摘要
目的探讨生血宁与硫酸亚铁／琥珀酸亚铁治疗肾性贫血的安全性与有效性。方法依据PICOS原则通过电子检索和人工检索综合检索公开发表及未公开发表的中文或英文相关生血宁的随机对照试验文献，电子数据包括中国知网、万方数据库、中国生物医学文献数据库以及PubMed、ThecochraneLibrary、Springer；人工检索《中华肾脏病学杂志》、《中西结合肾脏病学杂志》、《中医杂志》、《中西结合杂志》及《中西结合学报》。检索时间为1990年1月至2014年11月。按照纳入标准和排除标准筛选文献，提取资料和进行质量评价后，采用RevMan5．1软件进行分析。结果共纳人5个随机对照试验，Meta分析结果显示：①口服生血宁组（观察组）患者血红蛋白升高水平较琥珀酸亚铁／硫酸亚铁组（对照组）高，差异有统计学意义EWMD=13．14，95％CI（7．74，18．54），P〈0．000013；②观察组患者血清铁蛋白升高水平较对照组高，差异有统计学意义EWMD=8．32，95％CI（2．21，14．42），P〈0．0001]；③观察组患者转铁饱和度升高水平较对照组高，差异有统计学意义EWMD=22．35，95％CI（63．64，181．06），P〈0．000013；④不良反应：观察组总不良反应率为1．74％，对照组总不良反应率为13．37％；Meta分析结果提示观察组不良反应率低于对照组，差异有统计学意义[OR=0．09，95％CI（0．03，0．25），P〈0．00001]。结论本系统评价结果显示，与对照组比较，生血宁不仅可以有效升高肾性贫血患者血红蛋白、血清铁蛋白及转铁饱和度，同时不良反应少，但缺乏大样本、多中心的、双盲的随机对照试验，增加相关终点指标／透析患者的病死率、非透析患者进入透析治疗的时间等的研究。
Objective To assess the efficacy and safety of Shengxuening（SXN）for renal anemia. Methods All randomized trials（RCTs） of SXN for renal anemia were collected from CNKI, CBM, Wan Fang Database, Springer and Pub Med. Two reviewers independently screened the included stud- ies, extracted the data, assessed the quality, and cross-checked. Then RevMan5.01 software was used for meta-analysis. Results A total of 5 RCTs were enrolled in the review. The results of meta-analy- sis showed that as compared with the control group, hemoglobin [WMD = 13.14, 95%CI （7. 74, 18. 54）, P〈 0. 00001], serum ferritin [WMD = 8. 32, 95 % CI （2. 21, 14. 42）, P〈0. 00001 ] and transferrin saturation [WMD= 22. 35, 95%CI（63. 64, 181.06）, P〈0. 00001] were significantly in- creased in SXN group. The adverse reactions were reported in all researches. The total adverse rate in SXN group and control group was 1.74% and 13. 37% respectively [OR = 0. 09, 95% CI （0. 03, 0. 25）, P〈0. 00001]. Conclusions The researches currently available show that SXN has more effi- cacy and safety in elevating the level of serum ferritin, transferrin saturation and hemoglobin than fer- rous sulfate/ferrous succinate. However, double-blinded RCTs are needed to access the SXN for pa-tients end point target including lifetime, risk of cardiovascular events and dialysis time.
出处
《临床肾脏病杂志》
2015年第6期353-358,共6页
Journal Of Clinical Nephrology
