培莫沙肽治疗腹膜透析肾性贫血的临床研究OA

Objective To observe the efficacy and safety of pembrolizumab injection in the treatment of maintenance peritoneal dialysis(PD)patients with newly diagnosed renal anemia who have not received previous erythropoietic stimulants(ESAs).Methods Patients with PD combined with renal anemia treated in our hospital were divided into treatment group and control group according to the queue method.The treatment group received subcutaneous injection of 0.04 mg·kg-1 of pembrolizumab injection every 4 weeks,while the control group received subcutaneous injection of 100-150 IU·kg-1 of recombinant human erythropoietin(rHuEPO)injection divided into 2-3 times a week.The hemoglobin(Hb),iron metabolism,inflammation,lipid metabolism,electrolytes and clinical efficacy between two groups were compared,and the safety were evaluated.Results This study screened a total of 97 cases and enrolled 58 cases,including 29 cases in control group and 29 cases in treatment group.After 24 weeks of treatment,the Hb levels of treatment group and control group were(103.80±14.10)and(102.50±16.00)g·L-1,respectively;the Hb compliance rates were 51.72％(15 cases/29 cases)and 37.93％(11 cases/29 cases),respectively;the Hb response rates were 72.41％(21 cases/29 cases)and 62.07％(18 cases/29 cases),respectively;after 52 weeks of treatment,Hb levels were(107.90±14.30)and(106.10±18.30)g·L-1,respectively;Hb compliance rates were 68.97％(20 cases/29 cases)and 72.41％(21 cases/29 cases),respectively;the Hb response rates were 72.41％(21 cases/29 cases)and 75.86％(22 cases/29 cases),respectively.There was no statistically significant difference in the above indicators between treatment group and control group(all P＞0.05).After 24 weeks of treatment,the mean arterial pressure(MAP)of treatment group and control group were(103.10±7.40)and(112.00±11.60)mmHg,respectively;the aspartate aminotransferase(AST)was(10.90±5.70)and(18.90±9.70)U·L-1,respectively.The above indicators in treatment group were statistically significantly lower than those in control group(P＜0.05,P＜0.001).After 52 weeks of treatment,the levels of AST in treatment group and control group were(27.40±19.20)and(20.40±15.10)U·L-1,with no statistically significant difference(P＞0.05).The clinical effective rates of treatment group and control group were 72.41％(21 cases/29 cases)and 75.86％(22 cases/29 cases),without statistically significant difference(P＞0.05).The adverse drug reactions of treatment group include hypertension,hyperkalemia,hypokalemia and gastrointestinal reactions,while control group includes hypertension,hyperkalemia,hypokalemia and gastrointestinal reactions.The total incidence of adverse drug reactions in treatment group and control group were 44.83％(13 cases/29 cases)and 51.72％(15 cases/29 cases),with no statistically significant difference(P＞0.05).Conclusion Pembrolizumab injection has a non inferior therapeutic effect to rHuEPO in the initial treatment of PD renal anemia patients with ESAs,with less impact on blood pressure and no clinical significance in the transient decrease of AST,which has good safety.