健脾生血片治疗COPD相关性贫血的临床观察

目的:探索健脾生血片治疗慢性阻塞性肺病(COPD)相关性贫血的疗效、安全性和作用机制。方法:选取2015年3月至2015年9月四川大学华西医院和成都市天府新区人民医院收治的COPD相关性贫血患者共72例,随机分入观察组和对照组。观察组给予健脾生血片治疗,2片/次,3次/d,疗程1月;对照组给予维生素C片治疗,2片/次,3次/d,疗程1月。比较2组患者治疗前后血清IL-1β、血清TNF-α、血清CRP、血清铁调素、血清铁、转铁蛋白饱和度、铁蛋白、网织红细胞、血红蛋白、红细胞计数、夜间睡眠血氧饱和度、肺功能(FEV1%)、改良COPD患者生命质量评估问卷评分(m MRC);评估2组治疗结束时的有效率;比较2组随访3月、6月、12月时血红蛋白、肺功能、改良COPD患者生命质量评估问卷评分(m MRC)、年急性加重次数;记录2组治疗期间不良事件。结果:全部72例患者完成了第1个月的治疗,随访期间观察组2例患者退出研究,1例患者失访,对照组6例患者退出研究,2例患者失访。2组患者基线情况比较无统计学意义(P0.05),具有可比性。观察组有效率91.7%,对照组有效率2.8%,组间比较有统计学意义(P0.05)。观察组IL-1β、血清TNF-α、血清CRP、血清铁调素水平均较对照组显著降低(P0.05)。观察组血清铁、转铁蛋白饱和度水平较对照组显著升高(P0.05)。观察组血清铁蛋白水平较对照组显著下降(P0.05)。观察组网织红细胞、血红蛋白、红细胞计数较对照组显著升高(P0.05)。观察组治疗后夜间睡眠血氧饱和度较对照组显著增高(P0.05),但肺功能、改良COPD患者生命质量评估问卷评分(m MRC)直到随访第3月和第6月才显著改善(P0.05)。观察组年急性加重次数显著少于对照组(P0.05)。治疗期间,观察组1例患者出现轻微便秘,对照组1例患者出现轻微便秘,5例患者出现轻微腹泻,1例患者出现下尿路感染,判断与药物治疗无关,未发现其他不良事件。结论:健脾生血片治疗COPD相关性贫血安全有效,其作用机制除了提供铁元素外,还包括抑制慢性炎性反应,抑制铁调素,值得扩大样本量进一步研究。

Clinical Observation on Jianpi Shengxue Tablet in the Treatment of COPD Related Anemia

To explore the efficacy, safety and mechanism of Jianpi Shengxue tablet in the treatment of chronic obstructive pulmonary disease (COPD) related anemia. Methods:A total of 72 patients with COPD related anemia in our hospital from March 2015 to September 2015 were randomly divided into the observation group and the control group, with 36 cases in each group. The observation group was given Jianpi Shengxue tablet, three times a day and two pills at a time for a course of a month. The control group was given vitamin C tablets, 2 tablets a time, three times a day, and the treatment course was a month. The serum IL-1 beta, serum TNF-, serum CRP, serum hepcidin, serum iron, transferrin saturation and ferritin, reticulocytes, hemoglobin, red blood cell count, nocturnal sleep oxygen saturation, lung function (FEV1%), modified COPD patients to evaluate the quality of life questionnaire score (mMRC) were compared before and after treatment. And the follow-up time was in the end of 3 months, 6 months and 12 months. Results:All of the 72 patients completed the treatment. During the follow-up period, 2 patients in the observation group withdrew from the study, and 1 patient was lost to visit. 6 patients in the control group withdrew from the study, and 2 patients were lost. There was no significant difference in baseline between the two groups (P>0.05), which was comparable. The effective rate of the observation group was 91.7%, while the control group was 2.8%. The difference between the two groups was significant (P<0.05). The levels of IL-1 beta, TNF-a, CRP and hepcidin in the observation group were significantly lower than those in the control group (P<0.05). The level of serum iron and transferrin in the observation group was significantly higher than that in the control group (P<0.05). But the level of serum ferritin in the observation group was significantly lower than that in the control group (P<0.05). The count of granulophilocyte, red blood cell and hemoglobin in the observation group was significantly higher than that of the control group (P<0.05). The sleep oxygen saturation in the observation group was significantly higher than that in the control group (P<0.05), but the lung function and the dyspnea score (mMRC) were not significantly improved until the follow-up of third months and sixth months (P<0.05). The number of acute exacerbations in the observation group was significantly less than that of the control group (P<0.05). During the treatment period, 1 patient in the observation group had mild constipation, while 5 cases had mild diarrhea, 1 case had lower urinary tract infection, and no other adverse events were found. Conclusion:Jianpi Shengxue tablet is effective and safe in the treatment of COPD related anemia. Except its iron supply, it also inhibits chronic inflammatory reaction and inhibits hepcidin. It is worth further studying the larger sample size.