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[1]鄭昱新,葛繼榮,劉文剛,等.痛寧凝膠外用治療輕中度膝骨關(guān)節(jié)炎腎虛筋脈瘀滯證的隨機(jī)、雙盲、安慰劑對(duì)照、多中心臨床研究[J].中醫(yī)正骨,2022,34(06):17-24.
　ZHENG Yuxin,GE Jirong,LIU Wengang,et al.External application of Tongning(痛寧)gel for treatment of mild-to-moderate knee osteoarthritis with syndromes of kidney deficiency and tendon-vessel stasis:a randomized,double-blind,placebo-controlled,multicenter clinical study[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2022,34(06):17-24.
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痛寧凝膠外用治療輕中度膝骨關(guān)節(jié)炎腎虛筋脈瘀滯證的隨機(jī)、雙盲、安慰劑對(duì)照、多中心臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第34卷
期數(shù):
2022年06期
頁(yè)碼:
17-24
欄目:
臨床研究
出版日期:
2022-06-20

文章信息/Info

Title:
External application of Tongning(痛寧)gel for treatment of mild-to-moderate knee osteoarthritis with syndromes of kidney deficiency and tendon-vessel stasis:a randomized,double-blind,placebo-controlled,multicenter clinical study
作者:
鄭昱新; 葛繼榮; 劉文剛; 楊俊興; 何承建; 盧敏; 沈霖; 尹宏; 陳永強(qiáng); 李智斌10; 孫慶; 謝利民; 詹紅生
(1.上海中醫(yī)藥大學(xué)附屬曙光醫(yī)院,上海 201203; 2.福建省中醫(yī)藥研究院,福建 福州 350003; 3.廣東省第二中醫(yī)院,廣東 廣州 510095; 4.廣州中醫(yī)藥大學(xué)第一附屬醫(yī)院,廣東 廣州 510405; 5.湖北省中醫(yī)院,湖北 武漢 430061; 6.湖南中醫(yī)藥大學(xué)第一附屬醫(yī)院,湖南 長(zhǎng)沙 410007; 7.華中科技大學(xué)同濟(jì)醫(yī)學(xué)院附屬協(xié)和醫(yī)院,湖北 武漢 430022; 8.南京市中醫(yī)院,江蘇 南京 210022; 9.上海市中醫(yī)醫(yī)院,上海 200071; 10.陜西中醫(yī)藥大學(xué)附屬醫(yī)院,陜西 咸陽(yáng) 712000; 11.天津中醫(yī)藥大學(xué)第一附屬醫(yī)院,天津 300193; 12.中國(guó)中醫(yī)科學(xué)院廣安門醫(yī)院,北京 100053)
Author(s):
ZHENG Yuxin; GE Jirong; LIU Wengang; YANG Junxing; HE Chengjian; LU Min; SHEN Lin; YIN Hong; CHEN Yongqiang; LI Zhibin; SUN Qing; XIE Limin; ZHAN Hongsheng
關(guān)鍵詞:
骨關(guān)節(jié)炎; 膝;  痛寧凝膠;  臨床試驗(yàn)
Keywords:
osteoarthritis; knee;  Tongning gel;  clinical trial
摘要:
目的:評(píng)價(jià)痛寧凝膠外用治療輕中度膝骨關(guān)節(jié)炎腎虛筋脈瘀滯證的臨床療效和安全性。方法:采用隨機(jī)、雙盲、安慰劑對(duì)照、多中心臨床試驗(yàn),共納入576例輕中度膝骨關(guān)節(jié)炎腎虛筋脈瘀滯證患者,痛寧凝膠組432例、安慰劑組144例。痛寧凝膠組于膝關(guān)節(jié)疼痛處外涂痛寧凝膠,安慰劑組于膝關(guān)節(jié)疼痛處外涂痛寧凝膠模擬劑; 2組均每日2次外涂皮膚,每次3 g,療程3周。分別于治療前及治療開始后1周、2周、3周記錄并比較2組患者的西安大略和麥克馬斯特大學(xué)骨關(guān)節(jié)炎指數(shù)(Western Ontario and McMaster Universities osteoarthritis index,WOMAC)疼痛評(píng)分、僵硬評(píng)分、日常活動(dòng)功能評(píng)分及總評(píng)分,于治療開始后3周比較2組患者的綜合療效,觀察并比較2組患者并發(fā)癥發(fā)生情況。結(jié)果:①受試者退出情況。痛寧凝膠組1例患者因未按要求治療而退出。②WOMAC疼痛評(píng)分。時(shí)間因素和分組因素存在交互效應(yīng)(F=166.662,P=0.000); 2組患者WOMAC疼痛評(píng)分總體比較,差異有統(tǒng)計(jì)學(xué)意義,即存在分組效應(yīng)(F=148.461,P=0.000); 治療前后不同時(shí)間點(diǎn)之間WOMAC疼痛評(píng)分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=3.823,P=0.022); 2組患者WOMAC疼痛評(píng)分隨時(shí)間延長(zhǎng)均呈下降趨勢(shì),但2組的下降趨勢(shì)不完全一致[(36.72±12.97)分,(31.93±12.22)分,(26.49±11.50)分,(20.29±11.79)分,F=148.461,P=0.000;(35.47±13.38)分,(33.44±13.11)分,(32.63±13.79)分,(31.61±15.00)分,F=8.574,P=0.000]; 治療前及治療開始后1周,2組患者的WOMAC疼痛評(píng)分比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=0.994,P=0.322; t=1.262,P=0.207); 治療開始后2周、3周,痛寧凝膠組的WOMAC疼痛評(píng)分均低于安慰劑組(t=4.813,P=0.000; t=8.241,P=0.000)。③WOMAC僵硬評(píng)分。