含砷中药复方青黄散安全有效治疗骨髓增生异常综合征方法研究

邓中阳，方苏，王洪志，郭小青，杨秀鹏，麻柔，许勇钢，杨晓红，赵攀，王明镜，伊博文，尚晓泓，胡晓梅

中国中医科学院西苑医院，北京 100091

摘要：目的 建立含砷中药复方青黄散安全有效治疗骨髓增生异常综合征（MDS）的应用方法。方法 纳入 MDS患者 200例，予复方青黄散治疗。治疗1个月时，血砷浓度＜20 µg/L 者 60例，随机分为对照组和试验组各 30例。对照组治疗方案不变；试验组增加雄黄剂量，每月测定1次血砷浓度，每次增加雄黄剂量0.1 g，

至血砷浓度≥20 µg/L、雄黄最大剂量≤0.3 g/d。观察 2组血砷浓度、临床疗效及安全性。结果 最终 2组纳入评价者各 24 例。与对照组比较，试验组治疗后血砷浓度明显升高（P＜0.05）。对照组治疗后血液学进步率为

29.2%（7/24），试验组为 54.2%（13/24），试验组明显高于对照组（P＜0.05）。试验组治疗后中性粒细胞、血

红蛋白及血小板与治疗前比较明显升高（P＜0.05）。消化道不良反应2 组比较差异无统计学意义（P＞0.05）。

2组肝、肾功能无损害。结论 应用复方青黄散治疗MDS可根据血砷浓度调整雄黄剂量，以提高有效血砷浓度，增强疗效，且不增加临床毒副反应。

关键词：骨髓增生异常综合征；雄黄；砷；安全性

DOI：10.3969/j.issn.1005-5304.2017.10.006

中图分类号：R259.513 文献标识码：A 文章编号：1005-5304(2017)10-0022-05

Study on Safe and Effective Clinical Methods for Arsenic-containing Compound Qinghuang Powder in Treatment of Myelodysplastic Syndrome

DENG Zhong-yang, FANG Su, WANG Hong-zhi, GUO Xiao-qing, YANG Xiu-peng, MA Rou, XU Yong-gang, YANG Xiao-hong, ZHAO Pan, WANG Ming-jing, YI Bo-wen, SHANG Xiao-hong, HU Xiao-mei (Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China)

Abstract: Objective To search for application ways for the safe and effective clinical methods of arsenic-containing Compound Qinghuang Powder (Compound QHP) for the treatment of myelodysplastic syndrome (MDS). Methods Totally 200 patients with MDS were included in the study and treated with Compound QHP. After one-month treatment, the 60 patients with the blood arsenic concentrations <20 µg/L were randomly divided into control group and treatment group, with 30 cases in each group. Control group was given stable treatment, while the treatment group was given increased dose of realgar; blood arsenic concentration was detected monthly; realgar 0.1 g was increased each time until blood arsenic concentrations ≥20 µg/L and realgar ≤0.3 g/d. The blood arsenic concentration, clinical efficacy and safety in the two groups were observed. Results Totally 24 cases in each group were included for evaluation finally. The average blood arsenic concentration of treatment group was significantly higher than those of control group (P<0.05). The rate of hematologic improvement was significantly higher in treatment group (54.2%, 13/24) than that in control group (29.2%, 7/24) , with significant difference (P<0.05). The Hb, ANC, and PLT significantly increased in treatment group after treatment (P<0.05). There was no significant difference of incidence rate of adverse reaction observed between treatment group and control group (P>0.05). Conclusion In application of Compound QHP, the blood arsenic concentration can be monitored to adjust the daily

基金项目：国家自然科学基金（81673821）；中央级公益性科研院所基本科研业务费专项（ZZ10-016）；北京市科委重点项目

（Z141100006014003）

通讯作者：胡晓梅，E-mail：huxiaomei_2@163.com