[1]梁博程,史晓林,施振宇,等.强骨膏方对绝经后骨质疏松性椎体骨折患者经皮椎体后凸成形术后骨代谢及生活质量的影响[J].中医正骨,2020,32(05):6-10.
　LIANG Bocheng,SHI Xiaolin,SHI Zhenyu,et al.Influence of Qianggu(强骨)paste on bone metabolism and life quality of patients who received percutaneous kyphoplasty for postmenopausal osteoporotic vertebral fractures[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2020,32(05):6-10.
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强骨膏方对绝经后骨质疏松性椎体骨折患者经皮椎体后凸成形术后骨代谢及生活质量的影响()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第32卷
期数:
2020年05期
页码:
6-10
栏目:
临床研究
出版日期:
2020-05-20

文章信息/Info

Title:
Influence of Qianggu(强骨)paste on bone metabolism and life quality of patients who received percutaneous kyphoplasty for postmenopausal osteoporotic vertebral fractures
作者:
梁博程1; 史晓林1; 施振宇2; 吴连国1; 涂冬鹏3; 李敏1
(1.浙江中医药大学附属第二医院,浙江 杭州 310005; 2.浙江中医药大学第一临床医学院,浙江 杭州 310053; 3.浙江中医药大学第二临床医学院,浙江 杭州 310053)
Author(s):
LIANG Bocheng1; SHI Xiaolin1; SHI Zhenyu2; WU Lianguo1; TU Dongpeng3; LI Min1
1.The Second Affiliated Hospital of Zhejiang Chinese Medical University,Hangzhou 310005,Zhejiang,China 2.The First Clinical Medical College of Zhejiang Chinese Medical University,Hangzhou 310053,Zhejiang,China3.The Second Clinical Medical College of Zhejiang Chinese Medical University,Hangzhou 310053,Zhejiang,China
关键词:
骨质疏松; 绝经后;  骨质疏松性骨折;  脊柱骨折;  椎体后凸成形术;  强骨膏方;  骨密度;  生活质量;  骨代谢;  临床试验
Keywords:
osteoporosis; postmenopausal;  osteoporotic fractures;  spinal fractures;  kyphoplasty;  Qianggu paste;  bone density;  quality of life;  bone metabolism;  clinical trial
摘要:
目的:观察强骨膏方对绝经后骨质疏松性椎体骨折患者经皮椎体后凸成形术(percutaneous kyphoplasty,PKP)后骨代谢及生活质量的影响。方法:选择2018年9—12月因骨质疏松性椎体骨折接受了PKP治疗的患者为研究对象。采用随机数字表将符合要求的患者随机分为2组。常规治疗组自术后第2天开始口服碳酸钙D3片(每天1次,每次600 mg)和阿法骨化醇软胶囊(每天1次,每次1 μg),强骨膏方组在常规治疗组治疗方案的基础上自术后第2天开始口服强骨膏方(每次15 mL,每天早晚各1次)。所有药物每服用3个月,停药1个月,共治疗1年。分别于入组时和治疗结束时,测定患者的血清总Ⅰ型原胶原氨基端前肽(total procollagen typeⅠN-terminal propeptide,T-PⅠNP)含量、Ⅰ型胶原羧基端肽β特殊序列(β-C-terminal telopeptide of typeⅠcollagen,β-CTX)含量、腰椎和髋部骨密度及简明健康状况调查表(short form 36 health survey questionnaire,SF-36)评分。结果:①分组结果。共纳入109例患者,强骨膏方组57例、常规治疗组52例。至试验结束时,强骨膏方组3例因出现药物性胃肠道不良反应退出、2例主动要求退出、1例因再次发生骨折退出; 常规治疗组2例因出现药物性胃肠道不良反应退出、1例主动要求退出、2例因再次发生骨折退出。出现药物性胃肠道不良反应患者改用抗骨质疏松针剂治疗,再次出现骨折患者均再次行PKP和抗骨质疏松治疗,预后良好。②骨转换标志物及骨密度测定结果。入组时2组患者的血清T-PⅠNP含量、血清β-CTX含量、腰椎骨密度及髋部骨密度比较,组间差异均无统计学意义(t=-1.335,P=0.185; t=0.471,P=0.693; t=-1.734,P=0.086; t=-1.190,P=0.237)。治疗结束时2组患者的血清T-PⅠNP和β-CTX含量均较入组时降低[T-PⅠNP:(60.83±4.57)ng·mL-1,(39.26±4.06)ng·mL-1,t=26.460,P=0.000;(62.14±5.11)ng·mL-1,(31.32±2.49)ng·mL-1,t=38.692,P=0.000; β-CTX:(0.77±0.08)ng·mL-1,(0.44±0.05)ng·mL-1,t=25.880,P=0.000;(0.76±0.10)ng·mL-1,(0.52±0.06)ng·mL-1,t=14.961,P=0.000],腰椎和髋部骨密度均较入组时升高[腰椎骨密度:(0.758±0.011)g·cm-2,(0.786±0.024)g·cm-2,t=-10.238,P=0.000;(0.761±0.006)g·cm-2,(0.779±0.028)g·cm-2,t=-4.239,P=0.000; 髋部骨密度:(0.528±0.008)g·cm-2,(0.567±0.036)g·cm-2,t=-7.550,P=0.000;(0.530±0.010)g·cm-2,(0.556±0.024)g·cm-2,t=-8.039,P=0.000]; 治疗结束时强骨膏方组的血清T-PⅠNP含量高于常规治疗组(t=11.754,P=0.000),血清β-CTX含量低于常规治疗组(t=-6.901,P=0.000),腰椎和髋部骨密度的组间差异均无统计学意义(t=1.355,P=0.179; t=1.770,P=0.080)。③SF-36评分。入组时2组患者的SF-36评分比较,差异无统计学意义(t=-1.212,P=0.229)。治疗结束时,2组患者的SF-36评分均较入组时升高[(102.22 1.69)分,(124.55±2.56)分,t=-98.085,P=0.000;(102.68±2.03)分,(115.34±2.29)分,t=-80.066,P=0.000],强骨膏方组的SF-36评分高于常规治疗组(t=18.702,P=0.000)。结论:绝经后骨质疏松性椎体骨折患者PKP术后应用强骨膏方,可以改善骨代谢、改善生活质量。
Abstract:
