牡丹颗粒治疗糖尿病性周围神经痛的疗效和安全性：一项双盲随机对照试验方案。

Efficacy and safety of Mudan granules for painful diabetic peripheral neuropathy: A protocol for a double-blind randomized controlled trial.

机构信息

Department of Physiology, Basic Medical College, Jiangxi Health Vocational College (Nanchang Medical College), Nanchang, Jiangxi Province, China.

Academic Affairs Department, Jiangxi Health Vocational College (Nanchang Medical College), Nanchang, Jiangxi Province, China.

出版信息

Medicine (Baltimore). 2022 Mar 11;101(10):e28896. doi: 10.1097/MD.0000000000028896.

DOI:10.1097/MD.0000000000028896

PMID:35451381

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8913075/

Abstract

BACKGROUND

As one of the most challenging complications in the management of diabetes mellitus, painful diabetic peripheral neuropathy (PDPN) is accompanied by various clinical manifestations, including numbness, burning, coldness, and other sensory abnormalities in the extremities. Meanwhile, PDPN seriously affects the life quality of patients and causes great pain. Western medicine mostly provides symptomatic treatments, such as antioxidants, aldose reductase inhibitors, nerve nutrition, microcirculation improvement, and analgesic drugs on the basis of blood sugar control. Although certain efficacy has been achieved, the problem has not been solved at root. Mudan granules have some advantages in the treatment of PDPN, but there is insufficient high-quality clinical studies to verify this. Therefore, the purpose of this study was to evaluate the efficacy and safety of Mudan granules in treating PDPN.

METHODS

A randomized, double-blind, placebo, and parallel-controlled trial design was used to study the efficacy and safety of Mudan granules in the treatment of PDPN. In this study, 93 patients with painful diabetic neuropathy were recruited and randomly divided into a treatment group and a placebo group based on 1:1. The treatment group was given Mudan granules and the control group accepted placebo treatment, and the basic treatment was performed according to the recommended guidelines. During the treatment period, the patients' visual analog scores, clinical efficacy, Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) scores, nerve conduction velocity, and drug-induced adverse reactions were observed at baseline after 8 and 10 weeks.

DISCUSSION

This study will evaluate the efficacy and safety of Mudan granules in treating PDPN. The experimental results will provide evidence support to treat PDPN with Mudan granules.

TRIAL REGISTRATION

DOI 10.17605/OSF.IO/5CE32.

摘要

背景

作为糖尿病管理中最具挑战性的并发症之一，痛性糖尿病周围神经病变（PDPN）伴有各种临床表现，包括四肢麻木、烧灼感、发冷和其他感觉异常。同时，PDPN 严重影响患者的生活质量，并带来极大的痛苦。西医主要在血糖控制的基础上，提供对症治疗，如抗氧化剂、醛糖还原酶抑制剂、神经营养、微循环改善和镇痛药。尽管取得了一定疗效，但问题并未得到根本解决。牡丹颗粒在治疗 PDPN 方面具有一定优势，但缺乏高质量的临床研究来验证这一点。因此，本研究旨在评估牡丹颗粒治疗 PDPN 的疗效和安全性。

方法

采用随机、双盲、安慰剂、平行对照试验设计，研究牡丹颗粒治疗 PDPN 的疗效和安全性。本研究共纳入 93 例痛性糖尿病周围神经病变患者，按 1：1 随机分为治疗组和安慰剂组。治疗组给予牡丹颗粒，对照组接受安慰剂治疗，并根据推荐指南进行基础治疗。在治疗期间，观察患者基线时、治疗 8 周和 10 周后的视觉模拟评分、临床疗效、健康调查 36 项简明量表（SF-36）评分、神经传导速度和药物不良反应。