Clinical Trial
Clinical Trial, Phase IV
English Abstract
Journal Article
Multicenter Study
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[Effects of sustained release morphine hydrochloride tablets in management of cancer pain: a survey of 567 patients].

OBJECTIVE: To evaluate the effect and adverse effects of morphine hydrochloric sustained release for patients with cancer pain.

METHODS: A total of 567 patients, 369 males (65.1%) and 198 females (34.9%), aged 65 - 90 with a mean age of 72.6, with cancer pain, 67.4% with severe pain, 28.2% with moderate pain, a and 4.4% with mild pain, that were treated in 25 hospitals from 13 provinces received oral morphine hydrochloric sustained release. The recommended initial dosage was 30 mg every 12 hours, and then the dosage was regulated according to the effects until the ideal anesthesia was achieved. All patients were asked to record the attacks of pain, quality of life, and any side effect of the treatment.

RESULTS: The baseline mean pain intensity (NRS) was 7.0 +/- 1.8. On the day 1, 5, 10, 15, 20, 25 and 30, the mean pain scores were decreased to 4.6 +/- 2.6, 2.8 +/- 1.8, 2.7 +/- 1.8, 2.6 +/- 1.7, 2.5 +/- 1.6, 2.3 +/- 1.4, and 2.2 +/- 1.4 respectively (all P = 0.000). The general effective rate on day 30 was 89.8%. The mean dosages were 66 +/- 56 mg/d initially, 84 +/- 64 mg/d (10 - 800 mg/d) on day 15, and 92 +/- 67 mg/d (10 - 800 mg/d) on day 30. On the day 30, 55.1% of the patients received a dosage or= 241 mg/d. Ninety-one point six percent (89.4% - 95.8%) of the patients took morphine orally twice daily. The poor quality of life rate in the patients was 90.5% before treatment, and were 56.8% and 49.6% respectively on the day 15 and day 30 (P = 0.0000 and P = 0.0009). The incidence of side effects was 35.6% on day 1, and 15.1% on day 30. The common side effects were constipation (14.3%), nausea (13.4%), dizziness (3.4%), vomiting (2.8%), drowsiness (0.7%), dysuria (0.4%), mental symptoms (0.2%), and respiratory depression (0.2%). Sixty-eight point four percent of the patients preferred continuation of sustained release morphine hydrochloride treatment.

CONCLUSION: Oral treatment with sustained release morphine hydrochloride for patients with cancer pain is effective, safe, and convenient, and can improve the quality of life. Sustained release morphine hydrochloride is worth recommending as a first-line drug for the treatment of patients with moderate to severe cancer pain, and the usually dosage is 120 mg or less per day.

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