A meta-analysis of safety and efficacy of regorafenib for refractory metastatic colorectal cancer.

BACKGROUND: Patients with metastatic colorectal cancer (mCRC) often suffer from progressive disease despite previous therapy. It has been a great challenge for those patients. In 2012, regorafenib was approved for mCRC. In this meta-analysis, we aimed to collect and present existing data to explorethe clinical use of regorafenib. METHODS: The online electronic databases, such as PubMed, Embase, and the Cochrane library, updated to November 2017 were systematically searched. Trials on the effectiveness of regorafenib in patients who suffer from treatment-refractory metastatic colorectal cancer were included, of which the main outcomes included 3 parameters: overall survival (OS), progression-free survival (PFS), and grade 3/4 AE. RESULTS: Totally, 4 trials were included in this meta-analysis. The OD was significantly better with the use of regorafenib (OR = 0.78, 95%CI = 0.65-0.94, I = 69%, P = .008), and PFS (OR = 0.52, 95%CI = 0.34-0.79, I = 97%, P = .002). However, the most common toxicities occurred more frequently in the regorafenib group than the control group (OR = 3.73, 95%CI = 1.68-8.28, I = 79%, P = .001). CONCLUSION: Regorafenib demonstrates better efficacy and has manageable adverse-event profile for treatment-refractory mCRC. Considering the safety feature of regorafenib, further studies and clinical trials are warranted to investigate the dosing of regorafenib and alternative approaches are needed to explore predictive biomarker fortherapy selection.

[Efficacies of lactulose plus live combined Bacillus subtilis and Enterococcus faecium capsules in the treatment of functional constipation: a multicenter, randomized, double blind, controlled trial].

OBJECTIVE: To explore the efficacies of live combined Bacillus subtilis (B. subtilis) and Enterococcus faecium (E. faecium) capsules plus lactulose in the treatment of functional constipation. METHODS: A total of 216 patients fulfilling the diagnostic criteria of functional constipation (slow transit pattern) were randomly enrolled from 9 participating hospitals and allocated into treatment group and control group. The patients of treatment group received lactulose plus live combined B. subtilis and E. faecium capsules for 14 days and only took the latter during the following 14 days. The patients of control group received lactulose plus placebo for 2 weeks and then only took placebo continually for the following 2 weeks. RESULTS: A total of 216 patients were analyzed (treatment group n = 104, control group n = 112). The effective rates of 7-day treatment were 88.46% (n = 92) and 84.82% (n = 95) for treatment and control groups respectively. And those of 28-day treatment were 87.50% (n = 91) and 81.25% (n = 91)respectively. And the inter-group differences were not statistically significant (all P > 0.05). Fecal form, frequency, difficulty, urgency, distension, abdominal pain and expelling rates of barium enema were not statistically significant (all P > 0.05). Comparing the effective rates of 28-day with that of 14-day, differences were not statistically significant in A group (S = 0.5, P = 0.4795), but in B group the effective rates of 28-day were lower than that of 14-day statistically(S = 11, P = 0.0009). CONCLUSION: The regiment of live combined B. subtilis and E. faecium capsules plus lactulose offers better efficacies in the treatment of functional constipation.