金天格胶囊辅助经皮椎体成形...腰椎骨质疏松性骨折临床研究_徐成.pdf

新中医2023年2月第55卷第4期NEW CHINESE MEDICINEFebruary 2023 Vol.55 No.4收稿日期 2022-04-25修回日期 2022-11-25作者简介徐成（1980-），男，主治医师，E-mail：。金天格胶囊辅助经皮椎体成形术治疗胸腰椎骨质疏松性骨折临床研究徐成丽水市人民医院骨科，浙江 丽水 323000摘要目的：观察金天格胶囊辅助经皮椎体成形术（PVP）治疗胸腰椎骨质疏松性骨折的临床疗效。方法：采用随机数字表法将 116 例胸腰椎骨质疏松性骨折患者分为对照组和观察组，每组 58 例。2 组均行PVP 治疗，对照组术后第 2 天可适当下床活动，并开始给予西药行抗骨质疏松治疗，术后 1 周开始行康复训练，在此基础上观察组于术后第 2 天起加用金天格胶囊治疗，2 组均治疗 3 个月，随访 1 年。比较 2 组临床疗效，术前、术后 3 个月中医证候评分及胸椎、腰椎骨密度，以及术后 1 年并发症发生率、骨折再发生率。结果：术后 3 个月，观察组临床疗效总有效率 98.28%，高于对照组 87.93%，差异有统计学意义（P0.05）。2 组胸部肿痛、腰脊刺痛、腰膝酸软、下肢痿弱、步履艰难、耳鸣评分均较术前降低（P0.05），观察组上述6 项中医证候评分均低于对照组（P0.05）。观察组胸椎、腰椎骨密度 T 值均较术前增大，且均大于对照组（P0.05）。术后 1 年，观察组并发症发生率 6.90%，低于对照组 20.69%，差异有统计学意义（P0.05）。观察组骨折再发生率 8.62%，低于对照组 22.41%，差异有统计学意义（P0.05）。结论：金天格胶囊辅助 PVP 治疗胸腰椎骨质疏松性骨折可提高临床疗效，缓解临床症状，减少并发症，增加胸椎、腰椎的骨密度，避免再发骨折。关键词胸腰椎骨折；骨质疏松；经皮椎体成形术；金天格胶囊；中医证候；骨密度中图分类号R274.13文献标志码A文章编号0256-7415（2023）04-0095-05DOI：10.13457/ki.jncm.2023.04.021Clinical Study on Jintiange Capsules in Adjuvant Therapy of Percutaneous Vertebroplasty for Osteoporotic Thoracolumbar Vertebral FracturesXU ChengAbstract：Objective：To observe the clinical effect of Jintiange Capsules in adjuvant therapy ofpercutaneous vertebroplasty(PVP)for osteoporotic thoracolumbar vertebral fractures.Methods：A total of116 cases of patients with osteoporotic thoracolumbar vertebral fractures were divided into the controlgroup and the observation group according to the random number table method，with 58 cases in eachgroup.Both groups were treated with PVP.On postoperative day 2，the control group could takeappropriate out-of-bed activities and started to take western medicine for anti-osteoporosis treatment；the rehabilitation training was started 1 week after the PVP.The observation group was additionally treatedwith Jintiange Capsules based on the treatment of the control group from postoperative day 2.Both groupswere given 3-month treatment and 1-year follow-up.Traditional Chinese medicine(TCM)syndromescores and the bone mineral density of the thoracic and lumbar spine 3 months before and after operation，the occurrence rates of complications and fracture recurrence rates within the first year after surgery，andclinical effects were compared between the two groups.Results：3 months after operation，the total 95新中医2023年2月第55卷第4期NEW CHINESE MEDICINEFebruary 2023 Vol.55 No.4胸腰椎骨质疏松性骨折是指骨质疏松患者钙量丢失，骨骼强度、骨密度下降，导致一处或多处椎体骨折1。若不及时治疗会出现持续性腰背部疼痛、椎体骨折加重等，严重影响患者的正常生活。现代医学常用于治疗胸腰椎骨质疏松性骨折的经皮椎体成形术（PVP）为微创手术，可有效镇痛、稳定骨折椎体，但单独使用不能从根本上改善骨质疏松，后期易再发骨折。