| Objective:Cisplatin is a first-line cancer drug for the treatment of lung cancer,testicular cancer,ovarian cancer and other solid tumors.However,cisplatin has strong renal toxicity,which limits the use of cisplatin in tumor treatment.In addition to hydration therapy,there is no effective prevention and treatment measures,which seriously affects the short-term or long-term prognosis of patients.Therefore,how to prevent and treat cisplatin nephrotoxicity effectively without affecting the therapeutic effect of cisplatin has become a hot issue in clinical and scientific research.Remote limb ischemia pretreatment is a potential organ damage protection procedure,an adaptive response of the body,and a new,noninvasive,economical and easy to operate method.Our previous animal experiments have proved that remote ischemic pretreatment can prevent kidney injury caused by cisplatin safely and effectively,and does not affect the chemotherapy effect of cisplatin,but its effect in human body is not clear.The main purpose of this experiment is to explore the effectiveness of limb ischemia pretreatment in the prevention of cisplatin nephrotoxicity in tumor patients.Methods: This is a prospective,single center,randomized controlled trial.From October 2019 to January 2021,patients with complete clinical data who were treated with cisplatin in Changzhou NO.2 People’s hospital were selected and randomly divided into two groups(group A and group B)by cross design method.We decided to observed for two consecutive chemotherapy cycles.Group A received limb ischemic preconditioning(LIPC)in the first chemotherapy cycle and sham LIPC in the second chemotherapy cycle,while group B did the opposite.LIPC operation is to pressurize any upper limb to 200 mmHg through sphygmomanometer cuff,maintain the upper limb ischemia for 5 minutes,then loosen the cuff,and conduct upper limb blood reperfusion for 5 minutes.If the systolic blood pressure of the patient is higher than185 mmHg,the sphygmomanometer cuff is inflated and pressurized to 15 mmHg higher than the basic blood pressure of the patient.The whole operation process is 40 minutes in total.Sham LIPC is performed on any upper arm for the cuff of sphygmomanometer inflated to 15 mmhg,and the rest of the operation process was consistent with LIPC.The primary endpoint was the incidence of cisplatin induced acute kidney injury(AKI).The secondary end points were the changes of serum creatinine(SCr),serum urea nitrogen(BUN),estimate Glomerular Filtration Rate(e GFR),albumin(ALB),white blood cell(WBC),24-hour urinary neutrophil gelatinase associated apolipoprotein(NGAL),and24-hour urinary kidney injury factor-1(Kim-1),before and after treatment.Results:According to the inclusion and exclusion criteria,a total of 50 patients were included in the trial.After the end of the first chemotherapy cycle,3 patients in each group withdrew from the trial due to the change of chemotherapy regimen.Finally,a total of 44 patients completed the trial.Among the patients treated with LIPC,8(18.18%)had acute kidney injury,and 10(22.72%)had acute kidney injury among the patients treated with sham LIPC.There was no significant difference in reducing the incidence of AKI(P = 0.597).Compared with the sham LIPC,LIPC decreased the levels of urinary KIM-1 and NGAL(P = 0.030;P = 0.047),but there was no significant difference in SCR,BUN,e GFR,ALB and WBC(P > 0.05).No adverse events occurred during the experiment.Conclusion: Although limb ischemic preconditioning did not significantly reduce the incidence of cisplatin induced AKI,it reduced the level of biomarkers of cisplatin induced kidney injury in tumor patients,which indicated that limb ischemic preconditioning may be able to reduce the nephrotoxicity of cisplatin and protect the kidney.The experiment has been registered with the China Clinical Trial Registry,ChiCTR1900026322. |
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