Jin Y Y, Qin C H, Duan B L, Huang Y Q, Ma K
Department of Pain Medicine, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200092, China.
Department of Pain Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.
Zhonghua Yi Xue Za Zhi. 2021 Nov 23;101(43):3575-3580. doi: 10.3760/cma.j.cn112137-20210817-01867.
To investigate the analgesic efficacy and safety of state-dependent sodium channel blocker-bulleyaconitine combined with calcium channel blocker-gabapentin on postherpetic neuralgia (PHN). A double-blind, randomized, placebo-controlled, parallel-group, multi-center study involving Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Qinghai Provincial People's Hospital, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, the Second Affiliated Hospital of Kunming Medical University was performed from September 2018 to December 2019. A total of 75 PHN patients were randomly divided into the experiment group (=41) and the control group (=34). On the basis of first-line treatment with gabapentin, the experiment group was given bulleyaconitine A tablets, while the control group was given placebo. The primary outcome was a 50% improvement in the visual analogue scale (VAS), and the effective rate of achieving the primary outcome between the two groups was compared; the Cox regression model was used to analyze the impact of related factors on the disease outcome. Secondary outcomes including scores of pain scales (ID-pain, DN4), Patient Health Questionnaire (PHQ-9), 7-item Generalized Anxiety Disorder (GAD-7) at 1, 2, 3, 4, 8, 12 weeks after treatment were applied to evaluate the efficacy and safety of the combination of bulleyaconitine A tablets with first-line drug in the treatment of PHN. The effective rate was 68.3% (28/41) and the time reached the primary outcome was 28 (7, 84) days in the experiment group, while in the control group, the effective rate was 52.9% (18/34) and the time reached the primary outcome was 56 (14, 84) days. Cox regression analysis indicated that the grouping factor of oral bulleyaconitine A tablets was an independent factor for improving the outcome of PHN (=2.063, 95%: 1.059-4.018, <0.05), and the probability of the experiment group reaching the primary outcome was 2.063 times that of the control group (<0.05). Meanwhile, the outcome probability of the long disease course group (>6 months) was only 0.201 times that of the short disease course group (<6 months) (=0.201, 95%: 0.073-0.551, <0.05). There was no statistically significant difference in the trend of VAS between the two groups (>0.05). The scores of ID-pain, DN4, PHQ-9, and GAD-7 of the two groups were significantly improved compared with those before enrollment (<0.05), but the differences between the two groups were not statistically significant (all >0.05). Bulleyaconitine A tablet can promote the therapeutic efficacy of gabapentin, and improve the outcome of PHN in a short period of 3 months.
探讨状态依赖性钠通道阻滞剂—草乌甲素与钙通道阻滞剂—加巴喷丁联合应用于带状疱疹后神经痛（PHN）的镇痛疗效及安全性。于2018年9月至2019年12月开展了一项双盲、随机、安慰剂对照、平行组、多中心研究，研究单位包括上海交通大学医学院附属新华医院、青海省人民医院、上海中医药大学附属岳阳中西医结合医院、昆明医科大学第二附属医院。共75例PHN患者被随机分为试验组（n = 41）和对照组（n = 34）。在加巴喷丁一线治疗基础上，试验组给予草乌甲素片，对照组给予安慰剂。主要结局为视觉模拟量表（VAS）改善50%，比较两组达到主要结局的有效率；采用Cox回归模型分析相关因素对疾病结局的影响。次要结局包括治疗后1、2、3、4、8、12周的疼痛量表（ID-疼痛、DN4）评分、患者健康问卷（PHQ-9）、广泛性焦虑障碍7项量表（GAD-7），用于评估草乌甲素片与一线药物联合治疗PHN的疗效和安全性。试验组有效率为68.3%（28/41），达到主要结局时间为28（7，84）天，而对照组有效率为52.9%（18/34），达到主要结局时间为56（14，84）天。Cox回归分析表明，口服草乌甲素片的分组因素是改善PHN结局的独立因素（HR = 2.063，95%CI：1.059 - 4.018，P < 0.05），试验组达到主要结局的概率是对照组的2.063倍（P < 0.05）。同时，病程长组（>6个月）的结局概率仅为病程短组（<6个月）的0.201倍（HR = 0.201，95%CI：0.073 - 0.551，P < 0.05）。两组VAS变化趋势差异无统计学意义（P > 0.05）。两组的ID-疼痛、DN4、PHQ-9和GAD-7评分与入组前相比均显著改善（P < 0.05），但两组间差异无统计学意义（均P > 0.05）。草乌甲素片可提高加巴喷丁的治疗效果，并在3个月的短时间内改善PHN结局。
