[1]姬艳波,韩宏妮,陈立忠,等.208痛风合剂治疗痛风性关节炎的临床研究[J].中医正骨,2012,24(10):20-25.
　JI Yan-bo*,HAN Hong-ni,CHEN Li-zhong,et al.Clinical study on the curative effect and safety of 208 gout drug combinations in the treatment of gouty arthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2012,24(10):20-25.
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208痛风合剂治疗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24卷
期数:
2012年10期
页码:
20-25
栏目:
临床研究
出版日期:
2012-10-20

文章信息/Info

Title:
Clinical study on the curative effect and safety of 208 gout drug combinations in the treatment of gouty arthritis
作者:
姬艳波; 韩宏妮; 陈立忠; 王海燕
中国人民解放军第208医院,吉林 长春 130062
Author(s):
JI Yan-bo*; HAN Hong-ni; CHEN Li-zhong; WANG Hai-yan.
*The 208th Hospital of the Chinese People's Liberation Army,Changchun 130062,Jilin,China
关键词:
关节炎; 痛风性 高尿酸血症 治疗; 临床研究性 208痛风合剂
Keywords:
Arthritis; gouty;  Hyperuricemia;  Therapies; investigational;  208 gout drug combinations
摘要:
目的:观察208痛风合剂治疗痛风性关节炎的临床疗效和安全性。方法:132例痛风性关节炎患者,均为男性; 年龄45～60岁,中位数46.5岁; 病程3 d至5年,中位数3.5年。急性痛风性关节炎患者60例,中医辨证均为湿热蕴结证,随机分为2组,治疗组33例,208痛风合剂1号口服及外敷患处治疗; 对照组27例,口服秋水仙碱片及依托考昔片治疗; 两组均治疗7 d。慢性痛风性关节炎患者72例,中医辨证均为痰浊阻滞证,随机分为2组,治疗组37例,口服208痛风合剂2号治疗; 对照组35例,口服苯溴马隆片治疗; 两组均治疗20 d。治疗结束后观察各组患者疗效、不良反应发生率及各项化验指标改善情况。结果:急性痛风性关节炎患者治疗7 d后,治疗组治愈18例,显效13例,有效2例; 对照组治愈10例,显效14例,有效3例; 2组疗效比较差异无统计学意义(Z=-1.251,P=0.178)。治疗组未发生药物不良反应; 对照组出现腹泻2例,呕吐2例,皮疹2例; 2组不良反应发生率比较,差异有统计学意义(P=0.006)。治疗组患者血尿酸[(375.69±110.99)μmol·L-1]、C反应蛋白[(35.61±18.67)mg·L-1]、血沉[(23.12±15.83)mm·h-1]均较治疗前[(474.05±89.67)μmol·L-1、(60.46±13.99)mg·L-1、(39.67±16.46)mm·h-1]降低(t=6.256,P=0.000; t=6.119,P=0.000; t=4.163,P=0.001),尿液pH值(6.13±0.44)较治疗前(5.81±0.39)升高(t=3.126,P=0.004); 血肌酐[(98.62±17.37)μmol·L-1]、血尿素氮[(4.84±1.49)mmol·L-1]与治疗前[(99.13±11.81)μmol·L-1、(5.44±0.99)mmol·L-1]相比,差异无统计学意义(t=0.139,P=0.912; t=1.927,P=0.073)。对照组患者血尿酸[(380.41±116.78)μmol·L-1]、C反应蛋白[(37.16±19.11)mg·L-1]、血沉[(24.73±17.13)mm·h-1]均较治疗前[(469.85±90.21)μmol·L-1]、C反应蛋白[(61.06±12.14)mg·L-1]、血沉[(38.97±17.58)mm·h-1]降低(t=5.065,P=0.000; t=5.487,P=0.000; t=3.015,P=0.005); 血肌酐[(97.98±20.14)μmol·L-1]、血尿素氮[(4.95±1.62)mmol·L-1]、尿液pH值(6.02±0.51)与治疗前[(98.97±12.45)μmol·L-1、(5.29±1.12)mmol·L-1、(5.80±0.42)]相比,差异均无统计学意义(t=0.020,P=0.989; t=0.897,P=0.432; t=1.730,P=0.122)。2组间治疗后各项化验指标比较差异均无统计学意义(t=0.219,P=0.797; t=0.317,P=0.657; t=0.377,P=0.698; t=0.132,P=0.845; t=0.274,P=0.765; t=0.897,P=0.301)。慢性痛风性关节炎患者治疗20 d后,治疗组治愈17例,显效16例,有效3例,无效1例; 对照组治愈15例,显效17例,有效3例; 2组疗效比较,差异无统计学意义(Z=-0.119,P=0.903)。治疗组未发生不良反应; 对照组出现皮疹2例; 2组患者不良反应发生率比较,差异无统计学意义(P=0.233)。治疗组血尿酸[(385.60±128.35)μmol·L-1]、C反应蛋白[(20.75±14.97)mg·L-1]、血沉[(37.80±13.50)mm·h-1]、血尿素氮[(3.54±0.65)mmol·L-1]均较治疗前[(537.42±122.88)μmol·L-1、(32.67±10.78)mg·L-1、(52.13±10.18)mm·h-1、(4.44±1.32)mmol·L-1]降低,尿液pH值(6.15±0.45)较治疗前(5.79±0.42)升高,差异有统计学意义(t=5.197,P=0.000; t=3.930,P=0.001; t=5.155,P=0.000; t=3.721,P=0.001; t=3.577,P=0.001); 血肌酐[(93.80±26.02)μmol·L-1]与治疗前[(97.44±20.52)μmol·L-1]相比,差异无统计学意义(t=0.668,P=0.499)。对照组血尿酸[(390.30±131.16)μmol·L-1]、C反应蛋白[(21.05±15.81)mg·L-1] 、血沉[(39.01±14.62)mm·h-1]均较治疗前[(531.23±127.36)μmol·L-1、(31.89±11.66)mg·L-1、(51.67±12.31)mm·h-1]降低,尿液pH值(6.10±0.49)较治疗前(5.89±0.43)升高,差异有统计学意义(t=4.560,P=0.001; t=3.593,P=0.001; t=4.357,P=0.001; t=2.087,P=0.047); 血肌酐[(96.15±25.66)μmol·L-1]、血尿素氮[(3.98±1.01)mmol·L-1]与治疗前[(98.07±21.54)μmol·L-1、(4.39±1.41)mmol·L-1]相比,差异无统计学意义(t=0.233,P=0.801; t=1.637,P=0.100)。2组间治疗后各项化验指标比较,差异无统计学意义(t=0.154,P=0.833; t=0.083,P=0.988; t=0.365,P=0.732; t=0.386,P=0.623; t=1.559,P=0.193; t=0.451,P=0.601)。结论:采用208痛风合剂分期论治治疗痛风性关节炎,辨病与辨证相结合,疗效满意,不良反应少,安全可靠。
