灸药结合防治血液透析中低血压(厥脱证)的临床研究

Clinical research of moxibustion combined with Shengmai Capsules on dialysis hypotension of the patients with chronic renal failure

目的:观察"灸药结合方案"防治血液透析中低血压的有效性及发生率,评价其在控制透析中低血压发生的作用。方法:采用前瞻性、多中心、交叉设计、随机对照法。病例来源为中国中医科学院望京医院、广安门医院等9家医院。234例患者随机分为两组,两组均采用西医常规治疗方法,试验组加用灸药结合防治方法,对照组加用西药防治方法。本研究观察8周,结束后随访8周(含洗脱期),随访期间两组仅采用西医常规治疗方法。根据交叉试验原则,在第一阶段随访结束后进行第二阶段的观察。结果:灸药结合方案能有效降低血液透析中低血压的发生率,其发生率较对照组降低17.13%(P<0.01),达到预期目标降低10%以上;两组患者在发生透析低血压时在西医干预措施、因低血压中断透析次数、因低血压未完成超滤脱水量等方面差异显著(P<0.05);改善患者临床症状,其积分在治疗前后变化差异有统计学意义(P<0.05)。结论:灸药结合方案可以降低血液透析中低血压的发生率;提高透析质量,减少血液透析中断次数,有利于超滤脱水目标的完成;减少透析中低血压的西医干预次数,减轻医护人员工作负荷;改善透析中低血压患者的临床症状;减少血液透析中低血压的发生,具有稳定持久的作用。

Objective： To observe the effects of moxibustion combined with Shengmai Capsules on the prevention of dialysis hypotension with chronic renal failure, evaluate its role in control of dialysis hypotension. Methods： Using prospective, multicenter, crossover design, randomized controlled method. Cases were in nine centers （Wangjing Hospital, Guang＇anmen Hospital, etc.）. 234 patients were randomly divided into two groups, and were adopted the conventional western medicine treatment in both groups, the observation group with moxibnstion combined with Shengmai Capsules of prevention and cure, the control group with western medicine of prevention and cure. The treatment phase of the control group using western conventional treatment methods, the observation group on the basis of using western medicine given moxibustion combined with Shengmai Capsules method. This study observed 8 weeks, follow-up after 8 weeks （including washout period）, two groups during the follow- up period with conventional western medicine treatment only. Accordance with the principle of cross-over trial, at the end of the first phase of the follow-up, the second phase of the observation that two sets of exchange treatment, treatment and follow-up observation time. Results： Moxibustion combined with Shengmai Capsules on the prevention of dialysis hypotension with chronic renal failure could effectively reduce the incidence of hypotension in hemodialysis and the incidence was reduced by 17.13% （P〈0.01）, the desired target to reduce more than 10%; Two groups of patients on dialysis hypotension occurs in western medicine interventions, for dialysis hypotension interruption times, due to the low blood pressure ultrafiltration completion to take off the water, etc., the difference was statistically significant （P〈0.05）, To improve the clinical symptoms, the integral change before and after therapy was statistically significant difference （P〈0.05）. Conclusion： The moxibustion combined Shengmai Capsules can reduce the incidence of hypotension in hemodialysis, reduce the interrupt frequency of hemodialysis and be conducive of ultrafiltration target completion, reduce the number of routine intervention, reduce staff workload, improve the clinical symptoms in patients with the dialysis hypotension, reduce the occurrence of dialysis hypotension have stable lasting effects.