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Assessing the analgesic efficacy of oral epigallocatechin-3-gallate on epidural catheter analgesia in patients after surgical stabilisation of multiple rib fractures: a prospective double-blind, placebo-controlled clinical trial
Pharmaceutical Biology ( IF 3.9 ) Pub Date : 2020-01-01 , DOI: 10.1080/13880209.2020.1797123
Lihong Zhang 1 , Weifeng Liu 1 , Haiping You 1 , Zhiyuan Chen 1 , Liming Xu 1 , Hefan He 1
Affiliation  

Abstract Context Thoracic trauma results in multiple rib fractures (MRF), and surgical stabilisation of rib fractures (SSRF) can relieve fracture pain. Epigallocatechin-3-gallate (EGCG) is reported to exhibit beneficial effects in bone-related metabolic and differentiation processes. Objective To study the clinical effect of EGCG on regional analgesia for pain relief in MRF patients after SSRF. Materials and methods Ninety-seven MRF patients (61 males, 36 females) who were on epidural catheter analgesia after SSRF were recruited. They were randomly divided into: oral EGCG 100 mg (oral grade) twice daily for 10 days and placebo groups. Pain scores, incentive spirometry (IS) volumes, respiratory rate and oxygen saturation (SpO2) were assessed day 10 after SSRF. Results Comparing results from the placebo and EGCG group, in the 10-day intervention course, oral EGCG reduced pain score (8 at base line vs. 4 at end of intervention in EGCG group, p < 0.05; 4 in EGCG group vs. 6 in placebo group at end of intervention, p < 0.05), improved IS volume (713 at base line vs. 1072 at end of intervention in EGCG group, p < 0.05; 1072 in EGCG group vs. 953 in placebo group at end of intervention, p < 0.05) and respiratory rate (24 at base line vs. 15 at end of intervention in EGCG group, p < 0.05; 15 in EGCG group vs. 19 in placebo group at end of intervention, p < 0.05). However, no further enhancing effect on SpO2 was observed in the EGCG group (0.98 in EGCG group vs. 0.98 in placebo group at end of intervention, p > 0.05). Discussion and conclusions Although the study is limited by a relatively small sample size and lack of serum factor analysis, the key results and the study design, for the first time, nevertheless pave the way for trials with larger number of patients to understand the effect of EGCG in MRF patients that are undergoing SSRF.

中文翻译:

评估口服表没食子儿茶素-3-没食子酸酯对多发肋骨骨折手术稳定后患者硬膜外导管镇痛的镇痛效果:一项前瞻性双盲、安慰剂对照临床试验

摘要 背景胸外伤导致多发肋骨骨折(MRF),肋骨骨折手术稳定(SSRF)可以缓解骨折疼痛。据报道,表没食子儿茶素-3-没食子酸酯 (EGCG) 在骨相关代谢和分化过程中表现出有益作用。目的研究EGCG局部镇痛缓解SSRF后MRF患者疼痛的临床效果。材料和方法 招募了 97 名在 SSRF 后使用硬膜外导管镇痛的 MRF 患者(61 名男性,36 名女性)。他们被随机分为:口服 EGCG 100 毫克(口服级),每天两次,持续 10 天和安慰剂组。在 SSRF 后第 10 天评估疼痛评分、刺激性肺活量测定 (IS) 量、呼吸频率和氧饱和度 (SpO2)。结果 比较安慰剂组和 EGCG 组的结果,在为期 10 天的干预过程中,口服 EGCG 降低了疼痛评分(EGCG 组基线时为 8 分,干预结束时为 4 分,p < 0.05;EGCG 组为 4 分,安慰剂组为 6 0.05)、改善 IS 体积(EGCG 组基线时 713 对干预结束时 1072,p < 0.05;EGCG 组 1072 对干预结束时安慰剂组 953,p < 0.05)和呼吸频率(24 EGCG 组干预结束时基线 vs. 15,p < 0.05;干预结束时 EGCG 组 15 vs. 安慰剂组 19,p < 0.05)。然而,在 EGCG 组中没有观察到对 SpO2 的进一步增强作用(在干预结束时,EGCG 组为 0.98,安慰剂组为 0.98,p > 0.05)。讨论与结论 虽然该研究受限于样本量相对较小和缺乏血清因子分析,
更新日期:2020-01-01
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