摘要
目的:评价纯中药复方制剂金乌骨通胶囊对绝经后骨质疏松患者的骨密度及骨代谢生化标志的影响,及使用6个月的安全性观察。方法:进行了为期6个月的前瞻性、随机双盲、安慰剂对照的临床研究。将确诊的140例绝经后骨质疏松症(postmenopausal osteoporosis,PMO)患者分为治疗组(n=70)和安慰剂组(n=70),2组均口服等量的元素钙,同时分别服用金乌骨通胶囊和安慰剂胶囊,观察新发骨折及骨痛等临床症状,测定腰椎及髋部骨密度及各项骨代谢生化指标。结果:治疗组与安慰剂组比较:1．腰椎及髋部骨密度明显增加,两组比较骨密度变化的百分数差异有显著性(P<0．01)。2．血清骨钙素、血清碱性磷酸酶、骨碱性磷酸酶明显升高(P<0．05),雌二醇／睾酮显著上升(P<0．01);尿羟脯氨酸／肌酐、尿钙／肌酐有明显下降(P<0．01)。结论:金乌骨通胶囊可以有效治疗PMO,能明显提高绝经后妇女的腰椎及髋部骨密度,未见严重不良反应。
Objective：To evaluate the efficacy and safety of jinwugutong capsule （JWGTC, a Chinese herbal compound preparation） on bone mineral density （BMD} and biochemical markers of bone metabolism in postmenopausal women. Methods： The clinical study was conducted adopting prospective, randomized,double blinded method for 6 months. 100 PMO patients with confirmed diagnosis were divided into the JWGTC group （n= 50 ） and the placebo group（n= 50 ）, they were treated with JWGTC and placebo capsule respectively. The symptoms,as new fracture and ostealgia,bone mineral density （BMD） of lumbar vertebraeand and hip,indexes for bone metabolism. Results：As compared with the placebo group,in the JWGTC group： 1. The BMD of lumbar vertebrae and hip have obviously increased, the JWGTC group was significantly better than the placebo group（P〈 0.01 ）. 2. Osteocalcin, serum and bone alkaline phosphatase were higher （P〈 0. 05 }, estradiol/testosterone were higher（P〈0.01）; levels of urinary oxyproline hydroxyproline/creatinine, urinary calcium/creatinine were lower（P〈 0.01 ）. Conclusion：JWGTC could treat PMO effectively,it can obviously increase the BMD of lumbar vertebrae and hip of the postmenopausal women.
出处
《中国中医骨伤科杂志》
CAS
2007年第3期30-32,共3页
Chinese Journal of Traditional Medical Traumatology & Orthopedics
关键词
金乌骨通胶囊
治疗
绝经后骨质疏松
Jinwugutong capsule
Treatment
Postmenopausal osteoporosis
