| ObjectiveThis article through the analysis of syndrome differentiation of patients with cancer due to fatigue,use Pisanzhen needles for therapy,evaluate the therapeutic effect of this therapy on patients,in order to explore the advantages of tired triple needle therapy in the treatment of cancer-induced fatigue,in order to better promote the clinical application.MethodsThis study uses a clinical randomized controlled trial,collected 60 cases of related cases at the First Affiliated Hospital of Guangzhou University of Chinese Medicine,Foshan Hospital of TCM,Shenzhen Bao'an District Hospital of TCM,randomly divided into treatment group and control group,30 cases in each group.Patient enrollment criteria include: 1,diagnostic criteria,(1)Cancer diagnostic criteria: Adopting the Diagnostic Criteria for Malignant Tumors in the "Code for the Diagnosis and Treatment of Common Malignant Tumors in China" edited by the Department of Medical Affairs of the Ministry of Health;(2)Diagnostic criteria for cancer-induced fatigue: In accordance with the10 th International Conference on Classification of Diseases and Diseases(ICD-10),the diagnostic criteria for cancer-induced fatigue were proposed:Symptoms of fatigue appear repeatedly,lasting more than 2 weeks,accompanied by the following 5 or more symptoms: 1 The body is weak or limbs heavy;2 can not concentrate;3 lack of passion,low mood,loss of interest;4 insomnia or drowsiness;5 feel restless after the break;6 activities difficult;7 there are emotional reactions,such as sadness,frustration sense;8 can not complete the original competent daily activities;9 short-term memory loss;10 fatigue symptoms can not be relieved for several hours.2.Inclusion criteria:Non-small cell lung cancer patients diagnosed by pathology or cytology;compliance with diagnostic criteria for cancer-causing fatigue;estimatedsurvival over 3 months;PS?2,age 18-80 years,stage IIIb-IV;patients not eligible for targeted drug therapy;patients willing to undergo this regimen according to doctor's advice,insist on outpatient treatment and compliance.3.Exclusion criteria: The chemotherapy regimens received by the subjects in the chemotherapy group were not included in the prescribed protocol;any condition that may impede the subject's completion of the clinical trial process,including but not limited to severe,uncontrollable organic lesions or infections,not stable angina,congestive heart failure,etc;severe liver and kidney function abnormalities(serum creatinine?1.5 times ULN;ALT or AST?5 times ULN;bilirubin?1.5 times ULN);patients with symptoms,difficult to control neurological,mental or mental disorders;poor compliance.4.Exclusion criteria: Patients who failed to use the chemotherapy regimen in the previous trial;those who received other chemotherapy or targeted therapy during the treatment period;those who violated the protocol regimen.All enrolled patients received platinum-based chemotherapy according to the NCCN guidelines,such as DP(docetaxel + cisplatin / carboplatin),GP(gemcitabine + cisplatin / carboplatin),AP(pemetrexed + cisplatin /carboplatin).On this basis,the treatment group was treated with Yifeisanjie Pill combined with three needles.Yifeisanjie Pill is an in-hospital preparation of the First Affiliated Hospital of Guangzhou University of Chinese Medicine,The original party is Professor Lin Lizhu's experience-"Yiqichutan prescipton".Yifei sanjie Pills are made from the eight flavors of American ginseng,Zhejiang Fritillaria,and Pinellia,with a specification of 10 g per bag.Usage is oral,2 bags at a time,3 times a day.Weak three-needle screening uses four needles,Neiguan and Zusanli as the basic prescription for acupuncture.During operation,the patient takes a supine position,after local routine disinfection,acupuncture with 0.25 mm×40 mm needles,the line was inserted and transferred to the leveling and relieving method,and the degree of soreness was locally expressed as degree,after getting Qi,keep the needle for 30 minutes,during which every 1 minute.2 times a week for a total of 6 weeks,a total of 12 times.Acupuncture point positioning and specific operations are as follows:Neiguan: Located in the anterior area of the forearm,2 inches distal to the lateral stripes on the palmar side of the palm,between the long palm spasm and the flexor carpi ulnaris.Operation: Piercing 0.5 to 1 inch,prickly anddeeply.Four Gods needle: 1.5-inch open on the front,rear,left and right sides of Baihui.Operation: Flat thorn 0.5~0.8 inch.Zusanli: Located on the lateral side of the lower leg,3 inches under the nose,1 lateral line at the front of the zygomatic ridge,and a line connecting the licking nose and the solution stream.Operation: 1 to 2 inches.Control