時(shí)間因素和分組因素存在交互效應(yīng)(F=80.764,P=0.000); 2組患者WOMAC僵硬評(píng)分總體比較,差異有統(tǒng)計(jì)學(xué)意義,即存在分組效應(yīng)(F=57.734,P=0.000); 治療前后不同時(shí)間點(diǎn)之間WOMAC僵硬評(píng)分的差異無(wú)統(tǒng)計(jì)學(xué)意義,即不存在時(shí)間效應(yīng)(F=1.920,P=0.148); 治療前及治療開始后1周,2組患者的WOMAC僵硬評(píng)分比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義[(23.93±15.76)分,(23.38±16.24)分,t=0.362,P=0.717;(21.22±14.74)分,(22.00±15.93)分,t=0.530,P=0.594]; 治療開始后2周、3周,痛寧凝膠組的WOMAC僵硬評(píng)分低于安慰劑組[(17.50±13.20)分,(20.95±15.75)分,t=2.374,P=0.019;(13.84±11.85)分,(20.21±15.87)分,t=5.103,P=0.000)。④WOMAC日常活動(dòng)功能評(píng)分。時(shí)間因素和分組因素存在交互效應(yīng)(F=159.442,P=0.000); 2組患者WOMAC日常活動(dòng)功能評(píng)分總體比較,差異有統(tǒng)計(jì)學(xué)意義,即存在分組效應(yīng)(F=145.611,P=0.000); 治療前后不同時(shí)間點(diǎn)之間WOMAC日常活動(dòng)功能評(píng)分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=7.790,P=0.000); 2組患者WOMAC日常活動(dòng)功能評(píng)分隨時(shí)間延長(zhǎng)均呈下降趨勢(shì),但2組的下降趨勢(shì)不完全一致[(34.11±11.51)分,(29.71±11.04)分,(24.42±10.37)分,(19.36±10.80)分,F=145.611,P=0.000;(32.65±11.94)分,(30.77±11.90)分,(29.66±12.46)分,(28.64±13.38)分,F=8.764,P=0.000]; 治療前及治療開始后1周,2組患者的WOMAC日常活動(dòng)功能評(píng)分比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=1.310,P=0.191; t=0.983,P=0.328); 治療開始后2周、3周,痛寧凝膠組的WOMAC日常活動(dòng)功能評(píng)分均低于安慰劑組(t=4.554,P=0.000; t=7.542,P=0.000)。⑤WOMAC總評(píng)分。時(shí)間因素和分組因素存在交互效應(yīng)(F=177.900,P=0.000); 2組患者WOMAC總評(píng)分總體比較,差異有統(tǒng)計(jì)學(xué)意義,即存在分組效應(yīng)(F=150.622,P=0.000); 治療前后不同時(shí)間點(diǎn)之間WOMAC總評(píng)分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=6.861,P=0.001); 2組患者WOMAC總評(píng)分隨時(shí)間延長(zhǎng)均呈下降趨勢(shì),但2組的下降趨勢(shì)不完全一致[(33.81±11.34)分,(29.47±10.88)分,(24.27±10.26)分,(19.09±10.61)分,F=150.622,P=0.000;(32.46±11.72)分,(30.60±11.66)分,(29.55±12.23)分,(28.55±13.16)分,F=8.694,P=0.000]; 治療前及治療開始后1周,2組患者的WOMAC總評(píng)分比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=1.224,P=0.223; t=1.063,P=0.289); 治療開始后2周、3周,痛寧凝膠組的WOMAC總評(píng)分均低于安慰劑組(t=4.662,P=0.000; t=7.820,P=0.000)。⑥綜合療效。治療開始后3周,痛寧凝膠組臨床控制29例、顯效66例、有效248例、無(wú)效88例,安慰劑組臨床控制2例、顯效6例、有效14例、無(wú)效122例; 痛寧凝膠組的綜合療效優(yōu)于安慰劑組(Z=12.310,P=0.000)。⑦依從性和安全性。除痛寧凝膠組1例患者退出外,其余患者依從性均較好,均按照醫(yī)囑完成治療。痛寧凝膠組1例出現(xiàn)轉(zhuǎn)氨酶輕度升高,1例出現(xiàn)局部皮膚輕度過(guò)敏; 安慰劑組4例出現(xiàn)局部皮膚輕度過(guò)敏; 均未做特殊處理,停藥后轉(zhuǎn)氨酶恢復(fù)正常,皮膚過(guò)敏自行消退。2組患者并發(fā)癥發(fā)生率比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(χ2=3.593,P=0.058)。結(jié)論:痛寧凝膠外用能減輕輕中度膝骨關(guān)節(jié)炎腎虛筋脈瘀滯證患者的膝關(guān)節(jié)疼痛和僵硬,改善患膝功能,且安全性較高。
Abstract:
Objective:To evaluate the clinical outcomes and safety of external application of Tongning(痛寧,TN)gel for treatment of mild-to-moderate knee osteoarthritis(KOA)with syndromes of kidney deficiency and tendon-vessel stasis.Methods:Five hundred and seventy-six mild-to-moderate KOA patients with kidney deficiency and tendon-vessel stasis syndromes were enrolled in the randomized,double-blind,placebo-controlled,multicenter clinical trial,432 cases in TN gel group and 144 cases in placebo group.The patients in TN gel group were treated with external application of TN gel at the pain spots of affected knee,while the ones in placebo