Comparative efficacy and safety of two insulin aspart formulations (Rapilin and NovoRapid) when combined with metformin, for patients with diabetes mellitus: a multicenter, randomized, open-label, controlled clinical trial.

OBJECTIVE: This phase 3 confirmatory diabetes mellitus treatment study compared the safety and efficacy of Rapilin and NovoRapid insulin asparts in combination with metformin. METHODS: This 24-week, open-label, randomized, active-controlled, noninferiority phase 3 confirmatory study conducted across centers in China aimed to enroll patients with type 2 diabetes mellitus and blood sugar glucose inadequately controlled by oral antidiabetic drugs. Randomized patients received subcutaneous mealtime Rapilin or NovoRapid (3:1) injections, with metformin. The primary objectives were to demonstrate noninferiority (margin of 0.4%) in HbA1c change from baseline and compare safety profiles of Rapilin versus NovoRapid after 24 weeks. Secondary outcomes included 2-h postprandial plasma glucose (PPG), fasting plasma glucose (FPG), and patients achieving HbA1c <7.0% and ≤6.5%. RESULTS: 590 patients with type 2 diabetes mellitus were randomized to Rapilin (n = 441) and NovoRapid (n = 149) groups. After 24 weeks, the mean HbA1c change from baseline was -2.20% (Rapilin) and -2.32% (NovoRapid); the estimated treatment difference based on least-square means was 0.04% (95% CI: -0.17, 0.26), meeting the noninferiority criteria for Rapilin versus NovoRapid. Comparable improvements were reported for mean 2-hour PPG (6.14 and 6.29 mmol/L), FPG (2.02 and 1.70 mmol/L), and patients with HbA1c <7.0% (52.6% and 51.0%) and ≤6.5% (34.2% and 30.9%), in the Rapilin and NovoRapid groups, respectively, with no significant safety or immunogenicity outcome differences. CONCLUSIONS: Rapilin demonstrated non-inferior glycemic control, and matching safety and immunogenicity to NovoRapid in patients with type 2 diabetes mellitus also receiving metformin over 24 weeks. TRIAL REGISTRATION: ChiCTR20003129041.

[The evaluation of the treatment for the cavernous hemangioma and peripheral vascular disorders with copper needles].

OBJECTIVE: The goal of this study was to evaluate the effect of different methods of treating for the cavernous hemangioma and peripheral vascular disorders with copper needles. METHODS: 21 cases were treated with copper needle retention only, 57 cases were treated with copper needle retention combined with a direct current of 6 - 9 V, both the inserted needles were kept in the site until the reaction was over, for about 10 to 20 days, 27 cases were treated with copper needle insertion combined with a direct current, and then the affection was ablated immediately. RESULTS: The early effective rate, the long-term effective rate, and the recurrence rate of the total cases were 94.3% , 88.6% and 28.6% respectively. Among the 3 groups, ablation of the affection after the use of copper needles and a direct current occupied the best results; copper needle retention combined with a direct current had a better result than copper needle retention only, and might shorten the time for therapy for about 42.6% (P < 0.01); their long-term effective rate were 100%, 89.5% and 71.4% respectively. CONCLUSIONS: The treatment for the cavernous hemangioma and peripheral vascular disorders with copper needles have a commendable result, copper needle retention combined with a direct current has a better result than copper needle retention only.

[Diagnosis and treatment of subcutaneous cavernous hemangioma with color Doppler ultrasonography].

OBJECTIVE: To discuss clinical application of the color Doppler ultrasonography in diagnosis and treatment of cavernous hemangioma in deep subcutaneous tissue. METHODS: From 1996, 15 cases of cavernous hemangioma were diagnosed and located with color Doppler ultrasonography and were embolized under monitoring of the ultrasonography or resected by operation before re-examination of the hemangioma via the color Doppler ultrasonography after the intervention. RESULTS: Direct embolization was achieved in 10 cases after pinpoint location of the hemangioma by the ultrasonography, and guided embolization was performed successfully in 2 cases via the monitoring of ultrasonography, and operation had to be adopted to remove the focus. No reoccurrence of the hemangioma was observed in all the cases. CONCLUSION: Cavernous hemangioma in deep subcutaneous tissue could be easily diagnosed and located with color Doppler ultrasonography, and could be removed by embolization under monitoring of the ultrasonography successfully.