强骨胶囊治疗原发性骨质疏松症、骨量减少的疗效及安全性评价

Evaluation of efficacy and safety of Qianggu capsules for the treatment primary osteoporosis and bone loss

目的探讨强骨胶囊治疗原发性骨质疏松症、骨量减少的有效性及临床应用的安全性。方法采用多中心、开放的临床试验,对原发性骨质疏松症、骨量减少患者给予强骨胶囊治疗共12周,治疗前、后用中医证候进行分级评分,检测血压、心率、血常规、尿常规、心电图及肝肾功能。部分患者治疗后复查骨密度。结果共入组2062例,年龄范围45～75岁。治疗后患者腰背疼痛、下肢无力、畏寒肢冷、抽筋、夜尿频多等证候明显改善,临床症状缓解率93.8%。治疗12周后,未发现腰椎2-4及股骨颈的骨密度有明显变化。全部不良事件发生率7.6%(157/2061),无严重不良事件及罕见不良反应发生。药物相关不良事件有:口干5.19%(107/2061)、便秘2.33%(48/2061)、胃部不适0.24%(5/2061),没有因与药物有关的不良事件而退出试验的病例。结论强骨胶囊能明显改善原发性骨质疏松症、骨量减少患者的腰背疼痛、下肢无力、畏寒肢冷、抽筋、夜尿频多等临床症状,同时具有良好的安全性。

Objective To investigate the efficacy and safety of Qianggu capsule for the treatment of primary osteoporosis and bone loss. Methods A multi-center and open trial study was performed. Patients with primary osteoporosis and bone loss were administered with Qianggu capsule for 12 weeks. The scores of the syndromes of traditional Chinese medicine, BP, HR, routine blood and urine test, ECG, and liver and kidney function were documented before and after the treatment. BMD measurement was performed in a portion of the patients. Results Two thousand and sixty-two 45-75 years old patients were enrolled. Obvious improvement was achieved in terms of back pain, weak legs, aversion to cold and cold limbs, cramp, and frequent nocturia. The total effective rate was 93.8%. No BMD changes of L2-4 and the femoral neck were observed after 12 weeks of the treatment. Total incidence of AEs was 7.6% （ 157/2061 ）, with absence of SAEs. Drug related AEs included dry mouth 5.19% （107/2061） , constipation 2.33% （48/ 2061） , and stomach discomfort 0. 24% （5/2061）. No patients withdrew because of drug-related AEs. Conclusion Qianggu capsule is capable of relieving symptoms of primary osteoporosis and bone loss. In addition, it is of better safety.