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[1]袁家駿,羅程,黃毅,等.口服自擬補腎活血湯治療早期膝骨關節(jié)炎的臨床研究[J].中醫(yī)正骨,2017,29(08):26-32.
　UAN Jiajun,LUO Cheng,HUANG Yi,et al.Clinical study on oral application of self-made Bushen Huoxue Tang(補腎活血湯)for treatment of early knee osteoarthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2017,29(08):26-32.
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口服自擬補腎活血湯治療早期膝骨關節(jié)炎的臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第29卷
期數(shù):
2017年08期
頁碼:
26-32
欄目:
臨床研究
出版日期:
2017-08-20

文章信息/Info

Title:
Clinical study on oral application of self-made Bushen Huoxue Tang(補腎活血湯)for treatment of early knee osteoarthritis
作者:
袁家駿; 羅程; 黃毅; 劉魏; 張舟; 丁谷淵; 肖魯偉; 童培建袁家駿1; 羅程1; 黃毅1; 劉魏1; 張舟1; 丁谷淵1; 肖魯偉1; 童培建2
1.浙江中醫(yī)藥大學,浙江 杭州 310053; 2.浙江省中醫(yī)院,浙江 杭州 310006
Author(s):
UAN Jiajun1; LUO Cheng1; HUANG Yi1; LIU Wei1; ZHANG Zhou1; DING Guyuan1; XIAO Luwei1; TONG Peijain2
1.Zhejiang Chinese Medical University,Hangzhou 310053,Zhejiang,China. 2.Zhejiang Provincial Hospital of Traditional Chinese Medicine,Hangzhou 310006,Zhejiang,China
關鍵詞:
骨關節(jié)炎; 膝;  中藥療法;  補腎活血湯;  蛋白聚糖類;  膠原Ⅱ型;  臨床試驗
Keywords:
Key words osteoarthritis; knee;  drug therapy(TCD);  Bushen Huoxue Tang;  proteoglycans;  collagen typeⅡ;  clinical trial
摘要:
目的:觀察口服自擬補腎活血湯治療早期膝骨關節(jié)炎的臨床療效。方法:將70例早期膝骨關節(jié)炎患者隨機分為2組,每組35例,分別采用口服自擬補腎活血湯和塞來昔布膠囊治療。自擬補腎活血湯口服每日1劑,早晚服用; 塞來昔布膠囊口服每日1次,每次200 mg,餐后服用; 15 d為1個療程,共6個療程。分別于治療前、治療1個月后及治療3個月后,記錄并比較2組患者膝關節(jié)疼痛視覺模擬量表(visual analogue scale,VAS)評分、美國膝關節(jié)協(xié)會評分(American knee society score,KSS)、膝關節(jié)軟骨T2值以及血清蛋白聚糖和血清Ⅱ型膠原的表達量。結果:①膝關節(jié)疼痛VAS評分。時間因素和分組因素存在交互效應(F=14.564,P=0.001); 2組患者膝關節(jié)疼痛VAS評分總體比較,組間差異有統(tǒng)計學意義,即存在分組效應(F=17.326,P=0.000); 治療前后不同時間點間膝關節(jié)疼痛VAS評分的差異有統(tǒng)計學意義,即存在時間效應(F=89.267,P=0.000); 2組患者膝關節(jié)疼痛VAS評分隨時間均呈降低趨勢(F=80.933,P=0.000; F=25.824,P=0.000),但2組的降低趨勢不完全一致; 治療前2組患者膝關節(jié)疼痛VAS評分的組間差異無統(tǒng)計學意義[(5.46±0.82)分,(5.57±0.95)分,t=-0.836,P=0.859]; 治療1個月后、治療3個月后補腎活血湯組膝關節(jié)疼痛VAS評分均低于塞來昔布膠囊組[(3.74±0.95)分,(4.34±0.94)分,t=-2.149,P=0.019;(1.94±0.97)分,(3.11±1.16)分,t=-4.385,P=0.000]。②KSS評分。時間因素和分組因素存在交互效應(F=13.453,P=0.006); 2組患者KSS評分總體比較,組間差異有統(tǒng)計學意義,即存在分組效應(F=18.536,P=0.000); 治療前后不同時間點間KSS評分的差異有統(tǒng)計學意義,即存在時間效應(F=64.329,P=0.000); 2組患者KSS評分隨時間均呈增高趨勢(F=75.632,P=0.000; F=16.738,P=0.000),但2組的增高趨勢不完全一致; 治療前2組患者KSS評分的組間差異無統(tǒng)計學意義[(55.91±5.68)分,(53.29±7.12)分,t=1.152,P=0.653)]; 治療1個月后、治療3個月后補腎活血湯組KSS評分均高于塞來昔布膠囊組[(66.92±5.82)分,(61.11±7.01)分,t=2.258,P=0.013;(82.20±5.01)分,(72.97±13.37)分,t=4.681,P=0.000]。③血清蛋白聚糖表達量。時間因素和分組因素存在交互效應(F=15.379,P=0.000); 2組患者血清蛋白聚糖表達量總體比較,組間差異有統(tǒng)計學意義,即存在分組效應(F=19.524,P=0.000); 治療前后不同時間點間血清蛋白聚糖表達量的差異有統(tǒng)計學意義,即存在時間效應(F=112.358,P=0.000); 2組患者血清蛋白聚糖表達量隨時間均呈降低趨勢(F=102.497,P=0.000; F=16.738,P=0.001),但2組的降低趨勢不完全一致; 治療前、治療1個月后,2組患者血清蛋白聚糖表達量的組間差異均無統(tǒng)計學意義[(227.98±10.71)mmol·L-1,(231.11±12.18)mmol·L-1,t=-0.942,P=0.528;(220.60±13.76)mmol·L-1,(226.16±11.45)mmol·L-1,t=-1.171,P=0.061]; 治療3個月后補腎活血湯組血清蛋白聚糖表達量低于塞來昔布膠囊組[(209.56±12.35)mmol·L-1,(220.12±17.23)mmol·L-1,t=-3.385,P=0.000]。④血清Ⅱ型膠原表達量。時間因素和分組因素存在交互效應(F=17.785,P=0.000); 2組患者血清Ⅱ型膠原表達量總體比較,組間差異有統(tǒng)計學意義,即存在分組效應(F=12.586,P=0.000); 治療前后不同時間點間血清Ⅱ型膠原表達量的差異有統(tǒng)計學意義,即存在時間效應(F=39.267,P=0.000); 2組患者血清Ⅱ型膠原表達量隨時間均呈降低趨勢(F=45.598,P=0.000; F=12.136,P=0.004),但2組的降低趨勢不完全一致; 治療前、治療1個月后,2組患者血清Ⅱ型膠原表達量的組間差異均無統(tǒng)計學意義[(2.58±0.22)mmol·L-1,(2.60±0.24)mmol·L-1,t=-0.636,P=0.923;(2.45±0.32)mmol·L-1,(2.52±0.35)mmol·L-1,t=-1.125,P=0.065]; 治療3個月后補腎活血湯組血清Ⅱ型膠原表達量低于塞來昔布膠囊組[(2.28±0.49)mmol·L-1,(2.41±0.52)mmol·L-1,t=-2.275,P=0.001]。⑤膝關節(jié)軟骨T2值。時間因素和分組因素存在交互效應(F=15.337,P=0.002); 2組患者膝關節(jié)軟骨T2值總體比較,組間差異有統(tǒng)計學意義,即存在分組效應(F=20.586,P=0.000); 治療前后不同時間點間膝關節(jié)軟骨T2值的差異有統(tǒng)計學意義,即存在時間效應(F=63.481,P=0.000),但2組的變化趨勢不完全一致; 補腎活血湯組膝關節(jié)軟骨T2值隨時間呈降低趨勢(F=75.438,P=0.000),塞來昔布膠囊組膝關節(jié)軟骨T2值隨時間無明顯變化(F=4.527,P=0.277); 治療前2組患者膝關節(jié)軟骨T2值的組間差異無統(tǒng)計學意義[(45.48±3.13)ms,(45.68±3.18)ms,t=-0.542,P=0.938]; 治療1個月后、治療3個月后補腎活血湯組膝關節(jié)軟骨T2值均低于塞來昔布膠囊組[(42.55±3.06)ms,(45.60±3.39)ms,t=-2.746,P=0.009;(38.75±3.24)ms,(45.50±3.62)ms,t=-4.635,P=0.000]。結論:口服自擬補腎活血湯治療早期膝骨關節(jié)炎可以緩解膝關節(jié)疼痛,改善膝關節(jié)功能,延緩軟骨退變,其療效優(yōu)于口服塞來昔布膠囊,值得臨床推廣應用。
