甘露聚糖肽口服液联合人免疫球蛋白治疗特发性血小板减少性紫癜的临床研究

Clinical study on Mannatide Oral Solution combined with human immunoglobulin in treatment of idiopathic thrombocytopenic purpura

目的探讨甘露聚糖肽口服液联合人免疫球蛋白治疗特发性血小板减少性紫癜的临床疗效。方法选取2014年8月—2015年8月在上海市浦东医院接受治疗的特发性血小板减少性紫癜患者74例,随机分为对照组和治疗组,每组各37例。对照组iv静注人免疫球蛋白(pH4),0.4 g/kg,1次/d。治疗组在对照基础上口服甘露聚糖肽口服液,1支/次,3次/d。两组患者均治疗4周。观察两组的临床疗效,比较治疗前后两组T淋巴细胞亚群、血小板相关抗体、血小板计数(PLT)、白细胞介素-4(IL-4)、止血时间和血小板数量达正常时间的情况。结果治疗后,对照组和治疗组的总有效率分别为78.38%、94.59%,两组比较差异有统计学意义(P<0.05)。治疗后,两组患者CD^(3+)和CD^(4+)的水平及CD^(4+)/CD^(8+)的比值均显著升高,而CD^(8+)的水平显著下降,同组治疗前后差异有统计学意义(P<0.05);且治疗组这些观察指标的改善程度优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者血小板相关免疫球蛋白G(PA IgG)、血小板相关免疫球蛋白A(PA IgA)和血小板相关免疫球蛋白M(PA IgM)的水平均明显降低,同组治疗前后差异有统计学意义(P<0.05);且治疗组这些观察指标的改善程度优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者PLT及IL-4水平均明显升高,同组治疗前后差异有统计学意义(P<0.05);且治疗组这些观察指标的改善程度优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组止血时间和血小板数量达正常时间均早于对照组,两组比较差异均具有统计学意义(P<0.05)。结论甘露聚糖肽口服液联合人免疫球蛋白治疗特发性血小板减少性紫癜具有较好的临床疗效,可提高患者机体免疫功能,加快止血,具有一定的临床推广应用价值。

Objective To investigate the clinical effect of Mannatide Oral Solution combined with human immunoglobulin in treatment of idiopathic thrombocytopenic purpura. Methods Patients（74 cases） with idiopathic thrombocytopenic purpura in Shanghai Pudong Hospital from August 2014 to August 2015 were randomly divided into the control and treatment groups, and each group had 37 cases. Patients in the control group were iv administered with Human Immunoglobulin（pH 4） for intravenous injection, 0.4 g/kg, once daily. Patients in the treatment group po administered with Mannatide Oral Solution on the basis of the control group, 1 tube/time, three times daily. Patients in two groups were treated for 4 week. After treatment, the efficacies were evaluated, and T lymphocyte subsets, platelet-associated antibody, PLT, IL-4, hemostatic time, and platelet count up to normal time in two groups were compared. Results After treatment, the efficacies in the control and treatment groups were 78.38% and 94.59%, respectively, and there was difference between two groups（P〈 0.05）. After treatment, the levels of CD^（3＋） and CD^（4＋）, and CD^（4＋）/CD^（8＋） ratio in two groups were significantly increased, but level of CD^（8＋） in two groups observably decreased, and the differences were statistically significant in the same group（P〈 0.05）. And the observational indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups（P〈 0.05）. After treatment, the levels of PA IgG, PA IgA, and PA IgM in in two groups observably decreased, and the differences were statistically significant in the same group（P〈 0.05）. And the observational indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups（P〈 0.05）. After treatment, the levels of PLT and IL-4 in two groups were significantly increased, and the differences were statistically significant in the same group（P〈 0.05）. And the observational indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups（P〈 0.05）. After treatment, hemostatic time, and platelet count up to normal time in the treatment group were shorten than those in the control group, and there were differences between two groups（P〈 0.05）. Conclusion Mannatide Oral Solution combined with human immunoglobulin has clinical curative effect in treatment of idiopathic thrombocytopenic purpura, and can improve the immune capacity of patients, accelerate hemostasis, which has a certain clinical application value.