【作者】 郭融；

【导师】 刘旭生；

【作者基本信息】 广州中医药大学 ， 中医内科学， 2012， 硕士

【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。更多还原

【Abstract】 Object iveUsing 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.MethodsIn 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.Results①The 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.ConclusionThrough 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.更多还原