«上一篇/Previous Article|本期目錄/Table of Contents|下一篇/Next Article»

[1]鄭昱新,詹紅生,莫文,等.滑膜炎顆粒治療膝關(guān)節(jié)滑膜炎濕熱阻絡(luò)證的隨機(jī)、雙盲、安慰劑對照、多中心臨床研究[J].中醫(yī)正骨,2015,27(12):29-36.
　ZHENG Yuxin,ZHAN Hongsheng,MO Wen,et al.A randomized,double-blind,placebo-controlled,multicenter,clinical trial of Huamoyan Keli(滑膜炎顆粒)for treatment of gonarthromeningitis with DAMPNESS-HEAT BLOCK COLLATERALS syndrome[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(12):29-36.
點(diǎn)擊復(fù)制

滑膜炎顆粒治療膝關(guān)節(jié)滑膜炎濕熱阻絡(luò)證的隨機(jī)、雙盲、安慰劑對照、多中心臨床研究()

分享到：

《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:: 第27卷
期數(shù):: 2015年12期

頁碼:: 29-36

欄目:: 臨床研究

出版日期:: 2015-12-30

文章信息/Info

Title:: A randomized,double-blind,placebo-controlled,multicenter,clinical trial of Huamoyan Keli(滑膜炎顆粒)for treatment of gonarthromeningitis with DAMPNESS-HEAT BLOCK COLLATERALS syndrome

作者:: 鄭昱新¹; 詹紅生¹; 莫文²; 聞輝³; 董忠⁴; 郭艷幸⁵; 林定坤⁶; 李慧英⁷; 湯敏予⁸; 趙建⁹; 1.上海中醫(yī)藥大學(xué)附屬曙光醫(yī)院,上海 201203;
2.上海中醫(yī)藥大學(xué)附屬龍華醫(yī)院,上海 200032;
3.長春中醫(yī)藥大學(xué)附屬醫(yī)院,吉林長春 130021;
4.福建省中醫(yī)藥研究院, 福建福州 350003;
5.河南省洛陽正骨醫(yī)院/河南省骨科醫(yī)院,河南洛陽 471002;
6.廣東省中醫(yī)院,廣東廣州 510120;
7.河南中醫(yī)學(xué)院第一附屬醫(yī)院,河南鄭州 450000;
8.江西中醫(yī)藥大學(xué)附屬醫(yī)院,江西南昌 330006;
9.河北省中醫(yī)院,河北石家莊 050011

Author(s):: ZHENG Yuxin¹; ZHAN Hongsheng¹; MO Wen²; WEN Hui³; DONG Zhong⁴; GUO Yanxing⁵; LIN Dingkun⁶; LI Huiying⁷; TANG Minyu⁸; ZHAO Jian⁹; 1.Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China
2.Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China
3.The Affiliated Hospital to Changchun University of Chinese Medicine,Changchun 130021,Jilin,China
4.Fujian Academy of Chinese Medicine,Fuzhou 350003,Fujian,China
5.Luoyang Orthopedic-Traumatological Hospital,Luoyang 471002,Henan,China
6.Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou 510120,Guangdong,China
7.The First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Zhengzhou 450000,Henan,China
8.The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine,Nanchang 330006,Jiangxi,China
9.Hebei Provincial Hospital of Traditional Chinese Medicine,Shijiazhuang 050011,Hebei,China

關(guān)鍵詞:: 滑膜炎; 膝關(guān)節(jié); 滑膜炎顆粒; 臨床試驗(yàn)

