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帕瑞昔布/间苯三酚联合治疗与帕瑞昔布单药治疗肾绞痛的疗效和安全性:一项随机、双盲临床试验。

Efficacy and safety of parecoxib/phloroglucinol combination therapy versus parecoxib monotherapy for acute renal colic: a randomized, double-blind clinical trial.

出版信息

Cell Biochem Biophys. 2014 May;69(1):157-61. doi: 10.1007/s12013-013-9782-6.


DOI:10.1007/s12013-013-9782-6
PMID:25453119
Abstract

To investigate whether the addition of phloroglucinol to parecoxib could improve the efficacy in patients with acute renal colic. Patients of acute renal colic were randomly allocated to receive intravenous Parecoxib 40 mg plus placebo or Parecoxib 40 mg plus phloroglucinol 80 mg, respectively. Pain intensity was recorded using a visual analog scale (VAS) before drug administration and 5, 15, 30, 60, and 120 min after treatment start. The primary outcome was the mean pain intensity difference (PID) at each checkpoint and the effectiveness of drugs (≥ 50 % decrease in VAS score at the end checkpoint). The need for rescue analgesics and the incidence of adverse effects were considered as secondary outcome of the study. Among 236 patients enrolled in the study, 119 patients received intravenous parecoxib plus placebo and 114 patients received intravenous parecoxib plus phloroglucinol, the remaining 3 patients given up treatment. Baseline demographics were similar between two groups. There are significant differences in the PID at 15 and 30 min between two groups (P15 min = 0.011, P30 min = 0.013). Rescue analgesics were required by 17 patients (14.3 %) receiving parecoxib, 7 patients (6.1 %) receiving parecoxib plus phloroglucinol (P = 0.041). There were no differences in PID at other checkpoints between two groups, as well as in the incidence of adverse events and the drug effectiveness. Parecoxib in combination with phloroglucinol for acute renal colic has a faster action, also reduces the demand of rescue analgesics.

摘要

目的:探讨在帕瑞昔布钠中添加间苯三酚是否能提高急性肾绞痛患者的疗效。

方法:将急性肾绞痛患者随机分为静脉注射帕瑞昔布钠 40mg 联合安慰剂组或帕瑞昔布钠 40mg 联合间苯三酚 80mg 组。治疗前、治疗后 5、15、30、60 和 120min 采用视觉模拟评分(VAS)记录疼痛强度。主要结局为每个时间点的平均疼痛强度差(PID)和药物疗效(VAS 评分终末时间点下降≥50%)。次要结局为解救性镇痛药物的需求和不良反应的发生率。

结果:共纳入 236 例患者,119 例接受帕瑞昔布钠联合安慰剂,114 例接受帕瑞昔布钠联合间苯三酚,3 例患者放弃治疗。两组基线人口统计学特征相似。两组在 15 和 30min 时的 PID 存在显著差异(P15min=0.011,P30min=0.013)。接受帕瑞昔布钠的 17 例(14.3%)患者和接受帕瑞昔布钠联合间苯三酚的 7 例(6.1%)患者需要解救性镇痛药物(P=0.041)。两组在其他时间点的 PID 无差异,不良反应发生率和药物疗效也无差异。

结论:帕瑞昔布钠联合间苯三酚治疗急性肾绞痛起效更快,也减少了对解救性镇痛药物的需求。

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Efficacy and safety of parecoxib/phloroglucinol combination therapy versus parecoxib monotherapy for acute renal colic: a randomized, double-blind clinical trial.

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引用本文的文献

[1]
Methodology and findings of randomized clinical trials on pharmacologic and non-pharmacologic interventions to treat renal colic pain - a review.

Cent European J Urol. 2023

[2]
Analgesic effect of paracetamol monotherapy vs. the combination of paracetamol/parecoxib vs. the combination of pethidine/paracetamol in patients undergoing thyroidectomy.

Prz Menopauzalny. 2021-12

[3]
Effectiveness of oral phloroglucinol as a premedication for unsedated esophagogastroduodenoscopy: A prospective, double-blinded, placebo-controlled, randomized trial.

PLoS One. 2021

[4]
Postoperative Pain Scores After Open Inguinal Hernia Repair: Comparison of Three Postoperative Analgesic Regimens.

Med Arch. 2020-10

[5]
Effects of Dexmedetomidine on the Pharmacokinetics of Parecoxib and Its Metabolite Valdecoxib in Beagles by UPLC-MS/MS.

Biomed Res Int. 2020

[6]
Exploitation of Drosophila Choriogenesis Process as a Model Cellular System for Assessment of Compound Toxicity: the Phloroglucinol Paradigm.

Sci Rep. 2020-1-14

[7]
Efficacy of Tamsulosin alone versus Tamsulosin Phloroglucinol combination therapy for medical expulsion of lower Ureteral calculi.

Pak J Med Sci. 2018

[8]
Efficacy of phloroglucinol for treatment of abdominal pain: a systematic review of literature and meta-analysis of randomised controlled trials versus placebo.

Eur J Clin Pharmacol. 2018-5

[9]
Analgesic Effects of Intra-Articular Bupivacaine/Intravenous Parecoxib Combination Therapy versus Intravenous Parecoxib Monotherapy in Patients Receiving Total Knee Arthroplasty: A Randomized, Double-Blind Trial.

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