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[1]王海生,顧新豐,劉婷,等.口服參蝎止痛膠囊治療膝骨關(guān)節(jié)炎的臨床研究[J].中醫(yī)正骨,2015,27(03):22-26.
 WANG Haisheng,GU Xinfeng,LIU Ting,et al.A clinical study on oral application of Shenxie Zhitong(參蝎止痛)capsule for treatment of knee osteoarthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(03):22-26.
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口服參蝎止痛膠囊治療膝骨關(guān)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27卷
期數(shù):
2015年03期
頁(yè)碼:
22-26
欄目:
臨床研究
出版日期:
2015-03-30

文章信息/Info

Title:
A clinical study on oral application of Shenxie Zhitong(參蝎止痛)capsule for treatment of knee osteoarthritis
作者:
王海生顧新豐劉婷何杰王學(xué)宗曹月龍鄭昱新詹紅生
上海中醫(yī)藥大學(xué)附屬曙光醫(yī)院,上海 201203
Author(s):
WANG HaishengGU XinfengLIU TingHE JieWANG XuezongCAO YuelongZHENG YuxinZHAN Hongsheng
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China
關(guān)鍵詞:
骨關(guān)節(jié)炎 中藥療法 治療臨床研究性
Keywords:
osteoarthritisknee drug therapy(TCD) therapiesinvestigational
摘要:
目的:觀察口服參蝎止痛膠囊治療膝骨關(guān)節(jié)炎的臨床療效和安全性。方法:將120例膝骨關(guān)節(jié)炎患者按2:1:1的比例隨機(jī)分為3組,分別采用口服參蝎止痛膠囊、抗骨質(zhì)增生膠囊和參蝎止痛膠囊模擬劑治療。分別于治療前和治療3周后,記錄并比較3組患者膝關(guān)節(jié)西安大略和麥克馬斯特大學(xué)(Western Ontario and McMaster Universities,WOMAC)量表總積分及疼痛、僵硬、功能障礙積分,并比較3組患者不良反應(yīng)發(fā)生情況。結(jié)果:治療3周后,8例患者脫落。治療前3組患者膝關(guān)節(jié)WOMAC量表總積分[(1044.43±76.04)分,(1014.93±83.13)分,(1034.03±74.10)分]、疼痛積分[(220.12 ±21.21)分,(213.87 ±22.59)分,(216.17 ±19.83)分]、僵硬積分[(66.77±10.31)分,(63.90±9.72)分,(63.67±9.46)分]及功能障礙積分[(757.55±52.43)分,(737.71±58.83)分,(754.20±52.74)分]比較,差異均無(wú)統(tǒng)計(jì)學(xué)意義(F=1.453,P=0.238; F=0.953,P=0.388; F=1.450,P=0.243; F=1.462,P=0.236)。治療3周后3組患者膝關(guān)節(jié)WOMAC量表總積分[(763.02±85.42)分,(751.21±118.58)分,(964.08±70.15)分]、疼痛積分[(162.18±23.31)分,(176.54±23.62)分,(200.48±18.34)分]、僵硬積分[(43.49±8.72)分,(44.54±13.74)分,(60.93±9.66)分]及功能障礙積分[(524.00±87.48)分,(557.35±59.71)分,(699.85±51.39)分]比較,差異均有統(tǒng)計(jì)學(xué)意義(F=52.310,P=0.000; F=27.108,P=0.000; F=27.756,P=0.000; F=57.788,P=0.000)。進(jìn)一步兩兩比較,參蝎止痛膠囊組WOMAC量表總積分和僵硬積分與抗骨質(zhì)增生膠囊組比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義(P=0.393,P=0.664); 參蝎止痛膠囊組疼痛積分及功能障礙積分均低于抗骨質(zhì)增生膠囊組(P=0.006,P=0.031); 參蝎止痛膠囊組和抗骨質(zhì)增生膠囊組的WOMAC量表總積分、疼痛積分、僵硬積分和功能障礙積分均低于參蝎止痛膠囊模擬劑組(P=0.000,P=0.000; P=0.000,P=0.000; P=0.000,P=0.000; P=0.000,P=0.000)。3組患者不良反應(yīng)發(fā)生率比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(χ2=0.386,P=1.000)。結(jié)論:采用口服參蝎止痛膠囊和抗骨質(zhì)增生膠囊治療膝骨關(guān)節(jié)炎,均能改善膝關(guān)節(jié)功能,緩解膝關(guān)節(jié)疼痛和僵硬,不良反應(yīng)小; 但在改善膝關(guān)節(jié)疼痛及功能障礙方面,參蝎止痛膠囊優(yōu)于抗骨質(zhì)增生膠囊,值得臨床推廣應(yīng)用。
Abstract:
