Zheng Li, Gu Xiaotong, Liu Ming, Fu Changhai, Wang Yan
Department of Pharmacy, China Aerospace Science and Industry Corporation 731 Hospital, Beijing, China.
Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China.
Front Pharmacol. 2025 Jun 24;16:1510227. doi: 10.3389/fphar.2025.1510227. eCollection 2025.
We aimed to evaluate the efficacy and safety of Shengxuening (SXN) in treating renal anemia by systematic review and meta-analysis.
PubMed, Embase, the Cochrane Library, the ClinicalTrials.gov, SinoMed, the China Knowledge Network, the Wanfang Data Knowledge Service Platform and Technology Journal Database were searched from inception to September 2024 randomized controlled trials (RCTs) that compared SXN and other drugs or placebo in treating renal anemia. We used the Cochrane Bias Risk Tool to evaluate the risk of bias of all included RCTs, and used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) to evaluate the certainty of the evidence.
31 RCTs involving 2,372 patients were included. The efficiency of SXN was superior than the control group (included placebo group, other drugs group) in improving hemoglobin (compared with placebo: MD: 7.15 g/L, 95% CI: 5.68-8.62, P < 0.001, GRADE: high; compared with other drugs: MD: 6.49 g/L, 95% CI: 3.50-9.47, P < 0.001, GRADE: very low), serum ferritin (MD: 57.53 ng/mL, 95% CI: 29.70-85.36, P < 0.001, GRADE: moderate; MD: 28.96 ng/mL, 95% CI: 1.88-56.04, P = 0.04, GRADE: moderate) and transferrin saturation level (MD: 7.00%, 95% CI: 3.40-10.60, P = 0.0001, GRADE: moderate; MD: 3.64%, 95% CI: 1.41-5.88, P = 0.001, GRADE: moderate). Besides, the efficiency of SXN combined with other drugs was superior than other drugs group in improving hemoglobin (MD: 11.95 g/L, 95% CI: 6.19-17.71, P < 0.001, GRADE: moderate), serum ferritin (MD: 53.43 ng/mL, 95% CI: 20.65-86.21, P = 0.001, GRADE: moderate) and transferrin saturation level (MD: 5.91%, 95% CI: 3.72-8.10, P < 0.001, GRADE: moderate). Additionally, the incidence of adverse drug reactions (ADRs) in the SXN group was lower than that in other drugs treatment group (OR: 0.20, 95%CI: 0.12-0.33, P < 0.00001).
The efficacy of SXN in treating renal anemia is convincing. Compared with other drugs, SXN is comparable or even better in treating renal anemia. Additionally, the safety of SXN is also relatively high.
通过系统评价和荟萃分析评估生血宁（SXN）治疗肾性贫血的疗效和安全性。
检索PubMed、Embase、Cochrane图书馆、ClinicalTrials.gov、中国生物医学文献数据库、中国知网、万方数据知识服务平台和维普期刊数据库，纳入从建库至2024年9月比较SXN与其他药物或安慰剂治疗肾性贫血的随机对照试验（RCT）。采用Cochrane偏倚风险工具评估所有纳入RCT的偏倚风险，并使用推荐分级、评估、制定与评价（GRADE）方法评估证据的确定性。
纳入31项RCT，共2372例患者。SXN在改善血红蛋白方面优于对照组（包括安慰剂组、其他药物组）（与安慰剂相比：MD：7.15 g/L，95%CI：5.68 - 8.62，P < 0.001，GRADE：高；与其他药物相比：MD：6.49 g/L，95%CI：3.50 - 9.47，P < 0.001，GRADE：极低）、血清铁蛋白（MD：57.53 ng/mL，95%CI：29.70 - 85.36，P < 0.001，GRADE：中等；MD：28.96 ng/mL，95%CI：1.88 - 56.04，P = 0.04，GRADE：中等）和转铁蛋白饱和度水平（MD：7.00%，95%CI：3.40 - 10.60，P = 0.0001，GRADE：中等；MD：3.64%，95%CI：1.41 - 5.88，P = 0.001，GRADE：中等）。此外，SXN联合其他药物在改善血红蛋白（MD：11.95 g/L，95%CI：6.19 - 17.71，P < 0.001，GRADE：中等）、血清铁蛋白（MD：53.43 ng/mL，95%CI：20.65 - 86.21，P = 0.001，GRADE：中等）和转铁蛋白饱和度水平方面优于其他药物组（MD：5.91%，95%CI：3.72 - 8.10，P < 0.001，GRADE：中等）。此外，SXN组药物不良反应（ADR）发生率低于其他药物治疗组（OR：0.20，95%CI：0.12 - 0.33，P < 0.00001）。
SXN治疗肾性贫血的疗效令人信服。与其他药物相比，SXN在治疗肾性贫血方面相当甚至更好。此外，SXN的安全性也相对较高。
