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[1]何才劍,萬(wàn)全增,陳天鵬,等.益氣溫經(jīng)方在絕經(jīng)后骨質(zhì)疏松癥腎虛血瘀證治療中的應(yīng)用[J].中醫(yī)正骨,2021,33(08):7-11.
　HE Caijian,WAN Quanzeng,CHEN Tianpeng,et al.Application of Yiqi Wenjing Fang(益氣溫經(jīng)方)in treatment of kidney-deficiency-blood-stasis-type postmenopausal osteoporosis:a clinical study[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2021,33(08):7-11.
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益氣溫經(jīng)方在絕經(jīng)后骨質(zhì)疏松癥腎虛血瘀證治療中的應(yīng)用()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第33卷
期數(shù):
2021年08期
頁(yè)碼:
7-11
欄目:
臨床研究
出版日期:
2021-08-20

文章信息/Info

Title:
Application of Yiqi Wenjing Fang(益氣溫經(jīng)方)in treatment of kidney-deficiency-blood-stasis-type postmenopausal osteoporosis:a clinical study
作者:
何才劍1; 萬(wàn)全增2; 陳天鵬1; 周航1; 房謀昊1; 余陽(yáng)1; 唐彬彬3; 史曉林3
(1.浙江中醫(yī)藥大學(xué)第二臨床醫(yī)學(xué)院,浙江 杭州 310053; 2.濟(jì)寧市中醫(yī)院,山東 濟(jì)寧 272003; 3.浙江中醫(yī)藥大學(xué)附屬第二醫(yī)院,浙江 杭州 310005)
Author(s):
HE Caijian1; WAN Quanzeng2; CHEN Tianpeng1; ZHOU Hang1; FANG Mouhao1; YU Yang1; TANG Binbin3; SHI Xiaolin3
1.The Second Clinical Medical College of Zhejiang Chinese Medical University,Hangzhou 310053,Zhejiang,China2.Jining Hospital of Traditional Chinese Medicine,Jining 272003,Shandong,China3.The Second Affiliated Hospital of Zhejiang Chinese Medical University,Hangzhou 310005,Zhejiang,China
關(guān)鍵詞:
骨質(zhì)疏松; 絕經(jīng)后;  腎虛血瘀;  骨密度;  益氣溫經(jīng)方;  碳酸鈣;  阿法骨化醇;  臨床試驗(yàn)
Keywords:
osteoporosis; postmenopausal;  kidney deficiency and blood stagnation;  bone density;  Yiqi Wenjing Fang;  calcium carbonate;  alfacalcidol;  clinical trial
摘要:
目的:觀察益氣溫經(jīng)方在絕經(jīng)后骨質(zhì)疏松癥(postmenopausal osteoporosis,PMOP)腎虛血瘀證治療中的應(yīng)用價(jià)值。方法:將符合要求的240例PMOP腎虛血瘀證患者隨機(jī)分為2組,每組120例,分別采用口服益氣溫經(jīng)方聯(lián)合碳酸鈣D3片和阿法骨化醇膠囊(益氣溫經(jīng)方組)與單純口服碳酸鈣D3片和阿法骨化醇膠囊(基礎(chǔ)用藥組)治療。益氣溫經(jīng)方,每日2次,每次1袋,每袋200 mL; 碳酸鈣D3片,每日1次,每次1片; 阿法骨化醇膠囊,每日1次,每次1粒; 均3個(gè)月為1個(gè)療程,療程間隔1個(gè)月,共9個(gè)療程。分別于治療結(jié)束時(shí)、治療結(jié)束后2年比較2組患者再骨折情況,分別于治療前及治療結(jié)束時(shí)、治療結(jié)束后2年比較2組患者腰椎骨密度、腰背部疼痛視覺(jué)模擬量表(visual analogue scale,VAS)評(píng)分,并觀察并發(fā)癥發(fā)生情況。結(jié)果:①受試者退出情況。共20例患者退出試驗(yàn),益氣溫經(jīng)方組13例因腹瀉及不愿再服中藥退出,基礎(chǔ)用藥組7例因服用其他藥物退出。②再骨折發(fā)生情況。治療結(jié)束時(shí),益氣溫經(jīng)方組4例出現(xiàn)再骨折、基礎(chǔ)用藥組6例出現(xiàn)再骨折; 2組患者再骨折發(fā)生率比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(χ2=0.313,P=0.576)。治療結(jié)束后2年,益氣溫經(jīng)方組6例出現(xiàn)再骨折、基礎(chǔ)用藥組16例出現(xiàn)再骨折; 益氣溫經(jīng)方組再骨折發(fā)生率低于基礎(chǔ)用藥組(χ2=4.466,P=0.035)。③腰椎骨密度。時(shí)間因素和分組因素存在交互效應(yīng)(F=3.063,P=0.048); 2組患者腰椎骨密度總體比較,組間差異有統(tǒng)計(jì)學(xué)意義,即存在分組效應(yīng)(F=11.788,P=0.000); 治療前后不同時(shí)間點(diǎn)腰椎骨密度的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=4.299,P=0.014); 益氣溫經(jīng)方組患者腰椎骨密度治療前后比較,差異無(wú)統(tǒng)計(jì)學(xué)意義[(54.902±32.465)mg·cm-3,(58.174±14.320)mg·cm-3,(54.223±14.053)mg·cm-3,F=0.943,P=0.391]; 基礎(chǔ)用藥組患者腰椎骨密度隨時(shí)間變化呈下降趨勢(shì)[(55.449±32.111)mg·cm-3,(50.800±20.377)mg·cm-3,(44.283±10.340)mg·cm-3,F=6.242,P=0.002]; 治療前,2組患者腰椎骨密度比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(t=0.126,P=0.900); 治療結(jié)束時(shí)、治療結(jié)束后2年,益氣溫經(jīng)方組患者腰椎骨密度均高于基礎(chǔ)用藥組(t=3.708,P=0.002; t=5.998,P=0.000)。④腰背部疼痛VAS評(píng)分。時(shí)間因素和分組因素不存在交互效應(yīng)(F=0.799,P=0.460); 2組患者腰背部疼痛VAS評(píng)分總體比較,組間差異無(wú)統(tǒng)計(jì)學(xué)意義,即不存在分組效應(yīng)(F=3.920,P=0.271); 治療前后不同時(shí)間點(diǎn)腰背部疼痛VAS評(píng)分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=402.283,P=0.000); 2組患者腰背部疼痛VAS評(píng)分隨時(shí)間變化均呈下降趨勢(shì),且2組的下降趨勢(shì)完全一致[(6.76±1.99)分,(3.16±1.99)分,( 2.21±1.52)分,F=181.117,P=0.000;(7.13±1.98)分,(3.10±1.79)分,(2.35±1.63)分,F=222.874,P=0.000]。⑤并發(fā)癥。益氣溫經(jīng)方組18例出現(xiàn)一過(guò)性胃部不適,基礎(chǔ)用藥組6例出現(xiàn)一過(guò)性胃部不適、4例出現(xiàn)一過(guò)性低熱。2組并發(fā)癥發(fā)生率比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(χ2=3.145,P=0.076)。結(jié)論:口服益氣溫經(jīng)方可以降低PMOP腎虛血瘀證患者再骨折的發(fā)生率,提高患者骨密度,緩解患者疼痛癥狀,且安全性高。
