黄蜀葵治疗慢性肾脏病的疗效与安全性：一项多中心、开放标签、单臂临床试验。

Efficacy and safety of Abelmoschus manihot in treating chronic kidney diseases: A multicentre, open-label and single-arm clinical trial.

作者信息

Sun Xuefeng, Li Ping, Lin Hongli, Ni Zhaohui, Zhan Yongli, Cai Guangyan, Liu Chao, Chen Qinkai, Wang Wenge, Wang Xiaoqin, Zhang Peiqing, Li Peng, Liang Meng, Zheng Hongguang, Wang Niansong, Miao Lining, Jin Ruixia, Guo Zhiyong, Wang Yong, Chen Xiangmei

机构信息

Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China.

出版信息

Phytomedicine. 2022 May;99:154011. doi: 10.1016/j.phymed.2022.154011. Epub 2022 Mar 3.

DOI:10.1016/j.phymed.2022.154011

PMID:35278897

Abstract

RATIONALE AND OBJECTIVE

The efficacy of Abelmoschus manihot (AM) in treating of chronic kidney disease (CKD) has been confirmed by prior trials. AM is also commonly combined to other medicines among CKD patients in clinic. This trial aimed at evaluating the safety of AM combination application, and further verifying the efficacy of AM in treating various types of CKD.

STUDY DESIGN

A multicentre, prospective, open-label, single-arm trial SETTING AND PARTICIPANTS: Approximately 2000 CKD patients with proteinuria (≥ 150 mg/d), from 105 centres across China INTERVENTIONS: AM was administered to patients three times per day for 24 weeks: the daily dose was based on age (> 12 years old: 2.5 g tid; 6∼12 years old: 1.5 g tid; 2∼6 years old: 1 g tid) OUTCOMES: The efficacy outcomes were the change in 24-hour proteinuria and estimated glomerular filtration rate (eGFR) from baseline to week 24. Safety outcomes included adverse events and laboratory tests.

RESULTS

2054 CKD patients from 105 centres were enrolled in this trial, with 1843 (89.7%) completing the 24-week follow-up. The participants' median age was 44 years old and 44.6% were female. Compared to baseline, 24-hour proteinuria decreased 471 mg (95% confident interval, 367 to 575, p < 0.001) at week 24. eGFR did not change significantly relative to baseline with the mean increase as 1.7 ml/min/1.73 m (95% confident interval, -0.3 to 3.7, p = 0.09). 902 (43.9%) participants combined medication to AM during follow-up. The total incidence of adverse events was 12.9%; and the most common adverse events were hyperlipidaemia (4.1%), abnormal liver function (2.3%), upper respiratory infection (1.8%), and hyperglycaemia (1.1%). Combined medications did not change the risk for hyperlipidaemia and upper respiratory infection. The combination application with antiplatelet reagents increased the risk of abnormal liver function, and with calcium channel blockers increased the risk of hyperglycaemia.

LIMITATIONS

Single-arm clinical trial and short observation time CONCLUSION: We have provided safety information of AM on various types of CKD in a large trial, especially when combination to medications most commonly prescribed to CKD patients. AM also showed to decrease proteinuria with stable kidney function during follow up. AM is a promising treatment for CKD patients.

摘要

原理与目的

前期试验已证实黄蜀葵（AM）治疗慢性肾脏病（CKD）的疗效。在临床中，CKD患者也常将AM与其他药物联合使用。本试验旨在评估AM联合应用的安全性，并进一步验证AM治疗各类CKD的疗效。

研究设计

一项多中心、前瞻性、开放标签、单臂试验

设置与参与者

来自中国105个中心的约2000例蛋白尿（≥150mg/d）CKD患者

干预措施

患者每日服用AM三次，共24周：每日剂量根据年龄而定（>12岁：2.5g，每日三次；6至12岁：1.5g，每日三次；2至6岁：1g，每日三次）

结果

疗效指标为从基线到第24周24小时蛋白尿和估计肾小球滤过率（eGFR）的变化。安全性指标包括不良事件和实验室检查。

结果

105个中心的2054例CKD患者纳入本试验，1843例（89.7%）完成24周随访。参与者的中位年龄为44岁，女性占44.6%。与基线相比，第24周时24小时蛋白尿减少471mg（95%置信区间，367至575，p<0.001）。eGFR相对于基线无显著变化，平均增加1.7ml/min/1.73m²（95%置信区间，-0.3至3.7，p=0.09）。902例（43.9%）参与者在随访期间将药物与AM联合使用。不良事件总发生率为12.9%；最常见的不良事件为高脂血症（4.1%）、肝功能异常（2.3%）、上呼吸道感染（1.8%）和高血糖（1.1%）。联合用药未改变高脂血症和上呼吸道感染的风险。与抗血小板药物联合应用增加肝功能异常风险，与钙通道阻滞剂联合应用增加高血糖风险。