蜂毒治疗帕金森病——一项随机对照临床试验
Bee Venom for the Treatment of Parkinson Disease - A Randomized Controlled Clinical Trial.
作者信息
Hartmann Andreas, Müllner Julia, Meier Niklaus, Hesekamp Helke, van Meerbeeck Priscilla, Habert Marie-Odile, Kas Aurélie, Tanguy Marie-Laure, Mazmanian Merry, Oya Hervé, Abuaf Nissen, Gaouar Hafida, Salhi Sabrina, Charbonnier-Beaupel Fanny, Fievet Marie-Hélène, Galanaud Damien, Arguillere Sophie, Roze Emmanuel, Degos Bertrand, Grabli David, Lacomblez Lucette, Hubsch Cécile, Vidailhet Marie, Bonnet Anne-Marie, Corvol Jean-Christophe, Schüpbach Michael
机构信息
Assistance Publique Hôpitaux de Paris (APHP), UPMC, INSERM, ICM, Centre d'Investigation Clinique Pitié Neurosciences, CIC-1422, Département des Maladies du Système Nerveux, Hôpital Pitié-Salpêtrière, Paris, France.
Assistance Publique Hôpitaux de Paris (APHP), Service de Médecine Nucléaire, Hôpital Pitié-Salpêtrière, Paris, France.
出版信息
PLoS One. 2016 Jul 12;11(7):e0158235. doi: 10.1371/journal.pone.0158235. eCollection 2016.
UNLABELLED
In the present study, we examined the potential symptomatic and/or disease-modifying effects of monthly bee venom injections compared to placebo in moderatly affected Parkinson disease patients. We conducted a prospective, randomized double-blind study in 40 Parkinson disease patients at Hoehn & Yahr stages 1.5 to 3 who were either assigned to monthly bee venom injections or equivalent volumes of saline (treatment/placebo group: n = 20/20). The primary objective of this study was to assess a potential symptomatic effect of s.c. bee venom injections (100 μg) compared to placebo 11 months after initiation of therapy on United Parkinson’s Disease Rating Scale (UPDRS) III scores in the « off » condition pre-and post-injection at a 60 minute interval. Secondary objectives included the evolution of UPDRS III scores over the study period and [123I]-FP-CIT scans to evaluate disease progression. Finally, safety was assessed by monitoring specific IgE against bee venom and skin tests when necessary. After an 11 month period of monthly administration, bee venom did not significantly decrease UPDRS III scores in the « off » condition. Also, UPDRS III scores over the study course, and nuclear imaging, did not differ significantly between treatment groups. Four patients were excluded during the trial due to positive skin tests but no systemic allergic reaction was recorded. After an initial increase, specific IgE against bee venom decreased in all patients completing the trial. This study did not evidence any clear symptomatic or disease-modifying effects of monthly bee venom injections over an 11 month period compared to placebo using a standard bee venom allergy desensitization protocol in Parkinson disease patients. However, bee venom administration appeared safe in non-allergic subjects. Thus, we suggest that higher administration frequency and possibly higher individual doses of bee venom may reveal its potency in treating Parkinson disease.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01341431.
未标注
在本研究中，我们比较了每月注射蜂毒与安慰剂对中度帕金森病患者的潜在症状改善和/或疾病修饰作用。我们对40例Hoehn & Yahr分期为1.5至3期的帕金森病患者进行了一项前瞻性、随机双盲研究，这些患者被随机分配接受每月一次的蜂毒注射或等量生理盐水注射（治疗/安慰剂组：n = 20/20）。本研究的主要目的是评估皮下注射蜂毒（100μg）与安慰剂相比，在治疗开始11个月后，对处于“关”状态的帕金森病统一评分量表（UPDRS）III评分在注射前和注射后60分钟间隔时的潜在症状改善作用。次要目的包括研究期间UPDRS III评分的变化以及[123I]-FP-CIT扫描以评估疾病进展。最后，通过监测针对蜂毒的特异性IgE并在必要时进行皮肤试验来评估安全性。在每月给药11个月后，蜂毒在“关”状态下并未显著降低UPDRS III评分。此外，在整个研究过程中，治疗组之间的UPDRS III评分和核成像结果也没有显著差异。4例患者因皮肤试验阳性在试验期间被排除，但未记录到全身性过敏反应。在所有完成试验的患者中，针对蜂毒的特异性IgE在最初升高后下降。与使用标准蜂毒过敏脱敏方案的安慰剂相比，本研究未证明在11个月期间每月注射蜂毒对帕金森病患者有任何明显的症状改善或疾病修饰作用。然而，在非过敏受试者中，蜂毒给药似乎是安全的。因此，我们建议更高的给药频率以及可能更高的个体剂量的蜂毒可能会显示出其治疗帕金森病的效力。
试验注册
ClinicalTrials.gov NCT01341431。
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