group received placebo and placebo treatment.Placebo entrusted the pharmacological department of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine to produce Yifei Sanjie Pill Simulator.Yifei Sanjie Pills Simulator requirements and Yifei Sanjie Pills remain exactly the same in appearance,color,odor,but there is no corresponding pharmacological effect.The specification is 10 g per bag.Usage is oral,2 bags at a time,3 times a day.The acupuncture needle is used for non-pricking acupuncture at the placebo needle.The needle is stabbed at the acupuncture point with a needle,but the needle does not penetrate into the patient's body so that the tip of the round needle sticks to the patient's skin and fixes the needle.Combined use of drugs: 1.The use of Western medicines and proprietary Chinese medicines that improve the immune function,such as lentinan,placenta polypeptide,and thymosin,are prohibited.2.The following anti-cancer proprietary medicines are allowed: Brucea javanica milk oil soft capsule,Brucea javanica oil emulsion injection,compound Kushen injection,compound cantharidin sodium vitamin B6 injection,Huachansu injection,Xihuang pill,Jinlong Capsules,ear particles.3.If the patient has severe anemia or thrombocytopenia during the course of treatment,it is permissible to perform safe and reasonable blood transfusions,including plasma,red blood cells,and platelets,in accordance with the principle of component transfusion.Efficacy assessment indicators include: 1.The main efficacy evaluation indicators,cancer-causing fatigue scale--using the Piper's Fatigue Scale(RPFS-Chinese Version)to evaluate the patient's cancer before and after treatment,the improvement of sexual fatigue was assessed before treatment and after the end of the second course of treatment,a total of 2 times.2.Secondary efficacy evaluation indicators,(1)Quality of Life Scale-The EORTC QLQ-C30 v3.0 Chinese version of the Cancer Patient Quality of Life Inventory was used to evaluate the quality of life improvement before and after treatment.Assessments were performed 2 times before treatment and after the end of the2 nd course of treatment.(2)Clinical symptom scores: fatigue related symptoms(such as Shenpi fatigue,less gas lazy words,poor appetite,weak backache,dizziness,etc.)before treatment,after the end of the first course,and after the second course of treatment.Self-sweat,etc.)were scored to evaluate the effect of treatment.(3)Immune function: Including TNF-?,IL-2,IL-6,NK cell activity,etc.,were detected before treatment and after the end of the second course of treatment,a total of 2 times.3.Safety indicators,(1)Vital signs observations were performed within 24 hours before treatment and during the course of treatment;(2)blood routine,urine routine,stool routine,liver function,renal function,coagulation four items and electrocardiogram examination were detected within 3 days before treatment,after the end of the first course of treatment,and after the end of the second course of treatment;(3)Adverse reactions that occurred during the course of treatment were graded according to the National Cancer Institute General Toxicity Criteria(NCI CTC 4.0),and the time,duration,severity of adverse reactions,relationship with trial medications,and adverse events were recorded at any time.Reaction measures taken.If the patient has severe anemia or thrombocytopenia during the course of treatment,safe and reasonable blood transfusion,including plasma,red blood cells,platelets,etc.,can be performed in accordance with the principle of component transfusion.If other adverse reactions occur,they will be treated accordingly.Statistical analysis: using SPSS statistical software package,measurement data were analyzed by t-test or analysis of variance.Count data were analyzed using?2 test or rank sum test.The statistical test level was ?=0.05.ResultsThe two groups of patients before treatment in general information,the cancer-induced fatigue(Piper fatigue revision scale Chinese version),quality of life scale score(EORTCQLQ-C30 v3.0 Chinese version),TNF-? content,IL-2 content,IL-6 content,NK cell content,etc.