人工虎骨粉胶囊治疗骨量低下与原发性骨质疏松症的多中心临床研究

Multicenter clinical trial of artificial tiger bone capsules in the treatment of osteopenia and osteoporosis

目的观察人工虎骨粉胶囊治疗骨量低下与原发性骨质疏松症的临床疗效及安全性。方法入选120例受试者,并予以人工虎骨粉胶囊每次1.2 g,tid,口服,连续52周。用双能X线吸收仪(DXA)法测定骨密度(BMD),统计其临床疗效和药物不良反应的发生情况。结果与基线比较,治疗52周后腰椎(L2-L4)BMD提高1.15%,符合方案数据集(PPS)的总有效率为81.73%(85例/104例)。研究期间未出现明显与药物有关的药物不良反应。结论人工虎骨粉胶囊用于骨量低下与原发性骨质疏松症的治疗,可抑制BMD下降,但未能显著提高腰椎和和股骨颈的BMD,可有效缓解骨质疏松症的主要临床症状,从而改善患者生活质量,且安全性较高。

Objective To observe the clinical efficacy and safety of artificial tiger bone capsules in the treatment of osteopenia and osteoporosis.Methods A total of 120 subjects were selected according to the inclusion criteria and treated with the artificial tiger bone capsule 1. 2 g per time for 52 weeks in 6 hospitals. The bone mineral density（ BMD） was measured by DXA at baseline and follow-up to statistic its clinical efficacy and the occurrence of adverse drug reactions. Results Compared with baseline,after 52 weeks of treatment,the BMD of lumbar spine（ L2-L4） increased by 1. 15%,the total clinical effective rate of PPS was 81. 73%（ 85 cases/104 cases）. There was no drug-related adverse drug reaction during the study. Conclusion The artificial tiger bone capsule could restrain the decline trend of BMD but failed to significantly improve the lumbar and femoral neck BMD. Besides,it could effectively alleviate the symptoms of osteoporosis to achieve the desired therapeutic goal,improve the quality of life of patients.