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一项随机对照双盲试验:比较氟哌啶醇联合传统疗法与单纯传统疗法治疗症状性胃轻瘫患者的疗效

Randomized Controlled Double-blind Trial Comparing Haloperidol Combined With Conventional Therapy to Conventional Therapy Alone in Patients With Symptomatic Gastroparesis.

作者信息

Roldan Carlos J, Chambers Kimberly A, Paniagua Linda, Patel Sonali, Cardenas-Turanzas Marylou, Chathampally Yashwant

机构信息

Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.

Department of Emergency Medicine, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX.

出版信息

Acad Emerg Med. 2017 Nov;24(11):1307-1314. doi: 10.1111/acem.13245. Epub 2017 Jul 26.

DOI:10.1111/acem.13245
PMID:28646590
Abstract

OBJECTIVE

Gastroparesis is a debilitating condition that causes nausea, vomiting, and abdominal pain. Management includes analgesics and antiemetics, but symptoms are often refractory. Haloperidol has been utilized in the palliative care setting for similar symptoms. The study objective was to determine whether haloperidol as an adjunct to conventional therapy would improve symptoms in gastroparesis patients presenting to the emergency department (ED).

STUDY DESIGN AND METHODS

This was a randomized, double-blind, placebo-controlled trial of adult ED patients with acute exacerbation of previously diagnosed gastroparesis. The treatment group received 5 mg of haloperidol plus conventional therapy (determined by the treating physician). The control group received a placebo plus conventional therapy. The severity of each subject's abdominal pain and nausea were assessed before intervention and every 15 minutes thereafter for 1 hour using a 10-point scale for pain and a 5-point scale for nausea. Primary outcomes were decreased pain and nausea 1 hour after treatment.

RESULTS

Of the 33 study patients, 15 were randomized to receive haloperidol. Before treatment, the mean intensity of pain was 8.5 in the haloperidol group and 8.28 in the placebo group; mean pretreatment nausea scores were 4.53 and 4.11, respectively. One hour after therapy, the mean pain and nausea scores in the haloperidol group were 3.13 and 1.83 compared to 7.17 and 3.39 in the placebo group. The reduction in mean pain intensity therapy was 5.37 in the haloperidol group (p ≤ 0.001) compared to 1.11 in the placebo group (p = 0.11). The reduction in mean nausea score was 2.70 in the haloperidol group (p ≤ 0.001) and 0.72 in the placebo group (p = 0.05). Therefore, the reductions in symptom scores were statistically significant in the haloperidol group but not in the placebo group. No adverse events were reported.

CONCLUSIONS

Haloperidol as an adjunctive therapy is superior to placebo for acute gastroparesis symptoms.

摘要

目的

胃轻瘫是一种使人衰弱的病症,会导致恶心、呕吐和腹痛。治疗方法包括使用镇痛药和止吐药,但症状往往难以缓解。氟哌啶醇已被用于姑息治疗中缓解类似症状。本研究的目的是确定氟哌啶醇作为传统疗法的辅助药物是否能改善前往急诊科(ED)就诊的胃轻瘫患者的症状。

研究设计与方法

这是一项针对既往诊断为胃轻瘫急性加重的成年急诊科患者的随机、双盲、安慰剂对照试验。治疗组接受5毫克氟哌啶醇加传统疗法(由主治医生确定)。对照组接受安慰剂加传统疗法。在干预前以及之后每15分钟对每位受试者的腹痛和恶心严重程度进行评估,持续1小时,疼痛采用10分制,恶心采用5分制。主要结局是治疗1小时后疼痛和恶心减轻。

结果

在33名研究患者中,15名被随机分配接受氟哌啶醇治疗。治疗前,氟哌啶醇组的平均疼痛强度为8.5,安慰剂组为8.28;治疗前的平均恶心评分分别为4.53和4.11。治疗1小时后,氟哌啶醇组的平均疼痛和恶心评分分别为3.13和1.83,而安慰剂组为7.17和3.39。氟哌啶醇组平均疼痛强度的降低为5.37(p≤0.001),而安慰剂组为1.11(p = 0.11)。氟哌啶醇组平均恶心评分的降低为2.70(p≤0.001),安慰剂组为0.72(p = 0.05)。因此,氟哌啶醇组的症状评分降低具有统计学意义,而安慰剂组则不然。未报告不良事件。

结论

氟哌啶醇作为辅助疗法治疗急性胃轻瘫症状优于安慰剂。

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