我国示范乡镇卫生院基本药物循证评价与遴选之三:普通感冒

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目的循证评价与遴选我国乡镇卫生院治疗感冒患儿发热、成人胃肠型感冒的基本药物。方法针对示范乡院反映的感冒药物配备问题,应用本系列研究之二制定的基本药物循证评价与遴选标准、方法和流程,循证评价并推荐相关药物。采用RevMan 5.1和GRADEpro等软件统计分析数据和评价证据质量。结果①共纳入12个治疗指南,其中11个是循证或结合专家意见制定,推荐药物包括解热镇痛、解充血、抗组胺、止咳、祛痰、治疗胃肠道症状。②4个RCT(极低质量证据)表明布洛芬混悬液对感冒患儿的解热效果与对乙酰氨基酚悬浮液相似,其6小时解热有效率合并结果为RR=1.48,95%CI(0.66,3.30),P=0.34;不良反应主要是消化道不良反应和出汗较多[RR=1.23,95%CI(0.72,2.11),P=0.45];药费1.93元/d;口服且不需督导用药,适用性好。③与布洛芬混悬液相比,3个RCT(低质量证据)表明用药30分钟、1小时后,对乙酰氨基酚(扑热息痛)栓剂降低体温效果较优[MD=–0.16°C,95%CI(–0.21,–0.11),P<0.01)与MD=–0.19°C,95%CI(–0.28,0.10),P<0.01];不良反应主要是肛门刺激不适症状、皮疹、出汗较多;药物不良反应[RR=1.84,95%CI(0.62,5.44),P=0.27];发热患儿药费0.90元/d;经肛门用药,适用性好。④与吗丁啉相比,5个CCT(低级证据质量)显示藿香正气软胶囊治疗胃肠道症状效果更好,有效率合并结果为RR=3.09,95%CI(2.01,4.75),P<0.05;1个RCT(中级证据质量)表明,该药治疗感冒所致胃肠道症状总有效率98.06%;无药物不良反应事件发生;药费0.67元/d;口服,适用性好。⑤治疗对乙酰氨基酚中毒,国外1项回顾性研究表明,15例(23%)在8小时内给予乙酰半胱氨酸注射液治疗的患者无死亡或进展为肝衰竭、肾衰竭。8小时后接受乙酰半胱氨酸注射液治疗的患者住院时间>3天,而8小时内接受该药治疗患者仅1天;15 min组肝毒性发生率为0%~9%(95%CI);25例60 min组为0%~12%(95%CI);可导致潮红、皮疹及瘙痒。注射用药需专业人员监督、指导使用,适用性差;药费儿童40元/d,成人160元/d。结论①儿童普通感冒发热对症治疗疼痛不适强推荐布洛芬混悬液、扑热息痛栓剂;强推荐藿香正气软胶囊治疗成人感冒胃肠症状。弱推荐乙酰半胱氨酸注射液治疗对乙酰氨基酚中毒。②建议尽量报道大样本对照研究,完善结局指标,以便生产高质量本土化证据。 Objective Evidence-based evaluation and selection of China’s township hospitals for the treatment of children with fever, adult gastrointestinal influenza basic drugs. Methods Aiming at the problem of cold medicine allocation reflected in Model Rural Hospital, the basic drug evidence-based evaluation and selection criteria, methods and procedures developed in this series two were applied to evaluate and recommend relevant drugs. RevMan 5.1 and GRADEpro software such as statistical analysis of data and evaluation of evidence of quality. Results ① A total of 12 treatment guidelines were included, of which 11 were evidence-based or combined with expert opinion. The recommended drugs included antipyretic and analgesic, decongestant, antihistamine, cough and expectorant treatment of gastrointestinal symptoms. ② Four RCTs (very low quality evidence) showed that the ibuprofen suspension had a similar antipyretic effect to acetaminophen suspension in children with colds. The 6-hour antipyretic efficiency was associated with RR = 1.48 and 95% CI (0.66, 3.30), P = 0.34; adverse reactions were mainly gastrointestinal adverse reactions and sweating more [RR = 1.23,95% CI (0.72,2.11), P = 0.45]; And without supervision of medication, good applicability. (3) Compared with the ibuprofen suspension, three RCTs (low quality evidence) showed that acetaminophen (acetaminophen) suppository had a lower body temperature effect after 30 minutes and 1 hour of treatment [MD = -0.16 ° C, 95 % CI (-0.21, -0.11), P <0.01) and MD = -0.19 ° C, 95% CI (-0.28,0.10), P <0.01]. The adverse reactions were mainly anal irritation, rash, sweating More; adverse drug reactions [RR = 1.84,95% CI (0.62,5.44), P = 0.27]; children with fever drug 0.90 yuan / d; anal medication, good applicability. ④ Compared with domperidone, 5 CCTs showed that Huoxiang Zhengqi Soft Capsule was more effective in treating gastrointestinal symptoms. The effective combined results were RR = 3.09, 95% CI (2.01, 4.75), P <0.05; one RCT (intermediate evidence quality) showed that the drug had the total effective rate of 98.06% for the treatment of gastrointestinal symptoms caused by colds; no adverse drug reactions occurred; the cost was 0.67 yuan / d; ⑤ treatment of paracetamol poisoning, a retrospective study showed that 15 patients (23%) given within 8 hours of acetylcysteine ​​injection in patients with no death or progression of liver failure and renal failure. Patients who received acetylcysteine ​​injection after 8 hours spent> 3 days in hospital, compared with only 1 day after receiving the drug within 8 hours. The incidence of hepatotoxicity in 15 min was 0% to 9% (95% CI ); 0% ~ 12% (95% CI) in 25 cases of 60 min group; could cause flushing, rash and pruritus. Injections need professional supervision, guidance, poor applicability; drug children 40 yuan / d, adult 160 yuan / d. Conclusion ① common cold fever in children symptomatic treatment of pain and discomfort strongly recommended ibuprofen suspension, paracetamol suppository; strongly recommended Huoxiangzhengqi soft capsule for the treatment of adult gastrointestinal symptoms of influenza. Weakly recommend acetylcysteine ​​injection for acetaminophen poisoning. ② It is advisable to report large sample control studies as far as possible and improve outcome indicators in order to produce high-quality indigenous evidence.
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