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.ME...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 month6(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.展开更多
OBJECTIVE:To investigate the safety profiles of Motherwort injection(MI).METHODS:A multi-center,prospective and drugderived hospital intensive monitoring method was conducted to assess the safety of MI in real world a...OBJECTIVE:To investigate the safety profiles of Motherwort injection(MI).METHODS:A multi-center,prospective and drugderived hospital intensive monitoring method was conducted to assess the safety of MI in real world applications.This study was based on a very large population after the injection was approved and marketed in China.All patients using the injection in participating hospitals were monitored to determine the incidence,pattern,severity and outcome of associated adverse events.RESULTS:The post-marketing surveillance was performed in 10 094 female patients from April to December,2015.The incidence of adverse drug reactions(ADRs) was 0.79‰(8/10 094).Among the 8 patients,the reported adverse events mainly included systemic abnormalities,such as fever,chills and eyelid edema;skin and appendages disorders,such as pruritus and rash;gastrointestinal disorders,such as nausea,abdominal distension and pain;heart rate and rhythm disorders,such as palpitation and increased heart rate.All of these ADRs were mild in severity.CONCLUSION:In this study the ADRs incidence rate of MI is very low,which supports that it is generally safe for use in obstetric and gynecological diseases.However,the total number of 8 ADRs recorded over a relatively short time span seems limited,and the low number of reports could not represent an absolute guarantee of safety.展开更多
Objective To investigate whether patients, who are at risk of major acute coronary events, are safe to undergo and benefit from early intervention after using simvastatin.Methods The study was a randomized, open, two-...Objective To investigate whether patients, who are at risk of major acute coronary events, are safe to undergo and benefit from early intervention after using simvastatin.Methods The study was a randomized, open, two-dosage-controlled trial to evaluate the safety and benefits of simvastatin administered to 197 patients (10 mg group, n =98 and 20 mg group, n =99), within 48 hours of hospitalization for a diagnosis of unstable angina or acute myocardial infarction (Ml), with total cholesterol (TC)≥180 mg/dL or low-density lipoprotein cholesterol (LDL-C) 3≥100 mg/dL. Lipid levels were measured immediately, followed by the 3rd, 6th and 12th month after admission and all adverse events were recorded during follow-up.Results TC levels fell by 10.15% and 14. 52% in the 10 mg and 20 mg groups (P<0. 05), and LDL-C levels fell 13. 87% and 19. 38% in the 10 mg and 20 mg groups, respectively (P<0. 01), 12 months after using simvastatin. The rates of achieving target TC reached 26. 3% and 36. 5% in the 10 mg and 20 mg groups (P<0. 01), and that of LDL-C reached 28. 2% and 40. 3% in the 10 mg and 20 mg groups, respectively (P<0. 01). There were higher rates of Ml and re-hospitalization resulting from angina pectoris and revascularization in the 10 mg group compared with the 20 mg group.Conclusions The results suggest that early intervention with the HMG-CoA reductase inhibitor, simvastatin, in acute coronary syndromes is possible and safe. It also indicates that the clinical dosage of simvastatin are relatively smaller than that for satisfactory lipid control in patients with acute coronary syndromes.展开更多
基金Supported by a project of the National Science Foundation of China(Mechanism Study of Age-related Macular Degeneration Based on IL-17RC Methylation,No.81373693)
文摘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 month6(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.
基金Sichuan Science and Technology Support Project:the Nested Case-control Study on Adverse Reaction Centralized Monitoring and Risk Factors of Leonurus Japonicus Injection(No.2014ZS0139)the Major State Basic Research Grant(973-program+2 种基金2011CB505406)Ph.D.Programs Foundation of Ministry of Education of China(No.2013-1210110001)State Administration of Traditional Chinese Medicine "Twelve-Five" Focus on Cultivating Subjects of Chinese Preventive Medicine[(2012)170]
文摘OBJECTIVE:To investigate the safety profiles of Motherwort injection(MI).METHODS:A multi-center,prospective and drugderived hospital intensive monitoring method was conducted to assess the safety of MI in real world applications.This study was based on a very large population after the injection was approved and marketed in China.All patients using the injection in participating hospitals were monitored to determine the incidence,pattern,severity and outcome of associated adverse events.RESULTS:The post-marketing surveillance was performed in 10 094 female patients from April to December,2015.The incidence of adverse drug reactions(ADRs) was 0.79‰(8/10 094).Among the 8 patients,the reported adverse events mainly included systemic abnormalities,such as fever,chills and eyelid edema;skin and appendages disorders,such as pruritus and rash;gastrointestinal disorders,such as nausea,abdominal distension and pain;heart rate and rhythm disorders,such as palpitation and increased heart rate.All of these ADRs were mild in severity.CONCLUSION:In this study the ADRs incidence rate of MI is very low,which supports that it is generally safe for use in obstetric and gynecological diseases.However,the total number of 8 ADRs recorded over a relatively short time span seems limited,and the low number of reports could not represent an absolute guarantee of safety.
文摘Objective To investigate whether patients, who are at risk of major acute coronary events, are safe to undergo and benefit from early intervention after using simvastatin.Methods The study was a randomized, open, two-dosage-controlled trial to evaluate the safety and benefits of simvastatin administered to 197 patients (10 mg group, n =98 and 20 mg group, n =99), within 48 hours of hospitalization for a diagnosis of unstable angina or acute myocardial infarction (Ml), with total cholesterol (TC)≥180 mg/dL or low-density lipoprotein cholesterol (LDL-C) 3≥100 mg/dL. Lipid levels were measured immediately, followed by the 3rd, 6th and 12th month after admission and all adverse events were recorded during follow-up.Results TC levels fell by 10.15% and 14. 52% in the 10 mg and 20 mg groups (P<0. 05), and LDL-C levels fell 13. 87% and 19. 38% in the 10 mg and 20 mg groups, respectively (P<0. 01), 12 months after using simvastatin. The rates of achieving target TC reached 26. 3% and 36. 5% in the 10 mg and 20 mg groups (P<0. 01), and that of LDL-C reached 28. 2% and 40. 3% in the 10 mg and 20 mg groups, respectively (P<0. 01). There were higher rates of Ml and re-hospitalization resulting from angina pectoris and revascularization in the 10 mg group compared with the 20 mg group.Conclusions The results suggest that early intervention with the HMG-CoA reductase inhibitor, simvastatin, in acute coronary syndromes is possible and safe. It also indicates that the clinical dosage of simvastatin are relatively smaller than that for satisfactory lipid control in patients with acute coronary syndromes.
