摘要
目的：
运用观察性研究及循证医学的方法,评价中药治疗隐匿性肾炎(Latent glomerulonephritis, LGN)的疗效及安全性,为中医治疗LGN提供科学证据。
方法：
采用回顾性及前瞻性研究方法,入选符合纳入标准的46例LGN患者,按照隐匿性肾炎中医诊疗方案治疗3个月,观察治疗前后中医症状积分、尿红细胞数计数的改变,进行临床疗效判定；按照国际Cochrane协作组制定的检索策略,计算机检索PUBMED、EMBASE、CENTRAL、中国生物医学数据库(CBM)、清华期刊全文数据库(CNKI)和维普期刊全文数据库(VIP),手工检索会议资料及未发表的文献。由两名研究者独立对所纳入的研究进行方法学质量评价,用Cochrane协作网提供的Rev. Man5.1软件进行Meta-分析,无法进行Meta-分析的进行描述性分析。
结果：
①隐匿性肾炎属于本虚标实证,本证以脾肾气虚证多见(47%),其次为气阴两虚证(26%),肝‘肾阴虚证(20%),脾肾阳虚证(7%)；标实证方面,以湿热证多见(34%),其次是湿热兼血瘀证(22%),外感风热证(22%)；②中医症状积分变化：46例LGN患者治疗后有效为29例,无效17例,症状改善有效率为63.04%,无效率为36.96%。患者治疗后的症状积分与治疗前相比较有明显的较少,差异有统计学意义(P<0.05)；③临床疗效评价：46例患者中,治疗后临床控制者3例(6.52%),显效15例(32.61%),有效21例(45.65%),总有效率84.78%,患者尿畸形红细胞数、尿沉渣红细胞数均有减少(P<0.05)；④共检索到6篇符合纳入标准的临床试验,共计455例病人。Meta-分析显示：中医药在临床综合疗效、减少尿红细胞数、降低血清IgA水平这几个方面优于西医治疗,但在降低24小时尿蛋白定量、血清IgG水平、血清IgM水平、血清C3水平方面,两组治疗无统计学差异。由于纳入文献数量偏少,且质量普遍较低,尚不能说明中医药在治疗LGN有确切的疗效。
结论：
通过观察中医药治疗46例LGN患者的研究表明,中药治疗能够有效的改善患者的临床症状和体征,减少尿红细胞数,为进一步开展大规模的临床研究奠定了基础；系统评价方面：由于纳入的临床试验方法学质量相对偏低,研究样本量较少,治疗和随访的时间不够长,使其证据强度较低,故对这些结果的解释应持谨慎态度。确切疗效有待于设计严格的多中心、大样本随机双盲、安慰剂对照试验进一步证实。
Object ive
Using the method of the observational and EBM to evaluate the efficiency and safety of traditional Chinese medicine therapy for latent glomerulonephritis. And then to provide TCM treatment of latent glomerulonephritis based on evidence.
Methods
In this retrospective and prospective study,46LGN patients who were eligible for the inclusion criteria were treated by LGN Chinese medicine diagnosis and treatment scheme for3months, the clinical efficacy evalulated by the changes of symptom scores, red blood cell count in urine before and after treatment; We searched for studies according to the search stategy of The Cochrane Collaboration Group. The following databases were searched:Pubmed, Embase, Central, Chinese Biological Medicine database (CBM), China National Knowledge Infrastructure (CNKI) and the VIP database (VIP), Manual retrieval conference material and literatures which were not published. Two authors independently assessed trial qualities and extracted Data from these Randomized Controlled Trails, then imported them into the Meta-analysis by Rev. Man5.1or did the descriptive analysis those who could not do the Meta-analysis.
Results
①The TCM pathogenesis of LGN was attributive to primary deficiency and secondary excess.In the respect of the primary deficiency syndrome, the most common type was spleen and kidney Qi deficiency, account for47%, followed by both Qi and Yin deficiency (26%), liver and kidney Yin deficiency (20%), spleen and kidney Yang deficiency(7%); In the respect of the secondary excess syndrome, the most common type was dampness and heat syndrome (34%), the secondary were dampness and heat accompanied by blood stasis(22%), pathogenic wind and hot syndrome (22%);②The changes of symptom scores:46LGN patients with effective29cases and ineffective17cases after TCM treatment, the effective rate of improved symptom was63.04%, and the ineffective rate of improved symptom was36.96%. Compared with before treatment, the changes of symptom scores was decreased after treatment, there is statistical differences (P<0.05);③The evaluation of clinical efficacy:In these46patients, there was3cases of clinical control (6.52%),15cases of apparent effective(32.61%) and21cases of effective. The total effective rate was84.78%, the number of derormed red blood cells and red blood cells in urine were all decreased.④Six trials involving455patients were included. The results of Meta-analysis indicated that TCM treatment on LGN have a better effect in respects of clinical comprehensive efficacy, reducing red blood cells in urine and serum IgA compared with Western-based treatment, there is no statistical differences in respects of decreasing the urine protein level, and serum IgG, serum IgM, serum C3. Owing to small simple and inferior quality of the included studies,it is still not sure that TCM treatment has a definite efficacy on LGN.
