Hou Chunliu, Liu Ying, Su Xuesen, Tian Shouyuan, Li Yan
College of Anesthesia, Shanxi Medical University, Taiyuan, Shanxi, People's Republic of China.
Department of Anesthesiology, Tianjin Jizhou People's Hospital, Tianjin, People's Republic of China.
J Pain Res. 2024 Aug 6;17:2571-2584. doi: 10.2147/JPR.S469646. eCollection 2024.
Due to the global prevalence of opioid drugs, postsurgical prescriptions can lead to substantial opioid consumption, highlighting the increasing need for alternative medications. Alternative medicines can markedly lessen the usage of opioids after surgery, but the variety and notable side effects of these alternatives require meticulous experimental support.
This study explored the efficacy and safety of ulinastatin for alleviating postsurgical pain, for reducing the need for opioids, and for inclusion in conventional treatment methods.
A total of 108 patients undergoing elective hip replacement were randomly allocated into either the experimental group (56 cases, standard pain relief treatment plus 60 IU ulinastatin) or the control group (40 cases, standard pain relief treatment). The main outcomes measured were the total consumption of opioids at 24, 48, and 72 h postoperatively. Secondary outcomes comprised patient-reported pain indices and levels of satisfaction with pain control. The frequency of adverse events evaluated medication safety.
There were no statistically significant differences in age, sex, or underlying diseases between the two groups. Over 24 hours, opioid consumption was higher in the standard treatment group (66.6 mg; mean difference [MD]: 4.43 mg; 95% CI: 57.6-75.5) than in the intervention group (54.5 mg; MD: 1.91 mg; 95% CI: 50.7-58.3). The standard treatment group exhibited a notably higher incidence of adverse reactions. However, there was no disparity in post-discharge satisfaction between the groups, with an odds ratio of 1.058 (95% CI: 0.62-1.82; P > 0.05). Additionally, significant differences in C-reactive protein levels were observed immediately and 6 h after surgery between the two groups.
Within 72 h post-surgery, ulinastatin was effective in substantially reducing the use of opioids while maintaining adequate pain control. Ulinastatin may be beneficial for postoperative pain management and for reducing the risks associated with opioid use.
ClinicalTrials.gov ChiCTR2300072126.
由于阿片类药物在全球范围内的广泛使用，术后处方可能导致大量阿片类药物的消耗，这凸显了对替代药物的需求日益增加。替代药物可以显著减少术后阿片类药物的使用，但这些替代药物的种类和显著的副作用需要细致的实验支持。
本研究探讨乌司他丁在减轻术后疼痛、减少阿片类药物需求以及纳入传统治疗方法方面的疗效和安全性。
总共108例行择期髋关节置换术的患者被随机分为实验组（56例，标准镇痛治疗加60 IU乌司他丁）和对照组（40例，标准镇痛治疗）。主要观察指标为术后24、48和72小时阿片类药物的总消耗量。次要观察指标包括患者报告的疼痛指数和对疼痛控制的满意度。不良事件的发生频率评估药物安全性。
两组患者在年龄、性别或基础疾病方面无统计学显著差异。在24小时内，标准治疗组的阿片类药物消耗量（66.6毫克；平均差[MD]：4.43毫克；95%置信区间：57.6 - 75.5）高于干预组（54.5毫克；MD：1.91毫克；95%置信区间：50.7 - 58.3）。标准治疗组的不良反应发生率明显更高。然而，两组出院后的满意度没有差异，优势比为1.058（95%置信区间：0.62 - 1.82；P>0.05）。此外，两组在术后即刻和术后6小时的C反应蛋白水平存在显著差异。
术后72小时内，乌司他丁在大幅减少阿片类药物使用的同时能维持充分的疼痛控制。乌司他丁可能有助于术后疼痛管理并降低与阿片类药物使用相关的风险。
ClinicalTrials.gov ChiCTR2300072126
