摘要
目的:观察泰淋方联合抗生素中西医结合方案和单纯抗生素方案治疗复发性尿路感染(RUTI)的临床疗效和对复发率的影响,并评价两者的安全性。方法:采用随机对照方法,将三家医院肾内科门诊及病房收治的RUTI患者120例,按1∶1对照原则随机分为治疗组和对照组,每组各60例。治疗组予泰淋方联合抗生素中西医结合方案,对照组予单纯抗生素方案,两组疗程均为12周;在12周用药期结束后,进入3个月随访期。检测指标包括:(1)用药前(0周)及用药后每2周检测尿沉渣、尿常规各1次;(2)用药前(0周)及用药后每4周检测清洁中段尿培养+药敏各1次;(3)在随访期第1个月、第3个月分别进行清洁中段尿培养+药敏各1次,以分别统计两组近期治愈率及近期总有效率、远期治愈率及远期总有效率;(4)两组近期及远期复发率比较;(5)检测用药前(0周)及用药第12周血常规、肝功能(ALT、AST)、肾功能(BUN、Scr)及心电图以进行安全性评价。结果:(1)基线值比较:最终完成本临床试验的病例共有111例(9例患者脱落),其中治疗组56例(4例脱落)、对照组55例(5例脱落)。治疗组患者平均年龄(57.25±13.45)岁,平均病程(43.50±16.83)个月;对照组患者平均年龄(58.20±11.82)岁,平均病程(43.04±14.89)个月;两组间比较差异无统计学意义(P>0.05),具有可比性。(2)两组随访1个月后疗效比较,治疗组近期治愈率82.0%、近期总有效率92.9%,对照组近期治愈率62.4%、近期总有效率80.8%(P<0.01)。(3)两组随访3个月后疗效比较,治疗组远期治愈率76.8%、远期总有效率89.3%,对照组远期治愈率54.7%、远期总有效率69.1%(P<0.01)。(4)治疗组和对照组的近期复发率分别为7.1%、20.0%(P<0.05),远期复发率分别为8.7%、32.4%(P<0.01)。(5)两组在用药期间均未见出现明显的安全性指标异常。结论:(1)泰淋方联合抗生素中西医结合方案的临床疗效显著优于单纯抗生素方案,除了能有效提高治愈率和总有效率外,还能有效降低复发率,值得临床进一步推广应用;(2)两种疗法均具有一定的用药安全性。
Objective:To observe the clinical efficacy and the influence on recurrence rate of recurrent urinary tract infection(RUTI)treated with Tailin Fang combined with antibiotics or antibiotics alone,and to evaluate their safety.Methods:120 patients with RUTI were randomly divided into treatment group and control group,60 cases in each group.The treatment group was treated with Tailin Fang combined with antibiotics,while the control group was treated with antibiotics alone.The course of treatment in both groups was 12 weeks.After the end of 12 weeks of medication,the patients were followed up for three months.The detection indexes included:(1)Urine sediment and urine routine were detected before(0 weeks)and every 2 weeks after medication;(2)Urine culture and drug sensitivity were detected before(0 weeks)and every 4 weeks after medication;(3)Clean middle urine cultivation and drug sensitivity were conducted respectively in the first month and the third month of the follow-up period,in order to calculate the short-term cure rate,short-term total effective rate,long-term cure rate and long-term total effective rate of the two groups;(4)Comparing the short-term and long-term recurrence rate between the two groups;(5)The blood routine test,liver function(ALT,AST),renal function(BUN,SCR)and electrocardiogram were detected before(0 week)and 12 weeks after treatment.Results:(1)Baseline value comparison:a total of 111 cases(9 patients dropped off)were finally completed,including 56 cases in the treatment group(4 cases falling off)and 55 cases(5 cases falling off)in the control group.The average age of patients in the treatment group was(57.25±13.45)years old,and the average course of disease was(43.50±16.83)months;the average age of patients in the control group was(58.20±11.82)years old,and the average course of disease was(43.04±14.89)months;there was no significant difference between the two groups(P>0.05).(2)After one month follow-up,the short-term cure rate was 82.0%and the total effective rate was 92.9%in the treatment group,and 62.4%and 80.8%in the control group(P<0.01).(3)After 3 months of follow-up,the long-term cure rate and total effective rate of the treatment group were 76.8%and 89.3%,respectively,while those of the control group were 54.7%and 69.1%,respectively(P<0.01).(4)The short-term recurrence rates of the treatment group and the control group were 7.1%and 20.0%(P<0.05),and the long-term recurrence rates were 8.7%and 32.4%respectively(P<0.01).(5)No obvious abnormality of safety index was found in the two groups.Conclusion:(1)The clinical efficacy of Tailin Fang combined with antibiotics is significantly better than that of antibiotics alone in treating RUTI,which was confirmed by the improved cure rate and total effective rate,as well as the reduced recurrence rate,thus such a new therapeutic method is worthy of further clinical application;(2)Both of the two therapies have certain medication safety.
作者
龚学忠
徐映茹
简桂花
陆文
叶紫
原道川
GONG Xuezhong;XU Yingru;JIAN Guihua(Department of Nephrology,Shanghai Municipal Hospital of Traditional Chinese Medicine(TCM),Shanghai University of Traditional Chinese Medicine,Shanghai,200071)
出处
《中国中西医结合肾病杂志》
2021年第3期222-226,共5页
Chinese Journal of Integrated Traditional and Western Nephrology
基金
国家自然科学基金面上项目(No.81873280)
上海市科委中医引导类项目(No.17401933800)
上海申康医院发展中心新兴前沿项目(No.SHDC12015126)
上海市卫健委转化医学重点项目(No.201540378)
上海中医药大学高水平大学团队项目。
关键词
复发性尿路感染
泰淋方
抑菌疗法
复发率
治疗方案
Recurrent urinary tract infection
Tailin Fang
Bacteriostatic therapy
Recurrence rate
Therapeutic method
