[1]袁家骏,罗程,黄毅,等.口服自拟补肾活血汤治疗早期膝骨关节炎的临床研究[J].中医正骨,2017,29(08):26-32.
　UAN Jiajun,LUO Cheng,HUANG Yi,et al.Clinical study on oral application of self-made Bushen Huoxue Tang(补肾活血汤)for treatment of early knee osteoarthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2017,29(08):26-32.
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口服自拟补肾活血汤治疗早期膝骨关节炎的临床研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第29卷
期数:
2017年08期
页码:
26-32
栏目:
临床研究
出版日期:
2017-08-20

文章信息/Info

Title:
Clinical study on oral application of self-made Bushen Huoxue Tang(补肾活血汤)for treatment of early knee osteoarthritis
作者:
袁家骏; 罗程; 黄毅; 刘魏; 张舟; 丁谷渊; 肖鲁伟; 童培建袁家骏1; 罗程1; 黄毅1; 刘魏1; 张舟1; 丁谷渊1; 肖鲁伟1; 童培建2
1.浙江中医药大学,浙江 杭州 310053; 2.浙江省中医院,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
关键词:
骨关节炎; 膝;  中药疗法;  补肾活血汤;  蛋白聚糖类;  胶原Ⅱ型;  临床试验
Keywords:
Key words osteoarthritis; knee;  drug therapy(TCD);  Bushen Huoxue Tang;  proteoglycans;  collagen typeⅡ;  clinical trial
摘要:
目的:观察口服自拟补肾活血汤治疗早期膝骨关节炎的临床疗效。方法:将70例早期膝骨关节炎患者随机分为2组,每组35例,分别采用口服自拟补肾活血汤和塞来昔布胶囊治疗。自拟补肾活血汤口服每日1剂,早晚服用; 塞来昔布胶囊口服每日1次,每次200 mg,餐后服用; 15 d为1个疗程,共6个疗程。分别于治疗前、治疗1个月后及治疗3个月后,记录并比较2组患者膝关节疼痛视觉模拟量表(visual analogue scale,VAS)评分、美国膝关节协会评分(American knee society score,KSS)、膝关节软骨T2值以及血清蛋白聚糖和血清Ⅱ型胶原的表达量。结果:①膝关节疼痛VAS评分。时间因素和分组因素存在交互效应(F=14.564,P=0.001); 2组患者膝关节疼痛VAS评分总体比较,组间差异有统计学意义,即存在分组效应(F=17.326,P=0.000); 治疗前后不同时间点间膝关节疼痛VAS评分的差异有统计学意义,即存在时间效应(F=89.267,P=0.000); 2组患者膝关节疼痛VAS评分随时间均呈降低趋势(F=80.933,P=0.000; F=25.824,P=0.000),但2组的降低趋势不完全一致; 治疗前2组患者膝关节疼痛VAS评分的组间差异无统计学意义[(5.46±0.82)分,(5.57±0.95)分,t=-0.836,P=0.859]; 治疗1个月后、治疗3个月后补肾活血汤组膝关节疼痛VAS评分均低于塞来昔布胶囊组[(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评分。时间因素和分组因素存在交互效应(F=13.453,P=0.006); 2组患者KSS评分总体比较,组间差异有统计学意义,即存在分组效应(F=18.536,P=0.000); 治疗前后不同时间点间KSS评分的差异有统计学意义,即存在时间效应(F=64.329,P=0.000); 2组患者KSS评分随时间均呈增高趋势(F=75.632,P=0.000; F=16.738,P=0.000),但2组的增高趋势不完全一致; 治疗前2组患者KSS评分的组间差异无统计学意义[(55.91±5.68)分,(53.29±7.12)分,t=1.152,P=0.653)]; 治疗1个月后、治疗3个月后补肾活血汤组KSS评分均高于塞来昔布胶囊组[(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血清蛋白聚糖表达量。时间因素和分组因素存在交互效应(F=15.379,P=0.000); 2组患者血清蛋白聚糖表达量总体比较,组间差异有统计学意义,即存在分组效应(F=19.524,P=0.000); 治疗前后不同时间点间血清蛋白聚糖表达量的差异有统计学意义,即存在时间效应(F=112.358,P=0.000); 2组患者血清蛋白聚糖表达量随时间均呈降低趋势(F=102.497,P=0.000; F=16.738,P=0.001),但2组的降低趋势不完全一致; 治疗前、治疗1个月后,2组患者血清蛋白聚糖表达量的组间差异均无统计学意义[(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]; 治疗3个月后补肾活血汤组血清蛋白聚糖表达量低于塞来昔布胶囊组[(209.56±12.35)mmol·L-1,(220.12±17.23)mmol·L-1,t=-3.385,P=0.000]。④血清Ⅱ型胶原表达量。时间因素和分组因素存在交互效应(F=17.785,P=0.000); 2组患者血清Ⅱ型胶原表达量总体比较,组间差异有统计学意义,即存在分组效应(F=12.586,P=0.000); 治疗前后不同时间点间血清Ⅱ型胶原表达量的差异有统计学意义,即存在时间效应(F=39.267,P=0.000); 2组患者血清Ⅱ型胶原表达量随时间均呈降低趋势(F=45.598,P=0.000; F=12.136,P=0.004),但2组的降低趋势不完全一致; 治疗前、治疗1个月后,2组患者血清Ⅱ型胶原表达量的组间差异均无统计学意义[(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]; 治疗3个月后补肾活血汤组血清Ⅱ型胶原表达量低于塞来昔布胶囊组[(2.28±0.49)mmol·L-1,(2.41±0.52)mmol·L-1,t=-2.275,P=0.001]。⑤膝关节软骨T2值。时间因素和分组因素存在交互效应(F=15.337,P=0.002); 2组患者膝关节软骨T2值总体比较,组间差异有统计学意义,即存在分组效应(F=20.586,P=0.000); 治疗前后不同时间点间膝关节软骨T2值的差异有统计学意义,即存在时间效应(F=63.481,P=0.000),但2组的变化趋势不完全一致; 补肾活血汤组膝关节软骨T2值随时间呈降低趋势(F=75.438,P=0.000),塞来昔布胶囊组膝关节软骨T2值随时间无明显变化(F=4.527,P=0.277); 治疗前2组患者膝关节软骨T2值的组间差异无统计学意义[(45.48±3.13)ms,(45.68±3.18)ms,t=-0.542,P=0.938]; 治疗1个月后、治疗3个月后补肾活血汤组膝关节软骨T2值均低于塞来昔布胶囊组[(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]。结论:口服自拟补肾活血汤治疗早期膝骨关节炎可以缓解膝关节疼痛,改善膝关节功能,延缓软骨退变,其疗效优于口服塞来昔布胶囊,值得临床推广应用。
Abstract:
ABSTRACT Objective:To observe the clinical curative effects of oral application of self-made Bushen Huoxue Tang(补肾活血汤,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