Keywords:: synovitis; knee joint; Huamoyan Keli; clinical trial

摘要:: 目的:評價(jià)滑膜炎顆粒治療膝關(guān)節(jié)滑膜炎濕熱阻絡(luò)證的療效和安全性。方法:采用隨機(jī)、雙盲、安慰劑對照、多中心的臨床試驗(yàn)方法,共納入480例膝關(guān)節(jié)滑膜炎濕熱阻絡(luò)證患者,滑膜炎顆粒組360例(急性120例,慢性240例),安慰劑組120例(急性40例,慢性80例)。滑膜炎顆粒組口服滑膜炎顆粒,安慰劑組口服安慰劑,2組患者均戴護(hù)膝作為基礎(chǔ)治療,同時(shí)將對乙酰氨基酚片作為疼痛應(yīng)急用藥。滑膜炎顆粒和安慰劑均為每次12 g,每日3次,急性膝關(guān)節(jié)滑膜炎患者治療4周,慢性膝關(guān)節(jié)滑膜炎患者治療8周。評價(jià)患者的膝關(guān)節(jié)腫脹改善情況、西安大略和麥克馬斯特大學(xué)(Western Ontario and McMaster Universities,WOMAC)骨關(guān)節(jié)炎指數(shù)、中醫(yī)證候療效、對乙酰氨基酚片應(yīng)用率、依從性及不良反應(yīng)發(fā)生情況。結(jié)果:2組患者依從性均較好,滑膜炎顆粒組脫落14例,安慰劑組脫落2例,其余患者均按照醫(yī)囑完成治療。滑膜炎顆粒組2例慢性滑膜炎患者發(fā)生不良反應(yīng),其中1例出現(xiàn)輕度上腹部不適,未采取措施繼續(xù)試驗(yàn); 1例出現(xiàn)輕度腹瀉,停用藥物并退出試驗(yàn)。急性膝關(guān)節(jié)滑膜炎患者治療2、4周后,滑膜炎顆粒組的膝關(guān)節(jié)腫脹改善情況均優(yōu)于安慰劑組(2周:R^-_{滑膜炎顆粒組}=73.85,R^-_安慰劑組=100.46,Z=-3.549,P=0.000; 4周:R^-_{滑膜炎顆粒組}=73.68,R^-_安慰劑組=109.95,Z=-5.000,P=0.000); 中醫(yī)證候療效也均優(yōu)于安慰劑組(2周:R^-_{滑膜炎顆粒組}=75.93,R^-_安慰劑組=92.11,Z=-2.291,P=0.022; 4周:R^-_{滑膜炎顆粒組}=69.21,R^-_安慰劑組=107.64,Z=-4.859,P=0.000)。治療前2組急性膝關(guān)節(jié)滑膜炎患者的WOMAC評分比較,差異無統(tǒng)計(jì)學(xué)意義(Z=0.272,P=0.790); 治療2、4周后滑膜炎顆粒組患者的WOMAC評分均低于安慰劑組(Z=4.089,P=0.000; Z=4.722,P=0.000)。急性膝關(guān)節(jié)滑膜炎患者在治療的4周內(nèi),滑膜炎顆粒組8例服用對乙酰氨基酚片,安慰劑組7例服用對乙酰氨基酚片。2組患者對乙酰氨基酚片應(yīng)用率比較,差異無統(tǒng)計(jì)學(xué)意義(P=0.058)。慢性膝關(guān)節(jié)滑膜炎患者治療2、4、8周后,滑膜炎顆粒組的膝關(guān)節(jié)腫脹改善情況均優(yōu)于安慰劑組(2周:R^-_{滑膜炎顆粒組}=156.65,R^-_安慰劑組=172.04,Z=-2.382,P=0.017; 4周:R^-_{滑膜炎顆粒組}=149.54,R^-_安慰劑組=193.38,Z=-4.244,P=0.000; 8周:R^-_{滑膜炎顆粒組}=143.30,R^-_安慰劑組=212.09,Z=-6.166,P=0.000); 中醫(yī)證候療效也均優(yōu)于安慰劑組(2周:R^-_{滑膜炎顆粒組}=150.69,R^-_安慰劑組=165.55,Z=-2.656,P=0.008; 4周:R^-_{滑膜炎顆粒組}=141.55,R^-_安慰劑組=192.03,Z=-4.964,P=0.000; 8周:R^-_{滑膜炎顆粒組}=133.90,R^-_安慰劑組=213.02,Z=-7.197,P=0.000)。治療前2組慢性膝關(guān)節(jié)滑膜炎患者的WOMAC評分比較,差異無統(tǒng)計(jì)學(xué)意義(Z=0.377,P=0.702); 治療2、4、8周后滑膜炎顆粒組患者的WOMAC評分均低于安慰劑組(Z=2.886,P=0.004; Z=5.182,P=0.000; Z=6.613,P=0.000)。慢性膝關(guān)節(jié)滑膜炎患者在治療的8周內(nèi),滑膜炎顆粒組1例服用對乙酰氨基酚片,安慰劑組2例服用對乙酰氨基酚片。2組患者的對乙酰氨基酚片的應(yīng)用率比較,差異無統(tǒng)計(jì)學(xué)意義(P=0.155)。結(jié)論:滑膜炎顆粒能夠減輕急性和慢性膝關(guān)節(jié)滑膜炎濕熱阻絡(luò)證患者的膝關(guān)節(jié)腫脹和疼痛,改善關(guān)節(jié)功能,而且具有較高的安全性。

