世界中医药

目的：探索健脾生血片治疗慢性心力衰竭伴贫血的疗效、安全性和作用机制。方法：选取2016年5月至2017年2月同济医院收治的慢性心力衰竭贫血患者144例，按照随机数字表法分为观察组和对照组，每组72例。观察组给予健脾生血片治疗，3片/次，3次/d，疗程3个月；对照组给予生血宝合剂治疗，15 mL/次，3次/d，3个月为1个疗程。比较2组患者治疗前与治疗后血红蛋白、红细胞计数、网织红细胞、血清铁、转铁蛋白饱和度、血清铁蛋白、血清铁调素（Hepcidin）、血清IL-1β、血清肿瘤坏死因子-α（TNF-α）、血清C反应蛋白（CRP）、左室射血分数（LVEF）、6 min步行距离、明尼苏达心力衰竭生命质量量表(MLHFQ)和不良事件。并随访2组心血管事件次数，住院次数与全因死亡率。结果：观察组72例患者完成了前3个月的治疗，随访期间脱失2例；对照组治疗期间1例患者退出研究，随访期间脱失4例。2组一般资料比较，差异无统计学意义（P>0.05），具有可比性。观察组贫血有效率98.6%，对照组有效率11.3%，差异有统计学意义（P<0.05）。治疗后观察组红细胞计数和网织红细胞、均显著高于对照组（P<0.05）。观察组血清铁、转铁蛋白饱和度水平均高于对照组,差异有统计学意义（P<0.05），但血清铁调素水平显著低于对照组,差异有统计学意义（P<0.05），血清铁蛋白水平2组差异无统计学意义（P>0.05）。观察组IL-1β、血清TNF-α、血清CRP均显著低于对照组,差异有统计学意义（P<0.05）。观察组LVEF、6 min步行距离、明尼苏达心力衰竭生命质量量表(MLHFQ)均显著高于对照组,差异有统计学意义（P<0.05）。2组不良事件总发生率比较，差异无统计学意义（P>0.05），但对照组4例患者出现血清肌酐、尿素氮水平异常，发生率高于观察组,差异有统计学意义（P<0.05）。经1年随访，观察组心血管事件人均发生次数显著少于对照组（P<0.05），但2组住院次数和全因死亡率比较，差异无统计学意义（P>0.05）。结论：健脾生血片可有效治疗心力衰竭伴贫血，减少心血管发生次数，并且安全性良好，其作用机制与提供准确足量铁元素、抑制铁调素表达，抑制慢性炎性反应有关。

English Summary:

To explore the clinical efficacy，safety and mechanism of Jianpi Shengxue Tablets in the treatment of chronic heart failure with anemia. Methods:A total of 144 patients with chronic heart failure anemia treated in Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology from May 2016 to February were selected and randomly assigned to the observation group and the control group according to the random number table method，with 72 cases in each group. The observation group was given Jianpi Shengxue Tablets，3 tablets once，three times a day for 3 months，and the control group was given Shengxuebao mixture，15 mL once，three times a day，and the course of treatment was 3 months. The hemoglobin，red blood cell count，reticulocyte，serum iron，transferrin saturation，serum ferritin，serum hepcidin，serum IL-1β，serum TNF-α，serum CRP，left ventricular ejection fraction (LVEF)，6 min walking distance，Minnesota Living with Heart Failure Questionnaire (MLHFQ)，and adverse events between the 2 groups before and after treatment were compared. The patients were followed up to record the number of cardiovascular events and the number of hospitalizations and all-cause mortality of the 2 groups in a year. Results:All the 72 patients in the observation group completed the first 3 months of treatment，and 2 cases were lost during the follow-up period. In the control group 1 patient withdrew from the study during the treatment period and 4 cases lost during the follow-up period. There was no significant difference in baseline between the 2 groups (P>0.05)，which was comparable. The anemia of the observation group was 98.6%，and the control group was 11.3%，the difference between the groups was significant (P<0.05). After treatment，the red blood cell count and reticulocytes of the observation group were significantly higher than the control group (P<0.05). The levels of serum iron and transferrin saturation in the observation group were significantly higher than those in the control group (P<0.05)，but the serum hepcidin level was significantly lower than that in the control group (P<0.05) and there was no significant difference in serum ferritin levels between the 2 groups (P>0.05). The IL-1β，serum TNF-α and serum CRP in the observation group were significantly lower than those in the control group (P<0.05). The left ventricular ejection fraction (LVEF)，6-min walking distance，and Minnesota Heart Failure Quality of Life Scale (MLHFQ) in the observers were significantly higher than that in the control group (P<0.05). There was no significant difference in the total incidence of adverse events between the 2 groups (P>0.05)，but the serum creatinine and urea nitrogen levels were abnormal of 4 patients in the control group，and the incidence rate was significantly higher than that in the observation group (P<0.05). After 1 year follow-up，the number of occurrence of cardiovascular events in the observation group was significantly lower than that in the control group (P<0.05)，but there was no significant difference in the number of hospitalizations and all-cause mortality between the 2 groups (P>0.05). Conclusion:Jianpi Shengxue Tablets can effectively treat heart failure with anemia，reduce the number of cardiovascular events，and has good safety. Its mechanism of action is related to providing accurate iron content，inhibiting the expression of hepcidin and inhibiting the genesis of chronic inflammation，which is worthy for promotion and use.

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