1. Preparation of tamsulosin hydrochloride sustained-release pellets
Academic Journal of Second Military Medical University 2016;37(4):493-497
Objective To prepare tamsulosin hydrochloride sustained-release pellet by coating with acrylic copolymers. Methods EUDRAGIT® NE 30 D was used as the main sustained-release material, EUDRAGIT® L 30 D-55 and Methocel® E3 were used as release adjust agent; a one layer sustained-release coating was done for tamsulosin hydrochloride-loaded pellet in bottom spray fluid bed. A three factor, three-level Box-Behnken design was used to optimize the percentages of EUDRAGIT® L 30 D-55 and Methocel® E3 in the total dry polymers and the weight gain of total dry polymers as the three nonlinear factors, which mainly influenced drug release of the pellets in the formula of sustained-release coating layer. In-vitro cumulative drug release after 2 h, 3 h and 5 h was tested and the following target range:2 h 12%-39%, 3 h 44%-70% and 5 h>70% were set for optimization. Results The formulation and process of one layer sustained-release coating, which was synergistically controlled by the three materials based on acrylic copolymers, was determined after optimization:the total dry polymers were applied with a weight gain of 12% on drug pellets, with EUDRAGIT® L 30 D-55 dry polymers and Methocel® E3 being 7% and 2% of the total dry polymers, respectively. The sustained-release pellets coated with the optimized formulation provided a release profile that was close to the predicted value and similar to that of the commercial product Harnal® capsule pellets by f2 similarity factor comparison (f2 values of three batches were 71,73 and 80). Conclusion The established formulation and process is a simple and reproducible method to prepare tamsulosin hydrochloride sustained-release pellets with good stability.
2.Therapeutic effectiveness of CCLG-97 protocol on standard-risk childhood acute lymphoblastic leukemia.
Pei-fang XIAO ; Yi-huan CHAI ; Jian-qin LI ; Hai-long HE ; Yi WANG ; Zhen-ping LI ; Ya-xiang HE ; Zheng-hua JI
Chinese Journal of Pediatrics 2005;43(7):486-489
OBJECTIVEWith the improvement of the diagnosis and treatment, the complete remission (CR) rate and the survival rate of childhood acute lymphoblastic leukemia have been increased in the recent 10 years. The objective of this study was to analyze the outcomes of 119 standard-risk childhood acute lymphoblastic leukemia (SR-ALL) patients, and explore how to improve the survival rate in ALL.
METHODSA total of 119 patients aged 14 months to 15 years were diagnosed as SR-ALL according to the Suggestion of Diagnosis And Treatment for Childhood Acute Leukemia-1993. Among them, seventy-nine were boys and 40 were girls. All of the patients were treated with the CCLG-97 protocol and were followed up for a period of 20 approximately 78 months.
RESULTSThe complete remission rate reached 97.4% in four-week induction. Twenty-one patients were out of follow-up, comprising 63%, 14%, 10%, 8% and 5% of all subjects in 1998, 1999, 2000, 2001 and 2002, respectively. The overall survival rates were 93.3%, 90.2%, 88.0%, 85.0%, 85.0% and 85.0% in 1 year, 2 years, 3 years, 4 years and 5 years, respectively. Relapses occurred in 13 patients (13.8%). Among 9 isolated hematologic relapses, 5 patients (56%) were given irregular therapy, 2 did not reach CR within 4 weeks and relapsed 2 years later, 2 accepted regular therapy, 1 was of hypodiploidy and 1 T-ALL. Isolated central nervous system (CNS) relapse occurred in 4 patients (4.3%). Fifteen patients (12.6%) died, 5 of whom (4.2%) died of complications.
CONCLUSIONReinforcing administration and regular therapy are important to improve the long-term survival rate in childhood ALL. The clinical classification should be adjusted with the improvement of diagnostic methods. CCLG-97 protocol decreased the rate of the relapses in SR-ALL and didn't increase the rate of therapy-related death. High-dose methotrexate should be used in therapy and its dosage, usage and individualized therapeutic regimen should be further studied.
Adolescent ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Child ; Child, Preschool ; China ; Disease-Free Survival ; Female ; Follow-Up Studies ; Humans ; Infant ; Male ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; drug therapy ; mortality ; prevention & control ; Remission Induction ; methods ; Risk Factors ; Secondary Prevention ; Survival Rate ; Time Factors ; Treatment Outcome
3.Free peroneal perforator-based sural neurofasciocutaneous flaps for reconstruction of hand and forearm.
Pei-hua CAI ; Sheng-he LIU ; Yi-min CHAI ; Hai-ming WANG ; Hong-jiang RUAN ; Cun-yi FAN
Chinese Medical Journal 2009;122(14):1621-1624
BACKGROUNDSural neurofasciocutaneous flap has been popularly used as an excellent option for the coverage of soft tissue defects in the lower third of leg, ankle and foot, but its free transplantation has been rarely reported. The objective of our work was to investigate the operative technique and clinical results of repairing the soft tissue defects of hand and forearm with free peroneal perforator-based sural neurofasciocutaneous flap.
METHODSBetween May 2006 and March 2007, 10 patients including 7 men and 3 women were treated. Their ages ranged from 22 to 51 years. They presented to emergency with large soft tissue defects of 16 cm x 7 cm to 24 cm x 10 cm in size in hand and forearm after injured by motor vehicle accidents (2 cases) or crushed by machine (8 cases). Thorough debridements and primary treatments to associated tendon ruptures or bone fractures were performed on emergency. And free peroneal perforator-based sural neurofasciocutaneous flaps were transplanted when the wound areas were stable at 5 to 7 days after emergency treatment. The flaps were designed along the axis of the sural nerve according to the shape and size of the soft tissue defects, with the peroneal perforator above the lateral malleolus as the pedicle and along with a part of the peroneal artery for vascular anastomosis. Then the flaps were harvested to repair the recipient sites with the peroneal artery anastomosed to the radial (or ulnar) artery and the peroneal veins to one of the radial (or ulnar) veins and the cephalic vein respectively. The flap sizes ranged from 18 cm x 8 cm to 25 cm x 12 cm. The donor areas were closed by skin grafts.
RESULTSAll of the 10 flaps survived after surgeries. Marginal necrosis occurred in only 2 cases. The skin grafts survived entirely in the donor sites, and no obvious influence on the donor legs was observed. All of the transplanted flaps presented favourable contours and good functions at 9 to 12 months' follow-up.
CONCLUSIONSPeroneal perforator-based sural neurofasciocutaneous flap has favourable appearance, constant vascular pedicle, reliable blood supply, large size of elevation, and minimal influence on the donor site. The free transplantation of this flap offers a satisfactory alternative for repairing the large soft tissue defects of forearm and hand.
Adult ; Female ; Forearm Injuries ; surgery ; Hand Injuries ; surgery ; Humans ; Male ; Middle Aged ; Reconstructive Surgical Procedures ; methods ; Skin Transplantation ; methods ; Surgical Flaps ; blood supply ; innervation ; Treatment Outcome ; Young Adult