Abstract:: Objective:To evaluate the clinical curative effects and safety of Huamoyan Keli(滑膜炎顆粒,HMYKL)in the treatment of gonarthromeningitis with DAMPNESS-HEAT BLOCK COLLATERALS syndrome.Methods:Four hundred and eighty patients with type DAMPNESS-HEAT BLOCK COLLATERALS gonarthromeningitis were recruited in a randomized,double-blind,placebo-controlled,multicenter,clinical trial.The patients were divided into HMYKL group(360 cases:120 acute cases and 240 chronic cases)and placebo group(120 cases:40 acute cases and 80 chronic cases)and were treated with oral application of HMYKL and placebo respectively(12 g at a time,three times a day).Meanwhile,all the patients were administered with kneepad and the acetaminophen tablets were used for emergency treatment of knee pain.The course of treatment was 4 weeks for acute cases and 8 weeks for chronic cases.Improvements in knee swelling,Western Ontario and McMaster Universities(WOMAC)osteoarthritis index,curative effect on TCM SYMPTOM COMPLEX,utility rate of acetaminophen tablets,compliance rates and incidence rate of adverse reactions were evaluated and compared between the 2 groups.Results:The compliance of patients was good in the 2 groups.Fourteen patients dropped out in HMYKL group and 2 patients dropped out in placebo group and the treatment were finished in other patients on the advice of doctor.Adverse reactions including mild epigastric discomfort and mild diarrhoea were found in 2 chronic cases in HMYKL group and one of them dropped out.The HMYKL group surpassed the placebo group in the improvements in knee swelling of patients with acute gonarthromeningitis after 2- and 4-week treatment(2 weeks:R^-_{HMYKL group}=73.85,R^-_{placebo group}=100.46,Z=-3.549,P=0.000; 4 weeks:R^-_{HMYKL group}=73.68,R^-_{placebo group}=109.95,Z=-5.000,P=0.000),and also the same to the curative effect on TCM SYMPTOM COMPLEX(2 weeks:R^-_{HMYKL group}=75.93,R^-_{placebo group}=92.11,Z=-2.291,P=0.022; 4 weeks:R^-_{HMYKL group}=69.21,R^-_{placebo group}=107.64,Z=-4.859,P=0.000).There was no statistical difference in the WOMAC scores between the 2 groups of acute cases before the treatment(Z=0.272,P=0.790).The WOMAC scores were lower in HMYKL group compared to placebo group after 2- and 4-week treatment(Z=4.089,P=0.000; Z=4.722,P=0.000).The acetaminophen tablets were used in 8 acute cases in HMYKL group and 7 acute cases in placebo group during the 4 -week treatment.There was no statistical difference in the utility rate of acetaminophen tablets between the 2 groups(P=0.058).The HMYKL group surpassed the placebo group in the improvements in knee swelling of patients with chronic gonarthromeningitis after 2-,4- and 8-week treatment(2 weeks:R^-_{HMYKL group}=156.65,R^-_{placebo group}=172.04,Z=-2.382,P=0.017; 4 weeks:R^-_{HMYKL group}=149.54,R^-_{placebo group}=193.38,Z=-4.244,P=0.000; 8 weeks:R^-_{HMYKL group}=143.30,R^-_{placebo group}=212.09,Z=-6.166,P=0.000),and also the same to the curative effect on TCM SYMPTOM COMPLEX(2 weeks:R^-_{HMYKL group}=150.69,R^-_{placebo group}=165.55,Z=-2.656,P=0.008; 4 weeks:R^-_{HMYKL group}=141.55,R^-_{placebo group}=192.03,Z=-4.964,P=0.000; 8 weeks:R^-_{HMYKL group}=133.90,R^-_{placebo group}=213.02,Z=-7.197,P=0.000).There was no statistical difference in the WOMAC scores between the 2 groups of chronic cases before the treatment(Z=0.377,P=0.702).The WOMAC scores were lower in HMYKL group compared to placebo group after 2-,4- and 8-week treatment(Z=2.886,P=0.004; Z=5.182,P=0.000; Z=6.613,P=0.000).The acetaminophen tablets were used in 1 chronic case in HMYKL group and 2 chronic cases in placebo group during the 8-week treatment.There was no statistical difference in the utility rate of acetaminophen tablets between the 2 groups(P=0.155).Conclusion:For patients with acute and chronic gonarthromeningitis with DAMPNESS-HEAT BLOCK COLLATERALS syndrome,HMYKL can relieve swelling and pain of the knee and improve the knee function,meanwhile it has high safety.

