Chan Kam Wa, Chow Tak Yee, Yu Kam Yan, Feng Yibin, Lao Lixing, Bian Zhaoxiang, Wong Vivian Taam, Tang Sydney Chi-Wai
Department of Medicine, The University of Hong Kong, Hong Kong SAR, P. R. China.
Hong Kong Association for Integration of Chinese-Western Medicine, Hong Kong SAR, P. R. China.
Am J Chin Med. 2022;50(2):371-388. doi: 10.1142/S0192415X2250015X. Epub 2022 Feb 7.
Diabetes and chronic kidney disease (CKD) are pandemic, requiring more therapeutic options. This retrospective cohort evaluated the effectiveness, safety profile and prescription pattern of a pilot integrative medicine service program in Hong Kong. Data from 38 patients with diabetes and CKD enrolled to receive 48-week individualized add-on Chinese medicine (CM) were retrieved from the electronically linked hospital database. A 1:1 cohort was generated with patients from the same source and matched by propensity score. The primary outcomes are the change of estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR) analyzed by analysis of covariance and mixed regression model adjusted for baseline eGFR, age, gender, duration of diabetes history, history of hypertension, diabetic retinopathy, and the use of insulin and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. The rate of adverse events and the change of key biochemical parameters were analyzed. After a median of 51 weeks, patients who received add-on CM had stabilized eGFR (difference in treatment period: 0.74 ml/min/1.73m, 95% CI: -1.01 to 2.50) and UACR (proportional difference in treatment period: 0.95, 95% CI: 0.67 to 1.34). Add-on CM was associated with significantly preserved eGFR (Inter-group difference: 3.19 ml/min/1.73m, 95%CI: 0.32 to 6.06, [Formula: see text] 0.030) compared to standard care. The intergroup ratio of UACR was comparable (0.70, 95% CI: 0.45 to 1.08, [Formula: see text] 0.104). The result is robust in sensitivity analysis with different statistical methods, and there was no interaction with CKD stage and UACR. The rate of serious adverse events (8.1% vs. 18.9%, [Formula: see text] 0.174), moderate to severe hyperkalemia (8.1% vs. 2.7%, [Formula: see text] 0.304) and hypoglycemia (13.5% vs. 5.4%, [Formula: see text] 0.223), and the levels of key biochemical parameters were comparable between groups. The top seven most used CMs contained two classical formulations, namely Liu-wei-di-huang-wan and Si-jun-zi-tang. Individualized add-on CM was associated with significant kidney function preservation and was well tolerated. Further randomized controlled trials using CM prescriptions based on Liu-wei-di-huang-wan and Si-jun-zi-tang are warranted.
糖尿病和慢性肾脏病（CKD）呈全球流行态势，需要更多治疗选择。本回顾性队列研究评估了香港一项整合医学服务试点项目的有效性、安全性概况及处方模式。从电子关联的医院数据库中检索了38例糖尿病合并CKD患者的数据，这些患者接受了为期48周的个体化中药加用治疗。通过倾向评分匹配，从同一来源选取患者生成1:1队列。主要结局指标为估计肾小球滤过率（eGFR）和尿白蛋白与肌酐比值（UACR）的变化，采用协方差分析和混合回归模型进行分析，并对基线eGFR、年龄、性别、糖尿病病程、高血压病史、糖尿病视网膜病变以及胰岛素和血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂的使用情况进行校正。分析不良事件发生率及关键生化参数的变化。中位随访51周后，接受中药加用治疗的患者eGFR稳定（治疗期间差异：0.74 ml/min/1.73m²，95%CI：-1.01至2.50），UACR也稳定（治疗期间比例差异：0.95，95%CI：0.67至1.34）。与标准治疗相比，加用中药与显著保留eGFR相关（组间差异：3.19 ml/min/1.73m²，9５%CI：0.32至6.06，P = 0.030）。UACR的组间比值具有可比性（0.70，95%CI：0.45至1.08，P = 0.104）。采用不同统计方法进行敏感性分析时结果稳健，且与CKD分期和UACR无交互作用。严重不良事件发生率（8.1%对18.9%，P = 0.174）、中重度高钾血症发生率（8.1%对2.7%，P = 0.304）和低血糖发生率（13.5%对5.4%，P = 0.223），以及两组间关键生化参数水平具有可比性。使用频率最高的七种中药中有两种经典方剂，即六味地黄丸和四君子汤。个体化加用中药与显著的肾功能保留相关且耐受性良好。有必要基于六味地黄丸和四君子汤的中药处方开展进一步的随机对照试验。
