采用随机、开放、阳性药物平行对照研究评价玄柏爽声颗粒治疗喉瘖的临床疗效

目的评价中成药玄柏爽声颗粒治疗喉瘖的安全性和有效性。方法采用随机、开放、阳性药物平行对照的临床研究方法,所有喉瘖患者被随机分配服用黄氏响声丸(对照药)或玄柏爽声颗粒(试验药)。安全性研究终点为随访第4周受试者实验室检查、心电图检查及不良反应情况。有效性研究主要终点为随访第4周受试者嗓音嘶哑评估(grade,roughness,breathiness,asthenia and strain scale,GRBAS)评分变化,次要终点为受试者主观感受(patient-reported outcome,PRO)评分变化。结果 2014年8月至2015年6月总计143位喉瘖患者参与研究。玄柏爽声颗粒的总有效率为81.9%,PRO评分疗效指数为70%±28%;对照药黄氏响声丸的总有效率为55.1%,PRO评分疗效指数为30%±35%。玄柏爽声颗粒组的总有效率和PRO评分疗效指数均高于黄氏响声丸组,差异有统计学意义(P<0.05)。两组服药前后实验室检查、心电图检查、生命体征检查等均未出现有临床意义的改变,无不良事件发生。结论与黄氏响声丸相比,玄柏爽声颗粒治疗喉瘖的效果更佳。

Two closely neighboring hepatocellular carcinomas mimicking intrahepatic metastasis are confirmed as double primary tumors by the loss of heterozygosity analysis of microsatellites

Hepatocellular carcinoma （HCC） is a common malignancy around the world.Among all HCCs,multifocal HCC accounts for 12%-19%.1 The origin of multifocal HCC can either be the intrahepatic metastasis of a single tumor clone,or independent primaries.2 It is crucial to distinguish intrahepatic metastatic tumor from multicentric HCC because this distinction has significant impact on tumor staging,treatment plan,and clinical outcome.Routine histological examination alone cannot determine the clonal origin of multifocal HCC and usually results in their arbitrary classification as satellite nodules.The only way to reliably determine clonality among multiple lesions is by molecular genetic analysis.We report a patient who underwent surgical resection for two neighboring hepatocellular carcinomas that were from independent primaries.These separate nodules mimicked a solitary primary with intrahepatic metastasis.Confirmation of separate clones was established by the loss of heterozygosity （LOH） of microsatellites.