地舒单抗联合特立帕肽治疗骨质疏松性骨折PKP术后患者的临床研究OA

Objective To observe the clinical efficacy and safety of denosumab injection combined with teriparatide injection in patients with osteoporotic fractures after percutaneous kyphoplasty(PKP).Methods Patients with osteoporotic fractures treated with PKP in our hospital were divided into treatment group and control group according to different medication regimens.On the basis of conventional treatment,the control group was subcutaneously injected with teriparatide injection at a dose of 20 μg once daily for consecutive 12 months.The treatment group was additionally subcutaneously injected with denosumab injection on the basis of the control group's regimen,at a dose of 60 mg once every 6 months,with a total of 2 administrations.The clinical efficacy,bone mineral density(BMD),bone metabolism indicators,pain relief and functional recovery status and incidence of refracture,and safety evaluation were compared between the two groups.Results A total of 108 patients were enrolled,including 53 in control group and 55 in treatment group.After treatment,the total effective rate was 90.91％(50 cases/55 cases)in treatment group and 75.47％(40 cases/53 cases)in control group;lumbar vertebrae L2-4 BMD levels were(0.88±0.13)and(0.82±0.11)g·cm-2,respectively;femoral neck BMD levels were(0.81±0.14)and(0.75±0.13)g·cm-2,respectively;greater trochanter BMD levels were(0.69±0.08)and(0.65±0.08)g·cm-2,respectively;total hip BMD levels were(0.85±0.16)and(0.78±0.16)g·cm-2,respectively;the receptor activator of nuclear factor-κB ligand(RANKL)levels were(4.82±1.24)and(5.53±1.29)pg·mL-1,respectively;total procollagen type ⅠN-terminal propeptide(T-P1NP)levels were(44.93±9.12)and(40.58±8.95)ng·mL-1,respectively;β-cross-linked C-telopeptide of type 1 collagen(β-CTX)levels were(0.38±0.08)and(0.43±0.07)ng·mL-1,respectively;N-terminal midfragment of osteocalcin(N-MID)levels were(19.32±2.97)and(17.93±2.59)ng·mL-1,respectively;the visual analog scale(VAS)scores were(1.88±0.66)and(2.16±0.55)points,respectively;the oswestry disability index(ODI)scores were(10.83±1.73)and(12.12±2.89)points,respectively;the incidence of refracture within 1 year of treatment was 0％(0 cases/55 cases)and 9.43％(5 cases/53 cases).The aforementioned indicators showed statistically significant differences between the two groups(P＜0.05,P＜0.01).The main adverse drug reactions in treatment group include nausea,muscle pain and injection site reactions;the control group included nausea,muscle pain,palpitations and injection site reactions,and both groups had mild adverse drug reactions.The total incidence of adverse drug reactions in treatment group and control group were 12.73％(7 cases/55 cases)and 9.43％(5 cases/53 cases),respectively,with no statistically significant difference(P＞0.05).Conclusion Denosumab injection combined with teriparatide injection in the treatment of patients with osteoporotic fractures after PKP surgery can significantly improve clinical efficacy and bone density,promote bone formation,reduce the recurrence of fractures,and has favorable safety.