长托宁改良方案治疗急性重度有机磷农药中毒效果的临床研究

Clinical study on revised penehyclidine hydrochloride treatment program for acute severe organophosphorus pesticide poisoning

[背景]长托宁常规方案治疗急性重度有机磷农药中毒(ASOPP)效果肯定,但不良反应发生率偏高。[目的]观察长托宁改良方案治疗ASOPP的临床效果。[方法]采用前瞻性单盲随机对照研究,将157例ASOPP患者按随机数字编码法随机分为改良方案组(82例)和常规方案组(75例),两组均予以积极生命支持;常规洗胃、导泻;氯解磷定使用方法相同。改良方案组采用长托宁改良方案(首剂采用较小的剂量,其后通过相对频繁的时间点进行观察,进行小剂量给药/停药调控);常规方案组采用目前临床常用的方案。比较两组的临床疗效及长托宁不良反应发生率。[结果]与常规方案组相比,改良方案组达到“长托宁化”时间延长,有效导泻成功率升高,全血胆碱酯酶拐点时间提前,平均住院时间缩短,差异均有统计学意义(均P <0.05);两组之间有机磷农药中毒症状消失时间、中间期肌无力综合征发生率、迟发性多发性神经病发生率、机械通气时间、治愈率差异均不具有统计学意义(均P> 0.05)。改良方案组心动过速发生率、谵妄发生率均低于常规方案组(均P <0.05)。[结论]与常规方案相比,长托宁改良方案临床疗效基本相同,不良反应发生率降低。

[Background] The current treatment program with penehyclidine hydrochloride(PHC) for acute severe organophosphorus pesticide poisoning(ASOPP) patients exerts a positive effect but with concerned adverse reactions.[Objective] To evaluate the treatment effect of a revised ASOPP treatment program with PHC.[Methods] A prospective single-blind randomized controlled trial was conducted. A total of 157 patients with ASOPP were divided into a revised treatment group(82 cases) and a conventional treatment group(75 cases) by random number table. The two groups received the same basic treatment measures including active life support, routine gastric lavage, catharsis, and pralidoxime treatment. The revised treatment group followed a revised PHC treatment protocol initiated by first a small dose of PHC and followed by small doses of PHC administration/discontinuation through frequent observations at different time points. The conventional treatment group received the conventional program. Treatment effects and incidence rates of possible adverse reactions were compared between the two groups.[Results] Compared with the conventional treatment group, the revised treatment group obtained delay in penetrogenation time point, higher success rate in catharsis, earlier cholinesterase-turning time, and shorter hospitalization period with statistical significance(all Ps < 0.05). No differences were found in terms of time for symptoms of poisoning to disappear, incidence rates of intermediate myasthenic syndrome and delayed polyneuropathy, mechanical ventilation time, and cure rate(all Ps > 0.05). Less adverse reactions occurred in the revised treatment group including tachycardia and delirium than in the conventional treatment control group(all Ps < 0.05).[Conclusion] The revised ASOPP treatment program with PHC is similar to the current recommended treatment program in treatment effects, but with less adverse reactions.