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[1]丁立,高寧陽,鄭昱新,等.復(fù)方紫荊消傷巴布膏治療慢性軟組織損傷的多中心臨床研究[J].中醫(yī)正骨,2020,32(03):21-25.
　DING Li,GAO Ningyang,ZHENG Yuxin,et al.A multicenter clinical study of Fufang Zijing Xiaoshang Babugao(復(fù)方紫荊消傷巴布膏)for treatment of chronic soft tissue injuries[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2020,32(03):21-25.
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復(fù)方紫荊消傷巴布膏治療慢性軟組織損傷的多中心臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第32卷
期數(shù):
2020年03期
頁碼:
21-25
欄目:
臨床研究
出版日期:
2020-03-20

文章信息/Info

Title:
A multicenter clinical study of Fufang Zijing Xiaoshang Babugao(復(fù)方紫荊消傷巴布膏)for treatment of chronic soft tissue injuries
作者:
丁立1; 高寧陽2; 鄭昱新2; 杜炯2; 詹紅生2
(1.上海市光華中西醫(yī)結(jié)合醫(yī)院,上海 200052; 2.上海中醫(yī)藥大學(xué)附屬曙光醫(yī)院,上海 201203)
Author(s):
DING Li1; GAO Ningyang2; ZHENG Yuxin2; DU Jiong2; ZHAN Hongsheng2
1.Shanghai Guanghua Combinational Hospital of Traditional Chinese Medicine and Western Medicine,Shanghai 200052,China 2.Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China
關(guān)鍵詞:
軟組織損傷;  復(fù)方紫荊消傷巴布膏;  臨床試驗(yàn)
Keywords:
soft tissue injuries;  compound Zijing Xiaoshang poultice;  clinical trial
摘要:
目的:觀察復(fù)方紫荊消傷巴布膏治療慢性軟組織損傷的臨床療效和安全性。方法:采用區(qū)組隨機(jī)、雙盲、陽性藥及安慰劑平行對(duì)照、多中心(10家醫(yī)院)臨床試驗(yàn)設(shè)計(jì)。試驗(yàn)設(shè)置復(fù)方紫荊消傷巴布膏組、骨通貼膏組和安慰劑組共3組,按照3:1:1的比例納入患者分別采用復(fù)方紫荊消傷巴布膏、骨通貼膏及復(fù)方紫荊消傷巴布膏模擬劑治療。治療時(shí)將貼膏貼于患處,每天1貼,連續(xù)使用14 d。試驗(yàn)期間緊急用藥選用布洛芬緩釋膠囊。選取治療開始后7 d和14 d兩個(gè)時(shí)間點(diǎn)進(jìn)行療效評(píng)價(jià)。療效評(píng)價(jià)指標(biāo)選擇疼痛視覺模擬量表(visual analogue scale,VAS)評(píng)分降低值和以中醫(yī)證候療效標(biāo)準(zhǔn)評(píng)定的有效率。同時(shí)觀察治療期間不良事件的發(fā)生情況。結(jié)果:①一般情況。共納入221例患者,其中復(fù)方紫荊消傷巴布膏組133例、骨通貼膏組44例、安慰劑組44例。至試驗(yàn)結(jié)束時(shí),復(fù)方紫荊消傷巴布膏組和安慰劑組分別有2例和4例因失訪脫落。②疼痛VAS評(píng)分降低值。復(fù)方紫荊消傷巴布膏組和骨通貼膏組治療開始后7 d時(shí)的疼痛VAS評(píng)分降低值比較,差異無統(tǒng)計(jì)學(xué)意義(協(xié)變量:F=33.010,P=0.000; 區(qū)組因素:F=8.790,P=0.000; 分組因素:F=0.900,P=0.345; 協(xié)變量與分組因素交互作用:F=0.470,P=0.894; 修正均數(shù):試驗(yàn)組2.30分,陽性對(duì)照組2.13分)。復(fù)方紫荊消傷巴布膏組和骨通貼膏組治療開始后14 d時(shí)的疼痛VAS評(píng)分降低值比較,差異無統(tǒng)計(jì)學(xué)意義(協(xié)變量:F=43.000,P=0.000; 區(qū)組因素:F=40.480,P=0.000; 分組因素:F=0.290,P=0.591; 協(xié)變量與分組因素交互作用:F=0.230,P=0.990; 修正均數(shù):試驗(yàn)組4.08分,陽性對(duì)照組4.02分)。復(fù)方紫荊消傷巴布膏組和安慰劑組治療開始后 7 d 時(shí)的疼痛VAS評(píng)分降低值比較,差異無統(tǒng)計(jì)學(xué)意義(協(xié)變量:F=18.120,P=0.000; 區(qū)組因素:F=9.040,P=0.000; 分組因素:F=0.620,P=0.434; 協(xié)變量與分組因素交互作用:F=1.040,P=0.411; 修正均數(shù):試驗(yàn)組2.25分,陽性對(duì)照組2.04分)。復(fù)方紫荊消傷巴布膏組治療開始后14 d時(shí)的疼痛VAS評(píng)分降低值高于安慰劑組(協(xié)變量:F=39.200,P=0.000; 區(qū)組因素:F=40.890,P=0.000; 分組因素:F=11.210,P=0.001; 協(xié)變量與分組因素交互作用:F=4.300,P=0.000; 修正均數(shù):試驗(yàn)組4.00分,陽性對(duì)照組3.27分)。③中醫(yī)證候療效。治療開始后7 d時(shí),3組患者的有效率比較,差異無統(tǒng)計(jì)學(xué)意義(χ2=5.867,P=1.000)。治療開始后14 d時(shí),3組患者的有效率比較,差異有統(tǒng)計(jì)學(xué)意義(P=0.022); 復(fù)方紫荊消傷巴布膏組和骨通貼膏組的有效率比較,差異無統(tǒng)計(jì)學(xué)意義(χ2=0.000,P=1.000); 復(fù)方紫荊消傷巴布膏組和骨通貼膏組的有效率均高于安慰劑組(χ2=6.375,P=0.012; χ2=4.208,P=0.004)。④不良事件發(fā)生率。共有4例患者發(fā)生不良事件4件,其中復(fù)方紫荊消傷巴布膏組1例發(fā)生貧血、1例發(fā)生口腔潰瘍,骨通貼膏組1例發(fā)生貧血,安慰劑組1例出現(xiàn)局部皮膚瘙癢。4例患者發(fā)生的不良事件均被判定為輕度,均未采取治療措施,均無后遺癥。3組患者的不良事件發(fā)生率比較,差異無統(tǒng)計(jì)學(xué)意義(P=1.000)。結(jié)論:復(fù)方紫荊消傷巴布膏可有效改善慢性軟組織損傷患者的臨床癥狀,療效與骨通貼膏相當(dāng),且安全性較高。
Abstract:
