藏药杞鹿温肾胶囊治疗原发性骨质疏松症的临床疗效观察
摘要：目的对藏药杞鹿温肾胶囊治疗原发性骨质疏松症的疗效及潜在的毒副作用进行临床观察。方法1.5年内分别用藏药杞鹿温肾胶囊和骨疏康治疗原发性骨质疏松症患者各30例，12个月为1个疗程，用药前及用药后12个月分别查血、尿、便常规、肝肾功能及电解质、心电图等，同时用QCT测第2~4腰椎的骨密度(BMD)，并对患者的腰背酸痛、腰膝酸软等肾虚症状进行评估。结果藏药杞鹿温肾胶囊治疗组总有效率为82.14％ ，骨疏康治疗组总有效率为67.86％。杞鹿温肾胶囊对心、肝、肾无毒副作用，对血常规及电解质无不良影响，且能改善心肌的血液循环。结论藏药杞鹿温肾胶囊是一个耐受性良好、安全有效的治疗原发性骨质疏松症的新药。
Abstract:ObjectiveTo investigate the effects and potential side efects of Qilu Wenshen Capsule as a novel candidate for the treatment of primary Osteoporosis．Methods60 patients with primary osteoporosis were randomly divided into group A and group B．Group A was given Qilu Wenshen Capsule and group B was treated with Gushukang granule for 12 months. Before and after the treatment，the patients were subjected to routine examination of blood，urine and stool．Electrocardiogram ，function of liver and kidney，serum electrolytes and bone mineral density(BMD)of the L2—4 vertebrae were evaluated pre—and post—treatment，subjective symptoms such as pain in the back and weakness in the knee were assessed during the treatment．ResultsBMD was increased and subjective symptoms were relieved in 82.14％ of patients in group A and 67.86％ in group B．No significant side effects on heart，liver，kidney and the homeostasis of blood and serum electrolytes were observed in patients treated with Qilu Wenshen Capsule．Moreover，Qilu Wenshen Capsule improved blood supply to the heart．ConclusionQilu Wenshen Capsule is a well tolerated，effective novel candidate for the treatment of primary osteoporosis．。
Key words:Qilu Wenshen Capsule； Osteoporosis； Clinical trial 骨质疏松症(osteoporosis, OP)是骨骼骨基质和骨矿物质丧失所致的一种骨代谢性疾病，以骨显微结构改变、单位骨体积骨量减少和骨生物力学改变为特征［1］。目前世界上骨质疏松患者约达2亿人，骨质疏松已成为世界性关注的严重社会问题，在我国也已将它列为重点攻关研究的老年性疾病之一。目前骨质疏松症的临床治疗多以西药为主，如雌激素、降钙素、钙剂、维生素D、二磷酸类及氟化物等［2］。疗效肯定，但价格昂贵，且有很多副作用［3］。近年来，人们对传统中药防治骨质疏松症有了较深入的研究［4~10］，但藏药治疗骨质疏松还未见报道。我们分别用藏药杞鹿温肾胶囊和中药骨疏康治疗原发性骨质疏松症患者各30例，对两者的疗效进行了对比，同时对藏药鹿茸健骨胶囊可能存在的毒副作用进行了临床观察。
1 材料和方法。
1.1 临床资料我院自200407~200601期间应用由青海省格拉丹东药业有限公司生产的藏药杞鹿温肾胶囊治疗原发性骨质疏松症门诊患者30例（A组），其中男4例，女26例。年龄52～70岁，平均(64．43±5．54)岁。对照组(B组)给予辽宁省东岗制药厂生产的治疗骨质疏松症的中药骨疏康，30例，其中男5例，女25例。年龄47~70岁，平均64.33岁。采用随机双盲的方法，分别用药12个月为1个疗程。用药前及用药后12个月分别检测血、尿、便常规、肝肾功能及电解质、心电图。患者在治疗过程中有不适症状，随时进行上述检查。同时用QCT测腰2~4椎体的骨密度(BMD)。其中每组各有2例因故退出治疗，所以各组只剩28例(治疗组一例因严重胃痛不能继续服用，另一例因中途发现乳腺癌而退出治疗。B组其中一例不能耐受药物的异味而停服，另一例因严重腹泻而停服)。
1.2 疗效评定标准腰膝酸软、腰背酸痛等症状完全消失，腰椎2~4椎体BMD比用药前明显提高，为显效；腰膝酸软、腰背酸痛等症状明显减轻或消失，腰椎2~4椎体BMD比用药前稍有改善，为有效；症状无改善，腰椎2~4椎体BMD比用药前无变化，为无效。
1.3 统计学方法腰椎2~4椎体BMD以±ｓ表示，组间比较用t检验。
2 结果。
治疗12个月后A、B两组腰椎2~4椎体BMD均明显提高(P0.001)，且A组较B组提高更显著(P0.05)。见表1。
治疗前两组比较，0.05。