參考文獻(xiàn)/References:

[1] Akmese R,Yildiz KI,Isik C,et al.Combined arthroscopic synovectomy and radiosynoviorthesis in the treatment of chronic non-specific synovitis of the knee[J].Arch Orthop Trauma Surg,2013,133(11):1567-1573.
[2] 王戰(zhàn)朝,杜志謙,閆永昌,等.通經(jīng)活利湯治療膝關(guān)節(jié)滑膜炎的臨床研究[J].中醫(yī)正骨,2012,24(4):26-29.
[3] 陳百成,王飛,孫然,等.滑膜炎顆粒治療急、慢性膝關(guān)節(jié)滑膜炎的臨床療效觀察[J].中國骨與關(guān)節(jié)外科,2014,7(3):226-230.
[4] Yusup A,Kaneko H,Liu L,et al.Bone marrow lesions, subchondral bone cysts and subchondral bone attrition are associated with histological synovitis in patients with end-stage knee osteoarthritis:a cross-sectional study[J].Osteoarthritis Cartilage,2015,23(11):1858-1864.
[5] 李永剛,李栗,劉芳,等.滑膜炎顆粒治療膝關(guān)節(jié)滑膜炎的療效觀察[J].臨床合理用藥雜志,2012,5(13):100.
[6] 中華醫(yī)學(xué)會.臨床診療指南:骨科分冊[M].北京:人民衛(wèi)生出版社,2009:82.
[7] 王和鳴.骨科學(xué)[M].北京:北京科學(xué)技術(shù)出版社,2007:654-657.
[8] 韋貴康,施杞.實(shí)用中醫(yī)骨傷科學(xué)[M].上海:上海科學(xué)技術(shù)出版社,2006:634-635.
[9] 國家中醫(yī)藥管理局.中醫(yī)病證診斷療效標(biāo)準(zhǔn)[M].南京:南京大學(xué)出版社,1994:197.
[10] 陳樹清,孫保國,周厚明,等.活血利水中藥聯(lián)合復(fù)方南星止痛膏治療慢性膝關(guān)節(jié)滑膜炎的病例對照研究[J].中國骨傷,2012,25(4):283-286.
[11] Case R,Thomas E,Clarke E,et al. Prodromal symptoms in knee osteoarthritis:a nested case-control study using data from the Osteoarthritis Initiative[J].Osteoarthritis Cartilage,2015,23(7):1083-1089.
[12] 劉悅,宋少江,徐綏緒.夏枯草的化學(xué)成分及生物活性研究進(jìn)展[J].沈陽藥科大學(xué)學(xué)報(bào),2003,20(1):55-59.
[13] Li S,Zhao J,Liu Y,et al.New triterpenoid saponins from Ilex cornuta and their protective effects against H2O2-induced myocardial cell injury[J].J Agric Food Chem,2014,62(2):488-496.
[14] 劉雨晴,梁婧,楊梓晨,等.薏苡仁的藥理作用研究進(jìn)展[J].安徽農(nóng)業(yè)科學(xué),2010,38(20):10678.
[15] 張超,吳素香,樓招歡,等.豨薟草化學(xué)成分、藥理作用及臨床應(yīng)用研究進(jìn)展[J].安徽醫(yī)藥,2011,15(3):274-276.
[16] 曹永飛,賈鵬,王長海.滑膜炎顆粒口服聯(lián)合中藥外敷治療急性創(chuàng)傷性膝關(guān)節(jié)滑膜炎臨床研究[J].中國中醫(yī)急癥,2015,24(3):413-414.
[17] 林詩富,潘富文,王啟琪,等.膝骨性關(guān)節(jié)炎關(guān)節(jié)鏡清理手術(shù)后輔以滑膜炎顆粒治療的臨床觀察[J].中國現(xiàn)代藥物應(yīng)用,2015,9(17):3-4.
[18] 董艷.滑膜炎顆粒治療膝關(guān)節(jié)創(chuàng)傷性滑膜炎49例[J].中國藥業(yè),2004,13(9):70-71.

