摘要
对国产的羟乙膦酸二钠(康骨片)进行治疗骨质疏松症的临床验证,考察其疗效和安全性。方法三家医院共观察骨质疏松患者180例,将病例接随机双盲法分组,其中羟乙膦酸二钠治疗组101例,安慰剂对照组79例。通过治疗前后腰椎和髋部骨密度值变化和临床症状缓解情况判断疗效。数据经配对t检验和X^(2)检验处理。结果经两个疗程共6个月的治疗,骨质疏松患者治疗前后的比较,治疗组2~4、股骨颈、大转子和Wards三角区等部位治疗后骨密度增加显著,对照组均无显著变化。两组间比较,L_(2~4)、大转子和Wards三角区骨密度指标差异有显著性。羟乙膦酸二钠还可缓解因骨质疏松引起的腰背痛等症状,增加关节活动度。治疗期间未见明显的副作用。治疗组晨尿HOP/Cr下降显著,表明羟乙膦酸二钠能抑制骨吸收。结论以上结果表明,羟乙膦酸二钠(康骨片)是骨质疏松症安全有效的治疗药物。
Climcal triel was conducred to test the efficacy and safety of domestie disodum etidronate tablets(EHDP)in treatment of osteoporosis,Methods One bundred and eighty cases were observed in three hospricals.The patients were divided inco two groups using random double-blind method,one beiug the treated group(n=101)reieiving EHDP,whle the other the control group(n=79)recerving placebo instead.The effeacy wits dete mined by the change of bone tmineral density(BMD)of lumbar vertebra and bip jcint,and the imprnene ot of elinical symptoms before and after the trial.All of the data were analysed statistirally.Results After two courses of therapy for 6 tmonths,the tre dedgroup demonstrated significunt incrrases in BMD of L_(2)to femoral neck.greater trochaoter and Wards'trangle,while the contrel group revealed no stotisticaily siguificant increase in BMD.In addinou,there was statistically difference in BMD of L_(2-t).femau lneck,greater trochanter and Wards'triangle hetweenthe two groups.EHDP ales reheved humhagalad Lnckacle caused by osteoporosis,and protmoted the flexbility of joints.No apparen serious adverse eflecte were cbserved during the trial.The significant decrease of urine HOP/Cr in the treated group how-d that EHDP could inhihit bone resorption.Conclusions The results indicate that EHDP is an efficacious and safe drug in treatment of osteoporosis.
作者
余传林
陈卫民
徐伟
徐继红
刘叔文
吴曙光
Yu Changin;Chen Weimin;Xa Wei(Phamateain alInstitute,The First Military Medical University-Guangzhou,510515,China)
出处
《中国骨质疏松杂志》
CAS
CSCD
1997年第2期52-55,共4页
Chinese Journal of Osteoporosis
