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在预防和治疗小儿镰状细胞病患者疼痛性危象发作方面,在标准治疗中添加ω-3或维生素D的比较疗效。

Comparative effectiveness of adding Omega-3 or Vitamin D to standard therapy in preventing and treating episodes of painful crisis in pediatric sickle cell patients.

作者信息

Abdelhalim S M, Murphy J E, Meabed M H, Elberry A A, Gamaleldin M M, Shaalan M S, Hussein R R S

机构信息

Department of Clinical Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt, A Ph.D. supervision Committee with the Department of Pharmacy Practice & Science, R.K. Coit College of Pharmacy, University of Arizona, Tucson, AZ, USA.

出版信息

Eur Rev Med Pharmacol Sci. 2022 Jul;26(14):5043-5052. doi: 10.26355/eurrev_202207_29290.

Abstract

OBJECTIVE

Sickle Cell Anemia (SCA), also called the Sickle Cell Disease (SCD), is an inherited hematological disorder characterized by a syndrome of acute anemia and a painful crisis. The sickling hemoglobin, Hgb-S causes viscosity and inflammation of blood vessels. Eventually, the red blood cells get eliminated from the circulation process, which leads to hemolytic anemia. This study examined the comparative effectiveness of supplementation of Omega-3 or vitamin-D to standard therapy (hydroxyurea + Ibuprofen) used for prevention and treatment of pain crises in pediatric patients living with SCD.

PATIENTS AND METHODS

165 patients participated in this randomized, double-blind, standard therapy-controlled, parallel-design trial. The patients were randomly divided into three groups, receiving three capsules of either 1,000 mg Omega-3 fish oil (400 mg EPA and 300 mg DHA) or 1.5 mL vitamin-D (2,800 IU/7 ml) daily for 10 months plus the standard therapy. Lactate dehydrogenase, high-density lipoprotein (HDL), low-density lipoprotein (LDL), hematocrit, reticulocyte count, and white-blood-cell count were determined at baseline (month zero) and end of the 10th month. The pain severity was measured using the visual analog scale method (VAS). Therefore, a 10-cm ruler with a VAS design was used to determine the patient pain intensity. The baseline time point was defined as the time spot before starting to deliver the experimental medication to the patients (month zero). At that time, the biodata of the patient on the frequency of pain episodes and the rest of the variables were collected, and the baseline data were one-year retrospective data.

RESULTS

Of 165 patients enrolled in the trial, 150 were included in the final analysis. At the end of the study, there was a significant increase in serum LDL and HDL in the Omega-3 group as compared with the control group (mean of 82 mg/dL vs. 57 mg/dL; p < 0.01 and mean of 47 mg/dL vs. 43 mg/dL; p < 0.028, respectively). Other laboratory parameters were significantly influenced. The number of painful crises and pain levels was significantly decreased in the Omega-3 group compared with the control group (mean of one-episode vs. mean of three episodes; p = 0.01, mean of three on pain scale vs. six on pain scale; p = 0.018).

CONCLUSIONS

Results showed that Omega-3 was more effective than vitamin-D or standard treatment alone relative to pain crises and most of the other studied items. Vitamin-D was more effective than standard therapy alone. Clinicians should consider the addition of Omega-3 supplements to the standard therapy and a de-escalation dose plan for the hydroxyurea medication.

摘要

目的

镰状细胞贫血(SCA),也称为镰状细胞病(SCD),是一种遗传性血液系统疾病,其特征为急性贫血综合征和疼痛危象。镰状血红蛋白Hgb - S会导致血管黏稠和炎症。最终,红细胞在循环过程中被清除,从而导致溶血性贫血。本研究考察了补充ω-3或维生素D与用于预防和治疗患有SCD的儿科患者疼痛危象的标准疗法(羟基脲+布洛芬)相比的相对疗效。

患者与方法

165名患者参与了这项随机、双盲、标准疗法对照、平行设计试验。患者被随机分为三组,每天服用三粒1000毫克的ω-3鱼油胶囊(400毫克二十碳五烯酸和300毫克二十二碳六烯酸)或1.5毫升维生素D(2800国际单位/7毫升),持续10个月,外加标准疗法。在基线期(第零个月)和第10个月末测定乳酸脱氢酶、高密度脂蛋白(HDL)、低密度脂蛋白(LDL)、血细胞比容、网织红细胞计数和白细胞计数。使用视觉模拟评分法(VAS)测量疼痛严重程度。因此,使用带有VAS设计的10厘米尺子来确定患者的疼痛强度。基线时间点定义为开始给患者使用试验药物之前的时间点(第零个月)。那时,收集患者关于疼痛发作频率和其他变量的生物数据,基线数据为一年的回顾性数据。

结果

在该试验纳入的165名患者中,150名被纳入最终分析。研究结束时,与对照组相比,ω-3组的血清LDL和HDL显著升高(平均分别为82毫克/分升对57毫克/分升;p<0.01和47毫克/分升对43毫克/分升;p<0.028)。其他实验室参数也受到显著影响。与对照组相比,ω-3组的疼痛危象次数和疼痛程度显著降低(平均发作一次对平均发作三次;p = 0.01,疼痛量表平均分为3分对6分;p = 0.018)。

结论

结果表明,相对于疼痛危象和大多数其他研究项目,ω-3比单独使用维生素D或标准治疗更有效。维生素D比单独使用标准疗法更有效。临床医生应考虑在标准疗法中添加ω-3补充剂,并制定羟基脲药物的减量剂量方案。

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