金天格胶囊治疗原发性骨质疏松症660例临床疗效

Clinical study on effect of JINTIANGE capsules for treatment of primary osteoporosis

目的评价金天格胶囊治疗原发性骨质疏松症的临床疗效和安全性。方法入选原发性骨质疏松症患者660例,完成660例,采用多中心、随机、双盲对照试验设计分为5组,其中泰格1组(人工虎骨健步虎潜丸)120例、泰格2组(天然虎骨健步虎潜丸)120例、泰格3组(金天格胶囊)120例、泰格4组(天然虎骨胶囊)120例、开放组(泰格1的开放组)180例。其中治疗组420例,对照组240例,男性157例,女性505例,年龄41～50岁,按病程分为小于1a,1～3a,3～5a,大于5a。各服用以上药物3#tid,疗程3m。结果5组治疗原发性骨质疏松症显效率分别为29.17,30.83,33.33,27.50,35.00%,总有效率分别为88.34,84.16,80.83,80.83,83.33%,各组总体疗效无显著性差异;各组患者治疗前后均不同程度提高骨密度,各组间比较差异无显著意义(P>0.05);从症状和体征改善方面,各组治疗前后在腰背疼痛、腰膝酸软、下肢酸痛等改善具有非常显著性差异(P<0.001),症状和体征起效时间各组t检验分析差异无显著性意义(P>0.05);各组不良反应无显著性差异。结论金天格胶囊治疗原发性骨质疏松症有效,安全,无不良反应。

Objective To investigate the effect of JINTIANGE capsules in treating primary osteoporosis. Methods Totally,660 patients with primary osteoporosis were divided into 5 groups randomly and a multi-center randomize double-blind controlled trial was couducted. Different Chinese medicines were given to the 5 groups ：Tiger 1 group： bionic tiger bone pill;Tiger 2 group： natural tiger bone pill;Tiger 3 group： JINTIANGE Capsules;Tiger 4 group： natural tiger bone capsule ; Open group： open for Tiger 1 group. All of the groups were treated orally for 3 months with 3 capsules/pills, rid. Dual energy X-ray absorptionmetry（DEXA） scanner was used for measuring BMD at spine （L2-4） and hip. The blood Ca^2＋ , P concentration and alkali phosphatase activity were also detected. Results （ 1 ） The effective rate and total effective rate were 29.17 and 88.34% for Tiger 1 group,30.83% and 84.16% in Tiger 2 group, 33.33 and 80.83 % in Tiger 3 group and 27.50 and 80.83 % in Tiger 4 group. The efficacy among the 4 groups showed no significant difference（ P 〉 0.05） . （2）The score of symptom and physical signs in all of the groups showed significant decrease after 3 months treatment（ P 〈 0.001 ） indicating significant change in physical signs and symptoms after treatment. （3）The BMD measurement showed that all of the Chinese medicines could enhance spine and hip bone density without significant difference among all groups. （4）The efficacy difference between Tiger 1 and Tiger 3 were irrelevant（ P 〉 0.05 ） to age, sex, illness and duration of disease. Conclusions JINTIANGE Capsules has the same efficacy on primary osteoporosis as the natural tiger bone pill and capsules. JINTIANGE Capsules will be the ideal Chinese medication for primary osteoporosis patients to enhance bone strength. The bionic tiger bone power would be possible to substitute the natural tiger bone as an important ingredient in TCM for treatment of bone related diseases in the future.