Conclusion
Through the study of46LGN patients who treated by TCM therapy, Traditional Chinese medicine can improve clinical symptom and signs, decrease red blood cells in urine,which will lay the foundation for a massive clinical research in future. The study drawn that TCM therapy can improve the clinical efficacy for latent glomerulonephritis to some extent. Because of the low qualities of researches,the small sample sized researches and not long enough therapy and follow-up time, the evidence is very low. It is caution to interpret these results. The exact effect need to design a strict multi-center, large sample randomized, double-blind, placebo-controlled trial futher confirmed.
引文
[1]倪青.时振声治疗血尿型隐匿性肾炎的经验[J].辽宁中医杂志,1996,23(2)：52-53.
[2]王建明,孙云松.皮持衡从“热、虚、瘀”论治肾炎血尿经验[J].江西中医药,2001,32(2)：12.
[3]史佳影,董志刚.董志刚教授治疗肾炎血尿的经验[J].中华中医药学刊,2008,26(6)：1139-1140.
[4]施卿卿.黄春林教授妙用中药治疗蛋白尿血尿经验摭拾[J].中医药学刊,2002,20(2)：157-159.
[5]黄雄亮.刘旭生教授治疗肾小球性血尿的经验与体会[J].深圳中西医结合杂志,2004,14(2)：81-83.
[6]米秀华.郭恩绵治疗隐匿性肾小球肾炎血尿型的经验[J].辽宁中医杂志,2002,24(8)：461-462.
[7]傅怡愫,王宁.聂莉芳老师诊治肾炎血尿的经验简介[J].新疆中医药.1998,16(1)：57-58.
[8]张宏俊,王道俊.江映青辨治尿血七法[J].辽宁中医杂志,1992,4(1)：12-13.
[9]甄仲,黄文政,朱小棣,等.黄文政治疗肾病经验撷英[J].辽宁中医杂志,2006,33(7)：779.
[10]朱雪萍.叶景华诊治尿血证的经验[J].上海中医药杂志,1996,1(6)：12-13.
[11]林启展,马育鹏,潘碧琦,等.张琪教授辨治IgA肾病尿血证经验[J].广州中医药大学学报,2006,23(3)：234-236.
[12]张洁.凉血活血法治疗隐匿性是肾炎单纯性血尿20例总结[J].湖南中医杂志,2005,21(5)：31-32.
[13]沈惠风,李群,李鹤.益气健脾法治疗单纯性肾性血尿的临床研究[J].成都中医药大学学报,2006,29(1)：18-19.
[14]王耀光.肾性血尿的中医辨证治疗及中西医结合治疗体会[J].中医药学报,2007,35(1)：28-31.
[15]Chow KM, Kwan BC, Li PK, et al. Asymptomatic isolated microscopic haernaturia:long-term follow-up[J].QJM, 2004, 97(11):739-745.
[16]孟梅霞,胡卫军,尹爱萍.原发性肾小球性血尿185例临床与病理分析[J].中国社区医师,2006,8(152)：86
[17]Hall CL, Bradley R, Kerr A, et al. Clinical value of renal biopsy in patients with asymptomatic microscopic hematuria with and without low-grade proteinuria. Clin Nephrol,2004,62(4):267-272.
[18]刘水琴,刘淮阳.成人无症状性血尿蛋白尿的临床病理分析及预后[J].四川医学,2002,23(1)：32-33
[19]全国原发性肾小球疾病分类与治疗及诊断标准专题座谈会纪要[J].中华内科杂志,1993,2：(2).
[20]于顺义.张大宁教授治疗血尿经验[J].吉林中医药,2004,25(1)：13.
[21]孙诗佳,何学红.何学红教授辨证治疗肾炎性血尿经验[J].吉林中医药,2008,28(4)：246-247.
[22]陈明.刘渡舟辨治慢性肾小球肾炎主要症状的经验[J].北京中医杂志,2003,22(2)：10-12.
[23]田甜,刘平夫.刘平夫教授治疗肾性血尿经验[J].吉林中医药,2007,27(4)：12-13.
