【作者】 杨丽虹；

【导师】 林启展；

【作者基本信息】 广州中医药大学 ， 中医学， 2012， 硕士

【摘要】 背景：经过多年的临床实践检验,中医药治疗或中西医结合治疗慢性肾脏病具有一定的临床疗效优势。慢性肾脏病中晚期,尤其少尿或无尿患者,是发生高钾血症的高危人群。对口服含钾量尚缺乏系统数据的中药汤剂,是否增加高钾血症的发生风险?目的：本研究主要研究口服中药汤剂治疗对慢性肾脏病3-5期非透析患者血清钾离子水平的影响以及引起高钾血症的危险性,同时分析影响血清钾水平的其他可能的相关因素,探讨慢性肾脏病3-5期非透析患者长期服用中药汤剂治疗的安全性。方法：采用非对照的观察性研究的方法,纳入2010年11月至2012年2月在广东省中医院肾内科门诊随诊坚持服用中药汤剂的慢性肾脏病3、4、5期非透析患者。由肾脏病慢病管理门诊的医护专员进行肾脏病相关知识宣教进行低钾饮食洗脱。分别在0周(治疗前)、4周、8周、12周进行抽血以及留取尿液检测相关指标。不予干预中药、西药具体用药,仅详细记录上述四个时间点患者所服用药物的剂量与频率。使用EXCEL软件建立数据库,采用SPSS18.0统计软件进行统计分析。采取双侧检验,检验水准α取0.05,参数的可信区间估计采用95%可信区间,P<0.05为有统计学意义。采用卡方检验或Fisher确切概率检验以及单因素重复测量数据的方差分析进行单因素分析后,采用多因素重复测量数据的方差分析以及logistic回归模型进行多元分析,分析引起血钾升高的保护和危险因素。结果：最终共纳入病例65例,其中男性31例,女性34例,年龄18～80岁,平均60.23±14.7岁；CKD3期21例,CKD4期28例,CKD5期16例。研究发现：1.血钾水平呈轻度上升趋势,但无统计学意义(P>0.05)；2.纳入时血钾在正常范围的患者,发生高钾血症组高钾血症组血钾基线明显高于未发生高钾血症组(P<0.05)；3.血钾变化趋势与中药含钾量多少无相关性(P>0.05)；4.血钾升高于血肌酐以及合并服用升高血钾药物(ACE、ARB、β Rbs、保钾利尿药)有相关性,为血钾升高的危险因素,分别是使血钾升高风险增加3.8倍和7.9倍。结论：血钾在正常范围的慢性肾衰竭中晚期非透析患者服用中药汤剂治疗相对安全,不会引起血钾异常升高。对于开始服用中药前血钾水平接近上限值,或合并服用ACE I、 ARB、β Rbs、保钾利尿药的患者,建议密切监测血钾水平,并衡量利弊后改用其他不影响血钾的同类药物。但由于本研究为无对照的观察性研究,此结局的可靠性尚有待进一步研究验证。更多还原

【Abstract】 ObjectivesTo investigate the safety of Chinese medicine decoction for treatment of the non-dialysis patients of chronic kidney disease (CKD) stages3to5on the point of serum potassium.MethodsThis study was designed as a non-controlled observational study. We included non-dialysis patients of CKD stages3-5who insist to treated with Chinese medicine decoction and visiting the renal outpatient clinic of Guangdong Province Hospital of Traditional Chinese Medicine(TCM) during November2010and February2012. All the participants were given the health care education of CKD, in order to have a low potassium diet wash period. There was no restriction on prescriptions of both TCM and western medicine. We recorded the data of blood and urine tests, components of TCM prescription, Chinese patent medicine and western medicine prescription on the start, the fourth week, the eight week and endpoint. We established the database by EXCEL, and data were analyzed by SPSS18.0. All statistic tests used in this study did on two-sided test and the a=0.05. Chi-square test or Fisher’s exact test and repeated measures analysis of variance were used for single factor analysis, and logistic regression model was used for multivariate analysis to detect to the protective and risk factors of hyperkalemia.Result65patients were included,31male and34female, age during18to80(60.23±14.7) years old。We found that:1. Serum potassium showed a slight rising trend, but there was no significant difference (P>0.05);2. The basic serum potassium was much higher in the hyperkalemia group than the normokalemia group (P<0.05);3. There was no correlation between the change of serum potassium and the potassium of chinese medicine;4. Serum creatinine (B=l.325,OR=3.674) and combining drugs including ACE inhibitor, ARB,?locker, or spirolactone (B=2.063,OR=7.868) were the risk factors of rising potassium.ConclusionChinese Medicine as a treatment for non-dialysis patients of chronic kidney disease stages3to5is relatively safe and will not rise the serum potassium within normal basic serum potassium. But it should pay attention to the patients who have a high potassium level before treatment, and who take ACE inhibitor, ARB,? Rbs or spirolactone. We advise to monitor serum potassium frequently when treated with chinese medicine. For the limitation of the design, further studies of well design are needed.更多还原