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[1]王金杰,俞倩麗,朱磊,等.黃精制劑聯(lián)合塞來昔布膠囊口服治療膝骨關(guān)節(jié)炎的臨床療效及其作用機制[J].中醫(yī)正骨,2018,30(04):32-38,42.
　WANG Jinjie,YU Qianli,ZHU Lei,et al.Clinical curative effect of oral application of polygonatum kingianum preparations and celecoxib capsules on knee osteoarthritis and its mechanism of action[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2018,30(04):32-38,42.
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黃精制劑聯(lián)合塞來昔布膠囊口服治療膝骨關(guān)節(jié)炎的臨床療效及其作用機制()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第30卷
期數(shù):
2018年04期
頁碼:
32-38,42
欄目:
臨床研究
出版日期:
2018-04-20

文章信息/Info

Title:
Clinical curative effect of oral application of polygonatum kingianum preparations and celecoxib capsules on knee osteoarthritis and its mechanism of action
作者:
王金杰1; 俞倩麗1; 朱磊1; 莊汝杰2
1.浙江中醫(yī)藥大學(xué),浙江 杭州 310053; 2.浙江省中醫(yī)院,浙江 杭州 310006
Author(s):
WANG Jinjie1; YU Qianli1; ZHU Lei1; ZHUANG Rujie2
1.Zhejiang University of Traditional Chinese Medicine,Hangzhou 310053,Zhejiang,China 2.Zhejiang Provincial Hospital of Traditional Chinese Medicine,Hangzhou 310006,Zhejiang,China
關(guān)鍵詞:
骨關(guān)節(jié)炎; 膝;  黃精;  塞來昔布;  白細胞介素1;  白細胞介素33;  基質(zhì)金屬蛋白酶13;  臨床試驗
Keywords:
Keywords osteoarthritis; knee;  polygonatum kingianum;  celecoxib;  interleukin1;  interleukin33;  matrix metalloproteinase13;  clinical trial
摘要:
目的:觀察黃精制劑聯(lián)合塞來昔布膠囊口服治療膝骨關(guān)節(jié)炎的臨床療效及其作用機制。方法:將100例膝骨關(guān)節(jié)炎患者隨機分為2組,每組50例,分別采用單純?nèi)麃砦舨寄z囊口服、黃精制劑聯(lián)合塞來昔布膠囊口服治療。塞來昔布膠囊口服,每日1片,飯后服用; 黃精制劑口服,每日3次,每次2袋,溫水沖服; 每隔3周停藥1周,1個月為1個療程,共3個療程。分別于治療前及治療開始后3個月、6個月記錄并比較2組患者膝關(guān)節(jié)疼痛視覺模擬量表(visual analogue scale,VAS)評分、美國膝關(guān)節(jié)協(xié)會評分(American knee society score,KSS)以及白細胞介素1(interleukin,IL)-1、IL-33、基質(zhì)金屬蛋白酶(matrix metalloproteinase,MMP)-13血清含量。結(jié)果:黃精制劑聯(lián)合塞來昔布膠囊組退出5例,單純?nèi)麃砦舨寄z囊組退出8例。①膝關(guān)節(jié)疼痛VAS評分。時間因素與分組因素存在交互效應(yīng)(F=0.451,P=0.038); 2組患者膝關(guān)節(jié)疼痛VAS評分比較,組間差異有統(tǒng)計學(xué)意義,即存在分組效應(yīng)(t=2.535,P=0.012); 治療前后不同時間點之間膝關(guān)節(jié)疼痛VAS評分的差異有統(tǒng)計學(xué)意義,即存在時間效應(yīng)(F=2.193,P=0.025); 2組膝關(guān)節(jié)疼痛VAS評分隨時間均呈降低趨勢,但2組的降低趨勢不完全一致[(6.36±1.18)分,(6.01±1.16)分,(5.82±1.01)分,F=2.749,P=0.030;(6.43±1.32)分,(6.31±0.96)分,(6.18±1.46)分,F=0.246,P=0.043]; 治療前和治療開始后3個月,2組患者膝關(guān)節(jié)疼痛VAS評分比較,組間差異均無統(tǒng)計學(xué)意義(t=1.042,P=0.304; t=1.325,P=0.189); 治療開始后6個月,黃精制劑聯(lián)合塞來昔布膠囊組膝關(guān)節(jié)疼痛VAS評分低于單純?nèi)麃砦舨寄z囊組(t=2.089,P=0.041)。②KSS膝關(guān)節(jié)臨床評分。時間因素與分組因素存在交互效應(yīng)(F=7.161,P=0.001); 2組患者KSS膝關(guān)節(jié)臨床評分比較,組間差異有統(tǒng)計學(xué)意義,即存在分組效應(yīng)(t=8.166,P=0.000); 治療前后不同時間點之間KSS膝關(guān)節(jié)臨床評分的差異有統(tǒng)計學(xué)意義,即存在時間效應(yīng)(F=39.069,P=0.000); 2組患者KSS膝關(guān)節(jié)臨床評分隨時間均呈升高趨勢,但2組的升高趨勢不完全一致[(61.22±2.81)分,(65.07±4.03)分,(67.27±3.49)分,F=40.270,P=0.000;(59.38±2.69)分,(60.21±3.49)分,(62.02±3.88)分,F=7.255,P=0.001]; 治療前2組患者KSS膝關(guān)節(jié)臨床評分比較,差異無統(tǒng)計學(xué)意義(t=3.119,P=0.082); 治療開始后3個月和6個月黃精制劑聯(lián)合塞來昔布膠囊組KSS膝關(guān)節(jié)臨床評分均高于單純?nèi)麃砦舨寄z囊組(t=5.985,P=0.000; t=3.060,P=0.003)。③KSS膝關(guān)節(jié)日常生活功能評分。