金匮肾气丸结合骨折三期辨证对骨质疏松性椎体压缩性骨折术后康复的影响

Effect of Jingui Shenqiwan Combined with Fracture Three-stage Syndrome Differentiation on Recovery of Patients with Osteoporotic Vertebral Compression Fractures After Operation

目的:评价金匮肾气丸结合骨折三期辨证治疗骨质疏松性椎体压缩性骨折(OVCF)术后的近期和远期疗效及对骨代谢标志物的调节作用。方法:将135例OVCF术后患者按随机数字表法分为对照组67和观察组68例。对照组脱落4例,失访2例,剔除3例,完成58例,观察组分别为3例,2例和3例,完成60例。两组均采用依降钙素注射液,20单位/次,肌肉注射,1次/1周,共12周;口服碳酸钙D3咀嚼片(Ⅱ),1片/次,2次/d;阿仑膦酸钠片,70 mg/次,1次/周。对照组口服补肾健骨胶囊,4粒/次,3次/d;观察组采用金匮肾气丸加减并结合骨折三期辨证内服,1剂/d;两组均连续治疗24周,并进行24周随访。近期疗效指标包括腰背疼痛、腰椎功能、中医证候和并发症情况,分别于术前、术后12周和24周各评价1次;远期疗效包括责任椎体恢复情况、腰椎功能、骨密度、生活质量和48周再骨折发生率;检测前后骨碱性磷酸酶(BALP),骨钙素(BGP),抗酒石酸酸性磷酸酶-5b(TRAP-5b),Ⅰ型胶原羧基端前肽(PICP),Ⅰ型胶原交联C端肽(β-CTX)和N端中段骨钙素(N-MID-OT)水平;进行安全性评价。结果:观察组综合疗效优于对照组(Z=2.026,P<0.05);观察组在术后12,24周的腰背疼痛、腰椎功能和中医证候评分均低于对照组(P<0.01),继续观察显示观察组在术后48周腰椎功能评分也低于对照组(P<0.01);观察组在术后24,48周L1-4骨密度高于对照组,生活质量评分低于对照组(P<0.01);观察组在术后24,48周Cobb角均小于对照组,责任椎体高度(前缘、中央、后缘)均高于对照组;对照组并发症累积发生率为51.72%(30/58),高于观察组的26.67%(16/60)(χ^2=7.784,P<0.01);术后24,48周观察组BGP水平均高于对照组,BALP,TRAP-5b,PICP,β-CTX和N-MID-OT均低于对照组(P<0.01);未发现口服金匮肾气丸有相关不良反应。结论:金匮肾气丸加减结合骨折三期辨证用于OVCF微创手术后患者,近期可减轻腰背疼痛等症状,促进腰椎功能的恢复,综合疗效显著,远期可改善责任椎体强度,恢复伤椎解剖结构,并能增加椎体的骨密度,进一步改善腰椎功能,降低并发症的发生,还可调节骨代谢标志物,起到改善骨质疏松的效果。

Objective: To evaluate the short-term and long-term efficacy of Jingui Shenqiwan combined with three-stage syndrome differentiation on osteoporotic vertebral compression fractures(OVCFs)after operation,and its regulatory effect on biomarkers of bone metabolism. Method: One hundred and thirtyfive patients were randomly divided into control group(67 cases)and observation group(68 cases)by random number table. A total of 58 patients in control group completed the treatment(4 patients were exfoliated,2 patients were lost to follow-up,3 patients were eliminated);and 60 patients in observation group completed the treatment(3 patients were exfoliated,2 patients were lost to follow-up,3 patients were eliminated). Both groups patients were given calcitonin injection through intramuscular injection,20 u/time,1 time/week,for 12 weeks,calcium carbonate D3 chewable tablets( Ⅱ ),1 tablet/time,2 times/day,and alendronate sodium tablets,70 mg/time,1 time/week. Patients in control group got Bushen Jiangu capsule,4 grains/time,3 times/day. And patients in observation group got modified Jingui Shenqiwan combined with fracture three-stage symptom differentiation,1 dose/day. The courses of treatment in the two groups were 24 weeks,and a 24 week follow-up was provided. Before the operation and at the 12 thand 24 thweek after operation,the short-term efficacy indexes,such as back pain,lumbar function,traditional Chinese medicine(TCM)syndromes and complications,were recorded. And the long-term efficacy indexes,such as recovery of responsible vertebral body,lumbar function,bone density and quality of life and incidence of 48 week re-fracture,were also recorded. Before and after operation,levels of bone alkaline phosphatase(BALP),osteocalcin(BGP),tartrate resistant acid phosphatase-5 b(TRAP-5 b),type I collagen carboxy terminal prepeptide(PICP),type I collagen cross-linked C-terminal peptide(β-CTX)and N-MID-OT were detected,and the safety was evaluated. Result:The comprehensive efficacy in observation group was superior to that in control group(Z=2.026,P<0.05). At the 12 thand 24 thweek after operation,scores of back pain,lumbar function and TCM syndromes were all lower than those in control group(P<0.01),and score of lumbar function at the 48 thweek after operation was also lower than that in control group(P<0.01). Bone density was higher than that in control group at the 24 thand 48 th week after operation,and score of quality of life was lower than that in control group(P<0.01). At the 24 thand48 thweek after operation,Cobb angles were less than those in control group,and heights of responsible centrums(anterior, central, posterior)were higher than those in control group. Cumulative incidence of complications in control group was 51.72%(30/58),which was higher than 26.67%(16/60)in control group(χ^2=7.784,P<0.01). The levels of BGP were higher than those in observation group at the 24 thand 48 thweek after operation,and the levels of BALP,TRAP-5 b,PICP,β-CTX and N-MID-OT were all lower than those in control group(P<0.01). And there was no side effect relating to Jingui Shenqiwan. Conclusion: Modified Jingui Shenqiwan combined with fracture three-stage symptom differentiation can reduce the symptoms of back pain and promote the recovery of lumbar function,with a significant short-term comprehensive efficacy. In the long term,it can improve the strength of responsible centrums,restore the anatomical structure of injured centrums,increase the bone density of centrums,further improve the lumbar function, reduce the occurrence of complications,regulate the markers of bone metabolism,and improve osteoporosis.