Objective: To assess the effect and adverse effects of transdermal fentanyl for elderly patients with cancer pain in China. Methods: A total of 1664 elderly patients (aged 65-90 with mean age of 72.6) with cancer pain enrolled in the multicenter study from 136 institutes in China. Of them, 408 (28.8%) patients were 75 years old or older. All patients received transdermal fentanyl for the management of cancer pain. The patients were asked to record the attacks of pain, quality of life, and any side effects of the treatment. Results: Baseline mean of pain intensity was 7.34. On day 1, 3, 6, 9 15, and 30, the pain mean scores were decreased to 3.82, 2.80, 2.43, 2.11, 1.83, 1.64 (P = 0.000). The effective rate was 97.18%. The mean doses of fentanyl was 31.34 µg/h (25-150 µg/h) initially, and 40.59 µg/h and 47.50 µg/h (25-200 µg/h) at day 15 and day 30. At treatment day 15, the dose of fentanyl was ranged from 25 to 50 µg/h in 91.8% of patients, 75 to 100 µg/h in 7.5% patients, and 125 to 200 µg/h only in 0.8% patients. The fine quality of life was in 25.4% patients before treatment, and was 71.15% and 73.04% at day 15 and day 30 respectively (P =0.0000). The common side effects were constipation (10.70%), nausea (11.96%), dizzy (6.85%), vomiting (3.85%), sedation (2.40%), respiratory depression (0.12%). 86.2% patients preferred continue treated by transdermal fentanyl. Conclusion: Transdermal fentanyl for the elderly with cancer pain is effective, safe, convenient, and can improve the quality of life. Transdermal fentanyl can be recommended as a first-line drug for the treatment of elderly patients with moderate to severe cancer pain, and the initial doses is recommended as 25 µg/h. The elderly patients are mostly population in the cancer. About half of the patients with cancer are over age 65. Whereas, there are a few of date about clinical trial for elderly patients before the new medicine in due form approved for clinic use. Statistically, the age is younger 10 years old in clinical trial population than in real cancer patient's population. In the most of clinical study, the exclude criteria of age are over 70 or 75 years old. Therefore, there were less than one fourth of the patients aged over 65 years old enrolled the clinical trial for new medicine. The age of elder might interfere to estimate the validity and safety of new medicine and new method, because of the impaired function of important organ and the more pre-existing or concomitant painful conditions common in elderly group. It is necessary to study the cancer pain management for elderly patients with cancer pain by new medicine or new method. The transdermal fentanyl patch is the transdermal drug of the strong opioid analgesics [1] . There is a lack of multicenter clinical trials on transdermal fentanyl patch therapy for elderly patients with cancer pain. The purpose of multicenter clinical trial is to Correspondence to: YU Shiying evaluate the effect and side effects of transdermal fentanyl for elderly patients with cancer pain in China.
Patients and ...