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[1]陳鵬,郭文韜,龍美兵,等.退癀消腫湯聯(lián)合洛索洛芬鈉片治療急性痛風(fēng)性關(guān)節(jié)炎的臨床研究[J].中醫(yī)正骨,2016,28(08):19-23.
　CHEN Peng,GUO Wentao,LONG Meibing,et al.Clinical study on Tuihuang Xiaozhong Tang(退癀消腫湯)combined with loxoprofen sodium tablets for treatment of acute gouty arthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2016,28(08):19-23.
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退癀消腫湯聯(lián)合洛索洛芬鈉片治療急性痛風(fēng)性關(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28卷
期數(shù):
2016年08期
頁碼:
19-23
欄目:
臨床研究
出版日期:
2016-08-20

文章信息/Info

Title:
Clinical study on Tuihuang Xiaozhong Tang(退癀消腫湯)combined with loxoprofen sodium tablets for treatment of acute gouty arthritis
作者:
陳鵬; 郭文韜; 龍美兵; 李楠
福建中醫(yī)藥大學(xué),福建 福州 350122
Author(s):
CHEN Peng; GUO Wentao; LONG Meibing; LI Nan
Fujian University of Traditional Chinese Medicine,Fuzhou 350122,Fujian,China
關(guān)鍵詞:
關(guān)節(jié)炎; 痛風(fēng)性;  退癀消腫湯;  秋水仙堿;  洛索洛芬鈉;  臨床試驗(yàn)
Keywords:
arthritis; gouty;  Tuihuang Xiaozhong Tang;  colchicine;  loxoprofen sodium;  clinical trial
摘要:
目的:觀察退癀消腫湯聯(lián)合洛索洛芬鈉片治療急性痛風(fēng)性關(guān)節(jié)炎的臨床療效和安全性。方法:將60例急性痛風(fēng)性關(guān)節(jié)炎患者隨機(jī)分為2組,每組30例,分別采用口服退癀消腫湯聯(lián)合洛索洛芬鈉片、口服秋水仙堿片聯(lián)合洛索洛芬鈉片治療。退癀消腫湯每袋200 mL,每日早、晚餐后30 min服用1袋; 洛索洛芬鈉片每次60 mg,每日2次,飯后服用; 秋水仙堿片每日服用3次,開始負(fù)荷劑量為1.0 mg,1 h后服用0.5 mg,12 h后服用0.5 mg; 上述藥物連續(xù)服用2周。分別于治療前和治療結(jié)束后2周比較2組患者白細(xì)胞介素(interleukin-1,IL-1)、IL-6及腫瘤壞死因子-α(tumor necrosis factor-α,TNF-α)的血清含量,并于治療結(jié)束后2周比較2組患者的臨床療效及并發(fā)癥發(fā)生情況。結(jié)果:①炎性因子血清含量。治療前2組患者IL-1、IL-6、TNF-α血清含量比較,組間差異均無統(tǒng)計(jì)學(xué)意義[(50.33±6.26)μg·g-1,(51.12±8.32)μg·g-1,t=-0.614,P=0.094;(43.27±7.14)μg·g-1,(41.35±8.27)μg·g-1,t=1.775,P=0.081;(55.23±9.71)pg·mL-1,(56.31±6.76)pg·mL-1,t=-0.587,P=0.075]。治療結(jié)束后2周,退癀消腫湯聯(lián)合洛索洛芬鈉片組IL-1血清含量與秋水仙堿片聯(lián)合洛索洛芬鈉片組比較,差異無統(tǒng)計(jì)意義[(34.28±4.57)μg·g-1,(35.16±6.73)μg·g-1,t=-0.701,P=0.176]; 退癀消腫湯聯(lián)合洛索洛芬鈉片組IL-6、TNF-α血清含量均低于秋水仙堿片聯(lián)合洛索洛芬鈉片組[(24.25±3.36)μg·g-1,(30.21±3.13)μg·g-1,t=-11.619,P=0.000;(41.16±5.39)pg·mL-1,(47.57±2.31)pg·mL-1,t=-8.741,P=0.000]; 2組患者IL-1、IL-6、TNF-α血清含量均低于治療前(t=56.716,P=0.000; t=28.734,P=0.000; t=25.524,P=0.000; t=12.062,P=0.000; t=23.538,P=0.000; t=18.330,P=0.000)。②臨床療效。治療結(jié)束后2周,參照《中醫(yī)病證診斷療效標(biāo)準(zhǔn)》中痛風(fēng)的療效評定標(biāo)準(zhǔn),退癀消腫湯聯(lián)合洛索洛芬鈉片組痊愈18例、顯效6例、有效4例、無效2例,秋水仙堿片聯(lián)合洛索洛芬鈉片組痊愈10例、顯效8例、有效6例、無效6例; 退癀消腫湯聯(lián)合洛索洛芬鈉片組的臨床療效優(yōu)于秋水仙堿片聯(lián)合洛索洛芬鈉片組(Z=-2.176,P=0.030)。③安全性。退癀消腫湯聯(lián)合洛索洛芬鈉片組1例患者出現(xiàn)胃腸道反應(yīng); 秋水仙堿片聯(lián)合洛索洛芬鈉片組16例患者出現(xiàn)胃腸道反應(yīng),1例患者血常規(guī)異常,1例患者肝功能異常,1例患者腎功能異常。退癀消腫湯聯(lián)合洛索洛芬鈉片組不良反應(yīng)發(fā)生率低于秋水仙堿片聯(lián)合洛索洛芬鈉片組(χ2=24.300,P=0.000)。結(jié)論:退癀消腫湯聯(lián)合洛索洛芬鈉片治療急性痛風(fēng)性關(guān)節(jié)炎,可以減輕關(guān)節(jié)炎癥,緩解關(guān)節(jié)紅腫和疼痛,不良反應(yīng)輕微,其療效和安全性優(yōu)于秋水仙堿片聯(lián)合洛索洛芬鈉片,值得臨床推廣應(yīng)用。
Abstract:
Objective:To observe the clinical curative effects and safety of Tuihuang Xiaozhong Tang(退癀消腫湯,THXZT)combined with loxoprofen sodium tablets for treatment of acute gouty arthritis.Methods:Sixty patients with acute gouty arthritis were enrolled in the study and were randomly divided into 2 groups,30 cases in each group.The patients were treated with oral application of THXZT and loxoprofen sodium tablets(group A)and oral application of colchicine tablets and loxoprofen sodium tablets(group B)respectively.The THXZT were taken at a dose of 200 mL at 30 minutes after breakfast and dinner respectively.The loxoprofen sodium tablets were taken at a dose of 60 mg after the meal,twice a day.The colchicine tablets were taken 3 times a day at a dose of 1.0 mg(initial loading dose),0.5 mg(1 hour later)and 0.5 mg(12 hours later)respectively.All of the drugs were taken for consecutive 2 weeks.The serum contents of interleukin-1(IL-1),IL-6 and tumor necrosis factor-α(TNF-α)were detected and compared between the 2 groups before treatment and at 2 weeksafter the end of the treatment respectively,and the clinical effects and complication rates were compared between the 2 groups at 2 weeks after the end of the treatment.Results:There was no statistical difference in the serum contents of IL-1,IL-6 and TNF-α between the 2 groups before treatment(50.33+/-6.26 vs 51.12+/-8.32 μg/g,t=-0.614,P=0.094; 43.27+/-7.14 vs 41.35+/-8.27 μg/g,t=1.775,P=0.081; 55.23+/-9.71 vs 56.31+/-6.76 pg/mL,t=-0.587,P=0.075).At 2 weeks after the end of the treatment,there was no statistical difference in the serum contents of IL-1 between group A and group B(34.28+/-4.57 vs 35.16+/-6.73 μg/g,t=-0.701,P=0.176)and the serum contents of IL-6 and TNF-α were lower in group A compared to group B(24.25+/-3.36 vs 30.21+/-3.13 μg/g,t=-11.619,P=0.000; 41.16+/-5.39 vs 47.57+/-2.31 pg/mL,t=-8.741,P=0.000).The serum contents of IL-1,IL-6 and TNF-α were lower in both of the 2 groups after treatment compared to pre-treatment(t=56.716,P=0.000; t=28.734,P=0.000; t=25.524,P=0.000; t=12.062,P=0.000; t=23.538,P=0.000; t=18.330,P=0.000).According to the therapeutic effects evaluation standard of gout which was extracted from Standard for diagnosis and therapeutic effectiveness evaluation of traditional Chinese medicine syndromes,18 patients were cured,6 good,4 fair and 2 poor in group A; while 10 patients were cured,8 good,6 fair and 6 poor in group B at 2 weeks after the end of the treatment.The group A surpassed the group B in the clinical curative effect(Z=-2.176,P=0.030).The gastrointestinal adverse reaction(1 case)was found in group A,while the gastrointestinal adverse reaction(16 cases),abnormal blood routine(1 case),hepatic dysfunction(1 case)and renal dysfunction(1 case)were found in group B.The incidence rate of adverse reactions was lower in group A compared to group B(χ2=24.300,P=0.000).Conclusion:Oral application of THXZT combined with loxoprofen sodium tablets can reduce joint inflammation and relieve joint swelling and pain with little adverse effects in treatment of acute gouty arthritis,and its curative effect is better than that of oral application of colchicine tablets combined with loxoprofen sodium tablets,so it is worthy of popularizing in clinic.

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備注/Memo

備注/Memo:
基金項(xiàng)目:福建中醫(yī)藥大學(xué)校管科研課題項(xiàng)目(X2015003-平臺) 通訊作者:李楠 E-mail:[email protected]
更新日期/Last Update: 1900-01-01