Objective:To observe the influence of Qianggu(强骨,QG)paste on bone metabolism and life quality of patients who received percutaneous kyphoplasty(PKP)for postmenopausal osteoporotic vertebral fractures.Methods:One hundred and nine patients with osteoporotic vertebral fractures who were treated with PKP from September 2018 to December 2018 were selected as the subjects,and were randomly divided into conventional therapy group(52 cases)and QG paste group(57 cases)by using random digits table.All patients in the 2 groups were treated with oral applications of calcium carbonate and Vitamin D3 tablets(once a day,600 mg at a time)and alfacalcidol soft capsules(once a day,1 μg at a time)since the postoperative day 2.Moreover,the patients in QG paste group were treated with oral application of QG paste(twice a day in the morning and evening respectively,15 mL at a time)since the postoperative day 2.All the medicines were taken for 1 year with a 1-month rest-insertion between every 3 months.The serum contents of total procollagen typeⅠN-terminal propeptide(T-PⅠNP)and β-C-terminal telopeptide of typeⅠcollagen(β-CTX),the bone mineral density(BMD)of lumbar spine and hip and the short form 36 health survey questionnaire(SF-36)scores were measured at the enrollment and the end of the treatment respectively.Results:By the end of the trial,6 patients in QG paste group dropped out of the trial for drug-induced gastrointestinal adverse reactions(3),initiative request(2)and refracture(1)respectively,while 5 patients in conventional therapy group dropped out of the trial for drug-induced gastrointestinal adverse reactions(2),initiative request(1)and refracture(2)respectively.The patients with drug-induced gastrointestinal adverse reactions were treated with anti-osteoporosis injection,and the patients with refractures were treated with another PKP and anti-osteoporosis therapy,and they all got a good prognosis.There was no statistical difference in serum contents of T-PⅠNP and β-CTX and BMD of lumbar spine and hip between the 2 groups at the enrollment(t=-1.335,P=0.185; t=0.471,P=0.693; t=-1.734,P=0.086; t=-1.190,P=0.237).The serum contents of T-PⅠNP and β-CTX decreased,while the BMD of lumbar spine and hip increased in the 2 groups at the end of the treatment compared to those at the enrollment(T-PⅠNP:60.83+/-4.57 vs 39.26+/-4.06 ng/mL,t=26.460,P=0.000; 62.14+/-5.11 vs 31.32+/-2.49 ng/mL,t=38.692,P=0.000; β-CTX:0.77+/-0.08 vs 0.44+/-0.05 ng/mL,t=25.880,P=0.000; 0.76+/-0.10 vs 0.52+/-0.06 ng/mL,t=14.961,P=0.000; lumbar BMD:0.758+/-0.011 vs 0.786+/-0.024 g/cm(2),t=-10.238,P=0.000; 0.761+/-0.006 vs 0.779+/-0.028 g/cm(2),t=-4.239,P=0.000; Hip BMD:0.528+/-0.008 vs 0.567+/-0.036 g/cm(2),t=-7.550,P=0.000; 0.530+/-0.010 vs 0.556+/-0.024 g/cm(2),t=-8.039,P=0.000).At the end of the treatment,the serum content of T-PⅠNP was higher while the serum content of β-CTX was lower in QG paste group compared to conventional therapy group(t=11.754,P=0.000; t=-6.901,P=0.000),and there was no statistical difference in BMD of lumbar spine and hip between the 2 groups(t=1.355,P=0.179; t=1.770,P=0.080).There was no statistical difference in SF-36 scores between the 2 groups at the enrollment(t=-1.212,P=0.229).The SF-36 scores increased in the 2 groups at the end of the treatment compared to those at the enrollment,and were higher in QG paste group compared to conventional therapy group(102.22+/-1.69 vs 124.55+/-2.56 points,t=-98.085,P=0.000; 102.68+/-2.03 vs 115.34+/-2.29 points,t=-80.066,P=0.000; t=18.702,P=0.000).Conclusion:QG paste can improve bone metabolism and life quality of patients with postmenopausal osteoporotic vertebral fractures after PKP.

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备注/Memo

备注/Memo:
(收稿日期:2020-03-08 本文编辑:李晓乐)基金项目:浙江省中医药科技计划项目(2019ZQ026); 浙江中医药大学附属第二医院“186”人才培养项目; 浙江省“十三五”中医药重点专科建设项目; “十三五”浙江省中医药(中西医结合)重点学科建设项目通讯作者:李敏 E-mail:liminist@163.com
更新日期/Last Update: 2020-08-15