中西医结合治疗糖尿病肾病多中心前瞻性队列研究

作者	单位
李青	北京中医药大学循证医学中心
张惠敏	北京中医药大学循证医学中心
费宇彤	北京中医药大学循证医学中心
邢建民	北京中医药大学循证医学中心
罗辉	北京中医药大学循证医学中心
刘建平	北京中医药大学循证医学中心

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中文摘要:

目的评价中西医结合治疗糖尿病肾病(diabetic nephropathy,DN)的疗效及其安全性,探讨DN中医辨证用药规律。方法选取170例2008年3月—2009年7月北京中医药大学东方医院、中国中医科学院西苑医院、卫生部中日友好医院门诊及住院DN患者。根据患者随访期间的暴露因素(是否接受中医辨证论治)分为中西医结合组(结合组)和西医组,其中结合组116例,西医组54例。定期随访两组病例3、6、12、18、24个月时终点事件发生率及次要结局指标[体重指数(body mass index,BMI)、收缩压(systolic blood pressure,SBP)、舒张压(diastolic blood pressure,DBP)、尿微量白蛋白排泄率(urinary albumin excretion rate,UAER)、24h尿蛋白定量、血肌酐(serum creatinine,SCr)、空腹血糖(fasting blood glucose,FBG)、糖化血红蛋白(glycosylated hemoglobin,HbA1c)]。对结合组患者进行辨证分型,收集中药处方,统计中药使用频率。观察并比较随访期间两组患者肝功能、血常规、心电图。结果随访时间3～24个月,平均14个月,可供分析的数据主要集中在随访第3、6、12、18个月,因此本研究主要分析两组在随访第3、6、12、18个月时的数据。符合方案分析(PPS):结合组终点事件发生率为3.7%,西医组为8.7%,两组比较,差异无统计学意义(P>0.05)。意向性分析(ITT):结合组终点事件发生率为11.2%,西医组为7.4%,两组比较,差异无统计学意义(P>0.05)。随访第6个月时,结合组BMI[(25.0±3.1)kg/m2]、FBG[(7.9±1.5)mmol/L]水平均低于西医组[分别为(28.6±4.4)kg/m2、(8.8±2.9)mmol/L],差异有统计学意义(P<0.05);随访第12个月时,结合组FBG[(7.9±1.4)mmol/L]、HbA1c[(7.8±1.4)%]水平均低于西医组[分别为(9.6±2.8)mmol/L、(8.5±1.6)%],差异有统计学意义(P<0.05,P<0.01),其余各时间点各指标两组比较,差异无统计学意义(P>0.05)。结合组随访前SCr为(96.8±35.2)μmol/L,西医组为(80.5±24.6)μmol/L,差异有统计学意义(P<0.01)。中心2(中国中医科学院西苑医院)与中心3(卫生部中日友好医院)随访第3、6、12、18个月两组SCr水平比较,差异均无统计学意义(P>0.05);中心1(北京中医药大学东方医院)随访第3、6、12个月时结合组SCr[分别为(82.4±25.7)、(78.1±25.9)、(80.3±24.0)μmol/L]水平均低于西医组[分别为(101.4±37.2)、(96.5±34.1)、(93.9±25.9)μmol/L],差异有统计学意义(P<0.05)。237张中药处方中使用频率前10位中药依次为黄芪(68.4%)、麦冬(67.5%)、生地(67.1%)、丹参(49.4%)、党参(41.8%)、玄参(35.4%)、五味子(29.5%)、红花(27.9%)、桃仁(26.2%)、当归(25.3%)。随访期间两组未见肝功能、血常规异常及严重不良事件。结论常规西医治疗联合中医辨证论治,能降低患者部分时点BMI、FBG、HbA1c以及SCr水平,具有良好的安全性。中医辨证论治DN主要使用益气滋阴、活血化瘀类药物。

英文摘要:

