归龟壮骨片治疗女性绝经后骨质疏松症肾阴阳两虚证腰背痛患者150例——随机、双盲、安慰剂对照临床研究  

Guigui Zhuanggu Tablet(归龟壮骨片)in the Treatment of Low Back Pain in Postmenopausal Osteoporosis Women with Kidney Yin and Yang Deficiency Syndrome:A Randomized,Double-blind,Placebo-controlled Trial of 150 Cases

作　　者：詹炜祎 刘光明 杨佳裕 季伟 孙波 ZHAN Weiyi;LIU Guangming;YANG Jiayu;JI Wei;SUN Bo(Xiangshan Hospital of Traditional Chinese Medicine,Shanghai,200020)

机构地区：[1]上海市黄浦区香山中医医院,上海市200020

出　　处：《中医杂志》2022年第9期839-844,共6页Journal of Traditional Chinese Medicine

基　　金：上海市卫生健康委员会中医药科研项目(2020LQ004)。

摘　　要：目的观察归龟壮骨片治疗女性绝经后骨质疏松症肾阴阳两虚证腰背痛患者的临床疗效及安全性。方法采用随机、双盲、安慰剂对照的设计方法,将150例绝经后骨质疏松症肾阴阳两虚证患者按照2∶1比例随机分为治疗组(100例)和对照组(50例)。两组患者均给予钙尔奇D片口服,每天600 mg;治疗组加服归龟壮骨片,对照组加服归龟壮骨片模拟剂,均每天3次,每次1.5 g,连续服用3个月。分别在治疗前,治疗1、2、3个月,随访6个月时比较两组患者疼痛视觉模拟(VAS)评分、临床常见症状积分,并在治疗前、随访6个月时比较两组患者骨密度、骨代谢指标[包括血钙(Ca)、血磷(P)、I型原胶原N端前肽(PINP)、Ⅰ型胶原β降解产物(β-CTx)、25羟维生素D(25-OH-VitD)、碱性磷酸酶(ALP)、骨钙素(BGP)]水平。结果治疗组临床常见症状疗效总有效率(96.88%)高于对照组(59.57%,P<0.05)。两组治疗后1、2、3个月及随访时的临床常见症状积分与治疗前比较均明显降低(P<0.05)。治疗组治疗后不同时间与过去时间点的两两比较均明显降低(P<0.05);对照组腰背疼痛、腰膝酸软无力治疗3个月较治疗1个月、随访时较治疗1个月及2个月均明显降低(P<0.05),而下肢抽筋、步履艰难、持重困难治疗后不同时间与过去时间点的两两比较均明显降低(P<0.05)。治疗2个月、3个月、随访时,治疗组腰背疼痛、腰膝酸软无力、下肢抽筋积分均低于对照组同期(P<0.05)。两组治疗后1个月、2个月、3个月、随访时的VAS评分与治疗前比较均明显降低(P<0.05)。治疗组治疗后不同时间VAS评分与过去时间点的两两比较均明显降低(P<0.05);对照组治疗3个月、随访时VAS评分与过去时间点的两两比较均明显降低(P<0.05)。治疗2个月、3个月、随访时,治疗组VAS评分均低于对照组同期(P<0.05)。两组随访时各骨代谢指标与治疗前比较差异均有统计学意义(P<0.05)。治�Objective To explore the clinical effect and safety of Guigui Zhuanggu Tablet(归龟壮骨片,GZT)in the treatment of low back pain in postmenopausal osteoporosis patients with kidney yin and yang deficiency syndrome.Methods A randomized double-blind placebo-controlled trial was designed.Totally 150 postmenopausal osteoporosis women with kidney yin and yang deficiency syndrome were randomized into treatment group(100 cases)and control group(50 cases).Both groups were given 600 mg Calci D tablets orally each day.Additionally,the treatment group was given GZT while the control group was given placebo,1.5 g per time,three times each day,for 3 months.The pain visual analogue scale(VAS)score and the clinical common symptom score were assessed before treatment,at 1-,2-and 3-month treatment and at 6-month follow-up.The bone mineral density(BMD)and the indexes of bone metabolism including blood calcium(Ca)and phosphorus(P),procollagen typeⅠN-terminal propeptide(PINP),C-terminal telopeptide of typeλcollagen(β-CTx),25-hydroxyvitamin D(25-OH-VitD),alkaline phosphatase(ALP),and bone gla protein(BGP)were assessed before treatment and at 6-month follow-up.Results The total effective rate of clinical common symptoms was 96.88%in the treatment group,significantly higher than59.57%in the control group(P<0.05).The clinical common symptoms score in both groups significantly decreased at 1-,2-,and 3-month treatment and at 6-month follow-up compared to that before treatment(P<0.05).And when compared between different time after treatment,the clinical common symptoms score significantly decreased than the former measurement in the treatment group(P<0.05).In the control group,the low back pain score and sore waist and knee score significantly decreased at 3-month treatment compared to those at 1-month treatment,also decrease at follow-up compared to those at 1-and 2-month treatment(P<0.05),while the score on lower extremity cramps,hard walk and heavy objects-lifting difficulty significantly decreased when compared between different

关 键 词：绝经后骨质疏松症 肾阴阳两虚证 腰背痛 随机对照研究 归龟壮骨片 

分 类 号：R271.116[医药卫生—中医妇科学]