Treatment of Aplastic Anemia with the Method of Kidney Nourishing and Blood Engendering and the Method of <italic style="font-style: italic">Qi</italic> Boosting and Blood Nourishing Combined with Western Medicine： A Prospective， Randomized， Double-blind， Placebo-controlled， Multi-center Clinical Stud

Peizhen JIANG; Yubin DING; Wenru WANG; Jinhuan WANG; Ruirong XU; Shulian YANG; Tao WANG; Qifeng LIU; Haixia WANG; Antao SUN; Jianping SHEN; Yamei XU; Jianying LI; Yuhong YAO; Xiaoqing DING; Zhexin SHI; Yongming ZHOU; Qi HU; Xiaohui SHEN; Yonggang XU; Feng LIU; Rou MA; Xudong TANG

doi:10.13288/j.11-2166/r.2022.11.010

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Treatment of Aplastic Anemia with the Method of Kidney Nourishing and Blood Engendering and the Method of Qi Boosting and Blood Nourishing Combined with Western Medicine： A Prospective， Randomized， Double-blind， Placebo-controlled， Multi-center Clinical Stud

更新时间：2022-05-28

- Treatment of Aplastic Anemia with the Method of Kidney Nourishing and Blood Engendering and the Method of Qi Boosting and Blood Nourishing Combined with Western Medicine： A Prospective， Randomized， Double-blind， Placebo-controlled， Multi-center Clinical Stud
- Journal of Traditional Chinese Medicine Vol. 63, Issue 11, Pages: 1043-1050(2022)
- 作者机构：
  
  1.中国中医科学院西苑医院，北京市海淀区西苑操场1号，100091
  2.广东省深圳市中医院
  3.黑龙江中医药大学附属第一医院
  4.山东中医药大学附属医院
  5.河北省廊坊市中医医院
  6.河南中医药大学第一附属医院
  7.吉林省人民医院
  8.潍坊医学院附属医院
  9.中国中医科学院广安门医院
  10.浙江省中医院
  11.北京中医药大学东直门医院
  12.河北省石家庄平安医院
  13.贵州中医药大学第二附属医院
  14.北京中医药大学东方医院
  15.天津中医药大学第一附属医院
  16.上海中医药大学附属岳阳医院
  17.上海市中医医院
  18.甘肃省中医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2022.11.010
  CLC：
- Received：13 October 2021，
  
  Revised：2022-02-25，
  
  Published：02 June 2022
- 稿件说明：
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蒋佩珍,丁宇斌,王文儒等.补肾生血法与益气养血法联合西药治疗再生障碍性贫血的前瞻性随机双盲安慰剂对照的多中心临床研究[J].中医杂志,2022,63(11):1043-1050.

JIANG Peizhen,DING Yubin,WANG Wenru,et al.Treatment of Aplastic Anemia with the Method of Kidney Nourishing and Blood Engendering and the Method of Qi Boosting and Blood Nourishing Combined with Western Medicine： A Prospective， Randomized， Double-blind， Placebo-controlled， Multi-center Clinical Stud[J].Journal of Traditional Chinese Medicine,2022,63(11):1043-1050.
蒋佩珍,丁宇斌,王文儒等.补肾生血法与益气养血法联合西药治疗再生障碍性贫血的前瞻性随机双盲安慰剂对照的多中心临床研究[J].中医杂志,2022,63(11):1043-1050. DOI： 10.13288/j.11-2166/r.2022.11.010.

JIANG Peizhen,DING Yubin,WANG Wenru,et al.Treatment of Aplastic Anemia with the Method of Kidney Nourishing and Blood Engendering and the Method of Qi Boosting and Blood Nourishing Combined with Western Medicine： A Prospective， Randomized， Double-blind， Placebo-controlled， Multi-center Clinical Stud[J].Journal of Traditional Chinese Medicine,2022,63(11):1043-1050. DOI： 10.13288/j.11-2166/r.2022.11.010.

