| Objective:To observe and compare the therapeutic effects and side effects of Fentanyl transdermal system and oral Morphine sulfate controlled-release tablets on the middle and severe cancer pain. Evaluate the clinic value of Fentanyl transdermal system.Methods:Ninety-four patients suffered from middle or severe cancer pain were randomly assigned into two groups. Patients in FT Group were treated with Fentanyl transdermal system, and after the first 72 hours doses were titrated to patients according to the degree of pain. Patients in MO Group were given Morphine sulfate controlled-release tablets, and after the first 24 hours doses were titrated to patients according to the degree of pain. During the whole research, immediate-release morphine was used to control breakthrough pain; and the preconcerted curative effect was maintained(VAS≤3). The rates of pain relieve (PAR) and side effects in the two groups were recorded; the qualities of life after using medicine than before were also compared respectively and the cost-effectiveness was analyzed. Measurement data was presented as mean±SD, and quantitative analysis was proceeded by t test while enumeration data was examined by x2 test with SPSS V17.0 system. P=0.05 was regarded as the limit of statistical significance.Results:Finally total of 86 patients completed this research.1. General informationThere were no differences in common data among all the patients (P>0.05).2. The doses of medicine Totol amount of release agent of FT group was (34.9±18.2) mg, and that of MO group was (1178.6±805.1) mg. The doses of rescue morphine analgesic consumption was (32.6±25.3) mg and (39.8±22.1) mg respectively, and no statistical difference(P>0.05) was present.3. The effective rate of pain relieveTransdermal Fentanyl system (86.7%) has been shown to be as effective as oral Morphine sulfate controlled-release tablets (87.8%) in the treatment of middle and severe cancer pain. No statistical difference(P>0.05) was present in the effective rate of pain relieve between the two groups.4. Side effectsThe occurrence rates of constipation (13.3% vs.56.1%), dizziness (20.0% vs. 24.4%), nausea/vomiting (22.2% vs.39.0%) and sedation (11.1% vs.14.6%) of the FT group were lower than those of the MO group; while the rate of itching (8.9% vs. 2.4%) of the FT group was higher than that of the MO group. And the statistical difference(P<0.05) was present.5. Quality of lifeThe better rates of quality of life increased obviously after using medicine than before in the FT group (51.1% vs.8.9%) and the MO group (43.9% vs.12.2%). And the statistical difference(P<0.05) was present. The comparison of quality of life between the two groups had no differences(P>0.05).6. Cost effectiveness analysisThere was no statistical difference in effective rate of pain relief and cost-effectiveness(P>0.05).Conclusion:Transdermal Fentanyl and oral controlled-release Morphine both have notable analgesic effect on the middle and severe pain. Quality of life improved obviously after using medicine. The major side effects due to the former are less than the latter, and. So, transdermal Fentanyl can be regarded as an effective analgesic because of its availability, safety and convenience. |
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