| [Background]Cancer pain seriously affects the quality of life of patients.And effective management of cancer pain is gaining more and more attention.Although the promotion of NCCN cancer pain guidelines has greatly promoted the standardized treatment of cancer pain,the side effects of treatment are difficult to avoid.Traditional Chinese medicine methods,such as traditional Chinese medicine orally,external treatment,acupuncture and moxibustion,are also quite effective in the treatment of cancer-induced pain.It can also alleviate the side effects of cancer pain treatment and play a synergistic and attenuating role.However,due to the low level of relevant clinical research evidence,it is not conducive to popularization and application.So a clinical study with high-level evidence-based tests to verify the clinical efficacy of Chinese medicine in the treatment of cancer-induced pain will help to improve the current status of cancer-induced pain treatment and better utilize the advantages of Chinese medicine.Professor Pei Wang,a well-known oncologist in our hospital,has rich experience in treating cancer-induced pain.He had proposed eight methods of treating traditional Chinese medicine on cancer-induced pain,that is,dispelling cold for analgesic,promoting blood flow for analgesia,activating qi for analgesia,dissipating phlegm for analgesia,astringing for analgesia,clearing heat for analgesics,tranquilizing the mind for analgesics,tonifying deficiency for analgesics.While he put forward three major rules of external treatment of cancer-induced pain,namely warming and dredging,activating qi,promoting blood circulation for removing blood stasis.Warming and dredging is very important on the choice of medicine.The research group conducted research on cancer pain related subjects in the early stage and warming yang was the main treatment of cancer pain.Among them,Dingxiang Analgesic paste for external use combined with three-step analgesia was mostly used,which has the effect of attenuating and synergizing.And the effect was better.However,the evidence-based level of previous studies was relatively low.The only two RCTs were only for cancer abdominal pain and bone metastasis cancer pain.However,clinical practice had found that the external application of Dingxiang Analgesic paste had a certain therapeutic effect on a variety of cancer pains,but the relevant research had a lower evidence-based level.Cross-over trial is a first-level design plan for clinical research.The evidence-based level is high.The specific implementation process is to take different measures to intervene in the two groups of subjects,then pass the washout period and exchange the two sets of interventions.Each patient can accept two different interventions.But the order of the interventions is different.The intervention not only avoids the differences between groups,but also eliminates the differences between individuals.And the patients compare with itself,So the effect evaluation is more accurate.The study used prospective,randomized,double-blind,cross-over trial.Under the guidance of warm yang theory,the treatment of"warming and dredging and removing toxin for dredging channels,regulating Qi-flowing and promoting blood circulation for relieving pain" was adopted.And "Dingxiang Analgesic paste" for external use,which had been modified and based on the experience formula of the department,was used to explore the therapeutic efficiency after expansion of cancer pain.[Objectives]1.To evaluate the therapeutic efficiency of external application of "Dingxiang Analgesic paste" for cancer pain patients;2.To evaluate the safety of external application of "Dingxiang Analgesic paste" in for cancer pain patients.[Methods]1.The subject adopted a prospective,randomized,double-blind,cross-over trial and was monitored by the person in charge of the out-patient department.Determine the final research plan after multiple protocol demonstrations,complete the preparation work before patient recruitment,including the ethical review of the research center,trainning the researcher and preparation of "Dingxiang Analgesic paste"and "placebo of Dingxiang Analgesic paste" based on the blind bottom preset by the evidence-based medical center by the external treatment room.2.The included patients were randomized(group A or group B).Test group scheme:Three-tiered cancer pain ladder+Dingxiang Analgesic paste.Control group scheme:Three-tiered cancer pain ladder+placebo.Group A implemented the test group scheme in the first phase and the control group scheme in the second phase.Group B implemented the control group scheme in the first phase and the experimental group scheme in the second phase.Intervention lasted for 3 consecutive days in both stages.The elution period of drug between the two phases was 3 days.3.Collect clinical data.The "Case Report Form" should be completed by the observing physician,and the "Patient Log" should be filled by the patient under the guidance of the physician.The main outcome indicators included NRS score and QOL score.The secondary outcome indicators included analgesic dose,gastrointestinal function score,mechanism indicators(PEG2,β-endorphin,ET-1,5HT)and satisfaction evaluation.Safety indicators including blood routine,liver and kidney function,ECG and skin adverse reactions.4.SPSS 21.0 statistical software was used for data processing and statistical analysis to evaluate the therapeutic efficiency of Dingxiang Analgesic paste in treating cancer pain and explore its mechanism.