目的 探讨再造生血胶囊联合右旋糖酐铁分散片治疗妊娠中晚期缺铁性贫血的临床疗效及安全性。方法 纳入2024年1月—2024年12月南阳市中心医院收治的140例妊娠中晚期缺血性贫血的孕妇，随机分为对照组和治疗组，每组70例。对照组患者口服右旋糖酐铁分散片，2片/次，3次/d。治疗组在对照组的基础上口服再造生血胶囊，5粒/次，3次/d。两组患者均治疗8周。观察两组患者临床疗效，比较治疗前后两组患者临床症状和体征缓解时间，血常规血红蛋白（Hb）、平均红细胞体积（MCV）、平均血红蛋白含量（MCH）和平均血红蛋白浓度（MCHC）水平，铁蛋白、铁表达、总铁结合力和可溶性转铁蛋白受体水平，锌原卟啉（ZnPP）和红细胞内游离原卟啉（FEP）表达水平，及不良妊娠结局发生率。结果 治疗后，治疗组患者总有效率为95.71%，对照组总有效率为84.29%，两组总有效率比较差异具有统计学意义（P＜0.05）。治疗后，与对照组相比，治疗组头晕、乏力及面色苍白缓解时间均显著降低（P＜0.05）。治疗后，两组Hb、MCV、MCH、MCHC、铁蛋白、铁表达水平均显著升高（P＜0.05），而总铁结合力、可溶性转铁蛋白受体、ZnPP和FEP表达水平均显著降低（P＜0.05），且治疗组这些指标改善程度均明显好于对照组（P＜0.05）。治疗后，对照组和治疗组不良妊娠结局发生率为18.57%和5.71%（P＜0.05）。结论 再造生血胶囊联合右旋糖酐铁治疗妊娠中晚期缺铁性贫血的临床疗效显著且安全性高，能快速缓解孕妇贫血相关不适症状，同时能明显提高血红蛋白水平，改善铁代谢以及卟啉水平，并减少不良妊娠结局的发生。

Objective To investigate the clinical efficacy and safety of Zaizao Shengxue Capsules combined with Iron Dextran Dispersible Tablets in treatment of iron deficiency anemia in the middle and late pregnancy. Methods Patients (140 cases) with iron deficiency anemia in the middle and late pregnancy in Nanyang Central Hospital from January 2024 to December 2024 were randomly divided into control and treatment group, and each group had 70 cases. Patients in the control group were po administered with Iron Dextran Dispersible Tablets, 2 tablets/time, three times daily. Patients in the treatment group were po administered with Zaizao Shengxue Capsules on the basis of the control group, 5 grains/time, three times daily. Patients in two groups were treated for 8 weeks. After treatment, the clinical evaluations were evaluated, and the the resolution time of clinical symptoms and signs, the serum expression levels of Hb, MCV, MCH and MCHC, the serum expression levels of ferritin, iron, total iron-binding capacity and soluble transferrin receptor, the serum expression levels of ZnPP and FEP, the incidence of adverse pregnancy outcomes in two groups before and after treatment were compared. Results After treatment, the total effective rate in the treatment group was 95.71%, and the total effective rate in the control group was 84.29%, the difference in the total effective rate between two groups was statistically significant (P < 0.05). After treatment, compared with the control group, the relief time for dizziness, fatigue, and pallor in the treatment group was significantly reduced (P < 0.05). After treatment, the expression levels of Hb, MCV, MCH, MCHC, ferritin, and iron were significantly increased in two groups (P < 0.05), while the expression levels of total iron binding capacity, soluble transferrin receptor, ZnPP and FEP were significantly decreased (P < 0.05), and the improvement of these indicators in the treatment group was significantly better than that in the control group (P < 0.05). After treatment, the incidence of adverse pregnancy outcomes in the control group and the treatment group was 18.57% and 5.71% (P < 0.05). Conclusion Zaizao Shengxue Capsules combined with iron dextran has significant clinical efficacy and high safety in treatment of iron deficiency anemia in the middle and late pregnancy, which can rapidly alleviates anemia-related symptoms, significantly increases hemoglobin levels, improves iron metabolism and porphyrin profiles, and reduces adverse pregnancy outcomes.

R984

河南省医学科技攻关计划项目（LHGJ20221051）