| [objective]To observe the effect of external analgesic Compound Chang Qing Xiao Tong Gao in the treatment of cancer pain, as well as its influence to quality of life, adverse reaction and safety. To provide a theoretical basis for its clinical application for cancer pain, enrich the method of activating blood, freeing the collateral vessels and detoxifying to relieve cancer pain, also to further expend the connotation of external treatment of TCM theory in cancer pain. This study aims to explore a kind of external analgesic which with reliable curative effect, easy to use, less adverse reaction.[method]Adopted the method of randomized controlled trial,90 cases eligible for the study were randomly divided into trial group (30 cases), traditional Chinese medicine (TCM) control group (30 cases) and western medicine control group (30 cases)by using the random number table method. Experimental group was treated with Compound Chang Qing Xiao Tong Gao, Chinese medicine control group was treated with the Compound Chan Su Gao, and Tramadol Hydrochloride SR Tablets in western medicine control group. Three groups cannot use other painkillers at all times during the treatment, and their medical foundation treatment is the same, all with best support treatment. Tramadol injection was used to treat breakthrough pain. After 7 days of the treatment, pain remission rate, analgesic effect time, duration of analgesia, the control of breakthrough pain, improvement to quality of life, safety and adverse reactions were compared in these three groups.[results]A total of 90 cases of hospitalized patients completed the study, Compound Chang Qing Xiao Tong Gao group, Compound Chan Su Gao group, Tramadol group are all 30 cases. All the patients completed the basic observation time of 7 days. Three groups of participants’ age, gender, disease, pain intensity score, KPS score, etc are equalization before the treatment, and there were good comparability between three groups.1 Analgesic efficacy in the three groups:(1) The total remission rate of cancer pain after treatment:Compound Chang Qing Xiao Tong Gao group was 80.0%, Compound Chan Su Gao group was 76.7%, and Tramadol group was 86.7%. The total remission rate of analgesia tramadol group was higher than Compound Chang Qing Xiao Tong Gao group and Compound Chan Su Gao group, but there were no statistically significant difference between the three groups, P> 0.05 (P=0.348) after statistics analysis. The total remission rate of cancer pain in Compound Chang Qing Xiao Tong Gao group was 80.0%, the rate was 90.5%(19/21) in moderate cancer pain, and 55.6% in severe cancer pain, P< 0.05(P= 0.03), the difference was statistically significant. It showed that its analgesic efficacy for moderate pain is superior to that for severe pain; and for some patients with moderate pain (3/21) it can be clinical cure.(2) The analgesia onset time:the average analgesia onset time of Compound Chang Qing Xiao Tong Gao group, Compound Chan Su Gao, Tramadol group was 1.25±0.52 hours,1.54±0.68 hours and 0.68±0.42 hours respectively. After statistics analysis, the difference between the three groups was statistically significant, P=0.001 (P<0.05). The onset time in Compound Chang Qing Xiao Tong Gao group was shorter than that in Compound Chan Su Gao; and Tramadol group was shorter than Compound Chang Qing Xiao Tong Gao group.(3) The duration of the analgesic effect:the average duration time of analgesia in Compound Chang Qing Xiao Tong Gao group, Compound Chan Su Gao group, Tramadol group was 4.74±1.34 hours,4.42±1.13 hours and 1.13±1.56 hours respectively. The duration time of the analgesic in Tramadol group is longer than that in Compound Chang Qing Xiao Tong Gao group and Compound Chan Su Gao group, the difference was statistically significant, P=0.027 (P<0.05). The duration time of analgesic in Compound Chang Qing Xiao Tong group was slightly longer than that in Compound Chan Su Gao group, P=0.083(P> 0.05),but there was no statistically significant difference; the duration time of the analgesic in these two groups were 4-6 hours.(4) The control of breakthrough pain:Treatment process, the number of breakthrough pain of three groups of patients were no more than 3 times, and statistical analysis was carried out on the outbreak of painful times, P =0.063 (P>0.05), there was no statistically significant difference.2 The improvement to the quality of life:Compound Chang Qing Xiao Tong Gao group can improve the quality of life for patients with cancer pain; the quality of life in the Compound Chan Su Gao group and Tramadol group was stable before and after treatment. P=0.002 (P<0.05), there was no statistically significant difference, it showed that Compound Chang Qing Xiao Tong Gao group had advantage over Compound Chan Su Gao group and Tramadol group in the improvement to the quality of life.3 The adverse reaction:During the treatment, Tramadol group appeared some common adverse reactions of tramadol such as nausea (7 cases), vomiting (5 cases), sweating (3 cases), dry mouth (4 cases), dizziness (2 cases), somnolence (3 cases), constipation (3 cases), and the adverse reaction severity was 1-3 degrees, alleviate after symptomatic treatment, no adverse reactions that couldn’t be tolerated. The adverse reactions of Compound Chang Qing Xiao Tong were mainly itchy skin (3 cases,10%), rash (1 case, 3.3%), plaster fall off (2 cases,6.7%), didn’t appear blisters or other damage. In Compound Chan Su Gao group, there was mild nausea (1 case), besides itchy skin, rash, plaster fall off, and no other obvious adverse reactions.4 Safety observations:After treatment, there were no significant changes in routine urine, blood routine, liver and kidney function, blood coagulation function compared with those before treatment,between three groups of patients.[conclusion]1 The Compound Chang Qing Xiao Tong Gao has good clinical efficacy to moderately-severe cancer pain, the total remission rate of cancer pain may be equal to Tramadol and Compound Chan Su Gao; Its analgesic efficacy for moderate pain is superior to that for severe pain; and for part of patients with moderate pain it can be clinical cure.2 The Compound Chang Qing Xiao Tong Gao has an advantage over Compound Chan Su Gao in the analgesia onset time; the duration of the analgesic effect in these two groups are about the same, the duration time of the analgesic was 4-6 hours.3 The Compound Chang Qing Xiao Tong Gao can not only remiss cancer pain effectively, but also can improve quality of life for the patients with cancer pain; Besides it has no obvious common adverse reaction of opioid painkillers, no toxic-side effects. It is worthy of promotion for cancerous pain patients with fixed pain. |
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