清喉咽含片治疗急性咽炎的临床研究
2022-06-09
[摘要]研究评价了清喉咽含片相较于清喉咽合剂治疗急性咽炎（肺热阴虚证）的临床有效性和安全性。本试验共纳入144例受试者，随机分为试验组和对照组（各72例），试验组服用清喉咽含片，对照组服用清喉咽合剂，疗程5d，以咽痛或吞咽痛消失率、中医证候的综合疗效、中医证候积分、单项症状及体征的消失率等为有效性评价指标，试验过程中密切观察生命体征、实验室检查指标、不良事件安全性评价指标。FAS结果显示，咳嗽消失率、中医证候愈显率、咽黏膜、悬雍垂轻度充血水肿体征消失率均为试验组优于对照组（P<0.05），中医证候积分的变化值2组间差异有统计学意义（P<0.05）;试验组有3例不良事件，对照组有6例不良事件，2组之间不良事件发生率差异无统计学意义，无严重实验室检查异常，无生命体征异常。综合以上研究，清喉咽含片治疗急性咽炎（肺热阴虚证）疗效优于清喉咽合剂，安全性良好。
[关键词]清喉咽含片;急性咽炎;咽痛;吞咽痛
Clinical stury on Qinghouyan lozenge in treatment of acute pharyngitis
YU Jiao-jiao1， XUAN Zhen-yu1*， RUAN Yan2， ZHANG Hui-yong3， SHI Ke-hua4， GUO Yu4
（1. Suzhou Youseen New Drug R&D Co.Ltd.， Suzhou 215123， China;
2. The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine， Guangzhou 510405， China;
3. Longhua Hospital Shanghai University of Traditional Chinese Medicine， Shanghai 200032， China;
4. Shanghai Municipal Hospital of Traditional Chinese Medicine， Shanghai 200071， China）
[Abstruct]To evaluate the clinical efficacy and safety of Qinghouyan lozenge in the treatment of acute pharyngitis due to Lung-heat and Yin-deficiency， and compare with Qinghouyan oral Liquid. Totally 144 subjects were enrolled and randomly divided into two groups （72 in the test group and 72 in the control group）. The participants in the test group were given Qinghouyan lozenge for 5 days， and those in the control group were given Qinghouyan oral Liquid for 5 days. The effectiveness evaluation indexes were pharyngalgia/odynophagia disappearance rate， overall efficacy of TCM syndromes， TCM syndrome scores， and single syndrome and sign disappearance rate. During the test， the safety was evaluated by vital sign， lab examination indexes and adverse events. The results for the full analysis set showed that the couth disappearance rate， the incidence rate of TCM syndromes， and the throat/uvula congestion disappearance rate of the test group were higher than that of the control group （P<0.05）， with significant differences in the changes in syndrome scores between the two groups （P<0.05）. Altogether 3 adverse events were observed in the test group while 6 adverse events in the control group， without significant differences in the adverse event rate between the two groups （P<0.05）， serious abnormal laboratory examinations and vital signs. In conclusion， Qinghouyan lozenge has better efficacy in treatment of acute pharyngitis due to Lung-heat and Yin-deficiency than Qinghouyan oral liquid， with good safety.
[Key words]Qinghouyan lozenge; acute pharyngitis; pharyngalgia; odynophagia
doi：10.4268/cjcmm20150235
急性咽炎为上呼吸道急性感染的一部分，多发于冬、春季，以病毒、细菌感染多见，临床上约有5%的发病率[1]。西医主要采取抗生素治疗，包括青霉素、大环内酯类及先锋霉素类[2]，对青霉素过敏的患者可用克拉霉素或红霉素替代[3-4]，但是青霉素V10d疗程治疗方案治疗失败率达30%[5]，其他抗生素的短程疗法在安全性和有效性方面没有差异[6-7]。另外临床上对于急性咽炎抗生素疗法也存在一定的争议，如欧美12个国家的急性咽炎诊疗指南中对于抗生素治疗的方案和疗程也有很大的差别[8]。
中医药在本病的诊疗上有着一定的优势，清喉咽合剂临床应用几十年，疗效确切，由玄参、生地、麦冬、黄芩、连翘组成[9]，具有养阴清热解毒、润肺利咽的功效。急性咽炎是1种以咽喉局部症状为主的疾病，改成含片后局部给药作用更直接迅速，日服药量也大大减少，降低了潜在的安全性风险，并且服用更方便，用药更准确，更利于临床使用推广。
1对象与方法
1.1病例来源
病例来自于2009年11月至2010年6月广州中医药大学第一附属医院、上海中医药大学附属龙华医院、上海市中医医院耳鼻喉科及呼吸科的门诊急性咽炎患者。
1.2诊断标准
