■钙激肽是一种罕见的高死亡率疾病,主要涉及慢性肾脏病(CKD)患者。硫代硫酸钠(STS)已被用作钙化预防的标签外治疗剂,但与没有STS治疗的患者相比,缺乏临床试验和研究证明其效果。
■对队列研究进行荟萃分析,该研究提供了比较接受和不接受静脉STS治疗的钙化预防患者结果的数据。
■PubMed,Embase,科克伦图书馆,WebofScience,和ClinicalTrials.gov使用相关术语和同义词进行搜索,包括硫代硫酸钠和calci*,没有语言限制。
■最初的搜索是在2021年8月31日之前发表的队列研究,其中包括诊断为CKD的成年患者经历钙化,并可以提供接受和不接受静脉STS治疗的患者之间的比较。如果仅报告STS非静脉给药的结果或未提供CKD患者的结果,则排除研究。
■进行随机效应模型。Egger检验用于测量发表偏倚。使用I2检验评估异质性。
■皮肤损伤改善和生存,通过随机效应经验贝叶斯模型合成为比率数据。
■在从目标数据库检索的5601个出版物中,19项回顾性队列研究,包括422例患者(平均年龄,57岁;37.3%男性)符合资格标准。在皮肤病变改善方面没有观察到差异(12项研究,110例患者;风险比,1.23;95%CI,0.85-1.78)在STS和比较组之间。死亡风险无差异(15项研究,158例患者;风险比,0.88;95%CI,0.70-1.10)和使用事件发生时间数据的总生存率(3项研究,269名参与者;风险比,0.82;95%CI,0.57-1.18)。在元回归中,与STS相关的病变改善与发表年份呈负相关,这意味着与过去的研究相比,最近的研究更有可能报告零关联(系数=-0.14;P=.008)。
■静脉STS与经历钙化的CKD患者的皮肤病变改善或生存获益无关。有必要进行未来的研究,以检查治疗钙化患者的疗效和安全性。
Calciphylaxis is a rare disease with high mortality mainly involving patients with chronic kidney disease (CKD). Sodium thiosulphate (STS) has been used as an off-label therapeutic in
calciphylaxis, but there is a lack of clinical trials and studies that demonstrate its effect compared with those without STS treatment.
To perform a meta-analysis of the cohort studies that provided data comparing outcomes among patients with
calciphylaxis treated with and without intravenous STS.
PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov were searched using relevant terms and synonyms including sodium thiosulphate and calci* without language restriction.
The initial search was for cohort studies published before August 31, 2021, that included adult patients diagnosed with CKD experiencing
calciphylaxis and could provide a comparison between patients treated with and without intravenous STS. Studies were excluded if they reported outcomes only from nonintravenous administration of STS or if the outcomes for CKD patients were not provided.
Random-effects models were performed. The Egger test was used to measure publication bias. Heterogeneity was assessed using the I2 test.
Skin lesion improvement and survival, synthesized as ratio data by a random-effects empirical Bayes model.
Among the 5601 publications retrieved from the targeted databases, 19 retrospective cohort studies including 422 patients (mean age, 57 years; 37.3% male) met the eligibility criteria. No difference was observed in skin lesion improvement (12 studies with 110 patients; risk ratio, 1.23; 95% CI, 0.85-1.78) between the STS and the comparator groups. No difference was noted for the risk of death (15 studies with 158 patients; risk ratio, 0.88; 95% CI, 0.70-1.10) and overall survival using time-to-event data (3 studies with 269 participants; hazard ratio, 0.82; 95% CI, 0.57-1.18). In meta-regression, lesion improvement associated with STS negatively correlated with publication year, implying that recent studies are more likely to report a null association compared with past studies (coefficient = -0.14; P = .008).
Intravenous STS was not associated with skin lesion improvement or survival benefit in patients with CKD experiencing
calciphylaxis. Future investigations are warranted to examine the efficacy and safety of therapies for patients with calciphylaxis.