GeroPharm · INSR · 重组蛋白
insulin 是一种重组蛋白，由GeroPharm研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intramuscular (IM) Injection、Intravenous (IV)、Subcutaneous Injection。
| 商品名 | Rinsulin R |
| 公司 | GeroPharm |
| 药物类别 | 重组蛋白 |
| 分子靶点 | INSR |
| 给药途径 | Injectable (Others), Intramuscular (IM) Injection, Intravenous (IV), Subcutaneous Injection |
| 状态 | Approved |
insulin 作用于 1 个分子靶点：
| INSR | insulin receptor (CD220, HHF5) |
insulin 针对 2 个适应症，涉及 1 个治疗领域。
| 治疗领域 | 疾病/病症 | 分期 |
|---|---|---|
| Metabolism and nutrition disorders | Type 1 diabetes mellitus | ✓ Approved |
| Metabolism and nutrition disorders | Type 2 diabetes mellitus | ✓ Approved |
Dagnegård Hanna S H HSH, Sigvardsen Per E PE, Ihlemann Nikolaj N, Kofoed Klaus F KF et al.
Katz Alexandra A, Shulkin Aidan A, Jacobson Samantha S, Price Chella C et al.
Antenatal corticosteroids (ACS) promote foetal lung maturation in pregnancies at risk of preterm birth; however, in gestational diabetes mellitus (GDM), they can exacerbate maternal glycemia and contribute to adverse neonatal outcomes. Clinical guidelines offer limited direction on optimal treatment adjustment. To synthesize the evidence on glycaemic responses and management strategies following ACS exposure in individuals with GDM. A systematic review of Embase, MEDLINE and CENTRAL in October 2025 in accordance with PRISMA guidelines. Studies reporting on glycaemic outcomes and/or management strategies following ACS exposure in individuals with GDM were included. Twenty studies were included. Maternal glycemia rose predictably after ACS, with hyperglycaemia typically emerging within 9-16 h, peaking over the subsequent 24-72 h and often persisting up to 5 days. Among individuals managed with medical nutrition therapy or oral hypoglycaemic agents at baseline, insulin initiation ranged from 13% to 91%. Among those already using insulin, 67%-88% required dose escalation, with mean increases typically ranging from 47% to 91%. Pregnancy-adapted intravenous insulin (IVI) pathways reported higher time-in-range and fewer hyperglycaemic/hypoglycaemic events than adult IVI protocols. However, emerging evidence suggests that structured, pregnancy-specific subcutaneous insulin protocols may achieve comparable or improved glycaemic control. ACS exposure in GDM is associated with a predictable but variable, transient deterioration in maternal glycaemia. GDM-specific evidence suggests that structured pregnancy-adapted monitoring and insulin-adjustment pathways may help attenuate post-ACS hyperglycaemia. However, the evidence remains heterogeneous and largely observational. Prospective studies are needed to validate GDM-specific algorithms, clarify thresholds for insulin initiation or escalation and define indications for subcutaneous versus IVI.
Fu Junfen J, Wu Jin J, Hui Yao Y, Zhu Weiwei W et al.
Insulin patch pumps offer advantages over multiple daily injections (MDI) for pediatric diabetes, but randomized trial evidence in Chinese children remains limited. To evaluate the efficacy and safety of a tubeless insulin patch pump (Equil™) compared with MDI in children and adolescents with diabetes. This multicenter, open-label, randomized, crossover, non-inferiority trial was conducted at seven pediatric endocrinology centers in China (September 2021 - October 2022). Patients aged 3-17 years with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) were randomized 1:1 to receive continuous subcutaneous insulin infusion (CSII) via Equil™ or MDI via insulin pen for 5 days, followed by crossover. The primary outcome was mean blood glucose (MBG). Non-inferiority margin was pre-specified as 0.386 mmol/L. Secondary outcomes included glycemic variability (standard deviation of blood glucose, SDBG), glycated albumin (GA), total daily insulin dose (TDD), hypoglycemia frequency, and adverse events. Patient satisfaction was assessed using a study-specific 11-item questionnaire. Of 74 enrolled patients, 72 (97.3%) completed the study. CSII demonstrated non-inferiority to MDI for MBG (8.43±1.88 mmol/L, n=74, vs 9.00±2.04 mmol/L, n=72); mean difference -0.606 mmol/L; 95% CI -0.988 to -0.223; upper CI limit -0.223 < non-inferiority margin 0.386. No significant differences were observed for secondary outcomes (SDBG: 3.019 vs 3.357; GA change: 2.52±3.03% vs 2.02±3.25%, p=0.184; TDD: 132.17±78.43 vs 147.52±91.59 IU, p=0.159; hypoglycemia events: 114 vs 106). Adverse event rates were similar (75.7% vs 69.4%, p=0.399); no serious adverse events occurred. Patient satisfaction was significantly higher with CSII (total score 21.03±4.47 vs 22.00±3.99; mean difference -0.97, 95% CI -1.75 to -0.19; p=0.015), with 68.1% of patients preferring the patch pump. The Equil™ patch pump is non-inferior to MDI in terms of glycemic control and safety for pediatric diabetes patients, with higher patient satisfaction. These findings support the patch pump as an effective alternative for children and adolescents requiring exogenous insulin therapy.
