Study On The Dose - Effect Relationship And Safety Of Insect - Type Medicine In The Treatment Of Idiopathic Pulmonary Interstitial Fibrosis

Objective:1 To observe the clinical efficacy of Idiopathic Pulmonary Interstitial Fibrosis (IP F) treated by insect drugs prescription.2 To explore the dose effect relationship of different doses of insect drugs prescri ption, which is composed of leech, earthworm, centipede. To evaluate the effectiveness and safety of the optimal dose prescription, so as to provide basis for clinical applic ation.Method:This research design used randomized controlled clinical trial, included in the pati ents with idiopathic pulmonary fibrosis in 88 cases, divided into the experimental grou p and control group. The prescription treatment of the experimental group was treated with small, large dose of leech, earthworm, centipede, which dose mainly referring to the latest China Pharmacopoeia, combined with Basic part;the control group treated w ith Basic part. The control group had 30 cases in each group, small dose group and high dose group had 29 cases in each group. The treatment period was 3 months. To observe and compare the clinical comprehensive therapeutic effect, integral evaluation in the following aspects, including the main symptoms, physical signs, secondary sym ptoms, lung function, HRCT, breathing difficulties. To explore the dose effect relations hip of different doses of insect drugs prescription in the treatment of the IPF. The tes t group and the control group were performed for safety assessment before and after t he experiment, including blood, urine, stool routine, liver, kidney function and ECG e xamination. SPSS 19.0 statistical software was used for data processing.Results:1 In the comprehensive evaluation of therapeutic efficiency, small dose group, ma rkedly effective in 0 cases (0%), effective 13 cases (44.8%), invalid 16 cases (55.2%), the total efficiency is 44.8%; the high dose group,1 case was cured (3.45%), effecti ve 21 cases (72.41%), invalid 7 cases (24.14%), the total efficiency of 75.86%; contro 1 group, markedly effective in 0 cases (0%), effective 13 cases (43.33%), invalid 17 c ases (56.67%), the total efficiency of 43.33%. There was statistically significant differe nces in the effect of the three groups by chi square test (P< 0.05). Through the com parison between groups, showed high dose group was superior to low dose group and the control group (P< 0.05); but no significant differences between the small dose g roup and control group (P> 0.05).2 Improvement in the main symptoms:high dose group was better than low dose group and control group in terms of shortness of breath and in asthmatic aspects (P < 0.05); high dose group, low dose group was better than the control group in terms of cough symptoms (P< 0.05).However, there is no statistical significance between the three groups in the improvement in sputum (P> 0.05).3 Improvement in the secondary symptoms:the three groups were decreased in m inor symptoms, and the difference between the three groups was statistically significant after treatment than before treatment(P< 0.05). The difference between the three gro ups was statistically significant by chi square test,(P< 0.05). Through the comparison between groups the difference between the three groups was not statistically significant (P> 0.05).4 Improvement in dyspnea:small dose group, high dose group were decreased co mpared with that before treatment in dyspnea scores, the difference has statistical diffe rence (P< 0.05). The difference between the three groups was statistically significant by chi square test (P< 0.05), the high dose group and small dose group has better c urative effect than the control group.5 In lung function improvement:the effective rates of three groups had no statisti cal difference by chi square test (P> 0.05). In TLC, VC, the three groups had varyin g degrees of decline; but in the high dose group,the increase in the DLCO value, the difference of large dose had statistical significance before and after treatment(P< 0.0 5); small dose group had no statistical significance before and after treatment (P> 0.0 5); and control group were decreased compared with that before treatment, the differen ce has statistical difference (P< 0.05).6 Improvement in signs and pulmonary CT:The difference between the three gro ups had no statistical significance by the chi square test (P> 0.05).7 In the security indicators, the three groups had no abnormal laboratory changes associated with therapy. The difference between the three groups was not statistically significant in the adverse reactions by chi square test (P> 0.05).Conclusion:The insect drugs prescription is effective and safe in the treatment of IPF to imp rove the patients clinical symptoms in the short term. The effect of high dose group may be the best dosage in clinic, and can improve the lung function of DLCO, but th e specific relationship needs to be further studied.