Abstract:
Objective:To observe the clinical curative effect and safety of 208 gout drug combinations in the treatment of gouty arthritis.Methods:One hundred and thirty-two patients with gouty arthritis were all males,ranging in age from 45 to 60 years with a median of 46.5 years,ranging in courses of disease from 3 days to 5 years with a median of 3.5 years.Sixty patients with acute gouty arthritis diagnosed as syndrome of accumulated dampness-heat by TCM differentiation were randomly divided into 2 groups,thirty-three cases in the treatment group were administrated with oral application of 208 gout drug combinations No.1 combined with external application on affected parts,while the others in the control group were administrated with oral application of colchicine tablets and etoricoxib tablets,and cases in the 2 groups were all treated for 7 days.Seventy-two patients with chronic gouty arthritis diagnosed as syndrome of phlegm stasis by TCM differentiation were randomly divided into 2 groups,thirty-seven cases in the treatment group were administrated with oral application of 208 gout drug combinations No.2,while the others in the control group were administrated with oral application of benzbromarone tablets,and cases in the 2 groups were all treated for 20 days.The curative effect,incidence rate of adverse effects and improvements of each laboratory indicator of patients in all the groups were observed after the treatment.Results:After 7-day treatment for the acute gouty arthritis,18 patients got an excellent result,13 good,and 2 fair in treatment group; while 10 patients got an excellent result,14 good,and 3 fair in control group; there was no statistical difference in curative effect between the 2 groups(Z=-1.251,P=0.178).No adverse drug reactions were found in treatment group,while 2 cases with diarrhea,2 cases with vomiting and 2 cases with rash were found in control group; there was statistical difference in incidence rate of adverse effects between the 2 groups(P=0.006).For patients in the treatment group,the values of their blood uric acid(BUA),C reactive protein(CRP)and erythrocyte sedimentation rate(ESR)were(375.69±110.99)μmol·L-1,(35.61±18.67)mg·L-1 and(23.12±15.83)mm·h-1 respectively,which were decreased compared with the values of(474.05±89.67)μmol·L-1,(60.46±13.99)mg·L-1 and(39.67±16.46)mm·h-1 before the treatment respectively(t=6.256,P=0.000; t=6.119,P=0.000; t=4.163,P=0.001); pH value of the urine was(6.13±0.44),which was increased compared with the value of(5.81±0.39)before the treatment(t=3.126,P=0.004); while the values of serum creatinine(Scr)and blood urea nitrogen(BUN)were(98.62±17.37)μmol·L-1 and(4.84±1.49)mmol·L-1 respectively,and there was no statistical difference between above values and the values of(99.13±11.81)μmol·L-1 and(5.44±0.99)mmol·L-1 before the treatment respectively(t=0.139,P=0.912; t=1.927,P=0.073).For patients in the control group,the values of their BUA,CRP and ESR were(380.41±116.78)μmol·L-1,(37.16±19.11)mg·L-1 and(24.73±17.13)mm·h-1 respectively,which were