Clinical observation of Zixian Pills combined with azithromycin in the treatment of children with henoch-schonlein purpura complicated with Mycoplasma pneumoniae infection
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摘要:
目的 探讨过敏性紫癜(HSP)合并肺炎支原体感染的患儿应用紫仙丹联合阿奇霉素治疗的疗效及安全性。 方法 选取安徽中医药大学第一附属医院儿科病房2021年1月—2024年2月接诊的100例儿童过敏性紫癜合并肺炎支原体感染的患儿，按照随机数字表法分为观察组(50例)和对照组(50例)。对照组给予阿奇霉素和HSP基础治疗，观察组在对照组的基础上给予中药紫仙丹口服，均治疗7~14 d。评估2组中医证候积分改善情况、临床疗效、用药不良反应，检测尿红细胞、尿微量白蛋白及尿β2-微球蛋白水平。 结果 治疗前2组中医证候积分比较，差异无统计学意义(P＞0.05)；治疗后2组中医证候积分均低于治疗前(P＜0.05)；治疗后2组中医证候积分比较，观察组[1.00(1.00，2.00)分]低于对照组[2.00(1.00，2.00)分，P＜0.05]。2组总有效率比较，观察组优于对照组[92.0%(46/50) vs. 76.0%(38/50)，P＜0.05]。治疗前2组尿红细胞、尿微量白蛋白、尿β2微球蛋白比较，差异均无统计学意义(P＞0.05)；治疗后2组尿红细胞、尿微量白蛋白、尿β2微球蛋白比较，差异均有统计学意义(P＜0.05)。2组用药不良反应发生率比较，差异无统计学意义(P＞0.05)。 结论 紫仙丹联合阿奇霉治疗儿童过敏性紫癜合并肺炎支原体感染在改善中医证候积分及减轻肾脏损害方面均有明显的效果，且具有良好的安全性。 Abstract:Objective To investigate the efficacy and safety of Zixian Pills combined with azithromycin in the treatment of Henoch-Schönlein purpura (HSP) complicated by Mycoplasma pneumoniae infection. Methods One hundred cases of children with HSP complicated by Mycoplasma. pneumoniae infection who were treated in the pediatric ward of the First Affiliated Hospital of Anhui University of Chinese Medicine from January 2021 to February 2024 were selected. They were divided into observation group (50 cases) and control group (50 cases) according to random number table method. The control group was given azithromycin and basic treatment for HSP, and the observation group was given oral Zixian Pills on the basis treatment of the control group, both of which were treated for 7-14 days. The improvement in traditional Chinese medicine (TCM) syndrome scores, clinical efficacy and adverse drug reactions were evaluated in the two groups, and the levels of urinary red blood cells, urinary microalbumin and urinary beta 2-microglobulin were measured. Results Before treatment, there was no significant difference in TCM syndrome scores between the two groups (P>0.05); After treatment, the scores of TCM syndromes in both groups were lower than those before treatment (P < 0.05); After treatment, the TCM syndrome score in the observation group [1.00 (1.00, 2.00)] was lower than that in the control group [2.00 (1.00, 2.00), P < 0.05]. The overall response rate (ORR) in the observation group was superior to that in the control group [92.0% (46/50) vs. 76.0% (38/50), P < 0.05]. There was no significant difference in urinary erythrocytes, urinary microalbumin and urinary beta 2-microglobulin between the two groups before treatment (P>0.05); there were significant differences in urinary erythrocytes, urinary microalbumin and urinary beta 2-microglobulin between the two groups after treatment (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups (P>0.05). Conclusion The treatment of HSP complicated by Mycoplasma. pneumoniae infection in children with Zixian Pills combined with azithromycin has obvious effects on improving TCM syndrome scores and reducing renal injury, and it has good safety. -
