金刚丸治疗绝经后骨质疏松症的疗效评价

Evaluation of Clinical Effect of Jingangwan(金刚丸)on Postmenopausal Osteoporosis

目的:探讨金刚丸治疗绝经后骨质疏松症的临床疗效。方法:运用随机数字表法将60例绝经后骨质疏松症患者分为治疗组(30例)及对照组(30例),对照组患者给予钙尔奇D片、阿仑膦酸钠维D3片口服,治疗组在对照组的基础上口服金刚丸,连续治疗3个月。在治疗前和治疗结束后观察两组患者的疼痛视觉模拟评分(VAS)、骨密度(BMD)、血钙(Ca)、血磷(P)、25羟维生素D(25-OH-VitD)、I型原胶原氨基端前肽(PINP)、I型胶原β降解产物(β-CTX)、中医证候评分及不良反应,并评价疗效。结果:治疗组脱落1例,对照组脱落2例;治疗组完成研究29例,对照组完成研究28例。治疗组临床总有效率优于对照组(P<0.05)。治疗3个月后,对照组患者L3~4及左股骨颈BMD均高于治疗前(P<0.05);治疗组患者腰椎L2~4及左股骨颈BMD均高于治疗前(P<0.05);治疗组患者治疗3个月后L2~4及左股骨颈BMD均高于对照组(P<0.05)。治疗3个月后,两组患者Ca、25-OH-VitD、PINP均高于治疗前(P<0.05),而P、β-CTx均低于治疗前(P<0.05);治疗组患者治疗3个月后25-OH-VitD、PINP均高于对照组(P<0.05),而β-CTX低于对照组(P<0.05)。治疗3个月后,两组患者VAS评分、中医证候评分均低于治疗前(P<0.05);治疗组患者治疗3个月后VAS评分、中医证候评分均低于对照组(P<0.05)。结论:金刚丸可有效缓解绝经后骨质疏松症患者的临床症状及体征,提高骨密度,调节骨代谢指标。

Objective:To observe the clinical efficacy of Jingangwan in the treatment of postmenopausal osteoporosis.Methods:60 patients with postmenopausal osteoporosis were randomized into two groups:treatment group(n=30)and control group(n=30).The patients in control group were given Caltrate D Tablets and Alendronate Sodium and Vitamin D3Tablets orally,the treatment group was treated with Jingangwan on the basis of the control group for 3 months.Visual analogue scale(VAS),bone mineral density(BMD),blood calcium(Ca),blood phosphorus(P),25-hydroxyvitamin d(25-OH-VitD),Procollagen I N-terminal peptide(PINP),β-C-terminal telopeptide of type I collagen(β-CTX),TCM syndrome score and adverse reactions were observed before and after treatment,and evaluate the efficacy.Results:In the treatment group,1 case dropped off,and in the control group,2 cases dropped off.29 cases in the treatment group and 28 cases in the control group completed the study.The total effective rate of the treatment group was higher than that of the control group(P<0.05).After3 months of treatment,the BMD of L3~4and left femoral neck in the control group was higher than that before treatment(P<0.05).The BMD of L2~4and left femoral neck in the treatment group was higher than that before treatment(P<0.05).The BMD of L2~4and left femoral neck in the treatment group was higher than that in the control group after 3 months treatment(P<0.05).After treatment for 3 months,the levels of Ca,25-OH-VitD and PINP in both groups were higher than those before treatment(P<0.05),while the levels of P andβ-CTX were lower than those before treatment(P<0.05).The levels of 25-OH-VitD and PINP in the treatment group were higher than those in the control group(P<0.05),while the levels ofβ-CTX in the treatment group were lower than those in the control group(P<0.05).After treatment for 3 months,VAS scores and TCM syndrome scores in both groups were lower than those before treatment(P<0.05).After 3 months treatment,the VAS score and TCM syndrome score in the treatment group were lower than those in the control group(P<0.05).Conclusion:Jingangwan has a significant therapeutic effect on postmenopausal osteoporosis,which can effectively relieve the symptoms and signs of the patients,improve bone mineral density,and regulate bone metabolism index content.