| ObjectiveIn order to evaluate the effectiveness and safety of Shenfu Injection(SFI) for Intradialytic Hypotension(IDH), and investigate the distribution characteristics of traditional Chinese medicine (TCM) syndromes of hemodialysis (HD) patients, providing theoretical and clinical evidence of SFI for IDH.MethodsData sources included Cochrane Central Register of Controlled Trials, Pubmed, Embase, CBM, CNKI, VIP and Wangfang Data were systematically searched up to April 2014. Randomized controlled trials (RCTs) involving SFI treating and preventing IDH were identified. Two researchers independently selected articles, extracted data, assessed quality and cross-checked the results. Revman 5.2 was used to analyze the results.Sixty HD patients who encountered IDH at least once in Fangcun Branch Hosptial of Guangdong Provincial Hospital of TCM was included for symptom analysis. Through observation, listening, interrogation, and pulse-taking, their symptoms, signs, tongue and pulse condition was cataloged to analysis the characteristics of symptom and syndrome of TCM, which was based on the Guiding Principles of Clinical Research on New drugs of TCM for the Treatment of Chronic Renal Failure. Data of age, gender, protopathy, duration of dialysis was collected to analysis the relationship with Syndrome differentiation of TCM. SPSS 18.0 was used for data statistics. Results8 RCTs was included. The meta-analysis indicated that compared with conventional therapies, SFI could evaluate SBP[MD=22.64,95%CI (7.35, 27.94), P<0.00001)], increase the clinical effective rate[OR=1.29, 95%CI(1.19,1.40), P<0.00001)], decrease the incidence of hypotension[prevention group:OR=0.46,95%CI(0.36,0.58), P<0.000001; treatment group:OR=0.72,95% CI (0.58,0.91), P<0.005)], raise serum albumin[MD=2.06,95%CI (1.87,4.42), P<0.00001)] and reduce C-reactive protein [MD=-2.42,95%CI (-3.40,-1.44), P<0.00001)]without serious adverse effects. GRADE quality of evidence:the quality of SBP, the effective rate, ALB and CRP was low, and hypotension incidence and DBP was very low.Sixty cases of IDH patients was included in the study of symptom analysis. The risk of IDH was increased along with age and duration of dialysis.The deficiency-excess complex syndrome was dominated in the syndrome type of TCM of IDH. Purely deficiency syndrome also could be seen and there was no purely excess syndrome. The principal syndrome mainly were spleen-kidney qi deficiency syndrome and spleen-kidney yang deficiency syndrome. Statistically, there was no significant relationship between the syndrome distribution with age and gender. The duration of dialysis of patients with syndrome of dual deficiency of yin and yang (P=0.016) and spleen-kidney yang deficiency(P=0.015) was longer than those with liver-kidney yin deficiency syndrome. By comparison, syndrome of dual deficiency of yin and yang could be often seen in the aged with longer duration of dialysis, liver-kidney yin deficiency syndrome in the young with shorter duration of dialysis. As for subordinate symptoms, dampness syndrome and blood-static sydrome was most commonly seen in the young with low dialysis age and the old with advanced dialysis age.ConelusionSFI is more effective than conventional therapies for prevention and treatment of IDH. However, a clinical recommendation is not warranted due to the small number of studies included and low methodology quality. Multi-center, high-quality RCTs with large sample sizes are needed to provide stronger evidence. Nevertheless, IDH is emergency Complication for HD patients, so exploration of effective measure for IDH is a problem urgently needed to be addressed. SFI is in line with the pathogenesis of IDH, which can make contribution to decreasing incidence rate of IDH, lessening suffering, improving quality of life and lightening financial burden for HD patients. |
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