Clinical study on the effectiveness of Dachaixian decoction in treating acute pancreatitis due to excess heat in the Fu organs based on the real world
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摘要: 目的 通过真实世界的临床研究，观察西医协同大柴陷汤治疗急性胰腺炎(腑实热结型)患者的有效性及安全性。 方法 选取40例符合筛选标准的急性胰腺炎患者为研究对象，分为两组，每组均20例。对照组给予西医常规治疗，观察组给予西医常规治疗协同大柴陷汤治疗，疗程均为7 d。比较两组患者治疗前后的血清WBC、C反应蛋白(C-reactive protein，CRP)、IL-6、血淀粉酶(blood amylase，AMS)及血脂肪酶(blood lipase，LPS)水平，两组患者的临床症状缓解时间、中医证候积分、改良Marshall评分、急性生理及慢性健康Ⅱ评分(acute physiology and chronic health evaluation-Ⅱ，APACHE-Ⅱ)。 结果 观察组的总有效率为94.74%，高于对照组的89.47%(P＞0.05)；两组患者的血清WBC、CRP、IL-6、AMS、LPS水平均比治疗前明显下降，且观察组比对照组下降更显著(P < 0.05)；治疗后两组患者的中医证候积分、改良Marshall评分、APACHE-Ⅱ评分均比治疗前下降，且观察组的下降趋势均优于对照组(P < 0.05)。 结论 西医常规治疗联合大柴陷汤能有效缓解急性胰腺炎患者的临床症状、体征，减轻炎症反应，改善胰腺功能，缩短病程，安全可行，效果优于单纯西医治疗，值得临床推广。Abstract: Objective To evaluate the efficacy and safety of combination therapy using Western medicine and Dachaixian decoction in patients with acute pancreatitis(excess heat in the Fu organs) through real-world clinical research. Methods Forty patients with acute pancreatitis who met the screening criteria were divided into two groups, 20 cases per group. The control group was treated with conventional Western medicine, while the observation group was treated with a combination of conventional Western medicine Dachaixian decoction. The treatment was for seven days. The levels of serum white blood cell count(WBC), C-reactive protein(CRP), IL-6, blood amylase(AMS) and blood lipase(LPS) indicators between the two groups were compared before and after treatment. The remission time of clinical symptoms, traditional Chinese medicine(TCM) syndrome scores, modified Marshall scores, acute physiology and chronic health evaluation-Ⅱscores(APACHE-Ⅱ) of the two groups were compared. Results The total effective rate was 94.74% in the observation group and 89.47% in the control group(P > 0.05). The serum WBC, CRP, IL-6, AMS, and LPS in the observation group were significantly lower than those before treatment, and the reduction during the treatment period was more significant than that in the control group(P < 0.05). After treatment, the TCM syndrome scores, modified Marshall scores, and APACHE-Ⅱ scores of the two groups were all lower than before treatment, and the downward trend of the observation group was better than that of the control group(P < 0.05). Conclusion Conventional Western medicine treatment combined with Dachaixian decoction can effectively relieve the clinical signs and symptoms of patients with acute pancreatitis, reduce inflammatory reaction, improve pancreatic function, and shorten the course of the disease. The combined therapy is safe and feasible, which is better than Western medicine treatment alone, and should be widely used in clinical research.
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Key words:
- acute pancreatitis /
- Dachaixian decoction /
- real world /
- clinical research
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表 1 两组患者的血清WBC、CRP、IL-6水平比较
X±S 组别 WBC/(×109/L) CRP/(mg/L) IL-6/(pg/mL) 治疗前 治疗7 d后 治疗前 治疗7 d后 治疗前 治疗7 d后 观察组(n=19) 16.41±2.56 8.37±1.841)2) 89.59±5.61 11.74±3.421)2) 65.46±6.89 4.73±3.511)2) 对照组(n=19) 15.89±4.66 10.76±2.351) 91.25±6.33 15.86±7.491) 63.21±7.19 6.92±2.651) 与治疗前比较，1)P < 0.05；与对照组比较，2)P < 0.05。 
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表 2 两组患者的血清AMS、LPS水平比较
U/L，X±S 组别 AMS LPS 治疗前 治疗3 d后 治疗7 d后 治疗前 治疗3 d后 治疗7 d后 观察组(n=19) 328.86±76.27 121.44±25.871)2) 36.38±11.471)2) 159.62±17.28 53.46±9.211)2) 30.75±6.381)2) 对照组(n=19) 335.42±68.59 143.69±30.021) 72.38±15.661) 162.85±15.47 92.15±8.531) 63.44±5.861) 与治疗前比较，1)P < 0.05；与对照组比较，2)P < 0.05。
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表 3 两组患者的改良Marshall评分、APACHE-Ⅱ评分比较
分，X±S 组别 改良Marshall评分 APACHE-Ⅱ评分 治疗前 治疗3 d后 治疗7 d后 治疗前 治疗3 d后 治疗7 d后 观察组(n=19) 1.47±1.07 0.36±0.501)2) 0.16±0.371)2) 12.81±7.26 4.11±2.721)2) 1.29±0.921)2) 对照组(n=19) 1.42±1.22 0.94±0.841) 0.63±0.681) 13.41±6.94 7.36±3.291) 3.85±1.461) 与治疗前比较，1)P < 0.05；与对照组比较，2)P < 0.05。
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表 4 两组患者的腹痛、腹胀缓解时间及肠鸣音、排便恢复时间比较
d，X±S 组别 例数 腹痛缓解时间 腹胀缓解时间 肠鸣音恢复时间 排便恢复时间 观察组 19 3.35±0.461) 2.93±0.711) 2.15±0.62 2.13±0.451) 对照组 19 4.96±0.88 5.78±0.52 2.09±0.97 4.87±0.39 与对照组比较，1)P < 0.05。
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表 5 两组患者的中医证候积分比较
分，X±S 组别 例数 治疗前 治疗3 d后 治疗7 d后 观察组 19 20.46±2.76 5.36±1.641)2) 2.75±0.821)2) 对照组 19 19.87±3.23 10.54±1.761) 6.42±0.711) 与治疗前比较，1)P < 0.05；与对照组比较，2)P < 0.05。
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