复方淫羊藿口服液治疗原发性骨质疏松症临床研究

Clinical Research on Compound Epimedium Oral Liquid Treatment of Primary Osteoporosis

目的:观察复方淫羊藿口服液辅助治疗原发性骨质疏松症肾阳虚证的临床疗效及其作用机制。方法:将118例原发性骨质疏松症(肾阳虚证)患者随机分为对照组和观察组,每组58例。对照组,在进行健康宣教育的基础上给予钙尔奇D片,每次1.5g,每天1次;阿仑膦酸钠,每次70 mg,每周1次,晨起顿服。观察组在对照组的基础加服复方淫羊藿口服液,每次10 m L,每天3次。疗程:两组患者均连续观察12个月。两组均采用双能X线骨密度测量仪测量治疗前后股骨颈、髓部关节和腰椎L2~4的骨密度;检测治疗前后骨碱性磷酸酶(bone alkaline phosphatase,BALP)、I型原胶原N-端前肽(type I procollagen n-propeptide,PINP)和血清I型胶原交联C-末端肽(serum type I collagen cross-linked C-terminal peptide,S-CTX)、碱性磷酸酶(alkaline phosphata,ALP)、骨钙素(bone gla protein,BGP)水平;进行治疗前后生活质量量表评分和中医证候评分。结果:观察组有效率为94.12%,高于对照组的76.00%,差异有统计学意义(χ2=6.553,P<0.05);治疗后观察组股骨颈、髓部关节和腰椎L2~4的骨密度高于对照组,差异有统计学意义(P<0.01);治疗后观察组患者BALP、S-CTX、PINP和ALP水平均低于对照组,BGP水平高于对照组,差异有统计学意义(P<0.01);治疗后观察组OQOLS量表疾病、生理、社会、心理和满意度评分均明显升高,并高于对照组,差异有统计学意义(P<0.01);观察组第3月、第6月、第9月、第12月中医证候评分均低于对照组,差异有统计学意义(P<0.01)。结论:复方淫羊藿口服液治疗原发性骨质疏松证肾阳虚证患者能改善临床症状,提高骨密度,调节骨代谢和骨转换,能提高骨质疏松症临床疗效。

Objective： To observe the clinical effect and the functional mechanism of compound Epimedium oral liquid treatment of primary osteoporosis（ kidney-Yang deficiency syndrome）. Methods： 118 patients of primary osteoporosis（ kidney-Yang deficiency syndrome） were randomly divided into the control group and the observation group,with 58 patients in each group. For the control group,in addition to health education,patients took Caltrate Vitamin D tablets（ once daily with 1. 5 g per time） and alendronate sodium（ once a week with 70 mg per time at a draught in the morning）. On the basis of the treatment of the control group,the observation group took an oral administration of compound Epimedium oral liquid,three times daily with 10 m L per time. The treatment course for both groups was 12 months which required for an uninterrupted observation. For both groups,dual energy X-ray bone densitometer was used to test the bone mineral densities of neck of femur,femoral medullary joint and lumbar vertebra L2-4before and after the treatment; the levels of bone alkaline phosphatase（ BALP）,type I procollagen n-propeptide（ PINP） and serum type I collagen cross-linked C-terminal peptide（ S-CTX）,alkaline phosphate（ ALP）,bone gla protein（ BGP） were tested;scores were given according to quality of life index and TCM syndromes before and after the treatment. Results： The effective rate of observation group was 94. 12%,higher than 76. 00% of the control group,and the difference was statistical significance（ χ2=6. 553,P 〈0. 05）; after treatment,the bone densities of neck of femur,femoral medullary and lumbar vertebra L2-4of treatment group were higher than those of the control group and the difference was statistical significant（ P 〈0. 01）; after treatment,the levels of BALP,S-CTX,PINP and ALP of observation group were lower than those of control group and BGP level of observation group was higher than that of control group,the difference was statistical significant（ P〈 0. 01）; after treatment,the scores of disease,physiology,society,psychology and satisfaction in OQOLS of observation group increased significantly,higher than those of control group,and the difference was statistical significant（ P 〈0. 01）; the scores for TCM syndromes of observation group in the third month,the sixth month,the ninth month and the twelfth month were lower than those of control group and the difference was statistical significant（ P〈 0. 01）. Conclusion： The treatment of POP（ kidney-Yang deficiency syndrome） with compound Epimedium oral liquid can improve clinical syndromes,improve bone density,regulate bone metabolism and turnover,and improve the clinical effect for osteoporosis.