decreased compared with the values of(469.85±90.21)μmol·L-1,(61.06±12.14)mg·L-1 and(38.97±17.58)mm·h-1 before the treatment respectively(t=5.065,P=0.000; t=5.487,P=0.000; t=3.015,P=0.005); while the values of Scr,BUN and pH value of urine were(97.98±20.14)μmol·L-1,(4.95±1.62)mmol·L-1 and(6.02±0.51)respectively,and there was no statistical difference between above values and the values of(98.97±12.45)μmol·L-1,(5.29±1.12)mmol·L-1 and(5.80±0.42)before the treatment respectively(t=0.020,P=0.989; t=0.897,P=0.432; t=1.730,P=0.122).There were no statistical difference in all the laboratory indicators between the 2 groups after the treatment(t=0.219,P=0.797; t=0.317,P=0.657; t=0.377,P=0.698; t=0.132,P=0.845; t=0.274,P=0.765; t=0.897,P=0.301).After 20-day treatment for the chronic gouty arthritis,17 patients got an excellent result,16 good,3 fair, and 1 poor in treatment group; while 15 patients got an excellent result,17 good, and 3 fair in control group; there was no statistical difference in curative effect between the 2 groups(Z=-0.119,P=0.903).No adverse reactions were found in treatment group,while 2 cases with rash were found in control group; there was no statistical difference in incidence rate of adverse effects between the 2 groups(P=0.233).For patients in the control group,the values of their BUA,CRP,ESR and BUN were(385.60±128.35)μmol·L-1,(20.75±14.97)mg·L-1,(37.80±13.50)mm·h-1 and(3.54±0.65)mmol·L-1 respectively,which were decreased compared with the values of(537.42±62.88)μmol·L-1,(32.67±10.78)mg·L-1,(52.13±10.18)mm·h-1 and(4.44±1.32)mmol·L-1 before the treatment respectively,while pH value of the urine was(6.15±0.45),which was increased compared with the value of(5.79±0.42)before the treatment(t=5.197,P=0.000; t=3.930,P=0.001; t=5.155,P=0.000; t=3.721,P=0.001; t=3.577,P=0.001); while there was no statistical difference in the value of Scr between pretreatment[(97.44±20.52)μmol·L-1]and post-treatment[(93.80±26.02)μmol·L-1](t=0.668,P=0.499).For patients in the control group,the values of their BUA,CRP and ESR were(390.30±131.16)μmol·L-1,(21.05±15.81)mg·L-1 and(39.01±14.62)mm·h-1 respectively,which were decreased compared with the values of(531.23±67.36)μmol·L-1,( 31.89±11.66)mg·L-1 and(51.67±12.31)mm·h-1 before the treatment respectively; while pH value of the urine was(6.10±0.49),which was increased compared with the value of(5.89±0.43)before the treatment,and there was statistical difference in above values(t=4.560,P=0.001; t=3.593,P=0.001; t=4.357,P=0.001; t=2.087,P=0.047); while there was no statistical difference in the value of Scr and BUN between pretreatment[(98.07±21.5)μmol·L-1,(4.39±1.41)mmol·L-1]and post-treatment[(96.15±25.66)μmol·L-1,(3.98±1.01)mmol·L-1](t=0.233,P=0.801; t=1.637,P=0.100).There was no statistical difference in all the laboratory indicators between the 2 groups after the treatment(t=0.154,P=0.833; t=0.083,P=0.988; t=0.365,P=0.732; t=0.386,P=0.623; t=1.559,P=0.193; t=0.451,P=0.601).Conclusion:The method of staging treatment with 208 gout drug combinations has satisfied curative effect on gouty arthritis with less adverse reactions by reason of combination of disease diagnosis and syndrome differentiation.

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更新日期/Last Update: 2012-10-20