| Background Chemotherapy induced peripheral neurotoxicity is the common adverse drug reactions which can limit clinical dose,the total incidence rate is than 60%,about 20%to 30%of patients suffered long-term CIPN problems.Oxaliplatin is the third generation platinum,is a commonly clinical used chemotherapy drug,OXAIPN may occur in 90%of patients receiving oxaliplatin chemotherapy.The mechanism of CIPN is not yet clear,the reported treatment strategies or drug failed to achieve a satisfactory control effect,Duloxetine is recommended only for CIPN-related pain symptoms.The clinical research of Chinese medicine on the prevention and treatment of OXAIPN is increasing,showing a certain effective and advantageous.Previous studies mostly classified OXAIPN into the category of "blood-arthralgia" in TCM,the Modified Huangqi Guizhi Wuwu Formula Granules is made of Huangqi Guizhi Wuwu Decoction and angelica sinensis.Huangqi Guizhi Wuwu Decoction is a special prescription for clinical blood-arthralgia,which has the effects of tonifying qi,warming the main and collateral channels,nourishing blood,promoting blood circulation and acesodyne when joined angelica sinensis.This subject is a multi-center,randomized,double-blind,controlled clinical study,the preventive and therapeutic effects of Modified Huangqi Guizhi Wuwu Formula Granules on OXAIPN were studied from the aspects of CIPN score,quality of life score and electromyogram test,which can provide the theoretical and clinical basis for the clinical.Objective Following the principle of multi-center,randomized,double-blind and control,this study observed the effect of Modified Huangqi Guizhi Wuwu Formula Granules on OXAIPN,observed the clinical effects of its preventive and therapeutic effects on OXAIPN for a preliminary exploratory.Methods A total of 64 patients with intestinal cancer undergoing adj uvant chemotherapy after radical resection were divided into experimental group and control group,with 32 cases in each group.The control group was treated with mFOLFOX6 and XELOX as basic therapy,placebo(the simulator of traditional Chinese medicine)was administered orally on the first day of chemotherapy,1 dose per day,twice a day.The experimental group was given Modified Huangqi Guizhi Wuwu Formula Granules for orally on the basis of chemotherapy in the control group,1 dose per day,twice a day,until the end of chemotherapy,a total of 6 months.EORTC QLQ-CIPN20 scores,KPS scores and EORTC QLQ-C30 scores were measured every month.The EMG were determined at the first months,fourth months and the end of treatments,including sensory and motor nerves of the upper and lower limbs.On the sensory nerves,we selected the finger 1-wrist,the finger 3-wrist of the right median nerve,the finger 5-wrist of the ulnar nerve and the toe 1-ankle of the posterior tibial nerve of both lower limbs to measure latency,amplitude and conduction velocity.On the motor nerves,we selected the wrist-abductor pollicis brevis,the elbow-wrist of the right median nerve,the wrist-abductor minor index and elbow-wrist of the ulnar nerve,the toe 1-ankle of the right posterior tibial nerve of lower limbs to measure distal latency,amplitude and conduction velocity.All the tests at each time node of each group were compared with the first month,and the two groups were also compared,to observe the clinical efficacy.Results ①A total of 59 patients were enrolled in the group,56 patients completed,3 patients dropped off,2 patients refused to continue taking because of vomiting,one case in the experimental group and one case in the control group,each case dropped off on the second day of the first chemotherapy,another case in the control group refused to receiving chemotherapy because of numbness and pain on hands and feets at the fifth month of chemotherapy,the rest of the patients were completed the study as planned,28 in the control group and 28 in the experimental group.②In terms of quality of life evaluation,there was no significant difference in KPS scores or EORTC QLQ-C30 scores in the first three months(P>0.05),there were statistical differences in KPS scores and overall health scores of EORTC QLQ-C30 at 4,5,6 months and the end(P<0.05).The pain and fatigue dimensions in EORTC QLQ-C30 scores were better in the experimental group than in the control group from the 5th month to the end,with statistical significance(P<0.05),the decreases of pain and fatigue in the experimental group were 28.00%-43.28%and 14.90%-38.21%respectively compared with the control groupand,and there were significant statistical differences in the dimension of pain between the two groups at 6 months and at the end(P<0.01).Chronic pain symptoms occurred in the control group when the cumulative dose of oxaliplatin was 650-680 mg/m2,while the cumulative dose of oxaliplatin was 850-910 mg/m2 in the experimental group.③In terms of CIPN20 scores,the difference between the two groups was more and more obvious from the 4th month to the end,with statistical significance(P<0.05),the experimental group was 6.28%-18.95%lower than the control groupand,and there were significant statistical differences between the two groups at 6 months and at the end(P<0.01)。.④In terms of EMG,in the fourth month,there were significant differences in latency,amplitude of right median nerve and amplitude of right posterior tibial nerve of motor nerve,and also significant differences in latency,amplitude,conduction velocity of right median nerve and amplitude of right ulnar nerve,amplitude of right posterior tibial nerve of sensory nerve between the two groups at the fourth month(P<0.05).At the end of the experiment,for motor nerve,the latency of the right median nerve and the right posterior tibial nerve in the control group was longer than that in the experimental group(P<0.05),the amplitudes of the right median nerve and the right posterior tibial nerve were lower than those of the experimental group(P<0.05).For sensory nerve,the latency of the right median nerve,the right ulnar nerve and the right posterior tibial nerve in the control group were longer than that in the experimental group(P<0.05),the amplitudes of right median nerve,right ulnar nerve and bilateral posterior tibial nerve were lower than those of the experimental group(P<0.05),the conduction velocity of the right median nerve,the right ulnar nerve and the right posterior tibial nerve were slower than that of the experimental group(P<0.05).⑤There was no significant difference in liver and kidney function,routine blood test and cardiogram between the two groups((P>0.05),and also no progress of tumors was found in imaging examination.Conclusions ①OXAIPN symptoms become more and more serious with the accumulation of oxaliplatin doses,when the doses is accumulated to 510-520 mg/m2,significant symptoms such as limb pain,numbness and electromyographic changes will appeare.These changes are mainly as the decrease of wave amplitude,sensory nerve injury,and upper limb is heavier than lower limb.When the dose accumulated to 1020-1040mg/m2,the symptoms are more serious,the injured nerves are more serious,the latency is prolonged,the amplitude is decreased,the conduction velocity is slowed down,the sensory nerve injury is more serious than the motor nerve,and the upper limb is more serious than the lower limb.②Modified Huangqi Guizhi Wuwu Formula Granules can alleviate pain and fatigue symptoms caused by chemotherapy,alleviate OXAIPN symptoms,improve physical function of patients,overall health status and quality of life and enhance patients’tolerance to OXAIPN and delay the occurrence of chronic pain.③Modified Huangqi Guizhi Wuwu Formula Granules can prevent and treat OXAIPN,reduce the extent of latency prolongation,amplitude reduction and slowdown of nerve conduction velocity,and the effect is more significantly with the accumulation of oxaliplatin dosage.④Modified Huangqi Guizhi Wuwu Formula Granules has a good effect on preventing and treating OXAIPN whether in upper limbs or lower limbs,sensory nerves or motor nerves.·⑤Modified Huangqi Guizhi Wuwu Formula Granules has no obvious toxicity and side effects,and does not lead a progression of tumors.It is a safe and reliable drug for the prevention and treatment of OXAIPN. |
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