尿畅舒胶囊治疗肾虚血瘀型绝经后尿道综合征的临床研究
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摘要
目的:探讨自拟中药复方尿畅舒胶囊治疗肾虚血瘀型绝经后尿道综合征的临床疗效及安全性。
方法:采用随机对照、双盲双模拟方法,选取肾虚血瘀型绝经后尿道综合征患者36例,分为2组,尿畅舒胶囊治疗组24例,尼二雌醇对照组12例,以下简称治疗组、对照组。整个试验历程9周。初燃符合入选标准的患者中,观察一周进行筛选检查,筛选合格者进入8周(一个疗程)的试验,将于治疗后第4周末和第8周末,返回医院进行访视。观察经1个疗程治疗后各组患者国际前列腺症状评分(Ⅰ—PSS)及生活质量评分(QOL)、中医证候积分的变化及血清雌二醇(E_2)、促卵泡生成素(FSH)的变化。所有结果均采用SPSS13.0进行统计分析,P＜0.05表示差异有统计学意义。
结果:治疗组临床痊愈3例,显效11例,有效7例,无效3例,总有效率87.5%,治愈率12.5%,显效45.8%,有效29.2%,无效12.5%,相比对照组(临床痊愈1例,显效6例,有效3例,无效2例,总有效率83.3%,治愈率8.3%,显效50%,有效25%,总有效率83.3%),疗效差异无统计学意义(P＞0.05)。但治疗组和对照组患者在I—PSS、QOL、中医证候积分均较治疗前有明显改善(P＜0.05)。两组血清激素水平均为绝经状态,两组治疗后E_2、FSH水平无统计学意义(P＞0.05),但较用药前FSH均降低,差异有统计学意义(P＜0.05)。
结论:中药尿畅舒胶囊治疗肾虚血瘀型绝经后尿道综合征临床有效,疗效与尼二雌醇相当,能改善患者的临床症状,提高患者生活质量,且未发现不良反应,可作为治疗肾虚血瘀型绝经后尿道综合征的一种良好选择。
Objiectives: To investigate the clinlical effect and security of Niao Changshu capsule on Shenxu Xueyu kind of female patients with post-menopause urethral syndrome.
Methods: A total of 36 female patients with post-menopause urethral syndrome were randomly assigned to two different groups ,trial group(treated with Niao Changshu capsule,include 24 patients) and compared group (treated with Nilestriol,incude 12 patients). The treatment lasts 9 weeks, the patients who in the first week have been checked fit for the diagnose standard can take part in the next 8 weeks' treatment. At the weekend of the 4th and 8th, the patients must go back to hospital for an asking test and rechecked. The doctor will see the changes in I-PSS and QOL, scores of various symptoms , the E_2 and FSH. All the results will be resolved by Spss 13.0, which p<0.05 seems to have a statistic meaning.
Results: The cure rate was87.5% , manifest improvement rate was45.8% , effectiveness rate was 29.2% and the non- effectiveness rate was 12.5% of the trail group. Compared with the compared group, there was no significant difference in the I-PSS and QOL, total Chinese Medicine scores. But the symptom scores before and after treatment have significant difference. The serum hormone level of two groups were in ost-menopause status. Compared with the compared group after treatment, there was no significant difference in the E_2 and FSH. After treatment, the two groups' FSH were lower, and have a statistic meaning.
Conclusion: There is good clinic effect on Shenxu Xueyu kind of female patients with post-menopause urethral syndrome by taking Niao Chang-shu capsule, and it could improve patients' various symptoms, increse quality of life. In clusion, it is safty to take Niao Changshu capsule for two months because there is no side effect, and it can be a good choice to treat Shenxu Xueyu kind of female patients with post-menopause urethral syndrome.
方法:采用随机对照、双盲双模拟方法,选取肾虚血瘀型绝经后尿道综合征患者36例,分为2组,尿畅舒胶囊治疗组24例,尼二雌醇对照组12例,以下简称治疗组、对照组。整个试验历程9周。初燃符合入选标准的患者中,观察一周进行筛选检查,筛选合格者进入8周(一个疗程)的试验,将于治疗后第4周末和第8周末,返回医院进行访视。观察经1个疗程治疗后各组患者国际前列腺症状评分(Ⅰ—PSS)及生活质量评分(QOL)、中医证候积分的变化及血清雌二醇(E_2)、促卵泡生成素(FSH)的变化。所有结果均采用SPSS13.0进行统计分析,P＜0.05表示差异有统计学意义。
结果:治疗组临床痊愈3例,显效11例,有效7例,无效3例,总有效率87.5%,治愈率12.5%,显效45.8%,有效29.2%,无效12.5%,相比对照组(临床痊愈1例,显效6例,有效3例,无效2例,总有效率83.3%,治愈率8.3%,显效50%,有效25%,总有效率83.3%),疗效差异无统计学意义(P＞0.05)。但治疗组和对照组患者在I—PSS、QOL、中医证候积分均较治疗前有明显改善(P＜0.05)。两组血清激素水平均为绝经状态,两组治疗后E_2、FSH水平无统计学意义(P＞0.05),但较用药前FSH均降低,差异有统计学意义(P＜0.05)。
结论:中药尿畅舒胶囊治疗肾虚血瘀型绝经后尿道综合征临床有效,疗效与尼二雌醇相当,能改善患者的临床症状,提高患者生活质量,且未发现不良反应,可作为治疗肾虚血瘀型绝经后尿道综合征的一种良好选择。
Objiectives: To investigate the clinlical effect and security of Niao Changshu capsule on Shenxu Xueyu kind of female patients with post-menopause urethral syndrome.
