Dan Luo1,2, Tingting Deng3, Wei Yuan1, Hui Deng1, Huan Meng1, Ming Jin1. 1. Department of Ophthalmology, China-Japan Friendship Hospital, Beijing 100029, China. 2. Department of Ophthalmology, Beijing Changping Hospital of Traditional Chinese Medicine, Beijing 102200, China. 3. Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing 100029, China.
Abstract
OBJECTIVE: 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. METHODS: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. RESULTS: 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. CONCLUSION: 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.
RCT Entities:
OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.