Backlund Anne E AE, Brigham Wyatt W, Dunne Clare C, Youngblom James J JJ et al.
Gene model for the ortholog of Phosphatidylinositol 3-kinase 21B ( Pi3K21B ) in the May 2011 (Agencourt dana_caf1/DanaCAF1) Genome Assembly (GenBank Accession: GCA_000005115.1 ) of Drosophila ananassae . This ortholog was characterized as part of a developing dataset to study the evolution of the Insulin/insulin-like growth factor signaling pathway (IIS) across the genus Drosophila using the Genomics Education Partnership gene annotation protocol for Course-based Undergraduate Research Experiences.
Liu Meijuan M, Wu Di D, Su Chang C
Severe hypertriglyceridemia (SHTG), characterized by plasma triglycerides (TG)>11.3 mmol/L is a rare but serious complication in children who develop diabetic ketoacidosis (DKA). However, the current body of evidence is predominantly composed of case reports, highlighting a substantial gap in both the understanding and management of this condition. This was a retrospective electronic medical record review of pediatric patients with DKA complicated by SHTG who were referred to the Beijing Children's Hospital over a 10-year period. A total of 21 pediatric patients with DKA complicated by SHTG were identified, with a male-to-female ratio of 8:13. The median age at diagnosis was 11.3 years [interquartile range (IQR) 10.5-13.2, range 2.0-17.4], with approximately 76.2% (16/21) of patients aged ≥10 years. Among these patients, 10 were diagnosed with type 1 diabetes mellitus, 5 with type 2 diabetes mellitus, and 6 with unclassified diabetes mellitus. 17 patients were newly diagnosed with diabetes, whereas 4 had a history of pre-existing diabetes. Notably, 3 of these 4 patients had discontinued insulin prior to admission. In terms of complications, 7 patients had acute pancreatitis. Regarding treatment, all patients received insulin therapy, among whom 7 patients were treated with plasmapheresis. Compared with insulin therapy alone, the plasmapheresis group showed a shorter median time to achieve the TG level <5.6 mmol/L, though this finding should be interpreted cautiously due to potential selection bias. Among the 7 patients who received plasmapheresis, 4 developed venous thrombosis. During follow-up, patients who underwent plasmapheresis maintained stable lipid profiles and achieved complete resolution of thrombosis. We present the largest single-center experience on SHTG in pediatric patients with DKA, with a particular focus on plasmapheresis. We recommend early assessment of dyslipidemia and pancreatic enzymes in patients with DKA. Insulin therapy remains the cornerstone of management. However, in children who show unsatisfactory reduction in triglyceride levels or persistent abdominal pain despite insulin treatment, prompt initiation of plasma exchange may be considered as a rescue therapy to rapidly lower TG levels, which could potentially mitigate the risk of developing or worsening acute pancreatitis. This hypothesis requires validation in larger prospective studies.
Wellens-Mensah Jude J, Konantambigi Akash A, Lopez Keimee K, Triay Jessica J et al.
To evaluate dose-normalised time in range (dn-TIR) and its log relative change (Δdn-TIR) as measures of within-person glycaemic change relative to total daily insulin exposure following hybrid closed-loop therapy (HCL/AID). We conducted a retrospective two-cohort study of people with type 1 diabetes commencing hybrid closed-loop/automated insulin delivery (HCL/AID) therapy in Australia and the United Kingdom (UK). dn-TIR was calculated as time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) divided by total daily insulin dose (TDD) and Δdn-TIR as log[(TIR/TDD)post/(TIR/TDD)pre]. The study comprised 86 people living with type 1 diabetes in Australia and 288 in the UK. In the fixed Australian dn-TIR cohort, TIR increased from 53.2% ± 20.7% to 70.4% ± 14.6% (n = 86; p < 0.001), whereas mean TDD changed from 53.3 to 52.0 units/day (n = 86; p = 0.724). Median Δdn-TIR was 0.224 [IQR: -0.033, 0.583]. In the UK cohort, TIR increased from a median 54% [34, 68] to 66% [54, 74] (n = 257; p < 0.001), whereas mean TDD changed from 44.1 to 46.3 units/day (n = 242; p = 0.152). Median Δdn-TIR was 0.194 [IQR: -0.097, 0.541]. HCL/AID therapy improved TIR relative to TDD in two real-world cohorts. dn-TIR and Δdn-TIR are not replacements for established CGM metrics or direct measures of insulin sensitivity; they may provide an adjunct longitudinal description of whether glycaemic improvement was accompanied by proportionately greater, similar or lower insulin exposure.
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