复方阿胶浆对气血两虚型精神病患者氯氮平治疗后不良反应的影响

Study on compound donkey-hide gelatin syrup in reducing adverse reactions of Qi-blood deficiency patients caused by clozapine

目的探讨复方阿胶浆对气血两虚型精神病患者氯氮平治疗后不良反应的疗效观察。方法收集2010年1月至2011年6月云南省精神病医院住院患者132例，按随机数字表法将患者随机分为两组，治疗组68例、对照组64例，采用单盲对照研究。两组均口服氯氮平治疗，在此基础上治疗组加服复方阿胶浆：对照组加服中药安慰糖浆制剂。治疗8周后，采用阳性和阴性症状量表评分表（PANSS）、不良反应量表（TESS）、体格检查及实验检查评价患者临床疗效及安全性。结果①临床疗效比较：治疗后，治疗组总有效率为73．53％（50／68），对照组为65．63％（42／64），两组总有效率比较，差异有统计学意义（x^2=2．543，P〈0．05）。⑦治疗前后PANSS总分变化比较：两组治疗后2、4、6、8周PANSS总分[治疗组分别为（72．51±27．55）分、（60．54±24．03）分、（53．12±15．27）分、（48．15±11．88）分，对照组分别为（70．71±23．90）分、（58．89±18．95）分、（53．06±14．38）分、（48．98±9．78）分]与同组治疗前[治疗组为（103．99±39．12）分，对照组为（99．78±34．35）分]比较，差异均有统计学意义（P均〈0．05），但两组治疗后比较，差异无统计学意义（F=2．413，P〉0．05）。③不良反应：治疗期间，治疗组不良反应发生率明显低于对照组（x^2=4．562，P〈0．05）。结论复方阿胶浆可缓解气血两虚型精神病患者氯氮平治疗后的不良反应，提高患者的药物耐受性。

Objective To investigate the compound donkey-hide gelatin syrup in reducing adverse reactions of qi-blood weakness patients caused by clozapine. Methods 132 patients from Psychiatric Hospital of Yunnan Province between January 2010 and June 2010 were randomly divided into a treatment group and a control group. Both groups were taken clozapine orally. On this basis, the treatment group was taken compound donkey-hide gelatin syrup and the control group was taken placebo syrup. After 8 weeks treatment for both groups, the PANSS, TESS, physical examination and experiment examination were observed to evaluate the clinical efficacy and safety. Results （1） the total curative effect： the treatment group was 73.53%, the control group was 65.63%, showing statistical difference （x2=2.543, P〈0.05）. （2） PANSS scores changes before and after the treatment： PANSS score at 2, 4, 6, 8 weeks after the treatment of both groups were [ （72.51 ±27.55）, （60.54±24.03）, （53.12± 15.27）, （48.15±11.88） in treatment group respectively, and （70.71 ±23.90）, （58.89±18.95）, （53.06±14.38）, （48.98±9.78） in the control group, respectively], both showing significant difference than the same group before the treatment [（103.99±39.12） in the treatment group, （99.78±34.35） in the control group] （P〈0.05）. But there was no statistical significance between two groups （F=2.413, P〉0.05）. （3） adverse reactions： during the treatment liver function, blood cell analysis, dystonia, Parkinson＇s obstacle, akathisia, abnormal gastrointestinal reaction, heart rate, heart rate variability and blood pressure in the treatment group was significantly lower than the control group （x2=4.562, P〈0.05）. Conclusion Compound donkey-hide gelatin syrup can effectively relieve adverse reactions in qi-blood weak psychosis patients after clozapine treatment and improve their drug tolerance.