目的观察益肾蠲痛口服液治疗肾阳虚型绝经后骨质疏松症（postmenopausal osteoporosis,PMOP）的临床疗效。方法将120例肾阳虚型PMOP患者随机分为治疗组和对照组,每组60例。两组患者均口服钙尔奇,治疗组患者加服益肾蠲痛口服液,对照组患者加服骨康口服液,疗程均为12个月,随访24个月。治疗前后及随访时,分别采用视觉模拟评分法（visual analogue scale,VAS）评价腰背疼痛,采用双能X线检测骨密度（bone mineral density,BMD）;并观察两组中医证候疗效及脆性骨折发生情况。结果治疗后,两组VAS评分均较治疗前显著降低（P〈0.01）;腰椎、股骨颈、Ward三角BMD均较治疗前显著上升（P〈0.01）;随访时,治疗组VAS下降值及腰椎（L2—4）、股骨颈、Ward三角BMD升高值均显著大于对照组（P〈0.01）。两组中医证候疗效及脆性骨折复发率比较,差异均无统计学意义（P〉0.05）。结论益肾蠲痛口服液可减轻PMOP患者腰背疼痛,提高BMD,改善中医症状,防止脆性骨折复发,在减轻腰背疼痛和提高BMD方面较对照药具有明显优势。
Objective To investigate the clinical efficacy of Yishen Juantong oral liquid in the treatment of kidneyyang deficiency type postmenopausal osteoporosis（PMOP）.Methods A total of 120 patients with PMOP（kidney-yang deficiency type）were randomly divided into treatment group（n=60）and control group（n=60）.Both groups received oral Caltrate;additionally,the treatment group was given Yishen Juantong oral liquid,while the control group was given Gukang oral liquid.The course of treatment was 12 months for both groups,and the follow-up was 24 months.Before and after the treatment and during the follow-up,the visual analogue scale（VAS）was used to assess low back pain,and dual-energy X-ray absorptiometry was used to determine the bone mineral density（BMD）;the improvement in traditional Chinese medicine（TCM）syndromes and the incidence of fragility fracture were evaluated.Results After treatment,both groups showed significantly reduced VAS scores（P〈0.01）and significantly increased BMD of the lumbar vertebrae,femoral neck,and Ward＇s triangle（P〈0.01）.During the follow-up,the treatment group had a significantly higher decrease in VAS score and significantly higher increases in BMD of the lumbar vertebrae（L2—4）,femoral neck,and Ward＇s triangle（P〈0.01）,as compared with the control group.There were no significant differences in the improvement in TCM syndromes and the recurrence rate of fragility fracture between the two groups（P〉0.05）.Conclusion For PMOP patients,Yishen Juantong oral liquid can relieve low back pain,increase BMD,improve TCM syndromes,and prevent the recurrence of fragility fracture,and it is superior to Gukang oral liquid in terms of relieving low back pain and increasing BMD.
Journal of Anhui Traditional Chinese Medical College
Yishen Juantong oral liquid
Gukang oral liquid
low back pain
bone mineral density