补肾益髓法治疗β地中海贫血的平行对照临床研究

目的:研究补肾益髓代表方益髓生血颗粒治疗β地中海贫血的临床效果及安全性。方法:采用随机、单盲和安慰剂平行对照进行60例患者临床观察,疗程3个月,观察治疗前后症状、血红蛋白、红细胞、胎儿血红蛋白、网织红细胞水平变化和肝、脾B超。结果:治疗组患者自疗程第1个月起至第3个月结束,各项血液学参数(血红蛋白、红细胞、胎儿血红蛋白、网织红细胞)均有提高,与治疗前相比,差异有统计学意义(P<0.01);肝脾肿大缓解(P<0.05);中医临床症状改善及动态观察与血液参数提高一致(P<0.01);未见副作用。安慰剂组患者各项血液指标及中医证候治疗前后无明显改善,肝脾肿大未见缓解(P>0.05)。结论:益髓生血颗粒治疗β地中海贫血疗效显著,未见毒副作用。

Treatment of β-thalassemia with Bushen Yisui therapy: a randomized controlled trial

OBJECTIVE: To investigate the efficacy and safety of Yisui Shengxue Granule (YSSXG), a compound traditional Chinese herbal medicine, in treating beta-thalassemia. METHODS: A randomized single-blinded trial was designed. Sixty patients with beta-thalassemia were divided into two groups: 30 patients in YSSXG-treated group and 30 in placebo parallel-control group. The patients in the two groups were assigned to receive either YSSXG or placebo for three months. The patients' symptoms and their blood indexes such as hemoglobin (Hb), red blood cell (RBC), reticulocytes (Ret) and fetal hemoglobin (HBF) were examined before and after the treatment. Meanwhile, the liver and spleen were examined with B-mode ultrasound. RESULTS: In the YSSXG-treated group, the blood indexes (Hb, RBC, Ret and HBF) and the symptoms of the patients were improved after three-month treatment, with statistical significance compared to those before treatment (P<0.01); hepatauxe and splenomegaly were also relieved (P<0.05) and no adverse reactions were monitored. In the placebo parallel-control group, no significant improvement of the blood indexes and symptoms, as well as the hepatauxe and splenomegaly had been found (P>0.05). CONCLUSION: YSSXG demonstrates obvious clinical efficacy and no adverse reactions in treating beta-thalassemia.