時間因素與分組因素存在交互效應(yīng)(F=1.426,P=0.043)。2組患者KSS膝關(guān)節(jié)日常生活功能評分比較,組間差異有統(tǒng)計學(xué)意義,即存在分組效應(yīng)(t=4.323,P=0.000); 治療前后不同時間點之間KSS膝關(guān)節(jié)日常生活功能評分的差異有統(tǒng)計學(xué)意義,即存在時間效應(yīng)(F=38.648,P=0.000); 2組患者KSS膝關(guān)節(jié)日常生活功能評分隨時間均呈升高趨勢,但2組的升高趨勢不完全一致[(66.83±2.39)分,(68.31±2.52)分,(71.02±3.66)分,F=39.330,P=0.000;(65.36±2.41)分,(66.90±3.46)分,(68.38±3.83)分,F=9.835,P=0.000]; 治療前2組患者KSS膝關(guān)節(jié)日常生活功能評分比較,差異無統(tǒng)計學(xué)意義(t=2.849,P=0.054); 治療開始后3個月和6個月黃精制劑聯(lián)合塞來昔布膠囊組KSS膝關(guān)節(jié)日常生活功能評分均高于單純?nèi)麃砦舨寄z囊組(t=2.176,P=0.032; t=3.289,P=0.001)。④IL-1血清含量。時間因素與分組因素不存在交互效應(yīng)(F=0.002,P=0.998); 2組患者IL-1血清含量比較,組間差異無統(tǒng)計學(xué)意義,即不存在分組效應(yīng)(t=0.652,P=0.515); 治療前后不同時間點之間IL-1血清含量的差異有統(tǒng)計學(xué)意義,即存在時間效應(yīng)(F=164.983,P=0.000); 2組患者IL-1血清含量隨時間均呈降低趨勢,且2組的降低趨勢完全一致[(2.85±0.46)ng·L-1,(2.18±0.37)ng·L-1,(2.00±0.48)ng·L-1,F=138.697,P=0.000;(2.79±0.45)ng·L-1,(2.15±0.34)ng·L-1,(1.95±0.08)ng·L-1,F=55.269,P=0.000]。⑤IL-33血清含量。時間因素與分組因素不存在交互效應(yīng)(F=0.039,P=0.962); 2組患者IL-33血清含量比較,組間差異無統(tǒng)計學(xué)意義,即不存在分組效應(yīng)(t=0.074,P=0.941); 治療前后不同時間點之間IL-33血清含量的差異有統(tǒng)計學(xué)意義,即存在時間效應(yīng)(F=151.452,P=0.000); 2組患者IL-33血清含量隨時間均呈降低趨勢,且2組的降低趨勢完全一致[(8.68±2.07)ng·L-1,(6.41±1.00)ng·L-1,(5.39±0.82)ng·L-1,F=73.238,P=0.000;(8.84±1.89)ng·L-1,(6.38±1.01)ng·L-1,(5.31±0.78)ng·L-1,F=78.417,P=0.000]。⑥MMP-13血清含量。時間因素與分組因素不存在交互效應(yīng) (F=0.017,P=0.983); 2組患者MMP-13血清含量比較,組間差異無統(tǒng)計學(xué)意義,即不存在分組效應(yīng)(t=0.241,P=0.810); 治療前后不同時間點之間MMP-13血清含量的差異有統(tǒng)計學(xué)意義,即存在時間效應(yīng)(F=76.474,P=0.000); 2組患者MMP-13血清含量隨時間均呈降低趨勢,且2組的降低趨勢完全一致[(2.83±0.97)ng·L-1,(2.02±0.68)ng·L-1,(1.68±0.42)ng·L-1,F=38.634,P=0.000;(2.88±0.98)ng·L-1,(2.06±0.28)ng·L-1,(1.66±0.42)ng·L-1,F=36.189,P=0.000]。結(jié)論:黃精制劑聯(lián)合塞來昔布膠囊口服與單純?nèi)麃砦舨寄z囊口服治療KOA,均能緩解膝關(guān)節(jié)疼痛和改善膝關(guān)節(jié)功能,但前者的療效優(yōu)于后者; 其作用機制可能與其能降低血清中IL-1、IL-33及MMP-13的含量有關(guān)。
Abstract:
ABSTRACT Objective:To observe the clinical curative effect of oral application of polygonatum kingianum preparations and celecoxib capsules on knee osteoarthritis(KOA)and to study its mechanism of action.Methods:One hundred patients with KOA were randomly divided into 2 groups,50 cases in each group,and were treated with monotherapy of oral application of celecoxib capsules(monotherapy group)and combination therapy of oral application of polygonatum kingianum preparations and celecoxib capsules(combination therapy group)respectively.The celecoxib capsules were taken after meal,one tablet a day.The polygonatum kingianum preparations were taken after mixing with warm water,three times a day,2 bags at a time.Both celecoxib capsules and polygonatum kingianum preparations were taken for consecutive 3 courses of treatment,1 month for each course with a 1-week rest-insertion between courses.The knee pain visual analogue scale(VAS)score,the American knee society score(KSS)and the serum contents of interleukin(IL)-1,IL-33 and matrix metalloproteinase(MMP)-13 were recorded and compared between the 2 groups before treatment and at 3 and 6 months after the beginning of the treatment