Efficacy and safety of high-dose intramuscular vitamin D2 injection in type 2 diabetes mellitus with distal symmetric polyneuropathy combined with vitamin D insufficiency: study protocol for a multicenter, randomized, double-blinded, and placebo-controlled trial.

Background: Distal symmetric polyneuropathy (DSPN) is the most common chronic complication of type 2 diabetes mellitus (T2DM). DSPN may lead to more serious complications, such as diabetic foot ulcer, amputation, and reduced life expectancy. Observational studies have suggested that vitamin D deficiency may be associated with the development of DSPN in T2DM. However, interventional studies have found that low-dose vitamin D supplementation does not significantly improve neuropathy in DSPN. This study aims to evaluate the efficacy and safety of intramuscular injection of high-dose vitamin D (HDVD) in T2DM with DSPN combined with vitamin D insufficiency. Methods and analysis: We will conduct a multicenter, randomized, double-blinded, and placebo-controlled trial in four large hospitals. All eligible participants will be randomly assigned to either the vitamin D2 supplement or placebo control group and injected intramuscularly monthly for 3 months. Additionally, anthropometric measurements and clinical data will be collected at baseline and 3 months. Adverse events will be collected at 1, 2, and 3 months. The primary outcome measure is the change in the mean Michigan Neuropathy Screening Instrument (MNSI) score at baseline and 3 months post-intervention. We will use the gold-standard liquid chromatography-tandem mass spectrometry method to distinguish between 25(OH)D2 and 25(OH)D3 levels. The MNSN score before the intervention will be used as a covariate to compare the changes between both groups before and after the intervention, and the analysis of covariance will be used to analyze the change in the MNSI score after HDVD supplementation. Discussion: Glycemic control alone does not prevent the progression of DSPN in T2DM. Some studies have suggested that vitamin D may improve DSPN; however, the exact dose, method, and duration of vitamin D supplementation are unknown. Additionally, neuropathy repair requires HDVD supplementation to sustain adequate vitamin D levels. This once-a-month intramuscular method avoids daily medication; therefore, compliance is high. This study will be the first randomized controlled trial in China to analyze the efficacy and safety of HDVD supplementation for patients with T2DM and DSPN and will provide new ideas for pharmacological research and clinical treatment of diabetic neuropathy. Clinical trial registration: https://www.chictr.org.cn/, identifier ChiCTR2200062266.

[Clinical characteristics and antibiotic resistance in children with invasive Acinetobacter baumannii infection].

OBJECTIVE: To analyze the clinical characteristics and antibiotic resistance in children with invasive Acinetobacter baumannii infection (IABI). METHODS: A retrospective analysis was performed on the clinical and drug sensitivity data of 52 children with IABI between January 2004 and December 2011. RESULTS: Of the 52 children with IABI, 35 (67%) were less than one year old and 35 (67%) had IABI in the summer and autumn, 19 (37%) of these children were clinically diagnosed with septicemia, 16 (31%) with urinary tract infection, and 12 (23%) with skin and soft tissue infection, and 38 (73%) of them suffered from underlying diseases. The incidence rates of hospital-acquired and community-acquired IABIs were 90% and 10% respectively; 44 cases (85%) were cured or showed improvement in symptoms, and 8 cases (15%) died. All the IAB strains isolated from these children were sensitive to amikacin, 82% of them were sensitive to imipenem, more than 70% were sensitive to fluoroquinolone and to cefoperazone/sulbactam, 13% were sensitive to cefoperazone, 8% were sensitive to aztreonam, 21% developed multidrug resistance, and 17% developed pan-drug resistance. CONCLUSIONS: IABI occurs more frequently in children under one year of age, and most children with IABI have underlying diseases. IABI mainly results in septicemia, urinary tract infection and skin and soft tissue infection and is mostly hospital-acquired. Multi-drug resistance and pan-drug resistance are severe in IAB strains.