Real-world evidence (RWE) is clinical evidence on a medical product’s safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. This study evaluates the clinical ef...Real-world evidence (RWE) is clinical evidence on a medical product’s safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. This study evaluates the clinical efficacy of amoxicillin + clavulanic acid in children with pharyngitis, acute otitis, or acute rhinosinusitis with suspected bacterial origin under normal office and home conditions. Methods: This was a real-life, prospective, observational, pharmacovigilance study. It included children of both sexes between 2 and 12 years old, with a diagnosis of Rhinopharyngitis (tonsillitis), Acute Otitis Media and Rhinosinusitis. The main effectiveness variable evaluated was reduction and time to resolution of symptoms. All patients received Amoxicillin/Clavulanic Acid suspension 600 mg/42.9 mg/5 mL at a dose of 90 mg/Kg/day in two doses, every 12 hours for 7 days. The evaluations were carried out at the beginning, at 72 hours (3rd day) and at 7 days. All patients underwent culture and antibiogram. Results: The majority of cultures were negative for pathogenic germs, suspecting unidentifiable germs, or viral etiology despite the rigorous selection of subjects following validated scores. The most frequently isolated germ was Staphylococcus aureus;growth of gram-negative bacteria was reported in 33.33% of the cultures. There was a significant improvement in symptoms in children with tonsillitis and rhinosinusitis from the first 72 hours of treatment, persisting until the 7 days. In the otitis media group, returning to normal by the tenth day. During the conduction of this investigation, no adverse effects associated with the prescribed therapy were reported.展开更多
【目的】评价加味普济消毒颗粒(由金银花、连翘、蒲公英、紫花地丁、荆芥、牛蒡子、皂角刺、赤芍、牡丹皮、芦根等组成)内服联合消肿散结膏(由黄芩、黄连、黄柏、皂角刺等组成)外敷治疗儿童急性扁桃体炎(acute tonsillitis in children,...【目的】评价加味普济消毒颗粒(由金银花、连翘、蒲公英、紫花地丁、荆芥、牛蒡子、皂角刺、赤芍、牡丹皮、芦根等组成)内服联合消肿散结膏(由黄芩、黄连、黄柏、皂角刺等组成)外敷治疗儿童急性扁桃体炎(acute tonsillitis in children,ATC)的临床疗效及对免疫功能与相关炎症指标的影响。【方法】将116例ATC肺胃郁热证患儿随机分为对照组和观察组,每组各58例。对照组给予头孢克肟分散片治疗,观察组给予加味普济消毒颗粒内服联合消肿散结膏外敷治疗,疗程为14 d并随访6个月。观察2组患儿治疗前后中医证候积分、外周血中白细胞计数(WBC)、T淋巴细胞亚群CD3^(+)、CD4^(+)、CD8^(+)和CD4^(+)/CD8^(+)水平及血清肿瘤坏死因子α(TNF-α)、白细胞介素1β(IL-1β)、白细胞介素6(IL-6)、C反应蛋白(CRP)水平的变化情况,比较2组患儿的临床疗效和各项临床症状消失时间,同时监测2组患儿的不良反应发生情况和扁桃体炎复发情况。【结果】(1)研究期间,对照组有8例患儿脱落,观察组无脱落病例,最终对照组50例、观察组58例患儿完成全部疗程的治疗。(2)治疗14 d后,观察组的总有效率为98.28%(57/58),对照组为90.00%(45/50);组间比较(秩和检验),观察组的临床疗效明显优于对照组(P<0.05)。(3)治疗后,观察组患儿的咽痛消失时间、脓点消失时间、退热时间及扁桃体恢复正常时间均较对照组明显缩短(P<0.05)。(4)治疗后,2组患儿的主症积分、次症积分和中医证候总积分均较治疗前明显降低(P<0.05),且观察组的降低幅度均明显优于对照组(P<0.05)。(5)治疗后,2组患儿的T淋巴细胞亚群CD3^(+)、CD4^(+)和CD4^(+)/CD8^(+)水平均较治疗前明显升高(P<0.05),CD8^(+)水平均较治疗前明显降低(P<0.05),且观察组对T淋巴细胞亚群CD3^(+)、CD4^(+)和CD4^(+)/CD8^(+)水平的升高幅度及对CD8^(+)水平的降低幅度均明显优于对照组(P<0.05)。(6)治疗后,2组患儿的WBC、TNF-α、IL-1β、IL-6及CRP水平均较治疗前明显降低(P<0.05),且观察组的降低幅度均明显优于对照组(P<0.05)。(7)治疗期间,2组患儿均未出现皮肤过敏及恶心、呕吐等胃肠道不良反应情况,具有较高的安全性。(8)随访6个月,观察组患儿的扁桃体炎复发率为5.17%(3/58),明显低于对照组的24.00%(12/50),组间比较,差异有统计学意义(χ2=8.330,P<0.05)。【结论】加味普济消毒颗粒内服联合消肿散结膏外敷治疗ATC肺胃郁热证患儿疗效显著,可明显缩短病程,改善临床症状,有效降低扁桃体炎复发率,其机制可能与增强机体免疫功能、抑制炎症反应有关。展开更多
文摘Real-world evidence (RWE) is clinical evidence on a medical product’s safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. This study evaluates the clinical efficacy of amoxicillin + clavulanic acid in children with pharyngitis, acute otitis, or acute rhinosinusitis with suspected bacterial origin under normal office and home conditions. Methods: This was a real-life, prospective, observational, pharmacovigilance study. It included children of both sexes between 2 and 12 years old, with a diagnosis of Rhinopharyngitis (tonsillitis), Acute Otitis Media and Rhinosinusitis. The main effectiveness variable evaluated was reduction and time to resolution of symptoms. All patients received Amoxicillin/Clavulanic Acid suspension 600 mg/42.9 mg/5 mL at a dose of 90 mg/Kg/day in two doses, every 12 hours for 7 days. The evaluations were carried out at the beginning, at 72 hours (3rd day) and at 7 days. All patients underwent culture and antibiogram. Results: The majority of cultures were negative for pathogenic germs, suspecting unidentifiable germs, or viral etiology despite the rigorous selection of subjects following validated scores. The most frequently isolated germ was Staphylococcus aureus;growth of gram-negative bacteria was reported in 33.33% of the cultures. There was a significant improvement in symptoms in children with tonsillitis and rhinosinusitis from the first 72 hours of treatment, persisting until the 7 days. In the otitis media group, returning to normal by the tenth day. During the conduction of this investigation, no adverse effects associated with the prescribed therapy were reported.
