Clinical and epidemiological data of patients.

BackgroundBothrops atrox envenomation can cause significant local and systemic effects. Adjunctive therapies, such as cold and heat applications, are proposed to enhance antivenom efficacy, but their clinical value remains unclear.MethodsThis randomized, three-arm clinical trial included 94 patients allocated in a 1:1:1 ratio to Cold Therapy Group (CTG, n = 30), Heat Therapy Group (HTG, n = 31), or Control Group (CG, n = 33). All participants received standard antivenom therapy, with CTG and HTG receiving additional interventions applied for 24 hours post-admission. Primary outcomes included changes in creatine kinase (CK) levels. Secondary outcomes assessed pain intensity, edema, local temperature, and functional recovery using the World Health Organization Disability Assessment Schedule (WHODAS 2.0) assessed four to six months after hospital discharge. Kaplan-Meier survival analysis evaluated time-to-event outcomes.FindingsBaseline characteristics were comparable across groups. CK levels decreased similarly in all groups at 48 hours (p = 0.89). No significant differences were observed in the reduction of limb circumference, edema extent and bite site temperature, either the ITT or PP analysis. CTG showed a significant reduction in pain within 24 hours in the per-protocol analysis (Log-rank p = 0.04). Disability assessed by WHODAS 2.0 revealed no significant differences between groups after 6 months of follow-up. No adverse events were associated with the interventions.InterpretationAdjunctive HTG had no efficacy in treating local effects of B. atrox envenomation. Adjunctive CTG demonstrated benefits observed in pain reduction.

背景
三色矛头蝮（Bothrops atrox）咬伤中毒可引发显著的局部及全身不良反应。诸如冷疗、热疗在内的辅助治疗手段被认为可提升抗蛇毒血清的治疗效能，但其临床价值仍未明确。

方法
本随机三臂临床试验共纳入94例患者，按1:1:1的比例随机分配至冷疗组（CTG，n=30）、热疗组（HTG，n=31）与对照组（CG，n=33）。所有受试者均接受标准抗蛇毒血清治疗，冷疗组与热疗组额外在入院后接受时长24小时的对应干预。主要结局指标为肌酸激酶（CK）水平的动态变化；次要结局指标包括疼痛强度、肢体水肿程度、局部温度，以及于出院后4~6个月采用世界卫生组织残疾评定量表（WHODAS 2.0）评估的功能恢复状态。本研究采用Kaplan-Meier生存分析对事件发生时间结局进行统计分析。

结果
各组受试者的基线特征具有可比性。入院后48小时，所有组的肌酸激酶水平均呈现相似幅度的下降（p=0.89）。无论是意向治疗（ITT）分析还是符合方案（PP）分析，各组在肢体周径缩减量、水肿程度及咬伤部位局部温度变化方面均未观察到显著差异。符合方案分析结果显示，冷疗组在入院后24小时内的疼痛缓解效果更为显著（对数秩检验p=0.04）。采用WHODAS 2.0评估的残疾状态显示，随访6个月后各组间无显著差异。本研究未发现与两类干预措施相关的不良事件。

结论
辅助热疗对改善三色矛头蝮咬伤中毒的局部症状无明确疗效；而辅助冷疗则在疼痛缓解方面展现出明确获益。