Abstract:
Objective:To observe the applied values of Yiqi Wenjing Fang(益氣溫經(jīng)方,YQWJF)in treatment of kidney-deficiency-blood-stasis-type postmenopausal osteoporosis(PMOP).Methods:Two hundred and forty patients with kidney-deficiency-blood-stasis-type PMOP were enrolled in the study and were randomly divided into YQWJF group and basic medication group,120 cases in each group.The patients in YQWJF group were treated with oral application of YQWJF(twice a day,200 mL at a time),calcium carbonate and Vitamin D3 tablets(one tablet a day)and alfacalcidol capsules(one capsule a day),while the others in basic medication group were merely with oral application of calcium carbonate and Vitamin D3 tablets and alfacalcidol capsules for consecutive 9 courses of treatment,3 months for each course with a 1-month rest-insertion between courses.The incidence rate of refracture was compared between the 2 groups at the end of treatment and at 2 years after the end of treatment respectively.The bone mineral density(BMD)of lumbar vertebrae and low back pain visual analogue scale(VAS)scores were recorded and compared between the 2 groups before the treatment,at the end of treatment and at 2 years after the end of the treatment respectively,and the complications were observed.Results:Thirteen patients in YQWJF group and seven patients in basic medication group dropped out of the trial for unwillingness to take the requested medications due to diarrhea and taking other medications respectively.At the end of treatment,the refracture was found in 4 patients in YQWJF group and 6 patients in basic medication group.There was no statistical difference in the incidence rate of refracture between the 2 groups(χ2=0.313,P=0.576).At 2 years after the end of treatment,the refracture was found in 6 patients in YQWJF group and 16 patients in basic medication group.The incidence rate of refracture was lower in YQWJF group compared to basic medication group(χ2=4.466,P=0.035).There was interaction between time factor and group factor in BMD of lumbar vertebrae(F=3.063,P=0.048).There was statistical difference in BMD of lumbar vertebrae between the 2 groups in general,in other words,there was group effect(F=11.788,P=0.000).There was statistical difference in BMD of lumbar vertebrae between different timepoints before and after the treatment,in other words,there was time effect(F=4.299,P=0.014).There was no statistical difference in BMD of lumbar vertebrae between pre-treatment and post-treatment in YQWJF group(54.902±32.465,58.174±14.320,54.223±14.053 mg/cm(3),F=0.943,P=0.391); while the BMD of lumbar vertebrae presented a time-dependent decreasing trend in basic medication group(55.449±32.111,50.800±20.377,44.283±10.340 mg/cm(3),F=6.242,P=0.002).There was no statistical difference in BMD of lumbar vertebrae between the 2 groups before the treatment(t=0.126,P=0.900),whereas the BMD of lumbar vertebrae was higher in YQWJF group compared to basic medication group at the end of treatment and at 2 years after the end of treatment(t=3.708,P=0.002; t=5.998,P=0.000)...

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備注/Memo

備注/Memo:
基金項(xiàng)目:國(guó)家自然科學(xué)基金項(xiàng)目(81873129,82074183); 浙江省中醫(yī)藥科技計(jì)劃項(xiàng)目(2018ZZ012,2020ZQ024)
通訊作者:史曉林 E-mail:[email protected]
更新日期/Last Update: 1900-01-01