| [Background]Pain is one of the most common symptoms in cancer patients, which seriously affects the quality of life. Since WHO raised and promoted the three-step analgesic ladder program, the treatment of cancer pain has been carried forward a great step. The control of cancer pain is still not ideal because of the policies and regulations, social and historical factors, and others. The opioid drugs are the first choice for the treatment of moderate to severe cancer pain, but they have obvious side effects. On the other hand, patients and clinicians have misunderstanding of opioid like drug addiction, which restricts the use of opioids.External treatment of Traditional Chinese Medicine has been widely used, and received good effect in pain treatment. Exernal application of Chinese medicine is the most common method, which is administered directly through the body surface, and can receive rapid analgesic effect with no significant systemic toxicity. There are complex pathological types of cancer pain, and external application of Chinese medicine is more suitable for the patients with fixed hurts in somatic pain. In recent years, there are many clinical reports for external treatment of Traditional Chinese Medicine used in treatment of cancer pain, but some of them lacked of rigorous scientific experimental design and theoretical basis. So, based on the theory of "Poison damage collaterals" and activating blood, detoxifying and freeing the collateral vessels as the treatment rule, we composed Bing Chong Zhi Tong Gao as external adjuvant treatment for local cancer pain, which had received good clinical results.[Objective]To get the clinical data of adjuvant treatment of moderate to severe cancer pain with Bing Chong Zhi Tong Gao, provide an objective basis for the method of activating blood, detoxifying and freeing the collateral vessels to relieve cancer pain, also enrich the connotation of external treatment of TCM theory.[Methods]Used method of single-blind prospective randomized controlled,80cases eligible for the study were randomly divided into treatment group (40cases) and control group (40cases). Prior to randomization,all patients were given the first stage of treatment (titrate with opioids in1-3days and then turn into sustained-release opioids), and then proceed to the second stage of treatment, the treatment group was added Bing Chong Zhi Tong Gao, the control group were treated with placebo ointment. Morphine was used to treat breakthrough pain,and the dose of sustained-release opioids was adjusted according to the intensity of pain. After the end of a course of treatment, pain intensity scores.pain remission rate, opioids dosage, breakthrough pain control, pain affect scores,quality of life, safety and adverse reactions were compared before and after treatment in two groups.[Results]80patients were included in this study, and excluded3cases. At last,39cases in the treatment group and38cases in the control group were included in the statistical analysis.1.Improvement in pain intensity:①After1-3days of strong opioids titration in the first stage, NRS of the treatment group decreased(5.08±1.33), the control group (5.21±0.99), NRS deviation between two groups was not statistically significant (P=0.931);②After the second stage of treatment, NRS of the treatment group was further declined, and decreased more significantly than the control group, NRS of the treatment group decreased (0.90±0.85), the control group (0.39±0.95), the difference was statistically significant (P=0.012).2.Pain remission rate (CR+PR):①After the first and second stages, the pain remission rate of the treatment group was84.62%, and73.68%in the control group, the pain remission rate of the treatment group was slightly higher than the control group, but the difference was not statistically significant (P=0.237);②Pain remission rate of the treatment group patients with moderate pain was90.91%, and82.14%in severe pain, pain remission rate of moderate pain was slightly higher than severe pain, but the difference was not statistically significant (P=0.495);③The pain remission rate of12bone metastases pain patients in the treatment group was83.33%, and50%in the control group of14cases of bone metastases pain, the difference was statistically significant (P=0.030).3.Opioids dosage:①The long-acting opioid dosage after the second stage, compared with the first stage dose, the treatment group decreased (4.10±12.08) mg, the control group increased (2.11±7.41) mg, the difference was statistically significant (P=0.004);②20patients’s (51.28%) basic opioids dosage decreased in the treatment group, and7cases (7.89%) in the control group, the reduction of the proportion of patients in the two groups was statistically different(P<0.001);③ln the moderate cancer pain cases of the treatment group, nine cases’s(81.81%) basic opioids dosage decreased,and11cases(32.29%) decreased in the severe cancer pain, moderate cancer pain cases were easier reduction in opioid consumption than the severe cases, there was a statistical difference (P=0.017) between the two. 4.Breakthrough pain control:During the second stage of treatment, breakthrough pain occurred (1.59±1.70) times in the treatment group, and (3.00±1.82) times in the control group, breakthrough pain occurred less in the treatment group, and there was statistical difference (P<0.001).5.Pain affect scores:After the first and second stages of treatment, pain affect scores of the treatment group was (20.13±10.29), and the control group (25.37±12.39), compared with pre-treatment, the treatment group decreased more than the control group, and difference was statistically significant (P=0.047).6.Quality of life:KPS scores had no significant difference in the treatment group and the control group before and after treatment (P>0.05).7.Safety and adverse reactions:①In the end of treatment all cases showed no abnormal changes in heart rate, blood pressure, respiration and blood, liver and kidney function, ECG caused by the clinical study medication;②Adverse reactions between the two groups were almost the same as opioid analgesics, and the extent of constipation of the treatment group was lighter compared with the control group, which was statistically different (P=0.024);③In the aspect of the adverse reactions of topical plaster, the treatment groups were1degrees of adverse reactions, and the rate was20.51%, which was higher than the control group,and was statistically different (P=0.007).[Conclusion]1.For patients with moderate to severe somatic cancer pain, the intensity of pain could be further relieve, pain remission rate was84.62%, and times of breakthrough pain could be reduced adding Bing Chong Zhi Tong Gao, based on effective opioid therapy.2.For patients with bone metastases pain, Bing Chong Zhi Tong Gao as adjuvant treatment could significantly increase the pain remission rate, which was more effective than a simple use of opioids.3.For patients with moderate to severe somatic cancer pain, adding Bing Chong Zhi Tong Gao could decrease the basis opioids dosage, and patients with moderate pain were easier reduction ones.4.For patients with moderate to severe somatic cancer pain, the pain affect scores could be further reduced adding Bing Chong Zhi Tong Gao, so as to soften its negative impact.5.There was no systemic side effects in external application of Bing Chong Zhi Tong Gao, and was safe and effective. It could reduce the dosage of opioids, so constipation could be improved to a certain extent due to heavy use of opioids. |
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