| 孟叶彩,冉来虎,楼秀霞,王业莉,金丽英,吴昊.补阳还五汤颗粒剂辅助治疗维持性血液透析患者不宁腿综合征的临床研究[J].浙江中西医结合杂志,2025,35(4): |
| 补阳还五汤颗粒剂辅助治疗维持性血液透析患者不宁腿综合征的临床研究 |
| Clinical observation on the treatment of restless leg syndrome in patients undergoing maintenance haemodialysis by the granules of Buyang Huanwu Formula |
| 投稿时间：2024-06-26 修订日期：2025-02-19 |
| DOI： |
| 中文关键词: 补阳还五汤颗粒剂 不宁腿综合征 气虚血瘀 血液透析 |
| 英文关键词:The granules of Buyang Huanwu formula Restless legs syndrome Qi deficiency and blood stasis Haemodialysis |
| 基金项目:浙江省中医药科技计划项目，浙江省县级中医药优势学科建设项目 |
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| 中文摘要: |
| 目的：探讨补阳还五汤颗粒剂辅助治疗气虚血瘀型血透患者不宁腿综合征的有效性与安全性。方法：本研究是一项随机、双盲、安慰剂对照临床试验，选取2022年1月—2022年12月于诸暨市中医医院血液透析中心规律透析的64例气虚血瘀型不宁腿综合征患者，采用简单随机法，按1:1将受试者随机分配到试验组和对照组，各为32例。试验组在常规治疗基础上加用补阳还五汤颗粒剂口服，每次1盒，开水50ml冲泡，早、晚2次饭后1h温服，4周为一个疗程，一共3个疗程。对照组在常规治疗基础上加用安慰剂口服，服用方法同试验组。两组疗程均为12周，并于治疗开始前、4周、8周、12 周各随访1次。主要终点指标为干预12周前后国际不宁腿量表（International Restless Legs Scale,IRLS）评分变化。次要终点包括IRLS评分变化（治疗后4周、8周）、贝克抑郁量表(Beck Depression Inventory,BDI）评分、汉密尔顿焦虑量表(Hamilton Anxiety Scale,HAMA）评分、匹兹堡睡眠质量指数（Pittsburgh Sleep Quality Index,PSQI)评分。比较两组临床疗效及患者治疗前后的症状改善情况，并观察记录患者的不良反应情况。结果：与治疗前比较，试验组治疗8周、12周后患者的IRLS评分均有下降，且治疗12周后的评分在组间的差异具有统计学意义。与对照组相比，治疗12周后的IRLS评分，两组亦有统计学意义。与治疗前比较，试验组治疗12周后的BDI评分、HAMA评分、PSQI评分均有下降，且PSQI评分在组间的差异具有统计学意义，P<0.05。与对照组相比，治疗12周后的HAMA评分、PSQI评分，两组之间的差异均有统计学意义，P<0.05。研究结束后，试验组、对照组总有效率分别为66.67%、27.59%，两组比较差异具有统计学意义(P＜0.05)。两组患者在研究期间均未出现明显不良反应。结论：采用补阳还五汤颗粒剂辅助治疗气虚血瘀型维持性血液透析患者不宁腿综合征，临床疗效确切，症状改善较明显，且具有良好的安全性，值得临床推广与应用。 |
| 英文摘要: |
| Objective To investigate the efficacy and safety of the granules of Buyang Huanwu formula in the treatment of restless leg syndrome in haemodialysis patients with qi deficiency and blood stasis. Methods This study was a randomized, double-blind, placebo-controlled clinical trial, in which 64 patients with restless legs syndrome of the qi deficiency and blood stasis type who were regularly dialyzed at the haemodialysis centre of Traditional Chinese Medical Hospital of Zhuji from January 2022 to December 2022 were selected. They were randomly divided into experimental group and control group according to a 1:1 ratio, with 32 cases in each group, using a stratified area group randomization method. Patients in the experimental group were given the granules of Buyang Huanwu formula, one box esch time, brewed with 50ml of boiled water, and taken warmly 1h after meals twice in the morning and evening, with 4 weeks as a course of treatment, and a total of 3 courses of treatment. Patients in the control group were given placebo orally, dosing method was the same as that of the experimental group. Both groups were treated for 12 weeks, and were followed up before treatment, 4 weeks, 8 weeks and 12 weeks.The change in RLS severity scale score before and after 12 weeks of intervention was used as the primary endpoint, and the changes in symptom severity IRLS scores (4 weeks and 8 weeks after treatment), assessment of depression status, assessment of anxiety status, and Pittsburgh Sleep Quality Index (PSQI) scores were used as the secondary endpoints. The clinical efficacy and the improvement of symptoms before and after treatment were compared between the two groups, and the adverse reactions were observed and recorded.Results For intra-group comparison, compared with before treatment, IRLS scores, PSQI scores, and HAMA scores were decreased after 12 weeks of treatment, and the decreases were statistically significant (P < 0.05). Compared with the control group, IRLS scores, PSQI scores, and HAMA scores improved in the experimental group after 12 weeks of treatment (P < 0.05). For intra-group comparison, compared with before treatment, the BDI scores of both groups decreased after 12 weeks of treatment, but the difference between groups was not statistically significant (P > 0.05). After the study, the total effective rates of the experimental group and the control group were 66.67% and 27.59%, respectively, and the difference between the two groups was statistically significant (P<0.05). There were no obvious adverse reactions in the two groups during the study.Conclusion The granules of Buyang Huanwu formula in the treatment of restless legs syndrome in maintenance haemodialysis patients with qi deficiency and blood stasis is effective and safe, which is worthy of clinical promotion and application. |
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