Realgar-Indigo naturalis formula (RIF), an oral traditional Chinese medicine mainly containing Realgar (As4S4), is highly effective in treating adult acute promyelocytic leukemia (APL). However, the treatment efficacy and safety of RIF have not been verified in pediatric patients. SCCLG-APL group conducted a multicenter randomized non-inferiority trial to determine whether intravenous arsenic trioxide (ATO) can be substituted by oral RIF in treating pediatric APL. Of 176 eligible patients enrolled, 91 and 85 were randomized to ATO and RIF groups, respectively. Patients were treated with the risk-adapted protocol. Induction, consolidation, and 96-week maintenance treatment contained all-trans-retinoic acid and low-intensity chemotherapy, and either ATO or RIF. The primary endpoint was 5-year event-free survival (EFS). The secondary endpoints were adverse events and hospital days. After a median 6-year follow-up, the 5-year EFS was 97.6% in both groups. However, the RIF group had significantly shorter hospital stays and lower incidence of infection and tended to have less cardiac toxicity. All 4 relapses occurred within 1.5 years after completion of maintenance therapy. No long-term arsenic retentions were observed in either group. Substituting oral RIF for ATO maintains treatment efficacy while reducing hospitalization and adverse events in treating pediatric APL patients, which may be a future treatment strategy for APL.
Arsenic , Leukemia, Promyelocytic, Acute , Child , Humans , Arsenic/adverse effects , Arsenic Trioxide/adverse effects , Arsenicals/adverse effects , Leukemia, Promyelocytic, Acute/drug therapy , Treatment Outcome , Tretinoin/therapeutic use
OBJECTIVE: To investigate the age-related change in biomechanical properties of the costal cartilage and its relevance to the timing of ear reconstruction with costal cartilage framework. METHODS: The patients of 5 to 25 years old were divided into three groups according to their age. The biomechanical properties of costal cartilage harvested from these patients during ear reconstruction were tested, including stree-strain relationship, stress relaxation and creep, tensile strength. All the results were analyzed statistically. RESULTS: The costal cartilage from children group had the best biomechanical properties, while the costal cartilage from the adolescent group had the worst. The difference had a statistically significance (P < 0.05). CONCLUSIONS: The biomechanical properties of costal cartilage are age-related. So it is recommended that ear reconstruction with costal cartilage framework should be performed in childhood when the costal cartilage has the best biomechanical properties.
Cartilage/physiology , Cartilage/transplantation , Ear Auricle/surgery , Ribs/physiology , Adolescent , Adult , Age Factors , Child , Child, Preschool , Female , Humans , Male , Plastic Surgery Procedures/methods , Ribs/transplantation , Stress, Mechanical , Young Adult
OBJECTIVE: To study the techniques of cranial flap fixation (suture, stainless steel wire, and rivetlike titanium clamp) on biomechanics. METHODS: Twenty-four cadaver craniotomy flaps were reattached with either suture, stainless steel wire, or rivetlike titanium clamp. Cranial flap fixation was timed and measured for the offset between cranial flap with craniotomy skull for every fixation technique. Load-bearing tests were performed by applying an external force until the failure of the fixation system. RESULTS: Rivetlike titanium clamp required significantly less time to fix (94 +/- 13 seconds) than either suture (172 +/- 14 seconds) or stainless steel wire (399 +/- 45 seconds). The offset of cranial flap after rivetlike titanium clamp fixation (0.20 +/- 0.12 mm) was significantly smaller than either suture (2.20 +/- 0.24 mm) or stainless steel wire (1.32 +/- 0.34 mm). Rivetlike titanium clamp was also stronger than suture and stainless steel wire in the load-bearing test. CONCLUSION: Rivetlike titanium clamp is easy to use, requires less time consumption, and shows accuracy and strength.
Bone Nails , Bone Wires , Craniotomy/instrumentation , Surgical Flaps , Suture Techniques , Biomechanical Phenomena , Cadaver , Humans , Stainless Steel , Stress, Mechanical , Titanium
BACKGROUND AND AIMS: For repairing the ear malformation, it is recommended in China to use the over than 10-years-old rib cartilage. However, according to our clinical experience, a better post-operation effect can be found using about the 7-years-old cartilage for the operation. To shape a harvested costal cartilage and to perform it on the transplant site depend on the mechanical properties of the costal cartilage. Hence, the aim of this study is to investigate the age and gender-related biomechanical properties of the human costal cartilage. METHODS: Human costal cartilages were harvested from 25 female and 45 male donors of 5-25 years old after auricular reconstructive surgery. The specimens were divided into six groups: children (5-10 years), adolescent (11-17 years) and adult (18-25 years), respectively, in males and females. Tensile strength, stress-strain relationship, stress relaxation and creep were tested by using a material testing machine. FINDINGS: The biomechanical properties of costal cartilage are donor age and gender related. The children group has the highest tensile strengths (P<0.01) in both male and female groups. The male group relaxed and crept more than that of the female group in all three age groups (P<0.01). INTERPRETATION: These findings provide a further support for the potential age acting on the human costal cartilage. The adolescent has the lowest strength, this could be a reason that compared to using the children costal cartilage, the bigger distortion happened after using the adolescent costal cartilage in the auricular reconstruction operation.
Cartilage, Articular/physiology , Adolescent , Adult , Age Factors , Child , Child, Preschool , Female , Humans , Male , Sex Factors , Tensile Strength
