Meta Analysis Of Efficacy And Safety Of Non-ergot-derived Dopamine's Treatment To Restless Legs Syndrome

Objective:To systematically evaluate the clinical efficacy and safety of rotigotine,pramipexole and ropinirol in the treatment of restless leg syndrome(RLS).Method:Use computer to search the SinoMed,CNKI,Wanfang Knowledge Service Platform,Wipe Journal Network,Pubmed,Cochrane Library and Embase and other databases,and manually search related magazines,papers,conferences and their references.Randomized controlled clinical trials(RCT)on the treatment of RLS with observational drugs(rotigotine,pramipexole,and ropinirole)were collected comprehensively.The included literature was evaluated for inclusion in the literature based on the Cochrane Collaborative Network Bias Risk Assessment Criteria.Meta-analysis was performed on the results of the study that met the study conditions using RevMan5.3 software.To observe the mean difference in the scores of the International Restless Leg Study Group Rating Scale(IRIS)scores between the drug group and the control group,and to observe the significant rate of clinical efficacy(CGI-I)in the drug group versus the control group.The relative risk was evaluated by the index,and the relative risk of adverse events was used as an indicator for safety evaluation.Results:Four RCT studies were included in the treatment of dialysis-related RLS with non-ergoline dopamine agonists(rotigotine,pramipexole and ropinirole),100 patients,including 50 in the experimental group and 50 in the control group.Meta-analysis results showed that:(1)International Restless Leg Study Group Rating Scale(IRLS)score change: Non-ergoline dopamine agonists group was better than control group: MD=-9.31,95% CI(-12.75,-5.86)),P <0.00001;(2)Adverse reactions:The incidence of adverse reactions in the non-ergoline dopamine agonists group was not statistically significant compared with the control group: RR = 1.27,95% CI(0.64,2.53),P = 0.50.Seven RCT studies were included in the treatment of primary RLS with rotigotine.1837 patients were enrolled,including 1393 in the experimental group and 444 in the control group.Meta-analysis showed that:(1)IRLS score change: Rotigotine group was better than placebo control group: MD=-4.67,95% CI(-5.75,-3.59),P < 0.00001;(2)Clinical Global Impression-Improvemen(CGI-I): Rotigotine group had higher response rate than placebo group: RR = 1.34,95% CI(1.26,1.42),P < 0.00001;Subgroup analysis indicated that the dose size affected the patient's efficacy.The dose >2mg was better than the dose ?2mg;(3)Adverse reactions: The incidence of adverse reactions was higher in rotigotine group than in the placebo group: RR = 1.38,95% CI(1.12,1.70),P = 0.002.Eleven RCT studies were included in the treatment of primary RLS with pramipexole.3090 patients were enrolled,including 1883 in the experimental group and 1207 in the control group.Meta-analysis showed that:(1)IRLS score change: the pramipexole group was better than the control group: MD=-5.16,95% CI(-6.40,-3.92),P < 0.00001;Subgroup analysis according to the course of treatment(<12 weeks and ?12 weeks),suggesting that the length of treatment may have an effect on the imPBOvement of RLS symptoms.The shorter the course of treatment,the more significant the improvement;(2)CGI-I: The pramipexole group had a higher response rate than the control group: RR=1.42,95% CI(1.42,1.61),P<0.00001;(3)Adverse reactions: The incidence of total adverse reactions was higher in the pramipexole group than in the control group: RR=1.20,95% CI(1.04,1.37),P=0.0004;the incidence of drug-related adverse reactions in the pramipexole group was higher than that in the control group: RR = 1.49,95% CI(1.31,1.69),P < 0.00001.Seven RCT studies were included in the treatment of primary RLS with ropinirol.2050 patients were enrolled,including 1079 in the experimental group and 971 in the control group.Meta-analysis results showed that:(1)IRLS score change: The ropinirole group was superior to the placebo control group: MD=-3.26,95% CI(-4.27,-2.25),P<0.00001;(2)CGI-I: The ropinirole group had a higher response rate than the placebo group: RR = 1.35,95% CI(1.24,1.47),P < 0.00001;(3)Adverse reactions: The incidence of adverse reactions in the ropinirole group was higher than that in the control group: RR=1.21,95% CI(1.15,1.29),P<0.00001.Conclusion:1.Non-ergoline dopamine agonists can effectively improve the symptoms of dialysis-related RLS with good safety,but relatively little evidence;2.Rotigotine,pramipexol and ropinirol are effective in improving the symptoms of primary RLS and are well tolerated.Increasing the dose of rotigotine and shortening the pramipexole treatment is more effective.It can provide a theoretical basis for dialysis-related RLS treatment.