体质调节法干预阳虚质绝经后骨质疏松症临床研究

Clinical Study on Constitution Regulation for Postmenopausal Osteoporosis with Yang Deficiency

目的观察体质调节法对阳虚质绝经后骨质疏松症(PMOP)的干预疗效,及对骨密度、骨代谢指标的影响。方法采用随机数字表法将100例阳虚质PMOP患者分为对照组和观察组各50例。对照组予碳酸钙D3片,600 mg/次,1次/d,口服;骨化三醇胶丸,0.25μg/次,2次/d,口服。观察组在对照组基础上予体质调节法(八段锦+当归生姜羊肉汤+金匮肾气丸)。2组均3个月为1个疗程,连续治疗4个疗程。评价2组治疗后中医体质疗效及临床疗效,检测2组治疗前及治疗3、6、12个月疼痛视觉模拟量表(VAS)评分、骨钙素(OC)、尿脱氧吡啶啉/肌酐(DPD/Cr)、雌二醇(E2)、腰椎(L2~4)骨密度,并监测不良反应。结果共95例完成研究。观察组中医体质疗效总有效率为95.83%(46/48),对照组为68.09%(32/47),观察组明显优于对照组(P<0.05)。观察组临床疗效总有效率为93.75%(44/48),对照组为74.47%(35/47),观察组明显优于对照组(P<0.05)。与本组治疗前比较,2组治疗3、6、12个月VAS评分、OC、DPD/Cr、E2均有不同程度改善(P<0.05);观察组治疗6、12个月及对照组治疗12个月骨密度明显升高(P<0.05)。治疗后不同时点比较,观察组治疗3、6、12个月VAS评分、DPD/Cr明显低于对照组(P<0.05),OC、E2明显高于对照组(P<0.05);观察组治疗6、12个月骨密度明显高于对照组(P<0.05)。2组血、尿常规及肝、肾功能未见异常。结论采用体质调节法干预阳虚质PMOP患者疗效满意,可改善患者偏颇体质、缓解腰背部疼痛、提高E2水平,改善骨代谢、增加骨密度。

Objective To observe the efficacy of constitution regulation on postmenopausal osteoporosis(PMOP)with yang deficiency and effects on bone density and bone metabolism.Methods Totally 100 cases of PMOP with yang deficiency were divided into control group and observation group according to random number table method,with 50 cases in each group.The control group was given calcium carbonate D3 tablets,600 mg/time,once a day,orally;calcitriol capsules,0.25μg/time,twice a day,orally.On the basis of the control group,the observation group adopted the method of constitution regulation(Baduanjin+Danggui Shengjiang Mutton Decoction+Jingui Shenqi Pills).The two groups were treated for one course of treatment for 3 months,and for 4 consecutive courses of treatment.TCM physique effect and clinical efficacy in two groups were evaluated after treatment.The visual analogue scale(VAS)score,osteocalcin(OC),urinary deoxypyridine/creatinine(DPD/Cr),estradiol(E2)and lumbar vertebrae(L2-4)bone mineral density were measured before treatment,3,6 and 12 months of treatment.Adverse reactions were monitored.Results Totally 95 patients completed the study.The total effective rate of TCM physique in the observation group was 95.83%(46/48)and 68.09%(32/47)in the control group.The observation group was significantly better than the control group(P<0.05).The total effective rate was 93.75%(44/48)in the observation group and 74.47%(35/47)in the control group.The observation group was significantly better than the control group(P<0.05).Compared with before treatment,VAS score,OC,DPD/Cr and E2 of the two groups improved in different degrees after 3,6 and 12 months of treatment(P<0.05);bone mineral density of the observation group increased significantly after 6,12 months of treatment and that of the control group after 12 months of treatment(P<0.05).After 3,6 and 12 months of treatment,the VAS score and DPD/Cr of the observation group were lower than those of the control group(P<0.05),OC and E2 were higher than those of the control group(P<0.05);bone mineral density of the observation group was higher than that of the control group after 6 and 12 months of treatment(P<0.05).There were no abnormalities in blood and urine routine and liver and kidney function in both groups.Conclusion For PMOP patients with yang deficiency,the efficacy of constitution regulation is satisfactory.It can improve the patients’imbalanced constitution,relieve back pain,improve E2 level and bone metabolism,and increase bone mineral density.