骨质疏松症归属于中医学骨枯、骨痿等范畴，中医学认为，骨痿由脾肾亏虚所致，以肾虚为主，病机为肾虚血瘀，属本虚标实之证。患者肾精渐衰，或脾胃虚弱，肾虚则无以生髓养骨，加之骨断筋离、脉络受损，气血乏源、运行失畅，骨髓化源不足，日久致筋骨痿软、关节不利等2。治疗应以补肾健脾、强筋健骨、活血化瘀为主。金天格胶囊有强筋健骨的功效，可治疗老年骨质疏松症、腰椎间盘突出症等，可有效提高骨密度、减轻腰背疼痛、改善腰椎功能3。本研究观察金天格胶囊辅助PVP 治疗胸腰椎骨质疏松性骨折的临床疗效，报道如下。1临床资料1.1诊断标准参考文献4制定。骨量减少，骨密度下降；X 线、CT 或 MRI 检查显示胸椎、腰椎压缩性骨折，前胸、腰背疼痛，全身无力，活动时疼痛剧烈；骨折处叩击痛、压痛。1.2辨证标准参考中医药防治原发性骨质疏松症专家共识（2020）5辨为肾虚血瘀证。主症：胸部肿痛，胸骨压痛明显，腰脊刺痛，腰膝酸软；次症：下肢痿弱，步履艰难，耳鸣；舌脉象：舌质淡紫，脉细涩。1.3纳入标准符合上述诊断及辨证标准；血清钙、磷水平正常；可耐受 PVP 治疗；患者及家属签署知情同意书。1.4排除标准患严重心、肝、肺、肾功能不全者；患继发、特发性骨质疏松者；患椎体爆裂骨折、椎管占位性病变、强直性脊柱炎者；脊髓、神经功能损伤者；长期应用影响骨代谢的药物者；患恶性肿瘤、免疫系统、血液系统疾病者；对本研究使用的药物有治疗禁忌证者。1.5剔除标准临床资料不完整，影响研究结果者；中途退出研究者。1.6一般资料选取 2019 年 10 月2021 年 10 月在丽水市人民医院治疗的 116 例胸腰椎骨质疏松性骨折患者，采用随机数字表法分为对照组和观察组，每组 58 例。对照组男 27 例，女 31 例；年龄 52effective rate of clinical effects was 98.28%in the observation group，higher than that of 87.93%in thecontrol group，the difference being significant(P0.05).The scores of local swelling pain in the chest，stabbing pain in the lumbar spine，soreness and weakness of the low back and knee，wilting andweakness of lower extremities，difficulty walking，and tinnitus in the two groups were decreased whencompared with those before operation(P0.05)，and the above 6 TCM syndrome scores in the observationgroup were lower than those in the control group(P0.05).The bone mineral density of the thoracic andlumbar spine in the observation group were enlarged before operation and were larger than those in thecontrol group(P0.05).A year after surgery，the occurrence rate of complications was 6.90%in theobservation group，lower than that of 20.69%in the control group，the difference being significant(P0.05).The fracture recurrence rate was 8.62%in the observation group，lower than that of 22.41%in thecontrol group，the difference being significant(P0.05).Conclusion：Jintiange Capsules in adjuvanttherapy of PVP for osteoporotic thoracolumbar vertebral fractures can enhance clinical effects，relieveclinical symptoms，reduce complications，increase the bone mineral density of the thoracic and lumbarspine，and avoid the recurrence of fractures.Keywords：Thoracolumbar fracture；Osteoporosis；Percutaneous vertebroplasty；Jintiange Capsules；Traditional Chinese medicine syndrome；Bone mineral density 96新中医2023年2月第55卷第4期NEW CHINESE MEDICINEFebruary 2023 Vol.55 No.482 岁，平均（61.545.24）岁；骨质疏松症病程 18 年，平均（3.630.64）年；骨折时间 13 d，平均（1.370.16）d；骨折部位：胸椎 12 例，腰椎14 例，胸腰椎 32 例。观察组男 26 例，女 32 例；年龄 5281 岁，平均（61.515.23）岁；骨质疏松症病程 17 年，平均（3.610.62）年；骨折时间 14 d，平均（1.380.18）d；骨折部位：胸椎 13 例，腰椎12 例，胸腰椎 33 例。2 组一般资料比较，差异均无统计学意义（P0.05），具有可比性。本研究经丽水市人