护骨胶囊治疗肾精亏虚证原发性骨质疏松症的随机对照临床试验

A clinical trial of Hugu Capsule in the treatment of primary osteoporosis (syndrome of deficiency of kidney essence)

目的评价护骨胶囊治疗肾精亏虚证原发性骨质疏松症的有效性和安全性。方法将158例肾精亏虚证原发性骨质疏松症患者随机分为试验组79例,给予口服护骨胶囊治疗;对照组79例,给予口服仙灵骨葆胶囊治疗。两组患者均治疗12周。观察比较治疗前后SF-36量表各维度评分、骨密度(bone mineral density,BMD)值、疼痛视觉模拟评分(visual analogue pain score,VAS)、中医证候评分以及安全性情况。结果①基线期试验组与对照组受试者年龄、身高、体重、性别、骨密度值、疼痛评分、SF-36问卷量表维度评分、中医证候量表总分、中医证候单项评分等指标在两组间分布均衡(P>0.05)。②SF-36量表各维度评分用药前后的变化:试验组治疗后总体健康维度评分较治疗前显著上升,差异有统计学意义(P<0.05);而对照组的总体健康评分前后对比,差异无统计学意义(P>0.05)。而且治疗后,两组躯体健康、躯体功能角色、社会功能、躯体疼痛维度的评分较治疗前均上升,差异有统计学意义(P<0.05)。③骨密度测定值:试验组腰椎L2、L3、L4部位及腰椎L2-L4平均骨密度测定值治疗前后对照,差异均无统计学意义(P>0.05)。对照组腰椎L2、L3、L4部位骨密度测定值治疗前后对照,差异均无统计学意义(P>0.05),腰椎L2-L4的骨密度值治疗后较治疗前下降,差异有统计学意义(P<0.05)。④疼痛评分:试验组与对照组疼痛评分较基线时均有明显降低,两者比较差异无统计学意义。⑤中医证候量表评分:试验组和对照组均能降低中医证候量化评分,两组组间比较差异无统计学意义。⑥安全性:试验期间发生的不良事件中,被判定为药物不良反应的有6例,其中试验组为1例(1.47%),对照组为5例(7.46%)。结论肾精亏虚证原发性骨质疏松症患者服用护骨胶囊后,显示有良好的治疗效果,且不良反应较少,安全性较佳。

Objective To evaluate the efficacy and safety of Hugu capsule in treating primary osteoporosis of kidney essence deficiency syndrome.Methods A totally 158 patients with primary osteoporosis were randomly divided into an experimental group(n=79)and a control group(n=79).The experimental group was given Hugu capsule orally,while the control group was treated by Xianlinggubao capsule orally.All patients were treated for 12 weeks.SF-36 scale score,bone mineral density(BMD),visual analogue pain score(VAS),TCM symptom score and other safety parameters were observed before and after the trial.Results①The distribution of age,height,weight,sex,bone mineral density,pain score,SF-36 questionnaire dimension score,total score of TCM syndrome scale and TCM syndrome-single score was balanced between the two groups.②Changes in the scores of the SF-36 scale before and after treatment:The overall health dimension score was significantly higher in the experimental group than before the treatment,and the difference was statistically significant,while the overall health score of the control group was not significantly different(P>0.05).Moreover,after treatment,the scores of physical health,somatic functional roles,social functions,and somatic pain dimensions of the two groups increased compared with before treatment,and the differences were statistically significant.③BMD measurement:In the experimental group,lumbar vertebra L2,lumbar vertebra L3,lumbar vertebra L4 and lumbar vertebrae L2-L4 mean bone mineral density were no statistically different before and after treatment(P>0.05).In the control group,there were no significant differences in the bone mineral density of the lumbar vertebra L2,lumbar vertebra L3 and lumbar vertebra L4 before and after treatment(P>0.05),whereas the bone density of lumbar spine L2-L4 decreased after treatment compared with before treatment.④Visual analogue pain score(VAS):the pain scores between the experimental group and the control group did not show significant differences,but the pain scores of the two groups at the end of treatment were significantly lower than those at baseline.⑤TCM syndrome scale score:There was no significant difference between the experimental group and the control group in the TCM syndrome score,but both treatments could reduce the TCM syndrome scale score.⑥Safety:During the trial,adverse reactions occurred in 1 case(1.47%)in the experimental group and 5 cases(7.46%)in the control group.Conclusion Primary osteoporosis patients with kidney essence deficiency syndrome showed good therapeutic effects after taking Hugu capsule,and had fewer adverse reactions and better safety.