Abstract:
ABSTRACT Objective:To observe the clinical curative effects of oral application of self-made Bushen Huoxue Tang(補腎活血湯,BSHXT)for the treatment of early knee osteoarthritis(KOA).Methods:Seventy patients with early KOA were randomly divided into 2 groups,35 cases in each group.The patients were treated with oral application of self-made BSHXT(group A)and celecoxib capsules(group B)respectively.The self-made BSHXT was taken one dose a day in the morning and evening,and the celecoxib capsules were taken once a day for 200 mg at a time after meals for consecutive 6 courses of treatment,15 days for each course.The knee pain visual analogue scale(VAS)scores,American knee society scores(KSS),T2 values of knee articular cartilage and the expression of serum proteoglycans and serum collagen typeⅡwere recorded and compared between the 2 groups before the treatment and after 1- and 3-month treatment respectively.Results:There was interaction between time factor and group factor in knee pain VAS scores(F=14.564,P=0.001).There was statistical difference in knee pain VAS scores between the 2 groups in general,in other words,there was group effect(F=17.326,P=0.000).There was statistical difference in knee pain VAS scores between different timepoints before and after treatment,in other words,there was time effect(F=89.267,P=0.000).The knee pain VAS scores presented a time-dependent decreasing trend in both of the 2 groups(F=80.933,P=0.000; F=25.824,P=0.000),while the 2 groups were inconsistent with each other in the decreasing trend of knee pain VAS scores.There was no statistical difference in knee pain VAS scores between the 2 groups before the treatment(5.46+/-0.82 vs 5.57+/-0.95 points,t=-0.836,P=0.859).The knee pain VAS scores were lower in group A compared to group B after 1- and 3-month treatment(3.74+/-0.95 vs 4.34+/-0.94 points,t=-2.149,P=0.019; 1.94+/-0.97 vs 3.11+/-1.16 points,t=-4.385,P=0.000).There was interaction between time factor and group factor in KSS scores(F=13.453,P=0.006).There was statistical difference in KSS scores between the 2 groups in general,in other words,there was group effect(F=18.536,P=0.000).There was statistical difference in KSS scores between different timepoints before and after the treatment,in other words,there was time effect(F=64.329,P=0.000).The KSS scores presented a time-dependent increasing trend in both of the 2 groups(F=75.632,P=0.000; F=16.738,P=0.000),while the 2 groups were inconsistent with each other in the increasing trend of KSS scores.There was no statistical difference in KSS scores between the 2 groups before the treatment(55.91+/-5.68 vs 53.29+/-7.12 points,t=1.152,P=0.653).The KSS scores were higher in group A compared to group B after 1- and 3-month treatment(66.92+/-5.82 vs 61.11+/-7.01 points,t=2.258,P=0.013; 82.20+/-5.01 vs 72.97+/-13.37 points,t=4.681,P=0.000).There was interaction between time factor and group factor in the expression of serum proteoglycans(F=15.379,P=0.000).There was statistical difference in the expression of serum proteoglycans between the 2 groups in general,in other words,there was group