环孢素A血药浓度对环孢素A联合雄激素与复方硫酸亚铁治疗再生障碍性贫血效果的影响

目的 探讨环孢素A血药浓度对环孢素A联合雄激素与复方硫酸亚铁治疗再生障碍性贫血（AA）效果的影响,为合理使用环孢素A提供参考.方法 选择2010年1月至2013年12月苏州沧浪医院血液科收治的126例AA患者为研究对象.根据患者疾病严重程度,分为重型AA组（n=55）与非重型AA组（n=71）,均给予环孢素A联合雄激素与复方硫酸亚铁治疗,观察不同时间的治疗效果,比较重型AA组与非重型AA组治疗有效率,并比较治疗有效组与治疗无效组环孢素A血药浓度差异,以及不同环孢素A血药浓度对治疗效果的影响.本研究遵循的程序符合苏州市沧浪医院人体试验委员会所制定的伦理学标准,得到该委员会批准,征得受试对象的知情同意,并与之签署临床研究知情同意书.重型AA组与非重型AA组患者的性别、年龄等一般临床资料比较,差异无统计学意义（P＞0.05）.结果 环孢素A联合雄激素与复方硫酸亚铁免疫治疗本组AA患者6个月时,治疗有效率为78.86％（97/123）,明显高于治疗2和3个月时的有效率,且差异有统计学意义（P＜0.05）;非重型AA患者治疗2,3及6个月时,治疗有效率分别为83.10％,88.72％与95.71％,均显著高于重型AA患者,且差异有统计学意义（P＜0.05）;治疗3个月时,治疗有效组AA患者的环孢素A血药谷浓度与血药峰浓度分别为（198.87±68.45）μg/L与（742.15±188.95） μg/L,均明显高于无效组,且差异有统计学意义（P＜0.05）;环孢素A血药谷浓度≥200 μg/L组治疗有效率（94.83％）明显高于血药谷浓度＜200μg/L组,且差异有统计学意义（P＜0.05）;血药峰浓度≥700 μg/L组治疗有效率（92.31％）显著高于血药峰浓度＜700 μg/L组,且差异有统计学意义（P＜0.05）.结论 环孢素A血药浓度与环孢素A联合雄激素与复方硫酸亚铁治疗AA患者的治疗效果相关,其血药谷浓度≥200 μg/L及血药峰浓度≥700 μg/L可作为一个较?

Effect of Blood Concentration of Cyclosporine A on Cyclosporine A Combined with Male Hormone and Compound Ferrous Sulfate in Treatment of Aplastic Anemia

Objective To study effect of blood concentration of cyclosporine A on cyclosporine A combined with male hormone and compound ferrous sulfate in treatment of aplastic anemia （AA）,providing reference for rational use of cyclosporine A.Methods From January 2010 to December 2013,a total of 126 cases with AA were selected into this study,all of whom were given cyclosporine A combined with male hormone and compound ferrous sulfate therapy.Treatment effect was observed at two months,three months and six months of treatment.And blood concentration of cyclosporine A was compared between effective and ineffective group.Influences of different blood concentration of cyclosporine A on treatment outcome were compared.The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Canglang Hospital of Suzhou.Informed consent was obtained from all participants.There were no signifcant differences of patients＇ general clinical features between severe AA patients and nonsevere AA patients （P＞0.05）.Results At six months of immunotherapy with cyclosporine A combined with male hormone and compound ferrous sulfate,the effective rate （78.86 ％） was significantly higher than those at 2 months and 3 months （P＜0.05）.The effective rate of non-severe AA patients at two months,three months and six months of treatment were 83.10％,88.72％ and 95.71％,respectively,and all of them were significantly higher than that of severe AA patients （P＜0.05）.At 3 months of treatment,blood trough concentration and blood peak concentration of cyclosporine A in effective group were （198.87 ±68.45） μg/L and （742.15±188.95） μg/L,respectively,and both of them were significantly higher than those in ineffective group （P＜0.05）.The effective rate of blood trough concentration ≥200 μg/L group （94.83 ％） was significantly higher than that of blood trough concentration ＜200 μg/L group （P＜0.05）.The effective rate of blood peak concentration ≥700 μg/L group （92.31％?