汉防己甲素辅助治疗硅沉着病的meta分析及GRADE质量评价

Tetrandrine Adjuvant Treatment of Silicosis: A Meta-analysis and GRADE Evaluation

关键词:  汉防己甲素  硅沉着病  尘肺  随机对照试验  meta分析

Key words:  tetrandrine  silicosis  pneumoconiosis  randomized controlled trials  meta-analysis

摘要:

目的 评价汉防己甲素辅助治疗硅沉着病的疗效及安全性。方法 检索数据库中关于汉防己甲素联合常规疗法治疗硅沉着病的临床研究，检索时间为各数据库建库至2021年1月1日。数据分析用RevMan 5.3软件。数据合并的效应量用风险比(risk ratio，RR)或平均差(mean deviation，MD)表示，均用其95%置信区间(95%CI)。采用The GRADEpro在线系统评价证据质量等级。结果 纳入21项研究，共1 700例患者。结果表明与常规治疗或矽肺宁联合常规治疗相比，汉防己甲素联合常规治疗组的临床总有效率更高，结果分别为(RR 1.31，95%CI[1.11，1.55]，n=7，I²=79%)和(RR 1.23，95%CI[1.10，1.36]，n=4，I²=37%)。汉防己甲素联合常规治疗组的用力肺活量(forced vital capacity，FCV)、一秒内用力呼气量(forced expiratory volume in one second，FEV1)和FVC/FEV1等肺功能值优于常规治疗组，结果分别为(MD 0.10，95%CI[0.02，0.17]，n=4，I²=48%)、(MD 0.05，95%CI[0.00，0.09]，n=5，I²=64%)和(MD 4.74，95%CI[2.32，7.16]，n=4，I²=58%)。汉防己甲素联合常规治疗组FVC和FEV1值高于矽肺宁联合常规治疗组，结果分别为(MD 0.09，95%CI[0.08，0.10]，n=2，I²=0%)和(MD 0.23，95%CI[0.14，0.31]，n=4，I²=0%)。汉防己甲素联合常规治疗组SGRQ评分在呼吸功能、疾病影响及总分积分方面均高于常规治疗组(P < 0.05)。汉防己甲素联合常规治疗组在咳嗽、胸痛、憋气等临床症状改善方面优于常规治疗组(P < 0.05)。试验组相关不良反应经对症处理可恢复，与对照组相比无统计学差异。当前证据的GRADE评价等级主要为“低级”或“极低级”。结论 汉防己甲素联合常规疗法治疗硅沉着病具有潜在疗效优势，不会增加相关不良反应的发生风险，但相关结果还需高质量研究进一步证实。

Abstract:

OBJECTIVE To evaluate the benefits and harms of tetrandrine adjuvant treatment of silicosis.METHODS The inclusion criterion was the RCT of tetrandrine plus the conventional therapy for silicosis. Systematically searched involving databases from their inception to January 1, 2021. Data were summarized using risk ratio(RR) or mean difference(MD), both with their 95% confidence intervals(CI). RevMan5.3 was used for data analyses. The GRADEpro online system was used to evaluate the quality level of current evidence.RESULTS Twenty-one RCTs were totally included, involving 1 700 patients. The pooled results showed clinical total effective rate in tetrandrine plus the conventional therapy group was higher than the conventional therapy group alone(RR 1.31, 95%CI[1.11, 1.55], n=7, I²=79%) or Xifei Ning plus the conventional therapy group(RR 1.23, 95%CI[1.10, 1.36], n=4, I²=37%); the forced vital capacity(FCV), forced expiratory volume in one second(FEV1), and FVC/FEV1 in tetrandrine plus the conventional therapy group were higher than the conventional therapy group alone(MD 0.1, 95%CI[0.02, 0.17], n=4, I²=48%), (MD 0.05, 95%CI[0.00, 0.09], n=5, I²=64%) and (MD 4.74, 95%CI[2.32, 7.16], n=4, I²=58%). The FCV and FEV1 in tetrandrine plus the conventional therapy group was higher than Xifei Ning plus the conventional therapy group (MD 0.09, 95%CI[0.08, 0.1], n=2, I²=0%) and (MD 0.23, 95%CI[0.14, 0.31], n=4, I²=0%). The improvement on SGRQ score was significant in tetrandrine plus the conventional therapy group(P < 0.05). The improvement on clinical symptoms(such as cough, chest pain, suffocation) was significant in tetrandrine plus the conventional therapy group(P < 0.05). The adverse reactions in treatment group could be recovered after according treatment without significant differences compared with control group. At present, the certainty of relevant efficacy evidence was mainly downgraded to "low" or "very low".CONCLUSION The effectiveness of tetrandrine plus the conventional therapy for silicosis seemed to be better than the conventional therapy alone. Application of tetrandrine plus the conventional therapy couldn't increase the occurrence of adverse events. However, rigorously designed well-reported studies are warranted to confirm the findings.