Objective To examine improvement effect of a compound soft capsule (mainly composed of Colla corii asini, ferrous lactate and Zaocys dhumnades) on iron deficiency anemia (IDA) in community patients and to provide references for the clinical application of the compound soft capsule.
Methods From September to October 2017, we recruited a group of 18 to 65 years old people with self-reported anemia in a region of Hunan province; then 350 people in the group were randomly selected for laboratory tests of IDA diagnosis; finally based on personal hemoglobin (Hb) content, 102 people confirmed with IDA were randomly assigned into two groups (51 in each group) : an experiment group with oral medication of the compound soft capsules (3 capsules once, 3 times per day continuously for 30 days) and a control group with the placebo capsules. Contents of Hb, free portoporphyrin in erythrocytes and serum ferritin of all the participants were detected and compared between the two groups before and after the medication of compound soft capsule and placebo.
Results There were no statistically significant differences in body weight, blood pressure, heart rate and biochemical indexes between the two groups before and after the trial ( P > 0.05 for all) and all the indicators were within the normal range. No adverse effect of the compound soft capsules on health was observed among all the participants and there were no significant differences in dietary energy, protein and iron intake between the two groups before and after the trail (all P > 0.05). Compared to those of before the administration of the compound soft capsule, the participants of experiment group had significantly higher Hb (121.96 ± 10.60 g/L vs. 104.40 ± 10.25 g/L) and serum ferritin (25.06 ± 7.71 ng/mL vs. 21.72 ± 4.03 ng/mL) after the treatment (both P < 0.05) and the Hb and serum ferritin of the participants of experiment group were also significantly higher than those of the control participants (104.96 ± 12.01 g/L and 21.73 ± 8.24 ng/mL) at the end of the trail (both P < 0.05). There was no significant difference in erythrocyte free portoporphyrin concentration between the two groups before and after the trial ( P > 0.05).
Conclusion The compound soft capsule has an obvious improvement effect on IDA but no adverse health impact in the trial among community IDA patients.
【摘 要】 目的 了解某复方软胶囊（以阿胶、乳酸亚铁及乌梢蛇为主要原料）对缺铁性贫血（IDA）的改善效果，为该复方软胶囊的推广应用提供参考依据。 方法 于 2017 年 9 — 10 月在湖南省某地招募自诉有贫血史的 18～65 岁人群，从中随机抽取 350 人筛查血红蛋白含量，将其中 102 例 IDA 患者按血红蛋白含量随机分为试食组和对照组，每组各 51 例。试食组每日服用复方软胶囊，对照组服用安慰剂，均连续服用 30 d，比较 2 组患者试食前后血红蛋白含量、红细胞内游离原卟啉浓度和血清铁蛋白含量，以评价该复方软胶囊对 IDA 的改善效果。 结果 试食前后 2 组 IDA 患者的体重、血压、心率及各项生化指标差异均无统计学意义（均 P > 0.05），且均在正常范围内，该复方软胶囊对人体健康无损害作用。试食组和对照组患者膳食能量、蛋白质和铁的摄入试食前后差异均无统计学意义（均 P >0.05）。试食后试食组患者血红蛋白含量[（121.96 ± 10.60）g/L]较试食前的[（104.40 ± 10.25）g/L]有所增加，较试食后对照组患者的[（104.96 ± 12.01）g/L]亦有所增加（均 P < 0.05）；试食后试食组患者血清铁蛋白含量[（25.06 ± 7.71）ng/mL] 较试食前的[（21.72 ± 4.03）ng/mL]有所增加，较试食后对照组患者的[（21.73 ± 8.24）ng/mL]亦有所增加（均 P < 0.05）；2 组患者红细胞内游离原卟啉浓度在试食前后差异均无统计学意义（均 P > 0.05）。 结论 该复方软胶囊对 IDA 有明显改善作用，对健康无明显危害。