respectively.Results:Five patients in combination therapy group and 8 patients in monotherapy group dropped out of the study.There was interaction between time factor and group factor in knee pain VAS scores(F=0.451,P=0.038).There was statistical difference in the knee pain VAS scores between the 2 groups,in other words,there was group effect(t=2.535,P=0.012).There was statistical difference in knee pain VAS scores between different timepoints before and after the treatment,in other words,there was time effect(F=2.193,P=0.025).The knee pain VAS scores presented a time-dependent decreasing trend in both of the 2 groups,while the 2 groups were inconsistent with each other in the decreasing trend of knee pain VAS scores(6.36+/-1.18,6.01+/-1.16,5.82+/-1.01 points,F=2.749,P=0.030; 6.43+/-1.32,6.31+/-0.96,6.18+/-1.46 points,F=0.246,P=0.043).There was no statistical difference in knee pain VAS scores between the 2 groups before the treatment and at 3 months after the beginning of the treatment(t=1.042,P=0.304; t=1.325,P=0.189).The knee pain VAS scores were lower in combination therapy group compared to monotherapy group at 6 months after the beginning of the treatment(t=2.089,P=0.041).There was interaction between time factor and group factor in KSS clinical scores(F=7.161,P=0.001).There was statistical difference in KSS clinical scores between the 2 groups,in other words,there was group effect(t=8.166,P=0.000).There was statistical difference in KSS clinical scores between different timepoints before and after the treatment,in other words,there was time effect(F=39.069,P=0.000).The KSS clinical scores presented a time-dependent increasing trend in both of the 2 groups,while the 2 groups were inconsistent with each other in the increasing trend of KSS clinical scores(61.22+/-2.81,65.07+/-4.03,67.27+/-3.49 points,F=40.270,P=0.000; 59.38+/-2.69,60.21+/-3.49,62.02+/-3.88 points,F=7.255,P=0.001).There was no statistical difference in KSS clinical scores between the 2 groups before the treatment(t=3.119,P=0.082).The KSS clinical scores were higher in combination therapy group compared to monotherapy group at 3 and 6 months after the beginning of the treatment(t=5.985,P=0.000; t=3.060,P=0.003).There was interaction between time factor and group factor in KSS activity of daily living(ADL)scores(F=1.426,P=0.043).There was statistical difference in KSS ADL scores between the 2 groups,in other words,there was group effect(t=4.323,P=0.000).There was statistical difference in KSS ADL scores between different timepoints before and after the treatment,in other words,there was time effect(F=38.648,P=0.000).The KSS ADL scores presented a time-dependent increasing trend in both of the 2 groups,while the 2 groups were inconsistent with each other in the increasing trend of KSS ADL scores(66.83+/-2.39,68.31+/-2.52,71.02+/-3.66 points,F=39.330,P=0.000; 65.36+/-2.41,66.90+/-3.46,68.38+/-3.83 points,F=9.835,P=0.000).There was no statistical difference in KSS ADL scores between the 2 groups before the treatment(t=2.849,P=0.054).The