[1]石瑛,庞坚,王翔,等.口服抗骨质增生合剂治疗膝骨关节炎的临床研究[J].中医正骨,2014,26(07):8-12.
　Shi Ying*,Pang Jian,Wang Xiang,et al.A clinical study on oral application of anti-hyperosteogeny mixture in the treatment of knee osteoarthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2014,26(07):8-12.
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口服抗骨质增生合剂治疗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26卷
期数:
2014年07期
页码:
8-12
栏目:
临床研究
出版日期:
2014-07-28

文章信息/Info

Title:
A clinical study on oral application of anti-hyperosteogeny mixture in the treatment of knee osteoarthritis
作者:
石瑛; 庞坚; 王翔; 郑昱新; 陈东煜; 石印玉; 詹红生
上海中医药大学附属曙光医院,上海 200021
Author(s):
Shi Ying*; Pang Jian; Wang Xiang; Zheng Yuxin; Chen Dongyu; Shi Yinyu; Zhan Hongsheng.
*Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200021,China
关键词:
骨关节炎; 膝 抗骨质增生合剂 抗骨增生胶囊 治疗; 临床研究性
Keywords:
Osteoarthritis; knee;  Anti-hyperosteogeny mixture;  Anti-hyperosteogeny capsule;  Therapies; investigational
摘要:
目的:观察口服抗骨质增生合剂治疗膝骨关节炎的临床疗效及安全性。方法:将108例膝骨关节炎患者随机分为治疗组55例和对照组53例。治疗组采用口服抗骨质增生合剂治疗,对照组采用口服抗骨增生胶囊治疗。分别于治疗前、治疗4周后、治疗结束后3个月,采用视觉模拟评分量表评价2组患者的患膝疼痛、僵硬、肿胀情况及日常活动能力。并于治疗4周后,评价2组患者的总体疗效及安全性。结果:①患膝疼痛视觉模拟评分。不同时间点间患膝疼痛视觉模拟评分的差异有统计学意义(F=103.401,P=0.000)。2组患者患膝疼痛视觉模拟评分的组间差异总体上有统计学意义(F=21.067,P=0.000)。治疗前2组患膝疼痛视觉模拟评分比较,差异无统计学意义[(4.43±0.77)分,(4.33±0.44)分,t=0.033,P=0.856]; 治疗4周后及治疗结束后3个月,2组患膝疼痛视觉模拟评分比较,差异均有统计学意义[(1.24±4.50)分,(1.88±3.60)分,t=3.818,P=0.045;(1.37±1.09)分,(2.03±0.93)分,t=3.961,P=0.045)]。时间因素与分组因素存在交互效应(F=9.595,P=0.003)。②患膝僵硬视觉模拟评分。不同时间点间患膝僵硬视觉模拟评分的差异有统计学意义(F=127.565,P=0.000)。2组患者患膝僵硬视觉模拟评分的组间差异总体上无统计学意义(F=2.643,P=0.109)。治疗前、治疗4周后及治疗结束后3个月,2组患膝僵硬视觉模拟评分比较,组间差异均无统计学意义[(4.58±0.86)分,(4.89±0.90)分,t=1.198,P=0.278;(1.62±1.55)分,(1.64±1.48)分,t=3.465,P=0.067;(2.00±1.26)分,(2.27±1.32)分,t=3.480,P=0.066)。时间因素与分组因素不存在交互效应(F=0.108,P=0.668)。③患膝肿胀视觉模拟评分。不同时间点间患膝肿胀视觉模拟评分的差异有统计学意义(F=79.974,P=0.000)。2组患者患膝肿胀视觉模拟评分的组间差异总体上无统计学意义(F=1.741,P=0.192)。治疗前、治疗4周后及治疗结束后3个月,2组患膝肿胀视觉模拟评分比较,组间差异均无统计学意义[(3.31±0.61)分,(3.43±0.86)分,t=1.014,P=0.207;(1.73±1.06)分,(1.78±1.00)分,t=3.451,P=0.069;(1.91±0.72)分,(1.93±1.24)分,t=0.715,P=0.401]。时间因素与分组因素不存在交互效应(F=0.907,P=0.345)。④患膝日常活动能力视觉模拟评分。不同时间点间患膝日常活动能力视觉模拟评分的差异有统计学意义(F=106.148,P=0.000)。2组患者患膝日常活动能力视觉模拟评分的组间差异总体上有统计学意义(F=5.080,P=0.024)。治疗前2组患膝日常活动能力视觉模拟评分比较,差异无统计学意义[(5.38±2.78)分,(5.64±2.22)分,t=3.306,P=0.155]; 治疗4周后及治疗结束后3个月,2组患膝日常活动能力视觉模拟评分比较,组间差异均有统计学意义[(1.16±3.80)分,(1.41±2.57)分,t=3.900,P=0.044;(1.20±2.63)分,(1.53±3.09)分,t=4.210,P=0.044]。时间因素与分组因素存在交互效应(F=5.355,P=0.024)。⑤总体疗效。治疗4周后,治疗组临床痊愈3例、显效16例、有效27例、无效9例; 对照组临床痊愈2例、显效12例、有效29例、无效10例。治疗组的总体疗效与对照组比较,差异无统计学意义(Z=-0.839,P=0.401)。⑥不良反应。治疗4周后,2组患者均未出现肝肾功能异常及胃肠道反应。结论:采用口服抗骨质增生合剂治疗膝骨关节炎,总体疗效和安全性与口服抗骨增生胶囊相当; 但在缓解膝关节疼痛和改善患者日常活动能力方面,疗效优于口服抗骨增生胶囊,值得临床推广应用。
Abstract:
Objective:To observe the clinical curative effect and safety of oral application of anti-hyperosteogeny mixture in the treatment of knee osteoarthritis(KOA).Methods:One hundred and eight patients with KOA were randomly divided into treatment group(55 cases)and control group(53 cases).Patients in the treatment group were treated with oral anti-hyperosteogeny mixtures,while the others in the control group were treated with oral anti-hyperosteogeny capsules.The knee pain,stiffness,swelling and daily activity were evaluated by using the visual analogue scale(VAS)and compared between the 2 groups before treatment,after 4-week treatment and 3 months after the end of the treatment respectively,and the total curative effect and safety were also evaluated and compared between the 2 groups after 4-week treatment.Results:There was statistical difference in the knee pain VAS scores between different time