| According to the three ladder principle of WHO,cancer patients with moderate and severe pain generally require strong use of opioid analgesics. Constipation, as the most common adverse reaction in the use of opioids analgesia in patients with adanced cancer treatment,, persist in the whole process of application of opioid drugs. It becomes the biggest obstacle of opioid analgesic therapy and poses serious impact on the treatment of diseases and the patient’s quality of life.OxyContin is commonly used in clinical opioid analgesics, the prevention and treatment of constipation in the application of OxyContin pain treatment can not be ignored. Chinese medicine treatment of constipation has many advantages,including orally Chinese herbal medicine, proprietary Chinese medicines,acupuncture,and acupuncture point paste. Proprietary Chinese medicine is more convenient and its clinical efficacy is good. Given cause for further study of its role in terms of OxyContin-induced constipation, we compare the efficacy of oral lactulose with proprietary Chinese medicine.Objective:To observe the curative effect of proprietary Chinese medicine on the treatment of cancer pain patients with OxyContin induced constipationMethods:A prospective multicenter randomized controlled study.96cases of patients met the inclusion criteria.They were divided into treatment group(proprietary Chinese medicine) of46cases, control group(lactulose) of50cases.Course of treatment:2weeks,Course of observation:2weeks. Main outcome indicators:stool frequency,stool property,constipation scores,clinical symptom scores and pain scores.Results:The main outcome indicators:(1) Stool frequency:After2week of treatment, the number of cases with autonomous defecate number3or more times a week in test group is36, accounting for78%. The number of cases with autonomous defecate number3or more times a week in control group is29, accounting for58%.By chi-square analysis,there is significant difference between two groups indicating that compared with lactulose, proprietary Chinese medicine can better increase autonomy weekly defecation.(2) Stool property:There are no significant differences of stool property scores between two groups before treatment,indicating that the two groups are balanced and comparable at baseline.After1week of treatment, there are no significant differences of stool property scores between two groups, indicating that there are no differences between two groups after one week of treatment. After2 week of treatment, there are significant differences of stool property scores between two groups (P<0.05), indicating that after two weeks of treatment, compared to lactulose, proprietary Chinese medicine can better change the stool propertySecondary outcome indicators:(1) Constipation scores:Average constipation scores of test group before treatment are14.97, after1week of treatment the mean scores are7.55,after two weeks of treatment the mean scores are3.60.By paired Wilcoxon signed rank test, before and after treatment, there are significant differences of constipation scores in the test group (P1-2=0.000, P1-3=0.000) which shows that constipation scores of patients with proprietary Chinese medicine treatment decrease significantly.Before treatment, the mean constipation scores of control group are14.37. After treatment of one week the average scores are8.43after two weeks of treatment the mean are5.83. By paired Wilcoxon signed rank test, before and after treatment, there are significant differences of constipation scores in the control group (P1-2=0.000, P1-3=0.000),which shows that constipation scores of patients with lactulose decrease significantly. These datas show that proprietary Chinese medicine and lactulose both can reduce constipation scale score. There are no statistically significant differences of constipation scores between the two groups at baseline and after1week of treatment, indicating that the decrease of constipation scores of the two groups after one week of treatment is no significant different; There are statistically significant differences of constipation scores between the two groups at baseline and after2weeks of treatment (P<0.01),which shows that after2weeks of treatment,compared with lactulose,constipation scores after proprietary Chinese medicine treatment are lower.(2)Clinical symptom scores:Average clinical symptom scores of test group before treatment are20.65, after one week of treatment the mean scores are13.04, after two weeks of treatment the mean are9.30. By paired Wilcoxon signed rank test, before and after treatment,there are statistically significant differences of clinical symptom scores in the test group (P1.2=0.000, P1-30.000),which shows that clinical symptom scores of patients with proprietary Chinese medicine treatment decrease significantly. By paired Wilcoxon signed rank test, before treatment, after1week and2weeks of treatment,there are no statistically significant differences of clinical symptom scores in the control group (P1-2=0.660, P1-3=0.087). It shows that lactulose can not effectively improve the clinical symptoms associated with constipation. There are no statistically significant differences of clinical symptom scores between two groups before treatment, indicating that the clinical symptom scores in both groups at baseline are balanced and comparable. There are statistically significant differences of clinical symptom scores between the two groups at baseline, after1week of treatment and2weeks of treatment (P<0.01),indicating that compared with lactulose, proprietary Chinese medicine treatment could decrease clinical symptom scores after1and2weeks of treatment.(3)Treatment efficiency of two groups:The test group:there are19cases cured after treatment,16markedly effective cases,9effective cases,2ineffective cases. The total effective rate is95.7%;The control group:there are12cases cured after treatment,19markedly effective cases,14effective cases,5ineffective cases,the total effective rate is90%. There is statistically significant differences of constipation treatment efficiency between two groups and the results show that the efficiency of proprietary Chinese medicine treatment of constipation is better than lactulose. With constipation degree as a stratification factor, we compare the constipation treatment efficiency between two groups. According to the statistical test results, there is statistically significant difference in moderate constipation (P<0.05) between two groups, indicating the test group therapy for moderate constipation is better than the control group therapy.(4) Clinical symptom improvement rate:In the test group:there are12cases with clinical symptoms significantly improved,28cases with clinical symptoms partial improved,6cases with clinical symptoms no improved,the total improvement rate of clinical symptoms is87%.In the control group:there are5cases with clinical symptoms significantly improved,30cases with clinical symptoms partial improved,15cases with clinical symptoms no improved,the total improvement rate of clinical symptoms is70%.There is statistically significant difference of the rate of clinical improvement after treatment (P<0.05) and the results show that Proprietary Chinese medicine improves clinical symptoms better than lactulose.(5)Pain scores:The average NRS scores are6before treatment, pain scores decrease after treatment, the average NRS scores after two weeks of treatment are2. Before and after treatment, there are statistically significant differences of pain scores in both groups. OxyContin analgesic therapy is effective.Conclusion:1. Proprietary Chinese medicine can effectively improve constipation caused by OxyContin.The advantage occurs in the treatment of moderate constipation.2. There are significant differences in the improvement of clinical symptoms between the Proprietary Chinese medicine and oral lactulose. |
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