国产羟乙膦酸二钠治疗骨质疏松症180例临床验证报告

Clinical trial of disodium etidronate in treatment of 180 cases of osteoporosis

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Ｘ２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，Ｌ２～４、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。

Clinical trial was conducted to test the efficacy and safety of domestic disodium etidronate tablets (EHDP) in treatment of osteoporosis. Methods One hundred and eighty cases were observed in three hospitals. The patients were divided into two groups using random double-blind method,one being the treated group (n=101) receiving EHDP,while the other the control group (n=79 )receiving placebo instead. The efficacy was determined by the change of bone mineral density(BMD) of lumbar vertebra and hip joint,and the improvement of clinical symptoms before and after the trial. All of the data were analysed statistically. Results After two courses of therapy for 6 months,the treated group demonstrated significant increases in BMD of L2~4, femoral neck, greater trochanter and Wards'triangle,while the control group revealed no statistically significant increase in BMD. In addition, there was statistically difference in BMD of L2~4,femoral neck,greater trochanter and Wards' triangle between the two groups. EHDP also relieved lumbago and backache caused by osteoporosis,and promoted the flexibility of joints. No apparent serious adverse effects were observed during the trial. The significant decrease of urine HOP/Cr in the treated group showed that EHDP could inhibit bone resorption. Conclusions The results indicate that EHDP is an efficacious and safe drug in treatment of osteoporosis.