effect(F=19.524,P=0.000).There was statistical difference in the expression of serum proteoglycans between different timepoints before and after the treatment,in other words,there was time effect(F=112.358,P=0.000).The expression of serum proteoglycans presented a time-dependent decreasing trend in both of the 2 groups(F=102.497,P=0.000; F=16.738,P=0.001),while the 2 groups were inconsistent with each other in the decreasing trend of expression of serum proteoglycans.There was no statistical difference in the expression of serum proteoglycans between the 2 groups before the treatment and after 1-month treatment(227.98+/-10.71 vs 231.11+/-12.18 mmol/l,t=-0.942,P=0.528; 220.60+/-13.76 vs 226.16+/-11.45 mmol/l,t=-1.171,P=0.061).The expressions of serum proteoglycans were lower in group A compared to group B after 3-month treatment(209.56+/-12.35 vs 220.12+/-17.23 mmol/l,t=-3.385,P=0.000).There was interaction between time factor and group factor in the expression of serum collagen typeⅡ(F=17.785,P=0.000).There was statistical difference in the expression of serum collagen typeⅡbetween the 2 groups in general,in other words,there was group effect(F=12.586,P=0.000).There was statistical difference in the expression of serum collagen typeⅡbetween different timepoints before and after the treatment,in other words,there was time effect(F=39.267,P=0.000).The expression of serum collagen typeⅡpresented a time-dependent decreasing trend in both of the 2 groups(F=45.598,P=0.000; F=12.136,P=0.004),while the the 2 groups were inconsistent with each other in the decreasing trend of expression of serum collagen typeⅡ.There was no statistical difference in the expression of serum collagen typeⅡbetween the 2 groups before the treatment and after 1-month treatment(2.58+/-0.22 vs 2.60+/-0.24 mmol/l,t=-0.636,P=0.923; 2.45+/-0.32 vs 2.52+/-0.35 mmol/l,t=-1.125,P=0.065).The expression of serum collagen typeⅡwas lower in group A compared to group B after 3-month treatment(2.28+/-0.49 vs 2.41+/-0.52 mmol/l,t=-2.275,P=0.001).There was interaction between time factor and group factor in the T2 values of knee articular cartilage(F=20.586,P=0.000).There was statistical difference in the T2 values of knee articular cartilage between the 2 groups in general,in other words,there was group effect(F=20.586,P=0.000).There was statistical difference in the T2 values of knee articular cartilage between different timepoints before and after the treatment,in other words,there was time effect(F=63.481,P=0.000),while the 2 groups were inconsistent with each other in variation tendency.The T2 values of knee articular cartilage presented a time-dependent decreasing trend in group A(F=75.438,P=0.000),and no significant time-dependent change of T2 values of knee articular cartilage was found in group B(F=4.527,P=0.277).There was no statistical difference in the T2 values of knee articular cartilage between the 2 groups before the treatment(45.48+/-3.13 vs 45.68+/-3.18 ms,t=-0.542,P=0.938).The T2 values of knee articular cartilage were lower in group A compared to group B after 1- and 3-month treatment(42.55+/-3.06 vs 45.60+/-3.39 ms,t=-2.746,P=0.009; 38.75+/-3.24 vs 45.50+/-3.62 ms,t=-4.635,P=0.000).Conclusion:The therapy of oral application of self-made BSHXT can effectively relieve the knee pain and improve the knee function and delay articular cartilage degeneration in the treatment of early KOA,and its curative effect is better than that of oral application of celecoxib capsules,so it is worthy of popularizing in clinic.

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更新日期/Last Update: 2017-12-29