Regenerative Injectable Therapies: Current Evidence.

Regenerative medicine is a growing field of musculoskeletal treatments that focuses on amplifying the body's natural healing properties to improve function and pain after injury. Regenerative treatments are applied locally at the site of injury and work though different mechanisms, some of which are unexplained at this time. Current evidence demonstrates benefit for certain regenerative treatments, but further standardization of treatments and additional studies are required to provide additional data to support specific regenerative treatments. This review seeks to explore the evidence and discuss appropriate use of the most common regenerative treatments including platelet-rich plasma, prolotherapy, autologous mesenchymal stem cells, human-derived allograft products, and saline.

Factors Associated With Narcotic Use After Clavicle Fractures.

Clavicle fractures are common in adults. Recent studies have shown that operative treatment of clavicle fractures has benefits in many situations. However, there is controversy about the indications. Data on social outcomes are limited. A total of 434 patients with 436 clavicle fractures treated both operatively and nonoperatively at a level 1 trauma center were identified. Narcotic use was recorded 2, 4, 6, 8, 10, 12, 14, and 16 weeks after injury for both treatment groups. Other descriptive data included age, sex, laterality, hand dominance, rib fractures, smoking, alcohol use, employment, long bone or spine fracture, open clavicle fracture, and mechanism of injury. Logistic regression analysis was performed to determine the independent predictors of narcotic use after clavicle fracture. Open reduction and internal fixation was performed in 105 fractures (24%), and 329 fractures were managed nonoperatively. A total of 154 patients (35%) reported some narcotic use 2 weeks after injury, and 15% were still using narcotics 16 weeks after injury. Narcotic use decreased over time in patients treated with open reduction and internal fixation (10% vs 15% after nonoperative management). Patients treated with open reduction and internal fixation reported reduced narcotic use at 16 weeks (odds ratio [OR], 0.454; P=.070). Concurrent rib fracture (OR, 5.668; P<.001), smoking (OR, 3.095; P=.013), unemployment (OR, 5.429; P<.0005), and long bone or spine fracture (OR, 6.761; P<.001) were predictors of narcotic use. Further studies of the social, economic, and financial outcomes of clavicle fracture and osteosynthesis are warranted. [Orthopedics. 2016; 39(5):e917-e923.].

Randomized, open-label, phase III study of a 28-day oral regimen of eniluracil plus fluorouracil versus intravenous fluorouracil plus leucovorin as first-line therapy in patients with metastatic/advanced colorectal cancer.

PURPOSE: To compare the efficacy and tolerability of eniluracil (EU)/fluorouracil (5-FU) with that of 5-FU/leucovorin (LV) as first-line therapy for patients with metastatic/advanced colorectal cancer. PATIENTS AND METHODS: This multicenter, randomized, open-label, phase III study (FUMA3008) conducted in the United States and Canada compared the safety and efficacy of EU/5-FU (11.5 mg/m(2)/1.15 mg/m(2) twice daily for 28 days every 35 days) with that of intravenous 5-FU/LV (425 mg/m(2)/20 mg/m(2) once daily for 5 days every 28 days) in patients with previously untreated metastatic colorectal cancer. Overall survival (OS) was the primary end point. RESULTS: A total of 981 patients were randomized and 964 patients received treatment (485 EU/5FU, 479 5FU/LV). Survival for EU/5-FU was not statistically equivalent (but not statistically inferior) to that for 5-FU/LV (hazard ratio, 0.880; 95% confidence interval [CI], 0.75 to 1.03). Median duration of survival was 13.3 months in the EU/5-FU group and 14.5 months in the 5-FU/LV group. Median duration of progression-free survival for EU/5-FU was statistically inferior to that of the control group (20.0 weeks [95% CI, 19.1 to 20.9 weeks] v 22.7 weeks [95% CI, 18.3 to 24.6 weeks]; P =.01). Both treatments were well tolerated. Diarrhea was the most common nonhematologic toxicity in both groups; treatment-related grade 3 or 4 diarrhea occurred in 19% of patients treated with EU/5-FU and 16% of patients receiving 5-FU/LV (P =.354). Grade 3 or 4 granulocytopenia occurred in 5% of EU/5-FU patients and 47% of 5-FU/LV patients. CONCLUSION: Safety profiles of both treatments were acceptable. Although antitumor activity was observed, EU/5-FU did not meet the protocol-specified statistical criteria for equivalence to 5-FU/LV in terms of OS.