Multicenter clinical study for evaluation of efficacy and safety of transdermal fentanyl matrix patch in treatment of moderate to severe cancer pain in 474 chinese cancer patients.

OBJECTIVE: Although a new matrix formulation fentanyl has been used throughout the world for cancer pain management, few data about its efficacy and clinical outcomes associated with its use in Chinese patients have been obtained. This study aimed to assess the efficacy and safety of the new system in Chinese patients with moderate to severe cancer pain. METHODS: A total of 474 patients with moderate to severe cancer pain were enrolled in this study and were treated with the new transdermal fentanyl matrix patch (TDF) up to 2 weeks. All the patients were asked to record pain intensity, side effects, quality of life (QOL), adherence and global satisfaction. The initial dose of fentanyl was 25 µg/h titrated with opioid or according to National Comprehensive Cancer Network (NCCN) guidelines. Transdermal fentanyl was changed every three days. RESULTS: After 2 weeks. The mean pain intensity of the 459 evaluated patients decreased significantly from 5.63±1.26 to 2.03±1.46 (P<0.0001). The total remission rate was 91.29%, of which moderate remission rate 53.16%, obvious remission rate 25.49% and complete remission rate 12.64%. The rate of adverse events was 33.75%, 18.78% of which were moderate and 3.80% were severe. The most frequent adverse events were constipation and nausea. No fatal events were observed. The quality of life was remarkably improved after the treatment (P<0.0001). CONCLUSION: The new TDF is effective and safe in treating patients with moderate to severe cancer pain, and can significantly improve the quality of life.

[Polymorphism of porcine myostatin gene].

Myostatin(MSTN) gene is expressed specifically in developing and mature skeletal muscle, and the expression products of MSTN gene inhibits muscle growth and differentiation. The polymorphism of the porcine MSTN gene was researched by PCR-SSCP. The SSCP was found in the MSTN gene exon 2 and exon 3. It showed three genotypes (CC, CT, TT) in exon 2 and two genotypes (AG, GG) in exon 3 in Large White pigs. The relationship between polymorphism in exons 2 and 3 and productive performance was analysed. Variance analysis showed that there was no significant relationship between the polymorphism in exon 2 and productive performance. But t test showed that there was a significant relationship between the polymorphism in exon 3 and back fat thickness (P < 0.05), there was also a relationship between the polymorphism in exon 3 and lean meat percentage, but not significant (P > 0.05). The fragments with SSCP polymorphism in exon 2 and 3 were sequenced, the sequencing results showed that there were two single nucleotides mutation, i.e. A-->G at 1008 (exon 3) and G-->T at 480 (exon 2). Two mutations did not change the amino acid but brought an Apa I site in exon 3, and PCR-RFLP molecular marker technique was established with Apa I.