Methods: A total of 36 female patients with post-menopause urethral syndrome were randomly assigned to two different groups ,trial group(treated with Niao Changshu capsule,include 24 patients) and compared group (treated with Nilestriol,incude 12 patients). The treatment lasts 9 weeks, the patients who in the first week have been checked fit for the diagnose standard can take part in the next 8 weeks' treatment. At the weekend of the 4th and 8th, the patients must go back to hospital for an asking test and rechecked. The doctor will see the changes in I-PSS and QOL, scores of various symptoms , the E_2 and FSH. All the results will be resolved by Spss 13.0, which p<0.05 seems to have a statistic meaning.
Results: The cure rate was87.5% , manifest improvement rate was45.8% , effectiveness rate was 29.2% and the non- effectiveness rate was 12.5% of the trail group. Compared with the compared group, there was no significant difference in the I-PSS and QOL, total Chinese Medicine scores. But the symptom scores before and after treatment have significant difference. The serum hormone level of two groups were in ost-menopause status. Compared with the compared group after treatment, there was no significant difference in the E_2 and FSH. After treatment, the two groups' FSH were lower, and have a statistic meaning.
Conclusion: There is good clinic effect on Shenxu Xueyu kind of female patients with post-menopause urethral syndrome by taking Niao Chang-shu capsule, and it could improve patients' various symptoms, increse quality of life. In clusion, it is safty to take Niao Changshu capsule for two months because there is no side effect, and it can be a good choice to treat Shenxu Xueyu kind of female patients with post-menopause urethral syndrome.
引文
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[9]宋莹.雌激素在治疗绝经期妇女尿路感染中的应用.浙江临床医学,2000,10(2);661.
[10]云曼丽,陈裕盛.尿道综合征诊断及治疗体会—附15例报告.湖南医学院学报,1998,1(4):23-24
[11]张殿廷等.尼二雌醇补充治疗对绝经后妇女膀胱粘膜的影响.中国城乡企业卫生,2001,1;30-31.
[12]冯凤芝.女性尿道综合征的诊治进展.现代妇产科学进展,2005, 2(14);147-148.
[13]刘新民,万小军,宋玉琴,主译.现代妇产科疾病诊断与治疗.北京:人民卫生出版社,1998,1071-1072
[14]高忠国.补肾活血法治疗更年期尿道综合征疗效观察.实用中医药杂志,2007,23(5);280
[15]卢子杰,黄树纲.女性尿道综合征中医辨证分型临床研究.安徽中医临床杂志,2001,13(2):106-107
[16]李亚萍.女性尿道综合征中医病因病机探讨.湖南中医药导报,2002,8(9);550-551
[17]陈国宏,李兰群.李曰庆治疗女性非感染性尿道综合征的经验.中国临床医生杂志,2007,8(35);67-68
[18]李玉婷,蔡红凯.中医药治疗非感染性尿道综合征的进展.光明中医,2006,21(9);44-46
[19]鲍红娟.肾气丸合逍遥散加减治疗女性非感染性尿道综合征30例[J].安徽中医临床杂志,2003,15(3):229
[20]陈锡林.加味四逆散治疗尿道综合征43例[J].湖北中医杂志,2004,26(10):40
[21]卢金荣.针刺配合艾灸治疗老年性尿道综合征45例.针灸临床杂志[J],2001,17(5):13
[22]夏长军.中药内服与外洗治疗女性尿道综合征118例[J].中医研究,2005,18(9):28
[23]俞霭锋.妇产科内分泌学.上册..上海;上海科学技术出版社1983. 213
[24]刘昌荣,颜奎钧,郭贤坤等,尿道内切开治疗尿道狭窄疗效观察附42例报告[J].临床泌尿外科杂志,2001,9,405
[25]CARTON FE,SCARDMO PL,QUATTESAUM RB.Treatment of urethral stricture with internal urethrotomy and six weeks of silastic catheter drainage[J].JUrol,1974,111:191.
[26]黄树纲,卢了杰,徐彦.补肾活血汤治疗女性尿道综合征60例.中华实用中西医杂志,1999,12(4):615
[27]朱文元,孙法泰.温阳通痹酒治疗痛痹100例[J1.陕西中医,2002.23(3):230-231.
