摘要
目的:在Ⅱa期临床试验基础上,探索新型光敏剂-注射用海姆泊芬联合532nm激光光动力治疗微静脉畸形的最佳剂量,初步评价该治疗方法的有效性及安全性,为后续临床试验提供依据。方法:遵循平行、对照、双盲的试验原则,对本科就诊的25例微静脉畸形患者,签署知情同意书后,按照2:2:1的比例随机分配入A组(高剂量组,5mg/kg)、B组(低剂量组,2.5mg/kg)和对照组(安慰剂组),接受不超过2个疗程的光动力治疗。光敏剂为注射用海姆泊芬冻干粉针剂,激光波长为532nm,功率密度为80～100mW/cm2,照射时间为20min。实验数据采用SAS9.1.3软件包进行统计学处理。结果:第1疗程8～12周后,A组治愈率为10.0%,总显效率为40.0%,总有效率为90.0%(n=10);B组治愈率为0.0%,总显效率为0.0%,总有效率为55.6%(n=9,脱落1例);对照组(C组)治愈率为0.0%,总显效率为0.0%,总有效率为40.0%(n=5)。A组总显效率和总有效率均优于B组,A组总有效率优于对照组(C组)(P<0.05)。第1疗程不良反应发生率分别为A组50.0%、B组22.2%和C组0.0%。第2疗程不良反应发生率为A组20%、B组33.3%和C组20%。各组间不良反应发生率无显著差异(P>0.05)。结论:注射用海姆泊芬光动力疗法用于微静脉畸形是一种安全、有效的方法。高剂量组(5mg/kg)的疗效明显优于低剂量(2.5mg/kg)组和对照组,各组间不良反应发生率无显著差异。
PURPOSE：To explore the reasonable drug dose in hemporfin photodynamic therapy（PDT） for venular malformation,and to evaluate the efficacy and safety,with the aim of providing a basis for subsequent clinical trials.METHODS：Paralleled,controlled,double-blinded.clinical trial with hemporfin used as photosensitizer,continuous laser（532nm,irradiation 80-100mW/cm2）,the exposure time was 20 minutes,the subjects were 25 venular malformation patients,after signing informed consent,they were randomly assigned into 3 groups with the ratio of 2：2：1.Group A（5mg/kg,high dose）,group B（2.5mg/kg,low dose） and control group（placebo）,accepted not more than two session of PDT.The data was analyzed with SAS 9.1.3 software package.RESULTS：Eight to12 weeks after the first treatment,the complete response rate（CR）,the partial response rate（PR）,and the total efficiency rate of group A were 10.0%,40.0% and 90.0%（n=10）;0.0%,0.0% and 55.6%（n=9,one drop out） for group B.The incidence of adverse effect after the first session was 50.0%（A）,22.2%（B）,0.0%（C）,respectively.And that of the second session was 20%（A）,33.3%（B）,20%（C）,respectively.There was no significant difference among those groups（P0.05）.CONCLUSION：Hemporfin-532nm KTP laser PDT is safe and effective for venular malformation.
出处
《中国口腔颌面外科杂志》
CAS
2010年第4期294-299,共6页
China Journal of Oral and Maxillofacial Surgery
基金
上海市科学技术委员会资助项目(08DZ2271100)~~
关键词
光动力治疗
海姆泊芬
微静脉畸形
光敏剂
Photodynamic therapy
Hemporfin
Venular malformation
Clinical trial
