Objective

2

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

qi

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

Methods

2

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

2

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 （

P

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

P

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

P

＜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 （

P

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

P

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

P

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

P

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

P

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

P

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

P

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

P

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

P

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

Conclusion

2

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.