points(F=103.401,P=0.000).In general,there was statistical difference in the knee pain VAS scores between the 2 groups(F=21.067,P=0.000).There was no statistical difference in the knee pain VAS scores between the 2 groups before treatment(4.43+/-0.77 vs 4.33+/-0.44 points,t=0.033,P=0.856).There was statistical difference in the knee pain VAS scores between the 2 groups after 4-week treatment and 3 months after the end of the treatment(1.24+/-4.50 vs 1.88+/-3.60 points,t=3.818,P=0.045; 1.37+/-1.09 vs 2.03+/-0.93 points,t=3.961,P=0.045).There was interaction between time factor and grouping factor(F=9.595,P=0.003).There was statistical difference in the knee stiffness VAS scores between different time points(F=127.565,P=0.000).In general,there was no statistical difference in the knee stiffness VAS scores between the 2 groups(F=2.643,P=0.109).There was no statistical difference in the knee stiffness VAS scores between the 2 groups before treatment,after 4-week treatment and 3 months after the end of the treatment(4.58+/-0.86 vs 4.89+/-0.90 points,t=1.198,P=0.278; 1.62+/-1.55 vs 1.64+/-1.48 points,t=3.465,P=0.067; 2.00+/-1.26 vs 2.27+/-1.32 points,t=3.480,P=0.066).There was no interaction between time factor and grouping factor(F=0.108,P=0.668).There was statistical difference in the knee swelling VAS scores between different time points(F=79.974,P=0.000).In general,there was no statistical difference in the knee swelling VAS scores between the 2 groups(F=1.741,P=0.192).There was no statistical difference in the knee swelling VAS scores between the 2 groups before treatment,after 4-week treatment and 3 months after the end of the treatment(3.31+/-0.61 vs 3.43+/-0.86 points,t=1.014,P=0.207; 1.73+/-1.06 vs 1.78+/-1.00 points,t=3.451,P=0.069; 1.91+/-0.72 vs 1.93+/-1.24 points,t=0.715,P=0.401).There was no interaction between time factor and grouping factor(F=0.907,P=0.345).There was statistical difference in the knee daily activity VAS scores between different time points(F=106.148,P=0.000).In general,there was statistical difference in the knee daily activity VAS scores between the 2 groups(F=5.080,P=0.024).There was no statistical difference in the knee daily activity VAS scores between the 2 groups before treatment(5.38+/-2.78 vs 5.64+/-2.22 points,t=3.306,P=0.155).There was statistical difference in the knee daily activity VAS scores between the 2 groups after 4-week treatment and 3 months after the end of the treatment(1.16+/-3.80 vs 1.41+/-2.57 points,t=3.900,P=0.044; 1.20+/-2.63 vs 1.53+/-3.09 points,t=4.210,P=0.044).There was interaction between time factor and grouping factor(F=5.355,P=0.024).After 4-week treatment,three patients were cured,16 good,27 fair and 9 poor in the treatment group; while 2 patients were cured,12 good result,29 fair and 10 poor in the control group.There was no statistical difference in the total curative effect between the 2 groups(Z=-0.839,P=0.401).No gastrointestinal adverse reaction and hepatorenal disfunction were found in the 2 groups after 4-week treatment.Conclusion:Oral application of anti-hyperosetogeny mixture is similar to oral application of anti-hyperosteogeny capsule in the total curative effect and safety in the treatment of KOA,while the former surpasses the latter in relieving knee pain and improving daily activity,so it is worthy of popularizing in clinic.

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备注/Memo

备注/Memo:
基金项目:“中医骨伤科学”国家重点学科项目(100508),上海市海派中医流派“石氏伤科”传承研究基地项目(ZYSNXD-CC-HPGC-JD-001),上海市卫生局中药新药及院内制剂研发项目(20112J012),上海市中医药领军人才建设项目(2012-63-15),上海领军人才项目(041)
更新日期/Last Update: 2014-07-28