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苏鹏，刘宇琨，梁小华，等 . 降低二甲双胍联合阿卡波糖治疗不佳的 2 型糖尿病患者不良事件风险：加用二肽基
肽酶 -4 抑制剂优于胰岛素［J］. 中国全科医学，2022，25（9）：1054-1061. ［www.chinagp.net］
SU P，LIU Y K，LIANG X H，et al. Reducing the risk of adverse events in patients with type 2 diabetes who are poorly
treated with metformin combined with acarbose：dipeptidyl peptidase-4 inhibitor is better than insulin［J］. Chinese General
Practice，2022，25（9）：1054-1061.

Reducing the Risk of Adverse Events in Patients with Type 2 Diabetes Who are Poorly Treated with Metformin
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Combined with Acarbose：Dipeptidyl Peptidase-4 Inhibitor is Better Than Insulin SU Peng ，LIU Yukun ，LIANG
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Xiaohua ，LIU Xin ，YU Yaohui ，HUANG Pengfei ，BAI Yuru ，HE Xiaoyan ，SHEN Zhihong ，MA Dong 1*
1.School of Public Health，North China University of Technology，Tangshan 063210，China
2.Nursing Department，Huaxin College of Hebei GEO University，Shijiazhuang 050702，China
3.Shijiazhuang Second Hospital，Hebei Province，Shijiazhuang 050051，China
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Corresponding author：MA Dong，Associate researcher，Master supervisor；E-mail：mamamadong@163.com
【Abstract】 Background Clinically，when metformin （Met） combined with acarbose （Aca） cannot achieve
the ideal hypoglycemic effect，a third drug will be usually added，such as insulin （Ins） or dipeptidyl peptidase-4 inhibitor
（DPP-4i）etc.，but there are few reports on the effect of triple therapy on complications related to type 2 diabetes （T2DM）.
Objective To explore the risk of adverse events of DPP-4i combined with Met and Aca，Ins combined with Met and Aca in
the treatment of T2DM patients，in order to provide help for the choice of drugs for clinical T2DM treatment. Methods In the
retrospective cohort study，patients diagnosed with T2DM and treated with Met+Aca+ DPP-4i or Met+Aca+Ins in Shijiazhuang
Second Hospital from November 1，2017 to August 1，2020 were selected as the study subject. Telephone follow-up was
conducted from November 20，2017 to August 4，2020，the follow-up wasn't terminated until a preset outcome occurred，
then that was recorded. The three prespecified outcome events were non-fatal cardiovascular disease，death from all causes，and
severe hypoglycemic events. The comprehensive outcome events including all-cause death，or composite non-fatal cardiovascular
events，or severe hypoglycemic events. Propensity score matching （1∶1 ratio for data matching，caliper value set to 0.02） was
used，and multivariate Cox proportional hazards regression model was used to analyze the risk of comprehensive outcome events in
T2DM patients after drug treatment. Stratified analysis was performed on the effect of each covariate on the risk of comprehensive
outcome events in patients treated with different drugs. Results Finally，1 570 patients with T2DM were enrolled，including
1 089 patients who received Met+Aca+Ins treatment （Met+Aca+Ins group） and 481 patients who received Met+Aca+DPP-4i
treatment （Met+Aca+DPP-4i group）. There were 434 cases in both groups after propensity score matching. Compared with the
Met+Aca+Ins group，the incidences of comprehensive outcome events （6.53/100 person-per year），non-fatal cardiovascular
disease （5.03/100 person-years），all-cause death （0.73/100 person-per year），and severe hypoglycemic （0.73/100
person-er year） were lower in the Met+Aca+ DPP-4i group. The multivariate Cox proportional hazards regression model analysis
showed that the risk of comprehensive outcome events in the Met+Aca+DPP-4i group was 67% lower than the Met+Aca+Ins group
〔HR=0.34，95%CI（0.23，0.50），P<0.001〕，the risk of composite non-fatal cardiovascular disease decreased by 52%
compared with the Met+Aca+Ins group 〔HR=0.48，95%CI （0.30，0.77），P=0.002〕，and the risk of all-cause mortality
was higher than the Met+Aca group. The Met+Aca+Ins group group decreased by 81% 〔HR=0.19，95%CI（0.07，0.56），
P=0.003〕，and the risk of severe hypoglycemia decreased by 80% compared with the Met+Aca+Ins group 〔HR=0.20，95%CI（ 0.07，
0.59），P=0.003〕. The survival curve was drawn with the comprehensive outcome events as the outcome event. The results of
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Log-rank test showed that the survival rate of Met+Aca+DPP-4i group was higher than the Met+Aca+Ins group （χ =32.849，
P<0.001）. The results of covariate interaction analysis showed that in patients with adequate sleep （>7 h/d），non-smoking，
and no family history of cardiovascular disease，Met+Aca+DPP-4i treatment reduced the incidence of comprehensive outcome
events in T2DM patients compared with Met+Aca+Ins treatment（P values were 0.008，0.031，and 0.042，respectively）.
Conclusion After failure treatment of Met and Aca in T2DM patients，the supplementation of DPP-4i was associated with a
lower risk of comprehensive outcome events，cardiovascular disease，all-cause mortality，and severe hypoglycemia compared
with the Ins addition，particularly in patients with adequate sleep，no smoking，and without family history of cardiovascular
disease.
【Key words】 Diabetes mellitus，type 2；Dipeptidyl-peptidase Ⅳ inhibitors；Metformin；Acarbose；Drug-related
side effects and adverse reactions；Cohort studies；Retrospective studies