[1]陈鹏,郭文韬,龙美兵,等.退癀消肿汤联合洛索洛芬钠片治疗急性痛风性关节炎的临床研究[J].中医正骨,2016,28(08):19-23.
　CHEN Peng,GUO Wentao,LONG Meibing,et al.Clinical study on Tuihuang Xiaozhong Tang(退癀消肿汤)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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退癀消肿汤联合洛索洛芬钠片治疗急性痛风性关节炎的临床研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第28卷
期数:
2016年08期
页码:
19-23
栏目:
临床研究
出版日期:
2016-08-20

文章信息/Info

Title:
Clinical study on Tuihuang Xiaozhong Tang(退癀消肿汤)combined with loxoprofen sodium tablets for treatment of acute gouty arthritis
作者:
陈鹏; 郭文韬; 龙美兵; 李楠
福建中医药大学,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
关键词:
关节炎; 痛风性;  退癀消肿汤;  秋水仙碱;  洛索洛芬钠;  临床试验
Keywords:
arthritis; gouty;  Tuihuang Xiaozhong Tang;  colchicine;  loxoprofen sodium;  clinical trial
摘要:
目的:观察退癀消肿汤联合洛索洛芬钠片治疗急性痛风性关节炎的临床疗效和安全性。方法:将60例急性痛风性关节炎患者随机分为2组,每组30例,分别采用口服退癀消肿汤联合洛索洛芬钠片、口服秋水仙碱片联合洛索洛芬钠片治疗。退癀消肿汤每袋200 mL,每日早、晚餐后30 min服用1袋; 洛索洛芬钠片每次60 mg,每日2次,饭后服用; 秋水仙碱片每日服用3次,开始负荷剂量为1.0 mg,1 h后服用0.5 mg,12 h后服用0.5 mg; 上述药物连续服用2周。分别于治疗前和治疗结束后2周比较2组患者白细胞介素(interleukin-1,IL-1)、IL-6及肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)的血清含量,并于治疗结束后2周比较2组患者的临床疗效及并发症发生情况。结果:①炎性因子血清含量。治疗前2组患者IL-1、IL-6、TNF-α血清含量比较,组间差异均无统计学意义[(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]。治疗结束后2周,退癀消肿汤联合洛索洛芬钠片组IL-1血清含量与秋水仙碱片联合洛索洛芬钠片组比较,差异无统计意义[(34.28±4.57)μg·g-1,(35.16±6.73)μg·g-1,t=-0.701,P=0.176]; 退癀消肿汤联合洛索洛芬钠片组IL-6、TNF-α血清含量均低于秋水仙碱片联合洛索洛芬钠片组[(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组患者IL-1、IL-6、TNF-α血清含量均低于治疗前(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临床疗效。治疗结束后2周,参照《中医病证诊断疗效标准》中痛风的疗效评定标准,退癀消肿汤联合洛索洛芬钠片组痊愈18例、显效6例、有效4例、无效2例,秋水仙碱片联合洛索洛芬钠片组痊愈10例、显效8例、有效6例、无效6例; 退癀消肿汤联合洛索洛芬钠片组的临床疗效优于秋水仙碱片联合洛索洛芬钠片组(Z=-2.176,P=0.030)。③安全性。退癀消肿汤联合洛索洛芬钠片组1例患者出现胃肠道反应; 秋水仙碱片联合洛索洛芬钠片组16例患者出现胃肠道反应,1例患者血常规异常,1例患者肝功能异常,1例患者肾功能异常。退癀消肿汤联合洛索洛芬钠片组不良反应发生率低于秋水仙碱片联合洛索洛芬钠片组(χ2=24.300,P=0.000)。结论:退癀消肿汤联合洛索洛芬钠片治疗急性痛风性关节炎,可以减轻关节炎症,缓解关节红肿和疼痛,不良反应轻微,其疗效和安全性优于秋水仙碱片联合洛索洛芬钠片,值得临床推广应用。
Abstract:
Objective:To observe the clinical curative effects and safety of Tuihuang Xiaozhong Tang(退癀消肿汤,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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备注/Memo

备注/Memo:
基金项目:福建中医药大学校管科研课题项目(X2015003-平台) 通讯作者:李楠 E-mail:569116779@qq.com
更新日期/Last Update: 1900-01-01