合评价指标体系具有较高的权威性、科学性和可行性，有助于提高临床妊娠期缺铁性贫血患者使用口服铁剂的合理性和规范性。

AIM A comprehensive clinical evaluation framework for oral iron supplementation in patients with iron deficiency anemia during pregnancy has been established to guide rational clinical practice. METHODS The Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(Trial Edition 2021) was used as an important basis, and relevant literature was referenced to fully consider the characteristics of anemia in special groups during pregnancy when developing a questionnaire for expert consultation. Two rounds of expert consultation were conducted using the Delphi method to determine the final index system for the clinical comprehensive evaluation of the rational use of oral iron supplementation for patients with iron supplementation deficiency anemia during pregnancy. RESULTS After 2 rounds of expert consultation and expert consensus meeting, a clinical comprehensive evaluation index system for the use of oral iron supplementation in patients with iron deficiency anemia during pregnancy was finally determined, including 6 first-level indicators, 13 second-level indicators and 31 third-level indicators. The weights of safety, effectiveness, economy, suitability, accessibility and innovation of the first-level indicators were 0.176 6, 0.184 1, 0.166 7, 0.159 2, 0.164 2 and 0.149 3, respectively. The expert positive coefficients of the 2 rounds of expert consultation were 100%, and the expert authority coefficients were 0.93 and 0.96, respectively. The difference in Kendall's coordination coefficient was statistically significant(P < 0.01). CONCLUSION The clinical comprehensive evaluation index system for the use of oral iron supplementation in patients with iron deficiency anemia during pregnancy is highly authoritative, scientific, representative and feasible, which helps to improve the rationality and standardization of the use of oral iron supplementation in patients with iron supplementation deficiency anemia during pregnancy.