新生儿退黄合剂的剂型改良及临床疗效

Improvement of Dosage Form for Xinshenger Tuihuang Mixture and Clinical Observation on Neonatal Jaundice

目的:对新生儿退黄合剂进行剂型改良,改变给药途径,探讨其对新生儿黄疸的临床治疗效果。方法:采用水提醇沉法制备新生儿退黄合剂、新生儿退黄洗剂和灌肠液。将符合纳入标准的病例采用随机分组平行对照法,分为观察组A,B和对照组,各60例。对照组给予苯巴比妥钠口服;观察组A给予新生儿退黄合剂口服;观察组B退黄液灌肠同时给予退黄洗剂药浴。比较3组治疗有效率,检测血清胆红素,评价其退黄效果。结果:灌肠联合药浴组与对照组比治疗有效率提高,血清胆红素值下降,差异有统计学意义(P<0.01);与口服退黄合剂组相比总有效率提高(P<0.05)。结论:中药灌肠联合药浴治疗新生儿黄疸有效率高,同时克服了新生儿口服药物的不便,值得临床推广应用。

Objective：To improve the dosage form of Xinshenger Tuihuang mixture（XTM） and to change the administration route,and to observe its curative effect on neonatal jaundice.Method：Water extraction and alcohol precipitation preparation for improving XTM were used,lotion and enteroclyster were prepared.Patients conforming to inclusion criteria were randomly divided into observation group A,B and control group（n = 60 each）.Control group was given oral dose of phenobarbital sodium 8 mg.kg-1,tid.for 4 d;observation group A was given oral dose of XTM 10 mL,tid.for 4 d;and observation group B was given Chinese materia medica as enteroclysm combined with medicated bath bid.for 4 d.Then we detected serum bilirubin（SB） level,compared the effects of jaundice-abating between three groups.Result： Compared with control group,Observation group B was statistical significance（P 0.01）.Compared with observation group A,the total effective rate in observation group B was raised（P 0.05）.Conclusion：Chinese materia medica as enteroclysm combined with medicated bath is effective in the treatment of neonatal jaundice.Compared with oral administration it is convenient and deserved to spread in clinic.