参照黄选兆等主编《实用耳鼻咽喉科学》[10]、《中药新药治疗急性咽炎的临床研究指导原则》2002版[11]、中华人民共和国中医药行业标准《中医耳鼻喉科病证诊断疗效标准》[12]制定。
1.2.1西医诊断标准急性发作，具备咽痛或吞咽痛主症，并有1项或1项以上检查见阳性体征，即可诊断。
1.2.2中医辨证标准凡具备主症咽痛或吞咽痛为必备项，阳性体征1项，次症≥1项者，同时参照上述舌脉象者，可诊断为肺热阴虚咽痛症。
[关键词]清喉咽含片;急性咽炎;咽痛;吞咽痛
Clinical stury on Qinghouyan lozenge in treatment of acute pharyngitis
YU Jiao-jiao1， XUAN Zhen-yu1*， RUAN Yan2， ZHANG Hui-yong3， SHI Ke-hua4， GUO Yu4
（1. Suzhou Youseen New Drug R&D Co.Ltd.， Suzhou 215123， China;
2. The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine， Guangzhou 510405， China;
3. Longhua Hospital Shanghai University of Traditional Chinese Medicine， Shanghai 200032， China;
4. Shanghai Municipal Hospital of Traditional Chinese Medicine， Shanghai 200071， China）
[Abstruct]To evaluate the clinical efficacy and safety of Qinghouyan lozenge in the treatment of acute pharyngitis due to Lung-heat and Yin-deficiency， and compare with Qinghouyan oral Liquid. Totally 144 subjects were enrolled and randomly divided into two groups （72 in the test group and 72 in the control group）. The participants in the test group were given Qinghouyan lozenge for 5 days， and those in the control group were given Qinghouyan oral Liquid for 5 days. The effectiveness evaluation indexes were pharyngalgia/odynophagia disappearance rate， overall efficacy of TCM syndromes， TCM syndrome scores， and single syndrome and sign disappearance rate. During the test， the safety was evaluated by vital sign， lab examination indexes and adverse events. The results for the full analysis set showed that the couth disappearance rate， the incidence rate of TCM syndromes， and the throat/uvula congestion disappearance rate of the test group were higher than that of the control group （P<0.05）， with significant differences in the changes in syndrome scores between the two groups （P<0.05）. Altogether 3 adverse events were observed in the test group while 6 adverse events in the control group， without significant differences in the adverse event rate between the two groups （P<0.05）， serious abnormal laboratory examinations and vital signs. In conclusion， Qinghouyan lozenge has better efficacy in treatment of acute pharyngitis due to Lung-heat and Yin-deficiency than Qinghouyan oral liquid， with good safety.
[Key words]Qinghouyan lozenge; acute pharyngitis; pharyngalgia; odynophagia
doi：10.4268/cjcmm20150235
急性咽炎为上呼吸道急性感染的一部分，多发于冬、春季，以病毒、细菌感染多见，临床上约有5%的发病率[1]。西医主要采取抗生素治疗，包括青霉素、大环内酯类及先锋霉素类[2]，对青霉素过敏的患者可用克拉霉素或红霉素替代[3-4]，但是青霉素V10d疗程治疗方案治疗失败率达30%[5]，其他抗生素的短程疗法在安全性和有效性方面没有差异[6-7]。另外临床上对于急性咽炎抗生素疗法也存在一定的争议，如欧美12个国家的急性咽炎诊疗指南中对于抗生素治疗的方案和疗程也有很大的差别[8]。
中医药在本病的诊疗上有着一定的优势，清喉咽合剂临床应用几十年，疗效确切，由玄参、生地、麦冬、黄芩、连翘组成[9]，具有养阴清热解毒、润肺利咽的功效。急性咽炎是1种以咽喉局部症状为主的疾病，改成含片后局部给药作用更直接迅速，日服药量也大大减少，降低了潜在的安全性风险，并且服用更方便，用药更准确，更利于临床使用推广。
1对象与方法
1.1病例来源
病例来自于2009年11月至2010年6月广州中医药大学第一附属医院、上海中医药大学附属龙华医院、上海市中医医院耳鼻喉科及呼吸科的门诊急性咽炎患者。
1.2诊断标准
参照黄选兆等主编《实用耳鼻咽喉科学》[10]、《中药新药治疗急性咽炎的临床研究指导原则》2002版[11]、中华人民共和国中医药行业标准《中医耳鼻喉科病证诊断疗效标准》[12]制定。
1.2.1西医诊断标准急性发作，具备咽痛或吞咽痛主症，并有1项或1项以上检查见阳性体征，即可诊断。
1.2.2中医辨证标准凡具备主症咽痛或吞咽痛为必备项，阳性体征1项，次症≥1项者，同时参照上述舌脉象者，可诊断为肺热阴虚咽痛症。