Objective:To observe the clinical curative effect and safety of oral application of Shenxie Zhitong(參蝎止痛)capsule in the treatment of knee osteoarthritis(KOA).Methods:One hundred and twenty patients with KOA were randomly divided into 3 groups with a ratio of 2:1:1,and were treated with oral application of Shenxie Zhitong capsules,anti-hyperosteogeny capsules and mimetic Shenxie Zhitong capsules respectively.The total scores,pain scores,stiffness scores and dysfunction scores were assessed by using Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)scale and compared between the 3 groups before the treatment and after 3-week treatment,and the incidence rate of adverse reactions was also recorded.Results:Eight patients fell off after 3-week treatment.There was no statistical difference in WOMAC aggregate scores(1044.43+/-76.04,1014.93+/-83.13,1034.03+/-74.10 points),pain scores(220.12 +/-21.21,213.87 +/-22.59,216.17 +/-19.83 points),stiffness scores(66.77+/-10.31,63.90+/-9.72,63.67+/-9.46 points)and dysfunction scores(757.55+/-52.43,737.71+/-58.83,754.20+/-52.74 points)between the 3 groups before the treatment(F=1.453,P=0.238; F=0.953,P=0.388; F=1.450,P=0.243; F=1.462,P=0.236).There was statistical difference in WOMAC aggregate scores(763.02+/-85.42,751.21+/-118.58,964.08+/-70.15 points),pain scores(162.18+/-23.31,176.54+/-23.62, 200.48+/-18.34 points),stiffness scores(43.49+/-8.72,44.54+/-13.74,60.93+/-9.66 points)and dysfunction scores(524.00+/-87.48,557.35+/-59.71,699.85+/-51.39 points)between the 3 groups after 3-week treatment(F=52.310,P=0.000; F=27.108,P=0.000; F=27.756,P=0.000; F=57.788,P=0.000).Further pairwise comparison showed that there was no statistical difference in WOMAC aggregate scores and dysfunction scores between Shenxie Zhitong capsules group and anti-hyperosteogeny capsules group(P=0.393,P=0.664).The pain scores and dysfunction scores were lower in Shenxie Zhitong capsules group compared with anti-hyperosteogeny capsules group(P=0.006,P=0.031).The WOMAC aggregate scores,pain scores,stiffness scores and dysfunction scores were lower in Shenxie Zhitong capsules group and anti-hyperosteogeny capsules group compared with mimetic Shenxie Zhitong capsule group(P=0.000,P=0.000; P=0.000,P=0.000; P=0.000,P=0.000; P=0.000,P=0.000).There was no statistical difference in the incidence rate of adverse reactions between the 3 groups(χ2=0.386,P=1.000).Conclusion:Oral application of either Shenxie Zhitong capsules or anti-hyperosteogeny capsules can improve the knee function and relieve knee pain and stiffness with less adverse reactions in the treatment of KOA.However,the former surpasses the latter in improving knee pain and dysfunction,so it is worthy of popularizing in clinic.

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備注/Memo

備注/Memo:
2014-11-13收稿 2014-12-18修回
基金項(xiàng)目:國(guó)家自然科學(xué)基金(81373665,81302988,81173277); 上海市教育委員會(huì)科研創(chuàng)新項(xiàng)目(11YZ64,12YZ064); “海派中醫(yī)流派傳承研究基地”項(xiàng)目(ZYSNXD-CC-HPGC-JD-001); 上海領(lǐng)軍人才(041); 上海市科委重點(diǎn)科技攻關(guān)項(xiàng)目及科技支撐項(xiàng)目(11DZ1972902,13411950500,13401902502)
通訊作者:鄭昱新 E-mail:sg_zyx1728@126.com
更新日期/Last Update: 2015-03-30