Department of Obstetrics, Ningbo Women and Children's Hospital, Ningbo, Zhejiang Province, 315012, China.
Department of Medical Intensive Care Unit, Ningbo Women and Children's Hospital, Ningbo, Zhejiang Province, 315012, China.
Chin J Integr Med. 2023 Jun;29(6):483-489. doi: 10.1007/s11655-023-3730-0. Epub 2023 Mar 26.
To evaluate the efficacy of Chinese plaster containing rhubarb and mirabilite on surgical site infection (SSI) in patients with cesarean delivery (CD) by performing a randomized controlled trial.
This randomized controlled trial included 560 patients with CD due to fetal head descent enrolled at a tertiary teaching center between December 31, 2018 and October 31, 2021. Eligible patients were randomly assigned to a Chinese medicine (CM) group (280 cases) or a placebo group (280 cases) by a random number table, and were treated with CM plaster (made by rhubarb and mirabilite) or a placebo plaster, respectively. Both courses of treatment lasted from the day 1 of CD, followed day 2 until discharge. The primary outcome was the total number of patients with superficial, deep and organ/space SSI. The secondary outcome was duration of postoperative hospital stay, antibiotic intake, and unplanned readmission or reoperation due to SSI. All reported efficacy and safety outcomes were confirmed by a central adjudication committee that was unaware of the study-group assignments.
During the recovery process after CD, the rates of localized swelling, redness and heat were significantly lower in the CM group than in the placebo group [7.55% (20/265) vs. 17.21% (47/274), P<0.01]. The durution of postoperative antibiotic intake was shorter in the CM group than in the placebo group (P<0.01). The duration of postoperative hospital stay was significantly shorter in the CM group than in the placebo group (5.49 ± 2.68 days vs. 8.96 ± 2.35 days, P<0.01). The rate of postoperative C-reactive protein elevation (≽100 mg/L) was lower in the CM group than in the placebo group [27.6% (73/265) vs. 43.8% (120/274), P<0.01]. However, there was no difference in purulent drainage rate from incision and superficial opening of incision between the two groups. No intestinal reactions and skin allergies were found in the CM group.
CM plaster containing rhubarb and mirabilite had an effect on SSI. It is safe for mothers and imposes lower economic and mental burdens on patients undergoing CD. (Registration No. ChiCTR2100054626).
通过随机对照试验评估大黄芒硝敷贴治疗剖宫产术（CD）患者手术部位感染（SSI）的疗效。
这项随机对照试验纳入了 2018 年 12 月 31 日至 2021 年 10 月 31 日在一家三级教学中心因胎头下降而接受 CD 的 560 例患者。通过随机数字表将符合条件的患者随机分配至中药（CM）组（280 例）或安慰剂组（280 例），分别接受 CM 膏（由大黄和芒硝制成）或安慰剂膏治疗。两组的疗程均从 CD 第 1 天开始，第 2 天继续使用直至出院。主要结局是浅层、深层和器官/间隙 SSI 的总患者人数。次要结局是术后住院时间、抗生素摄入量以及因 SSI 而计划外再入院或再次手术的次数。所有报告的疗效和安全性结局均由一个对研究分组不知情的中心裁决委员会确认。
在 CD 后的恢复过程中，CM 组局部肿胀、发红和发热的发生率明显低于安慰剂组[7.55%（20/265）vs. 17.21%（47/274），P<0.01]。CM 组术后抗生素摄入量短于安慰剂组（P<0.01）。CM 组的术后住院时间明显短于安慰剂组（5.49 ± 2.68 天 vs. 8.96 ± 2.35 天，P<0.01）。CM 组术后 C 反应蛋白升高（≦100 mg/L）的发生率低于安慰剂组[27.6%（73/265）vs. 43.8%（120/274），P<0.01]。然而，两组切口脓性引流率和切口浅层开口率无差异。CM 组未发现肠道反应和皮肤过敏。
大黄芒硝敷贴对 SSI 有疗效。它对接受 CD 的母亲是安全的，并且对患者的经济和心理负担较低。（注册号：ChiCTR2100054626）。