Objective:To observe the clinical curative effects and safety of Fufang Zijing Xiaoshang Babugao(復(fù)方紫荊消傷巴布膏,FFZJXSBBG)for treatment of chronic soft tissue injuries.Methods:A block randomized,double-blind,positive- and placebo-controlled,parallel-group,multicenter clinical trial was conducted by 10 hospitals.The patients included in the trial were divided into 3 groups with a ratio of 3:1:1 and were treated with FFZJXSBBG,Gutong(骨通,GT)plaster and FFZJXSBBG simulant respectively.The plaster were applied to the wounded parts once a day for consecutive 14 days.Ibuprofen sustained-release capsules were used as the emergency drug during the trial.The curative effects were evaluated at 7 and 14 days after the beginning of the treatment,and the decreased values of pain visual analogue scale(VAS)scores and effective rate that evaluated according to TCM symptom therapeutic effect standard were selected as the therapeutic effect evaluation indexes.The adverse reactions were observed during the treatment period.Results:Two hundred and twenty-one patients were included in the study,133 patients in FFZJXSBBG group,44 patients in GT plaster group and 44 patients in placebo group.By the end of the trial,2 patients in FFZJXSBBG group and 4 patients in placebo group lost to follow-up and dropped out of the trial.There was no statistical difference in decreased values of pain VAS scores between FFZJXSBBG group and GT plaster group at 7 days after the beginning of the treatment(Covariant:F=33.010,P=0.000; Block factor:F=8.790,P=0.000; Group factor:F=0.900,P=0.345; Interaction between covariant and group factor:F=0.470,P=0.894; Adjusted mean:2.30 points(experimental group),2.13 points(positive control group)).There was no statistical difference in decreased values of pain VAS scores between FFZJXSBBG group and GT plaster group at 14 days after the beginning of the treatment(Covariant:F=43.000,P=0.000; Block factor:F=40.480,P=0.000; Group factor:F=0.290,P=0.591; Interaction between covariant and group factor:F=0.230,P=0.990; Adjusted mean:4.08 points(experimental group),4.02 points(positive control group)).There was no statistical difference in decreased values of pain VAS scores between FFZJXSBBG group and placebo group at 7 days after the beginning of the treatment(Covariant:F=18.120,P=0.000; Block factor:F=9.040,P=0.000; Group factor:F=0.620,P=0.434; Interaction between covariant and group factor:F=1.040,P=0.411; Adjusted mean:2.25 points(experimental group),2.04 points(positive control group)).The decreased values of pain VAS scores were greater in FFZJXSBBG group compared to placebo group at 14 days after the beginning of the treatment(Covariant:F=39.200,P=0.000; Block factor:F=40.890,P=0.000; Group factor:F=11.210,P=0.001; Interaction between covariant and group factor:F=4.300,P=0.000; Adjusted mean:4.00 points(experimental group),3.27 points(positive control group)).There was no statistical difference in effective rate between the 3 groups at 7 days after the beginning of the treatment(χ2=5.867,P=1.000).There was statistical difference in effective rate between the 3 groups at 14 days after the beginning of the treatment(P=0.022).There was no statistical difference in effective rate between FFZJXSBBG group and GT plaster group(χ2=0.000,P=1.000).The effective rate was higher in FFZJXSBBG group and GT plaster group compared to placebo group(χ2=6.375,P=0.012; χ2=4.208,P=0.004).Anemia was found in 1 patient in FFZJXSBBG group and 1 patient in GT plaster group,oral ulcer was found in 1 patient in FFZJXSBBG group and local cutaneous pruritus was found in 1 patient in placebo group.The adverse reactions in the 4 patients belonged to mild-grade,and no special treatment were performed and no sequelae were found.There was no statistical difference in the incidence rate of adverse reactions between the 3 groups(P=1.000).Conclusion:FFZJXSBBG can effectively improve the clinical symptoms of patients with chronic soft tissue injuries,and it is similar to GT plaster in the curative effect,moreover,it has high safty.

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(收稿日期:2019-06-10 本文編輯:李曉樂) 通訊作者:高寧陽 E-mail:[email protected]
更新日期/Last Update: 2020-03-10