Prognosis of Patients With Heart Failure Receiving Autologous Myoblast Patches　- Comparison of Single-Arm Trial Data to Registry Data.

BACKGROUND: Clinical studies in regenerative medicine remain insufficient in Japan due to ethical concerns regarding the control group and a lack of statistical methodology to evaluate efficacy in a small treatment group. This study evaluated the efficacy of autologous myoblast patch (AMP) treatment for heart failure using restricted mean survival time (RMST) analysis by comparing data from a small single-arm trial to epidemiological data from a registry.Methods and Results: The clinical trial arm included 55 patients with advanced ischemic cardiomyopathy who received an AMP between 2010 and 2020. The registry-based control group comprised 937 participants with severely impaired left ventricular function who were hospitalized for heart failure during the study period. Due to the limited number of patients, RMST analysis was used to compare survival between the 2 groups. Cox regression analyses revealed non-significant differences in survival between the groups at 3, 3.5, and 4 years. In contrast, RMST analyses revealed significant differences in survival at 3 years (P=0.008) and 3.5 (P=0.024) years, but not at 4 years. CONCLUSIONS: This small single-arm trial using RMST analyses was able to detect the efficacy of AMP transplantation for advanced heart failure (compared with a registry-based control group), with better survival until 3.5 years. This approach may be useful for efficacy analyses in regenerative medicine, where traditional clinical trials are difficult.

[Influence of commercial soft drinks or green tea intake to occult blood and sugar tests with urinalysis reagent strips].

Consumption of commercial soft drinks or tea has increased in over recent years. In many case, these drinks contains large amount of ascorbic acid as an antioxidant. We examined the influence of ascorbic acid to the result of urine occult blood and sugar tests with urinalysis reagent strips. Three subjects took 3 brands of soft drinks (P, C, B) in 3 different days once in the morning. Other 3 subjects took 4 brands of green tea in 4 different days 4 times in a day. After 2 hours of first administration, urine specimen were collected every hour for 8-10 hours. Constant amount of hemoglobin or sugar was added in urine specimen and the reflectance was measured with AX-4280. As a results, urine ascorbic acid induced false negative results in both occult blood and sugar tests in all groups. These results indicate the necessity of patient education about commercial soft drinks or green tea consumption on the previous night and the day of the urinalysis.