作者
Qu Liu,Xuan Liang,Ganghong Tian,Gaili Zhang,Qing Wu,Xiumei Huang,Yazhong Cui,Yuling Liu,Zhufang Shen,Changfu Xiao,Yingfen Qin,Heng Miao,Yongyan Zhang,Ziling Li,Shandong Ye,Xuezhi Zhang,Jing Yang,Guichan Cao,Yang Li,Gangyi Yang,Jiang Hu,Xiaoyue Wang,Zhengfang Li,Yukun Li,Xiuzhen Zhang,Guangde Zhang,Li Chen,Wenjin Hua,Miao Yu,Chin‐Song Lu,Xiaomei Zhang,Hong Jiang
摘要
<b>OBJECTIVE </b>This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (sangzhi alkaloids, SZ-A) in the treatment of type 2 diabetes (T2D).<a></a> <p><b>RESEARCH DESIGN AND METHODS</b><b> </b><a></a>This was a multicenter, randomized, double-blind, double-dummy, and parallel controlled non-inferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group (<i>n</i>=360) or acarbose group (<i>n</i>=240). The primary efficacy endpoint was the change of glycosylated hemoglobin (HbA<sub>1c</sub>) in comparison to baseline. In addition, adverse events (AEs), severe adverse events (SAEs), <a>treatment-related </a><a>adverse events</a> (TAEs), and gastrointestinal disorders (GDs) were monitored.</p> <p><b>RESULTS</b> After treatment for 24 weeks, the change <a>in HbA1c was −0.93% (95% CI −1.03 to −0.83) (−10.2 mmol/mol, [95% CI −11.3 to −9.1]) and −0.87% (95% CI −0.99 to −0.76) (−9.5 mmol/mol, [95% CI −10.8 to −8.3]) in the SZ-A and acarbose groups, and the least squares mean difference was −0.05% (95% CI −0.18 to 0.07) (−0.5 mmol/mol, [95% CI −2.0 to 0.8]) between the two groups with no significant difference based on covariance analysis (P > 0.05). The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group (P < 0.01), but no differences were found for AEs or SAEs between two groups were observed (P > 0.05).</a></p> <p><b>CONCLUSION</b> SZ-A exhibited equivalent hypoglycemic effect to acarbose in patients with T2D. Nevertheless, the incidence of TAEs and GDs was lower following SZ-A treatment than that following acarbose treatment, suggesting good safety.</p>