摘要

目的

比较补肾生血法、益气养血法联合基础西药治疗再生障碍性贫血的临床有效性及安全性。

方法

采用前瞻、随机、双盲、安慰剂对照、多中心研究方法。以分层区组随机法将患者分为补肾生血组、益气养血组、对照组，中药治疗分别予补肾填精颗粒、补益气血颗粒、安慰剂（半量补肾填精颗粒），均联合口服环孢素A及雄激素。3个月为1个疗程，连续观察两个疗程治疗前后的血常规［包括白细胞计数（WBC）、血红蛋白含量（HGB）、血小板计数（PLT）、中性粒细胞计数（ANC）］、输血情况、中医证候积分、生活质量评分、安全性指标，并记录不良事件，治疗结束后1年进行随访并评定疗效。

结果

共纳入585例，剔除18例，进入FAS总病例数567例，其中补肾生血组184例、益气养血组191例和对照组192例，因失访共脱落75例。补肾生血组总有效率（86.4%）明显优于益气养血组（78.0%）与对照组（72.9%，

＜0.001）。各组治疗后HGB、PLT、WBC均升高（

＜0.05），尤以补肾生血组最佳（

＜0.05）；补肾生血组治疗后及随访时HGB明显高于益气养血组与对照组（

＜0.05），治疗后益气养血组HGB高于对照组（

＜0.05）；补肾生血组随访时PLT明显高于其余两组（

＜0.001）；各组治疗后及随访时WBC均升高（

＜0.05）。各组治疗后ANC均下降（

＜0.05），但补肾生血组与益气养血组随访时ANC均有回升（

＜0.001），而对照组ANC持续下降（

＜0.001）。各组输血情况均有改善（

＜0.05），其中补肾生血组患者输血人数最早清零（

＜0.05）；各组中医证候总积分均降低，生活质量评分均提高（

＜0.05）。观察期间均未出现与治疗相关的严重不良事件。

结论

补肾生血法、益气养血法联合西药治疗再生障碍性贫血疗效确切，安全性良好，可有效降低中医证候评分并提高生活质量评分，其中补肾生血法疗效更佳。

Abstract

Objective

To explore and compare the clinical effect and safety of kidney nourishing and blood engendering method （KNBE）， and

boosting and blood nourishing method （QBBN） in addition to basic western medicine in the treatment of aplastic anemia.

Methods

A prospective， double-blind， randomized placebo-controlled， multicenter study was designed. With a randomized block method， the patients were divided into KNBE group， QBBN group and control group， accepting

Bushen Tianjing Granules

（补肾填精颗粒），

Buyi Qixue Granules

（补益气血颗粒） and placebo （half amount of

Bushen Tianjing Granules

）， respectively， in addition to oral cyclosporine A and androgen. All groups were treated for two courses， with 3 months as a course. The blood routine test indicators including white blood cell count （WBC）， hemoglobin content （HGB）， platelet count （PLT） and neutrophil count （ANC）， the blood transfusion， traditional Chinese medicine （TCM） syndrome score， quality of life score， and safety indicators were evaluated before and after treatment， and the adverse events were recorded. Follow-up was performed 1 year after treatment and the effect was assessed.

Results

Of the initially included 585 cases， 18 cases were excluded， and 567 cases were analyzed in the full analysis set （FAS） including 184 cases in the KNBE group， 191 cases in the QBBN group and 192 cases in the control group. A total of 75 cases dropped out due to loss to follow-up. The total effective rate of the KNBE group was 86.4%， significantly higher than 78.0% of the QBBN group and 79.2% of the control group （

＜0.001）. After treatment， the levels of HGB， PLT and WBC in the three groups all increased （

＜0.05）， and the KNBE group was the highest （

＜0.05）. The HGB level in the KNBE group was significantly higher than that of QBBN group and control group after treatment and at follow up （

＜0.05）， and that in the QBBN group was higher than in the control group （

＜0.05）. The PLT level in the KNBE group was significantly higher than that of the other groups at follow up （

＜0.001）. The WBC levels in the three groups significantly increased after treatment and at follow up （

＜0.05）. The ANC level decreased in all three groups after treatment （

＜0.001）， but at follow up， it increased in KNBE and QBBN group while continuously decreased in the control group （

＜0.001）. The blood transfusion conditions of all the three groups improved （

＜0.05）， and the number of participants in need of blood transfusions in the KNBE group was the first to be reduced to zero （

＜0.05）. The total TCM syndrome score decreased in all three groups， while the scores of quality of life increased （

＜0.05）. No serious adverse events related to treatment occurred during the observation period.

Conclusion

The combination of KNBE and QBBN with western medicine has definite curative effect and sound safety in treating aplastic anemia， and can effectively reduce TCM syndrome score and improve the quality of life. Moreover， KNBE group has better effect.

关键词

Keywords

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Treatment of Aplastic Anemia with the Method of Kidney Nourishing and Blood Engendering and the Method of Qi Boosting and Blood Nourishing Combined with Western Medicine： A Prospective， Randomized， Double-blind， Placebo-controlled， Multi-center Clinical Stud

DOI：10.13288/j.11-2166/r.2022.11.010

摘要

Abstract

关键词

Keywords

references