相似文獻(xiàn)/References:

[1]鄧偉哲,王宏晶,王宇恒,等.微創(chuàng)針刀鏡治療難治性膝關(guān)節(jié)類風(fēng)濕關(guān)節(jié)炎[J].中醫(yī)正骨,2015,27(11):42.
[2]李楠,李鋒.脛骨平臺骨折的手術(shù)治療進(jìn)展[J].中醫(yī)正骨,2015,27(12):78.
[3]陳利軍,田野,劉文剛,等.非典型膝關(guān)節(jié)外傷后脛骨近端隱匿性骨折的影像診斷[J].中醫(yī)正骨,2015,27(06):26.
[4]湯金城,譚旭儀,成傳德.前外側(cè)切口可吸收螺釘內(nèi)固定治療Hoffa骨折[J].中醫(yī)正骨,2015,27(03):44.
[5]劉道兵,周宇,謝斌,等.關(guān)節(jié)鏡下滑膜切除術(shù)聯(lián)合中藥口服治療膝關(guān)節(jié)色素沉著絨毛結(jié)節(jié)性滑膜炎[J].中醫(yī)正骨,2013,25(09):34.
[6]張阿雷.關(guān)節(jié)囊外復(fù)位內(nèi)固定治療脛骨平臺骨折[J].中醫(yī)正骨,2016,28(01):54.
[7]李延紅,石耀武,張宏蕾.外敷滑膜膏配合口服四妙丸治療踝關(guān)節(jié)滑膜炎[J].中醫(yī)正骨,2016,28(01):68.
[8]路懷民,譚佳汶,劉蓓,等.運(yùn)動療法聯(lián)合中醫(yī)綜合療法治療早期創(chuàng)傷性半月板損傷[J].中醫(yī)正骨,2016,28(03):68.
[9]趙進(jìn)征,吳旭東,黃小剛,等.同種異體肌腱移植治療膝關(guān)節(jié)后外側(cè)角損傷[J].中醫(yī)正骨,2016,28(09):40.
[10]楊小廣,楊喬輝,劉長風(fēng),等.脛骨平臺骨折切開復(fù)位內(nèi)固定術(shù)后膝關(guān)節(jié)功能恢復(fù)的影響因素分析[J].中醫(yī)正骨,2016,28(10):11.
　YANG Xiaoguang,YANG Qiaohui,LIU Changfeng,et al.Analysis of factors influencing knee function recovery after open reduction and internal fixation for treatment of tibial plateau fractures[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2016,28(12):11.
[11]趙新杰,孫實(shí),武愛玲.中醫(yī)藥治療膝關(guān)節(jié)滑膜炎的研究進(jìn)展[J].中醫(yī)正骨,2015,27(08):65.
[12]徐武,程利華,張禮平,等.紫車散外敷聯(lián)合塞來昔布膠囊口服治療濕熱瘀閉型膝關(guān)節(jié)滑膜炎的臨床研究[J].中醫(yī)正骨,2017,29(10):30.
　XU Wu,CHENG Lihua,ZHANG Liping,et al.Clinical study on external application of Ziche San(紫車散)combined with oral application of celecoxib capsules for treatment of gonarthromeningitis with syndrome of BLOCKADE of DAMP-HEAT and STATIC BLOOD[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2017,29(12):30.
[13]赫軍,李冬冬,禹建春,等.口服狐惑蠲痹湯和西藥治療貝赫切特綜合征膝關(guān)節(jié)滑膜炎濕熱瘀阻證[J].中醫(yī)正骨,2019,31(03):51.
[14]彭德強(qiáng),林志東,鐘禮倫,等.全膝關(guān)節(jié)置換術(shù)與關(guān)節(jié)鏡下滑膜切除術(shù)治療晚期膝關(guān)節(jié)色素沉著絨毛結(jié)節(jié)性滑膜炎的Meta分析[J].中醫(yī)正骨,2022,34(01):50.
　PENG Deqiang,LIN Zhidong,ZHONG Lilun,et al.Comparison of total knee arthroplasty and arthroscopic synovectomy for treatment of terminal knee pigmented villonodular synovitis:a meta analysis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2022,34(12):50.

備注/Memo

備注/Memo:: 2015-04-08收稿 2015-11-04修回
通訊作者:詹紅生 E-mail:[email protected]

常用功能

工具/Tools

統(tǒng)計(jì)/Statistics

摘要瀏覽/Viewed2328
全文下載/Downloads699
評論/Comments

更新日期/Last Update: 2015-12-30

84年鼠女哪年财运最旺,857comvvv色九欧美激情|85PO_87国产精品欲av国产av资源