清开灵冻干粉针剂药物过敏试验及临床意义

清开灵冻干粉针剂是清开灵水针注射剂改变剂型而来,临床应用中发现有过敏反应.为保证临床用药的安全性,减少不良反应,在清开灵冻干粉针剂I、Ⅱ期临床试验中对受试者采用了皮内过敏试验法,Ⅱ期临床对照组用清开灵注射液(水针).结果显示Ⅰ期临床试验健康受试者38例中,出现皮试阳性2例,皮试阳性率为5.26%.Ⅱ期临床试验中,粉针组132例,皮试阳性4例,皮试阳性率3.03%.水针组132例,皮试阳性10例,皮试阳性率7.58%.两者比较P=0.08.皮试阴性者参加临床试验,但两组仍有1例发生过敏反应,发生率为0.43%.表明过敏试验对减少中药注射剂过敏反应可能有一定的临床意义.

Drug sensitivity test and clinical meaning of Qingkailing freeze-drying powder injection

"Qing Kai ling" powder injection is the changed dosage form of "Qing Kai ling"injection.They have been found allergic reactions in previous clinical trial.To assure the safety of drug usage and reduce adverse reactions,we used skin-test in phase I and phase II clinical trial. The treatment group of 132 cases was treated with "Qing Kai ling" powder injection and the control group of 132 cases was treated with "Qing Kai ling " injection in phase II clinical trial. Results In treatment group, the positive rate of skin-test was 3.03%. In control group ,the positive rate of skin-test was 7.58%. There was no significant differences between 2 groups (P=0.08),All the subjects with negative skin-test can take part in the clinical trial.One trial subject still happened allergic reactions.The rate of allergic reactions was 0.43%. Conclusion Skin-test can reduce the allergic reactions of TCM injection.