壮腰活络胶囊联合骨化三醇及碳酸钙D3治疗肾虚血瘀型老年性骨质疏松症的临床研究

Clinical study on therapeutic efficacy of ZHUANGYAOHUOLUO capsules combined with calcitriol and calcium carbonate D3 in treatment of senile osteoporosis of kidney deficiencies and blood stasis type

目的探究壮腰活络胶囊联合骨化三醇软胶囊及碳酸钙D3片(Ⅱ)治疗肾虚血瘀型老年性骨质疏松症(SOP)的临床疗效。方法选取2019年1月至2021年12月该院收治的60例符合标准的肾虚血瘀型老年性SOP患者,按照随机数字表法分为对照组和治疗组,每组30例。对照组患者采用口服骨化三醇软胶囊和碳酸钙D3片(Ⅱ)治疗;治疗组患者在对照组治疗基础上加用壮腰活络胶囊口服治疗。2组患者均连续治疗3个月,并继续随访6个月。观察对比2组患者治疗前后及随访6个月后的疼痛视觉模拟评分法(VAS)评分、骨密度(BMD)、骨代谢指标[Ⅰ型原胶原氨基端延长肽(PINP)、Ⅰ型胶原羧基端肽β特殊序列(β-CTX)]及中医证候评分的变化。结果在治疗后及随访6个月后,2组患者VAS评分、中医证候评分和β-CTX水平均较治疗前得到改善,且治疗组较对照组改善更为显著,差异均有统计学意义(P<0.01)。与治疗前比较,对照组PINP水平降低,差异有统计学意义(P<0.01),而治疗组PINP水平未降低,差异无统计学意义(P>0.05)。2组患者在随访6个月后的BMD水平均较治疗前升高,且治疗组的BMD水平较对照组更高,差异均有统计学意义(P<0.01)。治疗组患者治疗总有效率达到93.33%,明显高于对照组的80.00%,差异有统计学意义(P<0.05)。结论壮腰活络胶囊联合骨化三醇软胶囊和碳酸钙D3片(Ⅱ)治疗肾虚血瘀型老年性SOP,临床疗效确切,能缓解疼痛,改善中医证候评分及骨代谢标志物水平,提高BMD且具有安全性,值得临床推广。

Objective To investigate the clinical efficacy of ZHUANGYAOHUOLUO capsules combined with calcitriol soft capsules and calcium carbonate D3 tablets(Ⅱ)in the treatment of senile osteoporosis(SOP)of kidney deficiencies and blood stasis type.Methods From January 2019 to December 2021,a total of 60 eligible elderly patients with senile SOP of kidney deficiency and blood stasis type who met the criteria were selected and divided into the control group and the treatment group according to the random number table method,with 30 cases in each group.The control group was treated with oral calcitriol soft capsules and calcium carbonate D3 tablets(Ⅱ),while the treatment group was treated with ZHUANGYAOHUOLUO capsules in addition to the treatment given to the control group.Both groups of patients were treated continuously for three months and followed up for six months.The changes in Visual Analog Scale(VAS)scores,bone mineral density(BMD),bone metabolism markers[N-terminal peptide of typeⅠprocollagen(PINP),carboxy-terminal telopeptide of type I collagen(β-CTX)],and traditional Chinese medicine syndrome scores were observed and compared before and after treatment,as well as during a 6-month follow-up period for the two groups of patients.Results After treatment and six months of follow-up,the VAS score,TCM syndrome score,andβ-CTX level of both groups of patients all improved compared with before treatment,and the improvement in the treatment group was more significant than that in the control group,with statistically significant differences(P<0.01).Compared with before treatment,the PINP level in the control group decreased significantly(P<0.01),while the PINP level in the treatment group did not decrease significantly(P>0.05).The BMD levels of both groups of patients increased after a 6-month follow-up compared with before treatment,and the BMD level in the treatment group was higher than that in the control group with statistically significant differences(P<0.01).The total effective rate of treatment in the treatment group was 93.33%,significantly higher than that in the control group of 80.00%,with statistically significant difference(P<0.05).Conclusion ZHUANGYAOHUOLUO capsules combined with calcium carbonate D3(Ⅱ)and calcitriol soft capsules can effectively treat senile SOP with kidney deficiencies and blood stasis type,which can relieve pain,improve TCM syndrome score and bone turnover marker level,improve BMD and is safe.It is worthy of clinical promotion.