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[1]石瑛,龐堅,王翔,等.口服抗骨質增生合劑治療膝骨關節(jié)炎的臨床研究[J].中醫(yī)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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口服抗骨質增生合劑治療膝骨關節(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26卷
期數(shù):
2014年07期
頁碼:
8-12
欄目:
臨床研究
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; 龐堅; 王翔; 鄭昱新; 陳東煜; 石印玉; 詹紅生
上海中醫(yī)藥大學附屬曙光醫(yī)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
關鍵詞:
骨關節(jié)炎; 膝 抗骨質增生合劑 抗骨增生膠囊 治療; 臨床研究性
Keywords:
Osteoarthritis; knee;  Anti-hyperosteogeny mixture;  Anti-hyperosteogeny capsule;  Therapies; investigational
摘要:
目的:觀察口服抗骨質增生合劑治療膝骨關節(jié)炎的臨床療效及安全性。方法:將108例膝骨關節(jié)炎患者隨機分為治療組55例和對照組53例。治療組采用口服抗骨質增生合劑治療,對照組采用口服抗骨增生膠囊治療。分別于治療前、治療4周后、治療結束后3個月,采用視覺模擬評分量表評價2組患者的患膝疼痛、僵硬、腫脹情況及日常活動能力。并于治療4周后,評價2組患者的總體療效及安全性。結果:①患膝疼痛視覺模擬評分。不同時間點間患膝疼痛視覺模擬評分的差異有統(tǒng)計學意義(F=103.401,P=0.000)。2組患者患膝疼痛視覺模擬評分的組間差異總體上有統(tǒng)計學意義(F=21.067,P=0.000)。治療前2組患膝疼痛視覺模擬評分比較,差異無統(tǒng)計學意義[(4.43±0.77)分,(4.33±0.44)分,t=0.033,P=0.856]; 治療4周后及治療結束后3個月,2組患膝疼痛視覺模擬評分比較,差異均有統(tǒng)計學意義[(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)]。時間因素與分組因素存在交互效應(F=9.595,P=0.003)。②患膝僵硬視覺模擬評分。不同時間點間患膝僵硬視覺模擬評分的差異有統(tǒng)計學意義(F=127.565,P=0.000)。2組患者患膝僵硬視覺模擬評分的組間差異總體上無統(tǒng)計學意義(F=2.643,P=0.109)。治療前、治療4周后及治療結束后3個月,2組患膝僵硬視覺模擬評分比較,組間差異均無統(tǒng)計學意義[(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)。時間因素與分組因素不存在交互效應(F=0.108,P=0.668)。③患膝腫脹視覺模擬評分。不同時間點間患膝腫脹視覺模擬評分的差異有統(tǒng)計學意義(F=79.974,P=0.000)。2組患者患膝腫脹視覺模擬評分的組間差異總體上無統(tǒng)計學意義(F=1.741,P=0.192)。治療前、治療4周后及治療結束后3個月,2組患膝腫脹視覺模擬評分比較,組間差異均無統(tǒng)計學意義[(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]。時間因素與分組因素不存在交互效應(F=0.907,P=0.345)。④患膝日常活動能力視覺模擬評分。不同時間點間患膝日常活動能力視覺模擬評分的差異有統(tǒng)計學意義(F=106.148,P=0.000)。2組患者患膝日常活動能力視覺模擬評分的組間差異總體上有統(tǒng)計學意義(F=5.080,P=0.024)。治療前2組患膝日常活動能力視覺模擬評分比較,差異無統(tǒng)計學意義[(5.38±2.78)分,(5.64±2.22)分,t=3.306,P=0.155]; 治療4周后及治療結束后3個月,2組患膝日常活動能力視覺模擬評分比較,組間差異均有統(tǒng)計學意義[(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]。時間因素與分組因素存在交互效應(F=5.355,P=0.024)。⑤總體療效。治療4周后,治療組臨床痊愈3例、顯效16例、有效27例、無效9例; 對照組臨床痊愈2例、顯效12例、有效29例、無效10例。治療組的總體療效與對照組比較,差異無統(tǒng)計學意義(Z=-0.839,P=0.401)。⑥不良反應。治療4周后,2組患者均未出現(xiàn)肝腎功能異常及胃腸道反應。結論:采用口服抗骨質增生合劑治療膝骨關節(jié)炎,總體療效和安全性與口服抗骨增生膠囊相當; 但在緩解膝關節(jié)疼痛和改善患者日常活動能力方面,療效優(yōu)于口服抗骨增生膠囊,值得臨床推廣應用。
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.

參考文獻/References:

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備注/Memo

備注/Memo:
基金項目:“中醫(yī)骨傷科學”國家重點學科項目(100508),上海市海派中醫(yī)流派“石氏傷科”傳承研究基地項目(ZYSNXD-CC-HPGC-JD-001),上海市衛(wèi)生局中藥新藥及院內制劑研發(fā)項目(20112J012),上海市中醫(yī)藥領軍人才建設項目(2012-63-15),上海領軍人才項目(041)
更新日期/Last Update: 2014-07-28