Endoscopic cyanoacrylate injection with or without lauromacrogol for gastric varices: A randomized pilot study.

BACKGROUND AND AIM: Current guidelines recommend injection of cyanoacrylate as first-line therapy to prevent gastric variceal rebleeding. The method still poses a risk of ectopic embolism, which possibly correlates with the volume of cyanoacrylate used. In this trial, we evaluated the short-term efficacy and safety of tissue adhesive injection combined with lauromacrogol for treating gastric varices. METHODS: Patients admitted to our hospital for variceal hemorrhage were enrolled and blindly randomized into two treatment groups: lauromacrogol group (lauromacrogol-cyanoacrylate-lauromacrogol) and lipiodol group (lipiodol-cyanoacrylate-lipiodol). Patient follow-up was 6 months. Primary outcome was rebleeds, and secondary outcomes were mortality, gastric varices eradication, and treatment-related adverse events. RESULTS: Between March 6, 2013 and October 16, 2013, 96 patients met the criteria. Two cases were lost to follow-up, and all treated cases were successful. No procedural-related adverse events were observed in either group. Cyanoacrylate volumes used in the lauromacrogol group were significantly less than those of the lipiodol group (0.9 ± 0.5 vs 2.0 ± 1.2 mL, P = 0.000). Eleven patients developed upper gastrointestinal rebleeding, which did not show significant difference between groups. On multivaritate analysis, portal venous thrombosis and fever were potential risk factors of rebleeding. Treatment failure, complications, gastric varices obturation, and survival did not differ between the two groups. CONCLUSION: Tissue adhesives combined with lauromacrogol is a safe therapeutic option for gastric varices, with comparably less cyanoacrylate volume used. Because of the small number of study patients, it cannot be proven to have better efficacy than without lauromacrogol. Multicenter studies with larger patient groups are necessary.

The efficacy of Combizym in the treatment of Chinese patients with dyspepsia: a multicenter, randomized, placebo-controlled and cross-over study: Shanghai Combizym Clinical Cooperative Group.

OBJECTIVE: To evaluate the efficacy and safety of Combizym treatment in Chinese patients with dyspepsia. METHODS: In this multicenter, randomized, placebo-controlled cross-over study, a total of 151 patients (76 men and 75 women, mean age: 44.67 +/- 6.46 years, range: 22-67 years) with dyspepsia whose symptoms were not relieved by placebos were recruited. They were randomly divided into group A (79 patients, 2 weeks of Combizym treatment, two tablets post-meal, t.i.d.; then 1 week of wash-out, followed by 2 weeks of placebo treatment, two tablets post-meal, t.i.d.) or group B (72 patients, 2 weeks of placebo treatment, two tablets post-meal, t.i.d. then one week of wash-out, followed by 2 weeks of Combizym treatment, 2 tablets post-meal, t.i.d.). The index of severity of the dyspepsia symptoms was evaluated before and after each treatment phase with Combizym or the placebo. RESULTS: Compared with the placebo, 2 weeks of Combizym treatment decreased the severity index of dyspepsia symptoms significantly (27.64 +/- 1.77 to 9.72 +/- 1.33 vs 23.99 +/- 1.28 to 22.03 +/- 1.40, P < 0.01). The efficacy rates of Combizym and the placebo on dyspepsia were 89.63% and 21.68%, respectively (P < 0.01). According to the improvement of symptoms index, individual dyspepsia symptoms that could be attenuated by Combizym therapy were anepithymia, abdominal distension, belching, diarrhea, abdominal pain, epigastric burning. None of patients reported adverse events during the study. CONCLUSION: Combizym treatment effectively ameliorates dyspepsia symptoms in Chinese patients, with satisfactory safety and compliance.

[Clinical study of teicoplanin in the treatment of patients with gram-positive cocci: the Chinese experience].

OBJECTIVE: To evaluate the efficacy and safety of Teicoplanin (TEC) in the treatment of Chinese patients with moderate and severe Gram positive (G(+)) coccus infections. METHODS: A prospective, multicenter, non-comparator control, open-label drug clinical trial of phase IV was conducted. RESULTS: Totally 156 cases with established and highly suspected G(+) coccus infections are enrolled. Mean age was 53.6 +/- 20.9 (9-93). The infections included: lower respiratory tract infections (66.0%), sepsis (9.0%), catheters-associated infections (5.1%), endocarditis (1.9%), leucopenia with fever (14.1%), bone-joint infections (1.3%), skin-soft tissue infections (7.7%), and other infections (10.9%). Eighty seven point eight percent of the patients suffered from severe underlying diseases, 28.2% (44/156) had immunocompromised conditions. 69.2% had received antibiotics previously (57.4% with cephalosporins and 28.7% with carbapenem, respectively). One hundred and thirty strains of G(+) cocci were isolated from 123 patients (78.8%). Among them methicillin-resistant Staphylococcus aureus (MRSA) accounted for 90.7% (49/54) and methicillin-resistant coagulase-negative Staphylococcus (MRCNS) 88.2% (30/34). The TEC susceptibility test for 105 strains showed that all of the Staphylococci and Enterococci were susceptible. In 121 strains tested for vancomycin, all of the Staphylococci but only 78.3% (18/23) of the Enterococci were susceptible. There were 18 strains of Gram negative bacilli and 1 strain of Candida A. isolated concomitantly with G(+) cocci from 17 cases. The total clinical effectiveness was 82.1% by ITT (156 cases) analysis and 85.2% by PP (135 cases) analysis, respectively. Bacteriologic eradication rate was 87.7%. Thirty three patients with negative culture result were empirically treated with TEC and had 96.8% of clinical effectiveness. The efficacy of TEC to different infections was similar. The total adverse effects, such as decrease in blood cells and transient abnormal liver functions, accounted only for 1.28%. CONCLUSIONS: Teicoplanin was a very effective antibiotic for G(+) coccus infections and safe for patients. In highly suspected infections with methicillin-resistant Staphylococci or Enterococci, TEC may be a choice for initial empirical treatment.

[Cost-effective analysis of preventive treatment on diabetes].

OBJECTIVE: To evaluate the cost-effectiveness of preventive treatment on diabetes, using metformin or acarbose among patients with impaired glucose tolerance. METHODS: Using data from diabetes prevention program (DPP) and STOP-NIDDM study, we evaluated the cost of preventing one new onset of diabetes in Shanghai, and to compare its cost with the current treatment cost. RESULTS: If metformin was used for preventive treatment as in DPP study, a total cost of 69 122.95RMB was needed for preventing one new onset of diabetes in three years period. If acarbose was used for preventive treatment as in STOP-NIDDM, then 154 116.05RMB was the cost to prevent one diabetes in 3.3 years of treatment. However, if the generic metformin was used, the total cost was only 21 666.63RMB for the 3-years treatment. Data showed that the average cost for treating diabetes per year was 9143.70RMB in Shanghai. CONCLUSION: The total cost of diabetes prevention was formidable, although generic metformin showed the trend of cost-effective. The cost of drugs took the biggest part of the total cost. To choose the cheap but effective drug for treatment might save a large part of the cost. Further clinical research concerning the prevention of complications might provide us with more information on the cost-effectiveness of preventive treatment on diabetes.