[Results]1.The subject strictly followed prospective,randomized cross-control,double-blind design to study the therapeutic efficiency of Dingxiang Analgesic paste for cancer pain patients,which basically met the quality control standards expected.And we enrolled 58 patients with cancer pain according to the requirements,which lasted for 10 months.Among them,2 patients fell off due to death and 2 patients were discharged from hospital due to midway.A total of 54 patients completed the study.Baseline analysis showed that there were no significant differences between the two groups in age,sex,NRS score,QOL score,analgesic dose,gastrointestinal function score,mechanism indicators(PEG2,β-endorphin,ET-1,5HT)and safety indicators(P>0.05).It showed that the two groups of patients with cancer pain were comparable at the baseline of enrollment and met the random design.2.Comparing the NRS scores of the two groups,the NRS score of the experimental group after intervention was lower than that of the control group(P<0.05).Stratified statistics showed,comparing the NRS scores of the two groups of moderate pain subjects,the NRS score of the experimental group after intervention was lower than that of the control group(P<0.05).There was no significant difference in NRS scores between the two groups of mild pain patients(P>0.05).Comparing the QOL scores of the two groups,the QOL score of the experimental group after intervention was higher than that of the control group(P<0.05).Stratified statistics showed,comparing the QOL scores of the two groups of moderate pain subjects,the QOL score of the experimental group after intervention was higher than that of the control group(P<0.05).The QOL score of the experimental group after intervention was higher.There was no significant difference in QOL scores between the two groups of mild pain patients(P>0.05).3.Comparing the dosage of analgesics between the two groups,the overall and stratified statistics showed that there was no significant difference in the dosage of analgesics between the two groups of subjects(P>0.05).Comparing the gastrointestinal function scores between the two groups,the overall and stratified statistics showed that there was no significant difference in gastrointestinal function scores between the two groups of subjects(P>0.05).Comparing the four mechanism indicators(PEG2,β-endorphin,ET-1,5-HT)between the two groups,the overall and stratified statistics show that the four major mechanism indicators(PEG2,β-endorphin,ET-1,5-HT)(P>0.05).There was significant difference in the satisfaction scores between the two groups(P<0.05).The patients were more satisfied with the treatment of the experimental group.4.Regarding safety indicators,no significant difference was found in blood routine,liver function,renal function,or ECG between the two groups or within the group(P>0.05).Adverse reactions:1 patient developed local skin redness and 1 patient developed itching,both of which were in Group B patients and during the second stage of intervention.And they were relieved by themselves after stopping the external application of the drug without treatment.1 patient(Group B patient)was allergic to the dressing,and only the plaster was brought into contact with the patient’s skin during external application.Roll up the dressing to avoid contact with the skin.No other adverse reaction was found.[Conclusions]1.The project adopted a randomized cross-controlled,double-blind,single-center clinical project design to implement and complete strictly.It belonged to a higher level of evidence-based medicine and the conclusion was true and reliable.2.According to the analysis of the main outcome indicators,the external application of Dingxiang Analgesic paste under the guidance of warm yang theory can improve the NRS score and quality of life of patients with moderate cancer pain.However,to improve the NRS score and quality of life of patients with mild cancer pain,three-tiered cancer pain ladder with external application of Dingxiang Zhitong ointment had no obvious advantage.3.According to the analysis of the secondary outcome indicators,external application of Dingxiang Analgesic paste had no advantage in improving the gastrointestinal function,reducing the dose of analgesics and improving four mechanism indicators(PEG2,β-endorphin,ET-1,5-HT).Satisfaction evaluation showed that the patients were more satisfied with the treatment of Dingxiang Analgesic paste.4.External application of "Dingxiang Analgesic paste" was safe and reliable for cancer pain patients.Only a few patients had mild skin allergic reactions,which did not affect the clinical use of "Dingxiang Analgesic paste". |
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