[24]方洁.叶任高教授治疗隐匿性肾炎的经验[J].中国临床医生,2002,30：(1)53-54.
[25]郭玲.何学红教授中医治疗肾小球性血尿经验[J].实用中医内科杂志,2006,20(3)：244.
[26]郭银雪,詹继红.滋肾止血汤治疗阴虚型肾性血尿30例[J].江西中医药,2007,38(292)：43-44.
[27]李红哲.归脾汤加减配合西药治疗IgA肾病血尿100例疗效观察[J].中医中药导报,2011,8(6)：82-83
[28]刘新瑞,刘宝庆.连藕蒲黄汤治疗慢性肾炎血尿44例[J].杏林中医药,2006,26(8)：25.
[29]张栩,潘永福,周彩琴,等.知柏清凉方治疗慢性肾小球肾炎顽固性血尿48例临床观察[J].湖南中医药导报,2003,9(3)：22-23.
[30]林丹华,徐海山,陈洪,等.42例复方丹参滴丸治疗LGN单纯血尿型疗效观察[J].中国实用医药,2007,2(33)：123-124.
[31]郑露,徐学康.钱桐荪教授治疗肾小球性血尿的思维方法和经验[J].中国中西医结合肾病杂志,2005,6(6)：315-316.
[32]刘旭生,于晓瑜,梁晖等.尿血合剂治疗原发性肾小球性血尿33例临床观察[J].中成药,2007,29(8)：1109-1111.
[33]龙利,金晟,邱碧波等.尿血康胶囊治疗LGN单纯性血尿疗效观察[J].湖北中医杂志,2011,33(2)：45-46.
[34]刘迅.血尿安胶囊治疗LGN单纯血尿疗效观察[J].中国中西医结合肾病杂志,2008,9(1)：77.
[35]Yamagata K, Takahashi H, Tomida C, et al. Prognosis of asymptomatic hematuria and/or proteinuria in men. High prevalence of IgA nephropathy among proteinuric patients found in mass screening[J]. Nephron, 2002, 91(1):34-42.
[36]沈沛成,宦金星,曹长春,等.51例体检发现蛋白尿和/或血尿患者随访分析[J].复旦学报(医学版),2004,31(6)：649-652.
[37]Chow KM, Kwan BC, Li PK, et al. Asymptomatic isolated microscopic haematuria:long-term follow-up. QJM, 2004, 97(11):739-45.
[38]中华医学会肾脏病分会透析移植登记工作组.1999年度全国透析移植登记报告[J].中华肾脏病杂志,2001,17(2)：77-78.
[39]Zuo L, Wang M.Current status of hemodialysis treatment in Beijing, China[J]. Ethn Dis,2006,16(2 Suppl 2):S2-31-4.
[40]尹道馨,王梅.血尿流行病学调查的现状和方法及其对肾病预后的影响[J].中国全科医学,2011,14(38)：813-815.
[41]马红珍.隐匿性肾炎的辨证与辨病结合论治[J].浙江中医杂志,1997,32(5)：224.
[42]方积乾,孙振球.卫生统计学[M].北京：人民卫生出版社,2008,6：447.
[43]郭银雪,詹继红,王映林.滋肾止血汤治疗阴虚型肾性血尿30例[J].江西中医药,2007,38(292)：43-44.
[44]缪湘伊.宁血归经汤治疗儿童隐匿性肾炎血尿46例临床观察[J].湖南中医药导报,2003,9(4)：33-34.
[45]沈惠风,李群,李鹤.益气健脾法治疗单纯性肾性血尿的临床研究[J].成都中医药大学学报,2006,29(1)：18-19.
[46]梁桂仪,杨小红.中西医治疗单纯性血.尿临床疗效比较[J].实用医学杂志,2006,22(18)：2202-2204.
[47]黄健,陈云,周莉娅.益气养阴清热利湿法治疗隐匿性肾炎单纯性血尿30例临床观察[J].成都中医药大学学报,2007,30(2)：25-26.
[48]王晓卫,郑湘瑞.中医辨证治疗原发性隐匿性肾炎单纯性血尿47例[J].上海中医药杂志,2004,38(7)：28-29.
[49]刘关键,吴泰相.Meta-分析的森林图及临床意义[J].中国循证医学杂志,2004,4(3)：198-201.
[50]刘建平.临床试验随机化的概念与方法[J].中国中西医结合杂志,2003,23(4)：244-246
[51]Schulz KF, Chalmers I, Hayes RJ, et al. EmPirical evidence of bias:Dimensions of methodolonical quality associated with estmates of treatment effects in controlled trials[J]. JAMA, 1995,273(5):408-412.