补肾活血汤联合中药蜡疗治疗骨质疏松性椎体压缩性骨折术后腰背痛临床研究

Clinical Study on Bushen Huoxue Decoction Combined with Wax Therapy for Low Back Pain After Operation of Osteoporotic Vertebral Compression Fractures

目的:观察在抗骨质疏松基础上加用补肾活血汤联合中药蜡疗治疗肾虚血瘀型骨质疏松性椎体压缩性骨折(OVCF)经皮椎体后凸成形术(PKP)术后腰背痛的临床效果。方法:选取68例肾虚血瘀型OVCF PKP术后3 d仍存有腰背痛的患者,随机分为试验组和对照组各34例。2组术后3 d均服用阿法骨化醇软胶囊、碳酸钙D3片治疗,试验组术后3 d加予补肾活血汤联合中药蜡疗治疗。2组均持续治疗8周,8周治疗结束后继续随访4周。对比2组手术前后的腰背部疼痛视觉模拟评分法(VAS)评分、Oswestry功能障碍指数(ODI)、骨密度(BMD),比较2组的临床疗效,记录2组治疗过程中不良反应的发生情况。结果:治疗后,试验组总有效率高于对照组(P<0.05)。2组术后1周、2周、5周、8周的VAS评分均较术前、术后3 d下降(P<0.05)。2组术后2周、5周、8周的VAS评分均较前一个时间点下降(P<0.05)。试验组术后1周、2周、5周、8周的VAS评分均低于对照组(P<0.05)。2组术后1周、2周、5周、8周的ODI值均较术前、术后3 d下降(P<0.05)。2组术后2周、5周、8周的ODI值均较前一个时间点下降(P<0.05)。试验组术后1周、2周、5周、8周的ODI值均低于对照组(P<0.05)。2组术后8周、12周的BMD值均较术前、术后3 d升高(P<0.05);2组术后12周的BMD值与术后8周比较,差异均无统计学意义(P>0.05);试验组术后8周、12周的BMD值均高于对照组(P<0.05)。2组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论:在抗骨质疏松基础上加用补肾活血汤联合中药蜡疗治疗可有效缓解肾虚血瘀型OVCF PKP术后患者的腰背痛,改善患者的生活功能,增加骨量,且安全性高。

Objective:To observe the clinical effect of Bushen Huoxue Decoction combined with wax therapy on low back pain after percutaneous kyphoplasty(PKP)for osteoporotic vertebral compression fractures(OVCF)of kidney deficiency and blood stasis type on the basis of anti-osteoporotic.Methods:A total of 68 cases of patients who still had low back pain during the first 3 days after PKP for OVCF of kidney deficiency and blood stasis type were selected and randomly divided into the trial group and the control group,with 34 cases in each group.Both groups were treated with Alfacalcidol Soft Capsules and Calcium Carbonate-Vitamin D3 Tablets 3 days after PKP,and the trial group was additionally treated with Bushen Huoxue Decoction combined with wax therapy based on the treatment of the control group.Both groups were continuously treated for 8 weeks,and were followed up for 4 weeks after 8 weeks of treatment.Visual Analogue Scale(VAS)scores for low back pain,Oswestry Dysfunction Index(ODI),and bone mineral density(BMD)before and after PKP,and clinical effects were compared between the two groups.The incidence of adverse reactions during the treatment were recorded in the two groups.Results:After treatment,the total effective rate in the trial group was higher than that in the control group(P<0.05).The VAS scores in the two groups were decreased at 1 week,2 weeks,5 weeks,and 8 weeks after operation when compared with those before operation and within the first 3 days after operation(P<0.05).The VAS scores in the two groups were decreased at 2 weeks,5 weeks,and 8 weeks after operation when compared with those at the previous time points(P<0.05).The VAS scores at 1 week,2 weeks,5 weeks,and 8 weeks after operation in the trial group were lower than those in the control group(P<0.05).The ODI values in the two groups were decreased at 1 week,2 weeks,5 weeks,and 8 weeks after operation when compared with those before operation and within the first 3 days after operation(P<0.05).The ODI values in the two groups were decreased at 2 weeks,5 weeks,and 8 weeks after operation when compared with those at the previous time points(P<0.05).The ODI values at 1 week,2 weeks,5 weeks,and 8 weeks after operation in the trial group were lower than those in the control group(P<0.05).The BMD values at 8 weeks and 12 weeks after operation in the two groups were increased when compared with those before treatment and within the first 3 days after operation(P<0.05);there was no significant difference being found in the comparison of BMD values at 12 weeks after operation and at 8 weeks after operation in the two groups(P>0.05).The BMD values at 8 weeks and 12 weeks after operation in the trial group were higher than those in the control group(P<0.05).There was no significant difference being found in the comparison of the total incidence of adverse reactions between the two groups(P>0.05).Conclusion:Based on anti-osteoporotic,Bushen Huoxue Decoction combined with wax therapy can effectively relieve the low back pain after PKP for OVCF of kidney deficiency and blood stasis type,improve their ability of daily activities,increase bone mass,and have high safety.