西那卡塞对继发甲状旁腺功能亢进的肾移植患者治疗的有效性与安全性评估：meta分析

发布时间：2018-05-28 02:36

  本文选题：西那卡塞 + 继发性甲状旁腺功能亢进　； 参考：《浙江大学》2017年硕士论文

【摘要】：目的:探究西那卡塞对继发甲状旁腺功能亢进的肾移植患者的血清Ca、P、PTH、ALP、Cr、eGFR等的影响,尤其是其中对肾功能的影响,以评估西那卡塞治疗继发甲状旁腺功能亢进的肾移植患者的有效性及安全性。方法:本研究为meta分析,纳入截至2016年12月的23个研究,其中包括16个前瞻性研究,5个回顾性研究,2个RCT研究。进行数据提取,筛选并记录3m、6m、9m、12m、12m及随访终点的各指标研究结果。采用Review Manager 5.3进行数据分析;计量资料采用均数差(MD)为效应量,各效应量均以95%CI表示。研究结果的异质性用I2和P值来评估。若1250%并且P0.05则不考虑存在异质性。研究结果的显著性以P值来评估,若P0.05则代表研究结果存在显著性差异。结果:本meta分析纳入研究数23例,患者总数(除外RCT研究的对照组)610人,平均年龄53岁,男性比例55.2%,随访时长3～60个月,主要副反应事件发生数:胃肠道反应33例,肾功能异常6例,低钙血症3例。对继发甲状旁腺功能亢进的肾移植患者,西那卡塞可使患者的血清Ca浓度显著降低0.29mmol/L(95%CI,-0.33～-0.26),P0.00001;血清 P 浓度显著升高 0.14mmol/L(95%CI,0.10～0.18),P0.00001;血清 PTH 浓度显著降低 91.60pg/mL(95%CI,-116.62～-66.57),P0.00001;对患者血清ALP浓度的影响无统计学意义,P=0.23;对患者血清Cr的影响无统计学意义,P0.05;可使患者的eGFR显著降低3.61mL/min/1.73m2(95%CI,-5.65～-1.57),P=0.0005。以随访时间(FU)分组进行亚组分析,得到结果:FU≤6m组的继发SHPT的肾移植患者,使用西那卡塞后,eGFR显著降低2.21 mL/min/1.73m2(95%CI,-4.04～-0.38),P=0.02,而 FU6m 组则无显著性差异。但FU≤6m和FU6m组,Ca、P、PTH、ALP、Cr均无显著性差异,与初步分析结果一致。以基线eGFR分组进行亚组分析,得到结果:基线eGFR45的继发SHPT的肾移植患者,使用西那卡塞后,eGFR显著降低4.04mL/min/1.73m2(95%CI,-6.56～-1.52),P=0.002,而基线eGFR≤45组则无显著性差异。通过漏斗图发现,本研究的发表偏倚为低风险。结论:对继发SHPT的肾移植患者,西那卡塞在治疗SHPT(降低血PTH、血Ca)方面效果显著;会使血清P浓度有显著性增高。在用药早期,西那卡塞会使继发SHPT的肾移植患者的肾功能显著降低,而远期则可恢复。西那卡塞引起的肾功能损害,与基线Ca、P、PTH及服药后的变化值,无明显相关性。西那卡塞对肾功能影响的药理机制有待进一步研究。
[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，

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