金天格胶囊对股骨粗隆间骨折患者术后骨密度影响的临床研究

Effect and Safety of Jintiange Capsule for Treating Osteoporotic Intertrochanteric Fracture after Operation

目的:观察金天格胶囊治疗肝肾亏虚型骨质疏松性股骨粗隆间骨折对患者术后骨密度的影响。方法:选取68例肝肾亏虚型骨质疏松性股骨粗隆间骨折术后的患者,采用随机数字表法将其随机分为观察组和对照组,每组34例,均治疗6个月。观察组口服金天格胶囊,对照组口服钙尔奇D3片,对比两组患者治疗前和治疗6个月后的骨密度,骨代谢指标,3个月和6个月后的VAS评分及两组在治疗后不同时间段的骨痂评分和骨折愈合时间。结果:观察组治疗后骨密度明显升高,差异有统计学意义(P<0.01),且两组治疗后差异有统计学意义(P<0.05)。观察组治疗后血清钙、骨钙素(BGP)、碱性磷酸酶差异有统计学意义(P<0.01);在治疗3个月后两组VAS评分比较,差异无统计学意义(P>0.05),但6个月后两组差异有统计学意义(P<0.01)。观察组和对照组在治疗不同时间段后,断端骨痂X线评分对比均提示差异有统计学意义(P<0.05);但骨折愈合时间两组相比较差异无统计学意义(P>0.05)。结论:金天格胶囊用于肝肾亏虚型骨质疏松性股骨粗隆间骨折术后的患者,能有效增加骨密度和缓解疼痛,促进骨痂形成并且用药安全,值得临床推广。

Objective：To observe the effectiveness and safety of Jintiange capsule in the treatment of osteoporotic intertrochanteric fracture after operation.Methods：Sixty-eight patients with postoperative osteoporotic intertrochanteric fractures were randomized into observation and control groups using a random number table method.Each group consisted of 34 patients who were treated for 6 months.The observation group was given oral Jintiange capsule and the control group was given oral calcium gel D3 tablets.The BMD,bone metabolism index,VAS scores after 3 months and 6 months were compared between the two groups.The scores of bone spasm and fracture healing time at different time points after treatment were compared between the two groups.Results：Bone mineral density was significantly increased in the observation group before and after treatment（P〈0.01）,and there was a statistically significant difference between the two groups after treatment（P〈0.05）.Serum calcium and osteocalcin（BGP）were observed in the observation group before and after treatment in the observation group.There was a significant difference（P〈0.01）;after 3 months of treatment,there was no statistically significant difference in the VAS score between the observation group and the control group（P〉0.05）,but after 6 months of treatment,there was a statistically significant difference between the two groups（P〈0.01）.The Xray scores of the fractured iliac crest between the observation group and the control group at different time points indicated that the difference was statistically significant（P〈0.05）;however,the fracture healing time had no significant difference between the two groups（P〉0.05）.Conclusion：Jintiange capsules are used for the treatment of osteoporotic femoral intertrochanteric fractures after surgery,which can effectively increase the bone density and relieve pain,promote the formation of bone callus and are safe to use.It is worthy of clinical promotion.