[28]张永祥.中药药理学新论.人民卫生出版社,2004,6:487
[29]何晶.三七的药理作用及研究进展.天津药学,2004,16(5):58-60
[30]何明,胡昌奇.植物性雌激素的研究进展.中成药,1999,21(1):42
[31]张永华,杨剑.尿畅舒胶囊对动物雌激素样作用的实验研究.中国中医药信息杂志,2005,12:22-23
[32]谢晋良等.I-PSS和QOL对女性尿道综合征临床疗效的评定.中国现代医学杂志,2004,14(20):108-109
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[7]卢子杰.女性尿道综合征中医辨证分型研究.安徽中医临床杂志,2001,13(2):106-107
[8]陈国宏,李兰群.李曰庆治疗女性非感染性尿道综合征的经验.中国临床医生杂志,2007,8(35);67-68
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[24]卢金荣.针刺配合艾灸治疗老年性尿道综合征45例.针灸临床杂志[J],2001,17(5):13
[25]赖申昌,吕冬宁,卢玲.丹桅逍遥散化裁治疗女性急性尿道综合征36例[J].广西中医药,2003,26(4):26-27
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[2]冯凤芝.女性尿道综合征的诊治进展.现代妇产科进展,2005,14(2)、147-151。
[3]章婷婷,刚君,方小玲.雌激素替代疗法的利与弊.医学与哲学,2006,27(1):46-48
[4]中国妇产学专家经验文集.沈阳出版社,1994.468
[5]张殿延,刘珍.绝经后妇女尿道综合征雌激素补充治疗的临床研究.中国综合临床,2001,17(8):631-632
[6]吴阶平.泌尿外科.济南:山东科学技术出版社,1993.778
[7]MillerK L.Hormone replacement therapy in the elderly.Clir Obste Gynecol,1996,39(4);912.
[8]李旺群、马胜利等.雌激素补充治疗女性尿道综合征的疗效观察.医学新知杂志,2005,15(3)47-48.
[9]宋莹.雌激素在治疗绝经期妇女尿路感染中的应用.浙江临床医学,2000,10(2);661.
[10]云曼丽,陈裕盛.尿道综合征诊断及治疗体会—附15例报告.湖南医学院学报,1998,1(4):23-24
[11]张殿廷等.尼二雌醇补充治疗对绝经后妇女膀胱粘膜的影响.中国城乡企业卫生,2001,1;30-31.
[12]冯凤芝.女性尿道综合征的诊治进展.现代妇产科学进展,2005, 2(14);147-148.
[13]刘新民,万小军,宋玉琴,主译.现代妇产科疾病诊断与治疗.北京:人民卫生出版社,1998,1071-1072
[14]高忠国.补肾活血法治疗更年期尿道综合征疗效观察.实用中医药杂志,2007,23(5);280
[15]卢子杰,黄树纲.女性尿道综合征中医辨证分型临床研究.安徽中医临床杂志,2001,13(2):106-107
[16]李亚萍.女性尿道综合征中医病因病机探讨.湖南中医药导报,2002,8(9);550-551
[17]陈国宏,李兰群.李曰庆治疗女性非感染性尿道综合征的经验.中国临床医生杂志,2007,8(35);67-68
[18]李玉婷,蔡红凯.中医药治疗非感染性尿道综合征的进展.光明中医,2006,21(9);44-46
[19]鲍红娟.肾气丸合逍遥散加减治疗女性非感染性尿道综合征30例[J].安徽中医临床杂志,2003,15(3):229
[20]陈锡林.加味四逆散治疗尿道综合征43例[J].湖北中医杂志,2004,26(10):40
[21]卢金荣.针刺配合艾灸治疗老年性尿道综合征45例.针灸临床杂志[J],2001,17(5):13
[22]夏长军.中药内服与外洗治疗女性尿道综合征118例[J].中医研究,2005,18(9):28
[23]俞霭锋.妇产科内分泌学.上册..上海;上海科学技术出版社1983. 213
[24]刘昌荣,颜奎钧,郭贤坤等,尿道内切开治疗尿道狭窄疗效观察附42例报告[J].临床泌尿外科杂志,2001,9,405
[25]CARTON FE,SCARDMO PL,QUATTESAUM RB.Treatment of urethral stricture with internal urethrotomy and six weeks of silastic catheter drainage[J].JUrol,1974,111:191.
[26]黄树纲,卢了杰,徐彦.补肾活血汤治疗女性尿道综合征60例.中华实用中西医杂志,1999,12(4):615
[27]朱文元,孙法泰.温阳通痹酒治疗痛痹100例[J1.陕西中医,2002.23(3):230-231.
[28]张永祥.中药药理学新论.人民卫生出版社,2004,6:487
[29]何晶.三七的药理作用及研究进展.天津药学,2004,16(5):58-60
[30]何明,胡昌奇.植物性雌激素的研究进展.中成药,1999,21(1):42
[31]张永华,杨剑.尿畅舒胶囊对动物雌激素样作用的实验研究.中国中医药信息杂志,2005,12:22-23
[32]谢晋良等.I-PSS和QOL对女性尿道综合征临床疗效的评定.中国现代医学杂志,2004,14(20):108-109
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