KSS ADL scores were higher in combination therapy group compared to monotherapy group at 3 and 6 months after the beginning of the treatment(t=2.176,P=0.032; t=3.289,P=0.001).There was no interaction between time factor and group factor in the serum content of IL-1(F=0.002,P=0.998).There was no statistical difference in the serum content of IL-1 between the 2 groups,in other words,there was no group effect(t=0.652,P=0.515).There was statistical difference in serum content of IL-1 between different timepoints before and after the treatment,in other words,there was time effect(F=164.983,P=0.000).The serum content of IL-1 presented a time-dependent decreasing trend in both of the 2 groups,while the 2 groups were consistent with each other in the decreasing trend of serum content of IL-1(2.85+/-0.46,2.18+/-0.37,2.00+/-0.48 ng/L,F=138.697,P=0.000; 2.79+/-0.45,2.15+/-0.34,1.95+/-0.08 ng/L,F=55.269,P=0.000).There was no interaction between time factor and group factor in the serum content of IL-33(F=0.039,P=0.962).There was no statistical difference in the serum content of IL-33 between the 2 groups,in other words,there was no group effect(t=0.074,P=0.941).There was statistical difference in serum content of IL-33 between different timepoints before and after the treatment,in other words,there was time effect(F=151.452,P=0.000).The serum content of IL-33 presented a time-dependent decreasing trend in both of the 2 groups,while the 2 groups were consistent with each other in the decreasing trend of serum content of IL-33(8.68+/-2.07,6.41+/-1.00,5.39+/-0.82 ng/L,F=73.238,P=0.000; 8.84+/-1.89,6.38+/-1.01,5.31+/-0.78 ng/L,F=78.417,P=0.000).There was no interaction between time factor and group factor in the serum content of MMP-13(F=0.017,P=0.983).There was no statistical difference in the serum content of MMP-13 between the 2 groups,in other words,there was no group effect(t=0.241,P=0.810).There was statistical difference in serum content of MMP-13 between different timepoints before and after the treatment,in other words,there was time effect(F=76.474,P=0.000).The serum content of MMP-13 presented a time-dependent decreasing trend in both of the 2 groups,while the 2 groups were consistent with each other in the decreasing trend of serum content of MMP-13(2.83+/-0.97,2.02+/-0.68,1.68+/-0.42 ng/L,F=38.634,P=0.000; 2.88+/-0.98,2.06+/-0.28,1.66+/-0.42 ng/L,F=36.189,P=0.000).Conclusion:Both the combination therapy of oral application of polygonatum kingianum preparations and celecoxib capsules and the monotherapy of oral application of celecoxib capsules can relieve the knee pain and improve the knee function in the treatment of KOA,however,the former is better than the latter in curative effect and it can reduce the serum contents of IL-1,IL-33 and MMP-13,which may be the mechanisms of action.

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備注/Memo

備注/Memo:
基金項目:2014年浙江省重大科技專項計劃(2014C03038); 2016年浙江省中醫(yī)藥科技計劃項目(2016ZA085) 通訊作者:莊汝杰 E-mail:[email protected]
更新日期/Last Update: 2018-08-24