【作者】 王静；

【导师】 杨传华；

【作者基本信息】 山东中医药大学 ， 中医内科学（专业学位）， 2017， 硕士

【摘要】 目的:本研究在中医理论的指导下,通过观察调肝降压方对社区中老年轻中度肝火亢盛型高血压患者清晨点测的尿蛋白/尿肌酐(UACR)值的影响,评价其临床疗效并为社区高血压的防治方面提供更全面的中医药综合降压思路。方法:采用前瞻性、完全随机化、安慰剂对照的多中心临床试验研究,录入筛选合格的社区中老年轻中度单纯收缩期高血压(ISH)受试者。对其采用证型分层+区组随机方法进行随机双盲对照研究。对符合本研究的肝火亢盛型ISH受试者及对照组分别按导入期(2周)、双盲治疗期(24周)及开放随访期(12个月)开展治疗并填写研究病例。试验组采用非药物治疗措施、联合降压治疗以及调肝降压方的细颗粒剂辨证治疗,对照组采用非药物治疗措施、联合降压治疗以及与调肝降压方细颗粒剂相同规格的安慰剂治疗。全部合格受试者于访视2(0周)、访视11(用药后24周)进行UACR检查。试验全部结束后进行开盲及统计分析工作,研究病例的全部结果录入CRF。采用FAS分析、PPS分析、SS分析及SPSS17.0进行数据分析。观察调肝降压方对受试者UACR值的影响。结果:两组间治疗前的基线资料具有可比性。访视2(0周),试验组的UACR值与对照组的相比无差异,无统计学意义(p>0.05)。访视11(用药后24周),试验组的UACR值与对照组的相比,具有统计学意义(p<0.05)。结论:基于调肝降压方的中医药综合治疗方案相比单纯降压药物治疗方案,可更好地降低社区中老年轻中度高血压患者的UACR值,改善微量蛋白尿(MAU),推测调肝降压方可能有独立于降压之外的肾脏保护机制,还有待于进一步探讨。更多还原

【Abstract】 Objective:Based on the guidance of TCM theory,observe UACR of the middle-aged and elderly patients with mild-to-moderate Ganhuo Kangsheng type hypertention that take Tiaogan Jiangya decoction within the community in order to evaluate its clinical efficacy and provide a more comprehensive TCM integrated antihypertention thinking on the prevention and treatment of hypertension in community.Methods:Adopting a prospective,randomized,and placebo-controlled multicenter clinical study,input in eligible middle-aged and elderly ISH subjects in the community.They were stratified according to the pattern of TCM and selected to participate in randomized group in order to conduct a randomized,double-blind study.The experimental group who suffered mild-to-moderate Ganhuo Kangsheng type hypertention and the control group were carried out the treatment and filled in the cases according to the process of the induction period(2 weeks),double-blind treatment period(24 weeks)and open up follow-up period(12 months).The experimental group was treated with the combination of non-drug therapy,combined antihypertensive therapy and the treatment of the Tiaogan Jiangya decoction fine granules while the control group was treated with the combination of non-drug therapy,combined antihypertensive therapy and the treatment of the placebo which is the same specification of the Tiaogan Jiangya decoction fine granules.All eligible subjects were performed a UACR examination in interview 2(week 0)and interview 11(24 weeks after treatment).Unblind work and statistical analysis were performed at the end of the whole experiment,all results of the cases were recorded in CRF.Analyzed all date with the help of the FAS analysis,PPS analysis,SS analysis and SPSS 17.0.Observe the effects of the Tiaogan Jiangya decoction on the UACR value.Results:Baseline data were comparable between the two groups before treatment.In interview 2(week 0),the UACR value of the experimental group was no significant difference compared with the control group(p>0.05).In interview 11(24 weeks after treatment),the UACR value of the experimental group was significant difference compared with the control group(p<0.05).Conclusion:Compared with the simple antihypertensive drug treatment scheme,the TCM integrated antihypertention scheme which is based on the Tiaogan Jiangya decoction does better to decrease the UACR and improve the condition of MAU of the middle-aged and elderly ISH patients with mild-to-moderate hypertension in community.It is speculated that there may be a mechanism of renal protection independent of antihypertension in Tiaogan Jiangya decoction,which remains to be further explored.更多还原