title: Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus in Adults: A Prospective Randomized Controlled Trial in China.
abstract: Although generalized convulsive status epilepticus (GCSE) is a life-threatening emergency, evidence-based data to guide initial drug treatment choices are lacking in the Chinese population. We conducted this prospective, randomized, controlled trial to evaluate the relative efficacy and safety of intravenous phenobarbital and valproate in patients with GCSE.
  
  
  
  After the failure of first-line diazepam treatment, Chinese adult patients with GCSE were randomized to receive either intravenous phenobarbital (standard doses, low rate) or valproate (standard). Successful treatment was considered when clinical and electroencephalographic seizure activity ceased. Adverse events following treatment, as well as the neurological outcomes at discharge and 3 months later, were also evaluated.
  
  
  
  Overall, 73 cases were enrolled in the study. Intravenous phenobarbital was successful in 81.1% of patients, and intravenous valproate was successful in 44.4% of patients (p < 0.05). The relapse rate of status epilepticus within 24 h of receiving phenobarbital (6.7%) was significantly lower than that in patients receiving valproate (31.3%), and the total number of adverse events did not differ significantly between the two groups (p > 0.05). In the phenobarbital group, two patients (5.4%) required ventilation and two patients (5.4%) developed serious hypotension. The neurological outcomes of the phenobarbital group were generally better than those of the valproate group; however, no significant differences were observed between phenobarbital and valproate with respect to mortality (8.1 vs. 16.6%) at discharge, or mortality (16.2 vs. 30.5%) and post-symptomatic epilepsy (26.3 vs. 42.8%) at 3-month follow-up.
  
  
  
  Intravenous phenobarbital appears to be more effective than intravenous valproate for Chinese adult patients with GCSE. The occurrence of serious respiratory depression and hypotension caused by phenobarbital was reduced by decreasing the intravenous infusion rate; however, even at a lower infusion rate than typically used in other institutions, intravenous phenobarbital resulted in more serious adverse events than intravenous valproate. The better outcomes in the phenobarbital group compared with the valproate group suggest that phenobarbital should be considered for the early successful treatment of GCSE.
authors.affiliation: Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China. suyingying@xwh.ccmu.edu.cn.
authors.forename: Yingying
authors.initials: Y
authors.lastname: Su
authors.affiliation: Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Liu
authors.affiliation: Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Tian
authors.affiliation: Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
authors.forename: Guoping
authors.initials: G
authors.lastname: Ren
authors.affiliation: Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
authors.forename: Mengdi
authors.initials: M
authors.lastname: Jiang
authors.affiliation: Department of Neurosurgery, Wayne State University School of Medicine, Detroit, MI, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Chun
authors.affiliation: Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
authors.forename: Yunzhou
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Ye
authors.affiliation: Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
authors.forename: Daiquan
authors.initials: D
authors.lastname: Gao
authors.affiliation: Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
authors.forename: Weibi
authors.initials: W
authors.lastname: Chen
mesh_terms: D061605:Administration, Intravenous / Q000379:methods; D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D002681:China; D003975:Diazepam / Q000627:therapeutic use; D004827:Epilepsy / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010634:Phenobarbital / Q000627:therapeutic use*; D011446:Prospective Studies; D013226:Status Epilepticus / Q000188:drug therapy*; D016896:Treatment Outcome; D014635:Valproic Acid / Q000627:therapeutic use*
chemical_list: D000927:Anticonvulsants; D014635:Valproic Acid; D003975:Diazepam; D010634:Phenobarbital