Cho Seung-Yeon, Yang Seung-Bo, Shin Hee Sup, Lee Seung Hwan, Koh Jun Seok, Kwon Seungwon, Jung Woo-Sang, Moon Sang-Kwan, Park Jung-Mi, Ko Chang-Nam, Park Seong-Uk
Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Stroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea.
Trials. 2017 Jan 10;18(1):10. doi: 10.1186/s13063-016-1712-7.
Despite recent advances in the medical and surgical fields, complications such as infection, pneumonia, or brain swelling may occur after a craniotomy. In some patients, perioperative antibiotic prophylaxis causes adverse effects such as itching, rash, or digestive conditions. Certain patients still develop infections severe enough to require a repeat operation despite antibiotic prophylaxis. Acupuncture has been used to treat inflammatory conditions, and many basic and clinical studies have provided evidence of its anti-inflammatory and immune regulatory effects. The aim of this study is to explore the effects of acupuncture on inflammation and immune function after craniotomy.
This trial will be a single-center, parallel-group clinical trial. Forty patients who underwent craniotomy for an unruptured aneurysm, facial spasm, or a brain tumor will be allocated to either the study or the control group. The study group will receive conventional management as well as acupuncture, electroacupuncture, and intradermal acupuncture, which will start within 48 h of the craniotomy. The patients will receive a total of six sessions within 8 days. The control group will only receive conventional management. The primary outcome measure will be the C-reactive protein levels, while the secondary outcomes will be the serum erythrocyte sedimentation rate and the tumor necrosis factor-α, interleukin (IL)-1β, and IL-6 levels measured at four different time points: within 48 h prior to the craniotomy and on days 2, 4, and 7 after surgery. The presence of fever and infection, the use of additional antibiotics, the presence of infection, including pneumonia or urinary tract infection, and safety will also be investigated.
In this trial, we will observe whether acupuncture has anti-inflammatory and immune regulatory effects after a craniotomy. If our study yields positive results and a placebo-controlled study also finds favorable results following our study, acupuncture could be recommended as an adjunctive therapy after a craniotomy.
ClinicalTrials.gov: NCT02761096 . Registered on 27 April 2016.
尽管医学和外科领域最近取得了进展，但开颅手术后仍可能发生感染、肺炎或脑肿胀等并发症。在一些患者中，围手术期抗生素预防会引起瘙痒、皮疹或消化系统疾病等不良反应。尽管进行了抗生素预防，某些患者仍会发生严重感染，需要再次手术。针灸已被用于治疗炎症性疾病，许多基础和临床研究都提供了其抗炎和免疫调节作用的证据。本研究的目的是探讨针灸对开颅术后炎症和免疫功能的影响。
本试验将是一项单中心、平行组临床试验。40例因未破裂动脉瘤、面肌痉挛或脑肿瘤接受开颅手术的患者将被分配到研究组或对照组。研究组将接受常规治疗以及针灸、电针和皮内针治疗，治疗将在开颅术后48小时内开始。患者将在8天内共接受6次治疗。对照组仅接受常规治疗。主要结局指标将是C反应蛋白水平，次要结局指标将是血清红细胞沉降率以及在四个不同时间点测量的肿瘤坏死因子-α、白细胞介素（IL）-1β和IL-6水平：开颅术前48小时内以及术后第2、4和7天。还将调查发热和感染的情况、额外抗生素的使用、感染的存在，包括肺炎或尿路感染，以及安全性。
在本试验中，我们将观察针灸在开颅术后是否具有抗炎和免疫调节作用。如果我们的研究产生阳性结果，并且安慰剂对照研究在我们的研究之后也发现了有利结果，那么针灸可以被推荐为开颅术后的辅助治疗。
ClinicalTrials.gov：NCT02761096。于2016年4月27日注册。
