本文選題：西那卡塞 + 繼發(fā)性甲狀旁腺功能亢進(jìn)　； 參考：《浙江大學(xué)》2017年碩士論文

【摘要】：目的:探究西那卡塞對繼發(fā)甲狀旁腺功能亢進(jìn)的腎移植患者的血清Ca、P、PTH、ALP、Cr、eGFR等的影響,尤其是其中對腎功能的影響,以評估西那卡塞治療繼發(fā)甲狀旁腺功能亢進(jìn)的腎移植患者的有效性及安全性。方法:本研究為meta分析,納入截至2016年12月的23個研究,其中包括16個前瞻性研究,5個回顧性研究,2個RCT研究。進(jìn)行數(shù)據(jù)提取,篩選并記錄3m、6m、9m、12m、12m及隨訪終點(diǎn)的各指標(biāo)研究結(jié)果。采用Review Manager 5.3進(jìn)行數(shù)據(jù)分析;計量資料采用均數(shù)差(MD)為效應(yīng)量,各效應(yīng)量均以95%CI表示。研究結(jié)果的異質(zhì)性用I2和P值來評估。若1250%并且P0.05則不考慮存在異質(zhì)性。研究結(jié)果的顯著性以P值來評估,若P0.05則代表研究結(jié)果存在顯著性差異。結(jié)果:本meta分析納入研究數(shù)23例,患者總數(shù)(除外RCT研究的對照組)610人,平均年齡53歲,男性比例55.2%,隨訪時長3～60個月,主要副反應(yīng)事件發(fā)生數(shù):胃腸道反應(yīng)33例,腎功能異常6例,低鈣血癥3例。對繼發(fā)甲狀旁腺功能亢進(jìn)的腎移植患者,西那卡塞可使患者的血清Ca濃度顯著降低0.29mmol/L(95%CI,-0.33～-0.26),P0.00001;血清 P 濃度顯著升高 0.14mmol/L(95%CI,0.10～0.18),P0.00001;血清 PTH 濃度顯著降低 91.60pg/mL(95%CI,-116.62～-66.57),P0.00001;對患者血清ALP濃度的影響無統(tǒng)計學(xué)意義,P=0.23;對患者血清Cr的影響無統(tǒng)計學(xué)意義,P0.05;可使患者的eGFR顯著降低3.61mL/min/1.73m2(95%CI,-5.65～-1.57),P=0.0005。以隨訪時間(FU)分組進(jìn)行亞組分析,得到結(jié)果:FU≤6m組的繼發(fā)SHPT的腎移植患者,使用西那卡塞后,eGFR顯著降低2.21 mL/min/1.73m2(95%CI,-4.04～-0.38),P=0.02,而 FU6m 組則無顯著性差異。但FU≤6m和FU6m組,Ca、P、PTH、ALP、Cr均無顯著性差異,與初步分析結(jié)果一致。以基線eGFR分組進(jìn)行亞組分析,得到結(jié)果:基線eGFR45的繼發(fā)SHPT的腎移植患者,使用西那卡塞后,eGFR顯著降低4.04mL/min/1.73m2(95%CI,-6.56～-1.52),P=0.002,而基線eGFR≤45組則無顯著性差異。通過漏斗圖發(fā)現(xiàn),本研究的發(fā)表偏倚為低風(fēng)險。結(jié)論:對繼發(fā)SHPT的腎移植患者,西那卡塞在治療SHPT(降低血PTH、血Ca)方面效果顯著;會使血清P濃度有顯著性增高。在用藥早期,西那卡塞會使繼發(fā)SHPT的腎移植患者的腎功能顯著降低,而遠(yuǎn)期則可恢復(fù)。西那卡塞引起的腎功能損害,與基線Ca、P、PTH及服藥后的變化值,無明顯相關(guān)性。西那卡塞對腎功能影響的藥理機(jī)制有待進(jìn)一步研究。
[Abstract]:Objective: to investigate the effects of Sinakaser on the serum CaPPTHV, ALPHG, ALP, and GFR in patients with secondary hyperparathyroidism after renal transplantation, especially the effects on renal function, and to investigate the effect of Sinakaser on renal function in patients with secondary hyperparathyroidism. To evaluate the efficacy and safety of Sinakaser in the treatment of secondary hyperparathyroidism after renal transplantation. Methods: this study was a meta analysis and included 23 studies up to December 2016, including 16 prospective studies, 5 retrospective studies, and 2 RCT studies. The data were extracted, and the data were screened and recorded. The data were analyzed by Review Manager 5.3, and the mean difference was used as the effect quantity, and all the effects were expressed as 95%CI. The heterogeneity of the results was assessed with I 2 and P values. If 1250% and P0.05 does not consider the existence of heterogeneity. The significance of the results of the study was evaluated by P value, if P0.05, there was a significant difference in the results of the study. Results: this meta analysis included 23 patients, the total number of patients (excluding the control group of RCT study, mean age 53 years old, male ratio 55.2 months, follow-up time 3 ~ 60 months), the number of major side events: gastrointestinal reaction in 33 cases, the average age was 53 years old, the male ratio was 55.2 months, the follow-up period was 3 ~ 60 months. There were 6 cases of abnormal renal function and 3 cases of hypocalcemia. For renal transplantation patients with secondary hyperparathyroidism, Sinakaser significantly decreased serum Ca concentration by 0.29 mmol / L ~ (95) CI-0.33 ~ (-0.26) P 0.00001; increased serum P concentration by 0.14 mmol / L ~ (95) CIQ 0.10 ~ 0.18 ~ 0.18% P0.00001; decreased serum PTH concentration by 91.60 mg 路mL ~ (95) CI -116.62 ~ (-66.57) (P _ (0.00001); the effect of P _ (0.23) on serum Cr in patients was not statistically significant. No statistical significance was found (P0.05); the eGFR of the patients was significantly decreased by 3.61 mL / min / 1.73 m2 / 95 CIQ = -5.65 ~ 1.57 ~ 0.0005 / min / 1.73m-2 / 95, respectively. The subgroup analysis was carried out by follow up. The results showed that in the patients with secondary SHPT in the group of 鈮，

本文編號：1944909