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[1]姬艷波,韓宏妮,陳立忠,等.208痛風(fēng)合劑治療痛風(fēng)性關(guān)節(jié)炎的臨床研究[J].中醫(yī)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痛風(fēng)合劑治療痛風(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24卷
期數(shù):
2012年10期
頁(yè)碼:
20-25
欄目:
臨床研究
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:
姬艷波; 韓宏妮; 陳立忠; 王海燕
中國(guó)人民解放軍第208醫(yī)院,吉林 長(zhǎng)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
關(guān)鍵詞:
關(guān)節(jié)炎; 痛風(fēng)性 高尿酸血癥 治療; 臨床研究性 208痛風(fēng)合劑
Keywords:
Arthritis; gouty;  Hyperuricemia;  Therapies; investigational;  208 gout drug combinations
摘要:
目的:觀察208痛風(fēng)合劑治療痛風(fēng)性關(guān)節(jié)炎的臨床療效和安全性。方法:132例痛風(fēng)性關(guān)節(jié)炎患者,均為男性; 年齡45～60歲,中位數(shù)46.5歲; 病程3 d至5年,中位數(shù)3.5年。急性痛風(fēng)性關(guān)節(jié)炎患者60例,中醫(yī)辨證均為濕熱蘊(yùn)結(jié)證,隨機(jī)分為2組,治療組33例,208痛風(fēng)合劑1號(hào)口服及外敷患處治療; 對(duì)照組27例,口服秋水仙堿片及依托考昔片治療; 兩組均治療7 d。慢性痛風(fēng)性關(guān)節(jié)炎患者72例,中醫(yī)辨證均為痰濁阻滯證,隨機(jī)分為2組,治療組37例,口服208痛風(fēng)合劑2號(hào)治療; 對(duì)照組35例,口服苯溴馬隆片治療; 兩組均治療20 d。治療結(jié)束后觀察各組患者療效、不良反應(yīng)發(fā)生率及各項(xiàng)化驗(yàn)指標(biāo)改善情況。結(jié)果:急性痛風(fēng)性關(guān)節(jié)炎患者治療7 d后,治療組治愈18例,顯效13例,有效2例; 對(duì)照組治愈10例,顯效14例,有效3例; 2組療效比較差異無統(tǒng)計(jì)學(xué)意義(Z=-1.251,P=0.178)。治療組未發(fā)生藥物不良反應(yīng); 對(duì)照組出現(xiàn)腹瀉2例,嘔吐2例,皮疹2例; 2組不良反應(yīng)發(fā)生率比較,差異有統(tǒng)計(jì)學(xué)意義(P=0.006)。治療組患者血尿酸[(375.69±110.99)μmol·L-1]、C反應(yīng)蛋白[(35.61±18.67)mg·L-1]、血沉[(23.12±15.83)mm·h-1]均較治療前[(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)較治療前(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]與治療前[(99.13±11.81)μmol·L-1、(5.44±0.99)mmol·L-1]相比,差異無統(tǒng)計(jì)學(xué)意義(t=0.139,P=0.912; t=1.927,P=0.073)。對(duì)照組患者血尿酸[(380.41±116.78)μmol·L-1]、C反應(yīng)蛋白[(37.16±19.11)mg·L-1]、血沉[(24.73±17.13)mm·h-1]均較治療前[(469.85±90.21)μmol·L-1]、C反應(yīng)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)與治療前[(98.97±12.45)μmol·L-1、(5.29±1.12)mmol·L-1、(5.80±0.42)]相比,差異均無統(tǒng)計(jì)學(xué)意義(t=0.020,P=0.989; t=0.897,P=0.432; t=1.730,P=0.122)。2組間治療后各項(xiàng)化驗(yàn)指標(biāo)比較差異均無統(tǒng)計(jì)學(xué)意義(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)。慢性痛風(fēng)性關(guān)節(jié)炎患者治療20 d后,治療組治愈17例,顯效16例,有效3例,無效1例; 對(duì)照組治愈15例,顯效17例,有效3例; 2組療效比較,差異無統(tǒng)計(jì)學(xué)意義(Z=-0.119,P=0.903)。治療組未發(fā)生不良反應(yīng); 對(duì)照組出現(xiàn)皮疹2例; 2組患者不良反應(yīng)發(fā)生率比較,差異無統(tǒng)計(jì)學(xué)意義(P=0.233)。治療組血尿酸[(385.60±128.35)μmol·L-1]、C反應(yīng)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]均較治療前[(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)較治療前(5.79±0.42)升高,差異有統(tǒng)計(jì)學(xué)意義(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]與治療前[(97.44±20.52)μmol·L-1]相比,差異無統(tǒng)計(jì)學(xué)意義(t=0.668,P=0.499)。對(duì)照組血尿酸[(390.30±131.16)μmol·L-1]、C反應(yīng)蛋白[(21.05±15.81)mg·L-1] 、血沉[(39.01±14.62)mm·h-1]均較治療前[(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)較治療前(5.89±0.43)升高,差異有統(tǒng)計(jì)學(xué)意義(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]與治療前[(98.07±21.54)μmol·L-1、(4.39±1.41)mmol·L-1]相比,差異無統(tǒng)計(jì)學(xué)意義(t=0.233,P=0.801; t=1.637,P=0.100)。2組間治療后各項(xiàng)化驗(yàn)指標(biāo)比較,差異無統(tǒng)計(jì)學(xué)意義(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)。結(jié)論:采用208痛風(fēng)合劑分期論治治療痛風(fēng)性關(guān)節(jié)炎,辨病與辨證相結(jié)合,療效滿意,不良反應(yīng)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