group with external application of TN gel mimetic agent at the pain spots of affected knee.All patients in the 2 groups were treated twice a day,3 g at a time for consecutive 3 weeks.The Western Ontario and McMaster Universities osteoarthritis index(WOMAC)pain score,stiffness score,activity of daily living(ADL)function score and total score were recorded and compared between the 2 groups before the treatment and at 1,2 and 3 weeks after the beginning of the treatment respectively.Furthermore,the total outcomes were compared between the 2 groups at 3 weeks after the beginning of the treatment,and the complications were observed and compared between the 2 groups.Results:①One patient in TN gel group dropped out of the study for failing to be treated as required.②There was interaction between time factor and group factor in WOMAC pain score(F=166.662,P=0.000).There was statistical difference in WOMAC pain scores between the 2 groups in general,in other words,there was group effect(F=148.461,P=0.000).There was statistical difference in WOMAC pain scores between different timepoints before and after the treatment,in other words,there was time effect(F=3.823,P=0.022).The WOMAC pain scores presented a downward trend over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(36.72±12.97,31.93±12.22,26.49±11.50,20.29±11.79 points,F=148.461,P=0.000; 35.47±13.38,33.44±13.11,32.63±13.79,31.61±15.00 points,F=8.574,P=0.000).There was no statistical difference in WOMAC pain scores between the 2 groups before the treatment and at 1 week after the beginning of the treatment(t=0.994,P=0.322; t=1.262,P=0.207),however,at 2 and 3 weeks after the beginning of the treatment,the WOMAC pain scores were lower in TN gel group compared to placebo group(t=4.813,P=0.000; t=8.241,P=0.000).③There was interaction between time factor and group factor in WOMAC stiffness score(F=80.764,P=0.000).There was statistical difference in WOMAC stiffness scores between the 2 groups in general,in other words,there was group effect(F=57.734,P=0.000).There was no statistical difference in WOMAC stiffness scores between different timepoints before and after the treatment,in other words,there was no time effect(F=1.920,P=0.148).There was no statistical difference in WOMAC stiffness scores between the 2 groups before the treatment and at 1 week after the beginning of the treatment(23.93±15.76 vs 23.38±16.24 points,t=0.362,P=0.717; 21.22±14.74 vs 22.00±15.93 points,t=0.530,P=0.594),however,at 2 and 3 weeks after the beginning of the treatment,the WOMAC stiffness scores were lower in TN gel group compared to placebo group(17.50±13.20 vs 20.95±15.75 points,t=2.374,P=0.019; 13.84±11.85 vs 20.21±15.87 points,t=5.103,P=0.000).