Key words:
- Henoch-schonlein purpura /
- Mycoplasma pneumoniae infection /
- Azithromycin /
- Zixian Pills
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表 1 2组HSP合并MP感染患儿基本资料比较
Table 1. Comparison of basic data between the two groups of children infected with HSP combined with MP
组别 例数 性别[例(%)] 年龄
[M(P25, P75), 岁]体重
[M(P25, P75), kg]女 男 观察组 50 28(56.0) 22(44.0) 7.00(5.00，11.00) 30.00(20.63，45.00) 对照组 50 22(44.0) 28(56.0) 8.00(6.00，11.00) 28.50(21.50，41.25) 统计量 1.440a -1.001b -0.041b P值 0.230 0.317 0.967 注：a为χ2值，b为Z值。 
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表 2 HSP合并MP感染患儿中医证候积分评分
Table 2. TCM syndrome score basis for children infected with HSP combined with MP
主要症状及体征 正常
(0分)轻度
(1分)中度
(2分)重度
(3分)皮肤紫癜 无 少量丘疹，仅见于双下肢 较多丘疹或斑疹大疱，见于双下肢及臀部 大量斑、丘疹，甚至融合成片，见于四肢及臀部或全身 消化道症状 无 轻微腹痛不适，可耐受，无呕吐 腹痛明显，伴有呕吐，日常生活学习受限 腹痛剧烈，患儿苦恼不安，严重影响日常生活，伴呕血或便血 呼吸道症状 无 咽红、未见明显症状 有发热、鼻塞、流涕等相关症状，或咽痛，扁桃体大(I度) 咳痰、咳嗽、扁桃体大(Ⅱ~Ⅲ度)、肺部可闻及啰音 关节肿痛 无 轻度触痛，能正常日常生活 较为严重的肿痛，限制功能活动 红肿热痛，极大限制功能活动 肾脏症状 无 小便偶见不适，尿检未见异常 尿RBC异常 尿RBC、尿蛋白皆异常
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表 3 2组HSP合并MP感染患儿治疗前后中医证候积分比较[M(P25, P75), 分]
Table 3. Comparison of TCM syndrome scores between the two groups of children infected with HSP combined with MP [M(P25, P75), points]
组别 例数 治疗前 治疗后 差值 观察组 50 7.00(6.00，9.00) 1.00(1.00，2.00)a -6.00(-7.00，-5.00) 对照组 50 7.00(6.00，8.00) 2.00(1.00，2.00)a -5.00(-6.25，-4.00) Z值 -0.080 -2.552 -1.494 P值 0.936 0.011 0.135 注：与同组治疗前比较，aP＜0.05。
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表 4 2组HSP合并MP感染患儿总有效率比较[例(%)]
Table 4. Comparison of total effective rates between the two groups of children infected with HSP combined with MP [cases (%)]
组别 例数 治愈 显效 有效 无效 总有效 观察组 50 20(40.0) 10(20.0) 16(32.0) 4(8.0) 46(92.0) 对照组 50 12(24.0) 15(30.0) 11(22.0) 12(24.0) 38(76.0) 注：2组总有效率比较，χ2=4.762，P=0.029。
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表 5 2组HSP合并MP感染患儿尿红细胞、尿微量白蛋白、β2微球蛋白比较[M(P25, P75)]
Table 5. Comparision of urinary RBC, urinary microalbumin, and β2-microglobulin between the two groups of children infected with HSP combined with MP [M(P25, P75)]
组别 例数 尿红细胞(个/HP) 治疗前 治疗后 差值 观察组 50 34.10(30.98，47.53) 5.60(4.00，9.23)a -18.25(-30.90，-9.77) 对照组 50 32.05(29.78，37.03) 21.50(18.00，29.78)a -9.85(-14.22，-7.40) Z值 -1.458 -8.033 -7.210 P值 0.145 < 0.001 < 0.001 组别 例数 尿微量白蛋白(mg/L) 治疗前 治疗后 差值 观察组 50 32.55(22.08，41.23) 6.15(4.63，8.90)a -21.15(-31.15, -17.50) 对照组 50 32.95(25.15，39.25) 21.55(17.80，26.03)a -10.25(-16.85, -4.00) Z值 -0.452 -8.459 -5.254 P值 0.652 < 0.001 < 0.001 组别 例数 β2微球蛋白(mg/L) 治疗前 治疗后 差值 观察组 50 0.24(0.21，0.30) 0.11(0.10，0.18)a -0.11(-0.20, -0.08) 对照组 50 0.27(0.21，0.33) 0.15(0.10，0.21) -0.10(-0.21, -0.04) Z值 -0.673 -3.031 -1.118 P值 0.501 0.002 0.262 注：与同组治疗前比较，aP＜0.05。
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