二仙汤在绝经后骨质疏松症肾阳虚证治疗中的应用价值及作用机制研究  

Applied values and mechanism of action of oral application of Erxian Tang(二仙汤)in treatment of postmeno-pausal osteoporosis with syndrome of kidney-yang deficiency:a clinical study

作　　者：汪青[1] 黄昊强 陈勇[1] 陈吉[1] 洪嵘[1] WANG Qing;HUANG Haoqiang;CHEN Yong;CHEN Ji;HONG Rong(Kunshan Hospital of Chinese Medicine,Kunshan 215300,Jiangsu,China)

机构地区：[1]昆山市中医医院,江苏昆山215300

出　　处：《中医正骨》2022年第3期8-14,共7页The Journal of Traditional Chinese Orthopedics and Traumatology

基　　金：苏州市2020年度第二十九批科技发展计划(民生科技-医疗卫生应用基础研究)项目(SYS2020065)。

摘　　要：目的:探讨二仙汤在绝经后骨质疏松症肾阳虚证治疗中的应用价值,并探讨其作用机制。方法:将90例绝经后骨质疏松症肾阳虚证患者随机分为2组,每组45例,分别采用口服二仙汤联合碳酸钙D3和阿法骨化醇软胶囊(二仙汤组)与单纯碳酸钙D3和阿法骨化醇软胶囊(基础用药组)治疗。碳酸钙D3,每日1次,每次1片;阿法骨化醇软胶囊,每日1次,每次1粒;二仙汤,每日2次,每次1袋,早晚服用;均连续服用12周。分别于治疗前和治疗结束后,采用疼痛视觉模拟量表(visual analogue scale,VAS)评分评价腰背部疼痛情况,采用双能X线骨密度仪测定患者腰椎(L_(1)~L_(4))骨密度及股骨颈骨密度,采用酶联免疫吸附法测定血清骨钙素、Ⅰ型前胶原氨基端前肽(N-terminal propeptide of typeⅠprecollagen,PⅠNP)及Ⅰ型胶原羧基端肽β特殊序列(β C-terminal telopeptide of typeⅠcollagen,β-CTX)含量,采用化学发光法测定血钙及血磷含量,采用荧光定量PCR法测定血清miR-335-5p的表达量。结果:①受试者退出情况。共10例患者退出试验,其中二仙汤组3例因未能按时按计量服药退出,2例因失访退出;基础用药组1例因未能按时按计量服药退出,4例因失访退出。②腰背部疼痛VAS评分。治疗前,2组患者腰背部疼痛VAS评分比较,差异无统计学意义[(4.03±0.80)分,(3.90±0.93)分,t=0.645,P=0.521];治疗结束后,二仙汤组腰背部疼痛VAS评分低于基础用药组[(2.10±0.87)分,(2.98±1.10)分,t=-3.526,P=0.001],2组患者腰背部疼痛VAS评分均低于治疗前(t=14.198,P=0.000;t=7.656,P=0.000)。③骨密度。治疗前与治疗结束后,2组患者腰椎骨密度和股骨颈骨密度比较,组间差异均无统计学意义[腰椎:(0.886±0.040)g·cm^(-2),(0.880±0.030)g·cm^(-2),t=0.746,P=0.458;(0.888±0.040)g·cm^(-2),(0.878±0.030)g·cm^(-2),t=0.994,P=0.323。股骨颈:(0.763±0.070)g·cm^(-2),(0.767±0.070)g·cm^(-2),t=-0.263,P=0.794;(0.765±0.070)g·cm^(-2),(0.770±0.070)g·cm^(Objective:To explore the applied values of oral application of Erxian Tang(二仙汤,EXT)in treatment of postmenopausal osteoporosis(PMOP)with kidney-yang deficiency syndrome(KYDS),and to explore its mechanism of action.Methods:Ninety PMOP pa-tients with KYDS were enrolled in the study and were randomly divided into EXT group and basic medication group,45 cases in each group.The patients in EXT group were treated with oral applications of EXT(twice a day in the morning and evening respectively,1 bag at a time),calcium carbonate and Vitamin D3 tablets(once a day,1 tablet at a time)and alfacalcidol soft capsules(once a day,1 capsule at a time)for consecutive 12 weeks;while the ones in basic medication group were merely with oral applications of calcium carbonate and Vita-min D3 tablets and alfacalcidol soft capsules for consecutive 12 weeks.The low back pain was evaluated by using pain visual analogue scale(VAS)score,and the bone mineral density(BMD)of lumbar vertebra(LV)from L to L4 and femoral neck(FN),the serum levels of osteo-calcin(OCN),N-terminal propeptide of type I precollagen(P I NP)andβC-terminal telopeptide of type I collagen(β-CTX),the lev-els of serum calcium(Ca)and serum phosphorus(P)and the expression level of serum miR-335-5p were detected by using dual-energy X-ray absorptiometry(DEXA),enzyme linked immunosorbent assay(ELISA),chemiluminescence immunoassay(CLIA)and fluorescent quantitative PCR method respectively before the treatment and after the end of the treatment.Results:①Three patients in EXT group and 1 case in basic medication group dropped out of the study for failing to take medication as required,while 2 cases in EXT group and 4 cases in basic medication group dropped out of the study for losing to follow-up.②There was no statistical difference in low back pain VAS score between the 2 groups before the treatment(4.03±0.80 vs3.90±0.93 points,t=0.645,P=0.521).The low back pain VAS scores were lower in EXT group compared to basic medication group after the end of the treatment(2.10±

关 键 词：骨质疏松 绝经后 二仙汤 肾阳虚 碳酸钙 阿法骨化醇 背痛 骨密度 骨钙素 Ⅰ型前胶原氨基端前肽 Ⅰ型胶原羧基端肽β特殊序列 钙 磷 miR-335-5p 临床试验 

分 类 号：R259[医药卫生—中西医结合]