【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
OBJECTIVE: To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease(heat in the lung-wei) to further identify the indications....OBJECTIVE: To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease(heat in the lung-wei) to further identify the indications.METHODS: This randomized, double-blind, parallel, controlled trial will include patients with acute upper respiratory infection and wind-warmth lung-heat disease(heat in the lung-wei). Patientswith serious bacterial infection(white blood cell count > 12 × 10~9, neutrophils > 80%) will be excluded. Patients will be divided into three categories(blocks) according to their condition: fever only, a swollen and sore throat, and combined fever plus a swollen and sore throat. Patients within each of the three blocks will be further divided into a treatment group and a control group via stratified blocked randomization. The treatment group will be treated with Jinye Baidu granule, and the control group will be treated with Fufang Shuanghua granule. The primary outcome measure will be body temperature recovery time for patients with fever, throat symptom score for patients with a swollen and sore throat, and body temperature recovery time and throat symptom score for patients with combined fever plus a swollen and sore throat. Routine blood testing, urine testing, liver function, kidney function and ECG data of all patients will be collected as safety indices before and after enrollment, and adverse events will be recorded during the whole trial course.CONCLUSION: This study protocol will include stratified block analysis according to patients' symptoms, and identify the accurate clinical indications of Jinye Baidu granule. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment.展开更多
基金Supported by the Ninth Scientific Research Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(No.Z0406)the Research Project of World Federation of Chinese Medicine Societies(SCEPCM12E001)the Special Research Project of Traditional Chinese Medicines by the State Administration of Traditional Chinese Medicine(No.201507003-8)
文摘OBJECTIVE: To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease(heat in the lung-wei) to further identify the indications.METHODS: This randomized, double-blind, parallel, controlled trial will include patients with acute upper respiratory infection and wind-warmth lung-heat disease(heat in the lung-wei). Patientswith serious bacterial infection(white blood cell count > 12 × 10~9, neutrophils > 80%) will be excluded. Patients will be divided into three categories(blocks) according to their condition: fever only, a swollen and sore throat, and combined fever plus a swollen and sore throat. Patients within each of the three blocks will be further divided into a treatment group and a control group via stratified blocked randomization. The treatment group will be treated with Jinye Baidu granule, and the control group will be treated with Fufang Shuanghua granule. The primary outcome measure will be body temperature recovery time for patients with fever, throat symptom score for patients with a swollen and sore throat, and body temperature recovery time and throat symptom score for patients with combined fever plus a swollen and sore throat. Routine blood testing, urine testing, liver function, kidney function and ECG data of all patients will be collected as safety indices before and after enrollment, and adverse events will be recorded during the whole trial course.CONCLUSION: This study protocol will include stratified block analysis according to patients' symptoms, and identify the accurate clinical indications of Jinye Baidu granule. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment.