(P>0.05),no statistical difference(P>0.05)indicating comparability and balance between the two groups of patients.After treatment,the relevant scale score comparison,1.Compared with the scores of cancer fatigue,there was a significant difference between the treatment group and the pretreatment group(P<0.01),and there was a significant difference between the control group and the pretreatmentgroup(P<0.01),the difference between the two groups after treatment was statistically significant(P<0.05);2.Within the treatment group,there was a statistically significant difference in the quality of life scores after treatment and before treatment,and the quality of life scores increased significantly,all achieved better therapeutic effects(P<0.01);3,comparison of symptom improvement scores,treatment groups In comparison,there was a statistically significant difference between the post-treatment and pre-treatment symptom scores,with a significant decrease in symptom scores and good treatment outcomes(P<0.01).4.Compared with the TNF-?content,there was a significant difference between the treatment group and the pretreatment group(P<0.01),and there was a significant difference between the control group and the pretreatment group(P<0.01),the difference between the two groups after treatment was statistically significant(P<0.05);5.Compared with the IL-2 content,there was a significant difference between the treatment group and the pretreatment group(P<0.01),and there was a significant difference between the control group and the pretreatment group(P<0.01),the difference between the two groups after treatment was statistically significant(P<0.05);6.Compared with the IL-6 content,there was a significant difference between the treatment group and the pretreatment group(P<0.01),and there was a significant difference between the control group and the pretreatment group(P<0.01),the difference between the two groups after treatment was statistically significant(P<0.05);7.Compared with the NK Cells content,there was a significant difference between the treatment group and the pretreatment group(P<0.01),and there was a significant difference between the control group and the pretreatment group(P<0.01),the difference between the two groups after treatment was statistically significant(P<0.05).Efficacy assessment indicators include: 1.The main efficacy evaluation indicators,cancer-causing fatigue scale--using the Piper's Fatigue Scale(RPFS-Chinese Version)to evaluate the patient's cancer before and after treatment,the improvement of sexual fatigue was assessed before treatment and after the end of the second course of treatment,a total of 2 times.2.Secondary efficacy evaluation indicators,(1)Quality of Life Scale-The EORTC QLQ-C30 v3.0 Chinese version of the Cancer Patient Quality of Life Inventory was used to evaluate the quality of life improvement before and after treatment.Assessments were performed 2 times before treatment and after the end of the2 nd course of treatment.(2)Clinical symptom scores: fatigue related symptoms(such as Shenpi fatigue,less gas lazy words,poor appetite,weak backache,dizziness,etc.)before treatment,after the end of the first course,and after the second course of treatment.Self-sweat,etc.)were scored to evaluate the effect of treatment.(3)Immune function: Including TNF-?,IL-2,IL-6,NK cell activity,etc.,were detected before treatment and after the end of the second course of treatment,a total of 2 times.3.Safety indicators,(1)Vital signs observations were performed within 24 hours before treatment and during the course of treatment;(2)blood routine,urine routine,stool routine,liver function,renal function,coagulation four items and electrocardiogram examination were detected within 3 days before treatment,after the end of the first course of treatment,and after the end of the second course of treatment;(3)Adverse reactions that occurred during the course of treatment were graded according to the National Cancer Institute General Toxicity Criteria(NCI CTC 4.0),and the time,duration,severity of adverse reactions,relationship with trial medications,and adverse events were recorded at any time.Reaction measures taken.If the patient has severe anemia or thrombocytopenia during the course of treatment,safe and reasonable blood transfusion,including plasma,red blood cells,platelets,etc.,can be performed in accordance with the principle of component transfusion.If other adverse reactions occur,they will be treated accordingly.Statistical analysis: using SPSS statistical software package,measurement data were analyzed by t-test or analysis of variance.Count data were analyzed using?2 test or rank sum test.The statistical test level was ?=0.05.ConclusionThree-needle acupuncture therapy has a significant effect on improving the cancer-related fatigue and related clinical symptoms in cancer patients and improving the quality of life of patients.In this study,we used fatigue needle therapy to treat patients with cancer-induced fatigue and tried to verify the efficacy of the three-needle therapy.Therefore,the clinical promotion and application of this therapy will help improve clinical efficacy,increase treatment safety,reduce side effects,and have technical advantages and economic advantages. |
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