摘要
目的:观察抗骨衰丸治疗肝肾不足型原发性骨质疏松症的临床疗效,并探讨其作用机制。方法:选择1998-09/2002-01湖南中医药大学第一附属医院骨伤科收治的原发性骨质疏松症100例。①采用随机数字表法分为两组,观察组50例口服抗骨衰丸(组方:杜仲、鹿角霜、枸杞、当归、补骨脂、续断、狗脊、自然铜等,由湖南中医药大学第一附属医院制剂室制成蜜丸,每5丸含原药材3g),10丸/次,3次/d。连续服用6月。对照组50例口服骨愈灵胶囊[由骨碎补、五加皮等组成],5粒/次,3次/d。2组均以治疗6月为l疗程。②指标检测:治疗前后判定主、次症分级加权量化计分(腰脊疼痛,酸软少力,不能持重,目眩)改善情况;测定桡骨和尺骨的密度;测定血清雌二醇及睾酮。③疗效判定:参照《中药新药临床研究指导原则》标准,分为显效,有效,无效。结果:100例患者均进入结果分析。①观察组显效率明显高于对照组(82.0%,42.0%,P<0.01)。②两组治疗后均能提高骨密度值(P<0.01);但观察组骨密度(骨密度/骨横径)治疗前后差值显著大于对照组[桡骨:0.074±0.021,0.041±0.008;尺骨:0.072±0.012,0.039±0.010,P<0.01]。③观察组治疗前后血清雌二醇、睾酮差值显著大于对照组(P<0.01)。结论:①抗骨衰丸能促进肝肾不足型原发性骨质疏松症患者性激素分泌,提高骨矿物质含量。②抗骨衰丸治疗原发性骨质疏松症作用机制与其调节性腺轴、升高性激素水平、提高骨密有关。
AIM： To observe the clinical effects of anti-osteoporosis pill in the treatment of primary osteoporosis of liver and kidney deficiency, and probe into its mechanism.
METHODS： One hundred patients with primary osteoporosis between September 1998 and January 2002 were selected from the Department of Orthopedics and Trauma, First Hospital Affiliated to Hunan University of Traditional Chinese Medicine. ①Subjects were randomly divided into two groups, patients in the observation group （n=50） orally took anti-osteoporosis pill （gradients were eucommia bark, comu cervi degelatinatum, medlar, angelica, psoralea fruits, Himalayan teasel root, cibot rhizame and pyritum etc., which was manufactured by the Manufacturing Laboratory of First Hospital Affiliated to Hunan University of Traditional Chinese Medicine with 3 g of active compound in each 5 pill）, 10 pills each time and three times per day for 6 continuous months. Patients in the control group orally took guyuling capsule （composed of rhizoma drynariae and cortex acanthopanacis etc.） 5 pills each time and three times a day. The course in both groups included 6 months.②Index detection： the amelioration of primary and secondary symptoms were judged before and after the treatment according to the score and classification of weighting quantization （pain in lumbar vertebrae, feeling sour and soft and lacking of strength, unable to bear weight, dizzy）. The densities of radial bone and ulna bone were determined, and the contents of serum dihydrotheelin and testosterone were detected. ③Assessment of the curative effects： It was classified as effective, valid and invalid according to the standard of the Guidance Principle of the Clinic Research of New Traditional Chinese.
RESULTS： A total of 100 patients were involved in the analysis of results. ①The effective rate in the observation group was significantly higher than the control group （82.0%, 42.0%, P 〈 0.01）. ②The bone densities in patients of both groups after treatment were enhanced （P 〈 0.01）, while the differences in bone density （bone density/the diameter transverse of bone） of the observation group before and after treatment were obviously marked than the control group [radial bone： 0.074±0.021,0.041±0.008; ulna bone： 0.072±0.012,0.039±0.010,P 〈 0.01]. ③The differences in serum dihydrotheelin and testosterone before and after treatment were greater in the observation group than in the control group （P 〈 0.01）.
CONCLUSION： ①Anti-osteoporosis pill can promote the hormone secretion of patients with primary osteoperosis of liver and kidney deficiency as well as enhance the bone mineral contents.②The mechanism of anti-osteoporosis pill in the treatment of primary osteoporosis is in relatiou to the regulated sexual gland axis, enhanced level of sexual hormone as well as the elevated bone density.
出处
《中国临床康复》
CSCD
北大核心
2006年第23期13-15,共3页
Chinese Journal of Clinical Rehabilitation
基金
湖南省教育厅资助项目(97130)~~
