正骨灵胶囊合健脾补肾汤治疗脾肾两虚兼血瘀的骨质疏松性骨折术后临床效果

Clinical study of Zhengguling capsules combined with Jianpi Bushen decoction in the treatment of deficiency of spleen and kidney and blood stasis after osteoporotic fracture operation

目的探讨正骨灵胶囊合健脾补肾汤治疗脾肾两虚兼血瘀骨质疏松性骨折术后患者的临床效果。方法前瞻性选取2017年9月至2019年12月保定市第二医院收治的93例脾肾两虚兼血瘀骨质疏松性骨折术后患者,按照随机数字表法分为常规组(45例)与试验组(48例)。常规组给予西医常规治疗,试验组在常规组基础上另给予正骨灵胶囊合健脾补肾汤治疗。比较治疗前、治疗3个月后患者中医症状积分,治疗前、治疗1个月后、治疗3个月后的疼痛视觉模拟量表(VAS)评分,并对比治疗前、治疗3个月后骨代谢[骨钙素(BGP)、抗酒石酸酸性磷酸酶5b(TRAP-5b)、特异性骨碱性磷酸酶(BALP)、Ⅰ型胶原羧基端交联肽(CTX-Ⅰ)]及腰椎(L_(2)~L_(4))的骨密度,且观察术后下肢静脉血栓形成及不良反应发生情况。结果治疗前,2组患者中医症状积分比较,差异无统计学意义(P>0.05);治疗3个月后,试验组患者中医症状积分低于常规组,差异有统计学意义(P<0.05);治疗1、3个月后,试验组患者VAS评分均低于常规组,差异均有统计学意义(P<0.05);治疗前,2组患者BGP、TRAP-5b、BALP、CTX-Ⅰ水平比较,差异均无统计学意义(P>0.05);治疗3个月后,试验组患者BGP、BALP水平高于常规组,TRAP-5b、CTX-Ⅰ水平低于常规组,差异均有统计学意义(P<0.05)。治疗前,2组患者腰椎(L_(2)~L_(4))的骨密度比较,差异无统计学意义(P>0.05);治疗3个月后,试验组腰椎(L_(2)~L_(4))的骨密度高于常规组,差异有统计学意义(P<0.05)。试验组术后下肢静脉血栓形成发生率低于常规组,差异有统计学意义(P<0.05);试验组治疗期间总不良反应发生率与常规组比较,差异无统计学意义(P>0.05)。结论应用正骨灵胶囊合健脾补肾汤治疗脾肾两虚兼血瘀骨质疏松性骨折术后患者,可明显促进患者症状缓解及疼痛减轻,改善骨代谢,提高骨密度,并可减少术后下肢静脉血栓形成,且安全性良好。

Objective To explore the clinical effect of Zhengguling capsules combined with Jianpi Bushen decoction in the treatment of patients with deficiency of spleen and kidney and blood stasis after osteoporotic fracture operation.Methods A total of 93 patients with deficiency of spleen and kidney and blood stasis after operation of osteoporotic fracture were selected in The NO.2 Hospital of Baoding from September 2017 to December 2019,who were randomly divided into routine group(45 cases)and test group(48 cases).The routine group was treated with routine western medicine,while the test group was treated with Zhengguling capsules combined with Jianpi Bushen decoction on the basis of routine group.The traditional Chinese medicine(TCM)symptom score before and 3 month after treatment and the visual analogue pain score(VAS)before treatment,1 month after treatment,3 month after treatment were compared,and the bone metabolism related indexes[osteocalcin(BGP),tartrate resistant acid phosphatase-5b(TRACP-5b),bone specific alkaline phosphatase(BALP),type I collagen carboxy terminal crosslinking peptide(CTX-I)]and bone mineral density(BMD)of lumbar vertebrae(L_(2)-L 4)before and 3 month after treatment were compared,and the incidence of venous thrombosis of lower extremity after operation and adverse reactions were observed.Results Before treatment,there was no statistically significant difference in TCM symptom scores between the two groups of patients(P>0.05);after 3 months of treatment,the TCM symptom scores of patients in the test group were lower than those in the routine group,and the differences were statistically significant(P<0.05).After 1 and 3 months of treatment,the VAS scores of patients in the test group were lower than those in the routine group,and the differences were statistically significant(P<0.05);before treatment,the levels of BGP,TRAP-5b,BALP,and CTX-I in the two groups were compared,the difference was not statistically significant(P>0.05);after 3 months of treatment,the levels of BGP and BALP in the test group were higher than those in the routine group,and the levels of TRAP-5b and CTX-I were lower than those in the routine group,and the differences were statistically significant(P<0.05).Before treatment,there was no significant difference in the bone mineral density of the lumbar spine(L_(2)-L 4)between the two groups(P>0.05);after 3 months of treatment,the bone mineral density of the lumbar spine(L_(2)-L 4)of the test group was higher than that of the routine group,the difference was statistically significant(P<0.05).The incidence of posterior leg venous thrombosis was lower than that of the routine group,and the difference was statistically significant(P<0.05);the total adverse reaction rate during the treatment period of the experimental group was compared with that of the conventional group,and the difference was not statistically significant(P>0.05).Conclusion The application of Zhengguling capsules combined with Jianpi Bushen decoction in the treatment of patients with deficiency of both spleen and kidney and blood stasis after operation of osteoporotic fracture can significantly promote the relief of symptoms and alleviation of pain,improve bone metabolism and improve BMD,and reduce the formation of venous thrombosis of lower extremity after operation,with good safety.