金匮肾气丸合补中益气汤加减治疗绝经后骨质疏松症的疗效及对免疫炎症因子的调节作用

Regulation Effect and Clinical Efficacy of Addition and Subtraction Therapy of Jinkui Shenqiwan Combined with Buzhong Yiqitang on Immune Inflammatory Factors of Patients with Postmenopausal Osteoporosis and Deficiency of Spleen and Kidney

目的:观察金匮肾气丸合补中益气汤加减治疗绝经后骨质疏松症(PMO)脾肾两虚证的临床疗效,对细胞免疫炎症因子的调节作用。方法:将160例患者按随机数字表分为对照组和观察组,每组80例。两组患者均给予综合西医治疗措施,对照组口服壮骨止痛胶囊,4粒/次,3次/d;观察组口服金匮肾气丸联合补中益气汤治疗,1剂/d。两组均连续治疗24周。采用双能X射线吸收检测法(DXA)测量治疗前后腰椎L2-4骨密度和定量CT(QCT)测量治疗前后腰椎骨密度;进行中医证候评分和中国人骨质疏松症生存质量简明量表(COQOL)评分;检测治疗前后雌二醇(E2),Ⅰ型原胶原氨基端前肽(PINP),血清骨钙素(OC),骨保护素(OPG),Ⅰ型胶原交联C末端肽(S-CTX),抗酒石酸酸性磷酸酶(TRACP)和尿吡啶啉(PYD)水平;检测治疗前后CD4^(+)T细胞,CD8^(+)T细胞,白细胞介素-17(IL-17),肿瘤坏死因子-α(TNF-α),γ-干扰素(IFN-γ)和白细胞介素-4(IL-4)水平,计算CD4^(+)T细胞中辅助性T细胞(Th)17和调节性T细胞(Treg)的比例;进行安全性评价。结果:观察组DXA测量骨密度,T和QCT测量骨密度均高于对照组(P<0.01);观察组中医证候评分和COQOL评分均低于对照组(P<0.01);观察组PINP,OC,S-CTX,TRACP和PYD/Cr水平均低于对照组,OPG高于对照组(P<0.01);观察组CD8^(+)和Treg水平高于对照组(P<0.05),Th17,Th17/Treg,CD4^(+)/CD8^(+)低于对照组(P<0.05);观察组IL-17,TNF-α,IFN-γ水平低于对照组,IL-4和E_(2)水平高于对照组(P<0.01);观察组疗效优于对照组(Z=2.103,P<0.05)。结论:采用金匮肾气丸联合补中益气汤治疗PMO脾肾两虚型患者,可提高E_(2)水平,提高骨密度,减轻临床症状,提高生活质量,能调节骨代谢指标和免疫炎症反应,有着较好的临床疗效,且安全。

Objective:To observe the clinical efficacy of addition and subtraction therapy of Jinkui Shenqiwan combined with Buzhong Yiqitang to postmenopausal osteoporosis(PMO)with deficiency of spleen and kidney,and to investigate its regulation effect on immune inflammatory factors.Method:One hundred and sixty patients were randomly divided into observation group and control group,with 80 cases in each group.Both groups got comprehensive western medicine treatment measures.Patients in control group additionally got Zhuanggu Zhitong capsule,4 capsules/time,3 times/day.Patients in observation group additionally got addition and subtraction therapy of Jinkui Shenqiwan combined with Buzhong Yiqitang,1 dose/day.The treatment was continued for 24 weeks.Before and after treatment,lumbar L2-4 bone mineral density(BMD)was detected by Dual energy X-ray absorptiometry(DXA)and lumbar BMD was detected by quantitative CT(QCT).Scores of traditional Chinese medicine(TCM)syndromes and Chinese osteoporosis-targeted quality of life questionnaire(COQOL)were graded.Levels of Estradiol(E2),type Ⅰ procollagen amino terminal pro peptide(PINP),serum osteocalcin(OC),osteoprotegerin(OPG),type Ⅰ collagen cross-linked C-terminal peptide(S-CTX),tartrate resistant acid phosphatase(TRACP)and urinary pyridinoline(PYD)were detected.Levels of CD4^(+)T cells,CD8^(+)T cells,interleukin-17(IL-17),tumor necrosis factor-α(TNF-α),γ-interferon(IFN-γ)and interleukin-4(IL-4)were calculated.The proportion of T helper cell(Th)17 and regulatory T cell(Treg)in CD4^(+)T cells was calculated.Besides,the safety was evaluated.Result:Bone density was detected by DXA in observation group,and its T-value and bone density detected by QCT were all higher than those in control group(P<0.01).After treatment,scores of TCM syndrome and COQOL were lower than those in control group(P<0.01).Levels of PINP,OC,S-CTX,TRACP and PYD/Cr were all lower than those in control group(P<0.01).Levels of OPG,CD8^(+)and Treg were higher than those in control group(P<0.05),levels of Th17,Th17/Treg,CD4^(+)/CD8^(+),IL-17,TNF-α and IFN-γ were lower(P<0.01),and levels of IL-4 and E_(2) were higher than those in control group(P<0.01).The clinical efficacy in observation group was better than that in control group(Z=2.103,P<0.05).Conclusion:On the basis of calcium and vitamin D supplementation,Jinkui Shenqiwan combined with Buzhong Yiqitang can improve levels of E_(2) and bone density,reduce clinical symptoms,improve quality of life,regulate bone metabolism index and immune inflammation reaction,with better clinical efficacy and safety.