Objective To assess the efficacy and safety of integrative medicine(IM) treatment for diabetic nephropathy(DN) ,and to explore the medication laws by Chinese medicine(CM) syndrome typing.Methods One hundred and seventy outpatients or inpatients with DN at Dongfang Hospital of Beijing University of Chinese Medicine,Xiyuan Hospital of China Academy of Chinese Medical Sciences,and China-Japan Friendship Hospital of the Ministry of Health were recruited from March 2008 to July 2009.They were allocated into the IM group(116 cases) or the Western medicine group(54 cases) according to whether or not they were willing to receive CM syndrome typing.The incidence of endpoint events and secondary outcome measures [such as body mass index(BMI) ,systolic blood pressure(SBP) ,diastolic blood pressure(DBP) ,urinary albumin excretion rate(UAER) ,24 h urinary protein(24 hU) ,serum creatinine(SCr) ,fasting blood glucose(FBG) ,and glycosylated hemoglobin(HbA1c) ] of two groups were observed at 3,6,12,18,and 24 months respectively during the follow-ups.Patients in the IM group were syndrome typed.The CM recipes were collected to calculate the frequency of Chinese materia medica used.The liver function,blood routines,and ECG were observed and compared during the follow-ups.Results The follow-up period was 3 to 24 months with the mean of 14 months.Data suitable for analysis mainly covered the 3rd,6th,12th and 18th month of the follow-up.Both PPS and FAS analysis showed that there were no significant difference in the incidence of endpoint between two groups(11.2% vs 7.4%,P>0.05) .The level of body mass index(BMI) [(25.0±3.1) kg/m2] and fasting blood glucose(FBG) [(7.9±1.5) mmol/L] in the IM group were lower than those of the Western medicine group [(28.6±4.4) kg/m2 and(8.8±2.9) mmol/L respectively] at the 6-month follow-up(P<0.05) .The levels of FBG [(7.9±1.4) mmol/L] and HbA1c [(7.8±1.4) %] in the IM group were lower than those of the Western medicine group [(9.6±2.8) mmol/L and(8.5±1.6) % respectively] at the 12-month follow-up(P<0.05) .There was no significant difference in other indices between the two groups at the 3-or 12-month follow-ups.The level of SCr in the IM group and the Western medicine group before follow-up were(96.8±35.2) μmol/L and(80.5±24.6) μmol/L respectively,showing statistical difference(P<0.01) .There were no significance difference in SCr between the two groups at 3,6,12,18-month follow-ups for center 2(Xiyuan Hospital of China Academy of Chinese Medical Sciences) and center 3(China-Japan Friendship Hospital of the Ministry of Health) ,while the level of SCr in the IM group [(82.4±25.7) μmol/L,(78.1±25.9) μmol/L,(80.3±24.0) μmol/L,respectively] were lower than that of the Western medicine group [(101.4±37.2) μmol/L,(96.5±34.1) μmol/L,(93.9±25.9) μmol/L,respectively] for center 1(Dongfang Hospital of Beijing University of Chinese Medicine) at 3,6,12-month follow-ups(P<0.05) .The top ten drugs used most frequently in the 237 prescriptions collected was astragali(68.4%) ,ophiopogonis tube(67.5%) ,rehmannia dried rhizome(67.1%) ,danshen root(49.4%) ,Codonopsis pilosula(41.8%) ,figwort root(35.4%) ,Chinese magnoliavine fruit(29.5%) ,safflower(27.9%) ,peach seed(26.2%) ,and angelica root(25.3%) .There was no abnormal liver function,blood abnormalities,and serious adverse events in two groups during the follow-ups.Conclusions CM treatment based on syndrome typing in combination with routine Western medicine for DN could reduce the levels of BMI,FBG,HbA1c,and SCr at partial time points,showing favorable safety.Chinese medicinals applied in treatment based on syndrome typing for DN covered mainly supplementing qi,nourishing yin,and activating blood circulation to remove blood stasis.

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