Luo Dan, Deng Tingting, Yuan Wei, Deng Hui, Meng Huan, Jin Ming
Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China.
Department of Ophthalmology, Beijing Changping Hospital of Traditional Chinese Medicine, Beijing 102200, China.
J Tradit Chin Med. 2019 Dec;39(6):892-901.
To evaluate the clinical efficacy and safety of Chinese medicine formula Huangban Bianxing One decoction (HBOD) combined with ranibizumab for treating exudative age-related macular degeneration (AMD) patients.
Totally 75 cases with exudative AMD (75 eyes) were enrolled in this study and randomly divided into two groups to receive either HBOD with ranibizumab or only ranibizumab. Early treatment diabetic retinopathy study (ETDRS) letters for the best corrected visual acuity, center macular thickness (CMT), height of the lesion, fundus hemorrhage area, fundus fluorescein leakage area as the main outcomes and safety indexes were estimated and compared before and after treatment for 3 or 6 months.
Comparing with the before treatment, ETDRS letter scores of both groups after treatment at month 3 obtained a greater improvement (P < 0.05), but the significant improvement only existed in the HBOD+ranibizumab group at month 6 (P < 0.01), and better than the ranibizumab group (P < 0.05). At month 3, the CMT and lesion height of both groups were significantly lower than those before treatment (P < 0.01 or P < 0.05) and the HBOD + ranibizumab group had a similar result at month 6 (P < 0.01). The hemorrhage area and fluorescein leakage area of the HBOD+ranibizumab group were also significantly reduced and also smaller than those of the ranibizumab group at month 6 (P < 0.01 or P < 0.05). During treatment, no significant adverse events relating to HBOD or ranibizumab treatment were elucidated.
HBOD combined with ranibizumab can improve visual acuity and reduce hemorrhage and fluorescein leakage of patients with exudative AMD. These results also indicated that HBOD may function as an effective and safe adjuvant drug for exudative AMD.
评估中药方剂黄斑变性一号方(HBOD)联合雷珠单抗治疗渗出性年龄相关性黄斑变性(AMD)患者的临床疗效和安全性。
本研究共纳入75例渗出性AMD患者(75只眼),随机分为两组,分别接受HBOD联合雷珠单抗治疗或单纯雷珠单抗治疗。以早期糖尿病视网膜病变研究(ETDRS)字母视力表测量最佳矫正视力、中心黄斑厚度(CMT)、病变高度、眼底出血面积、眼底荧光素渗漏面积作为主要观察指标和安全性指标,在治疗3个月和6个月前后进行评估和比较。
与治疗前相比,两组在治疗3个月时ETDRS字母视力评分均有较大改善(P<0.05),但仅HBOD联合雷珠单抗组在治疗6个月时有显著改善(P<0.01),且优于雷珠单抗组(P<0.05)。在治疗3个月时,两组的CMT和病变高度均显著低于治疗前(P<0.01或P<0.05),HBOD联合雷珠单抗组在治疗6个月时也有类似结果(P<0.01)。HBOD联合雷珠单抗组的出血面积和荧光素渗漏面积在治疗6个月时也显著减小,且小于雷珠单抗组(P<0.01或P<0.05)。治疗期间,未发现与HBOD或雷珠单抗治疗相关的明显不良事件。
HBOD联合雷珠单抗可提高渗出性AMD患者的视力,减少出血和荧光素渗漏。这些结果还表明,HBOD可能是一种有效且安全的渗出性AMD辅助药物。