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硝酸银与滑石粉悬液用于有症状恶性胸腔积液胸膜固定术的前瞻性随机试验

Prospective randomized trial of silver nitrate vs talc slurry in pleurodesis for symptomatic malignant pleural effusions.

作者信息

Paschoalini Marcello da Silveira, Vargas Francisco S, Marchi Evaldo, Pereira José Rodrigues, Jatene Fabio B, Antonangelo Leila, Light Richard W

机构信息

Pérola Byington Hospital, São Paulo, Brazil.

出版信息

Chest. 2005 Aug;128(2):684-9. doi: 10.1378/chest.128.2.684.

DOI:10.1378/chest.128.2.684
PMID:16100154
Abstract

STUDY OBJECTIVES

To compare the efficacy and the safety of talc slurry and silver nitrate (SN) in the treatment of symptomatic malignant pleural effusions.

PATIENTS AND METHODS

Sixty patients were enrolled into the study, and all received a chest tube (26F or 28F) that was placed using local anesthesia. The patients were randomized to receive either 5 g talc diluted to a total volume of 50 mL with saline solution or 20 mL 0.5% SN through the chest tube. Patients were clinically evaluated before and after treatment regarding pain, and were evaluated at monthly intervals with respect to the effectiveness of pleurodesis. Eleven patients did not return for their 30-day follow-up visit and were excluded from further analysis. Pleurodesis therapy was considered to be successful if there was no recurrence of the effusion. The patients who did not have a pleurodesis at one visit were excluded from subsequent visits.

RESULTS

Forty-nine patients returned at 30 days for follow-up, including 24 patients who received SN and 25 who received talc. The groups were similar in age (p = 0.23), sex (p = 0.70), Karnofsky index (p = 0.94), and pathology (p = 0.68). After the induction of pleurodesis, neither the total mean (+/- SE) fluid drainage (SN, 901 +/- 125 mL; talc, 766 +/- 74 mL; p = 0.36) nor the level of pain (SN, 2.58 +/- 0.26; talc, 2.62 +/- 0.30; p = 0.91) differed significantly between the groups, and no patient in either group developed ARDS. The mean number of days spent in the hospital was nearly identical (SN group, 3.7 +/- 0.15 days; talc group, 3.6 +/- 0.13 days; p = 0.47). Both SN and talc were effective agents. Thirty days after the procedure, 23 of 24 patients (96%) who had received SN and 21 of 25 patients (84%) who had received talc showed an effective pleurodesis (p = 0.35). Similar results were observed after 60 days (SN group, 18 of 18 patients [100%]; talc group, 13 of 13 patients [100%]; p = > 0.99), 90 days (SN group, 16 of 16 patients [100%]; talc, 8 of 9 patients [89%]; p = 0.36), and 120 days (SN group, 4 of 4 patients [100%]; talc group, 4 of 4 patients [100%]; p > 0.99).

CONCLUSIONS

The present study suggests that SN is an effective agent for producing a pleurodesis. In the present study, SN showed a tendency to be more effective than talc, but the power of the test to detect a significance difference was low in this small group of patients. The side effects of 0.5% SN appear to be minimal, but since only a small number of patients received SN and nearly 20% of the patients were lost to follow-up, significant long-term side effects cannot be excluded. Since SN appears to be as effective as talc, and since there is no evidence that it induces ARDS as has been reported with talc, it should be considered as an alternative to talc for the production of a pleurodesis.

摘要

研究目的

比较滑石粉悬液和硝酸银(SN)治疗有症状恶性胸腔积液的疗效和安全性。

患者与方法

60例患者纳入本研究,均接受局部麻醉下放置的胸管(26F或28F)。患者随机分为两组,一组通过胸管接受用盐溶液稀释至总体积50 mL的5 g滑石粉,另一组接受20 mL 0.5% SN。治疗前后对患者进行疼痛的临床评估,并每月评估胸膜固定术的有效性。11例患者未进行30天随访,被排除在进一步分析之外。如果积液未复发,则胸膜固定术治疗被认为成功。一次就诊时未进行胸膜固定术的患者被排除在后续就诊之外。

结果

49例患者30天返回进行随访,其中24例接受SN,25例接受滑石粉。两组在年龄(p = 0.23)、性别(p = 0.70)、卡诺夫斯基指数(p = 0.94)和病理(p = 0.68)方面相似。胸膜固定术后,两组间总的平均(±标准误)引流量(SN组,901±l25 mL;滑石粉组,766±74 mL;p = 0.36)和疼痛程度(SN组,2.58±0.26;滑石粉组,2.62±0.30;p = 0.91)均无显著差异,两组均无患者发生急性呼吸窘迫综合征(ARDS)。住院天数的均值几乎相同(SN组,3.7±0.15天;滑石粉组,3.6±0.13天;p = 0.47)。SN和滑石粉都是有效的药物。术后30天,接受SN的24例患者中有23例(96%)和接受滑石粉的25例患者中有21例(84%)显示胸膜固定术有效(p = 0.35)。60天(SN组,18例患者中的18例[100%];滑石粉组,13例患者中的13例[100%];p>0.99)、90天(SN组,16例患者中的16例[100%];滑石粉组,9例患者中的8例[89%];p = 0.36)和120天(SN组,4例患者中的4例[100%];滑石粉组,4例患者中的4例[100%];p>0.99)时观察到相似结果。

结论

本研究提示SN是产生胸膜固定术的有效药物。在本研究中,SN显示出比滑石粉更有效的趋势,但在这一小群患者中检测显著差异的检验效能较低。0.5% SN的副作用似乎最小,但由于仅少数患者接受SN且近20%的患者失访,不能排除显著的长期副作用。由于SN似乎与滑石粉一样有效,且没有证据表明它像滑石粉那样可诱发ARDS,因此应将其视为滑石粉用于产生胸膜固定术的替代物。

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