④There was interaction between time factor and group factor in WOMAC ADL function score(F=159.442,P=0.000).There was statistical difference in WOMAC ADL function scores between the 2 groups in general,in other words,there was group effect(F=145.611,P=0.000).There was statistical difference in WOMAC ADL function scores between different timepoints before and after the treatment,in other words,there was time effect(F=7.790,P=0.000).The WOMAC ADL function scores presented a downward trend over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(34.11±11.51,29.71±11.04,24.42±10.37,19.36±10.80 points,F=145.611,P=0.000; 32.65±11.94,30.77±11.90,29.66±12.46,28.64±13.38 points,F=8.764,P=0.000).There was no statistical difference in WOMAC ADL function scores between the 2 groups before the treatment and at 1 week after the beginning of the treatment(t=1.310,P=0.191; t=0.983,P=0.328),however,at 2 and 3 weeks after the beginning of the treatment,the WOMAC ADL function scores were lower in TN gel group compared to placebo group(t=4.554,P=0.000; t=7.542,P=0.000).⑤There was interaction between time factor and group factor in WOMAC total score(F=177.900,P=0.000).There was statistical difference in WOMAC total scores between the 2 groups in general,in other words,there was group effect(F=150.622,P=0.000).There was statistical difference in WOMAC total scores between different timepoints before and after the treatment,in other words,there was time effect(F=6.861,P=0.001).The WOMAC total scores presented a downward trend over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(33.81±11.34,29.47±10.88,24.27±10.26,19.09±10.61 points,F=150.622,P=0.000; 32.46±11.72,30.60±11.66,29.55±12.23,28.55±13.16 points,F=8.694,P=0.000).There was no statistical difference in WOMAC total scores between the 2 groups before the treatment and at 1 week after the beginning of the treatment(t=1.224,P=0.223; t=1.063,P=0.289),however,at 2 and 3 weeks after the beginning of the treatment,the WOMAC total scores were lower in TN gel group compared to placebo group(t=4.662,P=0.000; t=7.820,P=0.000).⑥At 3 weeks after the beginning of the treatment,29 patients were controlled,66 good,248 fair and 88 poor in TN gel group; while 2 patients were controlled,6 good,14 fair and 122 poor in placebo group.The TN gel group surpassed placebo group in the total outcomes(Z=12.310,P=0.000).⑦All patients showed good compliance and finished the treatment as required except for 1 patient in TN gel group dropping out of the study.The mildly elevated transaminase(1 case)and mild local skin allergy(1 case)were found in TN gel group,while mild local skin allergy(4 cases)was found in placebo group.The transaminase returned to normal and the skin allergy subsided spontaneously after stopping the medication without any special treatment.There was no statistical difference in complication incidences between the 2 groups(χ2=3.593,P=0.058).Conclusion:External application of TN gel can relieve knee pain and stiffness and improve knee function in mild-to-moderate KOA patients with syndromes of kidney deficiency and tendon-vessel stasis,and it has high safety.

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(收稿日期:2020-05-19 本文編輯:時(shí)紅磊)

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通訊作者:詹紅生 E-mail:[email protected]
更新日期/Last Update: 1900-01-01